Servier Laboratories Limited, the licence holder of Protelos® (strontium ranelate), expressed satisfaction today at Mr Justice Holman’s ruling that the current National Institute for Health and Clinical Excellence (NICE) guidance for the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women will have to be re-evaluated after the consultees receive a copy of the economic model and their comments are considered. The Judge has not yet taken a decision on whether the guidance will be quashed.
Servier challenged NICE at Judicial Review because it believes the osteoporosis guidance unfairly and unnecessarily restricts access to Protelos for many patients who could benefit from it.
The High Court ruled 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.
NICE has been instructed to grant access to the economic model to stakeholders (including patient organisations, clinicians, professional organisations and industry) who will be given the opportunity to comment on the previously unknown assumptions NICE made when developing the guidance. NICE will then be required under its legal duty of transparency to re-evaluate the guidance in light of the comments it receives.
According to current NICE guidance, many patients who are unable to tolerate bisphosphonates (currently recommended as the initial approach) have to wait for their bone mineral density (BMD) to deteriorate before they are given an alternative treatment. This would leave the 15% of women with osteoporosis who cannot take or tolerate bisphosphonates unprotected from the risk of fracture – potentially for many years.
It has been demonstrated recently by leading experts in the UK using the World Health Organization’s health economic model that it is not necessary to restrict access to treatments to the extent to which NICE has, even when working within the UK’s restricted budget.
This makes today’s ruling to re-evaluate the NICE guidance so important as experts from medical and patient organisations will now be able to understand how NICE arrived at its recommendations in osteoporosis, which will ensure a fully transparent re-evaluation of the guidance.
Dr Tim Spector, Consultant Rheumatologist at St Thomas’ Hospital said “This is a great result for osteoporosis patients. Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance but I have to wait for their disease to deteriorate before I can give them an alternative treatment.
"This would leave them unprotected from the risk of fracture for many years. Today’s court decision will provide us with the opportunity to review the guidance and the economic assumptions made by NICE. This will hopefully result in new simpler and more flexible guidance in which clinicians have a real choice in the prescribing decisions they make for women with osteoporosis, who are all individuals with individual needs. ”
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