Oct 17, 2016
Emtricitabine/rilpivirine/tenofovir alafenamide in HIV: added benefit not proven
Research questions on adolescents not investigated / evidence on components not simply transferable to the combination
The drug combination emtricitabine/rilpivirine/tenofovir alafenamide (trade name: Odefsey) is approved for the treatment of adults and adolescents infected with human immunodeficiency virus type 1 (HIV-1). In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined whether in these patients this combination offers advantages over the appropriate comparator therapies. According to the findings, such an added benefit is not proven: No informative data were available for any of the four research questions. IQWiG did not accept the drug manufacturer’s postulate that the evidence on the individual drugs was transferable to the combination. It also did not accept the assumption that the same comparator therapies were appropriate for adolescents as for adults.
Adolescents not considered
The Federal Joint Committee (G-BA) distinguished four groups of patients according to treatment status and age. It specified different appropriate comparator therapies for treatment-naive adults, treatment-naive adolescents, pretreated adults, and pretreated adolescents.
The manufacturer did not investigate the two research questions for adolescents and justified this by claiming that adolescents only constituted a small proportion of the target population and that the guideline recommendations for adolescents and adults did not differ in principle. IQWiG did not accept these arguments: Adolescents are covered by the Summary of Product Characteristics for the drug combination and are therefore relevant for the benefit assessment. It cannot be concluded from the guideline recommendations that the appropriate comparator therapy is identical for adults and adolescents. This had no consequences for the benefit assessment, however, because no relevant studies had been identified anyway.
Evidence on components not simply transferable to the combination
No studies testing the new drug combination against the respective appropriate comparator therapy were identified for pretreated or treatment-naive adults either. Nonetheless, the manufacturer postulated a hint of a non-quantifiable added benefit for treatment-naive adults because the clinical evidence on rilpivirine and on emtricitabine/tenofovir alafenamide was transferable to the triple combination. These arguments were not supported with suitable clinical data, however, and were unsuitable for the derivation of an added benefit.
Hence an added benefit of the drug combination emtricitabine/rilpivirine/tenofovir alafenamide versus the appropriate comparator therapies is not proven for any of the four research questions.
G-BA decides on the extent of added benefit
The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.
More English-language information will be available soon (Sections 2.1 to 2.6 of the dossier assessment as well as easily understandable information on informedhealth.org). If you would like to be informed when these documents are available, please send an e-mail to info@iqwig.de.
