New reimbursement arrangements for special-order products ("specials") will be introduced on November 1, when 64 such products in a variety of formulations will be listed in the Drug Tariff, the Department of Health has announced.
The initial list, which will form a new part - Part VIIIB - of the Drug Tariff, will capture the majority of high-cost, high-volume specials prescribed, says the Department. The products on the new Specials Tariff and their reimbursement prices will be reviewed regularly and the list will be expanded as appropriate, it adds.
For specials not listed in Part VIIIB, payment will depend on how the product is sourced. A new fee for products made under the Sector 10 exemption and new arrangements for out-of-pocket expenses will apply.
The new arrangements, which have been agreed between the Department and the Pharmaceutical Services Negotiating Committee (PSNC), aim to create a more transparent system for reimbursing specials, linking the cost of reimbursement to the cost of the product while providing value for money for the NHS, says the Department.
"Having a Drug Tariff price will create an incentive for pharmacy contractors to procure in a manner that is cost-effective for the NHS. Further, the new arrangements will simplify the arrangements for claiming and payment for sourcing specials," it adds.
Specials are unlicensed medicines prescribed to meet the individual clinical need of a patient when a suitable licensed product is not available. They account for less than 1% of all prescriptions in the UK but are available in more than 75,000 different formulations.
The prices of products to be listed on the Specials Tariff have been calculated using a system similar to that used for calculating the price of category M generics, using sales and volume data from suppliers. Under a memorandum of understanding (MoU), a selection of licensed specials manufacturers have provided sales information to the Department, and this has been used to set a reimbursement price that includes margin, it says.
There will two types of review of the Specials Tariff: - a rolling quarterly review which will reassess prices only and update these as appropriate; and - a six-monthly review, in which prescribing data will be examined to allow products to enter and exit the list, with the aim of producing a list that can be easily updated to incorporate changes in prescribing habits.
However, the Department adds that flexibility concerning these reviews will be required, especially in the initial period as Part VIIIB becomes established. Also, where a special becomes available as a licensed product outside of these reviews, the Drug Tariff will be updated to reflect its introduction.
With the introduction of Part VIIIB, category E will be deleted from the Tariff from November, and the ingredients of products listed in category E will also be deleted, as appropriate.
Ahead of the final publication of the Specials Tariff, the Association of Commercial Specials Manufacturers (ACSM) said it was "hopeful" that its content would largely reflect the input and existing pricing structures of its members.
"If the net result is an end to uncontrolled price inflation within the distribution chain, then this will be a positive thing for the industry and will ultimately have the effect of reducing the overall spend on specials," said a spokeswoman for the Association.
Full details of the new Specials Tariff will be published in the November Drug Tariff, but for the proposed list visit the NHS Business Services Authority website at www.nhsbsa.nhs.uk.