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You are in: Home Page | Accident Types | Clinical Negligence | Clinical Negligence Articles | The Battle for Herceptin
March 2007
Introduction
Herceptin
Licensing and NICE appraisal
Obtaining Herceptin
Application for Exceptional Funding
Appeal to the Exception Funding Appeal Panel
Judicial Review
Conclusion
Advances in medical science continue apace and pharmacological advances and new drugs are being announced routinely.
The patients’ expectations in relation to access to new and potentially expensive treatments are continually raised with the availability of each new treatment. Furthermore they expect their cost of their treatment to be free on the NHS at the point of delivery. However, the development of new pharmaceutical products is hugely expensive and, with finite resources, these advances pose new challenges to the NHS. Where new drugs are available but are not fully licensed by the European Medicines Agency (EMEA) or approved by the National Institute for Clinical Health and Excellence (NICE) the decision as to whether to provide treatment is devolved to the level of the individual Primary Care Trust (PCT).
There are 152 PCTs in England. They have a wide range of responsibilities which include delivering primary care services in their particular area, buying services from hospitals on behalf of local patients and improving public health. Between them they control about 80% of the annual NHS budget.
An unfortunate by-product of this devolved decision making, however, has perpetuated a system whereby access to non-approved treatments has become a “postcode lottery”.
Breast cancer is the most common form of cancer in women with over 41 000 new cases diagnosed and 12 000 deaths in the United Kingdom each year.
Herceptin has been developed to treat only the HER2+ type of tumours.
HER2+ tumours grow more quickly than other types. HER2 is a protein that is found on the surface of certain cancer cells and is a receptor for a naturally occurring growth factor called human epidermal growth factor. About 20% of women who are diagnosed with breast cancer have HER2 receptors. When this growth factor attaches itself to the HER2 receptor on the surface of breast cancer cells, it stimulates the cells to divide and grow with the result that the tumour spreads. Herceptin works by interfering with this process.
If a patient
1. suffers from HER 2+ breast cancer and
2. also satisfies a criteria laid down in Clinical Guidelines for prescribing Herceptin published by the National Cancer Research Institute on 14th December 2005 (NCRI Guidelines).
then, at present, medical science cannot state whether that patient will benefit from Herceptin any more or any less than another patient who comes within that group.
This fact was to turn out to be crucial in a High Court battle to get the drug.
Herceptin was the first in a line of very expensive treatments based on new technology. It was licensed and approved for use in late stage (terminal) HER2+ breast cancer in 2002.
In 2004 three large scale randomised trials for use in early stage breast cancer demonstrated huge benefits in terms of the survival rates of women with early stage breast cancer who were in the Herceptin group. The testing clinicians argued that the results demonstrated that Herceptin had the potential to prevent the risk of cancer recurring by 50%. The trials were stopped so that the treatment could be made available to all who took part in the trial and led one of the leading testing clinicians to state that the treatment of early stage breast cancer must change immediately.
This was widely publicised and led to a huge demand for the drug. However, at that stage the drug did not have a license from the EMEA for use in early stage breast cancer and was not approved by NICE.
NICE appraisals are intended to provide guidance on the use of new and existing medicines and treatments within the NHS in England and Wales. Since January 2002, the NHS has been legally obliged to provide funding and resources in England and Wales for medicines and treatments recommended by NICE technology appraisal.
Herceptin was given a license by the EMEA for use in early stage breast cancer in April 2006. The application for the license was approved in a record 27 days.
NICE produced a draft recommendation on 8th June 2006 stating that Herceptin should be approved for use in early stage breast cancer where a patient has HER2+ breast cancer and satisfies the same criteria contained within the NCRI Guidelines. However, the final recommendation was delayed as one of the PCTs which was involved in the NICE appraisal appealed against the decision.
The appeal of the PCT was rejected on all grounds and Herceptin was finally recommended for use in early stage breast cancer by NICE on 23rd August 2006.
Elisabeth Cooke was diagnosed with type HER 2+ Breast Cancer in March 2005 and the tumour was removed privately the following month. After a further operation, Ms Cooke then underwent courses in radiotherapy and chemotherapy.
In September 2005 she was told by her consultant that she needed Herceptin in order to significantly reduce the chances of the cancer recurring. She wrote to the Chief Executive of Bristol North PCT to request Herceptin treatment on the NHS. The PCT refused stating that the drug was not routinely available and that Ms Cooke would have to apply for “exceptional funding” for the drug and demonstrate “exceptional personal
circumstances”.
If Ms Cooke have lived within the nearby areas that come within the North Somerset Coast PCT or the South West Peninsula Strategic Health Authority then she would have been prescribed the drug. Unfortunately for her, she lived within the Bristol North PCT area.
Following the refusal to provide the treatment Ms Cooke contacted her trades union, UNISON, who, in turn, instructed Thompsons Solicitors. An application for Exceptional Funding was made to the PCT.
The PCT said that an award of ‘exceptional funding’ required an applicant to demonstrate that “there are particular individual circumstances why a patient should be
considered for funding for treatment above other patients with a similar condition…” and stated that exceptional circumstances “ are primarily clinical rather than social reasons.”
On 21st December 2005 a meeting was held specifically to hear all of the Herceptin applications for exceptional funding. Ms Cooke’s application was refused.
Nine other applications for Herceptin were heard by the Exceptional Funding Panel on 21st December 2005 and all were rejected. The Panel concluded that none of the applicants could show an “exceptional need for treatment over and above others
potentially eligible for this treatment.”
An application was then made to the Exceptional Funding Appeal Panel. None of the Appeal Panel members had any particular knowledge of the treatment of breast cancer. As such the Appeal Panel were unable to make a clinical decision about the effect that refusal would have on Ms Cooke’s chances of survival. Therefore, they could not take exceptional clinical circumstances into account.
Two other patients made appeals on the same day. Ms Cooke and the other patients were all unsuccessful.
Ms Cooke started receiving Herceptin on 17th January 2006. She was forced to pay for this herself.
Ms Cooke felt an increased sense of injustice, not only in feeling that she had to prove her “moral worth” to society in making these application, but also knowing that patients who lived nearby were able to obtain Herceptin from the PCTs.
A Judicial Review is available to a Claimant where he or she feels that they have been unlawfully treated by a public body.
Judicial Review Proceedings were issued in the High Court on 27th January 2006. We were successful in obtaining an Order providing that the PCT provide Herceptin to Ms Cooke whilst the Judicial Review proceedings went through the Court process.
The Court was asked to determine whether the operation of the PCT’s policy not to supply Herceptin except where a patient could show exceptional circumstances was unlawful. The PCT had stated that in order to provide exceptional funding a patient must show “particular individual circumstances why a patient should be considered
for funding for treatment above other patients with a similar condition…” and further stated that exceptional circumstances “are primarily clinical rather than
social reasons.”
Representing Mrs Cooke, we stated that this meant that no patient would ever be able to obtain Herceptin under this policy as no one patient who comes within the group of patients eligible for the drug (i.e. suffering from HER2+ tumour and satisfies the NCRI Guidelines) could demonstrate on a clinical basis that she would derive more benefit from the drug than any other patient.
At a High Court Hearing on 9th September 2006 the PCT said it should not have to follow an earlier Court of Appeal decision that said that
1. where a PCT refuses to provide a patient with a non-licensed drug, and
2. that patient applies for funding based on exceptional circumstances
then it is unlawful if the PCT could not distinguish between any of the patients who satisfied a qualifying criteria for the treatment. The argument was based on the premise that the policy in the earlier case was a Herceptin only policy whereas the policy in this case applied to all non-licensed or non-approved drugs.
The Judge, Mr Justice Silber rejected the PCT’s argument and Ordered that the operation of the policy formulated by the PCT not to fund Herceptin except in exceptional circumstances was unlawful.
A few days before the hearing the PCT agreed to fund Ms Cooke’s Herceptin treatment as a result of the decision by NICE to recommend the drug for use in early stage breast cancer. The Judge also Ordered the PCT to pay Ms Cooke’s costs of bringing the Judicial Review proceedings.
The experience of the Herceptin cases has shown that it is possible to bring successful legal challenges against the refusal of individual PCTs to provide funding for healthcare. This has been a costly exercise for the PCTs involved and has raised patients’ expectations relating to access to healthcare even higher.
The current devolved system of each PCT assessing whether to fund non NICE approved drugs has the potential to throw up further high profile, expensive legal challenges. Unless or until this system is changed then individual PCTs will have to ensure that when they receive applications for drugs which are not approved by NICE (or approval is pending) then they must consider the clinical impact of the refusal on the particular patient and be able to justify any refusal to treat on clinical grounds.
This article was written by John Watkins in our national Clinical Negligence team.
For more information about Herceptin or the national postcode lottery please email thompsonsclinicalnegligence@thompsons.law.co.uk