GVS advice CGRP inhibitors erenumab, fremanezumab, galcanezumab (Aimovig®, AJOVY®, Emgality®) for the treatment of patients with episodic and chronic migraine
The National Health Care Institute has completed its assessment whether the CGRP inhibitors erenumab, fremanezumab, galcanezumab (Aimovig®, AJOVY®, Emgality®) are interchangeable and can be included in the Medication Reimbursement System (GVS). CGRP inhibitors are used for the treatment of patients with migraine. Our advice is to include these medicinal products in a new group of interchangeable medicinal products in List 1A of the GVS. Because the added value for a subset of the registered indication has been established, the National Health Care Institute advises the minister of Medical Care to attach a reimbursement condition to the inclusion in the GVS. The responsibility for determining appropriateness agreements lies with the neurologists and the health insurers.
In 2019, the National Health Care Institute already issued an advice on the CGRP inhibitor erenumab. At the time, the request for advice was related to an indication for a group of patients with episodic and chronic migraine. The National Health Care Institute at the time concluded that erenumab has the same therapeutic value as the medicinal product topiramate. Because of the considerable additional costs, the National Health Care Institute advised the minister not to include erenumab in the GVS.
In this advice, we also indicated that the National Health Care Institute would take the initiative to explore, together with the physicians’ association, whether there is a subset of patients for which evidence can be produced that a CGRP inhibitor such as erenumab has added value. In that exploration, the National Health Care Institute also wanted to include the two CGRP inhibitors fremanezumab and galcanezumab that had since become available. This intention to conduct further consultation was prompted by the observation that chronic migraine is a very debilitating disorder with a high burden of disease, with some of the patients not benefiting from existing medicinal products. For these therapy-resistant patients there is a clear medical need for new medicinal products such as CGRP inhibitors.
On the basis of the available evidence, in consultation with neurologists, a subset of patients with therapy-resistant chronic migraine has been defined, for whom CGRP inhibitors have added value. The joint marketing authorisation holders have subsequently submitted an application for reimbursement for this subset of patients.
The National Health Care Institute has concluded that the above CGRP inhibitors have a therapeutic added value compared to placebo in patients with chronic migraine who do not sufficiently benefit from topiramate/valproate and botulin toxin A. In clinical studies, 20% of patients with therapy-resistant chronic migraine had a clinically relevant effect from the use of a CGRP inhibitor, i.e. halving the number of days of migraine per month.
On the basis of the criteria for interchangeability, the CGRP inhibitors erenumab, fremanezumab, galcanezumab (Aimovig®, AJOVY®, Emgality®) can be placed directly together in a new cluster to be formed in List 1A for the prophylaxis of therapy-resistant chronic migraine.
Budget impact analysis
Inclusion of the CGRP inhibitors in the GVS List 1A in this newly formed cluster for the subset of patients for which added value has been established will be accompanied by additional charges for the pharmaceutical budget of € 11.9 million to € 15.7 million, depending on assumptions about the number of patients. The National Health Care Institute based this calculation on the average cost per year of the three products.
Since only a proportion of patients with therapy-resistant migraine eligible for treatment with CGRP inhibitors respond to the treatment, it is important that the operationalisation of start and stop criteria is recorded in the appropriateness agreements. In the context of appropriate care, we call on parties (healthcare providers and health insurers) to finalize the appropriateness agreements within one month.
The National Health Care Institute's advice
The National Health Care Institute advices to include the CGRP inhibitors erenumab, fremanezumab and galcanezumab (Aimovig®, AJOVY®, Emgality®) in a newly formed group of interchangeable medicinal products in List 1A. Because we have determined that a CGRP inhibitor only adds value to patients with chronic migraine who do not benefit from topiramate or valproate and botulin toxin A, we recommend that you attach the following condition to the inclusion in the GVS. These conditions are:
only for insured persons 18 years and older with chronic migraine after exclusion or treatment for headache medication overuse and after failing prophylactic treatment with:
(a) at least two months of topiramate or valproate in adequate doses and
(b) at least two attempts with botulin toxin A (6 months) in accordance with the PREEMPT protocol,
unless it is an insured person with chronic migraine who, prior to or on 17 September 2021, was already treated with a CGRP inhibitor under a managed access programme.
We also recommend that patients with chronic migraine who are already using a CGRP inhibitor as part of a MAP be exempt from this condition, partly due to the implementation issues identified by the neurologists.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.