“It is only now with the Herceptin that I feel that I have been given a small part of my life back and I have been able to start thinking about the future.”
“these trials have all reported considerable therapeutic benefit with around a 50% reduction in the risk of recurrence when trastuzumab was given in combination with or following chemotherapy.”
“…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”
“In reaching its decisions, Swindon PCT aims to • take into account and weigh all the relevant evidence; • take into account the opinion of relevant clinicians; • give proper consideration to the views of the patient or group of patients involved, and accord proper weight to their needs against other groups competing for scarce resources; • taking into account only material factors; • act in the utmost good faith; • make a decision that is in every sense reasonable. This ethical framework has been developed to enable Swindon PCT to make fair and consistent decisions that treat patients equally. It should be noted that sometimes the discretion of the Clinical Advisory Forum and Swindon PCT may be restricted or overridden by National Service Frameworks; guidance from the National Institute for Health and Clinical Excellence (NICE); and NHS directions. People have equal rights of access to health care, but there may be times when some categories of care are given priority in order to address health inequalities in the community. The Clinical Advisory Forum will not discriminate on grounds of personal characteristics such as age, sex, race, religion, lifestyle, social position, family or financial status, intelligence or cognitive functioning. A patient’s health needs will be assessed in relation to their capacity to benefit from a healthcare intervention. In the absence of evidence of health need, treatment will not generally be recommended solely because a patient requests it. Similarly, a treatment of potentially very little benefit will not be provided because it is the only treatment available. This is necessary to ensure that resources are used to provide the greatest health benefit. The Ethical Framework is especially concerned with the following: • evidence of clinical and cost effectiveness • the needs of the patient(s) • needs of the community” • take into account and weigh all the relevant evidence; • take into account the opinion of relevant clinicians; • give proper consideration to the views of the patient or group of patients involved, and accord proper weight to their needs against other groups competing for scarce resources; • taking into account only material factors; • act in the utmost good faith; • make a decision that is in every sense reasonable.
“Where Swindon PCT does not have a policy in place for a healthcare intervention, and in circumstances where an individual patient has a special healthcare problem that presents an exceptional need for treatment, Swindon PCT will consider such cases on their own merits. These ‘exceptional cases’ are considered by Swindon PCT’s Clinical Priorities Committee. The protocol and procedure for applying for ‘exceptional funding’ is included at Appendix 3 of this policy …”
“Swindon Primary Care Trust must ensure that it provides the community … with the best health care from the funds available.”
“The commissioning of new drugs not covered by NICE guidance Where NICE Guidance does not apply (see below), Swindon PCT will produce policy statements through the Clinical Advisory Forum that will allocate a commissioning priority to selected new drug therapies. Swindon PCT will not commission drugs that are unlicensed for use in the UK.”
“Herceptin has the potential to save many women’s lives and I want to see it in widespread use on the NHS. Today I am asking Professor Mike Richards [the National Cancer Director] to ensure that the facilities are put in place to enable women who require it to be tested. I want the licence for Herceptin to be granted as quickly as possible, without compromising people’s safety, and to be available within weeks of the licence being given. I share the huge frustration of many women about the delays in getting Herceptin licensed. I am determined to take action, and this represents a major step forward in our fight against cancer.”
“11. Any patient diagnosed with cancer wants to know that they will have access to the best possible treatment and care and we are committed to making sure that they get it. 12. Since I became the Health Secretary I have shared the huge frustration of many women about the delays in accessing new cancer drugs, in particular, Herceptin. 13. We know that Herceptin has the potential to work for around 1 in 4 women who are diagnosed with early stage breast cancer; those who test HER2 positive. It is important that we and the media do not give the wrong impression that it is suitable for everyone. 14. Nevertheless, even among those 1 in 4, it has the potential to save as many as a thousand lives a year. 15. The manufacturers have not yet applied for a licence for prescribing Herceptin for early stage breast cancer and I urge them again to get their application in as quickly as possible. 16. This leaves us with a difficult dilemma. The drug is already licensed and approved for late stage breast cancer but not for early breast cancer. There are some concerns amongst clinicians that it can cause serious cardiac problems for a small number of women who take it. And yet the early evidence suggests that it can be extremely effective for some early stage cancers which is why it has been fast tracked to NICE. I know that patients and clinicians alike will have seen the evidence presented recently in the New England Journal and will be very keen as patients to discuss the potential benefits of the drug. 17. As with other unlicensed drugs, it is down to individual clinicians to decide whether or not to prescribe Herceptin for 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 clinicians 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. I want to make it clear that PCTs should not refuse to fund Herceptin solely on the grounds of its cost. 18. I know that some PCTs are already under financial pressure and may have to make difficult trade-offs in priorities to fund this new treatment for women who want it and whose clinicians want it for them. Although that will not be easy, I believe it is the right thing to do, particularly as they will be managing it over two financial years. 19. As you know, some weeks ago I have asked Mike Richards, the National Cancer Director, to ensure that testing arrangements are put in place as soon as possible so that patients who may benefit from Herceptin are identified in good time. That is happening. 20. And I have asked the National Institute for Health and Clinical Excellence to start on a fast track appraisal of the use of Herceptin in parallel with the licensing process so that they can issue their guidelines to the NHS Herceptin within weeks of the licence being given. 21. I should stress that the steps I am taking today do not, in any way, replace either the licensing by the European Medicines Agency or the approval process by the National Institute for Health and Clinical Excellence. They are vital and will continue to play the crucial role in ensuring the safety and cost effectiveness of any drug used by the NHS.”
“Herceptin for early stage breast cancer On25 October 2005 the Secretary of State announced: ‘It is down to individual clinicians to decide whether…….to prescribe Herceptin for a woman who has tested HER2 positive………after discussions with the woman about potential risks and taking into account her medical history. I want to make it clear that PCTs should not refuse to fund Herceptin solely on the grounds of its cost.’ This applies to women prescribed Herceptin for early stage breast cancer ahead of a decision on licensing or NICE appraisal. PCTs should not rule out treatments on principle but consider individual circumstances. Further information: Lindsay Wilkinson, 020 7972 4819.”
“It was agreed by the SHAs [Strategic Health Authorities] and the PCTs that the Network as a whole will manage the requests for Herceptin from now until NICE approval next July by the use of exceptional funding panels through each PCT when the clinicians put patients forward.”
“From5th October 2005 , all newly diagnosed women with early breast cancer will be offered HER2 tests. Following this, the routine use of Herceptin will be introduced if and when NICE guidance is published in 2006. Clinicians will then prescribe the drug in accordance with this guidance. PCTs have a legal obligation to fund NICE-approved drugs. NICE guidance will only be published after the regulatory authority licenses Herceptin for use in early breast cancer. Until this time, the local NHS will not support the routine use of Herceptin in HER2+ve women with early breast cancer. However, a clinician may ask a PCT to approve the use of herceptin in exceptional personal circumstances. All PCTs have well established mechanisms to review such requests on a named patient basis. This is not the same as routine approval but does allow some discretion in individual cases. It is not appropriate to define these circumstances as each patient and their family’s needs will differ.”
“Swindon PCT’s current approach Swindon PCT’s Commissioning Policy states that the PCT will not commission unlicensed drugs. However, following the direction of the Department of Health, Swindon PCT will review each patient’s case, where the managing clinician believes trastuzumab should be considered as part of the patient’s treatment. The purpose of this approach is to establish whether there are any extenuating circumstances surrounding an individual’s case that would warrant an exception to the current policy of not commissioning unlicensed drugs.”
“[Jane Leaman] informed the meeting that, in accordance with the ASWCS’s policy, the PCT’s standard process for assessing requests for treatments not normally funded would be invoked for any applications received for trastuzumab for early breast cancer. This would mean each individual application would be reviewed by the Clinical Priorities Committee to ascertain if the patient’s case demonstrated any exceptionality.”
“Given the widely reported safety profile of this drug concerning cardio-toxicity, and the concerns raised in the medical press regarding the methodology through which trial results were generated (that the two reports in the New England Journal of Medicine have different variables therefore comparison is difficult and further, one paper combines data from two different trials sponsored by Genetech – the biotechnology company that developed Herceptin), I believe it would be irresponsible to introduce this drug in advance of licensing and NICE appraisal.”
“Mrs Rogers is not an exceptional case. She is one of about 20 patients per year in North Wiltshire who would stand to benefit from this treatment. She is certainly determined to receive this treatment and prepared to go to considerable lengths to do so. Her determination is partly due to her cousin’s experience. She sadly died under my care with breast cancer in her 40’s, a few years ago. She does have a relatively unfavourable prognosis breast cancer. According to the … nomogram she has a 25% chance of remaining free of breast cancer and 43% chance of being alive at 10 years of follow up. It is likely that she has a greater absolute benefit from Herceptin than somebody with a more favourable prognosis. In this sense, her case for receiving Herceptin is stronger because of her particularly poor prognosis.”
“Contacted Dr Janson to follow up referral form and discuss if there are any extenuating circumstances that wish to be considered for this case. Dr Janson confirmed that he has spoken to patient about this and discussed possible circumstances such as being a carer but there are none.”
“Unfortunately the PCT is unable to fund Herceptin in this instance as following the review of the evidence the panel concluded that there was insufficient evidence to substantiate long term benefit from the drug and there were no extenuating circumstances presented to the panel which meant we could consider this case as an exceptionality.”
“The purpose of this approach is to consider whether there are any extenuating circumstances surrounding an individual’s case that would warrant an exception to the current policy of non-prescribing. This would not be determined on cost grounds.”
“i) The statement by Dr Cole that “Mrs Rogers is not an exceptional case”, together with the fact that she was one of about 20 patients who would stand to benefit from Herceptin per year in North Wiltshire. ii) The fact that a member of Ms Rogers’ family had died from a similar disease. iii) Dr Cole’s view that the Claimant had a 43% chance of being alive after 10 years. iv) Dr Cole’s statement that “it is likely that she has a greater absolute benefit from Herceptin than somebody with a more favourable prognosis.”
“The court may not interfere with the exercise of an administrative discretion on substantive grounds save where the court is satisfied that the decision is unreasonable in the sense that it is beyond the range of responses open to a reasonable decision-maker. But in judging whether the decision-maker has exceeded this margin of appreciation the human rights context is important. The more substantial is the interference with human rights, the more the court will require by way of justification before it is satisfied that the decision is reasonable in the sense outlined above.”
“I have no doubt that in a perfect world any treatment which a patient, or a patient’s family, sought would be provided of doctors were willing to give it, no matter how much the cost, particularly when a life is 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. …. 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. In my judgment, it is not something that a health authority such as this authority can be fairly criticised for not advancing before the court.”
“As illustrated in the Cambridge Health Authority case[1999] 1 WLR 898 and Coughlan's case[2000] 2 WLR 622 , 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. Authorities might reasonably differ as to precisely where in the scale transsexualism should be placed and as to the criteria for determining the appropriateness and need for treatment of it in individual cases. It is proper for an authority to adopt a general policy for the exercise of such an administrative discretion, to allow for exceptions from it in "exceptional circumstances" and to leave those circumstances undefined: see In re Findlay [1985] A.C. 318, 335-336, per Lord Scarman. In my view, a policy to place transsexualism low in an order of priorities of illnesses for treatment and to deny it treatment save in exceptional circumstances such as overriding clinical need is not in principle irrational, provided that the policy genuinely recognises the possibility of there being an overriding clinical need and requires each request for treatment to be considered on its individual merits.”
“I accept, of course, that it is a matter for the medical judgment of the authority, not the court, what, if any, effective medical treatment there might be for transsexualism and any sequelae. As Sir Thomas Bingham MR said in the Cambridge Health Authority case[1995] 1 WLR 898 , 905: ‘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.’ However, if a regional health authority devises a policy not to provide treatment save in cases of overriding clinical need, it makes a nonsense of the policy if, as a matter of its medical judgment, there is no effective treatment for it for which there could be an overriding clinical need. The same applies to any other condition caused by transsexualism such as a mental illness of the seriousness described by Dr Sudell. If the authority considers the cause of such a condition to be untreatable by hormonal treatment and surgery, it is hard to see how it could regard the condition itself as an overriding need for such treatment. In my view, the stance of the authority, coupled with the near uniformity of its reasons for rejecting each of the applicants’ requests for funding was not a genuine application of a policy subject to individually determined exceptions of the sort considered acceptable by Lord Scarman in In re Findlay[1985] AC 318 . It is similar to the over-rigid application of the near “blanket policy” questioned by Judge J in Reg. v Warwickshire County Council, Ex parte Collymore[1995] ELR 217 , 224-226, ‘which while in theory admitting of exceptions, may not, in reality, result in the proper consideration of each individual case on its merits.’ (See p 227).”
“69. Ms Rogers’ case is that her cancer is life-threatening; if she waits for EMEA licensing and NICE appraisal of Herceptin, it may be too late; she is aware of the risk of side effects, but as an intelligent adult she is willing to take the chance. The Defendant’s case, on the other hand, while taking the Claimant’s arguments into account, is that the system of licensing and appraisal of drug treatments is essential and should not be bypassed; that medical opinion may be moving in the Claimant’s favour, but it is not yet unanimous; and that in the absence of unequivocal guidance from the Secretary of State that PCTs should (or a direction that they must) fund Herceptin treatment for all the eligible group, they are entitled to be cautious and wait for EMEA’s licensing decision and NICE’s appraisal. 70. Many people will think that the more generous policy of authorities such as those listed in paragraph 46 above is a better one than Swindon’s. Which is the better policy is a matter for political debate, but it is not an issue for a judge. The question for me is whether Swindon’s policy is irrational and thus unlawful. I cannot say that it is.”