Doravirine (Pifeltro®) for the treatment of adults infected with HIV-1
The National Health Care Institute has completed its assessment whether Pifeltro® (doravirine) can be included in the Medication Reimbursement System (GVS). Pifeltro® is registered for the treatment of adults infected with HIV-1. The advice of the National Health Care Institute is to include Pifeltro® in Appendix 1B of the Health Insurance Decree.
Assessment
The Minister of Health, Welfare and Sport (VWS) asked the National Health Care Institute to carry out a substantive assessment of whether the medicinal product Pifeltro® 100 mg/25 mg film-coated tablet can be included in the Medicine Reimbursement System (GVS). In the letter, the Minister also asked for an assessment of Delstrigo® 100 mg/300 mg/245 mg film-coated tablet. Though both products contain doravirine, they do not have the same composition, which is why these two products are dealt with separately. This advice relates only to the assessment of Pifeltro®.
Each Pifeltro® tablet contains 100 mg doravirine, a new antiretroviral product belonging to the group of non-nucleoside reverse transcriptase inhibitors (NNRTIs). Pifeltro® is registered, in combination with other antiretroviral products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI-class. The dosage of doravirine is 1 tablet once daily, together with the other antiretroviral medicinal products.
The advice of the National Health Care Institute
Pifeltro® (doravirine) can be included in the GVS on Appendix 1B of the Health Insurance Decree.
HIV-inhibiting medicinal products have held a special place within the GVS
The HIV-inhibiting medicinal products have held a special place within the GVS since 2000. All antiretroviral medicinal products for the treatment of HIV infection are, in principle, eligible for inclusion on Appendix 1B of the Health Insurance Regulation. No pharmacoeconomic analysis is required for these medicinal products. This means no assessment of their interchangeability is needed.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.