On 28 February 2020, the High Court handed down judgment in R
(Cotter) v National Institute for Health and Care Excellence [2020] EWHC 435
(Admin) (judgment available here).
The case concerned a decision by the Defendant (“NICE”) as
to how to assess whether to recommend a drug, sapropterin dihydrochloride, as a
treatment for Phenylketonuria (known as “PKU”). NICE is a statutory body
that publishes guidelines on clinical practice, the use of health technologies
in the NHS, and certain other matters. Among other things, NICE makes decisions
on whether to recommend drugs for NHS use based on an appraisal of their
cost-effectiveness and certain other factors. If NICE recommends a drug, then
the NHS is obliged to commission it.
NICE operates two separate appraisal mechanisms for assessing
drugs. One is its standard ‘Health Technology Appraisal’ (“HTA”). Most
drugs are assessed under the HTA. The other is its ‘Highly Specialised
Technology’ appraisal (“HST”). The HST is designed specifically to cater
for the needs of so-called ‘orphan drugs’, which treat rare conditions with
small patient populations.
Recognising that such patient populations are at risk of neglect in
favour of those with more common conditions, the HST offers a more flexible
assessment process for such drugs. As a result, drugs may be recommended under
the HST even if they do not meet the standard
cost-effectiveness thresholds in the HTA. However, a drug may be assessed under
the HST only if it meets certain routing criteria set out in a policy
promulgated by NICE.
NICE had made a decision to route sapropterin through its normal
HTA process rather than the HST. The Claimant feared that this would hurt the
drug’s chances of being recommended for NHS use, and challenged the decision.
She argued that NICE had misinterpreted its own routing criteria, leading it to
ask itself the wrong questions and to reach an irrational conclusion as to how
the drug should be assessed.
In particular, the Claimant argued that NICE had been wrong to find
that:
(a) sapropterin’s target patient group was not clinically distinct;
(b) sapropterin was not expected to be commissioned as part of a highly specialised service by the NHS;
(c) treatment with sapropterin was not likely to be concentrated in very
few centres in the NHS.
The High Court dismissed the application for judicial review. It
found that NICE’s interpretation of all three impugned routing criteria had
been correct, and that the challenge therefore failed on both grounds.
The decision may be of interest for its consideration of the
authorities on intensity of review in the context of expert decision makers, in
particular where a decision-maker is interpreting its own policy.
Daniel Stilitz KC and Michael White acted for NICE.
