PARIS, Dec 24 (APM) - The French national authority for health (HAS) has reviewed global methods for determining upper cost thresholds for quality-adjusted life years (QALYs), known in France as reference values, as it considers a way forwards for its relatively new assessment process.
A review of health literature has shown there are broadly differing approaches to setting QALY thresholds, with some countries such as the UK, setting ‘arbitrary’ limits, while other countries place a value on life-year based on health costs, HAS revealed in a document on its website on Friday.
While France’s experience of cost-effectiveness evaluations is still limited, it is considering the value of having QALY thresholds as part of the assessment process, and the usefulness and limitations of such a concept.
To interpret a cost-effectivess analysis where the product evaluated is both more effective and more costly than the comparator products, there is an interpretation rule that involves considering a product cost-effective if its cost per QALY gained is below a particular reference value.
Currently no such value has been set in France and only a very few institutions have adopted such values. In the UK, NICE formulates a high probability of recommendation if the ICER is below 20,000 pounds (25,500 euros), and a recommendation if the ICER is below 50,000 pounds (63,700 euros).
In Oregon in the U.S., the maximum threshold is set at $125,000, and in the Netherlands it is set at 80,000 euros. The World Health Organization (WHO) considers a product commercially viable if the ICER (in disability-adjusted life years) is less than three times the gross domestic product per capita.
The literature review points out that none of these values “explicitly claims” to relate to the methods identified by HAS to calculate a reference value.
In the UK and Oregon, the values used are not explicitly justified, according to HAS. The value adopted by the Netherlands relies on several references and particularly on the annual cost of a long hospital stay patient (60,000 euros), the WHO standard (90,000 euros) and the value of a statistical life established at 71,000 euros.
HAS lists four methods available to determine a reference value rationally: an empirical method, one based on individual preferences, another established using health gain under budgetary constraint and, finally, one that is set using statistical value defined in other economic sectors.
Concerning the latter, a report by France’s Commission for strategy and foresight (CGSP) established a value for a year of life saved at 115,000 euros. The CGSP plans to transpose this value to the health sector, provided it manages to integrate quality of life in its estimate, HAS says.
To decide on reimbursement, discounting two exceptions (UK and Oregon) interpretation of cost-effectiveness is never presented as a binary rule. On the subject of price, there are few systems that set prices based on value, the document shows. In Germany, the system based on the therapeutic added-value of a product only intervenes in cases where negotiation fails.
In France, there is not yet data to determine the place of cost-effectiveness opinions in the negotiation process, according to HAS.
Cost-effectivess evaluations of health products, included in the social security funding law (LFSS) for 2012, began in October 2013 for health products for which a clinical benefit ranking of major, important or moderate (ASMR I, II or III) is claimed by the drug company.
HAS on Friday announced, during a symposium on cost-effectiveness, that of 26 files examined by the economic and public health evaluation commission (CEESP) (25 drugs and a medical device), 15 have been validated and three opinions published.
The incremental cost-effectiveness ratios (ICERs) are highly variable ranging from under 30,000 euros per quality-adjusted life year (QALY) gained in the case of five files, to over 100,000 euros in three others.
CEESP would like to “progress to qualification of the ICERs” even in the absence of an upper ‘reference value’ or QALY threshold, beyond which authorities would refuse to reimburse a drug or medical device (APMMA 40892).
In this context, in order to “enlighten the decision-maker and the public on the expectations of the economic calculation,” last week HAS published a review of the scientific literature on cost per QALY thresholds.
vib/aki/hlc
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