"The effect of my ruling is that in reality the CCG could not lawfully disagree with the medical or scientific rational for NICE's recommendation"
Bevan Brittan LLP has recently acted in the case of Rose v Thanet CCG. This was a case that started off as a challenge to the CCG's exceptional funding decision but ended with the Judge commenting on how CCGs should implement NICE guidance.
The claimant, Ms Rose, suffered from a severe form of Crohn's disease. Her clinician had recommended that she have a bone marrow transplantation with chemotherapy, a treatment likely to lead to infertility. As a result, Ms Rose sought funding for oocyte cryopreservation.
The CCG's policy, as inherited from the PCT, was that it did not provide funding for oocyte cryopreservation for anyone receiving gonadotoxic treatment. This policy was based on the NICE guidance published in 2004. Further NICE guidance was published in February 2013 which provided that CCGs should: "Offer oocyte or embryo cryopreservation as appropriate to women of reproductive age (including adolescent girls) who are preparing for medical treatment for cancer that is likely to make them infertile…"
Following the introduction of the new NICE guidance the CCG, through the local CSU, carried out significant work on this area and introduced a new policy in October 2013. The CSU had considered the evidence and reached a recommendation that the cryopreservation would not be funded for patients undergoing gonadotoxic treatment because the evidence base for the intervention was lacking.
The Claimant challenge was to the original policy and to the process of the exceptional funding decision. The main ground of challenge on exceptionality appeared to be that the claimant, Ms Rose should be treated as exceptional on the basis that she had Crohn's disease. This argument was given short shrift by the Court.
The Judge also confirmed that the delay by the CCG in implementing the new NICE recommendations was not unlawful or irrational. The CCG needed time to formulate its considered response to the NICE Guidance published in February 2013
Alas, in order to "then went on to consider the lawfulness of the new CCG policy. Whilst this did not impact on the decision at hand, these comments have far greater impact on CCG commissioning. The Judge commented that:
- The CCG may not lawfully disagree with the medical or scientific rationale for NICE's recommendation in relation to oocyte cryopreservation; and
- It was irrational for the CCG to base their core reasoning on factors which NICE must already have taken into consideration. This was the case even though the NICE guidance did not make any reference to these factors.
The importance of these comments, whilst not binding, cannot be underestimated. This judgment has effectively required CCGs to fully comply with NICE guidance even though there is no statutory obligation on the CCG to comply.
The question is, in an age of reducing budgets and increasing treatments, can a CCG take local decisions about how to allocate its budget if NICE guidance has been published confirming cost effectiveness?
Would it be open to a CCG to decide that out of all of the interventions which NICE have deemed cost effective, some are more cost effective than others?
What this does mean is that where a CCG policy does not fully
implement NICE Guidance there will need to be clear and lawful
reasons for the decision and any equality factors will need to be
carefully addressed. If the decision is based on
affordability the CCG will need to be able to justify
its priority setting in a way that is more than just
accepting that existing services will be continued, and
deciding what new can be introduced, at least when
approaching the annual commissioning round. This type of local
priority setting will also need to be underpinned by the CCG's
public engagement processes.