December 2024

Drug changes and additions

Xonvea (doxylamine/pyridoxine) 10mg/10mg gastro-resistant tablets are recommended as a second-line option for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant women ≥ 18 years who do not respond to conservative management (i.e., lifestyle and diet change) and first line anti-emetics.

• Doxylamine/pyridoxine is considerably more expensive than other antiemetics that have long been used off-label for NVP, but there are currently no other licensed pharmacological treatments available in the UK.
• Doxylamine/pyridoxine should be administered on an empty stomach with a glass of water.

See here for the formulary entry.

Glycopyrronium bromide 1mg and 2mg tablets are recommended for the treatment of severe sialorrhoea (chronic pathological drooling) in patients with chronic neurological disorders.

Treatment may be started in primary care on the advice of a specialist.

The NHS Devon Medicines Optimisation Team recommends prescribing of glycopyrronium bromide tablets as Assicco brand to help ensure cost-efficient use of local NHS resources (see here).

See here for the formulary entry.

Kay-Cee-L syrup has been discontinued and removed from the Devon Formulary.

Revised formulary guidance

Management of Chronic Obstructive Pulmonary Disease (COPD): updated guidance based on the GOLD 2024 report with additional information from NICE Guideline NG115 (2019). Non inhaled prevention and maintenance strategies (smoking cessation, vaccinations, self-management plans, pulmonary rehabilitation [where available]) remain essential in the management of COPD. Rescue short-acting bronchodilators should continue to be prescribed to all patients for immediate symptom relief.

Key updates to the formulary guidance include:

• Eosinophil count to be taken into account when considering the use of ICS (this recommendation features more prominently than in previous guidance).
• Updated recommendations for initial pharmacological treatment:
  • LAMA monotherapy is recommended for all patients in group A (if unsuitable, LABA may be considered)
  • LABA + LAMA combination therapy is recommended for all patients in group B
  • Groups C and D have been combined into new group E, which includes all patients with ≥ 2 moderate exacerbations or ≥ 1 exacerbation leading to hospitalisation in the last year, regardless of symptom score
    • These patients are now recommended LABA + LAMA combination therapy as initial treatment, with triple therapy (ICS + LABA + LAMA) considered for those with blood eosinophils ≥ 0.3x10⁹/L
  • ICS + LABA is not encouraged (GOLD suggests triple therapy with ICS + LABA + LAMA is superior).
• Updated recommendations for follow up pharmacological treatment. Consider the predominant treatable trait to target: dyspnoea or exacerbations. Use exacerbation pathway if both exacerbations and dyspnoea need to be targeted.
• A visual summary which incorporates local treatment choices is in development.
• GOLD no longer refers to asthma and COPD overlap, instead emphasizing that these are different disorders, which may co-exist in an individual patient. If a concurrent diagnosis of asthma is suspected, pharmacotherapy should primarily follow asthma guidelines. The formulary information on Asthma - COPD Overlap Syndrome (ACOS) has been withdrawn.

See here for the formulary guidance.

Management of nausea and vomiting in pregnancy (NVP) and hyperemesis gravidarum (HG)

Updates include:

• Small amendments to self-care measures.
• Cyclizine reclassified as a first line option alongside promethazine.
• Inclusion of doxylamine/pyridoxine as a second line option alongside metoclopramide and prochlorperazine.
• Addition of oral prednisolone as a third line specialist input (amber) option.
• Updated timescales for review.
• Consider combinations of drugs from different classes in women who do not respond to a single anti-emetic.

See here for formulary guidance.

NICE Technology Appraisals

NICE TA995: Relugolix 120mg tablets have been added to the Devon Formulary as an amber (specialist input) option for treating hormone sensitive prostate cancer in line with NICE TA995.

See here for the formulary entry.

NICE TA996: Linzagolix 100mg and 200mg tablets have been added to the Devon Formulary as a red (hospital-only) option for treating moderate to severe symptoms of uterine fibroids in line with NICE TA996.

See here for the formulary entry.

November 2024

Drug changes and additions

Direct-acting oral anticoagulants (DOACs) have been updated to reflect updated commissioning recommendations from NHS England. 

For patients commencing treatment for atrial fibrillation, subject to the criteria specified in the relevant NICE TAs, clinicians should use the best value DOAC that is clinically appropriate for the patient. 

The ranking for best value DOACs is as follows: generic apixaban (twice a day) or generic rivaroxaban (once a day), followed by edoxaban, then Xarelto (branded rivaroxaban), then dabigatran, then Eliquis (branded apixaban).

See here for the formulary guidance.

An additional (higher) strength Epiduo (adapalene 0.3% / benzoyl peroxide 2.5%) gel has been added as a green (first line) option for the initial treatment for acne (as monotherapy or in combination with oral lymecycline or doxycycline) (for 12 weeks) and for the maintenance treatment for acne (as monotherapy).

An additional (lower) strength Benzoyl peroxide plus clindamycin (3% / 1%) gel has been added as a green (first line) option for the initial treatment for mild to moderate acne (for 12 weeks).

Trifarotene 50micrograms/g cream (a topical retinoid) has been added as a blue (second line) option for the maintenance treatment of acne where Epiduo is contraindicated or not suitable.

See here for the formulary entry.

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 acne: updated guidance based on NICE guideline (NG198) Acne vulgaris: management.

For initial treatment, the Devon Formulary now recommends a 12-week course of one of the following first-line treatment options:

• Mild to moderate acne:
  • Benzoyl peroxide plus clindamycin gel once daily in the evening, or
  • Epiduo (adapalene plus benzoyl peroxide) gel once daily in the evening, or
  • Treclin (clindamycin plus tretinoin) gel once daily in the evening.
• Moderate to severe acne:
  • Epiduo or Treclin (as above), or
  • Epiduo (as above) or azelaic acid (15% gel or 20% cream) twice daily, PLUS oral antibiotic (lymecycline or doxycycline) (refer to formulary guidance for second line oral antibiotic options and information regarding combined oral contraceptives).
• Benzoyl peroxide 5% gel (monotherapy) applied once or twice daily can be considered as an alternative treatment to any of the options above, if these treatments are contraindicated, or the person wishes to avoid using a topical retinoid, or an antibiotic (topical or oral).

Where maintenance treatment is indicated:

• Epiduo (adapalene plus benzoyl peroxide) gel once daily in the evening is first line.
• If this is contraindicated or not tolerated alternative maintenance options include topical adapalene, azelaic acid, benzoyl peroxide or trifarotene.

See here for the 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 years 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.