Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has reversed its negative recommendation for Gilead's Eviplera after the pharma company provided key study data.
The triple combination HIV pill was ruled in April to provide no additional benefit by the health technology assessment (HTA) advisers, despite rilpivirine – one of the Eviplera's components – being backed.
IQWiG said Gilead had failed to provide “important data” for Eviplera's first assessment under Germany's AMNOG legislation.
As a result IQWiG was unable to say whether it provided “added benefit”, in effect meaning it would hand a negative recommendation to the drug pricing watchdog the German Federal Joint Committee (G-BA), which is responsible for issuing final guidance.
IQWiG's new ruling was made possible after Gilead provided additional data from ongoing studies in the form of new subgroup analyses for Eviplera during the commenting period for the guidance.
“There is now proof that also in the fixed combination with emtricitabine and tenofovir disoproxil, rilpivirine offers a considerable added benefit for men infected with HIV-1. For women, the available studies provide corresponding indications. This matches the result of the dossier assessment of April 2012 on rilpivirine as a single agent,” IQWiG said in a statement.
Data from the manufacturer also suggested Eviplera may have fewer neurological side effects than monotherapy rilpivirine, but “a few uncertainties” in Gilead's analysis meant this was just an “indication of lesser harm”, IQWiG said.
Eviplera combines Tibotec and Johnson & Johnson's Edurant (rilpivirine) with Gilead's own double therapy Truvada (emtricitabine and tenofovir disproxil).
It was approved in Europe in November last year as a once-daily treatment for patients starting antiretroviral therapy for the first time.