Specials prescriptions are on the rise, but the underfunded and time pressed community pharmacy sector is still unsatisfied with the cost and mechanics of supply.
There are regular stories in the mainstream media about the “cost to the NHS” of pharmaceutical specials – “specials” - formulations, where journalists keen to expose money pits in the nation’s health service ask why a product costing thousands of pounds is prescribed when there is a “similar” (although never quite the same) commercial version available.
There are of course plenty of reasons why a clinician would decide that a special is needed for a particular patient, and The Association of Pharmaceutical Specials Manufacturers (APSM) claims more than 75,000 different formulations of specials are prescribed every year.
While this sounds like a lot, APSM data shows specials represent only around 1 per cent of prescriptions, and although the number of prescriptions is on the rise, overall spend has declined steadily over the last few years. For context, spend on all medicines in England was £20 billion in 2017/18, while spend on specials in primary care in the same period was just £74 million.
For national news outlets, £74m is, understandably, a headline figure, but the APSM is at pains to point out that the specials industry “continues to work hard to provide value for money to the NHS, whilst still maintaining the highest levels of patient safety”. What’s more, APSM chair Brian Fisher says since Drug Tariff Part VIIIB was introduced in 2011 to control the cost of specials (and more recently Part 7S in Scotland) many higher volume specials have been incorporated into the tariffs and “their average cost has reduced by more than a third”, plus “reimbursement value in primary care has reduced by more than 50 per cent”.
There is a lack of understanding about specials, the reasons they are prescribed and the quality and nature of manufacture
As the tariffs continue to evolve, Mr Fisher says they rely on APSM engagement and industry data to ensure the NHS is achieving best value for money. He offers the assurance that these processes are “rigorous and regularly reviewed, and the consensus is that they are robust and effective”.
Nonetheless, as the representative body for the sector, the APSM has to jump to it when these scare stories raise their heads. While the Association won’t discuss pricing policies of individual member companies, Mr Fisher says its response depends on the circumstances, within a wider remit to educate about the sector.
“There is a lack of understanding about specials, the reasons they are prescribed and the quality and nature of manufacture demanded by the MHRA [Medicines and Healthcare products Regulatory Agency]”, he says. “National press reports often make incorrect comparisons between a bespoke special and an off-the-shelf drug, so often our response is to educate about the nature of clinical need.”
Headlines aside, Mr Fisher says the sector has reshaped itself in response to many factors in recent years. “Emphasis on quality and GMP has meant additional responsibilities for manufacturers”, he says. “This, combined with the reduction in market size and pressure to find cost savings across the NHS, has resulted in consolidation within the sector and a smaller number of highly specialised manufacturers. Other factors include political influence, clinical developments and continued investment and innovation by the sector, in which APSM members are particularly active.”
The England & Wales specials tariff was introduced by the Department of Health in 2011 to provide sustainability of supply and a mechanism to ensure that safe and effective specials are available to the NHS.
Tariff changes are made every three months based on volume and pricing data submitted by organisations involved in specials supply and manufacture. Some specials are not included in the tariff if, for example, only a very small number of prescriptions are required each year making the cost too small to warrant inclusion.
Prescriptions are reimbursed at tariff price. For non-tariff items, reimbursement is at net price (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 of products on the specials tariff in Scotland is similar to England, with some fluctuations as the sizes and volumes are not always comparable.
This evolution appears to be heading in a positive direction, but ask most community pharmacists about specials and their response still puts cost squarely in the crosshairs. “It does frustrate me that there are companies out there which are charging a fortune for specials – such as creams – that, when I first qualified, we used to make up ourselves in the pharmacy,” says one independent community pharmacist, who asked not to be identified.
And then there is the time element involved in sourcing the right product at the right price. “We are careful to find the cheapest source so that we can get reimbursed from the NHS, but not at an extortionate price”, says the pharmacist. “I have absolutely no desire to make a profit off the NHS, but this comparison takes time. We work quite closely with our local CCG’s medicines optimisation pharmacist, but of course they are looking for the best prices for specials and will use the pharmacy that will get the best value for them.”
The role of the pharmacist in specials supply is clearly defined in RPS guidelines. They need to fulfil prescriptions without any delay to the patient, but additional frustration comes from not always being able to offer the most appropriate formulation requirements for patients’ needs because of cost.
“Patients with swallowing problems or a PEG tube, for example, would be better off having a liquid special, rather than crushing up their tablets – which is unlicensed – but the high cost is often a deterrent for prescribers”, says another pharmacist. “Yes, we understand that formulation and stability testing is time consuming and therefore expensive, but often I fail to see why it’s as expensive as the end result appears to be.”
Thankfully, these frustrations are experienced infrequently, as the need to source specials is rare. Mr Fisher says pharmacists typically receive fewer than five specials prescriptions a month, and while the Association’s experience is that pharmacists are “proactive and knowledgeable in their approach to understanding patient need”, APSM member companies can also provide dedicated pharmacy support services to assist with any queries and concerns.
Addressing cost and supply issues, Mr Fisher says the APSM has “always supported” the specials tariffs, has frequent meetings and regular dialogue with the Department of Health & Social Care and provides the data that helps to inform prices. “DHSC is looking at ways to extend the system to ensure transparent pricing across all specials in England and Wales, and the APSM is supporting them to achieve this,” he adds.
Although the APSM is not a campaigning group, Mr Fisher says it takes a proactive stance about anything it believes compromises patient access to a special where there is an established clinical need: “Our remit is to ensure a sustainable and high-quality specials sector that meets the specialist needs of vulnerable patient groups. Much of our work is to promote technical, quality and regulatory excellence and we have committees that regularly share and advance best practice. We also collaborate with regulators to help maintain and raise standards across the sector.”
Acknowledging pharmacists’ role in fulfilling prescriptions in a timely and high quality way, Mr Fisher says the APSM is always open to working with healthcare professionals and organisations, politicians and payers to ensure they understand the implications of failing to meet patient need within a high quality supply chain.
As the discussions continue, one thing remains constant: the rare and costly sourcing of specials is yet another vital part of the range of services provided by an increasingly underfunded community pharmacy network.
The following guidance documents and policies might be useful: