Appeal Takes Place Against NICE Osteoporosis Decision Which Restricts Access To Effective Medicines And Puts Patients At Unnecessary Risk Of Fracture

Main Category: Bones / Orthopaedics
Also Included In: Pharmacy / Pharmacist
Article Date: 23 Oct 2007 - 1:00 PDT

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

An appeal hearing involving the National Osteoporosis Society (NOS), the Alliance for Better Bone Health and Servier Laboratories Ltd takes place after the National Institute for Health and Clinical Excellence (NICE) recommended only one single treatment (alendronate) for the estimated 2 million1 post-menopausal osteoporosis sufferers in England and Wales. Unfortunately, this treatment is not appropriate for all women with osteoporosis. This leaves a large section of the patient population without any access to publicly-funded treatment for a disease which significantly affects the patient population's well-being and safety.

Servier Laboratories Ltd believe this recommendation will severely restrict patients' access to alternative effective treatments in osteoporosis and have appealed on the following grounds:

- NICE has failed to address the increased risk of fractures associated with the use of acid suppressive medication, in particular proton pump inhibitors. 3,4,5 These medicines are commonly prescribed to treat side effects of alendronate such as dyspepsia or heartburn.6,7

- NICE has unduly rejected data that were accepted by the EMEA (European Medicines Agency)2 and the Scottish Medicines Consortium, resulting in unfair discrimination

- NICE has effectively discriminated against women on the basis of age and also on the basis of whether they can or cannot tolerate bisphosphonates

- NICE did not provide access to assumptions behind the economic model in sufficient detail to allow stakeholders to understand and criticise the economic model as confirmed in the recent Eisai judgment (Eisai v NICE and others)

- NICE has violated its procedural rules in changing the scope of the appraisal without consulting the Department of Health and stakeholders

Commenting on NICE's decision, Dr Alun Cooper, a GP with a Special Interest in osteoporosis and Chair of the National Osteoporosis Society's Primary Care Forum said "After five years and what must be a cost of several million pounds, NICE has come to the conclusion that the cheapest drug should be prescribed, ignoring the clear safety concerns that have been presented by leading academics."

Professor Tim Spector, Consultant Rheumatologist at St Thomas' Hospital, London said "It is vital for clinicians and patients to have alternative treatments available so we can maximise patient choice, reduce avoidable drug side effects and reduce the risk of osteoporotic fractures"   Servier Laboratories Ltd. trust NICE will take on board the appeal points from all three organisations and establish a solution that will provide the hundreds of thousands of women with postmenopausal osteoporosis with a greater choice of long term medication, in order to ensure equitable access to treatment for all women regardless of age, drug intolerance or contraindications.

References

1. National Osteoporosis Society

2. Summary of Product Characteristics for alendronate, ibandronate (po) and risedronate

3. Vestergaard, P., L. Rejnmark, L. Mosekilde. 2006 Proton Pump Inhibitors, Histamine H2 Receptor Antagonists, and Other Antacid Medications and the Risk of Fracture Calcified Tissue International Vol 79:76-83.

4. Yang Y-X, J.D. Lewis, S. Epstein, D.C. Metz. 2006, Long term proton pump inhibitor therapy and risk of hip fracture, JAMA, 296:2947-2953.

5. Yu E.W. C. Shinoff, T. Blackwell, K. Ensrud, T. Hillier, D.C. Bauer. Use of Acid-Suppressive Medications and Risk of Bone Loss and Fracture in Postmenopausal Women. J. Bone Min Res 2006; 79(2):76-83.

6. Summary of Product Characteristics for alendronate, ibandronate (po) and risedronate

7. Roughead EE, McGeechan K, Sayer GP. 2004. Bisphosphonate use and subsequent prescription of acid suppressants. Br J Clin Pharm., 57(6), 813 816.

http://www.nice.org.uk/