Doctors urge NICE to reverse decision on new osteoporosis drug

More than NHS 100 clinicians have called on NICE to reverse its provisional rejection of the first new drug for severe osteoporosis in over a decade.

An elderly woman with one arm in a plaster cast sits resting both hands on her walker
Romosozumab (Evenity) is licensed to treat severe osteoporosis in postmenopausal women at high risk of fracture. | GETTY IMAGES

In a letter published in The Times on Sunday 2 January, a group of clinicians led by the Royal Osteoporosis Society say they are 'troubled' by NICE's decision not to recommend romosozumab (Evenity) as an option for women with severe osteoporosis.

Romosuzumab is already approved for use in Scotland and Northern Ireland, as well as much of Europe. To deny patients in England and Wales access to the antibody 'will worsen health inequalities across the four nations', warns the letter.

Unfair scenario

Romosozumab is one of only two treatments licensed by MHRA which induces new bone formation, and the first of these to simultaneously reduce bone loss. The letter argues it is 'highly effective in reducing the risk of fracture and will provide relief and hope to women who are at very high risk of fractures'.

Craig Jones, chief executive of the Royal Osteoporosis Society, said: 'We’re calling on NICE and the applicant company to get back round the table and work with us to ensure equal access to this important new treatment. Osteoporosis clinicians fear that technical misunderstandings are leading to an unfair scenario where Scottish and Northern Irish patients have access to this life-changing medication, while people in England and Wales are left at the mercy of fractures. We hope both parties will work with us to find a way forward in the public interest.'

The letter also raises alarm over the sparseness of the drug pipeline for osteoporosis, as well as a lack of public funding for new research. Recent government figures show the National Institute for Health Research (NIHR) invested less than £1m in osteoporosis research in 2020-1 – a fraction of the £4.6bn per year cost to the NHS of fractures.

NICE's appraisal consultation document on romosozumab is under consultation, pending a hearing scheduled for early 2022.

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