Specialised Commissioning Drugs Briefing: Spring 2019 · 2019-04-26 · 2 Specialised Services Circulars The following circulars, with corresponding letters sent to Trusts, have been

Contents

Specialised Services Circulars ................................................................................... 2

Specialised Commissioning Clinical Commissioning Policies .................................. 10

Individual Funding Requests .................................................................................... 10

Medicines Optimisation CRG ................................................................................... 11

MO CQUIN update ................................................................................................... 12

Trigger 1: Improving efficiency in the IV chemotherapy pathway from pharmacy to patient ................................................................................................................... 12

Trigger 2: Managed access agreement compliance ............................................. 12

Trigger 3: Supporting uptake of national treatment criteria and algorithms, including appropriate use of prior approval system (Blueteq) ............................... 13

Trigger 4: Faster adoption of prioritised best value medicines and treatments ..... 14

Trigger 5: Anti-Fungal Stewardship ...................................................................... 14

Blueteq ..................................................................................................................... 15

CAR-T Therapy ........................................................................................................ 25

Cancer Drugs Fund .................................................................................................. 26

Dose Banding of Chemotherapy .............................................................................. 26

Immunoglobulin update ............................................................................................ 26

Truvada® and Atripla® ............................................................................................. 27

Biosimilars ................................................................................................................ 27

Adalimumab .......................................................................................................... 27

Hepatitis C update .................................................................................................... 28

Programme of Care Pharmacy Leads ...................................................................... 29

Contacts ................................................................................................................... 29

Specialised Commissioning Drugs Briefing: Spring 2019

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Specialised Services Circulars

The following circulars, with corresponding letters sent to Trusts, have been published on SharePoint (an internal NHS England website) since October 2017 (please note the list does not include circulars relating to cancer drug funding within the interim CDF):

1875: NICE Technology Appraisal 509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer

NHS England to routinely commission pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer from 5th June 2018

1876: NHS England Interim Clinical Commissioning Policy (D12X02): Adalimumab for Children with Severe Refractory Uveitis Policy – Policy Withdrawal

To advise that the NHS England policy had been withdrawn following publication of NICE TA460 and advising that access would continue under the NHS England Medicines for Children Policy

1878: National Framework Agreement for Human Immunoglobulins

To advise on the latest CMU framework for intravenous and subcutaneous human immunoglobulin products

1880: Cancer Drugs Fund – Drug MDS update and timetable for 2018/19

To advise on the minimum data set required for drugs used within the CDF

1881: Addition of Glycerol Phenylbutyrate (Ravicti) to the list of drugs commissioned by NHS England

Advises that Ravicti® a newly licensed presentation of glycerol phenylbutyrate will be funded by NHS England

1882: Early Access to Medicines Scheme – idebenone as a treatment for slowing the decline of respiratory function in patients with Duchenne Muscular Dystrophy (DMD) from the age of 10 years who are currently not taking glucocorticoids

Access to idebenone as a treatment for slowing the decline of respiratory function in patients with Duchenne Muscular Dystrophy (DMD) from the age of 10 years who are currently not taking glucocorticoids has been opened through the Early Access to Medicines Scheme from June 2018. Access will continue until the product receives its Marketing Authorisation. For information regarding access please contact the Santhera EAMS team at [email protected]

1884: NICE Technology Appraisal 516: Cabozantinib for treating medullary thyroid cancer

NHS England to routinely commission cabozantinib for treating medullary thyroid cancer from 26th June 2018

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1885: NICE Technology Appraisal 513: Obinutuzumab for untreated advanced follicular lymphoma

NHS England to routinely commission obinutuzumab for untreated advanced follicular lymphoma from 19th June 2018

1886: NICE Technology Appraisal 512: Tivozanib for treating advanced renal cell carcinoma

NHS England to routinely commission tivozanib for treating advanced renal cell carcinoma from 19th June 2018

1892: NHS England Clinical Commissioning Policy: Emicizumab as prophylaxis in people with congenital haemophilia A with factor VIII inhibitors (all ages) NHS England Reference: 170067/P

NHS England will routinely fund emicizumab as prophylaxis in people with congenital haemophilia A with factor VIII inhibitors

1893: Publication of New Clinical Policies and Service Specifications Following Prioritisation

Provides an update of all products considered at the May 2018 relative prioritisation meeting

1894: Technology Appraisal 518: Tocilizumab for treating giant cell arteritis

NHS England to routinely commission tocilizumab for treating giant cell arteritis from 10th July 2018

1895: NHS Framework Agreements for the Supply of Icatibant and C1-Esterase Inhibitor (CM/PHS/15/5500) and products for the treatment of bleeding disorders (CM/PHS/15/5499)

To advise on the latest CMU framework for icatibant and C1-esterase inhibitors

1897: Use of atezolizumab or pembrolizumab as 1st line treatment of locally advanced/metastatic urothelial cancer in patients ineligible for cisplatin-based chemotherapy

Clarifies the funding position of the two drugs in urothelial cancer

1898: NICE Technology Appraisal 525: Atezolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy

NHS England to routinely commission atezolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy from 13th July 2018

1899: NICE Technology Appraisal 517: Avelumab for treating metastatic Merkel cell carcinoma

NHS England to routinely commission avelumab for treating metastatic Merkel cell carcinoma from 10th July 2018

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1903: Commissioning through Evaluation scheme: Rituximab for Standard Treatment Resistant Idiopathic Membranous Nephropathy in Adults

NHS England will fund a commissioning through evaluation study for rituximab for IMN. The study is planned to commence in August 2018 for a 20 month period.

1904: Early Access to Medicines Scheme – Patisiran-LNP for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis)

Access to patisiran-LNP for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) has been opened through the Early Access to Medicines Scheme from August 2018. The scheme has now closed as the product has received its Marketing Authorisation.

1906: Normal Human Immunoglobulin availability and supply

Provides a further update on the availability of immunoglobulins.

1909: NHS England Urgent Clinical Commissioning Policy Statement: Alemtuzumab for treating relapsing-remitting multiple sclerosis – third cycle [All ages]

NHS England to fund a third cycle of alemtuzumab for RRMS. A second Blueteq form must be completed to access funding

1911: NICE Technology Appraisal 520: Atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy

NHS England to routinely commission atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy from 14th August 2018

1912: Technology Appraisal 533: Ocrelizumab for treating relapsing–remitting multiple sclerosis

NHS England to routinely commission ocrelizumab for treating relapsing–remitting multiple sclerosis from 23rd October 2018

1914: NHS England Clinical Commissioning Policy Anakinra to treat periodic fevers and auto-inflammatory diseases (all ages) NHS England Reference: 170062P

NHS England policy to fund anakinra in various rare diseases

1915: Publication of new clinical commissioning policy (1621) for levofloxacin nebuliser solution for chronic pseudomonas lung infection in cystic fibrosis (all ages)

NHS England will routinely fund levofloxacin nebuliser solution for CF lung infections as a 3rd line option (this policy displaced the ‘not routinely’ commissioned policy)

1916: NHS England Clinical Commissioning Policy: Bortezomib for Relapsed/ Refractory Waldenstrom’s Macroglobulinaemia

NHS England will not routinely commission bortezomib for Relapsed/ Refractory Waldenstrom’s Macroglobulinaemia

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1917: NICE Technology Appraisal 536: Alectinib for untreated ALK-positive advanced non-small-cell lung cancer

NHS England to routinely commission Alectinib for untreated ALK-positive advanced non-small-cell lung cancer from 7th September 2018

1918: UPDATE - Individual Funding Requests relating to treatments commissioned by NHS England Specialised Services: Continuation of funding for chemotherapy following a break in treatment

Provides guidance on what constitutes a treatment break and whether an IFR is required

1919: Treatment Algorithm – Disease Modifying Therapies in Multiple Sclerosis [All ages]

NHS England has published a DMT algorithm for MS which includes guidance on when to switch and definitions of MS which can be found

1921: NICE Technology Appraisal 523: Midostaurin for untreated acute myeloid leukaemia

NHS England to routinely commission midostaurin for untreated acute myeloid leukaemia from 11th September 2018

1922: NICE Technology Appraisal 524: Brentuximab vedotin for treating CD30-positive Hodgkin lymphoma

NHS England to routinely commission brentuximab vedotin for treating CD30-positive Hodgkin lymphoma from 11th September 2018

1923: Review of the evidence for the use of ibrutinib in previously treated patients with chronic lymphocytic leukaemia (CLL)

Confirms that NHS England will fund ibrutinib according to NICE criteria when patients have been in remission for greater than three years after last treatment

1925: NICE Technology Appraisal 526: Arsenic trioxide for treating acute promyelocytic leukaemia

NHS England to routinely commission arsenic trioxide for treating mild to moderately active acute promyelocytic leukaemia from 11th September 2018

1930: Improving patient information and the consenting process for capecitabine treatment

This outlines the requirements for testing patients prior to commencement of capecitabine treatment

1931: National strategy for the procurement of HIV medicine, tenofovir and emtricitabine (Truvada®)

Provides information on the planned CMU tender

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1936: MHRA Alert: Radium-223 Dichloride: new restrictions on use due to increased risk of fracture and trend for increased mortality seen in a clinical trial

Advises on the new restrictions due to a change in the Marketing Authorisation

1937: Commissioning of Palivizumab (To Reduce the Risk of RSV in High Risk Infants) for the 2018 Vaccination Season

Advises on when palivizumab will be funded for RSV

1938: NHS England Clinical commissioning policy statement: Rituximab bio-similar for the treatment of Myasthenia Gravis [Adults]

NHS England to fund rituximab for the treatment of Myasthenia Gravis

1939: NICE Technology Appraisal 531: Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer

NHS England to routinely commission pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer from 16th October 2018

1940: NICE Highly Specialised Technology Appraisal 8: Burosumab for treating X-linked hypophosphataemia in children and young people

NHS England to routinely commission burosumab for treating X-linked hypophosphataemia in children and young people from 8th January 2019

1945: NICE Technology Appraisal 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine

NHS England to routinely commission lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine from 8th November 2018

1948: NICE Technology Appraisal 538: Dinutuximab beta for treating neuroblastoma

NHS England to routinely commission dinutuximab beta for treating neuroblastoma from 20th November 2018

1952: NHS England Clinical Commissioning Policy: Clofarabine for relapsed or refractory acute myeloid leukaemia (AML) as a bridge to transplant (all ages)

NHS England will not commission clofarabine for relapsed or refractory acute myeloid leukaemia (AML) as a bridge to transplant

1955: NICE Technology Appraisal 550: Vandetanib for treating medullary thyroid cancer

NHS England to routinely commission vandetanib for treating medullary thyroid cancer from 12th March 2018

1957: NHS England Clinical Commissioning Urgent Policy Statement Convection enhanced delivery for diffuse intrinsic glioma (children)

NHS England will not commission convection enhanced delivery for diffuse intrinsic glioma

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1958: NHS England Clinical Commissioning Policy: Infliximab for Progressive Pulmonary Sarcoidosis in Adults

NHS England will not commission infliximab for Progressive Pulmonary Sarcoidosis

1959: NHS England Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)

NHS England will not commission gemcitabine and capecitabine following surgery for pancreatic cancer

1960: Early Access to Medicines Scheme – Atezolizumab, in combination with bevacizumab, paclitaxel and carboplatin, for the treatment of adult patients with EGFR activating mutations or ALK positive tumour mutations metastatic non-squamous non-small cell lung cancer (NSCLC) after failure of appropriate targeted therapies

Access to Atezolizumab, in combination with bevacizumab, paclitaxel and carboplatin, for the treatment of adult patients with EGFR activating mutations or ALK positive tumour mutations metastatic non-squamous non-small cell lung cancer (NSCLC) after failure of appropriate targeted therapies has been opened through the Early Access to Medicines Scheme from January 2019. The scheme has now closed as the product has received its Marketing Authorisation.

1961: Publication and implementation of new clinical commissioning policies and service specifications following November 2018 Prioritisation

Provides information regarding the policies and service specifications considered at the November prioritisation meeting

1966: Early Access to Medicines Scheme – Dupilumab in the treatment of adolescent patients ≥12 to <18 years of age with severe atopic dermatitis who have responded inadequately to at least one systemic therapy or where the available systemic therapies are not recommended or are not tolerated

Access to Dupilumab in the treatment of adolescent patients ≥12 to <18 years of age with severe atopic dermatitis who have responded inadequately to at least one systemic therapy or where the available systemic therapies are not recommended or are not tolerated has been opened through the Early Access to Medicines Scheme from January 2019. Access will continue until the product receives its Marketing Authorisation. For information regarding access email [email protected]

1969: NICE Technology Appraisal 542: Cabozantinib for untreated advanced renal cell carcinoma

NHS England to routinely commission cabozantinib for untreated advanced renal cell carcinoma from 1st January 2019

1970: NICE Technology Appraisal 539: Lutetium (177Lu) oxodotreotide for treating unresectable or metastatic neuroendocrine tumours

NHS England to routinely commission lutetium (177Lu) oxodotreotide for treating unresectable or metastatic neuroendocrine tumours from 27th November 2018

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1974: NICE Technology Appraisal 541: Inotuzumab ozogamicin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia

NHS England to routinely commission inotuzumab ozogamicin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia from 18th December 2018

1975: Use of Immunoglobulin Commissioning Criteria and Immunoglobulin Update

Updates on the status of access to immunoglobulins and use of the Immunoglobulin Panels

1980: NICE Technology Appraisal 545: Gemtuzumab ozogamicin for untreated acute myeloid leukaemia

NHS England to routinely commission gemtuzumab ozogamicin for untreated acute myeloid leukaemia from 12th February 2019

1981: National contract award for HIV drug, tenofovir and emtricitabine (Truvada®) and tenofovir + emtricitabine + efavirenz (Atripla®).

Advises on the results of the CMU tender and the national contract award

1983: NHS England Clinical Commissioning Policy: Selective internal radiation therapy (SIRT) for the treatment of chemotherapy refractory or intolerant, unresectable primary intrahepatic cholangiocarcinoma (all ages)

NHS England will not commission selective internal radiation therapy (SIRT) for the treatment of chemotherapy refractory or intolerant, unresectable primary intrahepatic cholangiocarcinoma

1988: Drug MDS completion and price validation (CDF and HCD)

Advises on the requirements for the minimum data set to be submitted for drugs funded within the CDF

1991: Early Access to Medicines Scheme – Atezolizumab in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease

Access to atezolizumab in combination with nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease has been opened through the Early Access to Medicines Scheme from March 2019. Access will continue until the product receives its Marketing Authorisation. For information regarding the scheme send an email to [email protected]

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1993: NICE Technology Appraisal 551: Lenvatinib for untreated advanced hepatocellular carcinoma

NHS England to routinely commission lenvatinib for untreated advanced hepatocellular carcinoma from 20th March 2019

1994: NICE Technology Appraisal 552: Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia

NHS England to routinely commission Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia from 20th March 2019

1995: Technology Appraisal 565: Benralizumab for treating severe eosinophilic asthma

NHS England to routinely commission benralizumab for treating severe eosinophilic asthma from 4th June 2019

1998: NHS England Clinical Commissioning Policy for Selective internal radiation therapy (SIRT) for chemotherapy refractory/intolerant metastatic colorectal cancer (Adults)

NHS England will routinely commission selective internal radiation therapy (SIRT) for chemotherapy refractory/intolerant metastatic colorectal cancer in adults

1999: Cancer CAR T wave two providers

Provides information relating to the next wave of tenders for CAR-T to provide treatments for ALL and DBLC

2001: Cancer NaMuscla® (Mexiletine) for the treatment of myotonia in patients with non-dystrophic myotonic disorders

Advises that NHS England will fund a new presentation of mexiletine for the treatment of myotonia in patients with non-dystrophic myotonic disorders from April 1 2019

2003: Cancer NICE Technology Appraisal 555: Regorafenib for previously treated advanced hepatocellular carcinoma

NHS England to routinely commission regorafenib for previously treated advanced hepatocellular carcinoma from 9th April 2019

2004: Blood and Infection National strategy for HIV drugs

Provides an update on the national tenders for HIV medicines and timelines for the introduction of generic products

2006: Technology Appraisal 312: Alemtuzumab for treating relapsing‑remitting multiple sclerosis – update to access criteria

Provides an update on interim access criteria for alemtuzumab for RRMS following an announcement by the EMA on reported side effects

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Specialised Commissioning Clinical Commissioning Policies

NHS England’s Clinical Priority Advisory Group met in May to consider 9 policies for routine commissioning. 7 of the policies relate to medicines. An announcement on which policies have been supported will be announced in the summer. A number of other policies will be considered for relative prioritisation at our May meeting.

The policy pipeline can be found here:

www.england.nhs.uk/publication/clinical-commissioning-policy-work-programme/

The Methods for Clinical Policies can be found here:

www.england.nhs.uk/publication/methods-national-clinical-policies/

In addition, information on policies relating to licensed medicines being considered through the NICE Commissioning Support Programme can be found at:

www.nice.org.uk/about/what-we-do/our-programmes/commissioning-support-programme/our-work

Further information on Specialised Commissioning and how our policies our prioritised can be found here:

https://www.england.nhs.uk/commissioning/spec-services/

Individual Funding Requests

We reported last year that NHS England’s specialised commissioning team have

visited 18 of our biggest providers of services to review IFR processes and provide

information on how to submit policy propositions. In addition, 3 webex meetings were

run over the summer to the 35 next largest providers. The challenge was to reduce

the number of ‘screened out’ IFR submissions either because the request related to

CCG commissioned services, the request was for a treatment already commissioned

or the request did not provide a sufficient level of evidence to suggest the patient

could benefit exceptionally to other patients. The drive was to also encourage Trusts

to submit a policy proposition rather than an IFR request.

Information from Trusts visited during 2017 show that IFR requests have dropped

and the number of requests screened out has also reduced.

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Statistical Process Control chart showing total IFRs received by NHS England for trusts which were visited in December 20171, July 2016 to December 2018

Statistical Process Control chart showing number of screened out IFRs received by NHS England for trusts which were visited in December 20171, July 2016 to December 2018

Information on IFRs including a film on what constitutes an IFR and how the process

works can be found here:

www.england.nhs.uk/commissioning/spec-services/key-docs/#serv-dev

Medicines Optimisation CRG

The Medicines Optimisation CRG recently relaunched following the retirement of the

Chair Liz Kay and the appointment of Charlotte Skitterall as the new Chair. The

MOCRG will be refocusing its programme on all high cost drugs rather than those

just relevant to specialised commissioning. The new work programme will be

published in the next newsletter.

Version 14 of the high cost drugs list has been published. It includes new TA/HSTs

and NHS England policy published in the last 12 months. Where the drug is not on

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the national list it has been added to the lower section.

www.england.nhs.uk/publication/nhs-england-drugs-list/

The web portal for individuals and organisations to use to nominate drugs to be added to or removed from the high cost list for the 2020 national tariff is now live on the NHS England website at https://www.engage.england.nhs.uk/survey/0fad6f51/ The closing date for responses is 31 May 2019.

The Multiple Sclerosis algorithm was launched in September 2018 with a further

update in February of this year. The algorithm can be found here:

https://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-d/d04/

To note the access criteria for alemtuzumab has recently been restricted by the

EMA. A letter has been sent to Trusts to advise on the interim access criteria while

the EMA review its status.

MO CQUIN update

The Medicines Optimisation (MO) CQUIN is a two year scheme and includes both qualitative and quantitative elements which are aligned with NHS Improvement targets.

A new set of CQUIN targets have been launched for 2019/2020. This includes the ongoing CQUIN for uptake of best value medicines as listed below:

• Trigger 1 - Improving efficiency in the IV chemotherapy pathway from pharmacy to patient.

• Trigger 2 - Managed access agreement compliance

• Trigger 3 - Supporting uptake of national treatment criteria and algorithms, including appropriate use of prior approval system (Blueteq)

• Trigger 4 - Faster adoption of prioritised best value medicines and treatment

• Trigger 5 - Anti-Fungal Stewardship

Trigger 1: Improving efficiency in the IV chemotherapy pathway from pharmacy to patient

Approx. £1.7billion is spent on systemic anticancer therapy (SACT) in England, with annual growth of around 8%. Approx. £1 billion is spent on IV chemotherapy. Case studies suggest levels of waste of around 2% of provider spend on IV SACT (approx. £34m).

Trigger 2: Managed access agreement compliance NHS England has three managed access agreements (MAAs) in place for Highly Specialised Technologies. These agreements allow for early access to treatments where clinical and cost effectiveness is yet to be determined by NICE.

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Experience to date shows that providers of highly specialised technologies are

struggling with capacity to evaluate. The information from the patient reviews and

data collection is required to ensure that NHSE receives the appropriate value from

the schemes and so the technologies can be assessed by NICE.

There are currently less than 100 patients accessing an MAA, however, there are a further ten HSTs in the pipeline. The scale of service to which the trigger is applicable is currently £30m per annum. Likely to increase as number of HSTs increases.

Trigger 3: Supporting uptake of national treatment criteria and algorithms, including appropriate use of prior approval system (Blueteq)

The online clinical decision support tool (Blueteq) was implemented in 2015/16 as NHS England’s standard electronic contractual prior approval system, covering a range of high cost drugs excluded from tariff. The rationale for the scheme is to ensure that treatment decisions are made in line with agreed commissioning policy or NICE TA and that clinical resource is being utilised in line with commissioning policy and evidence base. To support trigger 3 in supporting uptake of national treatment criteria Trusts will be required to demonstrate that prior approval forms are being completed for a number of high cost drugs, this will be communicated ahead of each quarter. Quarter 1 includes Bortezomib and Daratumumab. To assess compliance, Trusts will be required to undertake an internal audit on a sample of forms identified by NHS England as being completed accurately. The results and action plans will be shared to assure themselves and NHS England that there is not unwarranted variation in access to these medicines.

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Trigger 4: Faster adoption of prioritised best value medicines and treatments

Drug name Description

Expected loss of exclusivity

On CMU framework from

Indications not included Comments

Bosentan Generics 01/08/2018 Full year effects from 2018/19

Tenofovir disoproxil Generics 01/08/2018 Full year effects from 2018/19

Glatiramer acetate Generics 01/08/2018 Full year effects from 2018/19

Mycophenolic acid Generics 01/08/2018 Full year effects from 2018/19

Anidulafungin Generics 01/08/2018 Full year effects from 2018/19

Tadalafil Generics 01/08/2018 Full year effects from 2018/19

Nitisinone Generics 01/08/2018 Full year effects from 2018/19

Trastuzumab (FYE) Biosimilar 16/07/2018 Full year effects from 2018/19

Adalimumab (FYE) Biosimilar 01/12/2018

Full year effects from 2018/19. Reference price from 1st April 2019 so not within BV savings

Miglustat Generic Q3 Wockhardt to launch Oct/Nov 18

Tenofovir disoproxil/ emtricitabine/efavirenz

Generics (Atripla) Q1 Phased implementation

Tenofovir DF/emtricitabine Generics (Truvada) Q1 Phased implementation

Everolimus Generics Jan-19 Q3 TSC Patent challenges

Bortezomib – non-mannitol containing products Generics

Apr 19 (TBC may be 2020) Q3

(Bortezomib products containing mannitol – 2022)

Aprepitant Generics May-19 Q3 On Draft Generic Transition List

Darunavir Generics Feb-19 Q3 On Draft Generic Transition List

Gefitinib Generics Jun-19 Q3

Unclear if products will be available - On Draft Generic Transition List

Arsenic trioxide Generics Jul-19 TBC

Teriparatide Biosimilar Aug-19 TBC

Atazanavir Generics Sep-19 TBC

Cinacalcet Generics Oct-19 TBC

Although Prescribing Outlook (PO) suggests April 2020

Posaconazole Generics Dec-19 TBC Oral solution

Sodium oxybate Generics Jan-20 TBC

Trigger 5: Anti-Fungal Stewardship

NHS England Specialised commissioning has commissioning responsibility for antifungal drugs that are excluded from national tariff. The overall NHS England drug spend for antifungals is more than £80 million per annum. We estimate that there is

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an overall financial opportunity of between £4m-8m per annum through improved anti-fungal stewardship. The high drug costs and toxicities and the potential for patient harm from using antifungal agents are the principal rationale for antifungal stewardship, while antifungal resistance is an emerging issue, identified in the 5 year AMR national action plan for 2019-24. Until recently there have been suboptimal diagnostic tools, which have driven the overuse of antifungal agents. Anti-fungal Stewardship will be a major tool for NHS England/NHS improvement and Public Health England in the fight against antifungal resistance. If the World Health Organisation is correct and there is a worldwide build-up of resistance. The costs associated with treating patients who have developed fungal resistance will increase rapidly. Stewardship is a clear proven way of ensuring that the anti-fungals the NHS has at its disposal will be more effective for longer.

Blueteq

Blueteq and GDPR

As you will be aware the General Data Protection Regulations came into force on Friday 25th May 2018. These regulations will be incorporated into a new Data Protection Act which represents the biggest change to data protection laws in twenty years.

With this in mind, we have reviewed the way that NHS England operates with the prior approval system; Blueteq. We will shortly be circulating an information governance pack to explain these updates. The pack will include: a copy of our data protection impact assessment (DPIA), a System Level Security Policy for the Blueteq system, a copy of our fair processing notice, a copy of the data processing agreement between NHS England and Blueteq, an explanation around the upcoming updates to the information schedule and some overarching guidance to explain how all the contracts link together.

This pack will be disseminated through each of the supplier managers who will be asked to circulate it among their colleagues in each trust. A copy of the fair processing notice is reproduced below for medicines routinely commissioned, which should be communicated to patients if their treatment is processed via Blueteq. A separate notice has also been produced medicines funded through the CDF.

The treatment that your doctor is looking to offer to you requires us to confirm that you meet the required clinical criteria defined by either NICE or NHS England policy. These aim to ensure that treatments are offered to those patients most likely to benefit clinically from them. In order to do this, your doctor will complete a form with your information through a website provided by Blueteq. If you are eligible for the treatment your doctor has prescribed, NHS England will immediately approve this application so you can begin your treatment without delay. Once you have received your treatment, your hospital will ask NHS England for payment for your treatment and NHS England will go through a process to authorise the payment. To allow NHS England to ensure that it pays for treatments for patients who meet the necessary clinical criteria, your personal details will be processed by NHS Digital teams; NHS Digital is the national safe haven set up under the Health and Social Care Act 2012 - Safe Havens have been set up in the NHS to ensure that confidential patient data

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can be transmitted and stored securely. NHS Digital will de-identify the data so NHS England can match the clinical approval and payment without being able to link any information to a specific individual. Data which identifies you is only used for your direct care purposes. All data required by NHS England for commissioning purposes is de-identified by NHS Digital in line with the Information Commissioners Code of Practice on Anonymisation.

Blueteq forms will only be uploaded in those Trusts where a relevant service is commissioned and designated for the treatment. The full list of new Blueteq forms since May 2018 is listed in the following table.

Drug Title Last Enabled

On

Ibrutinib IBR5 NHS England - Initial Funding Application - Ibrutinib for the treatment of relapsed/refractory mantle cell lymphoma in patients who have only received 1 prior line of systemic therapy.

02/05/2018

Elosulfase alfa

NHS England - Continuation Funding Application - Elosulfase alfa for the treatment of mucopolysaccharidosis type IVa

10/05/2018

Sofosbuvir/ velpatasvir/ voxilaprevir

(54) NHS England - Retreatment Funding Application - Sofosbuvir/velpatasvir/voxilaprevir (12 weeks) for the retreatment of genotype 1, 2, 3, 4, 5 and 6 chronic hepatitis C. (TA 507)

11/05/2018

Sofosbuvir/ ledipasvir/

(28a) NHS England - Initial Funding Application - Sofosbuvir/ledipasvir (12 weeks) for previously untreated genotype 4 chronic hepatitis C without cirrhosis

11/05/2018

Bosentan NHS England - Initial Funding Application - Bosentan for the treatment of digital ulceration in systemic sclerosis.

14/05/2018

Rituximab NHS England - Initial Funding Application - Rituximab for 2nd line treatment of anti-NMDAR autoimmune encephalitis (all ages).NHS England Reference: 170039P

24/05/2018

Rituximab NHS England - Funding Application - Rituximab (top up dose) for 2nd line treatment of anti-NMDAR autoimmune encephalitis (all ages).NHS England Reference: 170039P

24/05/2018

Rituximab NHS England - Funding Application - Rituximab (redosing)for 2nd line treatment of anti-NMDAR autoimmune encephalitis (all ages).NHS England Reference: 170039P

24/05/2018

Implantation (autologous chondrocyte)

NHS England - Initial Funding Application - Autologous chondrocyte implantation using chondrosphere for treating symptomatic articular cartilage defects of the knee (TA 508)

06/06/2018

Adalimumab (M4C) NHS England - Initial Funding Application - Adalimumab for the treatment of posterior-segment involving non-infectious uveitis in children.

06/06/2018

Adalimumab (M4C) NHS England - Initial Funding Application - Adalimumab for the treatment of severe refractory uveitis in children.

06/06/2018

Sofosbuvir/ velpatasvir

(44+45+46) NHS England - Initial Funding Application - Sofosbuvir/velpatasvir (12 weeks) for the treatment of genotype 1, 2, 3, 4, 5 and 6 chronic hepatitis C in adults. (TA 430)

06/06/2018

Ombitasvir/ paritaprevir/ ritonavir/ dasabuvir

(18a) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir with dasabuvir (12 weeks) for the treatment of genotype 1b chronic hepatitis C without cirrhosis (TA365)

06/06/2018

Ombitasvir/ paritaprevir/ ritonavir/ dasabuvir

(18b) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir with dasabuvir (8weeks) for the treatment of genotype 1b chronic hepatitis C without cirrhosis (TA365)

06/06/2018

Glecaprevir/ Pibrentasvir

(47) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (12 weeks) for the treatment of genotype 3 chronic hepatitis C with compensated cirrhosis.

06/06/2018

Glecaprevir/ Pibrentasvir

(48) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (16 weeks) for the treatment of genotype 3 chronic hepatitis C with compensated cirrhosis.

06/06/2018

17

Glecaprevir/ Pibrentasvir

(49) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (8 weeks) for the treatment of genotype 3 chronic hepatitis C without cirrhosis.

06/06/2018

Glecaprevir/ Pibrentasvir

(50) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (16 weeks) for the treatment of genotype 3 chronic hepatitis C without cirrhosis.

06/06/2018

Belimumab NHS England - Continuation Funding Application - Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus (TA 397)

06/06/2018

Pertuzumab PER1 NHS England - Initial Funding Application Form – Pertuzumab for the first line treatment of locally advanced or metastatic breast cancer.

08/06/2018

Glecaprevir/ Pibrentasvir

52 NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (12 weeks) for the treatment of genotypes 2,5 and 6 chronic hepatitis C with compensated cirrhosis

15/06/2018

Glecaprevir/ Pibrentasvir

(51) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (8 weeks) for the treatment of genotypes 2,5 and 6 chronic hepatitis C without cirrhosis.

15/06/2018

Tivozanib TIV1 NHS England - Initial Funding Application - Tivozanib for treating advanced renal cell carcinoma (TA512)

19/06/2018

Cabozantinib CABO1_v2.0 NHS England – Initial Funding Application - Cabozantinib for treating medullary thyroid cancer

26/06/2018

Idebenone NHS England - Early Access to Medicines Scheme (EAMS) application form – Idebenone as treatment for slowing the decline of respiratory function in patients with Duchenne Muscular Dystrophy (DMD)

02/07/2018

Tocilizumab NHS England – Initial Funding Application – Tocilizumab for the treatment of Adult-Onset Still's Disease (AOSD) - NHSE Commissioning Policy 170056P

08/07/2018

Anakinra NHS England – Initial Funding Application – Anakinra for the treatment of Hyperimmunoglobulin D syndrome (HIDS) also known as Mevalonate Kinase Deficiency (MKD) all ages – NHSE Commissioning Policy Ref 170062P v1

08/07/2018

Anakinra NHS England – Initial Funding Application – Anakinra for the treatment of Schnitzler’s syndrome all ages –NHSE Commissioning Policy Ref 170062P v1

08/07/2018

Anakinra NHS England – Initial Funding Application – Anakinra for the treatment of tumour necrosis factor receptor-associated periodic syndrome (TRAPS) all ages – NHSE Commissioning Policy Ref 170062P v1

08/07/2018

Anakinra NHS England – Initial Funding Application – Anakinra for the treatment of Adult-Onset Still's Disease (AOSD) - NHSE Commissioning Policy 170056P

08/07/2018

Tocilizumab NHS England - Initial Funding Application - Tocilizumab for the treatment giant cell arteritis. (TA 518)

09/07/2018

Anakinra NHS England – Initial Funding Application – Anakinra for the treatment of Familial Mediterranean Fever (FMF) all ages – NHSE Commissioning Policy Ref 170062P v1

09/07/2018

Avelumab AVE2_ver1.0 NHS England - Initial Funding Application - Avelumab in patients previously treated with systemic cytotoxic chemotherapy for metastatic Merkel cell carcinoma (TA517).

10/07/2018

Volanesorsen Vol01_ver1.0 - Early Access to Medicines Scheme Application Form – volanesorsen sodium in the treatment of patients with familial chylomicronaemia syndrome

11/07/2018

Bendamustine BEN1_v2.0 NHS England - Initial Application Form – Bendamustine for Low Grade Non-Hodgkin’s Lymphoma (1st line treatment) - NHSE policy 170055P

13/07/2018

Bendamustine BEN2_v2.0 NHS England Initial Application Form – Bendamustine for Mantle Cell Non-Hodgkin’s Lymphoma (1st Line Treatment) - NHSE Policy 170066P

13/07/2018

Sofosbuvir/ ledipasvir

(28 M4C) NHS England - Initial Funding Application - Sofosbuvir/ledipasvir (8 weeks) for previously untreated chronic hepatitis C without cirrhosis in children (as referenced in TA363)

17/07/2018

Glecaprevir/ Pibrentasvir

(51 M4C) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (8 weeks) for the treatment of genotypes 2, 5 and 6 chronic hepatitis C without cirrhosis in children

17/07/2018

18

Glecaprevir/ Pibrentasvir

(52 M4C) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (12 weeks) for the treatment of genotypes 2, 5 and 6 chronic hepatitis C with compensated cirrhosis in children

17/07/2018

Sofosbuvir/ ledipasvir

(30 M4C) NHS England - Initial Funding Application - Sofosbuvir/ledipasvir (12 weeks) for the treatment of genotype 1 and 4 chronic hepatitis C with compensated cirrhosis in children (as referenced in TA363)

17/07/2018

Glecaprevir/ Pibrentasvir

(50 M4C) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (16 weeks) for the treatment of genotype 3 chronic hepatitis C without cirrhosis in children

17/07/2018

Sofosbuvir/ velpatasvir

(44+45+46 M4C) NHS England - Initial Funding Application - Sofosbuvir/velpatasvir (12 weeks) for the treatment of genotype 1, 2, 3, 4, 5 and 6 chronic hepatitis C in children (as referenced in TA 430)

17/07/2018

Sofosbuvir/ ledipasvir

(28a M4C) NHS England - Initial Funding Application - Sofosbuvir/ledipasvir (12 weeks) for previously untreated genotype 4 chronic hepatitis C without cirrhosis in children (as referenced in TA363)

17/07/2018

Elbasvir/ grazoprevir

(34a M4C) NHS England - Initial Funding Application - Elbasvir/grazoprevir for the treatment of genotype 1(not 1b) and 4 chronic hepatitis C in children (as referenced in TA413)

18/07/2018

Elbasvir/ grazoprevir

(36a M4C) NHS England - Initial Funding Application - Elbasvir/grazoprevir (12 weeks) for the treatment of genotype 1b chronic hepatitis C in children (as referenced in TA413)

18/07/2018

Glecaprevir/ Pibrentasvir

(49 M4C) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (8 weeks) for the treatment of genotype 3 chronic hepatitis C without cirrhosis in children

18/07/2018

Ombitasvir/ paritaprevir/ ritonavir/ dasabuvir and ribavirin

(17 M4C) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir with dasabuvir and ribavirin for the treatment of genotype 1a chronic hepatitis C with compensated cirrhosis in children (as referenced in TA365)

18/07/2018

Ombitasvir/ paritaprevir/ ritonavir/ dasabuvir and ribavirin

(16 M4C) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir with dasabuvir and ribavirin (12 weeks) for the treatment of genotype 1a and 1 unknown chronic hepatitis without cirrhosis in children (as referenced in TA365)

18/07/2018

Ombitasvir/ paritaprevir/ ritonavir/ dasabuvir

(18 M4C) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir with dasabuvir (8/12 weeks) for the treatment of genotype 1b chronic hepatitis C without cirrhosis in children (as referenced in TA365)

18/07/2018

Ombitasvir/ paritaprevir/ ritonavir/ dasabuvir

(19 M4C) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir with dasabuvir (12 weeks) for the treatment of genotype 1b chronic hepatitis C with compensated cirrhosis in children (as referenced in TA365)

18/07/2018

Sofosbuvir/ velpatasvir/ voxilaprevir

(54 M4C) NHS England - Retreatment Funding Application - Sofosbuvir/velpatasvir/voxilaprevir (12 weeks) for the retreatment of genotype 4 chronic hepatitis C without cirrhosis in children (as referenced in TA507)

18/07/2018

Ombitasvir/ paritaprevir/ ritonavir/ ribavirin

(31 M4C) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir and ribavirin (12 weeks) for the treatment of genotype 4 chronic hepatitis C with compensated cirrhosis in children

18/07/2018

Ombitasvir/ paritaprevir/ ritonavir/ ribavirin

(20 M4C) NHS England - Initial Funding Application - Ombitasvir/paritaprevir/ritonavir and ribavirin (12 weeks) for the treatment of genotype 4 chronic hepatitis C without cirrhosis in children (as referenced in TA365)

18/07/2018

Glecaprevir/ Pibrentasvir

(47 M4C) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (12 weeks) for the treatment of genotype 3 chronic hepatitis C with compensated cirrhosis in children

19/07/2018

Glecaprevir/ Pibrentasvir

(48 M4C) NHS England - Initial Funding Application - Glecaprevir/pibrentasvir (16 weeks) for the treatment of genotype 3 chronic hepatitis C with compensated cirrhosis in children

19/07/2018

Sofosbuvir/ ledipasvir +/- ribavirin

Paediatric (11 NEW) NHS England - Initial Funding Application - Sofosbuvir/ledipasvir +/- ribavirin (12 weeks) for the treatment of chronic hepatitis C in patients with decompensated cirrhosis (as referenced in NHS England Commissioning Policy B07/P/a)

24/07/2018

Sofosbuvir/ ledipasvir

(29 M4C) NHS England - Initial Funding Application - Sofosbuvir/ledipasvir (12 weeks) for previously treated genotype 1 and 4 chronic hepatitis C without cirrhosis in children (as referenced in TA363)

24/07/2018

19

Lomitapide NHS England - Initial Funding Application – Lomitapide for treating homozygous familial hypercholesterolaemia in adults (NHS England Commissioning Policy 170059P)

03/08/2018

Alemtuzumab NHS England - Initial Funding Application - (Cycle 3) Alemtuzumab for the treatment of relapsing-remitting multiple sclerosis (NHS England Commissioning Policy 170075P)

16/08/2018

Cabozantinib CABO2_v1.1 NHS England - Initial Funding Application – Cabozantinib for previously treated advanced renal cell carcinoma (TA 463)

28/08/2018

Belimumab (M4C) NHS England - Continuation Funding Application - Belimumab for the treatment of active autoantibody-positive systemic lupus erythematosus in children (as referenced in TA 397)

28/08/2018

Omalizumab (M4C) NHS England - Initial Funding Application - Omalizumab for the treatment of chronic spontaneous urticaria (CSU) in children from 6 years old (in relation to NICE TA339)

30/08/2018

Anakinra NHS England – Continuation Funding Application – Anakinra for the treatment of Adult-Onset Still's Disease (AOSD) – NHSE Commissioning Policy 170056P

30/08/2018

Tocilizumab NHS England – Continuation Funding Application – Tocilizumab for the treatment of Adult-Onset Still's Disease (AOSD) – NHSE Commissioning Policy 170056P

30/08/2018

Ibrutinib IBR7_ver1.0 NHS England – Initial Funding Application Form – Ibrutinib for previously treated chronic lymphocytic leukaemia in patients failing to respond to chemoimmunotherapy OR having a progression-free interval of <3 years with the preceding treatment OR having a progression free interval of at least 3 years with the preceding treatment and comorbidities which contraindicate consideration of further chemoimmunotherapy NOTE: there is a separate form for the funding of ibrutinib in patients with a progression-free interval of at least 3 years with the preceding treatment and who do not have comorbidities which contraindicate consideration of chemoimmunotherapy

31/08/2018

Ibrutinib IBR8_ver1.0 NHS England – Initial Funding Application Form – Ibrutinib for previously treated chronic lymphocytic leukaemia in patients with a progression-free interval of at least 3 years with the preceding treatment and who do not have comorbidities which contraindicate consideration of chemoimmunotherapy NOTE: there is a separate form for the funding of ibrutinib in patients failing to respond to chemoimmunotherapy OR having a progression-free interval of <3 years with the preceding treatment OR having a progression free interval of more than or equal to 3 years with the preceding treatment and who have comorbidities which contra-indicate consideration of further chemoimmunotherapy

31/08/2018

Anakinra NHS England – Continuation Funding Application – Anakinra for the treatment of Familial Mediterranean Fever (FMF) all ages – NHSE Commissioning Policy Ref 170062P

03/09/2018

Anakinra NHS England – Continuation Funding Application – Anakinra for the treatment of Hyperimmunoglobulin D syndrome (HIDS) also known as Mevalonate Kinase Deficiency (MKD) all ages – NHSE Commissioning Policy Ref 170062P

03/09/2018

Anakinra NHS England – Continuation Funding Application – Anakinra for the treatment of Schnitzler’s syndrome all ages –NHSE Commissioning Policy Ref 170062P

03/09/2018

Anakinra NHS England – Continuation Funding Application – Anakinra for the treatment of tumour necrosis factor receptor-associated periodic syndrome (TRAPS) all ages – NHSE Commissioning Policy Ref 170062P

03/09/2018

Palivizumab (18/19) NHS England - Initial Funding Application - Palivizumab to reduce the risk of respiratory syncytial virus (RSV) in infants with congenital heart disease (CHD) for the 18/19 season.

06/09/2018

Palivizumab (18/19) NHS England - Initial Funding Application - Palivizumab to reduce the risk of respiratory syncytial virus (RSV) in infants with bronchopulmonary dysplasia (BPD) (also known as chronic lung disease) for the 18/19 season.

06/09/2018

alectinib ALE1_ver1.0 NHS England - Initial Funding Application – Alectinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer (TA536)

07/09/2018

Palivizumab (18/19) NHS England - Initial Funding Application - Palivizumab to reduce the risk of respiratory syncytial virus (RSV) in infants with severe combined immunodeficiency syndrome (SCID) for the 18/19 season.

07/09/2018

Mepolizumab M4C NHS England - Initial Funding Application - Mepolizumab for treating severe refractory eosinophilic asthma in children (in relation to TA431)

07/09/2018

Mepolizumab M4C NHS England - Continuation Funding Application - Mepolizumab for treating severe refractory eosinophilic asthma in children (in relation to TA431)

07/09/2018

Arsenic Trioxide ARS1_ver1.1 NHS England - Initial Funding Application Form – Arsenic trioxide for treating newly diagnosed low to intermediate risk acute promyelocytic leukaemia in ADULTS (TA526)

11/09/2018

20

Arsenic Trioxide ARS2_ver1.1 NHS England - Initial Funding Application Form – Arsenic trioxide for treating relapsed/refractory acute promyelocytic leukaemia in ADULTS (TA526)

11/09/2018

Arsenic Trioxide ARS3_ver1.1 NHS England - Initial Funding Application – Arsenic trioxide for treating newly diagnosed low to intermediate risk acute promyelocytic leukaemia in CHILDREN (as referenced in TA526)

11/09/2018

Arsenic Trioxide ARS4_ver1.1 NHS England - Initial Application Form – Arsenic trioxide for treating relapsed/refractory acute promyelocytic leukaemia in CHILDREN (as referenced in TA526)

11/09/2018

Brentuximab BRE5_ver1.1 NHS England Initial Funding Application Form – Brentuximab-naïve relapsed/refractory Hodgkin lymphoma following at least 2 prior therapies when autologous stem cell transplant or multi-agent chemotherapy is not a treatment option in ADULT patients (TA524)

11/09/2018

Brentuximab BRE6_ver1.1 NHS England - Initial Funding Application Form – Brentuximab-naïve relapsed/refractory Hodgkin lymphoma following at least 2 prior therapies when autologous stem cell transplant or multi-agent chemotherapy is not a treatment option in CHILD patients (as referenced in TA524)

11/09/2018

Midostaurin MID1_ver1.1 NHS England - Initial Funding Application Form – Midostaurin for treating FLT3 mutation positive acute myeloid leukaemia in adults (TA523)

11/09/2018

Interferon beta NHS England - Initial Funding Application - Beta Interferon for the treatment of relapsing remitting multiple sclerosis in adults (TA527)

17/09/2018

Interferon beta NHS England - Initial Funding Application - Beta Interferon for the treatment of relapsing progressive multiple sclerosis (TA527)

17/09/2018

Alemtuzumab NHS England - Initial Funding Application - (Cycle 1 or 2) Alemtuzumab for the treatment of relapsing-remitting multiple sclerosis. (TA 312)

17/09/2018

Cladribine NHS England - Initial Funding Application - (Course 1 or 2) Cladribine for the treatment of highly active relapsing-remitting multiple sclerosis in adults (TA493)

17/09/2018

Fingolimod NHS England - Initial Funding Application - Fingolimod for the treatment of highly active relapsing remitting multiple sclerosis after natalizumab treatment (NHS England Policy)

17/09/2018

Glatiramer acetate

Form MS3 - NHS England - Initial Funding Application - Glatiramer acetate for relapsing-remitting multiple sclerosis in adults (TA527)

17/09/2018

Natalizumab NHS England - Initial Funding Application - Natalizumab for the treatment of rapidly evolving severe (RES) relapsing-remitting multiple sclerosis. (TA 127)

17/09/2018

Interferon beta

NHS England - Continuation Funding Application - Beta Interferon for the treatment of relapsing progressive multiple sclerosis (TA527)

17/09/2018

Interferon beta

NHS England - Continuation Funding Application - Beta Interferon for the treatment of relapsing remitting multiple sclerosis (TA527)

17/09/2018

Cladribine NHS England - Continuation Funding Application – (Course 1 or 2) Cladribine for the treatment of highly active relapsing-remitting multiple sclerosis in adults (TA493)

17/09/2018

Fingolimod NHS England - Continuation Funding Application - Fingolimod for the treatment of highly active relapsing remitting multiple sclerosis after natalizumab treatment (TA254)

17/09/2018

Glatiramer acetate

NHS England - Continuation Funding Application - Glatiramer acetate for relapsing-remitting multiple sclerosis in adults (TA527)

17/09/2018

Emicizumab NHS England – Initial Funding Application – Emicizumab for the treatment of Haemophilia A with a factor VIII inhibitor - NHS England Clinical Commissioning Policy 170067/P

05/10/2018

Nintedanib NHS England - Continuation Funding Application - Nintedanib for the treatment of idiopathic pulmonary fibrosis (TA379)

05/10/2018

Pirfenidone NHS England - Continuation Funding Application - Pirfenidone for treatment of idiopathic pulmonary fibrosis (TA504)

05/10/2018

Dimethyl Fumarate

Form MS17 - NHS England - Initial Funding Application - Dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis in children (with reference to TA320)

08/10/2018

Rituximab NHS England – Continuation Funding Application – Rituximab bio-similar for the treatment of myasthenia gravis (NHS England Commissioning Policy 170073P)

22/10/2018

Rituximab NHS England - Initial Funding Application – Rituximab bio-similar for the treatment of myasthenia gravis (NHS England Commissioning Policy 170073P)

22/10/2018

21

Interferon beta

Form MS12 - NHS England - Initial Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527) - Avonex

23/10/2018

Interferon beta

Form MS28 - NHS England - Initial Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in children (NHS England Policy) - Extavia

23/10/2018

Interferon beta

Form MS13 - NHS England - Initial Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527) - Rebif

23/10/2018

Interferon beta

Form MS14 - NHS England - Initial Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (NHS England Policy) - Plegridy

23/10/2018

Interferon beta

Form MS15 - NHS England - Initial Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527) - Extavia

23/10/2018

Interferon beta

Form MS25 - NHS England - Initial Funding Application - Beta Interferon for the treatment of relapsing progressive multiple sclerosis in children (As referenced in TA527) - Extavia

23/10/2018

Interferon beta

Form MS26 - NHS England - Initial Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in children (NHS England Policy) - Avonex/Betaferon

23/10/2018

Interferon beta

Form MS27 - NHS England - Initial Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in children (NHS England Policy) - Rebif

23/10/2018

Fingolimod Form MS19 - NHS England - Initial Funding Application - Fingolimod for the treatment of highly active relapsing remitting multiple sclerosis in children after natalizumab (NHS England Policy)

23/10/2018

Glatiramer acetate

Form MS16 - NHS England - Initial Funding Application - Glatiramer acetate for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527)

23/10/2018

Natalizumab Form MS22 - NHS England - Initial Funding Application - Natalizumab for the treatment of rapidly evolving severe (RES) relapsing-remitting multiple sclerosis in children (as referenced in TA 127)

23/10/2018

Alemtuzumab Form MS21 - NHS England - Initial Funding Application - (Cycle 1 or 2) Alemtuzumab for the treatment of relapsing-remitting multiple sclerosis in children (as referenced in TA312)

23/10/2018

Alemtuzumab M4C NHS England - Initial Funding Application - (Cycle 3) Alemtuzumab for the treatment of relapsing-remitting multiple sclerosis in children (in relation to NHS England Commissioning Policy 170075P)

23/10/2018

Cladribine NHS England - Initial Funding Application - (Course 1 or 2) Cladribine for the treatment of highly active relapsing-remitting multiple sclerosis in children (as referenced in TA493)

23/10/2018

Teriflunomide Form MS20 - NHS England - Initial Funding Application - Teriflunomide for the treatment of relapsing-remitting multiple sclerosis in children (as referenced in TA303)

23/10/2018

Romiplostim (M4C) NHS England – Initial funding application(Medicines for Children Policy) - Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) in children (in relation to NICE TA221 for adults) (Enabled since 15/02/2018)

24/10/2018

Ocrelizumab NHS England - Continuation Funding Application - Ocrelizumab for treating relapsing–remitting multiple sclerosis (TA533)

30/10/2018

Interferon beta

(MS2) - NHS England - Continuation Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in adults (NHS England policy)

30/10/2018

Interferon beta

(MS2) - NHS England - Initial Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in adults (NHS England policy)

30/10/2018

Radium 223 NHS England - Initial Funding Application - Radium 223 dichloride for treating hormone-relapsed prostate cancer with bone metastases. (TA 412)

30/10/2018

Interferon beta

Form MS12 - NHS England - Continuation Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527) - Avonex

01/11/2018

Interferon beta

Form MS28 - NHS England - Continuation Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in children (NHS England Policy) - Extavia

01/11/2018

Interferon beta

Form MS13 - NHS England - Continuation Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527) - Rebif

01/11/2018

Interferon beta

Form MS14 - NHS England - Continuation Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (NHS England Policy) - Plegridy

01/11/2018

22

Interferon beta

Form MS15 - NHS England - Continuation Funding Application - Beta interferon for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527) - Extavia

01/11/2018

Interferon beta

Form MS25 - NHS England - Continuation Funding Application - Beta Interferon for the treatment of relapsing progressive multiple sclerosis in children (As referenced in TA527) - Extavia

01/11/2018

Interferon beta

Form MS26 - NHS England - Continuation Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in children (NHS England Policy) - Avonex/Betaferon

01/11/2018

Interferon beta

Form MS27 - NHS England - Continuation Funding Application - Beta Interferon for the treatment of Clinically Isolated Syndrome in children (NHS England Policy) - Rebif 44

01/11/2018

Fingolimod Form MS18 - NHS England - Continuation Funding Application - Fingolimod for the treatment of highly active relapsing remitting multiple sclerosis after 1st line treatment in children (with reference to TA 254)

01/11/2018

Fingolimod Form MS19 - NHS England - Continuation Funding Application - Fingolimod for the treatment of highly active relapsing remitting multiple sclerosis in children after natalizumab (NHS England Policy)

01/11/2018

Glatiramer acetate

Form MS16 - NHS England - Continuation Funding Application - Glatiramer acetate for the treatment of relapsing remitting multiple sclerosis in children (as referenced in TA527)

01/11/2018

Natalizumab Form MS22 - NHS England - Continuation Funding Application - Natalizumab for the treatment of rapidly evolving severe (RES) relapsing-remitting multiple sclerosis in children (as referenced in TA 127)

01/11/2018

Cladribine M4C NHS England - Continuation Funding Application – (Course 1 or 2) Cladribine for the treatment of highly active relapsing-remitting multiple sclerosis in children (with reference to TA493)

01/11/2018

Teriflunomide Form MS20 - NHS England - Continuation Funding Application - Teriflunomide for the treatment of relapsing-remitting multiple sclerosis in children (as referenced in TA303)

01/11/2018

Dimethyl Fumarate

Form MS17 - NHS England - Continuation Funding Application - Dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis in children (with reference to TA320)

01/11/2018

Ocrelizumab M4C NHS England - Continuation Funding Application - Ocrelizumab for treating relapsing–remitting multiple sclerosis in children (as referenced in TA533)

01/11/2018

Sorafenib NHS England - Initial Funding Application - Sorafenib for first line treatment of Child-Pugh A locally advanced or metastatic hepatocellular carcinoma.

05/11/2018

Sorafenib SOR2_v3.0 NHS England - Initial Funding Application - Sorafenib for treating differentiated thyroid cancer after radioactive iodine (TA535)

06/11/2018

Lenvatinib LNV2_v1.0 NHS England - Initial Funding Application – Lenvatinib for treating differentiated thyroid cancer after radioactive iodine (TA535)

06/11/2018

Dinutuximab beta

DIN1_ver1.0 NHS England - Initial Application Form – Dinutuximab beta as part of 1st line therapy for high risk neuroblastoma in patients aged 12 months and above and who have both responded to induction chemotherapy and been treated with myeloablative therapy and stem cell transplantation (TA538)

20/11/2018

Dinutuximab beta

DIN2_ver1.0 NHS England - Initial Application Form – Dinutuximab beta for the treatment of RELAPSED or REFRACTORY neuroblastoma in patients aged 12 months and above and who have then both responded to intensive induction chemotherapy used to treat high risk 1st line patients and been treated with myeloablative therapy and stem cell transplantation (TA538)

20/11/2018

Lomitapide NHS England - Continuation Funding Application – Lomitapide for treating homozygous familial hypercholesterolaemia in adults (NHS England Commissioning Policy 170059P)

23/11/2018

lutetium (177Lu) oxodotreotide

LUT1_ver1.0 NHS England - Initial Funding Application Form – Lutetium (177Lu) oxodotreotide for unresectable or metastatic, progressive, well differentiated and somatostatin receptor positive gastroenteropancreatic neuroendocrine carcinoma (TA539)

27/11/2018

Pemetrexed NHS England - Initial Funding Application - Pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin (TA 402)

27/11/2018

Abatacept NHS England - Initial Funding Application - Abatacept for the treatment of non-systemic juvenile idiopathic arthritis (JIA) in children (3rd line biologic) (updated 3.12.18)

03/12/2018

Tocilizumab NHS England - Initial Funding Application - Tocilizumab for the treatment of non- systemic juvenile idiopathic arthritis (JIA) in children (3rd line biologic) (updated 3.12.18)

03/12/2018

23

Fingolimod Form MS18 - NHS England - Initial Funding Application - Fingolimod for the treatment of highly active relapsing remitting multiple sclerosis after 1st line treatment in children (with reference to TA 254) (updated 4.12.18)

04/12/2018

Burosumab NHS England - Initial Funding Application – Burosumab for treating X-linked hypophosphataemia in children and young people (HST8)

06/12/2018

Inotuzumab ozogamicin

INO1_ver1.0 NHS England - Initial Funding Application Form – Inotuzumab ozogamicin for treating relapsed/refractory Philadelphia positive and Philadelphia negative B cell precursor acute lymphoblastic leukaemia in ADULT patients (TA541)

18/12/2018

Inotuzumab ozogamicin

M4C INO2_ver1.0 NHS England - Initial Funding Application Form – Inotuzumab ozogamicin for treating relapsed/refractory Philadelphia positive and negative B cell precursor acute lymphoblastic leukaemia in CHILD patients (as referenced in TA541)

18/12/2018

Nivolumab M4C NHS England - Initial Funding application - Nivolumab for treating relapsed or refractory classical Hodgkin Lymphoma in PAEDIATRIC patients (as referenced in TA 462)

19/12/2018

Nivolumab NHS England - Initial Funding Application - Nivolumab for the treatment of relapsed or refractory classical Hodgkin lymphoma in adults (TA 462)

19/12/2018

Atezolizumab ATE2_ver1.1 NHS England - Initial Application Form - Atezolizumab for treating previously platinum-treated locally advanced/ metastatic NON SQUAMOUS or SQUAMOUS non-small cell lung cancer which has been prospectively determined before this application to be PD-L1 positive or PD-L1 negative or PD-L1 unquantifiable at PD-L1 assay or one in which PD-L1 status cannot be determined on account of insufficient lung cancer tissue being available for PD-L1 assay

19/12/2018

Atezolizumab ATE3_ver1.1 NHS England - Initial Application Form – Atezolizumab for locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy (TA525)

19/12/2018

Pembrolizumab NHS England - Initial Application Funding - Pembrolizumab for the treatment of PD-L1-positive non small cell lung cancer after chemotherapy (TA 428)

19/12/2018

Pembrolizumab PEMB2_ver1.2 NHS England - Initial Funding Application – Pembrolizumab for treating untreated PD-L1-positive metastatic non-small-cell lung cancer (TA531)

19/12/2018

Sofosbuvir/ velpatasvir

(Pan genotypic pilot) NHS England - Initial Funding Application - Sofosbuvir/velpatasvir (12 weeks) for the treatment of chronic hepatitis C in adults with an unknown genotype

23/12/2018

Cabozantinib CABO3_ver1.0 NHS England Initial Funding Application – Cabozantinib for treatment-naïve intermediate or poor risk advanced renal cell carcinoma (TA542)

31/12/2018

Nivolumab/ ipilimumab

NHS England - Initial Funding Application - Nivolumab in combination with ipilimumab for treating advanced melanoma (TA 400)

03/01/2019

Nivolumab NHS England - Initial Funding Application - Nivolumab for previously treated advanced renal cell carcinoma. (TA 417)

04/01/2019

Ocrelizumab M4C NHS England - Initial Funding Application – Ocrelizumab for treating relapsing–remitting multiple sclerosis in children (as referenced in TA533)

07/01/2019

Ocrelizumab NHS England - Initial Funding Application – Ocrelizumab for treating relapsing–remitting multiple sclerosis (TA533)

15/01/2019

Rituximab M4C NHS England - Initial Funding Application – Rituximab bio-similar for the treatment of myasthenia gravis in children (in relation to NHS England Commissioning Policy 170073P)

15/01/2019

Macitentan M4C NHS England - Initial Funding Application – macitentan for the treatment of pulmonary hypertension in children (in relation to NHS England Commissioning Policy (A11/P/b)

15/01/2019

Rituximab M4C NHS England – Continuation Funding Application – Rituximab bio-similar for the treatment of myasthenia gravis in children (In relation to NHS England Commissioning Policy 170073P)

15/01/2019

Dabrafenib & Trametinib

TRADAB2_ver1.0 NHS England - Initial Funding Application – Dabrafenib in combination with trametinib for the adjuvant treatment of completely resected stage III BRAF V600 positive malignant melanoma (TA544)

17/01/2019

Palbociclib PAL1_ver1.2 NHS England - Initial Funding Application Form – Palbociclib in combination with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (TA495)

17/01/2019

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Ribociclib RIB1_ver1.2 NHS England Initial Funding Application Form – Ribociclib in combination with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (TA496)

17/01/2019

Sofosbuvir/ velpatasvir/ voxilaprevir

(54a M4C) NHS England - Retreatment Funding Application - Sofosbuvir/velpatasvir/voxilaprevir (12 weeks) for the retreatment of genotype 1, 2, 3, 4, 5 and 6 chronic hepatitis C in children (as related to TA 507)

18/01/2019

Dupilumab DUP01_ver1.0 Early Access to Medicines Scheme Application Form – Dupilumab for the treatment of adolescent patients =12 to <18 years of age with severe atopic dermatitis who have responded inadequately to at least one systemic therapy or where the available systemic therapies are not recommended or are not tolerated

29/01/2019

Nivolumab NIV8a_ver1.0 NHS England Initial Funding Application Form – Nivolumab monotherapy (with or without initial combination treatment with ipilimumab) for treating unresectable or advanced malignant melanoma: REGISTRATION OF START OF NIVOLUMAB MONOTHERAPY OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED NIVOLUMAB MONOTHERAPY (WITHOUT INITIAL COMBINATION WITH IPILIMUMAB) OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED NIVOLUMAB MONOTHERAPY AFTER INITIAL COMBINATION WITH IPILIMUMAB (clinicians starting patients on nivolumab plus ipilimumab combination treatment should only use this form after the ipilimumab part of the treatment has been completed).

01/02/2019

Nivolumab NIV8b_ver1.0 NHS England Initial Funding Application Form – Nivolumab for treating unresectable or advanced malignant melanoma: REGISTRATION OF DISCONTINUATION OF NIVOLUMAB

01/02/2019

Nivolumab NIV8c_ver1.0 NHS England Initial Funding Application Form – Nivolumab for treating unresectable or advanced malignant melanoma: RE-START OF NIVOLUMAB MONOTHERAPY

01/02/2019

Pembrolizumab PEMB9a_ver1.0 NHS England Initial Funding Application Form – Pembrolizumab monotherapy for treating unresectable or advanced malignant melanoma: REGISTRATION OF START OF PEMBROLIZUMAB MONOTHERAPY OR OF PREVIOUSLY COMMENCED AND CURRENTLY CONTINUED PEMBROLIZUMAB MONOTHERAPY

01/02/2019

Pembrolizumab PEMB9b_ver1.0 NHS England Initial Funding Application Form – Pembrolizumab monotherapy for treating unresectable or advanced malignant melanoma: REGISTRATION OF DISCONTINUATION OF PEMBROLIZUMAB

01/02/2019

Pembrolizumab PEMB9c_ver1.0 NHS England Initial Funding Application Form – Pembrolizumab monotherapy for treating unresectable or advanced malignant melanoma: RE-START OF PEMBROLIZUMAB MONOTHERAPY

01/02/2019

Gemtuzumab ozogamicin

GEM1_ver1.1 NHS England - Initial Funding Application Form – Gemtuzumab ozogamicin as part of chemotherapy for previously untreated CD33 positive acute myeloid leukaemia in patients AGED 15 YEARS AND OVER (TA545).

12/02/2019

Gemtuzumab ozogamicin

GEM2_ver1.1 M4C NHS England - Initial Funding Application – Gemtuzumab ozogamicin as part of chemotherapy for previously untreated CD33 positive acute myeloid leukaemia in CHILD patients AGED LESS THAN 15 YEARS. (TA545)

12/02/2019

Pertuzumab NHS England - Initial Funding Application - Pertuzumab for the neoadjuvant treatment of locally advanced, inflammatory or early breast cancer at high risk of recurrence. (TA 424)

15/02/2019

Ceritinib CER1_ver1.0 NHS England - Initial Funding Application - Ceritinib for anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer previously treated with crizotinib (TA 395)

15/02/2019

Bedaquiline M4C NHS England - Initial Funding Application - Bedaquiline for the treatment of multi-drug resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in children (with reference to NHSE Urgent Policy Statement)

20/02/2019

Rituximab (M4C) NHS England - Induction Funding Application - Rituximab for the treatment of ANCA-associated vasculitis in children (as referenced in Policy A13/P/a)

05/03/2019

Rituximab (M4C) NHS England - Maintenance Funding Application - Rituximab for the treatment of ANCA-associated vasculitis in children (as referenced in Policy A13/P/a)

05/03/2019

Obinutuzumab OBI1 NHS England - Initial Funding Application - Obinutuzumab for untreated advanced follicular lymphoma.

12/03/2019

Mecasermin NHS England - Initial Funding Application - Mecasermin for the treatment of growth failure (NHSE Commissioning Policy NHSCB/E03/P/a)

14/03/2019

Lenvatinib LNV3_v1.0 NHS England Initial Funding Application – Lenvatinib as the first line systemic therapy of Child-Pugh A locally advanced or metastatic hepatocellular carcinoma (TA551)

19/03/2019

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Liposomal cytarabine and daunorubicin

LCD1_ver1.1 NHS England Initial Funding Application – Liposomal cytarabine and daunorubicin for treating adults with newly diagnosed acute myeloid leukaemia (AML) that is secondary to therapy or myelodysplasia or chronic myelomonocytic leukaemia (TA552)

19/03/2019

Tocilizumab M4C NHS England - Initial Funding Application – Tocilizumab for Takayasu arteritis in children (as referenced in NHS England Commissioning Policy 16056/P)

25/03/2019

Everolimus NHS England - Initial Funding Application – Everolimus for refractory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above) (NHS England Commissioning Policy 170093P)

01/04/2019

Everolimus NHS England - Continuation Funding Application – Everolimus for refractory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above) (NHS England Commissioning Policy 170093P)

01/04/2019

Trientine dihydrochloride

NHS England - Initial Funding Application – Trientine dihydrochloride for Wilson Disease (all ages) (NHSE Commissioning Policy 170094P)

01/04/2019

Metreleptin NHS England - Continuation Funding Application – Metreleptin for congenital leptin deficiency (all ages) (Clinical Commissioning Policy 170095P)

01/04/2019

Metreleptin NHS England - Initial Funding Application – Metreleptin for congenital leptin deficiency (all ages) (Clinical Commissioning Policy 170095P)

01/04/2019

Mexiletine NHS England - Initial Funding Application - Mexiletine (NaMuscla®) for the treatment of myotonia in adults with non-dystrophic myotonic disorders.

03/04/2019

Tofacitinib M4C NHS England - Initial Funding Application – Tofacitinib for moderately to severely active ulcerative colitis in children (as referenced in TA547)

03/04/2019

Belimumab (M4C) NHS England - Initial Funding Application - Belimumab for treating active autoantibody-positive systemic lupus erythematosus in children (as referenced in TA 397)

03/04/2019

Belimumab NHS England - Initial Funding Application - Belimumab for treating active autoantibody-positive systemic lupus erythematosus (TA 397)

03/04/2019

CAR-T Therapy

CAR-T – chimeric antigen receptor T-cell – therapy is specifically developed for each individual patient and involves reprogramming the patient’s own immune system cells which are then used to target their cancer. It is a highly complex and potentially risky treatment but it has been shown in trials to cure some patients, even those with quite advanced cancers and where other available treatments have failed.

NHS England have commissioned several centres to provide CAR-T treatment for children and young people with B cell acute lymphoblastic leukaemia and for adults with diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma in England.

NHS England has been working with The Joint Accreditation Committee ISCT-Europe and EBMT (JACIE) and the life sciences companies to identify centres that can provide CAR-T therapies.

The following centres are providing CAR-T for acute lymphoblastic leukaemia for children and young people up to the age of 25:

Great Ormond Street Hospital University College London Hospital King’s College Hospital University Hospitals Bristol NHS Trust The Christie NHS Foundation Trust Manchester Royal Infirmary Royal Manchester Children’s Hospital Queen Elizabeth Hospital (Birmingham) Newcastle Hospitals NHS Foundation Trust

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The following centres are providing CAR-T for adults with large B-cell lymphoma:

University College London Hospital King’s College Hospital University Hospitals Bristol NHS Trust The Christie NHS Foundation Trust Manchester Royal Infirmary Queen Elizabeth Hospital Birmingham Newcastle Hospitals NHS Foundation Trust Further centres will be commissioned later on in 2019.

Cancer Drugs Fund

A regularly updated version of the CDF list can be found at www.england.nhs.uk/cancer/cdf/cancer-drugs-fund-list/.

Dose Banding of Chemotherapy

NHS England has now published dose banding tables relating to 67 chemotherapy products. These can be found at:

www.england.nhs.uk/publication/national-dose-banding-tables/

Product specifications to support tendering of standard ready-made products according to the dose banding tables have also been published at

www.england.nhs.uk/commissioning/spec-services/npc-crg/group-b/b02/dose-banded-chemotherapy-standardised-product-specifications/

This national standardisation of intravenous chemotherapy products is driving patient safety, reducing capacity demands in NHS aseptic units and reducing waste.

Immunoglobulin update

Immunoglobulins (Igs) are predominantly used in haematology, immunology and neurology, as well as in the treatment of infectious diseases. Internationally, growth in demand for immunoglobulins continues to increase and this is having an impact on the amount of Ig available to individual countries including England. NHS England has seen an increase of c.8-10% per annum in usage over the last three years. Also within the last 12 months, there have been further pressures due to additional supply issues. NHS England is taking a number of steps to improve the stewardship of immunoglobulins to ensure that patients most in need clinically, have access to this treatment, both for existing and future patients. To support trusts to better manage the use of immunoglobulins NHS England has set up sub-regional Immunoglobulin Assessment Panels (IAPs) and has recently revised the immunoglobulin commissioning criteria. The latest commissioning criteria on the use of therapeutic immunoglobulin in immunology, haematology, neurology and infectious diseases can be viewed on the MDSAS website. The updated criteria was published in January 2019. NHS England is also working closely with manufacturers to ensure that enough Ig is made available to meet patient needs.

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New patients Clinicians/prescribers are advised not to start any patients on subcutaneous Ig. NHS England is currently investigating the amount of stock available and will be working with panels to manage allocation of remaining stock

Completing data returns

Hospital teams are asked to be mindful of recording data on Ig accurately and in a timely manner. When completing data returns on the national MDSAS database and in the Minimum Data Set returns to NHS England, please ensure that the brand of Ig is recorded rather than the generic term of human normal immunoglobulin. This is required to support forecasting future demand.

NHS England is also developing an electronic Ig referral form within the MDSAS database to support decision making between Immunoglobulin Assessment Panels and clinicians and trusts. We will keep you updated on this work in future editions of this newsletter.

Further information

If you have any questions or require any further information please contact [email protected]

Truvada® and Atripla®

NHS England have recently awarded contracts for generic versions of Truvada® and Atripla®. These contracts will commence on the 21st May 2019 and will be in place for 18 months. To minimise the risk of supply shortages, NHS England have awarded contracts to four suppliers for “generic Truvada” and two suppliers for “generic Atripla”. In the first instance, the transition to the generic equivalent will only be for patients who are on the branded medicine. Patients who may want to switch from branded Truvada® and generic efavirenz to the single tablet generic Atripla®, will need to be transitioned at a later stage when patient numbers have been identified. This will ensure that there is no adverse effect on volumes awarded and there is no impact on supply. Interim contract prices with Gilead Sciences Ltd have been extended until 30th June 2019 to support a smooth transition to the new contract.

Biosimilars Adalimumab From 1 April 2019, NHS England expects commissioners to require providers to use the adalimumab suppliers allocated to their regional group, at the corresponding supplier invoice price. Reference prices will be used to reimburse providers for adalimumab 20mg and 40mg from 1 April 2019 and replace any current pass-through payments. Commissioners and

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Providers have recently been advised of the reference prices via a letter from Matthew Swindells. The reference price is applicable to all patients being treated with adalimumab and is intended to support the uptake of the best value biologics for each regional group. It also ensures that patients are able to access a citrate-free product where clinically required and that providers are fully reimbursed for their costs. Framework tender prices for adalimumab became available for NHS commissioners and providers from 1 December 2018 and the tender will run until 30 November 2019 with an option for NHS England to extend, as well as to take advantage of the normal framework mechanisms to secure continued best value. For any questions or concerns relating to the implementation of the framework prices please contact the contact NHS England’s Medicines Policy Unit [email protected]

Hepatitis C update

A new hepatitis C rate card is to be implemented in May 2019. This will provide clinicians with two first line choices in all but three of the combined genotype/cirrhosis status types. A number of initiatives will also be implemented to improve case finding over the next three years.

Any queries regarding the rate card and the hepatitis C strategy can be directed to [email protected]

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Programme of Care Pharmacy Leads

For information on specific items relating to the Programmes of Care you can contact the pharmacy lead (or deputy). These are as follows:

National Programme of Care

NPoC Pharmacy Lead NPoC Pharmacy Support

Internal Medicine Helen Potter Helen Knight

Cancer Tracey Williams Susanna Taylor

Mental Health Lynne Richley

Trauma Vivek Soni

Women & Children Heather Weaver Lynne Richley

Blood & Infection Will Horsley Joe Kerin

National Cancer Pharmacy Lead:

Steve Williamson – stevewilliamson

Specific contact details are listed below.

Contacts

Specialised Commissioning Pharmacy Contacts (@nhs.net)

London Heather Weaver

healther.weaver

Vivek Soni

vivek.soni

Midlands & East

Joe Kerin

joe.kerin

Manjit Dulay

manjit.dulay

Susanna Taylor

susanna.taylor

North Will Horsley

william.horsley

Helen Thorp

Helenthorp

Katie Page

Katie.page2

Helen Potter

helenpotter1

South Vivek Soni

vivek.soni

Bryan Foreshew

Bryan.foreshew1

Lynne Richley

lynne.richley

Tracey Williams

tracey.williams10

This briefing is produced periodically. For internal NHS purposes only.