Erenumab (Aimovig®) for the prophylaxis of adults with migraine
The National Health Care Institute has completed its assessment whether erenumab (Aimovig®) for the prophylaxis of adults with migraine, can be accepted into the Medicine Reimbursement System (GVS). For now, the National Health Care Institute's advice is not to include this medicinal product in the insured package.
Registered indication
Erenumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Reimbursement is being requested for 2 subgroups within the registered indication of erenumab. These are adult patients with:
- Chronic migraine, without medication overuse, as 1st line treatment;
- Episodic migraine with at least 4 migraine days per month, with insufficient response – or a contraindication or intolerance – to at least two other preventive medicinal treatments (candesartan and one beta-blocker (metoprolol or propranolol)).
Assessment
Scientific advice from the Dutch Neurologists’ Association (NVN), suggests to use erenumab instead of topiramate for both episodic migraine and chronic migraine, because of its more favourable safety profile. For this reason, in assessing erenumab, the National Health Care Institute regards usual treatment with the orally administered topiramate as the comparative treatment.
It is therefore a missed opportunity that the manufacturer did not carry out any study comparing the effect of erenumab directly with that of topiramate. The National Health Care Institute therefore indirectly compared older studies using topiramate with newer studies with erenumab. The comparison was hampered by the fact that these studies all had different set-ups, and the patients were not entirely comparable either. The National Health Care Institute concludes that the therapeutic value of erenumab is equal to that of topiramate. No difference was found in the number of days that patients suffered from migraine; it was the same for erenumab and topiramate. Nor was a difference found in the chance of suffering severe side effects or in the number of patients who stopped treatment due to side effects. In fact, if the National Health Care Institute corrects for the study differences, in the short term, no chance of a difference was demonstrated in the number of patients stopping treatment due to side effects. Furthermore, possible long-term side effects of erenumab are not known.
The National Health Care Institute's advice
The therapeutic value of erenenumab is equal to that of topiramate. Based on the criteria for interchangeability, erenumab is not eligible for inclusion on List 1A. Nor is erenumab eligible for inclusion on List 1B. In the event of an identical therapeutic value, the inclusion on List 1B would only be acceptable if it does not involve additional costs to the pharmacy budget. The additional costs are, however, considerable, being estimated at circa €73.5 million.
The National Health Care Institute proposes, with due heed to the Minister's response, to take the initiative and invite the professional group to join them in exploring the possibility of creating a subgroup for which evidence of the medicine’s added value can be found.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.