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SUMATRIPTAN SUN (sumatriptan)
Reason for request
Key points
Approval of reimbursement only in the treatment of severe episodic migraine attacks with a major digestive component and rapidly progressive onset, when other oral and nasal migraine-attack treatments cannot be used.
Disapproval of reimbursement in the other marketing authorisation situations.
What progress?
No progress in management.
Role in therapeutic strategy?
Migraine management is based on the treatment of attacks with non-specific molecules (analgesics, non-steroidal anti-inflammatory drugs) or migraine-specific molecules (mainly triptans and ergot derivatives).
In the event of associated digestive disorders during the attack (nausea and/or vomiting), the medicinal products concerned should be administered by a route other than the oral route (intranasal, injectable or rectal).
The recent 2021 recommendations of the French Society for Migraine and Headache Studies (SFEMC) also advocate the use of metoclopramide (intravenous or suppository) as a specific treatment for attacks associated with severe nausea and/or vomiting.
A basic treatment can be introduced, according to the symptomatology of the attacks (frequency and severity) and their impact on daily life.
Role of the medicinal product
Considering:
- the evidence of the superiority of sumatriptan 3 mg by injection only over placebo in the treatment of moderate to severe episodic migraine attacks,
- the lack of efficacy and safety data versus a clinically relevant comparator,
- and taking into account the known safety profile of injectable sumatriptan,
SUMATRIPTAN SUN 3 mg/0.5 ml, solution for injection in a pre-filled syringe (sumatriptan) is a therapeutic option for the treatment of severe episodic migraine attacks with a major digestive component and rapid progressive onset, when other oral and nasal treatments for migraine attacks cannot be used.
In the other situations covered by the marketing authorisation, SUMATRIPTAN SUN 3 mg/0.5 ml, solution for injection in a pre-filled syringe (sumatriptan) has no role in the therapeutic strategy.
Clinical Benefit
| Substantial |
The Committee considers that the actual clinical benefit of SUMATRIPTAN SUN 3 mg/0.5 ml, solution for injection in a pre-filled syringe (sumatriptan) is substantial only in the treatment of severe episodic migraine attacks with a major digestive component and rapid progressive onset, when other oral and nasal treatments for migraine attacks cannot be used. |
| Insufficient |
The Committee considers that the actual clinical benefit of SUMATRIPTAN SUN 3 mg/0.5 ml, solution for injection in a pre-filled syringe (sumatriptan) is insufficient to justify public funding in the other marketing authorisation situations. |
Clinical Added Value
| no clinical added value |
Considering:
The proprietary medicinal product SUMATRIPTAN SUN 3 mg/0.5 ml, solution for injection in a pre-filled syringe (sumatriptan) provides no clinical added value (CAV V) in the treatment of severe episodic migraine attacks with a major digestive component and rapid progressive onset, when other oral and nasal treatments for migraine attacks cannot be used.
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