National Osteoporosis Society welcomes Court Judgement

The National Osteoporosis Society has welcomed today’s ruling that the National Institute of Health and Clinical Excellence (NICE) has acted unlawfully by not allowing public scrutiny of their economic model.

Today’s ruling will give the National Osteoporosis Society the opportunity to prove that the economic model used by NICE is flawed, which the charity believes is key to securing cost effective treatments for a wide range of people.

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.

Professor David Reid, Chair of the National Osteoporosis Society said:

“The release of the models ordered by the court will gives us the opportunity to prove that a wider range of treatment options giving patients is cost effective. Now that annual treatment has come down to as little as £20 as opposed to the £95 quoted by NICE, we will be able to ensure that more patients can get effective and inexpensive treatment.

The truth is that we are spending £2.3 billion a year treating hip fractures, but spend very little preventing those fractures from occurring in the first place. This has got to change and today the Court has given us the chance to make real progress.’’

In the UK one in two women and one in five men over the age of 50 will break a bone, manly because of osteoporosis.

Judicial Review on NICE Guidance for the Primary and Secondary Prevention of Postmenopausal Osteoporosis (TAG 160 and 161)

Following the announcement by the High Court that NICE must reconsider the current TAG 160 and 161 for the primary and secondary prevention of postmenopausal osteoporosis (following the appeal by Servier Laboratories), Procter & Gamble Pharmaceuticals (P&GP) issue the following statement.

MEDIA STATEMENT

Within the scope of its guidance (TAG 160 and 161), which, following the outcome of the judicial review, will now be reconsidered but will not necessarily change, NICE recommended a range of treatment options. These were: alendronate first line, risedronate and etidronate as the first alternative treatment options, followed by strontium ranelate, raloxifene and teriparatide (secondary prevention only) by taking into consideration both the clinical efficacy and the acquisition costs of the treatmentsⁱ.

P&GP welcomed the recommendation of risedronate as one of the first alternative treatment options to generic alendronate, given its proven fracture protection at all key osteoporotic sites^{ii,iii,iv,v,vi} and favourable tolerability profile for postmenopausal osteoporosis patients who are intolerant to alendronate^vii.  TAGs 160 and 161 remain in force until they are confirmed or revised. 

P&GP also acknowledge the concerns with the NICE TAG 160 and 161 due to the complexity of its clinical implementation.  The High Court has announced that the guidance should be reviewed as a result of the cost economic data on which the guidance was based, not being shared transparently amongst stakeholders. 

A pragmatic approach to prescribing based on individual patient needs is required. By balancing the overall proven efficacy profiles of the drugs with their proven cost effectiveness, the treatment pathways recommended in the NICE TAGs can still be useful until such time as this guidance is confirmed or revised.

Oral bisphosphonate treatments are the most used pharmacological intervention for osteoporosis, with alendronate and risedronate as the most commonly prescribed treatments in the UK^viii. There are differences between oral bisphosphonates, such as chemical structure, tolerability profiles and proven fracture protection efficacy at vertebral, hip and other non-vertebral sites that need to be considered when making prescribing choices^ix.

(19/2/09)