APSM Blog

Friday, 1 November 2013

THE SPECIALS TARIFF - 2 YEARS ON


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.”


Notes:

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.

-ends-

1. NHSBSA. Special Order National Items and NIC Charts
 

 

Thursday, 27 June 2013

The Specials Tariff is important to ensure confidence and best practice within the sector


In response to an article in The Daily Telegraph June 22nd, 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 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 and we (the APSM) are confident that the Specials Tariff prices allow us to provide a high quality product at a fair price whilst keeping patient safety as our priority.   
The initial Specials Tariff list was relatively small but captured the majority of high cost, high volume specials prescribed. The list and the reimbursement prices of the products listed are reviewed regularly and the list has now expanded to 141 products.
The Daily Telegraph reported up to 20,000 unregulated items, but in reality the top 500 specials (by value) account for 96% of all spend.  Almost half of the top 100 specials (by value) are now on The Specials Tariff and there is a process in place to regularly review these in two ways. A rolling quarterly review reassesses prices and updates as appropriate and a six monthly review examines prescribing data to allow products to enter and exit the list.
A survey of pharmacists by the APSM this month shows that 64.4% (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 shows a shift in confidence from 33% in 2012 to 41% in 2013.
We believe the Specials Tariff has been successful in reducing cost and improving transparency within the specials sector and we will continue to work with the DOH to ensure that confidence in this system is maintained.   



Sources:  NHS BSA
Survey of 200 pharmacists and 200 GPs conducted by Opinion Health on behalf of APSM

For more information please contact:  lyn@wallacehcl.com





Friday, 21 June 2013

Ref. Daily Telegraph article, The NHS, the drug firms ... June 21st, 2013



In response to an article in The Daily Telegraph on Friday 21st 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 term approach to promoting best practice in line within the pharmaceutical sector.   

The Association of Pharmaceutical Specials Manufacturers, APSM, sets out a Code of Conduct to which all APSM Members subscribe. The APSM can consider an alleged breach of the code by a member.

One of the companies mentioned by the Daily Telegraph, Quantum Pharmaceuticals, is a member of the APSM. APSM understands that Quantum has carried out an internal investigation following the allegations and has denied the allegations made by the Daily Telegraph relating to overcharging.


For more information:
07734 101024