Jam tomorrow?

Medicines uptake in England and Wales has, over the last ten years or so, been most heavily influenced by the National Institute for Health and Clinical Excellence (NICE) technology appraisal guidance. This guidance has now provided recommendations on the usage of more than 380 individual medicines and indications to the NHS.

To support the implementation of NICE guidance, a mandatory direction to Primary Care Trusts (PCTs) and NHS Trusts has been in place since 2001, which requires that within 90 days of guidance being published to the NHS, funding should be made available to allow eligible patients to access endorsed treatments. In January 2009, the NHS Constitution was published. The Constitution gives patients the additional right to drugs and treatments that have been recommended by NICE for use on the NHS if their clinician thinks it appropriate. Similarly, the Scottish Medicines Consortium (SMC) has now published more than 600 individual recommendations since its inception and, although there is no mandatory funding direction, Scottish Health Boards are strongly encouraged to follow SMC advice. In Wales, the All Wales Medicines Strategy Group (AWMSG) has also separately published more than 80 pieces of advice about medicines.

Mandatory recommendations
Implementing a national guidance strategy has had a significant effect on access to medicines, though Extent and causes of international variations in drug usage: a report for the Secretary of State for Health, published on July 27, confirms the extent of uptake of medicines that have received positive recommendations varies between primary and secondary care and between disease areas. Overall this report places the UK eighth out of 14 countries in terms of medicines uptake.

Interestingly, across some disease areas, other countries that also have well developed health technology assessment processes (such as Australia, Canada, Sweden and New Zealand) have levels of medicines uptake similar to that of the UK. Other reports on the implementation of NICE guidance, including those available from the NICE website, also demonstrate that there remain significant geographical variations at all levels within the UK, including between England and the devolved nations, and within England between Strategic Health Authorities (SHAs), PCTs and Cancer Networks.

All these reports demonstrate that, even with 10 years of nationally published mandated guidance about medicines behind us, the UK still ranks about two thirds of the way down the list. So what does the future hold for medicines uptake?

The future
The coalition Government's health reform programme includes proposals to reform the role of NICE, with a new focus on health and social care and an extensive new work programme to develop quality standards. Three quality standards have already been published, and there are plans to produce another 150 over the next three to four years. Alongside this work programme, technology appraisals are set to continue, but it is anticipated that the status of the outputs from appraisals may change from being 'guidance' to 'advisory'. Advice would be provided to the new National Commissioning Board, which in turn might be expected to determine how the advice is implemented (or otherwise).

Clearly there are many details to be worked out, particularly in terms of how the Board will operate and what regional structures might be put in place to support it. What is clear, however, is that the new arrangements will have a strong influence on the uptake of medicines going forward.

A recent lead editorial in The Lancet raised concerns about the proposed new Cancer Drugs Fund and whether patients might be denied access to a cancer treatment, not on the basis of their condition, but because the SHA or regional organisation administering its part of the fund may have exhausted its share of the fund or be applying specific funding criteria, which are different from those of its neighbours. In other words, the fund may reinforce a form of postcode prescribing. Similarly, if national guidance from NICE becomes advisory only, this may also reinforce postcode prescribing and cause extensive regional variation in medicines uptake. It will all depend on the role and mode of operation of the National Commissioning Board.

Going forward it will be important to have good baseline measures in place so that medicines uptake can be monitored closely before and after the reforms start to take effect. Companies should also ensure they have good systems to track eligible patient uptake of their medicines at the appropriate level of granularity (PCT, Cancer Network or SHA) in order that local and regional changes in medicines uptake can be observed closely.

The Author
Paul Catchpole, value & access director, ABPI

To comment on this article, email pm@pmlive.com