November 2024

Drug changes and additions

Kay-Cee-L syrup will be discontinued from late November 2024; refer to the National Patient Safety Alert for guidance.

Primary and secondary care providers MUST:

1. not initiate new patients on Kay-Cee-L syrup
2. proactively review all patients currently prescribed Kay-Cee-L syrup to establish if potassium supplementation is still required, and switch to an alternative treatment, if considered necessary, ensuring no intolerance of excipients.

See here for the formulary entry.

Revised formulary guidance

Management of blood lipids: updated guidance based on NICE guidance NG238

A summary of the updates:

• Baseline measurements and monitoring: HbA1c no longer required at baseline. Check patient’s diabetes status.
• Primary prevention: risk assessment:
  • QRISK3 is the current version of the calculator. QRISK2 can be used if QRISK3 is not available. QRISK3 has been updated with indicators for certain patient groups to incorporate disease or medication specific risks of cardiovascular disease (CVD). QRISK3 (on-line version if necessary) should be used for the following patient groups:
    • people taking corticosteroids or atypical antipsychotics or people with systemic lupus erythematosus, migraine, severe mental illness (schizophrenia, bipolar disorder or other psychoses), or erectile dysfunction.
  • Consider using QRISK3-lifetime to inform discussions on CVD risk and to motivate lifestyle changes particularly for people with a 10-year QRISK3 score less than 10%, and people under 40 who have CVD risk factors.
• Secondary prevention:
  • New target lipid level: LDL-C 2.0 mmol/L or less, or non-HDL-C 2.6 mmol/L or less.
  • Consider ezetimibe in addition to maximum tolerated intensity and dose of statin to reduce CVD risk further, even if the lipid target for secondary prevention of CVD is met.

See here for the formulary guidance.

October 2024

Drug changes and additions

Advice from the Joint Committee on Vaccination and Immunisation (JCVI) on the COVID-19 vaccination programme has been updated for autumn 2024. The JCVI advises that a COVID-19 vaccine should be offered to:

• adults aged 65 and over
• residents in a care home for older adults
• persons aged 6 months to 64 years in a clinical risk group.

The following COVID-19 vaccines are advised in the national programme and have been added to the Devon Formulary:

• Spikevax JN.1 vaccine 50micrograms
  • for all individuals aged 18 years and over
• Comirnaty JN.1 vaccine 30micrograms
  • for all individuals aged 12 years and over
• Comirnaty JN.1 vaccine 10micrograms
  • for children aged 5 to 11 years
• Comirnaty JN.1 vaccine 3micrograms
  • for children aged 6 months to 4 years

The following vaccines remain in the Devon Formulary as booster doses when alternative products are considered not clinically suitable:

• Bimervax vaccine 40micrograms
  • for individuals aged 16 years and over
    
• Nuvaxovid XBB.1.5 vaccine 5micrograms
  • for individuals aged 12 years and over
    

See here for the formulary entry.

Cytisine (cytisinicline) 1.5mg tablets have been added to the formulary as a green (first line) option for smoking cessation in adults (aged 18-65 years), as part of a programme of behavioural support.

• To optimise the results from smoking cessation programmes it is advised that patients access motivational support from specialist services.
• Cytisine is taken in a reducing regimen over 25 days.
• Do not offer cytisine to pregnant or breastfeeding women. 
• Women of childbearing potential must use highly effective contraception during treatment (refer to formulary entry for additional information). Specialist smoking cessation services should ensure that highly effective contraception is in place and that the GP is informed of this when recommending cytisine.

Varenicline 500micrograms and 1mg tablets have been reclassified as a green (first line) option for smoking cessation in adults, as part of a programme of behavioural support.

• To optimise the results from smoking cessation programmes it is advised that patients access motivational support from specialist services.
• Generic varenicline tablets are now available following stock shortages and discontinuation of the brand (Champix).
• Do not offer varenicline to pregnant or breastfeeding women.

See here for the formulary entry.

Tirzepatide 12.5mg/0.6ml and 15mg/0.6ml solution for injection pre-filled KwikPens are commercially available and have been added to the Devon Formulary for the treatment of type 2 diabetes in adults in line with NICE TA924. One KwikPen provides 4 weeks supply. Needles are not provided and will need to be prescribed.

See here for the formulary entry.

The following devices have been added to the formulary:

Dexcom ONE+ continuous glucose monitor for use in diabetes

• This device replaces Dexcom ONE which is due to be discontinued in May 2025.
• Information is available in the formulary entry to help guide the transition of patients from Dexcom ONE to Decom ONE+.
• Dexcom ONE+ sensors now have an integrated transmitter meaning that this item does not need to be prescribed separately.
• See here for the formulary entry.

FreeStyle Libre 2 Plus continuous glucose monitor for use in diabetes

• This device replaces FreeStyle Libre 2 which is due to be discontinued in June 2025.
• Information is available in the formulary entry to help guide the transition of patients from FreeStyle Libre 2 to FreeStyle Libre 2 Plus.
• FreeStyle Libre 2 Plus sensors require replacement every 15 days.
• See here for the formulary entry.

FreeStyle Libre 3 continuous glucose monitor for use in diabetes

• This system is only recommended when used as part of a hybrid closed loop system in pregnancy in line with NICE TA943.
• Not recommended as a standalone CGM.
• See here for the formulary entry.

Continuous glucose monitors are listed as amber items in the formulary meaning that they are usually initiated by specialist diabetes teams; however, initiation by primary care health professionals who are confident to do this without specialist input is accepted.

Finerenone 10mg and 20mg tablets have been reclassified to amber (specialist input) in the Devon Formulary for use in stage 3 and 4 chronic kidney disease (with an albumin to creatinine ratio that is persistently 3mg/mmol or more and eGFR of 25ml/min/1.73m2 or more) associated with type 2 diabetes in line with NICE TA877.

• Finerenone is only recommended as an add-on to optimised standard care; this should include, unless they are unsuitable, the highest tolerated licensed doses of:
  • angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) and
  • sodium–glucose cotransporter 2 (SGLT2) inhibitors.
• The specialist will start treatment with finerenone, prescribe, and monitor until the dose is stabilised.

See here for the formulary entry.

Daktacort (hydrocortisone 1% / miconazole 1%) cream has been discontinued and removed from the formulary.

Fludroxycortide 0.0125% ointment has been discontinued and removed from the formulary.

Revised formulary guidance

Management of hypertension: Updated guidance based on NICE guidance NG136, which also applies to patients with type 2 diabetes. There continue to be specific BP targets and treatment recommendations for type 1 diabetes and for chronic kidney disease. For women considering pregnancy or who are pregnant or breastfeeding, refer to formulary guidance on the management of hypertension in pregnancy.

See here for the formulary guidance.

Visual summaries

A visual summary of formulary recommended systemic HRT treatment options has been produced; it is intended to supplement the formulary pages (here) and act as a quick reference / aide-mémoire for local clinicians.

Revised sections:

Lower urinary tract symptoms (LUTS) in men: addition of vibegron 75mg tablets

Vibegron has a positive TA recommendation for symptoms of overactive bladder syndrome (NICE TA999). 

• Vibegron is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects. 
• Vibegron has been added to the guidance as a blue (second line) option alongside mirabegron.

See here for the full guidance.

Urinary incontinence in women: addition of vibegron 75mg tablets

Vibegron has a positive TA recommendation for symptoms of overactive bladder syndrome (NICE TA999). 

• Vibegron is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects. 
• Vibegron has been added to the guidance as a blue (second line) option alongside mirabegron.

See here for the full guidance.

NICE Technology Appraisals:

NICE TA999: Vibegron for treating symptoms of overactive bladder syndrome

Vibegron 75mg tablets have been added to the Devon Formulary as a blue option for symptoms of overactive bladder syndrome in line with NICE TA999. 

• Vibegron is only recommended if antimuscarinic medicines are not suitable, do not work well enough or have unacceptable side effects. 
• Vibegron has a similar mechanism of action to mirabegron and is recommended in the same place in therapy as mirabegron. 
• Vibegron is a lower cost than mirabegron.

See here for the formulary entry.

NICE TA981: Voxelotor for treating haemolytic anaemia caused by sickle cell disease

Pfizer has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that voxelotor is being withdrawn due to emerging data from clinical trials and registry-based studies; therefore, voxelotor has been removed from the Devon Formulary.

September 2024

Drug changes and additions

The tadalafil drug entry notes have been updated to remove reference to the NHSE guidance on “items which should not routinely be prescribed in primary care” (which no longer includes once daily tadalafil). The 2.5mg and 5mg tablets remain non-formulary for erectile dysfunction, and the routine commissioning of tadalafil is not accepted in Devon for the treatment of benign prostatic hyperplasia in adult males.

See here for the formulary entry.

Prednisolone 5mg soluble tablets have been discontinued and replaced with prednisolone 5mg soluble tablets sugar free.

See here for the formulary entry.

Budesonide orodispersible tablets sugar free (500micrograms and 1mg) are now recommended for maintenance of remission of eosinophilic oesophagitis.

• Prescribing is to remain with specialists during induction of remission (usually 6 weeks, extended up to 12 weeks if required).
• GPs may be asked to prescribe ongoing supplies for maintenance of remission if required. The specialist will continue to oversee the ongoing management of eosinophilic oesophagitis, including review of the need for ongoing treatment at least annually.
• If there are any changes in the severity of the patient’s condition, concomitant medication, or if troublesome adverse reactions develop, the GP should seek advice from the specialist.
• See here for the formulary entry.

Olanzapine orodispersible tablets sugar free have replaced olanzapine orodispersible tablets in the Devon Formulary as an amber (specialist input) option.

• They should only be used for patients with swallowing difficulties or to support supervised administration.

See here for the formulary entry.

Following the recent discontinuation of Asacol (mesalazine) 400mg MR gastro-resistant tablets and the low prescribing of Asacol 800mg MR gastro-resistant tablets in the county, Asacol has been removed from the Devon Formulary. Local specialists support this decision.

• The BNF states there is no evidence to show that any one oral preparation of mesalazine is more effective than another, but the delivery characteristics of oral mesalazine preparations may vary.
• Octasa MR gastro-resistant tablets are a brand generic version of Asacol with the same site of drug release; it is recommended in the formulary as an amber (specialist input) option.

See here for the mesalazine formulary entry.

Abilify Maintena (aripiprazole) 720mg/2.4ml and 960mg/3.2ml prolonged-release suspension for injection pre-filled syringes have been added to the Devon Formulary as a red (hospital only) option for the maintenance of schizophrenia.

See here for the formulary entry.

Desflurane has been decommissioned by NHS England on environmental grounds and consequently removed from the Devon Formulary.

Revised formulary guidance

International travel formulary guidance has been updated to reflect the change from European Health Insurance Cards to Global Health Insurance Cards; information on immunisations and taking medicines abroad has also been updated.

Prophylaxis of migraine: addition of atogepant and revised guidance for rimegepant

• Atogepant and rimegepant have positive NICE Technology Appraisal recommendations for the prophylaxis of migraine (TA906; TA973) and may be started in primary care on the advice of a specialist. The Formulary Interface Group considered atogepant and rimegepant in light of the new safety measures for topiramate and the limited number of options available for initiation by GPs without specialist input. Although currently classified as amber for the prophylaxis of migraine, initiation of atogepant or rimegepant in appropriate patients by GPs who are confident to do this without specialist input is accepted. It is anticipated that initiation of atogepant and rimegepant in primary care without specialist input will increase as GPs become more familiar with these medicines. Patient groups requiring specialist input are listed in the formulary guidance. Information is provided to support GP initiation of these medicines.

Rimegepant for the acute treatment of migraine remains a blue (second line) formulary option.

See here for the full guidance.

NICE Technology Appraisals

NICE TA973: Atogepant 10mg and 60mg tablets have been added to the Devon Formulary as an amber (specialist input) option for the prophylaxis of migraine in line with NICE TA973. Treatment with atogepant may be started in primary care on the advice of a specialist. In addition, initiation of atogepant by GPs who are confident to do this without specialist input is accepted. Refer to guidance on the prophylaxis of migraine for further information.

• See here for the formulary entry.

"Shared Care" / Specialised Medicines Service (SMS) prescribing guidelines

Updated guidelines

• Once weekly oral methotrexate for patients within adult gastroenterology services (Devon wide)
  • The updated guideline covers the use of methotrexate for the treatment of the following indications: Maintenance of remission of severe Crohn's disease (unlicensed) and reducing risks of immunogenicity alongside anti-TNF treatments in the management of inflammatory bowel disease (unlicensed).
  • The guideline will be remunerated at Tier 2.
  • The guideline can be found on the NHS Devon ICB website, or via the individual drug entry.