PharmExec Blog

NICE: What the New Compliance Regime Will Mean for Pharma

By Martin Smith and Tim Suter.

A recent decision by the Department of Health (DoH) to introduce a compliance regime for NICE (National Institute for Health and Clinical Excellence) technology appraisals will open the door to ensuring better implementation by NHS Trusts and Joint Prescribing Groups of NICE guidance.

Importantly, the regime will also open new avenues for pharmaceutical companies and patient campaign groups to monitor levels of compliance and pursue judicial review claims to ensure that regional NHS funding decisions do not override national NICE guidance on the availability of new drugs and treatments.   

Local Formularies
All PCT clusters in England will now be required to publish, no later than 1 April 2013, information on what NICE recommended medicines and technologies they have available for patients.  This is a significant development that will, according to NICE, end the blacklisting of NICE-approved drugs and ensure that data on local formularies are made available as part of standard terms and conditions on NHS contracts.  Importantly, this will also allow pharmaceutical companies and patient lobby groups to scrutinize more closely which NHS Trusts are meeting, and which are failing, their obligations to fund treatments recommended by NICE’s technology appraisal guidance.

All NHS Primary Care Trusts in England are under a legal duty to ensure that funding is made available for the provision of NICE approved ‘health care intervention’.  There are limited, specified exceptions to this requirement, but generally a PCT must make any treatment or drug approved by NICE ‘normally available’ within three months of the date of the technology appraisal.

In theory, this has meant that any PCT failing to ensure that new NICE approved medicines or treatments are available for prescription to patients could be subject to a claim for judicial review, most likely on the grounds that they are acting unlawfully.

In practice however, there has been a dearth of direct evidence that implementation failures are due to directive decision-making taken by NHS Trusts on a local level.  The new duty to publish local formulary details is a welcome opportunity that will allow pharmaceutical companies, and those in the life sciences industry, to monitor implementation of their NICE approved treatments more closely.  It will also allow better analysis of whether what many have always suspected is correct; that some NHS Trusts have not complied with their duty to implement NICE guidance.

The decision to force the hand of local formularies and make them publish what NICE approved drugs they have available will be a vital new tool to avoid the pitfalls of postcode prescribing and, one that pharmaceutical companies can take advantage of to monitor local levels of implementation.  Although the full details are not yet available, the new regime will bring implementation into much clearer view, with an evidence-based, publically available system of compliance.  In essence a league table of all English PCTs, that will sift the NICE compliant from those who are resistant to implementation.

Judicial Review
To date, the main legal focus for the pharmaceutical industry has been on ensuring that NICE and its Centre for Health Technology Evaluation properly scope, assess and appraise drugs selected for the technology appraisal process.  This will continue to be important and indeed grow more so in future if NICE guidelines are more vigorously adhered to.  The appraisal system is a complex and lengthy one, that may result in an MHRA licensed drug or treatment being excluded from the NHS health market.

So far in 2012, NICE has concluded 23 technology appraisals.  Its most recently available guidance, on the use of the breast cancer treatment Bevacizub, concluded that it should not be recommended as a first line treatment.  This is a clear example of the impact that NICE decisions can have, not only on pharmaceutical companies, but also on the treatment that will be made available on the NHS.   Any perceived failure by NICE to make thorough, well reasoned decisions on whether to approve particular drugs is therefore, and will continue to be, an area that is ripe for legal challenge.

A New Challenge?
Traditionally, the courts have been reluctant to interfere with decisions on healthcare resource allocation. How an NHS provider chooses to spend its finite resources is, the courts have made clear, a political decision that should not usually be litigated before the courts.

However, in the last ten years, the courts have, on occasion, shown themselves willing to adopt a more interventionist approach.

When the NICE compliance regime comes in to force next year, it will throw into sharp focus where there are local formulary groups failing to comply with their duty to implement NICE guidance.  This will act as an incentive to ensure implementation, which will be good for industry and patients in ensuring proper access to health technology that NICE has approved.  It will also show up those local areas that are not complying with their duty to use new drugs and technologies and will so provide pharmaceutical companies and patient groups with grounds to challenge prescribing groups that drag their feet through proceedings for judicial review.

Martin Smith is a partner and Tim Suter a senior associate in the Public & Regulatory Law Group at Field Fisher Waterhouse.

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