1 March 2010, Wexham - Servier Laboratories Limited, the licence holder of Protelos® (strontium ranelate), has been successful at the Court of Appeal in overturning a High Court decision on one legal point made at a Judicial Review in February 2009. 1 At the High Court in February 2009 Servier was 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.2,3 Servier has now been successful in a second point – rejection of the results of Servier’s clinical data on the reduction of risk of hip fracture by its osteoporosis treatment, Protelos®, with the court ruling that NICE was unlawful in its decision making. NICE has been ordered to make a fresh decision and issue new guidance in relation to Protelos® within three months.

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

This ruling means that NICE cannot depart from the assessment conducted by relevant regulatory authorities (i.e. EMA or MHRA) on quality, safety and efficacy without proper justification.

Michael Sumpter, CEO of Servier Laboratories Ltd, commented; “We are satisfied with today’s victory, which was awarded by the Court of Appeal on the basis of the unlawful consideration by NICE of data submitted by Servier during the appraisal process. This is a victory for all patients as the Court confirmed that NICE cannot disregard the assessment conducted by regulatory authorities without proper justification. We hope that NICE will now take proper account of our clinical data and issue new guidance which enables all the appropriate patients to access Protelos.”

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 consultees who submitted comments on the appropriateness of the model for the current NICE guidance. Disappointingly, however, NICE has not changed any features of the model despite the significant reservations held by consultees about the model.

Professor Cyrus Cooper - Chair of the International Osteoporosis Foundation Scientific Committee said; “Many of my patients are unable to tolerate the first-line 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. It is regrettable that the original NICE guidance was not amended in light of the disclosure of the economic model. However, 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.4 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.5


- ENDS -

For more information, please contact Servier Laboratories Ltd Corporate Affairs:
01753 666411 / 07734 719682
corporate.affairs@uk.netgrs.com

Professor Cyrus Cooper is also available for further comment on 02380764032


NOTES TO EDITORS
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. Rejection of the results 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.

• In light of February’s decision NICE was ordered to grant access to the economic model to consultees who were given the opportunity to comment on the assumptions NICE made when developing the guidance. NICE was then required under its legal duty of transparency to re-evaluate the guidance in light of the comments it received. NICE, however, did not change any features of the model.

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

• In July 2009 Servier was successful in its application to the Court of Appeal for permission to appeal against February 2009’s ruling on one legal point – point two: rejection of the results of Servier’s clinical data on the prevention of hip fracture.

• The appeal was heard by the Court of Appeal on 17 December 2009 with a ruling handed down on 31 March 2010.

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. The Court of Appeal hearing took place on 17 December 2009 and the ruling was announced on 31 March 2010.

References
1. Case number C1/2009/0805 The Queen (on the application of Servier Laboratories Ltd) v The National Institute for Health and Clinical Excellence
2. The Queen (on the application of Servier Laboratories Ltd) v The National Institute for Health and Clinical Excellence [2009] EWHC 281 (Admin)
3. 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://www.nice.org.uk (last accessed February 09)
4. Cooper C, et al. Am J Epidemiol 1993;137:1001-1005
5. Osnes EK, Lofthus CM, Meyer HE, et al. Osteoporos Int 2004;15:567 - 574
6. Jiang Y, Zhao JJ, Genant HK. Osteoporos Int 2006;17(suppl2):late breaking news
7. Arlot ME, et al. J Bone Miner Res 2008;23(2):215-222
8. Ammann P, et al. J Bone Miner Res 2004;19(12):2012-2020
9. Protelos SPC
10. Meunier PJ, et al. N Engl J Med 2004;350:459-468
11. Reginster JY, et al. Arthritis Rheum 2008;58(6):687-1695
12. Reginster JY, et al. J Clin Endocrinol Metab 2005;90(5):2816-2822