Early access or speed kills? A payer s perspective

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Philomena Russell
6 years ago
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1 Dürfen lebenswichtige Medikamente Early access or speed kills? A payer s perspective Health as the real winner: Presidency Conference on Options to Provide Better Medicines for All Sofia, , Director General Dr. Josef Probst Main Association of Austrial Social Security Institutions

2 Why are we talking about early access? Fast access to safe and effective therapies! Health for all! Sustainability! Time to market = Time to money! 1

3 Current status: two procedures Two procedures: Source: Eichler HG. Nat Rev Drug Discov. 2010;9(4):277-91; 2

4 EMA - existing approval tools Source: EMA Final report on the adaptive pathways pilot

5 Market authorisation vs. added value? 68 new oncologic indications authorised (2009 and 2013): At the time of market authorisation: No evidence on improvement in overall survival or quality of life Mehr als 3 Jahre nach Markteintritt: 33 keine Verbesserung der Endpunkte Gesamtüberleben und Lebensqualität 6 Source: Davis et. al.: Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals , in: BMJ. 2017; 359: j

6 Market authorisation vs. added value? 68 new oncologic indications authorised (2009 and 2013): At the time of market authorisation: No evidence on improvement in overall survival or quality of life More than 3 years after market authorisation: 33 No evidence on improvement in overall survival or quality of life 6 Source: Davis et. al.: Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals , in: BMJ. 2017; 359: j

7 Evidence at market authorisation 72 trials for market authorisation of cancer drugs (2009 and 2013): Add on therapy 22% No comparator 10% Active comparator 33% Placebo controlled 35% Source: Davis et. al.: Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals , in: BMJ. 2017; 359: j

8 Conditional approval: added value? EMA Conditional Approval ( ) and their Prescrire ratings Not acceptable 27% A real advance 0% Bravo 0% Offers an advantage 18% Possibly helpful 18% Judgement reserved 28% Nothing new 9% Sources: Joint Briefing Paper from Health Action International et al. (2015); 7

9 Time to market: authorities under pressure years of research up to 180 days until decision on reimbursement up to 277 days until marketing authorisation Up to 25,5 years of patent protection Source: Pharmig; EMA; 8

Time to market: authorities under pressure up to

180 days until decision on the 10-12 years of

reimbursement marketing authorisation up to 277

years of patent protection Source: Pharmig; EMA;

10 Time to market: authorities under pressure up to 180 days until decision on reimbursement up to 180 days until decision on the years of research up to 277 days until application for reimbursement marketing authorisation up to 277 days until marketing authorisation Up to 25,5 years of patent protection Source: Pharmig; EMA; 9

11 Restriction to access: affordability Cost of cancer drugs per capita (in 2014 prices) 2005 and 2014 Source: Jönsson, B. IHE Report 2016:4, IHE: Lund. 10

Orphan drugs the price of rarity Orphans are given an advantage in the clinical approval process, while orphan prices often stay the same or at a similar level even as indications are added and the

12 Orphan drugs the price of rarity Orphans are given an advantage in the clinical approval process, while orphan prices often stay the same or at a similar level even as indications are added and the orphan status no longer applies. Strensiq (Asfosfatase alfa): for the treatment of a rare bone disease, Licensed 2015: data of 71 patients, improvement of joint structure visible on x-rays, increase in body height, not a cure, longer survival? Yearly costs for a baby weighing 4 kg up to 2 Mio. for an adult of 80 kg* * Health insurer s price

New developments new prices Treatment of acute lymphoblastic leukemia Treatment cost $ 475.

yet available Treatment of some forms of non-hodgkinlymphoma Treatment cost $ 373.

13 New developments new prices Treatment of acute lymphoblastic leukemia Treatment cost $ /patient Serious adverse effects Long-term data relevant for efficacy and safety not yet available Treatment of some forms of non-hodgkinlymphoma Treatment cost $ /patient Serious adverse effects Long-term data relevant for efficacy and safety not yet available

14 Global trend: from blockbuster to nichebuster 13

Council of the EU concerns Council conclusions on the strengthening the balance in the pharmaceutical systems in the EU and its Member States: [ ] NOTES WITH CONCERN an increasing number of examples

15 Council of the EU concerns Council conclusions on the strengthening the balance in the pharmaceutical systems in the EU and its Member States: [ ] NOTES WITH CONCERN an increasing number of examples of market failure in a number of member states, where patient acces to effective and affordable essential medicines is endangered by very high unsustainable price levels [ ] [ ] NOTES WITH CONCERN that companies may seek very high prices while the added value of some of the products is not always clear [ ] Source: Council Conclusions ( ) 14

16 Concerns from payers/hta 15

17 Patients: aware of the risks associated with early access Source: European Consumer Organisation 16

18 Reimbursement & access Market authorisation Evaluation & Negotation Reimbursement & access Regular approval Early access 17

19 18

This video gives an overview of the centralised procedure at the European Medicines Agency

This video gives an overview of the centralised procedure at the European Medicines Agency In Europe today, all medicines must have a marketing authorisation before they can be used by patients And there