Justice Holman today set out a clear process for the re-evaluation of National Institute for Health and Clinical Excellence’s (NICE) osteoporosis guidance following the ruling in February that the organisation had acted unlawfully by not releasing its economic model
Follow the ruling in February by Mr Justice Holman that NICE’s current guidance for the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women will have to be re-evaluated, Mr Justice Holman today set out a clear process for the re-evaluation of the guidance. This includes the release by NICE of the economic model to consultees, their subsequent comments and a re-evaluation of the guidance by NICE in light of these comments.
Servier Laboratories, the licence holder of Protelos (strontium ranelate), which instigated the review, remains satisfied with Mr Holman’s judgement that NICE acted with procedural unfairness, and therefore unlawfully, by not releasing the economic model on which it based its decisions in the osteoporosis guidance. According to the NICE guidance, patients who are unable to tolerate bisphosphonates (recommended as the initial approach) must wait until their bone mineral density (BMD) deteriorates before they are given an alternative treatment. This means that the 15 per cent of women with osteoporosis who cannot tolerate bisphosphonates will not be protected against the risk of fracture, potentially for a number of years.
Using the World Health Organisation’s health economic model, UK experts were able to demonstrate that it is not necessary to restrict access to treatments to the extent that NICE has. The ruling requires that NICE demonstrates how it arrived at its recommendations in osteoporosis, and in so doing will open the guidance up to transparent re-evaluation.