The health technology assessment (HTA) landscape in France took on a new look last Autumn when amendments to social security legislation were introduced.
The headline-grabbing element of the 2012 Social Security Funding Law was that, as of October 2013, health economic evaluations are compulsory, in certain cases, as scrutiny of drugs and devices steps up a gear.
The direction of travel shouldn’t come as too much of a surprise, following the PIP breast implant health scare and the subsequent scandal around diabetes drug Mediator (benfluorex).
Economic evaluations may apply if, in its first two years, a drug’s sales are expected to exceed €20m
The fallout from the latter issue saw the country’s medicines regulator dissolved and a new body, the National Security Agency for Medicines and Health Products (ANSM), set up to replace it and restore confidence. The issues may have seen blanket coverage for French drug regulation, but market access for drugs in the light of the Social Security Funding Law has been significantly under-reported.
Long-term efficiencies not short-term savings
The legislation changes the main criteria for assessing a drug’s reimbursement level, which is no longer the severity of the condition being treated and will instead be based on a medicine’s efficacy. In addition, claims for innovation will now face more scrutiny.
The changes will see the French National Authority for Health (Haute Autorité de Santé or HAS), the country’s HTA agency, conduct parallel evaluations of a new medicine’s efficacy as well as its admission for reimbursement.
The agency’s Transparency Committee will take the lead on economic evaluation while the Public Health Committee (CEESP) will be in charge of evaluating their medicoeconomic benefits.
Despite the burden of the country’s healthcare spending, HAS stresses that the change in policy should not be viewed as a strategy that is simply about realising the greatest short-term savings, but rather one whose object is to achieve the best value in the medium to long term. Nevertheless, healthcare systems across Europe face the double challenge of health spending that is consistently higher than their gross domestic product – clearly an unsustainable situation in the long term – and the issue of an ageing population, which increasingly suffers from multiple chronic diseases and requires long-term medical management and social care outside hospitals.
In terms of how the process will work, the CEESP will publish a notice of efficiency that will be forwarded to the Comité Economique des Produits de Santé (CEPS), the inter-ministerial body in charge of setting drugs prices – after negotiating with manufacturers – for medicines deemed eligible for reimbursement.
Products that could be affected are those that:
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Could have a significant impact on health insurance expenditure
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Have an expected turnover of €20m after two years of commercialisation.
Even if a product’s sales forecast is expected to come in under the €20m threshold, its effect on health insurance expenditure, whether directly or through the changes it necessitates to care practices, could still see it become subject to an economic evaluation. Conversely, HAS says, some products whose estimated revenue exceeds the threshold may not justify an assessment of efficiency.
Manufacturers will be required to document these items in a ‘significant impact rating’ and, should companies decline, they will find that HAS stonewalls them when it comes to reimbursement decision requests.
Pharma will have to prove the effectiveness of its products in France more than ever before
The implications
These changes will force pharma to really focus on comparative effectiveness and cost effectiveness more than ever before in France.
As many in the industry are already finding in other markets, it won’t be enough to bolt-on these considerations after products have won marketing authorisation. They need to be anticipated – just as companies are beginning to do with appraisals by the National Institute for Health and Care Excellence (NICE) in the UK – during development.
But, unlike NICE or Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), there remains a lack of clear guidance on what could be requested and how it will be judged and this will add considerable uncertainty to the French market in the short- to medium-term. Ultimately the French pharmaceutical industry – and, indeed, all stakeholders – look set for an operating environment that is more complex and more challenging than ever before.