BLACK FOSTAMATINIB tablets (Tavlesse®▼) for the treatment of refractory chronic immune thrombocytopenia
Fostamatinib is not recommended for treating refractory chronic immune thrombocytopenia.
BLACK Dapagliflozin for treating type 1 diabetes
RAG change from Amber Retained to Black. The Amber Retained statement has been withdrawn from the Pan Mersey APC website. The license for dapagliflozin for use in type 1 diabetes has been withdrawn and NICE TA597 was subsequently withdrawn. Dapagliflozin for treating type 1 diabetes is now Black in the formulary with a link to the withdrawn TA and link to the MHRA Drug Safety Update.
Clinicians are advised to follow the MHRA Drug Safety Update advice for healthcare professionals with regards to review and discontinuation of dapagliflozin.
RED SOLRIAMFETOL tablets (Sunosi®▼) for treating excessive daytime sleepiness caused by narcolepsy
PBR excluded high cost drug, for specialist sleep service use only. NICE does not expect implementing this guidance to have a significant impact on resources because this is a further treatment option, and the overall cost of treatment will be similar.
The current University Hospital Aintree Sleep Service Pathway for Narcolepsy (March 2019) predates the availability of solriamfetol and is currently under review. Solriamfetol will be included when the pathway is updated.
GREY BOTULINUM NEUROTOXIN TYPE A injection (Xeomin®) for chronic sialorrhoea in children and adolescents
This will be reviewed by the Formulary and Guidelines Subgroup review on receipt of an application for use.
GREY RISANKIZUMAB solution for injection (Skyrizi®▼) for psoriatic arthritis
Not recommended until NICE TA is published.
AMBER INITIATED CENOBAMATE tablets (Ontozry®▼) for treating focal onset seizures in adults with epilepsy
Cenobamate requires specialist initiation in a tertiary epilepsy service by a consultant neurologist with appropriate experience in the treatment of drug resistant epilepsy. Prescribing is to be continued by the specialist until stabilisation of the dose and the patient’s condition is achieved, and the patient has been reviewed by the specialist. The specialist may then request the patient’s GP to take over prescribing responsibilities of treatment.
NICE does not expect this guidance to have a significant impact on resources. This is because cenobamate is a further treatment option available at a similar price to the current treatment options and NICE does not think practice will change substantially as a result of this guidance.
AMBER INITIATED Ticagrelor – prevention of thrombotic events post-intracranial stent
The statement proposes an amber specialist initiation designation, implementation information and prescribing in line with currently approved indications. There is a requirement for the specialist to provide information to the GP regarding ticagrelor duration of treatment alongside recommendation for treatment duration of concurrent aspirin.
Total cost of treatment per patient is £350. This is based on twice daily dose of ticagrelor for 6 months plus once daily dose of aspirin for 2 years. It is estimated that 26 patients per annum in the Pan Mersey region may require treatment. The cost of treatment for clopidogrel would be £9.70.
AMBER INITIATED Lyumjev® (insulin lispro)
Standard rapid-acting insulin analogues (NovoRapid®, Apidra®, Humalog®) will typically be offered first and people can be switched to an ultra-rapid acting insulin (Lyumjev® or Fiasp®) if it is felt that this would increase their time in range and reduce post meal peaks and hypoglycaemia. Lyumjev® will be an additional brand of insulin lispro available for prescribing. There are no financial implications as it is cost-neutral with Humalog® and similar in cost to NovoRapid® and Fiasp®. (Lyumjev® pre-filled pens and cartridges are slightly cheaper than NovoRapid® and Fiasp®).
AMBER INITIATED Direct oral anticoagulants (DOACs) in treatment and prevention of deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
This is an updated version of the current Pan Mersey statement and aligns the statement with that on DOAC use in non-valvular atrial fibrillation regarding information on ORBIT or HAS-BLED score, information on the Pan Mersey recommendation that andexanet may be used as a reversal agent for edoxaban (off-label use) and use of actual body weight for calculating CrCl when initiating DOACs.
GREEN Direct oral anticoagulants (DOACs) in atrial fibrillation
This new statement replaces the current statement and is based on the updated NICE NG196: Atrial Fibrillation: Management. It also includes information on the Pan Mersey recommendation that andexanet may be used as a reversal agent for edoxaban (off-label use).
Adopted SPS document, "Switching between liquid and tablet/capsule formulations", added to each chapter of the formulary, replaces entries into individual drug monographs.
Routine review at the document expiry date. Amendments to signpost to BNF for dosing and recommend healthcare professional to use ampoules and syringes in clinical settings. Core message on training and carrying two devices remains.
Routine review at the document expiry date. Minor amendments. Authorisation and prescription sheet templates removed.
Routine review of the UTI chapter within the managing common infections in adults antimicrobial guidelines. Minor amendments in line with NICE guidance and local implementation.
Routine review of the skin chapter within the managing common infections in adults antimicrobial guidelines. Amendments in line with new NICE guidance including acne vulgaris NG198 (June 2021) and human and animal bites (NICE CKS revised Aug 2021)
Significant changes made to the C.difficile section within the gastrointestinal chapter to align with new NICE NG199 (updated Jul 2021).
GREEN FIDAXOMICIN (Dificlir®)
Change of RAG rating for fidaxomicin from AMBER recommended to GREEN in adults for the second line treatment of C.difficile infection to allow for prescribing in primary care in accordance with NICE NG199.