The Scottish Medicines Consortium (SMC) has recommended abaloparatide, marketed by London-based Theramex as Eladynos, for treatment of osteoporosis in postmenopausal women who are at very high risk of fracture through the National Health Service in Scotland. The announcement, made on July 7, 2025, expands UK-wide access to this anabolic therapy following previous approval by the National Institute for Health and Care Excellence (NICE) for England, Wales, and Northern Ireland in August 2024.
Significant Disease Burden and Healthcare Costs
Osteoporosis represents a substantial healthcare challenge, with Theramex estimating that half of all women over 50 will experience fragility fractures, which are made more likely by the bone-weakening condition. The disease burden is particularly severe for hip fractures, which account for approximately 50% of fracture-related deaths in women, with one-quarter of patients who suffer a hip fracture dying within one year.
The economic impact on the NHS is considerable, with hip fractures alone costing £2 billion (US$2.7 billion) per year. Total osteoporotic fracture costs presently account for more than £4.6 billion (US$6.3 billion) of direct costs to the NHS, with projections indicating this will increase to £6 billion (US$8.2 billion) by 2030.
Despite these significant figures, treatment gaps persist in the healthcare system. A quarter of women endure more than three fractures before receiving a diagnosis, and two-thirds of high-risk individuals don't receive appropriate treatment, highlighting delays in both diagnosis and therapeutic intervention.
Treatment Characteristics and Patient Population
Abaloparatide is an anabolic therapy that promotes new bone formation and is administered as a daily injection. Treatment duration can extend up to 18 months and may be followed by other therapies. UK guidelines recommend anabolic treatments as a first-line option for women at very high risk of fracture.
Theramex estimates that more than 1,000 postmenopausal women in Scotland would be eligible for treatment under the SMC recommendation. The approval ensures that women in Scotland have access to diverse treatment options, addressing previous disparities in osteoporosis care across the UK.
Clinical Expert and Industry Response
Professor David Reid, Consultant Rheumatologist and Osteoporosis Specialist, welcomed the decision, stating: "Today's news provides a welcome treatment option grounded in robust evidence for both clinicians and patients."
Tina Backhouse, UK General Manager at Theramex, emphasized the significance of the approval: "With women at a five times greater risk of osteoporosis than men, I am thrilled that we are able to expand access further across the United Kingdom and bring this treatment to women in Scotland. This approval not only ensures women in Scotland have access to a diversity of treatment options but also reinforces our ongoing efforts to collaborate with healthcare providers and policymakers to eliminate disparities in osteoporosis care across the UK."
Broader SMC Decision Context
The SMC's July 7 announcement included positive opinions on several other treatments across various therapeutic areas. The consortium accepted bevacizumab gamma (Lytenava, Outlook Therapeutics) for wet age-related macular degeneration, osimertinib (Tagrisso, AstraZeneca) with chemotherapy for first-line treatment of advanced non-small cell lung cancer with specific EGFR mutations, pembrolizumab (Keytruda, Merck) with chemotherapy for newly diagnosed or recurrent advanced endometrial cancer, and selpercatinib (Retsevmo, Eli Lilly) for advanced thyroid cancer with RET gene mutations in patients aged 12 and older.
Conversely, the SMC declined to recommend amivantamab (Rybrevant, Johnson & Johnson) for advanced non-small cell lung cancer with EGFR exon 20 mutations, fezolinetant (Veoza, Astellas) for moderate to severe vasomotor symptoms caused by menopause, and lecanemab (Leqembi, Eisai/Biogen) for early-stage Alzheimer's disease in specific patient populations.
