100 clinicians call on NICE to reverse ‘unequal’ decision on the first new drug for severe osteoporosis in a decade

Over 100 NHS clinicians have called on the National Institute for Health and Care Excellence (NICE) to change course over its decision to decline to recommend romosozumab, the first new drug for severe osteoporosis for over a decade.

In a joint letter published on Sunday 2 January, the clinicians warn of the consequences of barring access to the drug to women who suffer a severe form of the bone-weakening disease.

Half of women over 50, and one-fifth of men, will suffer fractures (broken bones) due to osteoporosis. Fractures are one of the most urgent threats to living well in later life, undermining quality of life and independence. As many people die of fracture-related causes as from lung cancer, diabetes or chronic lower respiratory diseases.

Romosuzumab is already transforming the lives of women with severe osteoporosis in Scotland, Northern Ireland and much of Europe. This new treatment prevents fractures by stimulating bone formation, as well as reducing bone loss, and would offer much-needed hope and relief for patients living in England and Wales.

The joint letter, led by the Royal Osteoporosis Society (ROS), raises alarm over the lightness of the drug pipeline for osteoporosis, as well as a lack of public funding for new research. Recent figures from Government showed the National Institute for Health Research (NIHR) invested less than £1m in osteoporosis research in 2020-1 – a figure which pales in comparison with the £4.6bn per year cost to the NHS of fractures – and which bodes ill for the development of further such innovative treatments.

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 provisional decision from NICE is under consultation, pending a hearing scheduled for early in 2022.

The joint letter

Sir/Madam,

We write as a group of 100 clinicians operating in one of the most under-served fields in the NHS: osteoporosis and bone health. Half of women over the age of 50 – and one-fifth of men - will break a bone due to osteoporosis, causing long-term pain, disability and loss of independence. The condition is one of the most urgent threats to living well in later life.

Mercifully, osteoporosis is treatable, given the right therapies. That’s why we’re troubled by the decision of the National Institute for Health and Care Excellence (NICE) to decline to recommend use of the first new osteoporosis medication for over a decade. With a drugs pipeline that’s historically light, and chronically underfunded public research, women with severe osteoporosis deserve the chance to benefit from this innovative new treatment.

Romosozumab is one of only two treatments licensed by MHRA which induces new bone formation, and the first in this category to simultaneously reduce bone loss. 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.

This medication is already approved for use in Scotland and Northern Ireland, as well as much of Europe. To deny access to patients in England and Wales will worsen health inequalities across the four nations.
We’re calling on NICE to work with us to explore how patients in England and Wales can benefit from this therapy, sparing them the pain and fear of fractures.

Women’s health is already beset by structural inequalities which run deep across society. We must make sure the benefits of scientific breakthroughs are made available to everyone who needs them, no matter where they live.