PARIS, Dec 19 (APM) - The French national authority for health (HAS) has published the cost-effectiveness opinion by the economic and public health evaluation commission (CEESP) on Gilead’s HCV drug Sovaldi (sofosbuvir).

The decision published online on Thursday is the third CEESP opinion to be made public, following those for ViiV Healthcare’s HIV drug Tivicay (dolutegravir) and Roche’s cancer drug Kadcyla (trastuzumab emtansine) earlier this month (APMMA 40742).

This publication has come after the drug obtained the price at which hospital pharmacists can dispense it to out-patients (41,000 euros before tax for a 12-week course) on November 20 (APMMA 40512). The opinion is dated April 15.

As announced, the price the pharma company requested has been kept secret. The opinion was drafted while Gilead marketed the drug within the framework of a group temporary authorisation (ATU de cohorte) at 56,000 euros before tax for a 12-week course.

The opinion reveals that Gilead claimed a clinical benefit ranking of ASMR II (important) for its drug and this is the ranking it obtained, in all but one indication, from the Transparency Commission (CT) (APMMA 38510).

Gilead proposed cost-efficacy ratio calculations in 16 cases depending on the genotype, on whether the patient had already received HCV treatment, on whether the patient was co-infected with HIV and eligibility for interferon or not, but not on fibrosis stage.

The resulting “ratio differentiel coût-résultat - RDCR,” incremental cost-effectiveness ratio (ICER) works out at between 7,335 and 75,518 euros per quality-adjusted life year (QALY) gained. The ICER is below 30,000 euros in 14 cases out of 16.

CEESP says the method selected by the pharma company “is considered acceptable although it raises substantial reservations in comparison with HAS methodological recommendations”.

“These reservations do not compromise the validity of the study but they increase the uncertainty concerning the result. (They) concern the strategy evaluated, the validity of the efficacy data, the sensitivity analyses and the presentation of the results,” says CEESP that considers that calculating a mean cost-efficacy ratio in the entire HCV population is “not methodologically acceptable”.

The commission notes that the “data supplied did not make it possible to inform on the impact of variations in sofosbuvir price on the ICERs”.

“The structure of the model does not address the analysis of the efficiency of sofosbuvir depending on the fibrosis stage at which treatment is planned,” CEESP also emphasises. The drug was registered for reimbursement essentially in the following liver fibrosis stages “severe F2”, F3 and F4.

CEESP has informed the French economic committee for health products (CEPS) that pre- or post-liver transplant treatment has not been covered in its model.

It specifies that the economic model presented to it “did not evaluate a strategy aiming to eradicate the virus. Evaluation of a treatment within a perspective of eradication should pay particular attention to the hypotheses used concerning the levels of patients diagnosed and the risk of re-contamination of cured patients”. The perspective of eradication was rejected in a recommendation by the HAS board published in July (APMMA 38962).

Finally, the file submitted by Gilead did not comprise a budgetary impact study.

eh/aki/rs