Further details have emerged concerning potential delays to the new Pharmaceutical Price Regulation Scheme (PPRS).

Last week, in a surprise development, the Department of Health announced a public consultation on how the Scheme’s loss of exclusivity (LOE) provisions linking the prices of patent-expired branded medicines to those of any equivalent generics will apply to individual products. It acknowledged that this will delay the introduction of a major part of the new PPRS by at least three months.

However, industry insiders are also seriously concerned about the potential for further delays to another element of the PPRS which formed part of the “heads of agreement” settled back in June. This calls for a 5% reduction in the prices of all branded drugs to the National Health Service (NHS) from next January, with provisions for a further one-off reduction of 2% in 2010 or 2011 if the NHS drugs bill should grow faster than 6.7% in either 2008 or 2009. Pharma Times was told that the Department has admitted that it lacks the data set to measure this 2% “safety valve,” and a letter sent this month by NHS chief executive David Nicholson to NHS Trust chief executives, financial directors and chief pharmacists outlines where these “gaps in the information” exist.

“I am writing to seek your support in identifying any relevant information you may be able to provide the NHS Purchasing and Supply Agency (PASA) when they contact your Trust. This will be crucial in determining whether or not an additional 2% price cut is triggered for the NHS as a whole in 2010 or 2011,” Mr Nicholson tells the Trust officials, adding: “as the NHS branded drugs bill in primary and secondary care currently stands at £8 billion, the savings we would get if this additional 2% were triggered are substantial.”

Mr Nicholson’s letter, which is published on the Department website, emphasizes that gathering “robust” information on medicines expenditure in secondary care, where growth rates are significantly higher than in community care, is crucial. To date, he says, there has been good support from hospital pharmacists in gathering data on secondary care from NHS PASA and through the PharmEx data monitoring system developed by the Agency, which collects data from the 95% of NHS Trust pharmacy systems that can provide it. However, there are gaps in the information available through PharmEx, most notably concerning medicines dispensed at home where purchasing sometimes bypasses pharmacy information systems. Many NHS Trusts have developed such systems including homecare data, but coverage is patchy across the country, he says.

Therefore, NHS PASA is writing to hospital pharmacies looking for any further data on expenditure on medicines not entered into such systems, most likely those dispensed in a home setting, says Mr Nicholson. The Agency will not be looking to the Trusts to duplicate information already available through Pharmex or other systems - the aim is to identify whether they may have additional information which would support the development of a comprehensive information set on the total drugs bill in 2007, 2008 and 2009, he tells the officials.

Mr Nicholson’s letter was dated October 9, and sources close to the PPRS negotiations describe as “ambitious” the three-week timescale to which the Department has committed in order to complete the development of such an information set.