Friday, 1 November 2013


A November boost and why it’s good for payors, patients and APSM members

29th October 2013. In the latest (November) update to the Specials Tariff 51 new products have been added, bringing the total number of specials regulated under the Tariff to 188.  The addition was widely anticipated by the APSM members and includes both larger prescribed specials as well as smaller volume specials.

Although there are potentially thousands of different formulations of specials, the top 500 (by value) account for 96% of all spend.  It is these 500 where much of the focus has been and now around half of the Top 100 specials are captured in the Tariff.   Amongst the latest round of changes more than half are in the Top 500 and represent around 3,500 prescriptions each quarter. 

Says the APSM, “Creating a workable Tariff for specials was not an easy process. Partly due to the sheer variety and number of formulations involved, but also because of the highly bespoke nature of production and the importance of responding quickly to patient need.”

“Two years on, we feel that the Tariff has achieved this and allows us to provide a high quality product at a fair price whilst keeping patient safety as our priority.”  

At the same time, customer confidence has improved considerably. A survey of pharmacists by the APSM this summer showed that 63.7% (agree to strongly agree) are more confident dispensing now a Specials Tariff is in place - an increase from 47.8% in the same poll last year.  A similar survey of GPs showed a shift in confidence from 33% in 2012 to 41% in 2013.

Since the introduction of the Specials Tariff in November 2011, the average cost per item has fallen by 25% (from £180 to £135).   The APSM acknowledge that some pharmacists are still under pressure to reduce spending on specials, but this is by no means unique to their sector.  Says the APSM, “Every single area of spend within the NHS has come under scrutiny in recent years and we are just a part of that process.  It is up to us to continue to demonstrate our value by delivering a high quality product even through difficult economic times.”  

“Over the last 2 years, APSM members have continued to invest £millions in process, facilities and infrastructure to ensure we have a specials sector that is unparalleled compared with most other countries in the world.”


The price set for specials takes into the account the high quality manufacturing processes that must be adhered to by companies wishing to supply products listed on the Specials Tariff – all of whom must hold an MHRA licence and follow best practice such as quality assurance processes, batch testing, product labelling, adverse event reporting and customer support lines.    

The DOH used different sources to set the Tariff including feedback from APSM and its members.

Quality Commitment from a licenced Specials Manufacturer

  • Premises inspected by MHRA for compliance to GMP (good manufacturing practice)
  • A pharmaceutical quality assurance system, e.g. pharmacopoeia monograph, stability tests
  • Batch testing / certificates of analysis provided
  • Certificates of compliance (for single products)
  • Best practice labelling
  • Customer support line
  • Unique product codes on all products
  • Innovation – e.g. clearer patient labelling
  • Yellow card adverse event reporting
  • Investment in facilities for medicines manufacture

Confidence in quality and market structure is high, in spite of continued pressure from CCGs (PCTs)

APSM launch results of 2013 Specials Survey

When it comes to dispensing Specials, pharmacists are as likely to refer to CCG (PCT) advice as to their own RPS Guidelines on best practice.  This is clear evidence of the continued and increasing pressure by CCGs (PCTs) to focus on cost, even though the overall Specials bill has decreased by 25%1 since the introduction of the Specials Tariff in November 2011. 

A survey conducted by the Association of Pharmaceutical Specials Manufacturers in June 2013 explored the attitudes of 200 pharmacists into various aspects of the Specials sector and compared the results with a similar survey conducted in 2012.  

A year ago, pharmacists were most likely to refer to a GP for advice about a Specials prescription (49.5%).  However, in 2013 pharmacists ranked CCGs (PCTs) their first source of advice (52.5%) - a significant increase from 46.5% in the previous year.  The poll of pharmacists went on to state that 50% had been asked to monitor or reduce their specials dispensing (compared with 42% in 2012) and 24% said they had been asked to reduce their spend on Specials (compared with 13% in 2012).
The concern is that pressure from CCGs (PCTs) could eventually compromise quality, says the APSM.  There are already signs that this could be happening, for example, a corresponding survey of GPs showed an increase in doctors prepared to offer a tablet with instructions to crush or split (64% in 2013 compared with 55% in 2012). The survey showed that GPs are under similar pressure to cut cost – more than half indicated that they have been asked by their CCG (PCT) to reduce spend. 

Confidence returning thanks to RPS Guidelines and Specials Tariff

But the overall theme of the survey is positive.  There are strong indications of increased confidence in Specials as well as a measured and informed approach by pharmacists to where, when and how to dispense.  Say the APSM, we believe two factors have contributed to this, firstly the RPS Guidelines on Specials Prescribing and secondly the Specials Tariff.  These both provide an important framework for making the right choices about source of supply and cost and this is reflected in our survey results.

For example, 64% are now more comfortable dispensing Specials since the Tariff was introduced to regulate prices (45% in 2012).  73% think Specials should be made up by specialist pharmaceutical companies (63.5% in 2012), which reflects the RPS best practice guidelines about hierarchy of risk. 

One of the most encouraging results is the confidence in quality, 72% feel that the quality of Specials compares with licensed medicines (58% in 2012).  This really underlines the fact that we have a very high quality Specials sector in the UK and one where increased investment over the years has created an environment where pharmacists feel that they can put patient safety as the key priority.  

However, part of the fall-out from the increased focus on cost in recent years is that there has been a potential to lose sight of the patient.   For example, although 83% of pharmacists believe that Specials are essential to meet the special clinical needs of some patients (an increase from 74% in 2012) the same number have concerns that Specials are sometimes prescribed unnecessarily.  Say the APSM, “The difficulty with Specials is that they are so unique to the individual needs of one patient and only their prescribing doctor can make that decision. As an industry we need to be very careful that these generalisations don’t impact on individual patients.” 

There is a slight increase in the number of pharmacists who feel that doctors should be able to prescribe Specials freely according to patient need, 22% (compared with 17% in 2012), but as an industry the Specials sector needs to work hard to continue to provide information that helps prescribers and dispensers to make the right judgements in relation to patient need.

Patient need comes first

There is still concern about cost, but also a significant change in pharmacists understanding of why the cost of specials reflects patient needs with 41.5% of pharmacists agreeing with this statement, compared with just 18% a year ago.  Says the APSM, “This is because there is far more transparency around Specials and we need to continue to build on this in partnership with pharmacists to create an environment where decisions can be made freely and confidently – and ultimately in the best interest of the patient.”

Specials account for less than 1% of all prescriptions, 96% of spend is accounted for by the top 500 specials and of these more than a third are now covered by the Tariff – with that number increasing with  every review. Since the introduction of the Tariff, the overall cost of Specials has reduced by 25% and, according to the APSM survey, confidence in quality and in the market structure is at an all-time high.


1. NHSBSA. Special Order National Items and NIC Charts