HTA and managed entry practices in Europe - Pharmaceutical industry perspective. Edith FRENOY Director Market Access EFPIA

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1 HTA and managed entry practices in Europe - Pharmaceutical industry perspective Edith FRENOY Director Market Access EFPIA Piperska workshop 19 March 2011

2 EFPIA members are committed to demonstrating the added value of their innovative medicines with high quality, transparent data

3 A few principles Health Technology Assessment (not only medicines...) HTA to address allocation of healthcare resources rather than only assessing individual treatment options HTA to go beyond relative efficacy and relative effectiveness and address aspects of value such as severity of disease; degree of medical need and impact on disease management HTA to provide appropriate signals to incentivise research

4 Assessment of clinical added value at the time of launch If economic evaluation, use of variable thresholds to reflect public health priorities Follow-up of products in real life HTA trends in Europe

5 Historically: one-off licensing MA Warning, DHPC Withdrawal backlash Level of understanding of benefitrisk Drug Development Phase PhV PhV, other sources Time 5

6 Level of understanding of benefitrisk What it should be: a live-licence approach Earlier (conditional?) MA MA Amended MA/SmPC, Communicate Matched by a live-access approach: i.e. evidence based licensing, reimbursement and medicine Drug Development Phase PM-studies, PhV Amended MA/SmPC, Communicate Outcomes Research Time 6

7 Why following products? Because of UNCERTAINTIES about the effects of a product on the patient and on the healthcare system About clinical and/or cost-effectiveness About utilisation About budget impact

8 Patients are different

9

10 Following products with managed entry agreements Arrangement between a manufacturer and payer/provider that enables access to (coverage/reimbursement of) a health technology subject to specified conditions European Commission, Platform on Access to Medicines in Europe, Managed Entry Agreements Workstream, Terms of Reference

11 Towse and Garrison: Pharmacoeconomics 2010; 28 (2):

12 AGREEMENTS BETWEEN PAYERS AND MANUFACTURERS TRADITIONAL CONTRACTING/ TENDERING VALUE BASED AGREEMENTS Rebate Discount Pricevolume Portfolio deals Performancebased agreements Financial agreements Service agreements Price is only relevant attribute Value of innovation is ignored Impacts future product values Results in downwards spiral Value attributes are most relevant Value of innovation is secured Supports future product values Results in reassurance of value

13 For industry PROS Access to market for promising technologies Best performance of product through targeted use CONS Costs/bureaucracy required for implementation of agreement Payback/price reductions if pre-agreed outcomes are not met Limited access if budget cap is reached Real-world clinical effectiveness of a technology could be compared with comparators effectiveness in controlled trials Klemp at al, INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 27:1, 2011

14 For payers PROS Provide the technology in such a way that it demonstrates value Provide early access for patients and share risk with manufacturer if the product is not performing as agreed Limit total budget impact Build evidence base to resolve uncertainties CONS Costs/bureaucracy required for implementation of agreement Duplication of schemes with lack of transparency Managing multiple schemes in small providers Possible need to withdraw technologies at the end of theagreement/difficult to withdraw once in practice Klemp at al, INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 27:1, 2011

15 For patients / society PROS Access to promising technologies thus permitting greater choice or only possible treatment Investment in innovation is promoted CONS Barriers to participation in MEA (such as administration in specialist center) Risk that the product does not show the benefit that is expected Possible withdrawal of a technology at the end of the agreement Data protection issues Other more robust research is not undertaken Klemp at al, INTL. J. OF TECHNOLOGY ASSESSMENT IN HEALTH CARE 27:1, 2011

16 The future

17 Targeted medicines Today Future Today we diagnose and treat based on symptoms and a subjective interpretation of symptoms In the future we diagnose and treat based on biology and select medication based on an objective evaluation of the benefit/risk for the individual patient

18 Goh K et al. PNAS 2007;104: by National Academy of Sciences

19 2007 by National Academy of Sciences Goh K et al. PNAS 2007;104:

20 Targeted reimbursement? Value-based pricing at country level Differential pricing at EU level Make valuable innovations accessible to all EU citizens requires solidarity within and solidarity between Member States (EU Belgian Presidency, Innovation and Solidarity in Pharmaceuticals)

21 A vision Every patient is followed for outcomes Data is used by regulators to follow benefit-risk by payers to devise policy on usage by providers and patients to optimise care for B2B negotiations between industry and payers (eg managed entry) as opposed to outdated price controls In the end: the only thing that matters is whether patients get the medicines and if they benefit!

22 Thank you