GVS advice fostemsavir (Rukobia®) for the treatment of adults with multidrug resistant HIV-1 infection
The National Health Care Institute has completed its assessment whether the medicinal product fostemsavir (Rukobia®) can be included in the Medicine Reimbursement System (GVS). Fostemsavir is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen. The National Health Care Institute advises the Minister to include fostemsavir (Rukobia®) on List 1B and List 2 of the Health Insurance Regulation.
Indication for which reimbursement is requested
Per tablet, Rukobia® contains 600mg fostemsavir, an antiretroviral drug with a new mechanism of action compared to current HIV-inhibiting medicinal products. Fostemsavir is an attachment inhibitor from a new therapeutic class.
Fostemsavir, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen. The recommended dose is 600 mg twice a day.
The marketing authorisation holder claims that this medicinal product, in combination with other antiretroviral drugs, has a therapeutic added value for the treatment of adults for whom it is otherwise not possible to construct a suppressive anti-viral regimen. The application is related to the placement of fostemsavir (Rukobia®) on List 1B of the Health Insurance Regulation.
The National Health Care Institute's advice
The National Health Care Institute recommends the Minister to include fostemsavir (Rukobia®) in the GVS on List 1B and List 2 of the Health Insurance Regulation.
For all antiretroviral drugs, condition 8 applies:
- Only for an insured person who has a medical indication for treatment with such a medicinal product for which the medicinal product is registered under the Medicines Act, provided that this medicinal product does not belong to the insured benefits if it is used as a pre-exposition prophylaxis to reduce the risk of infection with the human immunodeficiency virus.
In addition, we recommend the following additional condition for fostemsavir:
- Only for an insured person with a multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.