MSD sways NICE with Simponi patient access scheme

pharmafile | August 26, 2011 | News story | Sales and Marketing NICE, Simponi, ankylosing spondylitis 

A patient access scheme which lowers Simponi’s cost has led to Merck Sharp and Dohme’s drug being given the thumbs up by NICE to treat an inflammatory back problem.

The final guidance sees Simponi join two others in the tumour necrosis factor (TNF) inhibitor class – Abbott’s Humira (adalimumab) and Pfizer’s Enbrel (etanercept) – as recommended treatments for severe cases of ankylosing spondylitis.

The condition can be particularly unpleasant, with the sacroiliac joint at the base of the spine becoming inflamed, leading to stiffness and pain.

Where ligaments and tendons attach to bone, the disease can even lead to new bone development and joint fixation (ankylosis), in which joints and bones fuse together.

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Simponi (golimumab) can now be used on the NHS for treating ankylosing spondylitis in specific circumstances, one of which is that MSD provides the 100mg dose at the same price as the 50mg dose.

Its big selling point over other anti-TNFs is that it is a subcutaneous injection given only once a month, rather than by infusion or via more frequent injections: it costs £763 for a 50mg pre-filled injection pen, or £9,155 a year.

Available data suggests clinical response is usually achieved after three or four doses.

“The evidence for golimumab demonstrated comparable clinical and cost effectiveness to the two drugs that we had already recommended for this condition,” explained Professor Carole Longson, Health Technology Evaluation Centre Director at NICE.

“This meant that we were able to complete the appraisal faster,” she added.

A NICE technology appraisal which applies to all three drugs says Simponi can be used where patients are assessed on two separate occasions 12 weeks apart as having active spinal disease.

The drugs can be used after the failure of at least two non-steroidal anti-inflammatory agents taken sequentially to control symptoms.

Patients receiving Simponi who do not fulfil the criteria for Humira or Enbrel should be allowed to continue with the treatment, NICE says.

In May, NICE provisionally recommended Simponi for rheumatoid arthritis, following a ‘no’ ruling last November following doubts about data and its cost.

Adam Hill

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