Court warns CCG over disagreeing with NICE guidance
6 May 2014 12:55 PM
Clinical Commissioning Groups (CCGs) cannot
choose not to follow NICE guidance because they merely disagree with it, even
where there is no statutory duty to do so, a court has
ruled.
This follows the case of Elizabeth Rose, a 25 year old
woman who has suffered from a severe form of Crohn's disease since she was
14. Her condition had deteriorated and her doctors recommended bone marrow
transplantation and chemotherapy to hopefully bring the disease into remission.
This treatment can, however, lead to infertility and the early onset of the
menopause.
The
claimant wished to secure the best chance of having her own genetic children,
and sought NHS funding for oocyte cryopreservation before beginning
chemotherapy.
In
February 2013, NICE updated its clinical
guideline on fertility which gave stronger support for the
effectiveness of oocyte cryopreservation. NICE recommends that oocyte or embryo
cryopreservation is offered as appropriate to women of reproductive age who are
preparing for medical treatment for cancer that is likely to make them
infertile.
Clinicians at King's College Hospital Foundation
Trust applied for funding for Ms Rose's treatment but Thanet CCG denied the
treatment in May 2013 on the grounds that there was not enough evidence to
demonstrate its effectiveness. The cost of the Procedure is
£4,050.
The
CCG's policy was not to grant funding for the procedure unless the
applicant has any exceptional clinical circumstances. The CCG considered that
the claimant's circumstances were broadly in line with the group of similar
patients addressed by the policy and that no exceptionality had been
established. Consequently, the CCG refused funding in June
2013.
The
NICE fertility guidance was not in the form of a technology appraisal or
specialised technology appraisal which CCGs must legally comply with and
provide funding for within three months of publication. Instead, the
recommendations were made as part of a clinical guideline, and so CCGs do not have a legal duty to comply
with NICE guidelines.
Despite this, the court ruled that the CCG was under an
obligation in public law to have regard for the NICE guidance and to provide
clear reasons for any general policy that does not follow NICE
guidance.
The
issue in this case was whether CCGs may legitimately disagree with NICE on
matters concerning the current state of medical science. It was NICE's view
that the evidence base supported the effectiveness of the procedure, and the
CCG's sole basis for not following NICE's recommendation was that it
disagreed.
Previous case law from 1997 (R v North Derbyshire Health
Authority, ex parte Fisher) had found that a decision not to follow national
policy in the form of guidance from the Secretary of State was only lawful if
there was some 'special factor' which 'exceptionally justified
departure'. Disagreement with the policy was not enough. The court applied
this judgment to the present case and found that no basis or reasoning on
grounds of exceptionality was put forward by the CCG.
The
judge, Justice Jay, pointed out that the CCG could have found other reasons, on
the basis of exceptionality, for not following the guidance. It had not done so
and mere disagreement was insufficient. The policy was therefore
unlawful.
Thanet CCG has said that they will consider the full
written judgement carefully and will work closely with NHS England in doing so.
If necessary they will review their policy on the freezing of
eggs.
Sir
Andrew Dillon, Chief Executive of NICE, said: “This court ruling
highlights that CCGs cannot simply ignore NICE guidelines without having a
clear clinical case for doing so. NICE guidelines are based on the best
available evidence. Our fertility guideline was recently updated and provides
clear support for the use of oocyte cryopreservation.”