THE SIZE OF THE MARKET
Spend on medicines in England 2018/19 - £20 billion. Specials account for less than 0.5% of all prescriptions.
Spend on specials in England 2019/20 (primary care) - £50.7 million. The annual cost of unlicensed medicines to the NHS across all four authorities is less than half that it was 10 years ago, declining over the decade since the Specials Tariffs were introduced; and although the number of specials prescribed shows a shallower decline the average cost of a special in England is now at its lowest point, just £111.
The industry continues to work hard to provide value for money to the NHS, whilst still maintaining the highest levels of patient safety.
The size of the market is recorded by the NHS Business Services Authority at https://www.nhsbsa.nhs.uk/prescription-data/prescribing-data/volume-and-cost-special-order-products
THE SPECIALS TARIFFS
The reimbursement prices of Specials in England, Wales and Scotland is regulated by Tariff.
The England & Wales Specials Tariff was introduced by The Department of Health and Social Care (DHSC) in 2011 to provide sustainability of supply and a mechanism to ensure that safe and effective Specials are available to the NHS. This is done via a resilient supply chain that provides a fair return, ensuring the long term sustainability of the Specials market.
Tariff changes are made every 3 months based on volume and pricing data submitted to the MHRA by organisations involved in Specials supply and manufacture, including APSM member companies. Some Specials are not included in the Tariff, if for example, only a very small number of prescriptions are required each year and so the cost is too small to warrant inclusion. Prescriptions are reimbursed at Tariff price. For non-Tariff items reimbursement is at net price i.e. invoice price less any discount given.
The Scottish Tariff covers a smaller number of products and uses a different mechanism for setting prices, although commercial and NHS prices are also taken into account. Overall, the price of the majority products on the Specials Tariff in Scotland is similar to the England Tariff with some fluctuations as the sizes and volumes are not always comparable.
REGULATION AND RESPONSIBILITIES
The Specials sector can be a complex one to navigate and a key aim of the APSM is to provide advice and support to healthcare professionals throughout the prescribing and dispensing process.
The decision to prescribe a Special rests with the clinician and they take responsibility for the overall safety of the patient. They can prescribe an unlicensed medicine in the knowledge that it will be reimbursed, however, this is as long as there is no licensed alternative available.
The pharmacist is under an obligation to fulfil a prescription for any Special that is handed to them, but they may question a formulation or the availability of a licensed alternative.
A Specials manufacturer has expert customer services teams available to provide advice and guidance about any aspect of a Specials prescription and this resource is widely used by pharmacists. A list of customer services contacts for all APSM members can be found in our members section.
As an organisation, the APSM works closely with professional and government organisations to develop standardised guidelines and practices. For example, the APSM has recently worked with the Royal Pharmaceutical Society (RPS) to provide Specials guidance for pharmacists.
Below are links to some of the Specials Guidance documents and policies available to healthcare professionals:
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MHRA Guidance, section 14; The Supply of Unlicensed Relevant Medicinal Products for ("Specials")'
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https://www.gov.uk/government/publications/ supply-unlicensed-medicinal-products-specials
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RPS, ‘Good Practice Guidance on: The Procurement and Supply of Pharmaceutical Specials'
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NPA, 'Specials Information Factsheet – Use of Unlicensed Medicines'
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NPA, 'The General Medical Council (GMC) - Prescribing Guidance : Prescribing Unlicensed Medicines