As a new one-off gene therapy for SMA nears the US market, effective pricing will be crucial in ensuring sustainabl… https://t.co/H7NpYRf7pg
The impact of pharmaco-economic analyses and efficiency opinions in France
2014 was marked by the completion of the first pharmaco-economic analyses in France, a move that highlights France's transition from a pricing model mainly based on clinical benefit towards a more economically-driven system. With four efficiency opinions published so far, it is about time we examine how the new pharmaco-economic evaluations impact market access conditions for innovative medicines in the country.
New pharmaco-economic analysis
Pharmaco-economic assessments became mandatory in October 2013 as part of the pricing process in France. The country traditionally only considered the therapeutic benefit of new drugs to inform pricing decisions. But the need to provide access to the latest innovation in a context of increasing prices and growing demand drove the country to introduce pharmaco-economic analysis as part of its pricing process. Such evaluation is now mandatory for products with a moderate to major improvement in therapeutic benefit with a significant impact on public finances.
A look back after one year
The so-called "efficiency opinions" issued by the HTA body CEESP provide a new decision-making tool that allows the pricing committee to discern cost-effective products.
Between October 2013 and October 2014, a total of 21 healthcare products entered the new process; and by the end of 2014, the CEESP had completed 12 economic evaluations, four of which are now publicly available. Many products subject to the economic evaluation are highly innovative medicines in the areas of hepatitis C virus (HCV) treatment, oncology, and vaccines, as well as drugs for extremely rare diseases.
The four efficiency opinions that have so far been published include Viiv Healthcare's Tivicay, Bayer's Adempas, Roche's Kadcyla and Gilead's HCV treatment Sovaldi. The price tag of the new generation of hepatitis C drugs being one of the dominant themes in the pricing and reimbursement space during 2014 and a spending limit being in place in France for those products, it is not surprising that 3 of them are currently being economically assessed in addition to Sovaldi. What is certain is that if Olysio, Harvoni and Daklinza were to face the same scenario as Sovaldi, manufacturers can expect to face significant pressure in their negotiation with the pricing committee, with a final price potentially below expectations.
Impact on pricing
The introduction of the PE assessment in the pricing process already showed to provide strong negotiation power to the French pricing committee. Even the European price level rule, which up to now guaranteed a price in the medium range among the EU5 markets in France for innovative medicines, is no more a due for manufacturers. Maintaining the list price within the European price level corridor could come at the cost of a lower net price for manufacturers with discounting and innovative agreements set to become more common in France.
No reference threshold
One aspect of the pharmaco-economic evaluation is still being discussed by the HAS: the reference threshold. There is indeed no consensus as to which financial threshold is acceptable when looking at the conclusions of the efficiency opinions. Its place within the decision-making process remains unclear and the HAS may need to issue additional guideline on that question. This is a point that clearly differentiates the CEESP from the National Institute for Health and Care Excellence (NICE), its counterpart in the UK, whose cost-effectiveness threshold is GBP30,000 per QALY.
While both manufacturers and pricing authorities in France are clearly undergoing a learning curve with some questions remaining unanswered, the CEPS pricing committee definitely now has stronger tools in hand both at launch but also throughout the product life. The economical evaluation will indeed impact pricing at launch but also repricing following re-evaluation of established medicines. As such, recourse to real world data in cost-effectiveness and clinical assessments is expected to become, as in many developed countries, a key aspect of the market access environment in France.
Anne-Charlotte Ackermann is a senior life sciences analyst for IHS
Published 25 March 2015
- Argentina announces innovative reimbursement deal for Spinraza
- New payment-by-results and payback regulations for Bulgaria
- Laying the Foundations of Pharmacare in Canada
- Zolgensma may be a potential game-changer for SMA
- India issues new clinical trial rules to expedite new drug approvals
- Medicare X
- Pharmacare for all in Canada: Unlikely proposal to imminent threat
- Accuracy check: Norwegian health expenditure data
India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Democrats explore creative ways to expand health insurance access with Medicare X https://t.co/kAsNBvtiuz