Servier Commited To Working With Nice To Ensure Timely Re-Evaluation Of Osteoporosis Guidance, UK

Main Category: Bones / Orthopaedics
Also Included In: Menopause;  Regulatory Affairs / Drug Approvals
Article Date: 24 Mar 2009 - 0:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Following the successful Judicial Review instigated by Servier Laboratories Limited, the licence holder of Protelos® (strontium ranelate), against the National Institute for Health and Clinical Excellence (NICE) guidance for the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women,1,2 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 remains satisfied with the ruling by Mr Justice Holman on 19 February 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.

Servier successfully 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. 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 many of the 15% of women with osteoporosis who cannot take or tolerate bisphosphonates unprotected from the risk of fracture - potentially for many years.3,4,5

It has been demonstrated recently by leading experts in the UK using the World Health Organisation'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.6, 7

Commenting on today's decision, Michael Sumpter, CEO of Servier Laboratories Limited said: "The lack of transparency shown by NICE in the development of the osteoporosis guidance was unfair and potentially compromised patient care. It is unfortunate that the current NICE guidance, which has been deemed to be unlawful, will remain in place whilst the re-evaluation of the guidance takes place. We will work with NICE to ensure that the osteoporosis guidance is now updated as quickly as possible to enable all patients to have access to the most appropriate treatments, including Protelos."

Dr Tim Spector, Consultant Rheumatologist at St Thomas' Hospital said "I am disappointed that Justice Holman has ruled that the NICE guidance on osteoporosis will not be quashed pending its re-evaluation. I am, however, confident that healthcare professionals will exercise their professional judgement and ensure the best possible care for their patients. I hope the re-evaluation will 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. "

Osteoporosis is a severe disease which affects 1 in 2 women over the age of 50 and 1 in 5 men. Up to 20% of women who suffer a hip fracture die within the first year of a fracture.8 Half of people suffering an osteoporotic hip fracture can no longer live independently as a result of the injury. Following a hip fracture, 64% of people need a walking aid and half can no longer move about outside on their own.9 The combined cost of social and hospital care for patients with a hip fracture is estimated to be £2.3 billion, which is more than £6 million a day.10

About the Judicial Review

- Servier challenged NICE on three grounds at trial:

1. Lack of transparency around the economic model used
2. Misinterpretation of Servier's clinical data around hip fracture data
3. Unlawful discrimination on the basis of disability

- 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 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 the 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 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 were 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 ethical 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 characterized 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 pre-dominantly a disease of post-menopausal women and risk of fracture increases with age.

About Protelos

- Protelos is a true innovation which was developed to improve quality of life for osteoporosis patients. 11,12,13,14 Protelos is unlike other treatments and works by building bone to promote bone strength and reducing hip and spinal fractures. 15,16,17 The most common side effects of Protelos are mild and transient.14

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'. www.nice.org.uk (last accessed February 09)

3. Biswas PN, Wilton LV, Shakir SAW. Osteoporos Int. 2003;14:507-514

4. Barrera BA, et al. Osteoporos Int. 2005;16:1989-1998

5. Ettinger B, et al. J Managed Care Pharm. 1998:4:488-492

6. Kanis JA, et al. Bone. 2008;42:4-15

7. Osteoporosis Clinical Guideline for prevention and treatment, Executive Summary by the National Osteoporosis Guideline Group, http://www.shef.ac.uk/NOGG(last accessed January 09)

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

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

10. NOS (Last accessed February 2009)

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

12. Arlot M E, et al. J Bone Miner Res. 2008;23(2):215-222.

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

14. Protelos SPC.

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

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

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

Source
Nice