NICE approves apremilast for refractory psoriasis

In new guidance NICE recommends the use of apremilast for certain patients with chronic plaque psoriasis unresponsive to other systemic therapies.

Apremilast (Otezla) is available as oral tablets which are given twice daily following a five-day loading period. | SCIENCE PHOTO LIBRARY
Apremilast (Otezla) is available as oral tablets which are given twice daily following a five-day loading period. | SCIENCE PHOTO LIBRARY

In earlier NICE guidance published in November 2015 apremilast was not approved for the treatment of psoriasis.

Following a review of the available evidence NICE now recommends apremilast as an option for treating chronic plaque psoriasis in adults whose disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA, or when these therapies are contraindicated or not tolerated, only if the following conditions are met:

  • the disease is severe - defined as a total Psoriasis Area Severity Index (PASI) of ≥10 and a Dermatology Life Quality Index (DLQI) >10

  • treatment is stopped if inadequate response at 16 weeks - defined as:
    - a 75% reduction in the PASI score from start of treatment or
    - a 50% reduction in the PASI score and a 5-point reduction in DLQI from start of treatment

  • the company provides apremilast with the discount agreed in the patient access scheme

The guidance states that any patients already being treated with apremilast prior to its publication may continue according to whatever funding arrangements were already in place.


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