The introduction of the specials tariff in 2011 has fulfilled its role of reducing the cost of specials to the NHS, with a reduction in cost of almost 30 per cent in the past four years. Specially formulated unlicensed medicines (specials) now account for only 0.95 per cent of prescription costs, an equivalent spend of £1.57 per person. Specials must be produced to rigorous pharmaceutical standards and there is concern that cost cutting may compromise quality through sourcing lower-cost supply or a reluctance to prescribe a special when needed.
A recent survey conducted by the Association of Pharmaceutical Specials Manufacturers (APSM) asked GPs if they had been asked to reduce specials prescribing by the CCG – 54 per cent said they had. Some 45 per cent of GPs said they were happy to prescribe a licensed medicine with instructions to the patient to crush or split tablets/capsules, compared with only 29 per cent in 2012. In a specials White Paper published in December the APSM explored the true cost of choosing a higher-risk alternative to a special through a series of case studies which examine what happens when patient need and safety are compromised to the extent that additional costs to the NHS are incurred.
‘There is robust guidance and regulation in place to ensure that specials should only ever be prescribed when there is no alternative to meet patient need. However, when a special is indicated, it is clear that attempts to cut cost in the supply chain are likely to result in increased demands on the NHS,’ says the APSM.
The introduction of the tariff has had a positive effect on the category and in general has made ordering and dispensing specials easier for pharmacists. ‘The introduction of the tariff has helped control the cost of specials and made pricing more transparent, which is of benefit to prescribers, patients and the NHS as a whole,’ says Chris Palmer, product manager at specials manufacturer Rosemont Pharmaceuticals.
At the APSM, chair Sharon Griffiths says, ‘The APSM supports the tariff. It has restored confidence in the supply chain and provided a framework to ensure that patients continue to receive essential medicines according to clinical need. In a recent APSM survey conducted by Opinion Health, 66 per cent of pharmacists questioned agreed or strongly agreed with the statement “I am more comfortable dispensing specials now there is a tariff in place to regulate prices”.’
At Mr Pickford’s pharmacy in Leicester, pharmacist Mukesh Lad agrees. ‘The number of lines on the tariff has increased and the system is much more transparent now. While it used to be that 20 per cent of our specials were on tariff and 80 per cent non-tariff, now it’s the opposite way round,’ he explains. At Hodgson Pharmacy in Longfield, Kent, pharmacist Amish Patel says that around 60 per cent of their specials are tariff and the rest nontariff.
£89.5 million = total spend on specials (2014)
32 per cent = mean cost per item reduction on specials since 2011
0.95 per cent = proportion of drugs budget spend on specials
£179.56 = mean cost per item before specials tariff introduced
£128.17 = mean cost per item after tariff introduced
£1.57 = equivalent per person spend on specials
75,000 = number of formulations of specials prescribed each year.
The top 500 specials are listed at www.nhsbsa.gov.uk and account for 55 per cent of all specials prescriptions
‘We have one supplier for all our specials, but once a month I do ring round other suppliers to ensure we’re still getting the best value for money. Though of course you do have to balance quality and reputation of the supplier as well as price.’ At Pharma Nord, commercial manager Claire Lawson says,
‘Pharmacists are often the middlemen between the GP and the CCG. It’s important for them to get the best possible cost, while ensuring they are dispensing a quality product. The introduction and continued growth of the tariff has been a positive initiative, which has helped stabilise the specials market. The only concern I see for the future is the high emphasis placed on bringing costs down. As the tariff prices get lower, some specials lines may not be viable to manufacture.’
Pharma Nord says is committed to delivering cost savings for the NHS, she says. ‘We secured the first distribution deal of its kind on our Bio- Melatonin 3mg tablets, distributing through our partners Phoenix Healthcare and Quantum Pharmaceuticals. This allowed us to set the price at 50 per cent less than the average endorsement price at the time, saving millions to the NHS,’ says Ms Lawson.
At Quantum Pharmaceuticals, group commercial director Brian Fisher says, ‘The specials tariff was introduced to reduce the cost of the highest-volume specials to the NHS and it appears the tariff has resulted in efficiency savings. We all have an interest in keeping NHS costs down, but this cannot be at the expense of positive patient outcomes; we must not forget, for example, that crushing tablets can affect drugs’ pharmacological effects and the likelihood of adherence.’
‘We should be aware that the specials industry, like any other sector, is subject to market forces and commercial considerations. If the current trend continues, costs could be squeezed to such an extent that it would no longer be viable for manufacturers to provide the level of service that they do today.’
There is still a lack of understanding about specials and why they are needed with the public and prescribers. ‘There still seems to be some confusion about specials, off-licence and unlicensed medicines,’ says Mr Palmer. ‘Many prescribers seem to believe that all liquid medicines are specials and vice-versa. Clarity is needed to help optimise prescribing practices.’
‘For example, an off-label medicine may need to be prescribed to a child. The medicine might only have a licence for use in adults, but may be prescribed to an infant if a suitable licensed paediatric formulation is not available. More than 50 per cent of medicines used in children in the EU have never been studied in this age group, so it’s not surprising that in the UK unlicensed products account for:
With an increasing birth rate, demand for paediatric formulations is likely to continue rising and many of these formulations will be in liquid format, says Mr Palmer. Ms Griffiths says, ‘The public don’t always appreciate the difference between a special and a licensed product. GMC guidelines require doctors to explain the nature of the medicine to their patients, including that it is a special.’
Mr Lad says education among GPs regarding specials is improving. ‘We have to query far fewer specials with GPs these days than we used to a few years ago. They are now acutely aware of their budget spend and the cost of prescribing specials.’
At Pharma Nord, Ms Lawson says, ‘On the whole, we believe that confidence in the quality of specials is rising. However, there are many pharmacies that will only see a handful of specials each month and this may in some cases lead to the misconception that unlicensed medicines are a lower quality. In this case, I would point them to the strict MHRA legislation and processes that must be adhered to gain a licence to not only manufacture but also to distribute unlicensed medicines in the UK.’
Mr Fisher says, ‘Specials are unusual by definition, so it’s important the pharmacists can get expert guidance promptly so they can in turn give guidance to prescribers when necessary. When selecting a specials partner, you should check you can speak to a specialist when you need to about ingredients, interactions, etc. A pharmacist should only partner with a trusted, reputable supplier who is on hand to give reliable product and technical advice should the need arise.’
Many patients who need specials have complex medical needs. The APSM White Paper illustrates how patient safety can be compromised if a higher-risk alternative to a special is selected, such as crushing or splitting capsules.
‘Specials must be produced to pharmaceutical standards and licensed manufacturers will continue to be robust in their quality processes to meet the requirements of the MHRA. However, there are concerns that increased pressure to reduce cost could be compromising quality through sourcing lower-cost supply, or even reluctance to prescribe a special when required,’ says Ms Griffiths (see APSM White Paper – ‘How Specials can deliver value to the NHS without compromising patient safety’).
‘While costs need to be contained, potential savings are comparatively small, particularly compared to patient safety issues. This is of particular relevance to liquid specials, where the alternative practice of crushing tablets or opening capsules (to make them easier to swallow) may significantly compromise patient safety as well as render the prescriber legally liable for any untoward events,’ says Mr Palmer.
‘It’s estimated that 60 per cent of patients presenting to community pharmacy experience problems swallowing capsules or tablets, meaning that liquid medicines have a significant role to play in medicines optimisation,’ he adds. An APSM survey showed that pharmacists have confidence in the quality of specials from manufacturers, with 72 per cent feeling that the quality of specials compares favourably with that of licensed medicines.
Rosemont Pharmaceuticals has launched a new website which features 24-hour online ordering. Patient information leaflets and certificates of analysis are available to download for all products. It’s been designed to work across multiple platforms and browsers. The latest addition from Pharma Nord is a Coenzyme Q10 liquid.
A sugar-free formulation is now available in two strengths. Quantum Pharmaceuticals – part of the Quantum Pharma group – is exploring opportunities to combine synergistic services from all its subsidiary companies. One example is providing the opportunity to optimise adherence to all medicines, licensed and unlicensed, through the Biodose Connect medicines management system, due for launch in 2016.