SRP 058 Heavy Menstrual Bleeding (including uterine fibroids)

Policy number: SRP 058
Policy name: Heavy Menstrual Bleeding (including uterine fibroids) 
Status: Group Prior Approval
Effective date: 1 May 2025
Next review date: 1 April 2027

Heavy Menstrual Bleeding (HMB) is defined as excessive menstrual blood loss which interferes with physical, emotional, social and material quality of life, and which can occur alone or in combination with other symptoms.  This policy does not apply to post-menopausal, inter-menstrual or post-coital bleeding.

Mid and South Essex ICB will routinely fund the following pathway taking into account NICE guidance¹ as to appropriateness of procedures.  https://www.nice.org.uk/guidance/ng88/resources/diagnosis-care-pathway-pdf-4783791277

People should be provided with information about HMB and its management. Follow the principles in the NICE guidelines on patient experience in adult NHS services and shared decision making in relation to communication, information and shared decision-making. A NICE endorsed shared decision aid is available.

If the individual’s history and/or examination suggests a low risk of fibroids, uterine cavity abnormality, histological abnormality or adenomyosis, GPs should only refer to specialist care when:

• There has been a trial with a levonorgestrel-releasing intrauterine system LNG-IUS, e.g. Mirena®, unless contraindicated, for at least 12 months and this has not successfully relieved symptoms or has produced unacceptable side effects.
  Contraindications to the levonorgestrel intrauterine system are:
  • Distorted or small uterine cavity (with proven ultrasound measurements; uterocervical canal length < 5cm) 
  • Genital malignancy 
  • Active trophoblastic disease 
  • Active pelvic inflammatory disease 
  • Large cavity over 10cm length 

AND

• At least two of the following drug treatments (for at least 3 months each) have failed to relieve symptoms (unless contraindicated or inappropriate): 
  • Alternative hormonal treatment in keeping with NICE guidance e.g. combined or progestogen only oral contraceptives, injected progesterone, Gn-RH analogues 
  • NSAIDs 
  • Tranexamic Acid 

For those who for ethical or clinical reasons cannot accept the use of a levonorgestrel-releasing intrauterine system LNG-IUS they should have tried at least two of the alternative treatments. 

If the individual’s history and/or examination suggests a high risk of fibroids, uterine cavity abnormality, histological abnormality, or adenomyosis, arrange further investigations to determine the cause of menorrhagia and consider referral to a specialist.

The specialist should have a full discussion with the individual about all possible treatment options for HMB and including implication of the different options- surgical and non-surgical- before a decision is made.  The discussion should include sexual feelings, fertility impact, bladder function, need for further treatment, treatment complications, the individual’s expectations, alternative surgery and psychological impact and must be fully documented in the clinical record.

Discussions should cover:  

• the benefits and risks of the various options  
• suitable treatments if trying to conceive.  
• whether wishes to retain fertility and/or uterus. 

When agreeing treatment options for HMB with the patient, take into account:  

• the patient’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. 

A NICE endorsed shared decision aid is available.

Oral treatments are now available as an option for management of moderate to severe symptoms of uterine fibroids where the individual meets the NICE defined criteria.

Relugolix–estradiol–norethisterone acetate (TA 832) is recommended by NICE, within its marketing authorisation, as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age.  Relugolix–estradiol–norethisterone acetate has been assigned a YELLOW Traffic light status within MSE.  Treatment should be initiated and monitored by a specialist experienced in managing uterine fibroids. Prescribing may be continued in primary care once the patient is stabilised on treatment. Specialist reviews are planned at 3 months and 12 months after initiating treatment.

A dual X ray absorptiometry (DXA) scan is recommended after 1 year of treatment. In patients with risk factors for osteoporosis or bone loss, a DXA scan is recommended prior to starting treatment. The specialist is responsible for requesting and acting on the results of the scan. The decision to continue or discontinue treatment must be clearly communicated to the patient’s GP.

Relugolix-estradiol-norethisterone acetate provides adequate contraception for the patient after one month of use. During the first month of treatment, non-hormonal contraception is advised. If two consecutive doses are missed, then non- hormonal contraception should be used for 7 days.

Further information and dosage schedule is available in the summary of product characteristics for relugolix-estradiol-norethisterone acetate.

Linzagolix (TA 996) is recommended by NICE as an option for treating moderate to severe symptoms of uterine fibroids in adults of reproductive age only if:

• it is intended to be used for longer-term treatment (normally for more than 6 months and not for people who need short-term treatment, for example, before planned surgery)
• the following dosage is used:
  • with hormonal add-back therapy (ABT): 200mg once daily.
  • without hormonal ABT: 200mg once daily for 6 months, then 100mg once daily.

Linzagolix has been assigned a YELLOW Traffic light status within MSE. Treatment should be initiated and monitored by a specialist experienced in managing uterine fibroids. Prescribing may be continued in primary care once the patient is stabilised on treatment. Specialist reviews are planned at 3 months and 12 months after initiating treatment.

Further information is available in the summary of product characteristic for linzagolix.

In patients with risk factors for osteoporosis or bone loss, a DXA scan is recommended prior to starting treatment. A DXA scan is recommended after 1 year of treatment and there is a need for continued bone mineral density (BMD) monitoring thereafter. The specialist is responsible for requesting and acting on the results of the scan. The decision to continue or discontinue treatment must be clearly communicated to the patient’s GP.

Linzagolix with or without concomitant ABT has not been demonstrated to provide contraception. Individuals of childbearing potential at risk of pregnancy should use effective non-hormonal contraception while on treatment with linzagolix.

Discontinuation of pharmacological treatments should be considered when the patient enters menopause, as the symptoms of uterine fibroids are known to regress when menopause begins.

Ulipristal acetate 5mg should no longer be prescribed for controlling symptoms of uterine fibroids while waiting for surgical treatment. It should be used only for intermittent therapy of moderate to severe uterine fibroid symptoms before menopause and when surgical procedures are not suitable or failed.  See updated MHRA safety advice on the risk of serious liver injury.

People offered hysterectomy should be informed of the increased risk of serious complications (such as intraoperative haemorrhage or damage to other abdominal organs) associated with hysterectomy when uterine fibroids are present. Taking into account the need for individual assessment, the route of hysterectomy should be considered in the following order: first line vaginal; second line abdominal or laparoscopic.

People should be informed of the risk of possible loss of ovarian function and its consequences, even if their ovaries are retained during hysterectomy.

NICE guidelines state that removal of healthy ovaries at the time of hysterectomy should not be undertaken; however prophylactic removal of fallopian tubes may be considered to reduce the risk of ovarian cancer.  Ovary removal should be discussed with the patient on an individual basis and the age of the patient should also be taken into account.  Ovary removal should only be undertaken with the expressed wish and consent of the woman.

In relation to the above Heavy menstrual bleeding: management path, please note:
¹Ulipristal acetate 5mg should no longer be prescribed for controlling symptoms of uterine fibroids while waiting for surgical treatment. It should be used only for intermittent therapy of moderate to severe uterine fibroid symptoms before menopause and when surgical procedures are not suitable or failed See updated MHRA safety advice on the risk of serious liver injury.

Interventions not funded by MSE ICB

NICE has issued interventional procedures guidance on various interventions related to HMB.  Each procedure will be subject to the MSE overarching policy on interventional procedures guidance or this policy.

MSE ICB does not fund procedures where NICE IPG recommends the intervention should not be used in the NHS or that Special Arrangements apply or only undertaken in the context of Research.  * see MSE ICB Commissioning policy.

Other procedures not noted either in the pathway or not listed in the ‘not funded’ interventions list, will not be funded.  See also D&C Policy.

There is limited evidence on the role of other interventions such as uterine artery ligation and myolysis which are not funded by the ICB.

²MRgFUS appears comparable with myomectomy and UAE in the short term (up to 36 months) with a lower than 30% re-intervention rate but the re-intervention rate increased to 49% in the 60^th month.  This procedure is not funded as not considered to be cost-effective by the ICB.

Funding for patients not meeting the above criteria will only be made available in clinically exceptional circumstances.  Individual funding requests should only be made where the patient demonstrates clinical exceptionality.

References: 

1. NICE Heavy Menstrual Bleeding –Clinical Guideline March 18
2. The comparison of myomectomy, UAE and MRgFUS in the treatment of uterine fibroids: a meta analysis