Financial impact
The overall financial impact of the above changes is expected to be a decrease in net expenditure of up to £54,000 pa.
Mrs Alison Creed, PBAC Chair
12 February 2021
Recommendations
- Items to be added to the Prescribed List
1.1 Colecalciferol (vitamin D) 400 units capsules
Vitamin D is recommended in public health guidelines for healthy bones and muscles. Too little vitamin D can lead to bone problems such as rickets in children, and bone pain and muscle weakness in adults, which may also increase the risk of falls in older people.
A daily supplement of vitamin D 400 units should be taken by everyone during winter months when there is too little sun for people to make enough vitamin D from sunlight on the skin. Individuals at risk of not having enough vitamin D even in spring and summer, including those with dark skin (such as those with African, African-Caribbean or south Asian backgrounds), those who are not outdoors often, those in care homes, and those who cover up most of the skin when outdoors are advised to take a supplement all year round.
The public are encouraged to buy their own vitamin D supplement, however GPs will prescribe, particularly for those in residential care, with a low income, or in the belief that a prescription will encourage patients to engage with advice to take a supplement.
The Prescribed List currently includes a number of vitamin D supplements, mostly high-strength products for the treatment of confirmed deficiency. The lowest strength on the List contains 800units and, in the past 12 months, nearly 9,000 prescriptions have been dispensed for this product at a net cost of over £55,000.
PBAC considered the addition of vitamin D (colecalciferol) capsules 400 units to the List. This product provides the recommended daily dose of vitamin D and is less expensive than the 800 unit product; if all prescriptions for vitamin D 800unit were switched to 400 units, total expenditure would be reduced by around £40,000 pa. The addition of vitamin D (colecalciferol) 400 unit capsules to the List was recommended by PBAC.
1.2 Melatonin tablets modified-release 1mg, 5mg (Slenyto) and 2mg (Circadin)
Melatonin modified-release tablets are indicated, where sleep hygiene measures have been insufficient, for the treatment of insomnia in the following groups: adults aged 55 years and older, patients with autism spectrum disorder or Smith-Magenis syndrome, and (unlicensed) in patients with learning disabilities. Immediate release tablets are also indicated for the management of jet lag but were not considered further by PBAC due to the self-limiting nature of the condition.
In the management of insomnia associated with autism spectrum disorder/Smith-Magenis syndrome/learning disability, PBAC heard that these are specialist conditions with patients typically managed under the care of the child and adolescent, or adult mental health teams. There are currently a small number of patients receiving their on-going prescriptions for melatonin from the hospital (total expenditure c£5,000 pa) who could switch to receiving repeat prescriptions from their GP.
In the management of insomnia in adults aged 55 years and older, PBAC considered the evidence that melatonin is no more effective than other treatments for insomnia on the Prescribed List such as zopiclone and zolpidem. Like these established treatments, melatonin is only licensed for short-term use (maximum of 13 weeks) where non-pharmacological interventions are inadequate, but it has a mode of action that is different to the ‘sedating’ hypnotics currently available. For this reason, melatonin offers a potentially safer alternative. However, it is more expensive at around 7-times the reimbursement price for the commonly prescribed hypnotics. Hypnotic medicines currently account for around 16,000 prescriptions dispensed each year in the community in Jersey and a total net cost of around £26,000 pa. If melatonin uptake reaches 20% of hypnotic prescriptions, as in England, total net expenditure could increase by around £40,000 pa.
In their deliberations, PBAC were mindful of the risks of drug treatments for insomnia, their problems with misuse, and long-standing advice for prescribers to reduce their prescribing of these medicines, which has resulted in a more than 50% decline in their use over the past 10 years. Adding another, more expensive medicine to the List, therefore, was a difficult recommendation to make but the Committee felt that melatonin could provide a more acceptable, short-term option for prescribers and patients.
PBAC recommended the addition of melatonin modified-release tablets to the List, to be Prescribed by brand name to avoid confusion, for the treatment of insomnia in adults aged 55 years and older and in children, adolescents and adults with autism spectrum disorder, Smith-Magenis syndrome and learning difficulties (unlicensed use), subject to education of prescribers around the appropriate use of hypnotics and monitoring of melatonin prescribing with feedback to PBAC every 6 months.
1.3 Nebivolol tablets 1.25mg, 2.5mg, 5mg
Nebivolol is an established beta blocker licensed for the treatment of high blood pressure and heart failure. It is a more selective beta-blocker than bisoprolol and carvedilol, which are already on the Prescribed List, and so offers an effective and potentially better tolerated option for patients at a similar cost to other drugs in its class. PBAC, therefore, recommended addition of nebivolol tablets to the List with no overall cost impact anticipated.
1.4 Buprenorphine 15micrograms/hour transdermal patches
The strengths of buprenorphine patch are currently included in the Prescribed List but a further strength, 15mcg, is also available. PBAC recommended that this is added to the List for patient convenience with no overall cost impact anticipated.
- Items to be removed from the Prescribed List
The following items were considered for removal from the Prescribed List as the first stage of a review of ‘low priority prescribing’ products. These products have been included in the List for many years, probably since the List was first created, but have little, if any, therapeutic benefit. Aside from their reimbursement cost, these products incur dispensing fees and consume resources to issue and dispense the prescriptions. But, most importantly, low priority products distract patients from adhering to those prescribed treatment that do make a difference to the length and quality of their lives.
PBAC recommended removal of the following products from the List following a 6-month period of education and information for patients and prescribers about their limited value. If there is no feedback that removal of these products will be demonstrably detrimental to patients, the Committee recommended their removal at the end of September 2021.
2.1 Vitamin B compound/vitamin B compound strong tablets
Historically, vitamin B compound tablets have been prescribed for patients who are alcohol dependent despite a lack of evidence of its value. Current guidelines recommend thiamine tablets to treat and prevent thiamine deficiency in such patients.
In the past 12 months, around 7,400 prescriptions for vitamin B compound/compound strong tablets were dispensed with a net reimbursement cost of £27,000. If 75% of these prescriptions are discontinued, with the remainder switched to similarly priced thiamine, the net saving will be around £20,000 pa.
2.2 Vitamin C/ascorbic acid tablets
Vitamin C tablets are commonly co-prescribed with iron tablets, for the management of iron deficiency anaemia, since vitamin C has been shown to increase the absorption of iron. However, there is no evidence that co-administration improves the treatment of anaemia and vitamin C can be obtained from the diet, for example by taking iron tablets with orange juice.
In the past 12 months, around 1,600 prescriptions for vitamin C tablets were dispensed with a net reimbursement cost of over £37,000, all of which will be saved if these products are removed from the Prescribed List.
2.3 Vitamin capsules
Vitamins Capsules BPC contain only vitamins A, C, D, thiamin, riboflavin and nicotinamide, and the amounts provided are mainly less than required amounts (Reference Nutrient Intakes (RNIs), Department of Health, 1991) and less than the amounts provided by many over the counter (OTC) products. There are 3 branded multivitamin products on the List, Renavit, Dalivit, and Abidec, for specific populations of patients and these products should remain.
In the past 12 months, over 3,600 prescriptions for vitamins capsules were dispensed with a net reimbursement cost of over £2,300, all of which will be saved if these products are removed from the Prescribed List. The remaining products (Renavit, Abidec, Dalivit) account for a further 400 prescription items/£2,300 per year.
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