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Management of blood lipids
New formulary guidance has been published, which is based on the NHS England/Accelerated Access Collaborative (AAC) summary of lipid guidance and statin intolerance pathway. The AAC guidance is endorsed by NICE and reflects NICE guidelines for cardiovascular disease and familial hypercholesterolaemia, and NICE technology appraisals (TAs) for lipid-modifying drugs.
Click here for the formulary guidance
Key changes to the formulary guidance are outlined below:
Baseline investigations and monitoring: updated recommendations for identifying cases of suspected familial hypercholesterolaemia and inclusion of measuring the lipid profile for inclisiran.
Primary and secondary prevention: the place in therapy for ezetimibe, bempedoic acid (with ezetimibe) and the injectable therapies (inclisiran and the PCSK9 inhibitors [alirocumab and evolocumab]) is more clearly defined.
- Ezetimibe continues to be recommended in primary or secondary prevention for addition to a statin where the maximum tolerated dose of statin is insufficiently effective. Ezetimibe may be given as monotherapy where there is a contraindication to a statin or a statin is not tolerated.
- Bempedoic acid (with ezetimibe) 180mg/110mg has been reclassified from amber (specialist) to blue (second line). Bempedoic acid should be prescribed with ezetimibe and is only recommended where a statin is contraindicated or not tolerated and ezetimibe monotherapy is insufficiently effective. Bempedoic acid (with ezetimibe) may be used in primary or secondary prevention. Currently, there is no evidence from a cardiovascular clinical outcome trial for bempedoic acid (with ezetimibe).
- Inclisiran 284mg injection is recommended only for secondary prevention in line with NICE TA733. New guidance is included on whether to continue oral treatments, when to consider seeking specialist advice and measuring the lipid profile at the start of treatment and annually. Currently, there is no evidence from a cardiovascular clinical outcome trial for inclisiran.
- Alirocumab and evolocumab (PCSK9 inhibitors), have been reclassified from red (hospital) to amber (specialist). They are administered by subcutaneous injection. Alirocumab and evolocumab are recommended for secondary prevention and primary prevention (familial hypercholesterolaemia only) in line with NICE TA393 and NICE TA394 respectively. The updated guidance indicates when to refer patients to lipid specialists for consideration of these therapies.
- Patients will be taught how to self-administer alirocumab and evolocumab injections by secondary care. The specialist will counsel patients, initiate and stabilise treatment before considering the appropriateness of patients for discharge from the secondary care clinic and continuation of prescribing in primary care. The amber classification applies only to patients who are able to self-administer injections. The specialists have produced prescribing guidance to support GPs. A link to this guidance is included under the drug entries for alirocumab and evolocumab.
- Alirocumab is available as a solution for injection pre-filled pen (75mg/1ml, 150mg/1ml, and 300mg/2ml).
- Evolocumab is available as a solution for injection pre-filled pen (140mg/1ml) and solution for injection pre-filled syringe (140mg/1ml).
Statin intolerance: new section which is a summary of the NHSE/AAC statin intolerance pathway outlining the approach to muscle-based symptoms, action to take in cases where CK is measured, and advice on treating with a statin in cases of muscle-based symptoms.
Familial hyperlipidaemia: new section which includes updated criteria for referral to specialists including the Dutch Lipid Network Criteria (DLCN) for identifying cases of suspected familial hypercholesterolaemia (FH). Further information on the DLCN criteria is included in the guidance. The Simon Broome criteria remains an option for identifying cases of suspected FH.
Additional changes to lipid-regulating drugs:
- Rosuvastatin ‘hard’ capsules 5mg, 10mg, 20mg, and 40mg have been added for patients with swallowing difficulties. The capsules may be opened and the contents sprinkled onto soft food.
- A new note is included in the rosuvastatin drug entry on the 40mg dose (capsules and tablets) reminding clinicians there are contraindications specific to the 40mg/day dose and to ensure that it is clinically appropriate for patients to receive this dose.
Drug changes and additions
- Ilube (acetylcysteine) eye drops 5% have been reclassified as an amber (specialist input) option for the treatment of dry eye syndromes associated with deficient tear secretion, impaired or abnormal mucus production.
- Acetylcysteine eye drops are mucolytic and reduce the viscosity and tenacity of mucus in the eye, they are only recommended for use in dry eye syndromes with abnormal mucus production.
NICE Technology Appraisals
- In line with NICE TA773, empagliflozin tablets (10mg) are recommended as amber (specialist input) options for treating chronic heart failure with reduced ejection fraction.
- In line with NICE TA775, dapagliflozin tablets (5mg and 10mg) are recommended as amber (specialist input) options for treating chronic kidney disease.
Specialised Medicines Service (SMS) prescribing guidelines
- Attention deficit hyperactivity disorder (ADHD) service transitions
- Minor amendments have been made to Devon-wide SMS guidelines for atomoxetine for ADHD in adults, lisdexamfetamine for ADHD in adults, and methylphenidate for ADHD in adults, to support a smooth transition for young people with existing ADHD diagnosis between child/adolescent services and adult services.
- The updated SMS guidelines can be found on the One Devon Website, or via the individual drug entries on the CNS stimulants and drugs for attention deficit hyperactivity disorder page in the formulary
Shared Care / Specialised Medicines Service (SMS) guidelines
- Prolia (denosumab) for osteoporosis SMS is now Devon-wide
- The existing north, east, and west Devon SMS guideline has been extended to cover South Devon & Torbay. GPs may start to receive requests from specialist services for the provision of Prolia (denosumab) in line with this guideline over the coming months.
- Practices will be able to claim for this service in line with the usual SMS arrangements. Remuneration for this service is Tier 2 for year one, and Tier 3 for year two onwards.
- Specialist services will continue to provide this treatment for any patients whose GPs are unable or unwilling to provide this service.
- The updated SMS guideline can be found on the One Devon Website, or via the Prolia (denosumab) drug entry
- To avoid unnecessary out of pocket expenses, practices or pharmacies should order Prolia direct from AAH.
Drug changes and additions
- Anoro ellipta (combination of umeclidinium bromide and vilanterol (as trifenatate)) dry powder inhaler (DPI) 55micrograms / 22micrograms has been added as a green (first line) option for the maintenance of chronic obstructive pulmonary disease.
- Pancrex V powder (pancreatin) has been added as an amber (specialist input) option for the treatment of pancreatic exocrine insufficiency in patients requiring enteral feeding.
- Octasa suppositories (mesalazine 1g) have been added as an amber (specialist input) option for the treatment of acute mild to moderate ulcerative proctitis and the maintenance of remission of ulcerative proctitis.
- Pentasa suppositories (1g) have been removed from the formulary
- Click here for the formulary entry
- Utrogestan vaginal capsule (micronised progesterone 200mg) has been added as an amber (specialist input) option for threatened miscarriage in women with a history of miscarriage in line with NICE NG126 (off-label).
- Cenobamate tablets (50mg, 100mg, 150mg, 200mg) have been reclassified as amber (specialist input) options for treating focal onset of seizures in epilepsy in line with NICE TA753.
Shared Care / Specialised Medicines Service (SMS) guidelines
Last updated: 08-08-2022
- Riluzole for the treatment of individuals with the amyotrophic lateral sclerosis form of motor neurone disease
- This Devon-wide guideline updates and replaces previous individual riluzole guidelines for North & East, South, and West Devon
- The updated Devon-wide prescribing guideline can be found on the One Devon Website, or via the riluzole drug entry
- Azathioprine and mercaptopurine for the treatment of inflammatory bowel disease in adults
- This Devon-wide guideline updates and replaces previous individual gastroenterology guidelines for North & East, South, and West Devon
- The updated Devon-wide prescribing guideline can be found on the One Devon Website, or via the azathioprine and mercaptopurine drug entries
- First line
- Second line