UK’s NICE draft guidance negative on Stelara for psoriatic arthritis

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has opened a consultation on a negative draft guidance for Stelara (ustekinumab), a drug licensed to treat active psoriatic arthritis from US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen.

The NICE’s Independent Appraisal Committee examined the clinical and cost effectiveness of using ustekinumab alone or in combination with methotrexate, for treating active psoriatic arthritis in adults when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. The draft guidance proposes to not recommend ustekinumab for psoriatic arthritis within this marketing authorisation. This draft recommendation is now open for consultation; the NICE has not yet issued guidance to the National Health Service (NHS).

Advisory committee not convinced of clinical benefit versus TNF alpha inhibitors

Professor Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “NICE currently recommends golimumab, adalimumab, etanercept and infliximab for treating active and progressive psoriatic arthritis in adults (technology appraisal guidance 220 and 199). The Committee accepted that ustekinumab is clinically effective compared with conventional DMARD treatment, but the Committee was not persuaded that ustekinumab provides clinical benefits compared with TNF alpha inhibitors. The Committee also noted that the economic analyses found that ustekinumab was not a cost effective option. Whilst recognizing the severity of the disease, the Committee concluded that ustekinumab could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation.”

Stakeholders, including the company, health care professionals and members of the public are now able to comment on this draft guidance. The consultation is open until January 17, 2014 and any comments received will be fully considered by the Committee.

Until final guidance is issued to the NHS, NHS organizations should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.