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You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Otley, R (on the application of) v Barking & Dagenham NHS Primary Care Trust [2007] EWHC 1927 (Admin) (18 July 2007) URL: https://www.bailii.org/ew/cases/EWHC/Admin/2007/1927.html Cite as: [2007] EWHC 1927 (Admin) |
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QUEEN'S BENCH DIVISION
THE ADMINISTRATIVE COURT
Strand London WC2A 2LL |
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B e f o r e :
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THE QUEEN ON THE APPLICATION OF VICTORIA JUNE OTLEY | Claimant | |
v | ||
BARKING AND DAGENHAM NHS PRIMARY CARE TRUST | Defendant |
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Mr Jeremy Hyams (instructed by Barking and Dagenham NHS Primary Care Trust) appeared on behalf of the Defendant
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"She was started on first-line chemotherapy using Oxaliplatin and 5-FU as per protocol and she achieved a very good symptomatic response and improvement in her CT scans in the liver metastases. She was referred to the Royal London Hospital for consideration of resection of her liver metastases, but unfortunately at operation it was found that the CT scan had under staged her disease and operation could not be done. She was sent back to me for further chemotherapy and we started her on second-line chemotherapy using irinotecan and 5-FU. Unfortunately there has been no response to irinotecan and, in fact, her liver metastases have grown bigger and she has started having a lot of symptoms from them. At this juncture she sought the help of her sister who agreed to fund her for Avastin therapy, which is a VGEF receptor inhibitor, which added to chemotherapy improves the response rate and indeed survival. Miss Otley had four cycles of oxaliplatin, 5-FU and Avastin with excellent response, but funding could not be found for further therapy and she had to continue on chemotherapy without Avastin.
Ms Otley is extremely young and very fit despite her condition...
There is mounting evidence that adding Avastin to chemotherapy in metastatic colorectal cancer does improve the response rate and indeed survival. This has been confirmed in first and second-line therapy and indeed the resistance usually encountered on chemotherapy alone is reversed with the addition of Avastin. I am aware that NICE has preliminarily reviewed the use of Avastin and voted against it on cost effectiveness rather than clinical reasons."
He enclosed summaries of studies undertaken to the PCT.
"While adding bevacizumab [the generic name for Avastin] is not going to cure her, it may certainly improve her survival from this terrible illness..."
He enclosed further summaries of studies undertaken into Avastin, in particular a reference to the eastern trial known as the E3200 trial performed in 2005 which suggested an increase in overall survival by two months compared with Oxaliplatin and 5FU alone. He also enclosed an abstract of a smaller study of 16 patients which suggested that the use of Avastin in combination with chemotherapy produced an overall response rate of 37.5 per cent and a stable outcome of 25 per cent. The overall response rate refers to a partial reduction in the size of tumours when the treatment is administered and the stable outcome to no reduction but no increase either.
"The PCT is required to consider applications to fund a number of procedures which are excluded from its service level agreements. These may be for mainstream, but expensive treatments. They may be for novel procedures, where there is limited evidence of effectiveness.
Decisions about whether to fund such cases must be taken carefully, both to ensure that no harm comes to the patient, but also to ensure that best use is made of health service resources. Decisions must be made in the context of theHuman Rights Act and other statutes and guidance appertaining to the National Health Service."
A decision-making framework is set out. It provides:
"The framework requires that consideration is given to:
i. evidence of effectiveness
ii. equity
iii. patient choice
iv. cost effectiveness
v. due regard to exceptional circumstances."
Under the heading "Effectiveness" it states:
"Funding should not be approved where there is good evidence that the treatment is not effective. Equally, sound evidence about effectiveness ought to lead to approval of funding, although the PCT will need to consider the impact of funding on the health of the whole population."
Under the heading "Equity", the unexceptional statement is made that:
"Equity requires maximising the welfare of patients within available resources and giving priority to those in most need."
Under "Patient choice" it is noted that:
"Outcome measures used in research need to include those which matter to the individual patient,"
but that the Trust will not fund an intervention merely because a patient wants it. There then follow unexceptionable references to the relevant provisions, Articles 2 and 3 of the European Convention on Human Rights.
"7.1. This appraisal recommends that because of the issues of cost-effectiveness and state of the evidence, bevacizumab is not routinely commissioned but is only commissioned in exceptional circumstances.
7.2. This raises the issues of what counts as exceptional. Current legal opinion is that exceptional is not just 'not the norm'. There needs to be a baseline or comparator for something to be exceptional against. The comparator or baseline should be the cohort of people with the condition. So exceptionality here is exceptional for someone with metastatic colorectal cancer compared to the rest of the cohort of patients with such cancer being treated.
7.3 Suggested exceptionality criteria for considering applications for this drug are below. This is an initial and not an exhaustive list. Item 1 is taken from the trial populations.
1. Fitness of the patient in terms of ability to benefit from chemotherapy. This has at least some salience in the
2. Differences in clinical circumstances to the rest of the cohort of patients such as
a. Reactions to other treatment, tolerances etc
b. Specific clinical history and prognosis
c. Other clinical circumstances exceptional compared to the rest of the population with this cancer."
The criteria went on to deal with a matter that the panel found rightly to be of no relevance in these circumstances: other social circumstances.
"The median progression-free survival for the group treated with FOLFOX4 [Oxaliplatin plus 5FU] in combination with bevacizumab was 7.3 months, compared with 4.7 months for the group treated with FOLFOX4 alone..."
He also noted the conclusions of the study about the response rate in these words:
"The corresponding overall response rates were 22.7%, 8.6% and 3.3% respectively..."
"Dr AS questioned the evidence for clinical effectiveness of Avastin over and above the other two drugs in the three drug cocktail.
In the case-mix reviewed by NICE it was DR AS's understanding that the patient's profile was consistent with the cohort that NICE have looked at and their evidence and recommendations were directly relevant on a population basis to the patient in question.
Avastin was introduced to Ms O due to her low tolerance of other interventions. AS noted that no information was given on whether her other medication was reduced when Avastin was added to her regime and therefore it was not possible to establish which had had the greater effect.
Ms O has not received Avastin for several months and her disease does not appear to have significantly progressed in that time. She has been receiving other treatments that are licensed and available on the NHS."
"Dr Raouf has indicated that treatment for this patient with Avastin would be ongoing until such time as her disease progresses further. He has also indicated that a CT scan will be necessary after 4-5 treatments to assess any response to the treatment before continuing with further treatments."
Under the heading "Human Rights", the following was noted:
"AS felt that the statistical expectation of 2-6 months was not a certainty and Ms O's response to the drug had not been sufficiently proven."
"Dr Raouf reported that, whilst taking this combination, Ms Otley had symptomatic relief and her metastases shrunk from 10mm to 8mm."
And in paragraph 24(iii):
"Members, myself included, could not identify sufficient evidence that Avastin was the active ingredient in Ms Otley's reported improvement or that further treatment would shrink her liver metastases to render them operable."
"She does fit the cohort of patients the drug has been tested on - age, no other medical conditions, relatively fit. AT [Angela Todd, the non-executive director] felt that this did not make her an exceptional case in relation to the study criteria. AS felt that Ms O did fit the criteria used in the studies but there was not sufficient evidence of her personal and medical profile to make her an exceptional case."
"The Panel felt that as there were other treatments available to Ms O not funding this treatment did not breach Article 2 or 3 of the Act."
That statement appears to be based either upon a misreading of the information provided by Dr Raouf or upon a conclusion for which there is no evidence. As Dr Raouf had said in his letters, the only treatment which it was open to him to provide in the immediate future, Irinotecan plus 5FU, had not worked in the past. Further it had had seriously adverse affects for Ms Otley. That treatment accordingly does not fit within the description "other treatments available to Ms O" save in the most literal sense. It was certainly not treatment which on the past history had any realistic prospect of providing a significant benefit, short or long term, for her. It is not possible for me to discern from the documents available to the Panel what if any other treatments it may have had in mind.
"... the courts are not, contrary to what is sometimes believed, arbiters as to the merits of cases of this kind. Were we to express opinions as to the likelihood of the effectiveness of medical treatment, or as to the merits of medical judgment, then we should be straying far from the sphere which under our constitution is accorded to us. We have one function only, which is to rule upon the lawfulness of decisions. That is a function to which we should strictly confine ourselves."
and at page 906D to F:
"I have no doubt in a perfect world any treatment which a patient, or a patient's family, sought would be provided if doctors were willing to give it, no matter how much it cost, particularly when a life was potentially at stake. It would however, in my view, be shutting one's eyes to the real world if the court were to proceed on the basis that we do live in such a world. It is common knowledge that health authorities of all kinds are constantly pressed to make ends meet. They cannot pay their nurses as much as they would like; they cannot provide all the treatments they would like; they cannot purchase all the extremely expensive medical equipment they would like; they cannot carry out all the research they would like; they cannot build all the hospitals and specialist units they would like. Difficult and agonising judgments have to be made as to how a limited budget is best allocated to the maximum advantage of the maximum number of patients. That is not a judgment which the court can make."
"As illustrated in the Cambridge Health Authority and Coughlan cases, it is an unhappy but unavoidable feature of state funded health care that Regional Health Authorities have to establish certain priorities in funding different treatments from their finite resources. It is natural that each Authority, in establishing its own priorities, will give greater priority to life-threatening and other grave illnesses than to others obviously less demanding of medical intervention. The precise allocation and weighting of priorities is clearly a matter of judgment for each Authority, keeping well in mind its statutory obligations to meet the reasonable requirements of all those within its area for which it is responsible. It makes sense to have a policy for the purpose - indeed, it might well be irrational not to have one - and it makes sense too that, in settling on such a policy, an Authority would normally place treatment of transsexualism lower in its scale of priorities than, say, cancer or heart disease or kidney failure."