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Medical Claims – What is the Correct Treatment
Following the decision by the Court of Appeal in Rogers v Swindon NHS Primary Care Trust (2006), the popular press suggested that the Court of Appeal had opened the floodgates to having new, unapproved treatments provided to patients regardless of the cost. This is far from the truth. In fact, anyone reading the judgment will see that the Court made it clear that if the Primary Care Trust had decided not to give the drug on grounds of cost, then they were unlikely to have found that the refusal of the drug on such grounds was irrational.
Breast cancer and Herceptin
To understand the implications of the decision in Rogers it is necessary to look at the background to the case. Breast cancer is the most common form of cancer in women and is the greatest cause of death in the UK for women aged under 65. Established ways of treating the disease are mastectomy, chemotherapy and radiotherapy. Breast cancer can occur in a number of forms including ‘HER2-positive’ breast cancer. HER2 is a protein found on the surface of certain cancer cells.
HER2 is a receptor for a particular growth factor called human epidermal growth fact, which occurs naturally in the body. When human epidermal growth fact attaches itself to HER2 receptors of breast cancer cells, it can stimulate the cells to divide and grow. Some breast cancer cells have far more HER2 receptors than others. In this case, the tumour is described as being HER2-positive. It is thought that about one in five women with breast cancer will have HER2-positive tumours.
The drug called Trastuzumab (trade name Herceptin) was licensed to treat secondary or late-stage breast cancer in March 2002, but is not at present licensed in this country for the treatment of early stage breast cancer.
Possible problems with Herceptin
Results of clinical trials of Herceptin were first presented to the annual meeting of the American Society of Oncology in May 2005 and were published in two papers in the New England Journal of Medicine on 20 October 2005. The trials showed significant benefits to those patients who had been given Herceptin. However, there was a question over possible cardiac side effects of Herceptin, because in one set of trials, of the 1,964 patients who received the drug for a 12-month course of treatment, nine developed severe congestive heart failure, although there were no deaths. There was also an editorial in The Lancet on 12 November 2005, which, rather controversially, claimed:
….it is clear that Herceptin can precipitate severe heart failure in some patients. The best that can be said about Herceptin’s efficacy and safety for the treatment of early breast cancer is that the available evidence is insufficient to make reliable judgements. It is profoundly misleading to suggest, even rhetorically that the published data may be indicative of a cure for breast cancer.
It became clear that many women with early-stage breast cancer were asking their doctors to prescribe Herceptin and it was against this background that the Secretary of State for Health, Patricia Hewitt, became involved in the controversy. She acknowledged that the drug is already licensed and approved for late-stage breast cancer but not for early breast cancer. She recognised that there are some concerns among clinicians that it can cause serious cardiac problems for a small number of women who take it. However, she also recognised that the early evidence suggests that it can be extremely effective for some early-stage cancers, which is why it has been fast-tracked to the National Institute of Clinical Excellence. Ms Hewitt pointed out that patients and clinicians alike have seen the evidence presented recently in the New England Journal and were keen to discuss the potential benefits of the drug.
The Secretary of State pointed out that, as with other unlicensed drugs, it is for individual clinicians to decided whether or not to prescribe Herceptin to a woman who has tested positive for HER2. The clinician has to make this decision after discussions with the woman about the potential risks and taking into account her medical history. It is the patients and clinicans who are the best people to make that decision. But because it has not yet been licensed or evaluated for early-stage breast cancer, PCTs must also be involved and will have to decide whether to support the clinicians’ decisions and pay for Herceptin. She made it clear in her comments that PCTs should not refuse to fund Herceptin solely on the ground of its cost.
Rogers
In October 1995, following this advice, the Defendant PCT adopted the policy that all newly diagnosed women with early breast cancer would be offered HER2 tests, and that if the NICE guidance, which was to be published in 2006, indicated that it was appropriate to use Herceptin, then the clinicians would be able to prescribe the drug in accordance with this guidance. The NICE guidance would only be published after the regulatory authority licensed Herceptin for use in early breast cancer. Its decision was that whiles PCTs have a legal obligation to fund NICE-approved drugs, the local NHS would not support the routine use of Herceptin in HER-2 positive women with early breast cancer until NICE approval. However, the PCT indicated that a clinician may ask a PCT to approve the use of Herceptin ‘in exceptional personal circumstances.’
Background to the case
In January 2005 Mrs Rogers underwent a mastectomy, breast reconstruction and auxiliary surgery. She commenced chemotherapy in March 2005 and this lasted until 4 July 2005. She then went on a course of radiotherapy in August and September 2005. At t his time she also had adjuvant hormone therapy. Her son discovered on the Internet that there was the type of breast cancer known as HER2-positive that could be treated by Herceptin. Mrs Rogers was tested, and it was discovered that she had this type of breast cancer. Her doctor therefore sought to have Herceptin prescribed for Mrs Rogers. The application to the PCT was refused and the appeal was also refused. She sought judicial review of the decision and failed at first instance. She therefore appealed.
The main submissions
Mrs Rogers made a number of submissions about Herceptin, most of which were accepted by the PCT:
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Without Herceptin treatment she had a statistical 25% chance of remaining free of breast cancer after ten years and a 57% chance of dying from breast cancer within that period.
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According to paragraph 1.3 of the National Cancer Research Institute guidelines, the Herceptin trials reported considerable therapeutic benefit with about a 50% reduction in the risk of recurrence when Herceptin was given in combination with, or following, chemotherapy.
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The NCRI guidelines identify the eligible group and show that there are many women with breast cancer who are not eligible for Herceptin treatment.
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There was no suggestion (and nor is it the case) that any other drug offered this patient as good a prospect of survival as Herceptin.
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There was no evidence from any other specialist that Herceptin was not the best available treatment for a woman in the position of Mrs Rogers.
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The Secretary of State encouraged PCTs to consider providing Herceptin for woman who have been prescribed it by their clinicians, even though it is not licensed by the European Agency for the Evaluation of Medicinal Products or approved by NICE. Mrs Rogers had been prescribed Herceptin by her doctor.
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The PCT did not refuse funding on cost grounds.
The Court of Appeal accepted the submission on behalf of the PCT that the contents of The Lancet editorial and of the article in the Journal of the American Medical Association referred to in it show that there is a significant body of medical opinion that urges caution on a number of bases, including possible cardiac side effects and insufficient analyses of the trial results.
The Court found that these were only some of the facts that contributed to the policy adopted with regard to Herceptin. The Court of Appeal expressed the view that if that policy had involved a balance of financial considerations, with a general policy not to fund off-licence drugs not approved by NICE, then such a policy would not have been irrational.
However, it was not that policy that the PCT followed. The PCT did not adopt a policy of refusing to fund Herceptin treatment on the ground that it was not licensed by EMEA or approved by NICE. The PCT did not conclude that it would be irresponsible to introduce this drug in advance of licensing and NICE appraisal. If it had, it would not have admitted the possibility of funding Herceptin treatment for a woman in exceptional personal or clinical circumstances. It would simply have refused to do so on the ground that, if it did, it would be acting irresponsibly. It was influenced in not doing that by the Secretary of State’s guidance.
The Court of Appeal considered that the Secretary of State in her guidance was stressing the potential value of Herceptin while recognising its possible risks and emphasising that it was down to the clinician to decide whether to prescribe Herceptin in consultation with the patient. It was then for the PCT to decide whether to fund the treatment – its decision to be taken, not solely on the basis of cost or by ruling it out in principle, but having regard to individual circumstances.
Financial considerations
The Court indicated that this left the PCT to take account of the fact that the clinician had prescribed Herceptin notwithstanding that it was off-licence and not approved by NICE, and to balance cost considerations against the individual circumstances of the patient. The Court saw nothing arbitrary or irrational about that approach. It could properly involve a decision by a PCT that was subject to financial constraints and therefore decided that it could not fund all the patients who applied for funding for Herceptin treatment to make the difficult choice to fund treatment for a woman with, say, a disabled child and not for a woman in different personal circumstances.
However, the PCT adopted a policy that treated financial considerations as irrelevant. It thus had funds available for all women within the eligible group whose clinician prescribed Herceptin. Yet its policy was to refuse funding save where exceptional personal or clinical circumstances could be shown.
Once financial considerations are ruled out, and it has been decided not to rely on NICE without exeption, then the only concern that the PCT can have must relate to the legitimate clinical needs of the patient. Where the clinical needs are equal, and resources are not an issue, discrimination between patients in the same eligible group cannot be justified on the basis of personal characteristics not based on healthcare.
Medical considerations
It was suggested in argument on behalf of the PCT that one woman in the eligible group might have a greater clinical need for Herceptin than another. The Court of Appeal accepted that although this might be theoretically possible there was no indication that any such possibility in fact exists. The PCT rejected the suggestion that a distinction might be made between one person within the group and another on the ground that the prognosis of each was different, and that was on the basis that research does not support such an approach.
It was also suggested that one patient within the group might be unable for medical reasons to take another drug, such as Tamoxifen, whereas the rest of the group might be able to take it, and that such a case would be an example of an exceptional circumstance on which a decision to fund treatment for the former patient and not for the rest could be justified. There is, however, no evidence that supports such a possibility. In any event, the Court of Appeal held it would not be reasonable or rational to deny a patient Herceptin treatment because they can tolerate Tamoxifen, where there is no evidence that Tamoxifen, or any other drug, is an alternative to Herceptin.
Decision
The Court decided that a PCT could be cautious about funding drugs that were unlicensed. It was permissible for a PCT to carry out a cost/benefit analysis when deciding what treatment to fund and what to decline to fund. No PCT can afford to fund all patients who could benefit from the treatment that could be prescribed. If the PCT decided that cost grounds are relevant then it could be lawful for it to have a policy that says one patient will get funding because of relevant social circumstances, such as having disabled dependants.
The appeal in this case succeeded on the narrow grounds that the PCT said that cost was not relevant to its decision. The mistakes made by the PCT were to argue that cost and the allocation of limited resources were not relevant factors in making the decision and not to have well-defined eligibility criteria that could be justified.
At a recent Action against Medical Accidents oncology conference, the Herceptin issue loomed large and provided much interesting debate. However, it was interesting to note from the gastrointestinal expert that there are similar monoclonal antibodies that can be used with comparable efficacy to Herceptin and with similar cost (of the order of £20-30,000.00 for 12 months) in treating cancers in this area.
The cost/benefit argument in the use of these new drugs and indeed new treatments will undoubtedly provide fruitful ground for debate and further litigation unless PCTs take close note of the judgment in Rogers and adopt policies that can take account of cost, the allocation of limited resources, and include well-defined eligibility criteria that can be justified.
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