The National Institute for Health and Clinical Excellence (NICE) has issued final guidance recommending the use of Merck Sharp & Dohme's Simponi (golimumab) as an option for treating ankylosing spondylitis in specific circumstances.
Simponi is now recommended for use on the NHS in England and Wales as an option for the treatment of severe, active ankylosing spondylitis in adults when used as described for other tumour necrosis factor (TNF) inhibitor treatments - Abbott Laboratories' Humira (adalimumab) and Amgen/Pfizer's Enbrel (etanercept) - as covered by NICE Technology Appraisal (TA) No 143.
Also, the firm is required to provide the 100mg dose of Simponi at the same cost as the 50mg dose.
Simponi costs £762.97 for a 50mg pre-filled injection pen, excluding value-added tax (VAT), which is equivalent to an annual cost of £9,155.64 based on the 50mg dose. The manufacturer has agreed a patient access scheme with the Department of Health under which the 100mg dose will be available to the NHS at the same cost as the 50mg dose. The Department considered that this scheme does not constitute an excessive administrative burden on the NHS, notes NICE.
Ankylosing spondylitis is an inflammatory disease of unknown cause which leads to inflammation of the sacroiliac joint at the base of the spine and along the spine, resulting in back pain and stiffness. Inflammation at the sites where ligaments and tendons attach to bone can lead to new bone development and joint fixation (ankylosis), where joints and bones fuse together.
Professor Carole Longson, director of NICE's health technology evaluation centre, said the Institute was pleased to recommend Simponi as another treatment option for "this progressive and irreversible condition."
"Ankylosing spondylitis causes a great deal of pain and discomfort for individuals, impacting significantly on day-to-day life," she said. The evidence for Simponi demonstrated comparable clinical and cost-effectiveness to the two drugs, Humira and Enbrel, which NICE has already recommended for this condition, and this meant it was able to complete the appraisal faster, she added.
The recommendations given in TA 143, which now also apply to Simponi, say that the recommended drugs are treatment options for adults with severe ankylosing spondylitis only if all the specified clinical criteria are fulfilled, including: - having active spinal disease as assessed on two separate occasions 12 weeks apart; and - failure of conventional treatment with at least two non-steroidal anti-inflammatory drugs (NSAIDs) taken sequentially at maximum tolerated or recommended doses to control symptoms.