GVS advice on extension of List 2 reimbursement conditions of subcutaneous CGRP inhibitors
The National Health Care Institute assessed whether the reimbursement conditions of the subcutaneous CGRP inhibitors erenumab (Aimovig®), fremanezumab (Ajovy®) and galcanezumab (Emgality®) can be extended. These medicines are self-injectable under the skin. They are already eligible for reimbursement via the Medicine Reimbursement System (GVS) albeit with specific restrictions. They reduce the number, duration and severity of migraine attacks in approximately 20 percent of patients, who experience frequent or long lasting episodes of headaches and migraine. Currently the National Health Care Institute lacks adequate financial information from the marketing authorisation holders to determine whether they provide adequate therapeutic value in comparison with their costs. Until this is clear, it is not possible to provide the Minister of Health, Welfare and Sport (VWS) with a reliable and valid advice on their reimbursement also for episodic migraine.
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Indication for which extension of List 2 reimbursement conditions is requested
Erenumab, fremanezumab and galcanezumab are eligible for reimbursement via the GVS albeit with specific restrictions, the so-called List 2 reimbursement conditions. When used in adults for the treatment of chronic migraine in line with these conditions, the expenses are reimbursed. A person with chronic migraine suffers headaches on at least 15 days per month and with migraine on at least 8 of them.
The marketing authorisation holders of these CGRP inhibitors also claimed reimbursement, when they are used as a final treatment option in adults with episodic migraine. In episodic migraine a person suffers headaches less than 14 days per month and with migraine on at least 4 of them. Treatment with a CGRP-inhibitor is considered a final treatment option after treatment failures with 5 other categories of migraine medicines, as recommended in the applicable Dutch guidelines. These are (in no particular order): angiotensin receptor blockers (candesartan), betablockers (metoprolol or propranolol), antiepileptics (topiramate or valproate), a calcium receptor antagonist (flunarizine) and a tricyclic antidepressant (amitriptyline).
Advice from the National Health Care Institute
The National Health Care Institute could not complete its assessment on extending the reimbursement of these CGRP inhibitors also for episodic migraine. This is because it cannot reliably calculate whether their price is socially acceptable. The marketing authorisation holders did not submit all financial information that is required to determine whether the costs of CGRP inhibitors are reasonable in relation to the benefits, which they provide for patients and society. In other words, whether they are ‘cost-effective’. Several essential data are missing. Hence the National Health Care Institute could not provide the Minister of Health, Welfare & Sport with a well-considered advice on their reimbursement for episodic migraine. The Minister of Health, Welfare and Sport considers 'cost-effectiveness' a decisive factor for the inclusion of expensive medicines in the basic health care package. The CGRP inhibitors are expensive, because their estimated annual costs amount to more than €10 million in total.
However, the National Health Care Institute did conclude that the effectiveness of CGRP inhibitors in this indication was well-documented. Clinical studies show that they work in 25% of people with episodic migraine. Treatment with these medicines reduces the number of migraine days per month with 50%. For people with episodic migraine also other less expensive migraine medicines are available in the basic health care package. They are just as likely to be effective as CGRP inhibitors. However, a CGRP inhibitor has far less side effects and is therefore more appealing for long-term use.
Medicine Reimbursement System (GVS)
Erenumab, fremanezumab and galcanezumab are outpatient medicines. These are drugs for home use. They can be obtained at the pharmacy with a doctor’s prescription, but will only be reimbursed from the basic health care package when listed in the GVS. The level of reimbursement depends on its classification in the GVS. Interchangeable drugs are included in the same cluster in GVS List 1A. These may be subject to a reimbursement limit. Unique medicines are included as such in GVS List 1B. There is no reimbursement limit for these medicines. However, additional conditions may apply. If so, this medicine is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute about the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.