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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE Guidance - October 2021

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of October 2021. This month there is one technology appraisal and one guideline that impact upon primary care.

The Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia technology appraisal has been published. This treatment is recommended as an option for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults. It is recommended only if:

  • there is a history of any of the following cardiovascular events:
    • acute coronary syndrome (such as myocardial infarction or unstable angina needing hospital admission)
    • coronary or other arterial revascularisation procedures
    • coronary heart disease
    • ischaemic stroke or
    • peripheral arterial disease, and
  • low-density lipoprotein cholesterol (LDL-C) concentrations are persistently 2.6 mmol/l or more, despite maximum tolerated lipid-lowering therapy, that is:
    • maximum tolerated statins with or without other lipid-lowering therapies or,
    • other lipid-lowering therapies when statins are not tolerated or are contraindicated, and
  • the company provides inclisiran according to the commercial arrangement.

It would be expected that treatment would be commenced and supervised by a clinician with a special interest however there is a unique funding arrangement in place that includes a new section in the Drug Tariff (DT) that will encourage use in primary care.

The Looked-after children and young people guideline has been published. It covers how organisations, practitioners and carers should work together to deliver high-quality care, stable placements and nurturing relationships for looked-after children and young people. It aims to help these children and young people reach their full potential and have the same opportunities as their peers.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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SMC Update - October 2021

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Empagliflozin (Jardiance®) has been accepted for use in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. It is noted that empagliflozin offers an additional treatment choice in the therapeutic class of sodium glucose co-transporter 2 inhibitors in this indication.

Liraglutide (Saxenda®) has been rejected for use as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

  • ≥30kg/m² (obese), or
  • ≥27kg/m² to <30kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea

It is noted that the submitting company's justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Bempedoic acid / ezetimibe (Nustendi®) has been accepted for restricted use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
  • alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone
  • in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.

The SMC restriction limits use to patients who are:

  • statin intolerant or for whom a statin is contra-indicated
  • where ezetimibe alone does not appropriately control LDL-C
  • where proprotein convertase subtilisin / kexin type 9 (PCSK9) inhibitors are not appropriate

It is also noted that this advice only applies in the context of an approved NHSScotland Patient Access Scheme (PAS).

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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Drug Safety Update - October 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2021 (PDF).

This issue advises clinicians of a new restriction on the paediatric indication for chloral hydrate and cloral betaine. The treatments should only be used for the short-term treatment (maximum 2 weeks) of severe insomnia only when the child or adolescent has a suspected or definite neurodevelopmental disorder and when the insomnia is interfering with normal daily life. It is also recommended that these treatments are only used when other therapies (behavioural and pharmacological) have failed.

This issue also raises awareness of the sixth annual #MedSafetyWeek social media campaign. This year the focus is on he importance of reporting suspected adverse reactions to vaccines. Readers are encouraged to share MHRA materials on social media, as well as discussing with colleagues and patients how report adverse reactions to vaccines.

This issue also advises readers of the latest COVID-19 vaccine safety information including regulatory updates on the COVID-19 booster vaccine programme, updates to the Summary of Product Characteristics and Patient Information Leaflet for Janssen Vaccine and extension of the shelf life of the Pfizer/BioNTech Vaccine to 9 months

Lastly in this issue is a summary of letters to healthcare professionals in September.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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CKS Updates - September 2021

During September 2021 Clinical Knowledge Summaries were updated in the following areas.

All topics have been reviewed and updated in keeping with current guidance with minor layout changes. The Breast pain - cyclical topic has added a new section on differential diagnosis and the Bunions topic has been restructured and a section on surgical management has been added.

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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