July 2019 NHS England and NHS Improvement Regional Medicines Optimisation Committee Briefing Best Value Biologicals: Adalimumab Update 6 Biosimilar versions of the original biological medicine adalimumab (brand name Humira®) have been introduced in the NHS as part of a formal framework agreement dated 1 December 2018, after the patent for Humira® expired in October 2018. This briefing provides important details for ongoing implementation of best value adalimumab products. This briefing provides a regular update for provider trusts, clinicians and commissioners on adalimumab. Implementing best value biological medicines enables the NHS to continue to improve patient care and provide new treatments now and into the future. It is a key element of NHS England’s Medicines Value Programme. The framework agreement has been put in place for a one year period from 1 st December 2018, so the briefing considers the position and issues arising to date, and looks forward to 2020. 1. Review and context Adalimumab provides major clinical benefits to patients with severely debilitating diseases and NHS England is working closely with patient groups and clinical service providers as new medicines are made available to ensure that high quality patient care is maintained. Clinicians are responsible for the decision to prescribe a biological medicine, in consultation with individual patients. NHS England issued guidance to trusts and CCGs recommending in the ‘Commissioning Framework for Biological Medicines (including biosimilar medicines)’ that nine out of 10 new patients should be started on the best value biological medicine within three months of a biosimilar launch and at least eight out of ten existing patients should be switched to the best value biological medicine within 12 months. In May 2019, NHS England updated the ‘what is a biosimilar’ guide. This document is available on the NHS England website: https://www.england.nhs.uk/publication/what-is-a- biosimilar-medicine/. It provides an update for key clinical and non-clinical stakeholders about the role of biosimilar medicines in the NHS in England and to support the safe, effective and consistent use of all biological medicines, including biosimilar medicines, to
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July 2019
NHS England and NHS Improvement
Regional Medicines Optimisation Committee Briefing Best Value Biologicals: Adalimumab Update 6
Biosimilar versions of the original biological medicine adalimumab (brand
name Humira®) have been introduced in the NHS as part of a formal
framework agreement dated 1 December 2018, after the patent for Humira®
expired in October 2018. This briefing provides important details for ongoing
implementation of best value adalimumab products.
This briefing provides a regular update for provider trusts, clinicians and commissioners
on adalimumab. Implementing best value biological medicines enables the NHS to
continue to improve patient care and provide new treatments now and into the future. It
is a key element of NHS England’s Medicines Value Programme.
The framework agreement has been put in place for a one year period from 1st December
2018, so the briefing considers the position and issues arising to date, and looks forward
to 2020.
1. Review and context
Adalimumab provides major clinical benefits to patients with severely debilitating diseases
and NHS England is working closely with patient groups and clinical service providers as new
medicines are made available to ensure that high quality patient care is maintained.
Clinicians are responsible for the decision to prescribe a biological medicine, in consultation
with individual patients.
NHS England issued guidance to trusts and CCGs recommending in the ‘Commissioning
Framework for Biological Medicines (including biosimilar medicines)’ that nine out of
10 new patients should be started on the best value biological medicine within three
months of a biosimilar launch and at least eight out of ten existing patients should be
switched to the best value biological medicine within 12 months.
In May 2019, NHS England updated the ‘what is a biosimilar’ guide. This document is
available on the NHS England website: https://www.england.nhs.uk/publication/what-is-a-
biosimilar-medicine/. It provides an update for key clinical and non-clinical stakeholders
about the role of biosimilar medicines in the NHS in England and to support the safe,
effective and consistent use of all biological medicines, including biosimilar medicines, to
the benefit of patients. It includes a detailed summary of guidance and evidence so is an
excellent resource for investigating any issues in further detail.
2. Procurement update
The UK market has the following biosimilar products available in addition to the originator
product Humira® by AbbVie: Amgen’s Amgevita®, Biogen’s Imraldi®, Mylan’s Hulio® and
Sandoz’s Hyrimoz®.
It is anticipated that Fresenius Kabi’s product Idacio® will be a new entrant to the market
and details are included in section 9 below. This product is not currently incorporated in
any NHS England contract.
In planning the 2018 procurement, it was recognised that all trusts should retain access to
the originator product during the period of the first framework, in addition to their allocated
first-line biosimilar. The framework therefore ensures that Humira® is available in all parts
of the country. Some clinicians and patient groups fed back the need to have access to a
citrate-free biosimilar product for some patients, and a citrate-free biosimilar option in all
trusts. If the first-line biosimilar medicine isn't clinically appropriate for the patient they will
then have access to one of the other products available. The current contract is as detailed
below.
Outcome of tender: Market access awards by region:
Regional Group 1st line 40mg
biosimilar
2nd line 40mg
biosimilar
20mg/0.4ml
biosimilar
Originator
award
East Midlands
Biogen/ Imraldi®
Amgen/
Amgevita®
Amgen/
Amgevita®
AbbVie/
Humira®
East of England
South East
Thames Valley and
Wessex
South West
North East
Amgen/ Amgevita®
N/A North West
Yorkshire and
Humber
North London Sandoz/ Hyrimoz® Amgen/
Amgevita® West Midlands
South London Mylan/ Hulio®; But best value
biological: AbbVie / Humira®
July 2019
3 |
The first line treatment in each contract is to be the treatment of choice, but if individual patients require a citrate free formulation this is available. This is a clinical decision on an individual patient basis as detailed in section 6 below.
The current contract is set to run until 30 November 2019 with options to extend the
duration of the contract. Discussions concerning the next contract are currently underway
and a decision will be made regarding the future arrangements in due course.
3. Biosimilar uptake at month 6, end May 2019
Uptake of biosimilar adalimumab at the end of month 6 indicates that 63.6% of patients are
on biosimilar adalimumab (see figure below). It is therefore estimated that approximately
35,000 patients have received the biosimilar products. The current uptake of best value
adalimumab is higher than this for two reasons:
- This uptake is based on financial data so there is a time lag between the homecare
provision of the adalimumab injection and the reporting of financial information.
- South London remain on the originator product as this is the best value biological
product for that area
The transition to best value adalimumab has enabled substantial amounts of funding to be
redirected into supporting better patient care. The overall financial saving to the NHS in
2018/19 was £98m, and the total saving is expected to be £308m by the end of 2019/20.
Trusts are encouraged to take a proactive approach, using the materials shared on the SPS
website, ensuring good engagement with patients in the shared decision making process.
Figure 1
Monthly analysis of regional uptake of biosimilar adalimumab products (Note: London South
best value biological already in use)
(Source: Define® data)
July 2019
4 |
4. Feedback from patients and clinicians
There has been regular ongoing communication with patient groups and clinicians, and
close attention is being paid to any perceived adverse reactions. Patient groups are
currently undertaking helpful further work to assess patient experience.
Feedback has been that on some occasions consent has not been sought, and in some cases
patients only received written correspondence with no face to face or telephone
conversations. Patient dissatisfaction has been reported to patient groups, with concerns
raised about side effects and the lack of support from clinical teams.
One clear message is therefore variation in communication with patients. Clear, verbal
communication is an important element of high quality patient care and shared decision
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
Nov-18 Dec-18 Jan-19 Feb-19 Mar-19 Apr-19 May-19
South West
Yorks &HumberEast Midlands
North East
South EastCoastSouth Central
East of England
North London
North West
West Midlands
London South
National
London South: BVBalready in use
July 2019
5 |
making. Patient experience is one of the three key parts of clinical quality (alongside clinical
safety and clinical effectiveness). Any changes should have regard to shared decision
making as discussed in the NHS England website: https://www.england.nhs.uk/shared-
decision-making/. No changes in therapy should be implemented without patient
agreement.
Discomfort at the injection site reported by number of patients has been documented with
all products. This discomfort has not been directly linked to the citrate content of the
injection, and injection technique, speed of injection and temperature of the injection have
all been shown to influence the discomfort or pain experienced. Support should therefore
be provided to patients to ensure that any such discomfort is limited.
We have noted that there is a very low level of reporting through the yellow card MHRA
adverse reaction reporting process, so please ensure that any adverse events are reported.
Anyone unsure of how to report adverse events should be directed to
www.mhra.gov.uk/yellowcard or to the British National Formulary (BNF) section ‘Adverse
reactions to drugs’. Paper copies of yellow cards are also available at the back of any BNF.
It should be noted that all of the biosimilar adalimumab products are new medicines and
are therefore under additional monitoring (they have an inverted black triangle symbol (▼)
displayed in their package leaflet and summary of product characteristic, together with a
short sentence explaining what the triangle means). It does not mean that these medicines
are unsafe but that all suspected adverse drug reactions for these products should be
reported.
5. Clinical Advice
The Regional Medicines Optimisation Committee has been asked to provide advice for
circumstances in which the patient needs to switch from the selected biosimilar to an
alternative product.
Section 4.5 of the NHS England ‘What is a Biosimilar’ guide should be noted; this clarifies the
position regarding the use of biosimilar products.
In order to address the specific question regarding ‘biosimilar to biosimilar’ switching the
following statement has been produced by the Regional Medicines Optimisation