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Servier claims victory over NICE in osteoporosis

Published on 19/02/09 at 05:21pm

Servier has claimed victory in the first round of its legal battle against NICE's guidelines on osteoporosis.

A judicial review requested by the pharma company has now ruled that NICE acted unfairly in not disclosing the economic model it used to produce guidelines for treating osteoporosis.

NICE's guidelines state that patients who cannot tolerate treatment with the first choice treatment, bisphosphonates, must wait until their bone density deteriorates before they can receive other treatments.

Servier, which markets osteoporosis treatment Protelos says this leaves the 15% of women with osteoporosis who cannot take or tolerate bisphosphonates unprotected from the risk of fracture, potentially for many years.

But it is NICE not disclosing its reasoning - rather than the fairness of the decision itself - which the judge has ruled against.

Nevertheless, the legal ruling opens up the chance for a change in NICE's guidance.

"We are pleased with the outcome of the review and the decision by Mr Justice Holman to re-evaluate the NICE guidance", said Michael Sumpter, chief executive of Servier's UK operations.

He added: "The lack of transparency shown by NICE in the development of the osteoporosis guidance was unfair and potentially compromised patient care.

How can patient organisations, clinicians and industry make considered comment on guidance under development if the processes and information NICE use to reach their decisions are not clear?"  

Sumpter said the ruling would allow stakeholders to work with NICE to review the guidance, and enable access to appropriate treatments, including Servier's own Protelos.

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."

The decision is another serious blow to NICE and its working methods, which the judge Mr Justice Holman criticised in his ruling.

The case is the second judicial review mounted against NICE, and the second it has lost. A judicial review called for by Eisai and Pfizer relating to NICE's Alzheimer's ruling which began in 2007 eventually went against the cost effectiveness watchdog.

Although an initial judicial review ruled in NICE's favour, a last-ditch appeal by the company's succeeded in overturning this decision in May 2008.

This forced NICE to disclose the economic model it had used to calculate the cost effectiveness of the Alzheimer's drugs, and has kept secret until then.

NICE has yet to produce new guidance on Alzheimer's drugs, but campaigners are hopeful they can eventually secure access for people denied treatment under the guidelines.

Charity's response

Servier were supported in their challenge to NICE by two osteoporosis charities, the National Osteoporosis Society (NOS) and the Alliance for Better Bone Health.

Commenting on this background, Nick Rijke, Director of Public and External Affairs at the National Osteoporosis Society said: "This is the second time in ten months that NICE have been found to have acted unlawfully by not allowing proper public scrutiny of their economic modelling.

"Hopefully this judgement will force NICE to change the way they work and take public scrutiny more seriously. We welcome today's judgement, which finally gives us the proper access to the economic modelling that NICE use to decide which treatments the NHS should prescribe."

NICE responded to the ruling by pointing out that the judge had ruled in its favour on two out of three grounds.  The two grounds the judge supported NICE on were discriminating against disabled people, and not properly dealing with a specific clinical trial.

NICE will now have to provide stakeholders with the economic model, and are obliged to reconsider their guidance in light of the resulting views.

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