Utrogestan 100mg (micronised progesterone) capsules accepted by SMC for use as HRT in Scotland

12 December 2022 – Besins Healthcare UK has announced that Utrogestan 100mg has been accepted for use within NHS Scotland for adjunctive use with oestrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT)1. This approval has been long awaited by clinicians and women in Scotland and will provide greater patient equity across the UK. 

Utrogestan is the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) that can be used alongside any oestrogen-only HRT product for women with an intact uterus2,3. It is a body-identical hormone meaning that it has the same molecular structure as the hormone produced by the body. Body-identical hormones are believed to be associated with fewer risks than are synthetic hormones4. 

The symptoms of menopause arise from hormone deficiency when the ovaries produce less oestrogen and progesterone. Symptoms vary from one person to another but can include hot flushes, night sweats, anxiety, low mood, concentration and memory issues and a reduced libido as well as vaginal dryness and discomfort in intercourse. If a woman still has her uterus when being prescribed HRT, she needs to have both oestrogen and a progestogen prescribed5.  

It is recommended that an individualised approach be adopted when treating women with HRT5. Micronised progesterone can be prescribed alongside any oestrogen-only HRT product which makes tailoring of the oestrogen component of HRT to control symptoms possible. There are different types of oestrogen-only products available, from tablets and patches to gels and a spray that can all be used alongside Utrogestan3.  

Dr Claire Phipps, a GP and menopause specialist, who has been supporting her sister, Caroline Phipps-Urch, a menopause yoga teacher who spearheaded a petition to make micronised progesterone (Utrogestan) available as HRT for women in NHS Lothian, said: “This decision from the SMC is a real milestone and will mean so much for the women of Scotland. It’s important that there is equity and equality for all women in the management of their menopause symptoms and the availability of this product addresses what was a gap in the treatment options available to the women of Scotland.” 

Dr Paula Briggs, Consultant in Sexual and Reproductive Health and Chair of the British Menopause Society, said: “Every woman should have access to a range of approved HRT preparations to help them manage their symptoms if they are to optimise their menopause transition. The SMC decision supports greater empowerment for women across Scotland as they will now have an additional product to consider when discussing HRT options with their doctor which is critical as every woman’s experience of the menopause transition is unique to them.” 

Del Cohen, Managing Director at Besins Healthcare UK, said: “Utrogestan offers women an increased choice in approved medicines for HRT. We have worked diligently to provide the necessary evidence to inform the Scottish Medicines Consortium of the health and cost impact of this medicine. The SMC Executive’s approval is an important step towards greater patient equity across the UK and we welcome the news.”  

Cohen continued: “This decision has been long awaited by women and clinicians working in Scotland and granting nationwide access to Utrogestan aligns with the Scottish Women’s Health Plan to provide equitable access to, and choice of menopausal management for all women across Scotland.” 

ENDS 

Notes for Editors 

About Besins Healthcare 

Besins Healthcare is a global pharmaceutical company specialising in the development of innovative medicines for the well-being of men and women throughout their life. Besins Healthcare (UK) Ltd. has established a strong and reputable name for supply of medicines used in the treatment of gynaecological, fertility and obstetrical conditions as well as androgen deficiency and has become a renowned company focused on hormonal therapies. 

About Utrogestan 100mg2. 

Utrogestan 100mg is indicated for adjunctive use with oestrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT). 

Utrogestan 100mg is available in the UK as a soft capsule. 

Previous Utrogestan 100mg SMC application6.

In 2009 the SMC rejected Utrogestan on economic grounds. This full submission was undertaken by another company who marketed the product at that time not Besins Healthcare UK (Ltd). 

Media enquiry contact details 

Louise Coxon 

TALA  

+44 (0) 7870 661105 

louise.coxon@teamtala.com 

Lex Rosenthal 

TALA  

+44 (0) 7912 611 432 

lex.rosenthal@teamtala.com

References 

1 Scottish Medicines Consortium advice on micronised progesterone (Utrogestan) [Online]. Available from: https://www.scottishmedicines.org.uk/medicines-advice/micronised-progesterone-utrogestan-abb-smc2529/ [Accessed 12 December 2022]. 

2 Besins Healthcare (UK) Ltd. Utrogestan 100mg - Summary of Product Characteristics (SmPC) - (emc) [Online]. www.medicines.org.uk. 2022. Available from: https://www.medicines.org.uk/emc/product/352/smpc [Accessed 11 November 2022]. 

3 MIMS Online. Hormone replacement therapy (HRT). [Online]. Available from: https://www.mims.co.uk/hormone-replacement-therapy-hrt/womens-health/article/1415738 [Accessed 12 December 2022]. 

4 Panay N. Body identical hormone replacement. Post Reproductive Health 2014; 20(2): 69–72. Available from: doi.org/10.1177/205336911453667 

5 National Institute for Health and Care Excellence (NICE). Menopause: diagnosis and management [Online]. NICE. 2015. Available from: https://www.nice.org.uk/guidance/ng23 [Accessed 11 November 2022]. 

6 Previous Scottish Medicines Consortium advice on micronised progesterone (Utrogestan) [Online]. Available from: https://www.scottishmedicines.org.uk/medicines-advice/micronised-progesterone-utrogestan-fullsubmission-54209/ [Accessed 12 December 2022].