RECOMMENDATIONS OF THE
PHARMACEUTICAL BENEFIT ADVISORY COMMITTEE
Summary
The Pharmaceutical Benefit Advisory Committee (PBAC) met on 14 July 2020 to consider applications for changes to the Prescribed List.
The PBAC was unanimous in its recommendations for the following changes to the Prescribed List to be implemented from 1 September 2020, unless stated otherwise.
1. Items to be added to the Prescribed List
1.1 Vortioxetine tablets 5mg, 10mg, 15mg
1.2 Esomeprazole gastro-resistant capsule 20mg, 40mg
1.3 Estradiol 1.53mg/dose transdermal spray (Lenzetto)
1.4 Synalar N ointment
1.5 Medroxyprogesterone 100mg tablets
1.6 Isosorbide mononitrate MR 60mg Tablets
1.7 Methotrexate injection 22.5mg and 30mg
1.8 Budesonide m/r tablet 9mg
2. Items to be removed from the Prescribed List
2.1 Furosemide 5mg/5ml oral solution
2.2 Ketoprofen 50mg capsules
2.3 Spironolactone 10mg/5mL oral suspension
- Other changes to the Prescribed List
3.1 The requirement for prescriptions for acamprosate and nalmefene to be validated by the Alcohol & Drugs Service before dispensing is suspended during the COVID-19 pandemic pending review of the process.
- Other considerations
Applications for the following products were considered by the Committee but not supported.
4.1 Hyaluronic acid injection (e.g. Ostenil Plus, Durolane)
4.2 Colecalciferol (vitamin D) capsules 400 Units, 800units
Financial impact
The overall financial impact of the above changes is expected to be an increase in expenditure of up to `£10,000 pa.
Mrs Alison Creed, PBAC Chair
20 July 2020
Recommendations
- Items to be added to the Prescribed List
1.1 Vortioxetine tablets 5mg, 10mg, 15mg
Vortioxetine is an antidepressant licensed for the treatment of major depression in adults. It is supported by NICE “as an option for treating major depressive episodes in adults whose condition has responded inadequately to 2 antidepressants within the current episode.” Local psychiatrists find it particularly helpful in those who experience unwanted sexual side-effects with existing antidepressant options. The Committee recommend the addition of vortioxetine for prescribing in primary care only in patients who have been initiated by a hospital specialist.
1.2 Esomeprazole gastro-resistant capsule 20mg, 40mg
Esomeprazole is a proton pump inhibitor (PPI) that reduces the production of acid in the stomach and is used for the treatment of dyspepsia and other acid-related disorders. There are three other PPIs included in the Prescribed List. All four PPIs are now available as lower price generic products; esomeprazole is slightly more expensive than the others (£30-£50 pa compared with £15-£40pa). Esomeprazole is used in hospital practice, partly because patients will often have tried other PPIs before referral, but, in some patients, esomeprazole is found to be more effective. The Committee recommended the addition of esomeprazole to provide an alternative PPI and facilitate prescribing in the community for patients currently receiving repeat prescriptions through the hospital.
1.3 Estradiol 1.53mg/dose transdermal spray (Lenzetto)
Estradiol is used as hormone replacement therapy for the management of estrogen deficiency symptoms in postmenopausal women. It is commonly administered through the skin as a safer route than oral administration. Estadiol patches and estradiol gels are included in the Prescribed List but use of each of these forms can be problematic. The transdermal spray provides an alternative method of administration that can offer a few practical advantages, for example avoiding the adhesives used on patches that can cause skin reactions, and being less messy than gels. At usual daily doses, the transdermal spray has a similar cost to other transdermal products. The Committee recommended the addition of estradiol transdermal spray as an alternative to other transdermal estradiol products.
The Committee recommended addition of the following items, which provide alternative formulations or additional strengths for products already included in the Prescribed List, with no cost impact.
1.4 Synalar N ointment – as an alternative to Synalar N cream
1.5 Medroxyprogesterone 100mg tablets – to add to 5mg, 10mg and 200mg strengths included in Prescribed List
1.6 Isosorbide mononitrate MR 60mg Tablets - as alternative to capsules included in the Prescribed List
1.7 Methotrexate injection 22.5mg and 30mg - to add to all other strengths included in Prescribed List
1.8 Budesonide m/r tablet 9mg – as a once daily alternative to budesonide 3mg m/r capsule, which is taken 3-times daily.
2. Items to be removed from the Prescribed List
2.1 Furosemide 5mg/5ml oral solution – this product is now discontinued
2.2 Ketoprofen 50mg capsules – this product is now discontinued
2.3 Spirololactone 10mg/5mL oral suspension – in accordance with UK guidance, the range of liquid products for children should be rationalised to standard strengths; the 10mg/5mL oral suspension is recommended for removal while the 50mg/5mL oral suspension will remain on the Prescribed List.
- Other changes to the Prescribed List
3.1 The Committee supported a request from the Alcohol & Drugs Service to temporarily relax requirements for prescriptions for acamprosate and nalmefene to be validated by them before dispensing. The purpose of the validation is to confirm that these products, which are used in the treatment of alcohol mis-use, are only dispensed for those patients also receiving psycho-social support. However, this validation process has not been possible during the COVID pandemic and, prior to that, had been increasingly difficult to manage. The process is under review and an alternative approach will be submitted to the next meeting of PBAC.
- Other considerations
Applications for the following products were considered by the Committee but not supported.
4.1 Hyaluronic acid injection (e.g. Ostenil Plus, Durolane) – these products, used in the management of pain and restricted mobility in degenerative and traumatic changes of the knee joint and other synovial joints, are classed as medical devices and do not require prescription. The request was for them to be prescribed by a limited number of practitioners in primary care. After careful consideration, the Committee did not recommend their inclusion in the Prescribed List but suggested that access to the products should be considered as part of the pathway of care for patients with musculoskeletal conditions.
4.2 Colecalciferol (vitamin D) capsules 400 Units, 800units – the Committee noted that recently published recommendations from NICE that colecalciferol is not recommended in the treatment or prevention of COVID-19 infection. However, low dose colecalciferol (400units daily) remains helpful for bone health in the general population. Since low dose colecalciferol can be bought from pharmacies, the Committee did not see a need to add it to the Prescribed List.