The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Daridorexant (Quviviq®) has been accepted for restricted use in the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning. The restriction limits use to people who have failed cognitive behavioural therapy for insomnia (CBT-I) or for whom CBT-I is unsuitable or unavailable. It is noted that the prescribing information recommends using this treatment for the shortest period possible.
Tirzepatide (Mounjaro®) has been accepted for restricted use in the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
- as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
- in addition to other medicinal products for the treatment of diabetes
The restriction limits use to combination treatment with other oral anti-diabetic medicines as an option when glucagon-like peptide-1 (GLP-1) receptor agonists would be considered. Monotherapy treatment is not recommended as the company's submission related only to its use in addition to other medicinal products.
Glycopyrronium / formoterol fumarate (Bevespi Aerosphere®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During March 2024 Clinical Knowledge Summaries were published or updated in the following areas.
The Abortion topic is new. The remaining topics have all been reviewed and updated with minor structural and layout changes. The Breast cancer - managing FH topic now contains more details on risk factors. The Cirrhosis topic has been updated in line with current literature, a new section has been added detailing assessment of suspected cirrhosis, the criteria on when to consider palliative care referral have been expanded and the recommendations on primary care management of a person with cirrhosis have been updated and expanded.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2024 (PDF).
This issue only contains a summary of letters to healthcare professionals in February. These generally related to supply issues and recalls but also includes a letter warning that pseudoephedrine has been very rarely associated with posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), as reported last month.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of March 2024. This month there are four guidelines and one technology appraisal that impact upon primary care.
The Vitamin B12 deficiency in over 16s: diagnosis and management guideline has been published. It covers recognising, diagnosing and managing vitamin B12 deficiency in people aged 16 and over, including deficiency caused by autoimmune gastritis. It also covers monitoring for gastric cancer in people with autoimmune gastritis.
The COVID-19 rapid guideline: managing COVID-19 guideline has been updated. It covers managing COVID-19 in babies, children, young people and adults in community and hospital settings. The update aligns the therapeutics section with a recently updated Technology Appraisal.
The Meningitis (bacterial) and meningococcal disease: recognition, diagnosis and management guideline has been published. It covers recognising, diagnosing and managing bacterial meningitis and meningococcal disease in babies, children, young people and adults. It aims to reduce death and disability by helping healthcare professionals recognise meningitis and treat it quickly and effectively.
The Ovarian cancer: identifying and managing familial and genetic risk guideline has been published. It covers assessing the familial and genetic risk of having a pathogenic variant associated with ovarian cancer in adults.
The Nirmatrelvir plus ritonavir, sotrovimab and tocilizumab for treating COVID-19 technology appraisal has been updated. This update includes additional groups eligible for treatment with nirmatrelvir plus ritonavir.
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.
Pitolisant (Wakix®) has been rejected for use to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP). The manufacturer failed to make a submission for this indication.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
