Scottish Medicines Consortium accepts Theramex’ Bijuve HRT on NHS Scotland

The first and only body-identical HRT for post-menopausal oestrogen deficiency, Bijuve, has been passed by the SMC as suitable for use by Scotland’s National Health Service, after being advised by the NHS Boards and Area Drug and Therapeutics Committees (ADTCs).

The SMC, which decides the medicines acceptable for use by NHS Scotland, made its decision based on consideration of the “clinical and health economic evidence […in order] to decide whether [it] provides value for money”; that is to say, Bijuve’s additional benefits in comparison to other, already available HRT treatments.

Developed by the women’s health company, Theramex, Bijuve combines oestradiol and progesterone in an oral capsule for single daily dose. It is hoped it will serve to address the considerable unmet needs of post-menopausal women, and not just in Scotland.

The symptoms of menopause (also known as climacteric) result from hormone deficiency resulting when the ovaries produce less oestrogen and progesterone. Symptoms can include hot flushes and night sweats, vaginal dryness and discomfort in intercourse, as well as anxiety, low mood, a reduced libido, and even problems with concentration and memory.

Generally, it is recommended that an individualised approach be adopting in treating women with HRT. Therefore, there are different types, all of which offer a variety of combinations and dosages of hormones, as well as multiple methods of administration, from tablets and patches to gels and implants.

However, those HRT treatments which use body-identical hormones are thought to be better tolerated by patients. They are also associated with fewer risks than are synthetic hormones.

As Dr Paula Briggs, consultant in sexual and reproductive health and chair of the British Menopause Society (BMS) said, “[a]s clinicians, it is vital we empower our patients to make well-informed choices on what is available and what works best for them.” News of Bijuve’s availability on NHS Scotland follows BMS’s updated advice on HRT availability earlier this year.

A body-identical HRT treatment, Bijuve (1mg oestradiol / 100mg micronised progesterone) has been deemed suitable for use by those women who have an intact uterus and whose last menses were at least 12 months prior to starting treatment. There has been only limited experience of Bijuve’s use in women over the age of 65, however.

Dr Heather Currie, gynaecologist and associate medical director at Dumfries and Galloway Royal Infirmary said, “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.”

The case in England is a somewhat different one, though, with Bijuve available on only a handful of formularies. In part due to COVID-19 backlogs in approvals, it is nonetheless thought that this is also yet another symptom of the “lack of prioritisation of women’s health issues”.

Tina Backhouse, UK general manager at Theramex, said the company “would welcome the introduction of a centralised national formulary in England, which would take us a step closer to equitable access for patients.”

 

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