R Maria Rose Wallpott v Welsh Health Specialised Services Committee
| Jurisdiction | England & Wales |
| Judge | Mrs Justice Steyn |
| Judgment Date | 03 December 2021 |
| Neutral Citation | [2021] EWHC 3291 (Admin) |
| Docket Number | Case No: CO/3775/2021 |
| Year | 2021 |
| Court | Queen's Bench Division (Administrative Court) |
[2021] EWHC 3291 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Cardiff Civil Justice Centre
2 Park Street, Cardiff, CF10 1ET
THE HONOURABLE Mrs Justice Steyn DBE
Case No: CO/3775/2021
and
and
Vikram Sachdeva QC and Adam Boukraa (instructed by Irwin Mitchell LLP) for the Claimant
David Lock QC and Joel Semakula (instructed by) for the Defendants
Hearing dates: 1 and 2 December 2021
Judgment Approved by the court for handing down
(subject to editorial corrections)
A. Introduction
The claimant, Maria Wallpott, is suffering from a rare form of cancer. The doctors who are treating her have recommended that she undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (“CRS with HIPEC”), and the claimant fervently wishes to do so. As this treatment is not routinely available in Wales to those suffering with the type of cancer that the claimant has, her treating doctors made an individual patient funding request (“IPRF”). That request was refused by the first defendant, the Welsh Health Specialised Services Committee (“WHSSC”), acting on behalf of the second defendant, on 1 July 2021, and the decision to decline funding has been maintained on review.
The WHSSC is a joint committee of the seven local health boards in Wales, which is hosted by Cwm Taf Morgannwg University Health Board. The second defendant, Aneurin Bevan University Health Board is the local health board responsible for providing the claimant with NHS medical care. The decisions were made by the WHSSC on behalf of the second defendant.
In this claim for judicial review, the claimant seeks to challenge the defendants' decisions to refuse her funding request. She raises the following four grounds of challenge:
i) In concluding that the “information provided did not demonstrate that the patient is likely to gain significantly more clinical benefit form the intervention than would normally be expected from patients with the same condition and the same stage of disease”, the defendants failed to ask the right questions and/or reached an irrational conclusion.
ii) The defendants unlawfully failed to give reasons for rejecting the evidence before them regarding the clinical benefit of the treatment for the claimant.
iii) The defendants erred in their construction of the relevant guidance given by the National Institute for Health and Care Excellence (“NICE”).
iv) The defendants erred in taking into account the availability of alternative treatment in the form of the use of an EFGR inhibitor, in circumstances where such treatment was not in accordance with current practice in South East Wales for patients with the claimant's condition.
v) The defendants failed to ask the right questions in assessing the cost effectiveness of the treatment for which the claimant sought funding.
This claim was filed on 2 November 2021, together with an application for urgent consideration seeking a substantive hearing by 3 December 2021. In accordance with the order of HHJ Lambert made on 5 November, the claim was listed for an expedited ‘rolled up’ hearing (that is, a hearing to determine both permission and the substantive claim).
Mr Vikram Sachdeva QC and Mr Adam Boukraa appeared on behalf of the claimant. Mr David Lock QC and Mr Joel Semakula represented the defendants. I am grateful to them for the work they have all evidently put into ensuring that this claim was ready to be heard urgently.
B. The claimant's medical condition
The claimant is a 50 year old woman. On 28 April 2021 she was diagnosed with stage 4 metastatic appendiceal adenocarcinoma (more simply referred to as appendix cancer). The disease has spread to the claimant's omentum and peritoneum and has formed a large Krukenberg tumour. Appendix cancer is a type of colorectal cancer. As it has spread to the peritoneum, it is also a type of peritoneal carcinomatosis.
Peritoneal carcinomatosis is an advanced form of cancer found in the peritoneal cavity; the fluid-filled gap between the walls of the abdomen and the organs in the abdomen. This type of cancer occurs when cancers spread from their origin in, for example, the appendix, bowel, rectum or ovaries. It is associated with short survival and poor quality of life, and may lead to bowel obstruction, accumulation of fluid in the peritoneal cavity and pain.
The form of cancer from which the claimant suffers is described by Mr Gethin Williams, a consultant colorectal surgeon at Royal Gwent Hospital, in a letter to the claimant's GP dated 9 September 2021, as “exceedingly rare”. The claimant has been advised that it affects about one to two out of every one million people.
The claimant's case has been considered by multi-disciplinary teams (MDTs) in Gwent, Cardiff and Basingstoke. Her treating clinicians agree that despite being stage 4, her cancer is resectable and they have advised that she be offered CRS with HIPEC.
C. Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy
CRS with HIPEC is described in the WHSSC's policies as follows:
“ Cytoreductive Surgery involves removal of the maximum amount of the visible tumour through a number of surgical resections. The exact scope and extent of the surgery is dependent on the spread of the visible tumour assessed on an individual patient basis.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) involves flushing the abdominal cavity with a heated chemotherapy agent following surgical excision.”
The aim is to remove the macroscopic tumours using CRS and then, during the course of the operation, to treat any remaining microscopic traces of the cancer by distributing a heated chemotherapeutic drug uniformly to all surfaces within the abdominal cavity, to increase drug penetration.
There are two nationally designated centres in the UK where CRS with HIPEC can be provided, one of which is Basingstoke Hospital to which the claimant was referred by her treating clinicians in Gwent and Cardiff, and where it is proposed the surgery would be undertaken if funding can be obtained.
D. The policies and guidance
The context: resource allocation in the NHS
The context in which the policies in issue in this case have been adopted is explained by Professor Iolo Doull, the Medical Director of the WHSSC, in these terms:
“It is a feature of all national healthcare systems across the world, whether in the public or private sector, including the NHS, that demand for healthcare is rising and exceeds the ability of healthcare providers to meet all the healthcare demands of their local populations. This is a problem in both insurance and state-run healthcare systems across the globe. The only exception to this is for wealthy individuals who have unlimited resources to buy their own healthcare, but even then there can be limitations where the resource constraint is not money as, for example, with donated organs. However, for those of us without substantial personal wealth in the rest of the world, there is a gap between demand and the ability of a healthcare system to provide medical services to meet that demand.”
The combination of what he describes as “a massive rise in the demand for healthcare in the UK, as in all developed countries”, the development of new, but expensive, effective treatments and drugs, including “new, highly expensive cancer drugs being developed and tested all the time, some of which have considerable benefits for patients suffering from life-threatening conditions”, and the need to invest in health prevention means
“that the NHS has to make some very difficult decision about how to use its limited resources to best effect. We must always consider the opportunity costs of health investment, because money allocated to one type of health provision or prevention means, necessarily, that healthcare gain elsewhere will be foregone.”
There is, Professor Doull states, “enormous competition within the NHS for the allocation of budgets between different medical specialties”. “Oncologists want more investment in oncology, those working in paediatrics want more investment in paediatrics and there is a strong demand to increase investment in public health so as to improve people's overall health by more effective preventative measures.” And clinical teams working in other areas similarly, and rightly, seek more NHS investment to expand the range of treatments that they can offer to their patients.
Professor Doull explains:
“For individual patients, the balance is between the potential benefits of a treatment and the potential risks. However, it is different for NHS decision makers. We have to make decisions about which treatments to fund so that we use our allocated budget to provide the most benefit to the greatest number of patients in our population. The issue for NHS decision makers is not just whether a treatment is clinically effective. In order to deliver on our obligations to the population as a whole, we need to be satisfied that the proposed treatment is cost effective. The principles of cost effectiveness have been developed by academics and are now a part of the working methods of NICE.”
The approach to cost effectiveness taken by NICE is explained as follows:
“If possible, NICE considers value for money by calculating the incremental cost-effectiveness ratio (ICER). This is based on an assessment of the intervention's costs and how much benefit it produces compared with the next best alternative. It is expressed as the ‘cost (in £) per quality-adjusted life year (QALY) gained’. This takes into account the ‘opportunity cost’ of recommending one...
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