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SMC accepts HRT treatment for use by NHS Scotland

The Scottish Medicines Consortium (SMC) has accepted Theramex’s Bijuve® (1mg estradiol/100mg progesterone) for use across NHS Scotland.

Bijuve® is the first, and only, body-identical hormone replacement therapy (HRT) indicated for estrogen deficiency symptoms in post-menopausal women (with intact uterus and at least 12 months since last menses), which combines estradiol and progesterone in a single daily oral capsule.1

Acceptance by the SMC will ensure that women across Scotland will now be able to access this product. However, this is not the case in England where still only a handful of formularies have been updated to include this product. This is partly due to backlogs in formulary approvals caused by the COVID-19 pandemic3, as well as a lack of prioritisation of women’s health issues.

HRT is used to relieve symptoms of menopause, caused by hormone deficiency. The most common symptoms include hot flushes, night sweats, vaginal dryness and discomfort during sex, difficulty sleeping, low mood or anxiety, reduced sex drive (libido), problems with memory and concentration.4 There are different types of HRT, with treatments offering different combinations and dosages of hormones as well as different administration methods, including tablets, patches, gels and implants.5 Some HRT options contain body-identical hormones, it has been suggested that these hormones may be better tolerated and associated with fewer risks than synthetic hormones.6

National guidelines for the use of HRT recommend that an individualised approach should be adopted, allowing women to make informed choices, taking into consideration the types and forms of menopause treatments, as well as the benefits and risks.7,8

Dr Heather Currie, Gynaecologist and Associate Medical Director at Dumfries and Galloway Royal Infirmary, said: “This is helpful for women in Scotland and will offer another option for women who choose to take HRT. There is not one type or regimen which suits all women and having more options takes us a step closer to ensuring women across all nations in the UK are able to find a preparation that suits them.”

Tina Backhouse, UK General Manager, Theramex, said: “We are delighted that women in Scotland will now have access to a greater array of menopause treatments with the addition of Bijuve®. We do hope that timely adoption of Bijuve® onto local Scottish formularies is prioritised so women have access to more treatment choices. Theramex would welcome the introduction of a centralised national formulary in England, which would take us a step closer to equitable access for patients.”

References

1 Theramex 2021, Summary of Product Characteristics

3 British Menopause Society, 2022. Update on HRT supply (21st July 2022). Available at: British Menopause Society update on HRT supply – British Menopause Society (thebms.org.uk) Last accessed September 2022

4 Sussman M et al, (2015). Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC Womens Health 15(58). Available at: Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records | BMC Women’s Health | Full Text (biomedcentral.com) Last accessed September 2022.

5 NHS – Types of HRT. Available at: Hormone replacement therapy (HRT) – Types – NHS (www.nhs.uk) Last accessed September 2022.

6 British Menopause Society. Bioidentical HRT Consensus, 2019. [Cited 27th August 2020]. Available at: Bioidentical HRT – British Menopause Society (thebms.org.uk) Last accessed September 2022.

7 British Menopause Society, 2016. The British Menopause Society & Women’s Health Concern 2016 recommendations on hormone replacement therapy in menopausal women. Available at: The British Menopause Society & Women’s Health Concern 2016 recommendations on hormone replacement therapy in menopausal women (sagepub.com) Last accessed September 2022.

8 National Institute for Health and Care Excellence. Menopause: diagnosis and management (NG23). 2015, updated 2019. Available at: Overview | Menopause: diagnosis and management | Guidance | NICE Last accessed September 2022

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