Servier Laboratories has failed to sway National Institute for Health and Clinical Excellence recommendations for the use of Protelos in National Health Service patients with osteoporosis.
The long-running saga goes back to 2009, when Servier challenged in court the cost watchdog's recommendations that doctors should prescribe cheaper drugs to women with early signs of osteoporosis, even though up to one in five patients cannot take the drugs, there are crippling side effects and in spite of more effective treatments being available.
The firm argued that, according to the guidelines, patients would have to get 60% worse on a scoring system before being eligible for the more expensive Protelos (strontium ranelate).
While the final court ruling forced NICE to take another look at some of the evidence surrounding Servier's drug, this failed to persuade the Institute to alter its original position that Protelos should only be used to prevent osteoporosis fractures when patients are unable to tolerate oral bisphosphonates or in those who are considered to have high risk of osteoporotic fractures.
“NICE has complied fully with the Court’s judgement – having examined the evidence on strontium ranelate again very carefully, the new independent committee reached the same conclusions as the original committee, and so the recommendations on strontium ranelate remain unchanged from those published originally," noted Carole Longson, Director of the NICE Centre for Health Technology Evaluation.
Meanwhile, in final guidance published today, NICE has recommended Bristol-Myers Squibb and Otsuka Pharmaceuticals' Abilify (aripiprazole) as an option for the treatment of schizophrenia in patients aged 15 to 17 years.
The cost regulator has deemed Abilify a a cost-effective use of NHS resources when used in patients who cannot take Johnson & Johnson’s Risperdal (risperidone) or whose schizophrenia is not being adequately controlled with the latter drug, which is currently the most widely used first-line antipsychotic.
A base-case analysis showed that treatment sequences in which Abilify is used first result in an incremental cost of £52,750 per QALY (quality adjusted life year) gained to £108,800 per QALY gained compared with regimens in which Risperdal is used first, prompting NICE to only recommend the drug when J&J’s medicine is not an option.
"We are pleased to be able to recommend another treatment option for young people with this debilitating condition which will help young people with schizophrenia have greater control over their condition and support them in returning to previous normal functioning in terms of attending school or work," Longson said.