The UK’s National Institute for Health and Clinical Excellence has suggested that Servier’s Protelos (strontium ranelate) should only be used if bisphosphonate therapy is inappropriate in preventing fractures in women with osteoporosis.

The just-published appraisal document - which now enters a comment period as part of NICE’s continuing review of drugs for fracture prevention in osteoporosis - indicates that the agency is following the lead of Scotland in reserving Protelos to use as a back-up to the bisphosphonate class. In August, the Scottish Medicines Consortium restricted use of the drug to high-risk patients, including those who cannot take bisphosphonates, are aged over 75 years and have already had a fracture, as it said equivalent cost-effectiveness to bisphosphonate therapy had not been shown [[26/09/05g]].

Servier said it welcomed the NICE decision, particularly the recognition that Protelos is not associated with the sometimes severe gastrointestinal side effects that affect the bisphosphonate class. However, the company was disappointed by NICE’s conclusion that the data supporting Protelos’ efficacy in preventing hip fractures was less robust‚ than with some bisphosphonates.

“We are concerned that a significant part of the population will not get access to this innovative treatment because NICE refused to recognise the hip fracture efficacy data,” said Eric Falcand, the chief executive of Servier UK. He also said that Servier would lobby to persuade NICE to recognise the usefulness of the drug in preventing non-vertebral fractures in women aged over 80, something that is not reflected in the draft guidance.

Servier’s drug is being appraised alongside the three bisphosphonates approved in the UK - Merck Sharp and Dohme’s Fosamax (alendronate), Procter & Gamble’s Actonel (risedronate) and Didronel (etidronate) - as well as Eli Lilly’s selective oestrogen receptor modulator Evista (raloxifene) in primary prevention of fractures. The consultation document also suggested that Evista is not recommended as a treatment option for the primary prevention of osteoporotic fractures.

Protelos was approved for the treatment of women with post-menopausal osteoporosis by the European Medicines Agency last October, after results from the SOTI (Spinal Osteoporosis Therapeutic Intervention) trial showed that the agent reduced the risk of vertebral fractures in women 49% after one year. The product has also been launched in its first markets, including the Germany, Ireland, the UK, Spain and Italy.