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Exceptional funding
6 June 2009
Primary Care Trusts (PCTs) not only have a fixed budget to
provide healthcare to their respective populations, but also a
statutory duty to break even!
Accordingly, they will not be able to afford every medical
treatment available, and must make difficult decisions about what
will be funded and what won’t.
In theory, this decision making process should be relatively
easy, based on the principles of consistency, equity and
transparency. It would seem obvious that PCTs should evaluate
measures on the basis of their cost effectiveness (in terms of the
benefit they provide relative to their cost) and their clinical
effectiveness, in terms of the evidence available that support the
use of the treatment.
In practice, funding decisions are inherently controversial.
Where those decisions relate to “end of life” treatments, which the
National Institute for Health and Clinical Excellence (NICE) have
yet to evaluate, the implications for the patient and their family
where funding is refused, are such that applications for
exceptional funding are inevitable.
Most PCTs currently receive approx two to 300 applications per
year for exceptional funding, which tend to concentrate around 50
or so drugs, of which a quarter are cancer related. Unfortunately,
the decision making process for exceptional funding causes PCTs
even greater difficulty, not least because they have recently faced
a great deal of scrutiny from the Courts, the public and ultimately
the Department of Health.
In R (on the Application of Ross) v West Sussex PCT
(2008) [2008] EWHC 2252 (Admin) the High Court held that the
principles used to judge “exceptionality” for funding had to be
sufficiently fair to the individual that they did not have to prove
that they were “unique”. In this case uniqueness would be
impossible to prove since there would always be another patient who
was appropriately comparable, especially when the comparison had
wide criteria, e.g. are they the only patient with a particular
type of cancer suffering intolerable side effects from the
conventional treatment?
The Court ruled that once a patient had established
exceptionality, a PCT still had to consider clinical efficacy and
cost effectiveness, but should take a “less restrictive” approach
to cost effectiveness, especially where matters of extending life
were concerned.
Whilst the Courts are prepared to rule on the decision making
process, they are not and have never been prepared to rule on
whether a drug should actually be funded, simply stating that it is
for PCTs to ensure that their process is legally compliant and then
rule again on whether exceptional funding is appropriate.
So how do you get it right?
Applications for exceptional funding, by definition, require
PCTs to compromise on the usual effectiveness criteria on which
they evaluate treatments. They are additionally pressured to do so
by the emotions of the patient and their family and the possibility
of negative publicity, especially where some patients are funded
and others not, or where other PCTs have funded all comparable
patients.
Our health team have worked with a number of PCTs and have
particular expertise in the following areas:
- Ensuring exceptional funding policies are compliant with the
latest law and guidance - there has already been guidance issued by
the National Guidance Centre and Department of Health, as well as
new statutory directions just in the first five months of this
year!
- Advising on how to deal sensitively with the individuals and
families concerned as well as setting up an appropriate PR strategy
to minimise the risk of adverse publicity
- Advising on Freedom of Information Act requests, in accordance
with the Data Protection Act, from individuals wishing to know why
others have been successful in obtaining exceptional funding
- Conducting risk analysis where decision making has been
inconsistent and setting up a mechanism for fast-tracked repeat
panel hearings
- Advising on the make up of the Individual Case Panels and the
appeals panel
- Offering training using case based scenarios so as to ensure
that the application of the ICR process is fair and the decision is
transparent to the patient - reducing the risk of complaints and
claims
- Representing PCTs in Judicial Reviews of their decisions
talk to us
Simon Tait
0115 976 6559/0121 237 3913
Partner and Head of Health
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