It seems that the French are getting more comfortable with the idea of calling health-economics by its real name, and of carrying out explicit cost-effectiveness evaluations a la NICE in the UK. Equally worrying for pharma is that France — with its top-ranking pharma-per-capita spend — is also looking to its other neighbour, Germany, for ideas on how to further tighten entry hurdles for new pharmaceuticals.
The new HTA acronym to note: CEESP, the Commission d’Evaluation Economique et de Sante Publique (the commission for economic evaluation an public health). This body, until recently buried in an advisory capacity within the corridors of the country’s overarching drug reimbursement body, HAS, has had its teeth sharpened.
Thanks to the latest iteration of France’s finance and social security law, CEESP now has the same legal status as HAS’ powerful Transparency Commission (which basically determines reimbursability). It will analyse just how watertight companies’ economic models are for their new drugs, and that will inform decisions by the country’s drug pricing agency. Furthermore, the pricing agency may soon empower CEESP to carry out cost-effectiveness analyses of new drugs prior to reimbursement decisions.
To date, CEESP has only rarely commented on the cost-benefits of individual drugs. As such, its bumped-up role (with legal underpinning) marks “a big change,” noted Francois Meyer, head of international affairs at HAS, at a recent pricing and market access conference in London.
Currently all new drugs in France are assessed via a two-part process. First, researchers calculate a therapeutic value (SMR) based on whether alternative therapies exist and severity of the disease being treated to determine whether a drug merits reimbursement, and at what rate. Second, researchers assess the additional medical benefit a therapy provides of existing treatments (ASMR) to determine a pricing threshold; this decision feeds into negotiations between sponsors and the pricing committee (CEPS).
As such, there’s a link between clinical added-value and price, but drugs aren’t specifically given a cost-benefit score. “It’s not a [specific] process of economic evaluation,” says Meyer. Going forward, it may well be, as the goals of the pricing and health-economics committees converge – as their confusingly similar acronyms suggest they should – on cost-effectiveness.
QALY Will Feature, But Not Centrally
What drugs will be subject to such scrutiny, and what methods will CEESP use? How will its output be fed into the pricing committee’s decisions?
It’s unclear. But HAS (a supposedly independent body) will decide. And it late in 2011 published a set of 20 methodological guidelines (for now only published in French) that give some clue as to what its CEESP arm will be looking at.
Notably, the controversial quality-adjusted-life-year (QALY) measure prioritized by NICE does feature, and Meyer confirmed that “we don’t exclude a cost-per-QALY approach”. But it won’t be the linchpin of the assessment as it is at NICE, he added.
Still, having CEESP scrutinising the quality of health-economic data submitted to the pricing committee won’t make it any easier for drug firms to secure a decent price. But more systematic cost-benefit analyses, using whatever methodologies, may yet lead CEPS toward more conditional reimbursement based on outcomes, which it has said it wants to encourage, according to Johnson & Johnson, which experienced this with its anti-psychotic Risperdal Consta
Toward A Simpler, More Comparative Assessment Measure
Meanwhile, although France’s embrace of cost-benefit analyses won’t make things any easier, at least they may in future be simpler: HAS is proposing to merge the SMR and ASMR measures into just one, since they’re basically both comparative and having two “can jeopardize the predictability of our opinion,” claims Meyer. It seems the French are being inspired in part by Germany, whose new early-benefit-assessment system (AMNOG) slaps an added-benefit score on drugs which is then used in (downward-trending) price negotiations. “We will see what we can take from the AMNOG system,” said Meyer.
Flickr image by YoNoSoyTu courtesy of creative commons.