WIREDGOV

Following a legal challenge to the process used to produce NICE’s existing guidance on prevention of osteoporotic fractures, the original recommendations remain unchanged in the updated guidance documents published today (29 January 2010).  

This means that postmenopausal women with osteoporosis at risk of fractures will continue to have access to a range of drugs to help either prevent them suffering a first fracture (primary prevention) or prevent further fractures after they have suffered one (secondary prevention). The guidance documents have been updated to reflect the Appraisal Committee’s consideration of the additional stakeholder comments received following a further consultation in line with the court judgement.  The treatments NICE recommends for primary and secondary prevention of osteoporotic fractures are not affected, and the range of options still stands.

In October 2008, the National Institute for Health and Clinical Excellence (NICE) published these pieces of guidance for the NHS on the use of drugs to prevent osteoporotic fractures in postmenopausal women.  When this guidance was developed, NICE was prevented from releasing an executable economic model because it contained data that was deemed confidential by a third party.  However, following a legal challenge from a pharmaceutical company, which in part complained that consultees were not able to see the executable economic model, the owner of the third party data agreed to allow NICE to release the executable economic model to its stakeholders.  A small number of stakeholders submitted further comments after they had seen the executable model. Having taken these new comments fully into account, the independent Appraisal Committee considered that the model was fit for purpose and the original recommendations did not need to change.  No appeals were made against the final draft guidance which set out this decision, and so the updated guidance documents are published today. The recommendations therefore continue to allow access to a range of treatments for both primary and secondary prevention, including options for women who cannot take the recommended initial treatment, depending on how high their risk of fracture is.

Professor Peter Littlejohns, NICE Clinical and Public Health Director said: “I’m delighted that, having been forced to go through a long legal process, our original recommendations on preventing fractures caused by osteoporosis have been found to be robust. The NICE guidance development process is open and transparent, so we were pleased when we were finally given permission to share the economic model used to inform our recommendations.   The manufacturer of one of the treatments was initially unhappy with our guidance, but they have not lodged any further appeals against the independent Appraisal Committee’s recommendations.

“The guidance on preventing osteoporotic fractures continues to offer help to postmenopausal women and advice to the medical staff treating them. Crucially, NICE recommends preventative treatment for women at risk, before they suffer any fracture due to osteoporosis.  This is the first NHS guidance to offer this, and is great news for those women who need treatment to help stop a fracture from occurring in the future.  The secondary prevention guidance means that all postmenopausal women who have had a fracture because of osteoporosis will be offered alendronate. Alternative effective treatments are also recommended for women who cannot take alendronate.”

The drugs NICE was asked to appraise for osteoporotic fracture prevention are licensed by their manufacturers for use in postmenopausal women. As the guidance recommendations published in October 2008 are unchanged, the original review date for this guidance is also unchanged, remaining scheduled for July 2010.