2014 12-02 hta emro banken 2

HTA for pharmaceuticals, devices and other technologies: Impact and Applications

Cairo, Egypt, Dec 2, 2014Second Inter-Country Meeting on Health Technology AssessmentEMRO/WHO

Reiner Banken [email protected]

Dima Samaha [email protected]

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Outline

• HTA for non pharmaceuticals

• HTA for pharmaceuticals

• Importance of links to policy tools

• Conclusion

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Health Technology Assessment for Improving Health Systems and Health

Health Technology

Appropriate Use

Efficient Health SystemsImproving population health

DecisionsPolicy Tools

Governance

HTA

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Reasoning in HTA

Effectiveness and safeness

Can it work here?

(here=context of decision-

making)Theoretical safety and

efficacyCan it work?

AppropriatenessShould we do it here?

ImplementationHow should we do

it here?

Research

Tra

nsla

tion

al r

esea

rch

Adapted from Health technology assessment of medical devices. WHO Medical device technical series, 2011. Available at: http://whqlibdoc.who.int/publications/2011/9789241501361_eng.pdf

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INESSS assesses technologies and health and social care interventions

HTA of drugs for listing purposes ( new active substances, generics, new formulations …)

HTA of laboratory tests for listing purposes Full HTAs ( health and social care interventions) Optimal use guides Clinical practice guidelines Rapid HTAs Methodological tools Collective prescriptions ( in collaboration with MSSS)

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Technology assessment pathway: Drugs vs devices

Drugs Devices

Market authorization (Health Canada): Safety and efficacy

Notice of compliance (NOC) and Drug identification number (DIN)

Licence for classes II, III et IV

HTA Mandatory

•Patented Medicine Prices Review Board• INESSS• Canada: CADTH + provinces

On demand (INESSS, Hospital based HTA units)•MSSS• Decision makers (managers..)• …

Financing Ambulatory use – list :• List• List under exceptional medication section• Do not list

•Hospitals - list• Patient d’exception

• MSSS• Hospitals• Agencies• Purchansing groups• Foundations•…

Post-financing • Optimal use guidance• Post-market surveillance• Implementation study

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Health CanadaHealth Canada

INESSSINESSS Professional associations, patient groups , users

Professional associations, patient groups , users

Ministre de la santé et services sociaux

Ministre de la santé et services sociaux

DecisionDecisionRecommendationRecommendation

Market authorizationMarket authorization

CSP- santé et services sociaux

CSP-analyses de biologie médicale

CSP- santé et services sociaux

CSP-analyses de biologie médicale

MSSSMSSS Regional agenciesRegional agencies

RAMQRAMQ HospitalsHospitals

SponsorSponsor

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1Non drug technologiesNon drug technologies

Adapted from CIRS, 2012

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HTA for listing of laboratory tests

• The Ministère de la Santé et des Services sociaux (MSSS) publishes the Répertoire québécois et système de mesure des procédures de biologie médicale, annually

• Until 2012, all tests submitted for entry were accepted by committee with minimal evidentiary requirements

• June 2012 : Expert committee on appropriateness recommended to put in place a permanent assessment mechanism for biomedical tests

• Mandate given to INESSS to develop and implement this mechanism

https://www.inesss.qc.ca/en/activites/procedures-de-biologie-medicale/general-information.html

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HTA for listing of laboratory tests

Assessment framework:

- Clinical utility, clinical validity, analytical validity

- Economic, organizational , ethical , professional, legal and social dimensions to be added progressively

Recommendations:-Entry, Entry conditional on certain conditions being respected, Refused entry, Reassessment

Time frame: 4 months

Output: 42 recommandations (2013 ), minimum of 30 per year

https://www.inesss.qc.ca/en/activites/procedures-de-biologie-medicale/general-information.html

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HTA for appropriateness:Production of a Tool for appropriate use of 14 laboratory tests

https://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Technologies/INESSS_Usage_judicieux_14_analyses_biomedicales.pdf

April 2014

A practical tool for clinicians

Impact on clinical practice to be determined

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SponsorSponsor

Health CanadaHealth Canada

INESSSINESSS Professional associations, patient groups , users

Professional associations, patient groups , users

Minister of health and social services-QUEBEC

Minister of health and social services-QUEBEC

RAMQRAMQ

Basic prescription drug insurance plan

List of Medications

Basic prescription drug insurance plan

List of Medications

List of Medications List of Medications

PMPRB

Patented Medicine Prices Review Board

PMPRB

Patented Medicine Prices Review Board

DecisionDecisionRecommendationRecommendation

Notice of complianceNotice of compliance

2a

2b

1Drugs Drugs

CSEMICSEMI

Adapted from CIRS, 2012

Institutions

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HTA for drug listing purposes

Health Canada gives market authorization for all of Canada

Drug listing at a provincial level

INESSS Rapport d’activités 2012/2013 http://www.inesss.qc.ca/fileadmin/doc/INESSS/DocuAdmin/Rap_act/RACT_IMP.pdf

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HTA for drug listing purposes

Act respecting the INESSS article 7

If the Institute considers that the therapeutic value of a medication has been established, it sends its recommendation to the Minister after assessing:

1. the reasonableness of the price charged

2. the cost-effectiveness ratio of the medication

3. the impact that entering the medication on the list will have on the health of the general public and on the other components of the health and social services system

4. the advisability of entering the medication on the list, given the purpose of the basic prescription drug insurance plan

http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=2&file=/I_13_03/I13_03_A.html

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HTA for drug listing purposes

Deliberative process : clinicians, pharmacists, ethicists, economists, citizens

Reports are public on the day of the decision Decision to list: Drug is made available to all Quebecers Private insurers have to make available all drugs on

public formulary May be added to hospital formularies

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HTA to guide optimal use: The example of Proton Pump Inhibitors (PPI)

Institut national d’excellence en santé et en services sociaux (INESSS). Avis sur le remboursement des inhibiteurs de la pompe à proton. Avis rédigé par Cédric Jehanno, Nicole Déry, Julien Baril, Lucy Boothroyd, Marie-Ève Brouard, Carole Chamberland, Michel Rossignol et Éric Tremblay. ETMIS 2013; 9(2): 1-63. http://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Medicaments/ETMIS2013_Vol9_No2.pdf

2001 2002 2012

Quebec the only province reimbursing all PPIs available on market: $197 million (nearly 7% of public plan) of which nearly 64% are attributed to innovator drugs

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Proton Pump Inhibitors: clinical differences?

From a clinical standpoint, evidence showed: Clinical differences are not statistically significant except for particular clinical circumstances (ie. in the case of drug interactions , pregnant women and children)No data demonstrating superiority of any PPINo proven efficacy and safety data that promote the use of one PPI over another in particular populationsException: PPI formulations for young children, severe dysphagia and nasogastric or gastrojejunal tubes

Institut national d’excellence en santé et en services sociaux (INESSS). Avis sur le remboursement des inhibiteurs de la pompe à proton. Avis rédigé par Cédric Jehanno, Nicole Déry, Julien Baril, Lucy Boothroyd, Marie-Ève Brouard, Carole Chamberland, Michel Rossignol et Éric Tremblay. ETMIS 2013; 9(2): 1-63. http://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Medicaments/ETMIS2013_Vol9_No2.pdf

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Proton Pump Inhibitors: funding modalities

Most cost-effective products are: rabeprazole>lansoprazole> pantoprazole> omeprazole>dexlansoprazole> esomeprazole

7 reimbursement scenarios of which : - maximum payable price vs conditional reimbursement

(médicament d’exception)- Preferential reimbursement of 1,2,3 or 4 PPIs with

price fixed at the price of lowest cost-effective generic

Institut national d’excellence en santé et en services sociaux (INESSS). Avis sur le remboursement des inhibiteurs de la pompe à proton. Avis rédigé par Cédric Jehanno, Nicole Déry, Julien Baril, Lucy Boothroyd, Marie-Ève Brouard, Carole Chamberland, Michel Rossignol et Éric Tremblay. ETMIS 2013; 9(2): 1-63. http://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Medicaments/ETMIS2013_Vol9_No2.pdf

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Proton Pump Inhibitors: guiding decision

makers?

Savings on an annual and recurrent basis (MPP)

32-41 M$

35-44 M$

35-56 M$

57 M$

Institut national d’excellence en santé et en services sociaux (INESSS). Avis sur le remboursement des inhibiteurs de la pompe à proton. Avis rédigé par Cédric Jehanno, Nicole Déry, Julien Baril, Lucy Boothroyd, Marie-Ève Brouard, Carole Chamberland, Michel Rossignol et Éric Tremblay. ETMIS 2013; 9(2): 1-63. http://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Medicaments/ETMIS2013_Vol9_No2.pdf

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Proton Pump Inhibitors: accompanying health professionals with implementation

Given impact on community pharmacies: INESSS supported communication efforts to patients, pharmacists, physicians and other health professionals affected by these changes Development of a collective prescription to support therapeutic substitution Delay of 6 months before implementation Put in place a measure to support reimbursement in exceptional cases

6 months later: Savings of 34.4 M$ and price reductions

Institut national d’excellence en santé et en services sociaux (INESSS). Avis sur le remboursement des inhibiteurs de la pompe à proton. Avis rédigé par Cédric Jehanno, Nicole Déry, Julien Baril, Lucy Boothroyd, Marie-Ève Brouard, Carole Chamberland, Michel Rossignol et Éric Tremblay. ETMIS 2013; 9(2): 1-63. http://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Medicaments/ETMIS2013_Vol9_No2.pdf https://www.inesss.qc.ca/en/publications/publications/publication/suivi-de-la-mesure-de-remboursement-des-inhibiteurs-de-la-pompe-a-protons-ipp.html

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Impact of HTA depends on links to policy instruments

In some countries there are specific mechanisms that lead to the incorporation into policy instruments of research such as Health Technology Assessments (HTAs) ….no direct link between the amount of money spent on HTA and its impact on the decision-making process. Indeed, they suggest that small programmes can be involved in the core of the policy-making structure whilst larger HTA programmes have difficulty in demonstrating impact….It seems clear that HTAs have had most impact in those situations where there are specific mechanisms in place that require research evidence to support well-defined policy decisions on provision, coverage or reimbursement.

Citation from Hanney et al. The utilisation of health research in policy-making: concepts, examples and methods of assessment. Health Research Policy and Systems 2003, 1:2

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Viscosupplementation for knee osteoarthritis

• 2007: Request by ministry of health for a reimbursement decisions

Results of HTA:- clinically modest relief from the symptoms over a period that

could last up to several weeks - impossible to identify patient subgroups more likely to

benefit from this treatment - could be offered as a last-resort treatment to patients who do

not achieve pain relief from conventional therapies or for whom these are contraindicated on an exceptional basis

Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS). La viscosuppléance pour le traitement de la gonarthrose. Rapport préparé par Pierre Dagenais et Alicia Framarin. ETMIS 2007;3(6):1-64. https://www.inesss.qc.ca/fileadmin/doc/AETMIS/Rapports/Traitements/ETMIS2007_Vol3_No6.pdf

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Viscosupplementation for knee osteoarthritis

• Implementation issue:- Administration is in outpatient settings therefore not

covered by the hospital budget- An exceptional mechanism does not exist for devices in

the public outpatient regimen

The lack of policy tool hindered the adoption and integration of a device with a favorable recommendation

Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS). La viscosuppléance pour le traitement de la gonarthrose. Rapport préparé par Pierre Dagenais et Alicia Framarin. ETMIS 2007;3(6):1-64. https://www.inesss.qc.ca/fileadmin/doc/AETMIS/Rapports/Traitements/ETMIS2007_Vol3_No6.pdf

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Conclusion

• The use of HTA is tailored to the the decision makers’ needs.

• The closer the HTA is linked to decision making processes, the greater the contribution to evidence-informed decision making.

• Governance mechanisms and policy tools are essential for effective HTA