Conditions
The Zorginstituut attaches conditions to the reimbursement: only patients with chronic migraine who do not respond to 2 other treatment methods that are already reimbursed are eligible. Healthcare providers and health insurers still have to make clear agreements about appropriate use, such as start and stop criteria if the inhibitors do not give sufficient results for a patient.
Healthcare institute: waiting for new application for episodic migraine
The Zorginstituut also asks the minister to make an exception for a group of 400 to 500 people with chronic migraine. They have not always gone through all the treatment stages with the 2 other medicines, but they are already using the inhibitors because they have participated in a so-called Managed Access Program of the pharmaceutical companies.
Episodische migraine
People with episodic migraines are not yet reimbursed for the CGRP inhibitors. The reason for this is that no research file has yet been submitted to the Zorginstituut that can substantiate for which group of patients with episodic migraine these drugs have real added value. As soon as the pharmaceutical companies submit their application, the Zorginstituut can start an assessment. With episodic migraine, a person has fewer than 14 headache days per month.
Only proven effective in a small proportion of patients with chronic migraine
The 3 CGRP inhibitors that have been evaluated are: erenumab (Aimovig®), fremanezumab (AJOVY®), and galcanezumab (Emgality®). The scientific research provides evidence that these drugs work in patients with chronic migraine who are treatment-resistant to the 2 other migraine drugs that are included in the basic package. At 20%, the number of migraine days per month is halved. For them, this means a huge improvement in their quality of life. With chronic migraine, someone has a headache for at least 15 days a month, of which at least 8 days are migraines.
Second Assessment of CGRP Inhibitors
The Zorginstituut has previously (in 2019) assessed erenumab for the treatment of patients with both chronic and episodic migraine. At the time, our advice to the minister was not to reimburse the drug from the basic package, because erenumab did not demonstrably work better and was also much more expensive than the existing migraine drugs.
Major consequences of migraine
Because migraine has major consequences for patients’ daily lives, the Zorginstituut subsequently took the initiative to explore, together with the care providers and patient associations involved, for which group of migraine patients the CGRP inhibitors could be of added value. The outcome of this was that this is the case for patients with chronic migraine who do not (no longer) respond to the existing migraine drugs. Subsequently, the joint manufacturers of the CGRP products submitted a reimbursement request for 3 CGRP inhibitors for this specific group of patients.
Agreements on appropriate use
The CGRP inhibitors cost almost 6000 euros per patient per year. The Zorginstituut advises the minister to set a number of further conditions for inclusion in the basic package. One of those conditions is that patients with chronic migraine will only be reimbursed for a CGRP inhibitor if it has been shown that treatment with topiramate or valproate and then botulinum toxin A (botox) does not work. It is also important that patients stop taking the CGRP inhibitor if it appears that it does not work. The agreements about appropriate use are made in close consultation with the headache neurologists and health insurers. It is estimated that between 2700 and 3600 patients with chronic migraine are eligible for a CGRP inhibitor.
Good and accessible care for all Dutch people
Dutch healthcare is one of the best in the world. Everyone pays for it through taxes and compulsory basic health insurance. On behalf of the government, the Zorginstituut ensures that our care is and remains good and affordable. All this in order to spend our money for care only on valuable treatments that are proven to actually work. Ultimately, we make these complicated but necessary choices for and on behalf of 17 million Dutch people. So that everyone will continue to have access to good and affordable healthcare in the future.
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