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Hormone Replacement Therapy (HRT) (DRAFT)

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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

Estrogen Only

Sequential

Continuous

No uterus

Total hysterectomy

Use:

Daily estrogen

Perimenopausal

<54y with on-going menstruation

LMP <1y

Use:

Daily estrogen

Progestogen 12-14 days per month

NB: Should not be used for >5years

Post menopausal

LMP >1y

5 years of sequential HRT or >54y (whichever is earlier)

Following certain gynaecology procedures including endometrial ablation, subtotal hysterectomy, endometriosis surgery including hysterectomy*

Use:

Daily estrogen

Daily progestogen (including 52mg LNG-IUD)

*Please see Gynaecology 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).

01-BMS-GUIDELINE-Management-of-unscheduled-bleeding-HRT-APRIL2024-F.pdf (thebms.org.uk)

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

Practical tips

Gel	Apply to clean, dry skin, ideally after a bath or shower Can be applied to any area other than your breasts or genitals. Recommend thigh application to reduce risk of transfer and increased fat --> increased vascularity and absorption. Do not rub in, allow to dry naturally (this can take 5 minutes) before getting dressed. Do not shower or apply suncream for at least 1hour after application
Patches	Apply to clean, cool, dry skin Apply below the waist (usually thighs or buttocks) Do not apply in the same place twice in a row (but positions can be repeated) If using half a patch, cut on the diagonal If having a skin reaction to patches, off-licence an aerosol steroid inhaler can be applied to the skin prior to the patch to reduces localised skin reactions
Spray	Apply to clean, dry skin, hold the cannister on to the skin to apply Apply to the inner forearm or thigh, moving along the limb with each spray The spray should be applied to the same area each day Do not rub in, dry's naturally in 2-15 minutes Discard the first three sprays Do not shower or apply suncream for at least 1hour after application
Micronized progesterone	Advise to take at night (side effect is sleepiness, which may help with menopause insomnia) Aim to take on an empty stomach to reduce side effects Off-licence, the oral capsules can be used vaginally in the same dose (see BMS guidelines)
Commencing Sequential HRT	Patients should have their ‘withdrawal’ bleed after stopping the combined (progestogen) part of their HRT, bleeding outside of this should be managed as unscheduled bleeding Withdrawal bleeds are lighter in nature than periods and red flags which should prompt ultrasound assessment include bleeding more than 7days or flooding and/or clots If starting on day 1 of their cycle they should start with the estrogen only, then move on to combined. When prescribing sequential patches, warn patients that they will find two different types of patches in their packet and to seek help if they are unsure of the order in which to use them

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

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. See Unscheduled bleeding on HRT
Side effects. Encourage women to persist with treatment for 3 months if possible as side effects may resolve. See Side Effects and Risks
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
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.

If using oral estrogens, 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/

www.managemymenopause.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)

01-BMS-GUIDELINE-Management-of-unscheduled-bleeding-HRT-MAY2024-G.pdf (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.