GVS assessment of crisaborole (Staquis®) for the treatment of atopic dermatitis

Zorginstituut Nederland has completed its assessment whether crisaborole (Staquis®) is interchangeable with a product that is included in the medication reimbursement system (GVS). The Zorginstituut's recommends that crisaborole should not be included in the GVS.

Registered indication

Crisaborole (Staquis®) is indicated for the treatment of mild to moderate atopic dermatitis in adults and children over the age of 2 with ≤40 percent of the body surface affected. One gram of ointment contains 20 mg of crisaborole. In addition, the ointment contains 90 mg/g of propylene glycol as an adjuvant. Crisaborole ointment should be applied twice daily to the affected skin.

The marketing authorisation holder is asking for crisaborole to be included in List 1A of the Health Insurance Regulation.

Assessment

The Zorginstituut has come to the final conclusion that there is insufficient evidence to determine the value of crisaborole in relation to pimecrolimus and tacrolimus. This should lead to the conclusion that crisaborole does not comply with the established medical science and medical practice for the treatment of atopic dermatitis.

Zorgintituut's advice

Based on the considerations mentioned in the report, Zorginstituut Nederland recommends that crisaborole should not be included in the GVS.

The Zorginstituut is of course prepared to reconsider the package eligibility of crisaborole when additional research data not previously assessed by the Zorginstituut leads to scientific publications.

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