The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of June 2025. This month there is one guideline, one technology appraisal and one health technology evaluation that impact upon primary care.
The Headaches in over 12s: diagnosis and management guideline has been updated. It covers the diagnosis and management of tension-type headache, migraine (including migraine with aura and menstrual-related migraine), cluster headache and medication overuse headache in young people (aged 12 years and older) and adults. The update changed the strength of recommendations on migraine prevention to a 'consider' recommendation for all three options, to better reflect the balance between the benefits and harms. A link to the Rimegepant for treating migraine technology appraisal has also been added.
The Linzagolix for treating symptoms of endometriosis technology appraisal has been published. This treatment is recommended as an option, in combination with hormonal add-back therapy, within its marketing authorisation to treat symptoms of endometriosis in adults of reproductive age who have had medical or surgical treatment for their endometriosis.
The Topical antimicrobial dressings for locally infected leg ulcers health technology evaluation has been published. This is a late stage assessment, an approach to evaluate technologies that are already in widespread use within the NHS. It is noted that there is not enough evidence to determine whether price variations are justified between different antimicrobial agents in topical antimicrobial dressings. It is recommended that NHS trusts provide access to a range of different types of antimicrobial dressings, so that an appropriate dressing can be selected that satisfies clinical and patient need. When an antimicrobial dressing is needed, the choice of dressing should consider the impact on quality of life including physical health, mental health and wellbeing, relationships with others and ability to complete activities of daily living. The choice of dressing should consider:
- the cost of the primary dressing
- the need for and cost of additional products
- the frequency of dressing changes needed
- if a person can change their own dressing or if a visit by a healthcare professional is needed.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published two Drug Safety Update articles for June 2025.
Earlier this month updated safety and educational materials were made available to support the implementation of the regulatory measures for valproate containing medicines announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. These materials also include previous updates to product information on the risk of low birth weight in children exposed to valproate during pregnancy.
More recently, a temporary restriction on the use of the IXCHIQ® Chikungunya vaccine in people aged 65 years and over has been announced. This is a precautionary measure while the MHRA conducts a safety review following very rare fatal reactions reported globally.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Bempedoic acid (Nilemdo®) has been rejected for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
- alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.
The manufacturer failed to make a submission for this indication. It should be noted that the SMC have already accepted this treatment for primary hypercholesterolaemia or mixed dyslipidaemia and NICE Guidance has been published for this medication.
Bempedoic acid / ezetimibe (Nustendi®) has been rejected for use in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
- in patients on a maximum tolerated dose of a statin and not adequately controlled with additional ezetimibe treatment or,
- in patients who are either statin-intolerant, or for whom a statin is contraindicated, and not adequately controlled with ezetimibe treatment or,
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets.
The manufacturer failed to make a submission for this indication. It should be noted that the SMC have already accepted this treatment for primary hypercholesterolaemia or mixed dyslipidaemia and NICE Guidance has been published for this medication.
Sumatriptan 85mg / naproxen 457mg (Suvexx®) has been rejected for use in the acute treatment of the headache phase of migraine attacks with or without aura in adults where treatment with a mono-entity product has been insufficient. It is noted this product is available at a considerable cost premium to sumatriptan 100mg and naproxen 500mg tablets taken separately.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During May 2025 Clinical Knowledge Summaries were published or updated in the following areas.
All of the topics have been reviewed and updated with minor structural and layout changes. The Appendicitis topic has been updated with changes to the basis for recommendations amended in line with current clinical guidelines and expert opinion review articles. The Dupuytren's disease topic has been updated with minor additions and clarifications for the recommendations, to align with current evidence. The Menopause topic has been updated in line with the National Institute for Health and Care Excellence (NICE) clinical guideline. A section detailing the investigation and management of unscheduled bleeding on hormone replacement therapy (HRT) has been added in line with guidance prepared on behalf of the British Menopause Society by stakeholder organisations.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
