Green Light for Better Implementation of NICE Guidance?
11 October 2012
This article first appeared in
Pharmaceutical Executive, 21 Sept
A recent decision by the Department of Health
(DoH) to introduce a compliance regime for NICE 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
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
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
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.
Barriers and Obstacles
The perceived barriers to implementing NICE
technology appraisals are well documented. A September 2005
report by the Audit Commission on, “Managing the financial
implications of NICE guidance” found that 85 per cent of the
NHS Chief Executives it interviewed identified a lack of available
funds as the most significant obstacle to implementing NICE
guidance. Other problems included a lack of access to
manpower resources; too much organisational change; a lack of
knowledge; and apathy and resistance to change.
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.
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
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. R (Rogers) v Swindon NHS Primary Care
Trust  for example found that a PCT decision to refuse
treatment was irrational because it did not allow for any
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.
Smith is a partner and Tim Suter a senior associate in
the Public & Regulatory Law
Group at Field Fisher Waterhouse LLP