Pitolisant (Wakix®) for the treatment of narcolepsy in adults

Zorginstituut Nederland carried out a marginal assessment whether pitolisant (Wakix®) is interchangeable with a drug currently included in the reimbursed package. The Zorginstituut was advised by the Scientific Advisory Committee (WAR).

Registration

Pitolisant (Wakix®) is an orphan drug registered for the treatment of narcolepsy with or without cataplexy.

Assessment of interchangeability

Based on the criteria for interchangeability, pitolisant (Wakix®) is not interchangeable with other products included in the Medicines Reimbursement System (GVS).
Based on the above, pitolisant (Wakix®) cannot be placed on List 1A. What has to be examined is whether pitolisant is eligible for placing on List 1B.

Therapeutic value

This pharmacotherapeutic report compared pitolisant for the treatment of narcolepsy with and without cataplexy with modafinil or sodium oxybate. Zorginstituut Nederland concludes that for the treatment of narcolepsy without cataplexy, pitolisant had the same therapeutic value as modafinil.
For the treatment of narcolepsy with cataplexy, pitolisant may have a more favourable effect than modafinil, based on a possible clinically relevant difference in reducing the number of cataplexy attacks. When treating narcolepsy with cataplexy, pitolisant has a therapeutic added value compared to the combination therapy with sodium oxybate and modafinil, and compared to monotherapy with sodium oxybate, based on a clinically relevant difference in unintended effects.

Advice on inclusion in the GVS

Based on the criteria for interchangeability, pitolisant (Wakix®) is not eligible for inclusion on List 1A. Based on the above-mentioned considerations, the Zorginstituut advises the Minister to include pitolisant (Wakix®) on List 1B of the Health Insurance Decree. Its inclusion on List 1B will involve additional costs.

This report is a summary of recommendations by Zorginstituut Nederland. The original text of this excerpt is in Dutch.