Analysis: Specials market now strong and stable?

After a period of hitting the deadlines for all the wrong reasons, the specials market now seems to be enjoying some relative stability.

The addition of pharmacy specials to the Drug Tariff has achieved the Government’s aim of curbing costs by leading to a steady decline in reimbursement prices. For suppliers, declining revenues and a high regulatory burden mean it is not a market for the faint-hearted.

The market has declined year-on-year following the introduction of Part VIIIB in the Tariff in England and Wales (and Part 7S in Scotland) in November 2011, but is now stabilising at a about two-thirds of its original value. During this time, the mean cost per item has fallen from £180 (in November 2011) to an average of £118 over the 12-month period to June 2017.

Key facts

  • The Government added specials to the Drug Tariff in an attempt to curb costs
  • 80 per cent of specials originate from secondary care
  • In June 2017 there were 25,467 Drug Tariff special order items prescribed


The specials market in primary care was worth just under £80 million in the 12 months to June 2017 – a not insignificant sum for products that cannot be promoted or marketed, and which should only be supplied if no alternative is available. Specials account for approximately 1 per cent of all prescriptions in the UK.

Such a bespoke service, where manufacture is often on a very small scale and product is supplied within 24 hours, will never come cheap, especially when a high regulatory burden is thrown into the mix.

While some CCGs seek to minimise the amount spent on specials, seeing it drain in their prescribing budgets, it is worth noting that 80 per cent of specials originate from secondary care. This can make it difficult for a GP faced with a request for a repeat prescription, particularly if the discharge noted have not made clear why it was prescribed in the first place.

Pharmacy contractors should be aware that CCG or GP cannot insist on the source of the special. Dispensing is an essential service and pharmacists are responsible for the quality of medicines they supply. PSNC should be informed of any local initiatives that may end up subverting normal procurement practices.

For a hospital or GP practice, prescribing a special may have benefits but there are also risks. Prescribers must be satisfied there is sufficient evidence or experience to demonstrate safely and efficacy, bearing in mind the medicine is unlicensed to with no SmPC to advise on dose, side-effects and contraindications.

When prescribing responsibility transfers from one prescriber to another, ensuring a safe and timely supply of the special can present additional challenges for both the prescriber and the supplying pharmacist.

When are the specials appropriate?

There are a number of situation when prescribing a special might be the appropriate option:

For children it might be the only option in some circumstances. Liquid specials can be used to carry a lower dose and may also be easier for youngsters to take

In some therapy areas, such as dermatology and ophthalmology, a large number of specials are in regular use. The British Association of Dermatologists has produced its own formulary, ‘Specials recommended by BAD for skin disease’,1 while the Royal College of Ophthalmologists has recently updated its clinical guidance, ‘Ophthalmic special order products’2

Patient may require special formulations. If the patient has difficulty swallowing or is receiving medication via an enteral tube, then alternatives to solid dosage forms will be required.

Key principles

In its professional guidance, the Royal Pharmaceutical Society identifies five key principles for the procurement and supply of specials (see Figure 1).3

1. Establish the optimal treatment: All options should be evaluated to ensure that specials are only supplied when the patient has a clinical need that cannot be met by a licensed medicine.

2. Understand the patient’s experience: Ensure the patient’s needs and preferences are discussed to ensure that the implications and practicalities of supplying and using a special are understood.

When starting or taking over the supply of a special (e.g. on hospital discharge), full details must be obtained from whoever previously supplied the special.

Patients and/or carers must be made aware of the need for adequate advance notice of repeat prescription requests to ensure continuity of supply.

3. Identify a preparation and a suitable supplier: You should obtain evidence (documentation) that the product you supply meets appropriate standards. To ensure consistency/bioequivalence when dispensing a repeat supply, aim to use the same product specification and supplier if possible.

4. Review the need for a special: It is necessary to ensure a special remains the best option and ongoing supply is justified. Monitor the patient periodically since there may be an increased likelihood of adverse events or treatment failure.

5. Effective governance: Have the right procedures in place, document any discussions with the prescriber and source the item from a licensed specials manufacturer, ensuring you have the correct product specification and that it has been communicated accurately.

Record the receipt of the medicine and its supporting documentation and have procedures in place for reporting errors. The following records should be kept for at least five years:

  • The source from which the product was obtained, and the date it was received
  • The person to whom the sale or supply was made, and the date it was supplied
  • The quantity of the sale or supply
  • The batch number of the product from which the sale and supply was made
  • Details of any suspected adverse reactions that you become aware of – either at the time or subsequently.

A final point, which is not mentioned in the RPS professional guidance, is to ensure the prescription is properly endorsed and submitted.

Contractors in Scotland have to go through additional hoops for items not included in Part 7S of the Scottish Tariff. Pre-authorisation must obtained from the relevant NHS board before payment will be made for specials not listed in Part 7S, items not available from a NHS manufacturing unit and imported unlicensed medicines. The pre-authorisation will normally last for 12 months when the cost of the product does not vary by more than 20 per cent.

Both PSNC and Community Pharmacy Scotland provide factsheets on the correct endorsements and additional fees that can be claimed:

Dispensing Factsheet: Unlicensed Specials and Imports. PSNC.

Reimbursement for Specials – Key Facts. Community Pharmacy Scotland.

What next?

Brexit looms, but what it might mean is still anyone’s guess. The Healthcare Distribution Association, representing full-line wholesalers, has warned that the introduction of border controls and tariffs (potentially making medicines more expensive to import into the UK and substantially increasing the administrative burden) could have an impact on the security of the supply of medicines.4 The consequences for specials manufacturers are less clear.

Likely to have a more immediate impact is the Health Service Medical Supplies (Costs) Act 2017, which gives the Department of Health sweeping powers to collect information about the price of medical supplies.

The DH says it intends to use the information to “facilitate the determination of remuneration/payment of community pharmacies”. The consultation period on new regulations made under the Act closed on November 14, so watch this space…

Who can make specials?

Specials can be made in the UK by the holder of a Manufacturer’s (Specials) Licence (MS Licence), which is issued by the MHRA. They can also be imported from within the European Economic Area (EEA) by the holder of a Wholesale Dealer Licence, and from outside the EEA by the holder of a MS Licence.

Part VIIIB of the Drug Tariff includes high volume and high cost unlicensed specials and imports, with reimbursement prices set by analysis of a selection of unlicensed specials manufacturers’ prices, plus a margin for pharmacy purchase profit. In June 2017 there were 25,467 Drug Tariff special order items prescribed (i.e. those listed in Part VIIIB of the Tariff), along with 28,362 special orders. These figures include FP10HP items.

Net ingredient costs have remained fairly static over the past 12 months, averaging around £6.7 million a month for the 12 months to June 2017.6

Members of the Association of Pharmaceutical Specials Manufacturers claim to have invested more than £150 million in quality and infrastructure since the addition of specials to the Drug Tariff, leading to some concerns about the cost of maintaining quality standards in the face of declining revenues.

To reflect a broader view of the market, the association decided last year to broaden its membership criteria to the wider supply chain, including importers as well as virtual specials manufacturing organisations which own the rights to, and act as the first supplier of, a specials medicine in the UK.

 

References

1. bad.org.uk/shared/get-file.ashx?itemtype=document&id=1848

2. rcophth.ac.uk/wp-content/uploads/2016/09/Ophthalmic-Special-Order-Productsupdated-August-2016.pdf

3. rpharms.com/Portals/0/RPS%20document20library/Open20access/Support/toolkit/Specialsprofessional-guidance.pdf

4. hdauk.co.uk/hda-news/hda-brexit-submission-health-select-committee-press-release

5. psnc.org.uk/wp-content/uploads/2013/07/Dispensing-Factsheet-Unlicensed-Specialsand-imports.pdf

6. nhsbsa.nhs.uk/prescription-data/prescribing-data/volume-and-cost-Special-orderproducts

It is not a market for the faint hearted

PSNC should be informed of any local initiatives that may end up subverting normal procurement practices

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