The NHS in England could save nearly £72 million a year if the prices of unlicensed specials were limited to £75 per item, the BBC has reported.
The NHS in Coventry, for example, has paid “anything from £50 to £1,556” for Caporal Liquid Special 25mg/5mls, it says, adding that the cost of specials to the NHS in England has risen from £57 million to £160.5 million in four years, and that the problem also exists in England and Wales.
There is no price tariff for unlicensed specials, and the price variations occur when a pharmacist buys through a wholesaler - which adds its costs to the price - rather than directly from the specials manufacturer.
Commenting on these findings to the BBC, the Department of Health said it recognised that the system needs reforming, and it is working with the Pharmaceutical Services Negotiating Committee (PSNC) on proposals for new payment arrangements for specials.
The industry’s trade body, the Association of Commercial Specials Manufacturers (ACSM), agrees that change is needed and says it has been consulting with the Department “about a method of controlling the cost of specials that doesn’t compromise the supply to vulnerable patients.”
Until August 19, manufacturers of unlicensed specials were prohibited from issuing price lists to healthcare professionals without first having received a bona fide unsolicited order. This ban has now been lifted, through amendments to the Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010, and this is welcome, the ACSM adds.
“Anyone purchasing a special can now have some benchmark of what the original ex-factory price was and then make a decision about where to purchase,” said a spokesperson for the trade group.
Announcing the change, the Medicines and Healthcare products Regulatory Agency (MHRA) had advised makers of unlicensed specials that “any price list supplied should only consist of a basic line listing providing the following information: reference number, drug name (British Approved Name or equivalent), dosage form, strength, pack size, price. No product claims may be included.”
In its comments on the huge variations in the cost of unlicensed specials, and how this ultimately impacts on NHS spending, the Royal Pharmaceutical Society of Great Britain reminds pharmacists that they should supply a licensed product in preference to an unlicensed drug where there is one available which is clinically appropriate for the patient.
“All pharmacists are encouraged to ensure that the NHS receives good value from its expenditure. It is recommended that you have a Standard Operating Procedure (SOP) in place detailing the steps involved in ordering of specials and different options available,” the Society adds.
Meantime another report, in yesterday’s Daily Mail (September 27), warned of the potential legal issues arising from the fact that NHS hospitals are prescribing unlicensed drugs “because they cannot afford sky-high prices for branded versions.”
Since the European Medicines Agency (EMA) began permitting drug makers to license cheap and commonly-produced treatments for rare diseases two years ago, the firms which do so “then slap a huge price tag on their branded drug – even though doctors say it is almost identical to the old one,” says the report.
The EMA recently approved for marketing BioMarin’s Firdapse, a licensed version of 3,4DAP, an unlicensed preparation used in the treatment of the rare nerve condition Lambert Eaton Myasthenia Syndrome (LEMS), but the firm is charging £44,000 per year per patient for its drug, which is over 35 times more than the NHS had been paying, says the Mail.
It quotes an NHS board report on the issue as advising a Primary Care Trust (PCT) to continue using the cheaper unlicensed drug but also cautioning that this could leave it open to legal challenge from a patient or the licensed manufacturer.