Hormone Replacement Therapy (HRT) (DRAFT)

Prescribing guidance

Please see BNSSG HRT PRESCRIBING PATHWAY in the Formulary section for current BNSSG prescribing guidance.  

Prescribing should be in line with formulary guidelines. If prescribing off-license, you should consider relevant guidelines e.g. GMC Prescribing unlicensed medicines - professional standards - GMC (gmc-uk.org) 

Indications

• Symptom control  
• Premature ovarian insufficiency 
• Prevention and treatment of osteoporosis  

HRT is generally contraindicated in women with current or previous oestrogen-sensitive cancers (e.g. breast, intermediate endometrial, low-grade serous ovarian) and specialist input should be sought in cases of menopausal symptoms not responding to alternative treatment options.  

Please see relevant Remedy pages for further information 

• Hormone sensitive cancers  

• HRT and Breast conditions  

• Alternatives to HRT 

Other conditions will also require further considerations. Please review local and national guidance and seek Advice and Guidance or make a referral to a menopause specialist as required.  

Type of HRT

*Please see Gynaecology conditions and HRT

Tibolone

• This oral preparation has estrogenic, progestogenic and androgenic effects; it should be considered ccHRT 

• Not to be used in women over 60 or those with increased cardiovascular risk.  

See HRT over 60, Cardiovascular conditions and HRT  

Route of administration

Oral HRT is first line as recommended by BMS and NICE. This is currently the first line option for those at low risk of VTE in BNSSG.  

Transdermal administration of estradiol is unlikely to increase the risk of VTE or stroke above that in non-users and is associated with a lower risk compared with oral estradiol. The transdermal route should be considered the first line route of estradiol administration in women with related risk factors 

Transdermal HRT is first line for women: 

• Over 60years 
• Increased VTE risk (Please see HRT and VTE risk for further details) 
• Obesity (BMI >30kg/m²)  
• Migraine 
• Variable blood pressure control and hypertension 
• Increased cardiovascular risk
• Current use of hepatic enzyme inducing medication 
• Gall bladder disease 
• Hypothyroidism
• Malabsorption syndromes  

It should also be considered for women whose preference is transdermal HRT and those with poor symptom control with oral HRT.  

Dose

Generally, the lowest estrogen dose that provides symptom relief should be used. This should be balanced by an appropriate dose of progestogen for those requiring both hormones.  

Doses should not exceed ‘high’ without specialist input. Women requiring ‘high’ dose estrogen should also have their progestogen increased. The BMS has published guidance on managing unscheduled bleeding and details appropriate doses in Appendix 1 (see below).  

Management of unscheduled bleeding on hormone replacement therapy (HRT) - British Menopause Society (thebms.org.uk)

Women with POI or surgically induced menopause may require high doses. 

Practical tips

Testosterone

Please see specific testosterone advice page

Review and follow up

• Review at 3 months after initiation or change of HRT  
• At least annually thereafter  

Follow up at 3 months after initiating or changing HRT:  

• Assess symptom control  
• Bleeding pattern. If concerned, see Unscheduled bleeding on HRT for advice on further investigation, referrals and management
• Side effects. Encourage women to persist with treatment for 3 months if possible as side effects may resolve. See Side Effects and Risks  for further details.
• Check BP
• Reinforce lifestyle optimisation  

Annual Review:  

• Assess efficacy  
• Medication review including dose, preparation, compliance and side effects. 
• Bleeding pattern. See Unscheduled bleeding on HRT
• If uterus intact and taking oestrogen only HRT, ensure Mirena® Coil is in date and in situ. If Mirena® Coil is removed, ensure an appropriate combination of oestrogen and progesterone is prescribed.  
• Discuss risks vs benefits of continuing HRT 
• Discuss breast awareness, mammography & cervical screening attendance  
• Ask about symptoms of urogenital atrophy, +/- sexual dysfunction, and offer advice or treatment as required  
• Check BP, BMI, CVD risk factors  

Sequential HRT should not be continued for more than 5years. You can add a diary entry to remind you to consider switching at their HRT review. GP software also has review tools you can utilise, for example Arden’s.   

Stopping HRT

• Stop when the risks outweigh the benefits  

• Or the patient wishes to stop  

• There is no arbitrary limit on time of using HRT, risks vs benefit often changes after the age of 60 – See HRT over 60  

• Weaning HRT, as opposed to a sudden stop, is less likely to be associated with reflex symptoms in the short term.  

Estradiol levels

It is not recommended to check estradiol levels routinely. Doses should be adjusted based on symptom control.   

Levels can only be interpreted for people using transdermal estradiol. If using oral estradiol, the levels cannot be interpreted and should not be taken.

If symptoms are not being controlled by an increased dose of estrogen consider: 

• Are the symptoms due to the menopause? Need to investigate other causes or contributing factors? 

• Are they using the preparation as prescribed and correctly? Would an alternative be more suitable?  

• Are they part of the 10-15% of the population who do not well absorb through the transdermal route, would an oral preparation be appropriate to trial? (Oral HRT is first line on formulary guidance, in low-risk women provides good symptom control and a marginal increased VTE risk) 

Additional considerations

• Current or previous breast cancer

• Hormone Sensitive Cancers

• VTE or history of VTE 

• Cardiovascular conditions – Stroke, MI, Hypertension  

• Gynaecological conditions – endometriosis, subtotal hysterectomy

• Migraine and HRT

• Other Medical comorbidities - where oestrogen therapy can have deleterious effect such as Lupus, Epilepsy, Porphyria, unprovoked thrombosis, Fibroids, Endometriosis, Unstable liver disease, Connective tissue disorders, Histamine Sensitivity. Please refer to the complex menopause clinic as per referrals process.  

Body-identical and Bioidentical HRT

Regulated body-identical compounds are precise duplicates of hormones. They are regulated by the MHRA. Commonly used body-identical hormones used in HRT are:  

• Estradiol (E2)  

• Estriol (E3) 

• Micronised Progesterone (MP) (Gepretix (BNSSG preferred brand), Utrogestan) 

Body-identical hormones may have benefit over conventional HRT, for example improved tolerance (fewer side effects) and reduced risks (breast cancer, VTE, cardiovascular risks). However, MP use may increase the risk of breakthrough bleeding. After discussion of risks and benefits, many women choose to use body-identical preparations.  

Compounded ‘bio-identical’ HRT consists of multiple hormones together (estrogens +/- progestogens +/- testosterone +/- DHEA). These are manufactured by ‘Specialist Pharmacies’ and do not follow the same regulatory pathways as conventional pharmaceutical products. Their efficacy and safety is unknown and their use is not recommended by the British Menopause Society or NICE.  

HRT Pre-payment certificate

Women prescribed HRT can get an HRT prescription prepayment certificate (HRT PPC). This covers all eligible HRT prescriptions for a 12month period and offers a significant discount on individual prescription costs. Most, but not all, BNSSG formulary medications are eligible. Testosterone, norethisterone/medroxyprogestrone (individually) are not eligible.  

The certificate is available to buy here: 

NHS Hormone Replacement Therapy Prescription Prepayment Certificate (HRT PPC) | NHSBSA 

Resources

Patient Resources 

Treatment for symptoms of the menopause | RCOG 

Menopause and later life | RCOG 

WHC factsheets and other helpful resources - Women's Health Concern (womens-health-concern.org) 

NHS Hormone Replacement Therapy Prescription Prepayment Certificate (HRT PPC) | NHSBSA 

BMS TV - British Menopause Society (thebms.org.uk) 

https://www.nice.org.uk/guidance/ng23/resources/menopausepdf-718895758021  

https://www.womens-health-concern.org/  

www.menopausematters.co.uk/   

Find a BMS-recognised Menopause Specialist - British Menopause Society (thebms.org.uk)   

Understanding Menopause for Partners - Menopause Support 

References and Resources  

Bioidentical HRT - British Menopause Society (thebms.org.uk) 

Recommendations | Menopause: diagnosis and management | Guidance | NICE 

04-BMS-TfC-HRT-Guide-NOV2022-A.pdf (thebms.org.uk) 

03-BMS-TfC-HRT-Practical-Prescribing-NOV2022-A.pdf (thebms.org.uk) 

Management of unscheduled bleeding on hormone replacement therapy (HRT) - British Menopause Society (thebms.org.uk)

Efforts are made to ensure the accuracy and agreement of these guidelines, including any content uploaded, referred to or linked to from the system. However, BNSSG ICB cannot guarantee this. This guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, in accordance with the mental capacity act, and informed by the summary of product characteristics of any drugs they are considering. Practitioners are required to perform their duties in accordance with the law and their regulators and nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

Information provided through Remedy is continually updated so please be aware any printed copies may quickly become out of date.