Package advice eptinezumab (Vyepti®) for the treatment of migraine
The National Health Care Institute has assessed whether the CGRP inhibitor eptinezumab (Vyepti®) can be reimbursed from the basic health care package. This medicine can be used to prevent chronic migraine in certain patients for whom migraine medication does not work (sufficiently). The reason for this advice was the placing of the medicinal product in the so-called ‘lock procedure for expensive medications’. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to reimburse eptinezumab for the above condition from the basic health care package after price negotiations, provided that the total cost including hospital costs does not exceed the average cost of treatment with 1 of the 3 CGRP inhibitors already being reimbursed.
Previous advice from the National Health Care Institute on CGRP inhibitors
The National Health Care Institute previously gave its advice on 3 other CGRP inhibitors: erenumab (Aimovig®), fremanezumab (Ajovy®) and galcanezumab (Emgality®). These are already being reimbursed from the basic health care package. The advisory reports concerned were the following:
Indication for which reimbursement is requested
Eptinezumab can be used to prevent migraine in adults who have at least 4 monthly migraine days.
The reimbursement applies to the same patients who are eligible for the 3 CGRP inhibitors that are already being reimbursed: erenumab (Aimovig®), fremanezumab (Ajovy®) and galcanezumab (Emgality®). These CGRP inhibitors are administered by subcutaneous injection. A patient can do this at home. However, eptinezumab must be administered once a quarter under medical supervision in the hospital. This is done intravenously and with an infusion. Intravenous means that it is administered directly into a vein.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of VWS to reimburse eptinezumab from the basic health care package for the condition mentioned above, for an equal net price including hospital costs and the same conditions as the 3 CGRP inhibitors already being reimbursed. This means that the total cost including hospital costs should not exceed the average cost of treatment with 1 of the 3 CGRP inhibitors already being reimbursed.
Lock procedure for expensive medicinal products
The Minister has placed eptinezumab in the ‘lock procedure for expensive medicinal products’. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic health care package until:
- there is a positive package advice from the National Health Care Institute;
- arrangements and safeguards have been made for the appropriate use;
- price reductions have been successfully negotiated with the manufacturer.
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.