APSM

In response to an article in The Daily Telegraph June 22 nd , the APSM, Association of Pharmaceutical Specials Manufacturers, has spoken out in support of the Specials Tariff, a system that was introduced by the DOH to create a more transparent process for reimbursing specials, linking the cost of reimbursement to the cost of the product, while providing value for money for the NHS.  Since the introduction of the Specials Tariff in November 2011, the average cost per item has fallen by 25% (from £180 to £135).   The Specials Tariff was set using a system similar to that used for the calculation of the price of category M generics.  Under a memorandum of understanding (MOU), licensed specials manufacturers provided sales information to the DOH, which has been used to set a reimbursement price that includes margin.     These prices take into the account the high quality manufacturing processes that must be adhered to by companies wishing to supp...

In response to an article in The Daily Telegraph on Friday 21 st June, The Association of Pharmaceutical Specials Manufacturers, APSM, has stated that it strongly condemns any activity that would result in overcharging for supply of medicines to the NHS. The Daily Telegraph article alleges activity to overcharge on medicines, based on interviews with individuals working in the specials industry. The allegations in the Daily Telegraph article, if proven, would not be considered acceptable practice at any level and would not be reflective of the vast majority of specials manufacturers in the UK.  The APSM, which represents manufacturers of unlicensed medicines (specials) within the UK, has worked closely with the Department of Health in recent years to develop a more transparent system of pricing and supply that protects the interests of patients and the NHS.  The specials sector provides a vitally important service and those involved take a responsible and long t...

But specials scripts are not increasing says APSM One year after the introduction of the Specials Tariff, the APSM (Association of Pharmaceutical Specials Manufacturers) reports that the Tariff appears to have been successful in restoring confidence to the market, but says there is little evidence to date that this is having a positive impact on prescribing levels. A poll of pharmacists by Opinion Health showed that almost half are happier prescribing specials now that a tariff is in place.   But although latest figures from NHS Prescription Services show a gradual increase in the number of specials ordered month-on-month from November to June, the APSM challenges any interpretation that this is a sign of growth.   It is more likely a reflection of improved reporting by pharmacists and the DOH where prior to the Tariff, special scripts were frequently classified as ‘other’ rather than ‘unlicensed medicines’.   Says Sharon Griffiths, Vice Chair of the APSM,...

QUALITY PROCESSES FOR UNLICENSED MEDICINES Unlicensed medicines, or specials, are only offered to a patient when the physician has identified a clinical need that cannot be met by any available licensed alternative.   In the UK, the majority of specials are manufactured and prepared by Specials manufacturers who are licensed, regulated and inspected by the MHRA and must comply with the principles of Good Manufacturing Practice (GMP) adopted by the EU Commission.   These licensed manufacturers provide additional assurances of quality.   A certificate of analysis is provided for batch manufactured specials as evidence that critical parameters have been met through physical, chemical or microbiological analysis of the final product.   Where individual or bespoke specials are prepared, the manufacturer will provide a certificate of conformity to show that the product meets the specification. In addition, (ALL) APSM members voluntarily undertake to apply th...

The APSM (Association of Pharmaceutical Specials Manufacturers) recently conducted a survey of pharmacists which showed that nearly half* of pharmacists felt more comfortable dispensing specials now the tariff is in place.  This is a positive response, but the APSM believes there is more work to be done to ensure the long term effectiveness of the Specials Tariff as a means of supporting a viable Specials sector.  In the past two years there has been a lot of focus on cost and even though the tariff is in place, this is continuing with pressure from PCTs to reduce spend.  The APSM is concerned that this ongoing pressure on cost could impact on quality if those involved in prescribing and dispensing specials do not have sufficient knowledge to make value-based decisions about patient need and quality.  The APSM believe that there is a need for greater education and support for those with responsibility for patient safety and they need to be supported in ...

15 th NOVEMBER 2011 The ACSM has changed its name to the Association of Pharmaceutical Specials Manufacturers (APSM) to reflect the clinical nature of its members’ products and services. As the trade association representing the interests of companies involved in the manufacture of unlicensed medicines, the role and importance of the APSM has grown in recent months as the organisation has provided a conduit for information and advice to the DH in the lead up to the Specials Tariff (published this month).   Specials account for around 1% of the prescription budget but this can be made up of more than 75,000 different formulations – each designed to meet the specific need of a patient where a licensed medicine is not available.  Said APSM Chairman, Alan Krol, “Specials serve a vital clinical need, it really is tailored and personalised medicine in every way – no other pharmaceutical manufacturer gets closer to the patient.” Said APSM Vice Chair, Sharon Griffiths...

Please click here to view the article published 10th November 2011.