Oral HRT accepted for use across Scotland while availability remains limited in England

Bijuve has been been approved for use across Scotland, but it is only available in some local formularies in England, owing to backlogs caused by COVID-19.
Older woman taking HRT medicine

The Scottish Medicines Consortium (SMC) has accepted Bijuve (estradiol + progesterone; Theramex), an oral hormone replacement therapy (HRT), for use by the NHS across Scotland.

However, in England, the treatment is still only available in a some local formularies, which experts say is owing to backlogs caused by the COVID-19 pandemic.

According to Theramex, Bijuve is the “first and only”, body-identical HRT indicated for oestrogen-deficiency symptoms in post-menopausal women who have an intact uterus and for whom it has been at least 12 months since their last period.

The HRT combines oestradiol and progesterone (1mg oestradiol/100mg micronised progesterone) in a single daily oral capsule.

Paula Briggs, a consultant in sexual and reproductive health at Liverpool Womens NHS Foundation Trust and chair of the British Menopause Society, said Bijuve was a “great product”, that was “not excessively expensive” and had the least impact on blood clot risk and risk of breast cancer compared to other HRT products.

“The fact that the SMC [has] agreed to add it to their formulary is extremely positive,” she added.

However, she said that getting the drug onto local formularies in England was “a challenge”.

“We’ve been advised by [former health minister] Maria Caulfield that NHS England has written to all GPs to say that they are no longer restricted by their formulary because of the current issue with supply or demand and supply [of HRT].”

But she added that this message had not “filtered through” to all GPs, some of whom would still not prescribe it because it wasn’t in their local formulary.

Nuttan Tanna, a pharmacist consultant in women’s health and osteoporosis at London North West University Healthcare NHS Trust, said it would be “good” to get Bijuve formally assessed by NICE and a decision taken on whether it can be added onto formularies in England.

“This is the ‘formal’ process for optimisation of medicines/cost-effective use within the NHS … however, [delays have occurred owing] to COVID-19 backlogs and HRT shortages,” she added.

However, Tanna said that whenever she has asked for a patient to be prescribed Bijuve in her area, her local primary care colleagues have been “happy to do so”.

In May 2022, the NHS announced that it had issued ten more serious shortage protocols (SSPs) for HRT products, enabling pharmacists to restrict the amount supplied to patients or make substitutions without having to consult the patient’s GP.

Previously, pharmacists were given powers to limit dispensing of some types of HRT to three months, as of 29 April 2022, in an effort by the government to mitigate the impact of ongoing supply problems.

The latest SSPs, published on 19 May 2022, cover Estradiol (Sandrena; Orion Pharma) 0.5mg and 1mg gel sachets, estradiol (Lenzetto; Gedeon Richter) 1.53mg/dose transdermal spray, estriol (Ovestin 1mg cream; Aspen) 0.1% cream and estradiol Oestrogel Pump-Pack 0.06% gel (Besins Healthcare).

Last updated
The Pharmaceutical Journal, PJ, September 2022, Vol 309, No 7965;309(3965)::DOI:10.1211/PJ.2022.1.157449

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