Court Of Appeal To Re-Evaluate NICE Osteoporosis Decision, UK

Servier Laboratories Limited has been granted permission by the Court of Appeal to challenge a High Court decision made at a Judicial Review in February this year, in which Servier was previously successful in its claim that the National Institute for Health and Clinical Excellence (NICE) had unlawfully failed to provide the economic model underlying its Guidance for the primary and secondary prevention of osteoporotic fractures in postmenopausal women. 1,2


The Court of Appeal will hear Servier's appeal against February's ruling on one legal point - misinterpretation of Servier's clinical data on the reduction of risk of hip fracture by its osteoporosis treatment, Protelos® (strontium ranelate).



Michael Sumpter, CEO of Servier Laboratories Ltd, commented; "We are delighted with today's decision granting Servier the right to appeal on the basis of the irrational consideration by NICE of data submitted by Servier during the appraisal process."



NICE refused to accept a post hoc analysis of a randomised controlled trial titled "The TReatment Of Peripheral OSteoporosis" ("TROPOS"), which was specifically requested by European Medicines Agency's (the "EMEA") scientific committee and clearly showed the efficacy of Protelos in teducing the risk of hip fracture. It was accepted as the basis for granting a licence for reduction of risk of hip fracture in post menopausal osteoporotic women by the European Commission on the recommendation of the EMEA.


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. Servier remains satisfied with the ruling by Mr Justice Holman on 19 February 2009 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. As a result of the February ruling, NICE has shared a copy of the economic model with the stakeholders who submitted evidence for the current NICE guidance. In addition, the current guidance is now being re-evaluated.


Professor Tim Spector, Consultant Rheumatologist at St Thomas' Hospital said; "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 leaves them unprotected from the risk of fracture for many years. While the previous court ruling means that the original NICE guidance is already under review, today's decision means there is a greater chance of the appropriate data being considered. This will hopefully result in new guidance that is simpler and more flexible, giving clinicians a real choice in prescribing for women with osteoporosis, who all have individual needs."















Osteoporosis is a severe disease that affects one in two women over the age of 50 and one in five men. Up to 20% of women who suffer a hip fracture die within the first year of a fracture.3 Half of those suffering an osteoporotic hip fracture can no longer live independently as a result of the injury. Following a hip fracture, 64% need a walking aid and half can no longer move about outside on their own.4
The appeal will be heard by the Court of Appeal in due course. The date will be confirmed by the Court.


About the Judicial Review


-- In January 2009, Servier challenged NICE on three grounds:


1. Lack of transparency around the economic model used to evaluate cost effectiveness

2. Misinterpretation of Servier's clinical data around hip fracture data

3. Unlawful discrimination on the basis of disability


-- On 19 February 2009, the High Court found in Servier's favour on ground one: Lack of transparency around the economic model used. The Judge ruled that the procedure by which the NICE guidance on treatments for primary and secondary prevention of osteoporosis was produced (Final Appraisal Determination dated 30 June 2008) was unlawful and the guidance must therefore be re-evaluated. The Judge ruled that the current guidance will not be quashed pending re-evaluation.


-- In light of February's decision NICE has been ordered to grant access to the economic model to stakeholders who will be given the opportunity to comment on the assumptions NICE made when developing the guidance. NICE will then be required under their legal duty of transparency to re-evaluate the guidance in light of the comments it receives.


-- The High Court did not find in Servier's favour on grounds two and three.


About the NICE guidance


-- The Final Appraisal Determinations (FADs) on the treatment of osteoporosis were published on 26 June 2007. An appeal hearing involving the National Osteoporosis Society, the Alliance for Better Bone Health and Servier Laboratories took place in October 2007. A decision upholding the appeal was published in December 2007 and the revised FADs were published by NICE in July 2008. Servier's second appeal took place in September 2008. Subsequently, technology appraisal guidance for both the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women was published in October 2008. The Judicial Review took place 20-22 January 2009. The decision by Mr Justice Holman was announced on 19 February 2009.


About Servier Laboratories Limited


-- Servier Laboratories Limited is the UK subsidiary of The Servier Research Group, a research-based pharmaceutical company specialising in innovative pharmaceuticals. Servier UK offers a range of products in a number of medical areas: cardiovascular disease, especially hypertension and cardiac disease, diabetes, osteoporosis and diseases of the central nervous system. Servier develops truly innovative drugs and invests in therapeutic areas where there is an unmet patient need.


About osteoporosis


-- The World Health Organisation defines osteoporosis as a progressive skeletal disease characterised by low bone mass and micro-architectural deterioration of bone tissue with a consequential increase in bone fragility and susceptibility to fracture. There is increased risk of fracture particularly of spine, hip, pelvis and forearm. It is predominantly a disease of post-menopausal women and risk of fracture increases with age. Fractures caused by osteoporosis affect one in two women and one in five men over the age of 50.


About Protelos


-- Protelos is a true innovation which was developed to improve quality of life for osteoporosis patients.5,6,7 Protelos is unlike other treatments and works by building bone to promote bone strength and reducing hip and spinal fractures.8,9,10 Unlike more traditional osteoporosis treatments the most common side effects of Protelos are mild and transient.11


References


1. Case number CO/2469/2008 between The Queen on the application of Servier Laboratories Ltd and the National Institute for Health and Clinical Excellence


2. National Institute for Health and Clinical Excellence (NICE). 'Alendronate, etidronate, risedronate and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women' and 'Alendronate, etidronate, risedronate, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women'. Available from https://nice.uk (last accessed February 09)


3. Cooper C, et al. Am J Epidemiol 1993;137:1001-1005


4. Osnes EK, Lofthus CM, Meyer HE, et al. Osteoporos Int 2004;15:567 - 574


5. Jiang Y, Zhao JJ, Genant HK. Osteoporos Int 2006;17(suppl2):late breaking news


6. Arlot ME, et al. J Bone Miner Res 2008;23(2):215-222


7. Ammann P, et al. J Bone Miner Res 2004;19(12):2012-2020


8. Protelos SPC


9. Meunier PJ, et al. N Engl J Med 2004;350:459-468


10. Reginster JY, et al. Arthritis Rheum 2008;58(6):687-1695


11. Reginster JY, et al. J Clin Endocrinol Metab 2005;90(5):2816-2822


Source

Servier