NICE has today (7 August 2024)
published final guidance recommending abaloparatide as an option
for treating osteoporosis after menopause, if there is a
very high risk of fracture.
Abaloparatide (also called Eladynos
and made by Theramex) increases bone density by stimulating the
cells that make new bone and this reduces the risk of
fracture.
Abaloparatide can provide an
alternative for people who have not responded to, or cannot
tolerate, usual treatment options and is set to benefit over
14,000 people in England.
During the menopause oestrogen, the
hormone that is important for maintaining bone density and
strength, decreases and bone density reduces. This can lead to
bone thinning, known as osteoporosis, and therefore broken bones
become more common. Fractures can be very painful and limit
a person's independence, and they are also associated with
increased mortality.
Usual treatment for osteoporosis after
menopause in people with a very high risk of fracture includes
romosozumab or teriparatide followed by bisphosphonates such as
alendronic acid. Abaloparatide is a clinically and cost-effective
new option that can be used as an alternative.
It comes as a pre-filled pen that is
injected into the muscle through the skin. This means it can be
self-administered at home which is convenient for people who are
prone to fractures.
It will be available for use on the
NHS in England within 3 months.
Professor Jonathan Benger,
chief medical officer and deputy chief executive,
said: “The independent
committee heard from patients about how debilitating osteoporosis
can be and how it impacts all aspects of day-to-day life, such as
not going out for a walk because they are fearful of falling and
having a fracture. This can impair mental and physical
health.
“Our focus is on enabling access to
care that improves quality of life while offering value to the
taxpayer. Abaloparatide has been found by our independent
committee to be clinically and cost effective at reducing the
risk of fracture, giving people more independence and therefore a
better quality of life.”
Alison , patient representative
said:
“I know the devastating impact that
fractures can have on peoples' lives. I'm delighted that there is
going to be another safe and effective drug available which will
hopefully stop so many people suffering the effects and fear of
having more fractures”.
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The guidance can be accessed at this
link. Abaloparatide for
osteoporosis. EMBARGO 00.01 7 AUGUST 2024.pdf
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Recommendation:
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Abaloparatide is recommended as an
option for treating osteoporosis after menopause in women,
trans men and non-binary people, only if
they have a very high risk of
fracture. It is only recommended if the company provides
it according to the commercial
arrangement.
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If people with the condition and
their healthcare professional consider abaloparatide,
romosozumab and teriparatide to be suitable treatments, after
discussing the advantages and disadvantages of all the options,
the least expensive suitable treatment should be used.
Administration costs, dosages, price per dose and commercial
arrangements should all be taken into
account.
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This recommendation is not intended
to affect treatment with abaloparatide that was started in the
NHS before this guidance was published. People having treatment
outside this recommendation may continue without change to the
funding arrangements in place for them before this guidance was
published, until they and their NHS healthcare professional
consider it appropriate to stop.
