1. Category: Prior Approval

Prior approval from the Integrated Care Board (ICB) will be required before any treatment proceeds in secondary care unless an alternative contract arrangement has been agreed with the ICB that does not necessitate the requirement of prior approval before treatment.

2. Background

This commissioning policy has been produced in order to provide and ensure equity, consistency and clarity relating to the approach to Hysterectomy for heavy menstrual bleeding by the Integrated Care Board (ICB) and is based on NHS England’s Evidence-Based Interventions (EBI) recommendations. See link to programme below – accurate at the point of publication: Hysterectomy for heavy menstrual bleeding – EBI

Hysterectomy is the surgical removal of the uterus.

Based on NICE guidelines [NG88] Heavy menstrual bleeding: assessment and management, hysterectomy should not be used as a first-line treatment solely for heavy menstrual bleeding

It is important that healthcare professionals understand what matters most to each individual and support their personal priorities and choices

Hysterectomy should be considered ONLY when:

• other treatment options have failed
• are contradicted
• there is a wish for amenorrhoea (no periods)
• the individual (who has been fully informed) requests it
• the individual no longer wishes to retain their uterus and fertility

Patients must also be fully informed and made aware of any treatment under this policy which may impact their future fertility

Discussion must be held as to the clinical appropriateness of Cryopreservation of Gametes & Embryos and that NHS funded cryopreservation will only be made available where the patient meets the eligibility criteria of the ICB’s Policy for NHS Funded Cryopreservation of Gametes & Embryos

Furthermore, the patient must be made aware that NHS funded specialist infertility treatment will not be made available for any resulting infertility resulting from treatments within this policy on the basis that Surrogacy is not commissioned or funded by the NHS

Rationale for recommendation

NICE’s Guideline Development Group considered the evidence (including 2 reviews, four randomised control trials and one cohort study comparing hysterectomy with other treatments) as well as the views of patients and the public and concluded that hysterectomy should not routinely be offered as first line treatment for heavy menstrual bleeding

The Group placed a high value on the need for education and information provision for individuals with heavy menstrual bleeding

Complications following hysterectomy are usually rare but infection occurs commonly. Less common complications include: intra-operative haemorrhage; damage to other abdominal organs, such as the urinary tract or bowel; urinary dysfunction – frequent passing of urine and incontinence. Rare complications include thrombosis (DVT and clot on the lung) and very rare complications include death.

Complications are more likely when hysterectomy is performed in the presence of fibroids (non-cancerous growths in the uterus). There is a risk of possible loss of ovarian function and its consequences, even if their ovaries are retained during hysterectomy. If oophorectomy (removal of the ovaries) is performed at the time of hysterectomy, menopausal-like symptoms occur

3. Eligibility Criteria

NICE guideline NG88

1.5 Management of HMB

1.5.1 When agreeing treatment options for HMB with women, take into account:

• the woman’s preferences
• any comorbidities
• the presence or absence of fibroids (including size, number and location), polyps, endometrial pathology or adenomyosis
• other symptoms such as pressure and pain

Treatments for women with no identified pathology, fibroids less than 3 cm in diameter, or suspected or diagnosed adenomyosis

1.5.2 Consider an LNG-IUS (levonorgestrel-releasing intrauterine system) as the first treatment for HMB in women with:

• no identified pathology; OR
• fibroids less than 3 cm in diameter, which are not causing distortion of the uterine
• cavity or suspected; OR
• diagnosed adenomyosis.

Note that this is an off-label use for some LNG-IUSs. See NICE’s information on prescribing medicines

1.5.3 If a woman with HMB declines an LNG-IUS or it is not suitable, consider the following pharmacological treatments:

• non-hormonal: tranexamic acid; NSAIDs (non-steroidal anti-inflammatory drugs);
• hormonal: combined hormonal contraception, cyclical oral progestogens

Note that this is an off-label use for NSAIDs and some combined hormonal contraceptives.

See NICE’s information on prescribing medicines.

1.5.4 For gonadotrophin-releasing hormone (GnRH) antagonists recommended as options in NICE technology appraisal guidance for treating moderate to severe symptoms of uterine fibroids in some people, see the guidance on:

•  linzagolix (TA996, 2024)
•  relugolix–estradiol–norethisterone acetate (TA832, 2022)

1.5.5 Be aware that progestogen-only contraception may suppress menstruation, which could be beneficial to women with HMB

If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, consider referral to specialist care for:

• investigations to diagnose the cause of HMB, if needed, taking into account any investigations the woman has already had; AND
• alternative treatment choices, including:
• pharmacological options not already tried (see recommendations 1.5.2 and 1.5.3);
• surgical options: second-generation endometrial ablation hysterectomy

Fluid-filled thermal balloon and microwave endometrial ablation are recommended as options in NICE technology appraisal guidance when the woman and her clinician have decided that surgical intervention is appropriate

For full details, see the guidance on fluid- filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding (TA78, 2004).

1.5.7 For women with submucosal fibroids, consider hysteroscopic removal.

Treatments for women with fibroids of 3 cm or more in diameter

1.5.8 Consider referring women to specialist care to undertake additional investigations and discuss treatment options for fibroids of 3 cm or more in diameter

1.5.9 If pharmacological treatment is needed while investigations and definitive treatment are being organised, offer tranexamic acid and/or NSAIDs Note that this is an off-label use for NSAIDs. See NICE’s information on prescribing medicines

1.5.10 Advise women to continue using NSAIDs and/or tranexamic acid for as long as they are found to be beneficial Note that this is an off-label use for NSAIDs. See NICE’s information on prescribing medicines.

1.5.11 For women with fibroids of 3 cm or more in diameter, take into account the size, location and number of fibroids, and the severity of the symptoms and consider the following treatments:

• pharmacological:

o non-hormonal:

▪ tranexamic acid

▪ NSAIDs

o hormonal:

▪ LNG-IUS

▪ combined hormonal contraception

▪ cyclical oral progestogens

▪ ulipristal acetate (this is only indicated for some premenopausal

women; see recommendations 1.5.13 and 1.5.14 for more information)

o uterine artery embolization

o surgical:

▪ myomectomy

Note that this is an off-label use for NSAIDs and some LNG-IUSs. See NICE’s information

on prescribing medicines.

1.5.12 For GnRH antagonists recommended as options in NICE technology appraisal

guidance for treating moderate to severe symptoms of uterine fibroids in some people, see

the guidance on:

• linzagolix (TA996, 2024)

• relugolix–estradiol–norethisterone acetate (TA832, 2022).

1.5.13 Only think about ulipristal acetate for the intermittent treatment of moderate to severe

symptoms of uterine fibroids in premenopausal women if:

• surgery and uterine artery embolisation for fibroids are not suitable, for example, because the risks to a woman outweigh the possible benefits, or
• surgery and uterine artery embolisation for fibroids have failed, or
• the woman declines surgery and uterine artery embolisation for fibroids.

See the MHRA drug safety update on ulipristal acetate

1.5.14 Discuss with the woman the risks and possible benefits of intermittent treatment with ulipristal acetate.

• Advise that ulipristal acetate can be associated with serious liver injury leading to liver failure, and the signs and symptoms to look out for.
• Measure liver function before starting ulipristal acetate, monthly for the first 2 courses and once before each new treatment course when clinically indicated.
• If there is no underlying liver injury, and surgery and uterine artery embolisation for fibroids are unsuitable or have failed, consider ulipristal acetate 5 mg (up to 4 courses) for premenopausal women with heavy menstrual bleeding and fibroids of 3 cm or more in diameter, particularly if the haemoglobin level is 102 g per litre or below
• If a woman shows signs and symptoms of liver failure, stop ulipristal acetate and perform liver function tests urgently.

1.5.15 Be aware that the effectiveness of pharmacological treatments for HMB may be limited in women with fibroids that are substantially greater than 3 cm in diameter.

1.5.16 Prior to scheduling of uterine artery embolisation or myomectomy, the woman’s uterus and fibroid(s) should be assessed by ultrasound. If further information about fibroid position, size, number and vascularity is needed, MRI should be considered.

1.5.17 Consider second-generation endometrial ablation as a treatment option for women with HMB and fibroids of 3 cm or more in diameter who meet the criteria specified in the manufacturers’ instructions

Fluid-filled thermal balloon and microwave endometrial ablation are recommended as options in NICE technology appraisal guidance when the woman and her clinician have decided that surgical intervention is appropriate. For full details, see the guidance on fluid- filled thermal balloon and microwave endometrial ablation techniques for heavy menstrual bleeding

1.5.18 If treatment is unsuccessful:

• consider further investigations to reassess the cause of HMB, taking into account the results of previous investigations; AND
• offer alternative treatment with a choice of the options described in recommendation

1.5.11.

1.5.19 Pretreatment with a gonadotrophin-releasing hormone analogue before hysterectomy and myomectomy should be considered if uterine fibroids are causing an enlarged or distorted uterus

Note that this is an off-label use for some gonadotrophin-releasing hormone analogues. See NICE’s information on prescribing medicines.

For patients who DO NOT meet the eligibility criteria, the ICB will only consider funding the treatment if an Individual Funding Request (IFR) detailing the patient’s clinical presentation is submitted to the ICB.