R (Rogers) v Swindon NHS Primary Care Trust
| Jurisdiction | England & Wales |
| Judge | Mr Justice Bean,MR JUSTICE BEAN |
| Judgment Date | 15 February 2006 |
| Neutral Citation | [2006] EWHC 171 (Admin) |
| Date | 15 February 2006 |
| Court | Queen's Bench Division (Administrative Court) |
| Docket Number | Case No: CO/10217/2005 |
[2006] EWHC 171 (Admin)
IN THE HIGH COURT OF JUSTICE
ADMINISTRATIVE COURT
QUEEN'S BENCH DIVISION
The Hon. Mr Justice Bean
Case No: CO/10217/2005
Ian Wise (instructed by Irwin Mitchell) for the Claimant
Philip Havers QC and Matthew Barnes (instructed by Bevan Brittan LLP, Bristol) for the Defendant
Eleanor Grey (instructed by the Office of the Solicitor for the Dept. of Health) for the Interested Party
Mr Justice Bean:
In this application the Claimant, Ann Marie Rogers, claims that the Defendant, the Swindon NHS Primary Care Trust, has unlawfully refused to provide her with Herceptin to treat her breast cancer. In particular the Claimant claims that:
a) The Trust has unlawfully failed to act in accordance with what is said to be a Direction of the Secretary of State by providing Herceptin only in exceptional cases;
b) The formulation and application of the Trust's policy has been arbitrary and irrational, and
c) The decision of the Trust not to provide Ms Rogers with Herceptin is contrary to her rights under the Human Rights Act 1998 and the European Convention on Human Rights. All counsel made submissions first on domestic law without considering the Convention, then on the impact of the Convention, and I shall follow the same course.
The Claimant is 54 and lives in Swindon. She has three adult children and two young grandchildren. Prior to her diagnosis of breast cancer she had run the restaurant side of her sister's public house but since her treatment has been unable to carry on working.
Ms Rogers first noticed a lump in her breast in October 2004. She went to her general practitioner the following day and was given an appointment for a mammogram at her local hospital in Swindon which was conducted on 24 th November 2004. The mammogram result was initially thought to be normal but subsequent biopsies revealed invasive carcinoma.
In January 2005 the Claimant underwent a mastectomy, breast reconstruction and auxiliary surgery. Following a period of recovery from this surgery she commenced chemotherapy in March 2005. This course of chemotherapy lasted until 4 th July 2005. She found this treatment very difficult due to its gruelling side-effects.
Following the course of chemotherapy she embarked on a course of radiotherapy at the Churchill Hospital in Oxford in August and September 200This involved her travelling from her home in Swindon to Oxford every day for 5 weeks. At this time she also had adjuvant hormone therapy.
In the meantime the Claimant's son had discovered on the internet that there was a type of breast cancer known as HER2 positive which could be treated by Herceptin. Towards the end of her chemotherapy she accordingly asked her consultant, Dr Cole, if she could be tested for HER2 and on 30 th June 2005 was tested positive. In August 2005 Dr Cole wrote to the medical director of the Swindon and Marlborough NHS Trust informing him of the "exciting" results of the Herceptin trials that had been presented to the American Society of Oncology in May 2005 and asked whether Ms Rogers could pay for Herceptin whilst remaining an NHS patient; but the answer was that she could not. In due course Dr Cole agreed to treat the Claimant with Herceptin on a private basis and on 27 th October 2005 began treatment at the Ridgeway Hospital, Swindon. Although Ms Rogers had to pay for the drug she did not have to pay for the medical input as Dr Cole waived his fees.
Herceptin is given by a loading dose followed by a further 17 doses given at 3 week intervals. The estimated cost (including VAT) of the course of treatment was �26,328.22. Ms Rogers did not have this money. She borrowed �5,000 from which she paid for her first two treatments each of which cost �1,950. She could not afford to pay for her third course. Given her diagnosis she was unable to re-mortgage her house.
It was against this background that the Claimant sought legal advice. Her solicitors sent a letter before claim on 22 nd November 2005. The response, the same day, was that, although Herceptin is not prescribed by the NHS in the Swindon area, the Trust would review each individual case. Dr Cole duly applied to the Defendant PCT for funding for the Claimant's Herceptin treatment. As we shall see, the application was rejected.
This application was issued on 12 th December 2005. On 21 st December Charles J granted permission to apply for judicial review and ordered D to fund and provide Herceptin for C from 5 th January 2006 (the date of her next course of treatment) until the determination of this application or further order. Ms Rogers duly received treatment on 5 th January and again on 26 th. In her witness statement she says:
"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."
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. Traditional forms of treatment for breast cancer have been mastectomy, chemotherapy and radiotherapy. There has been considerable research into treatments for this cancer, the causes of which remain unclear.
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. It is made by a specific gene called the HER2/neu gene. HER2 is a receptor for a particular growth factor called human epidermal growth factor, which occurs naturally in the body. When human epidermal growth factor attaches itself to HER2 receptors on 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 1 in 5 women with breast cancer will have HER2-positive tumours.
Tumours that are HER2-positive tend to grow more quickly than other types of breast cancer. A drug called trastuzumab has been developed to be effective against HER2-positive breast cancer. It is a type of monoclonal antibody. Monoclonal antibodies are treatments that can target particular proteins within the body. An HER2 test can assess whether a particular cancer has a specific receptor on the surface of the cancer cells.
Trastuzumab attaches itself to the HER2 protein and stops human epidermal growth factor from reaching the breast cancer cells and stimulating their growth. Trastuzumab only works in people who have high levels of the HER2 protein.
Herceptin is the trade name given by Roche to the drug trastuzumab. Herceptin was licensed to treat secondary or late stage breast cancer in March 2002 but is not currently licensed for the treatment of early stage breast cancer. The manufacturer has first to obtain a licence from the European Medicines Agency (EMEA); then the drug will be appraised by the National Institute of Health and Clinical Excellence (NICE), which is responsible for providing national guidance on treatments and care in the UK.
Adjuvant Herceptin (that is treatment of breast cancer with Herceptin along with other treatments such as chemotherapy) has been the subject of trials in the USA and elsewhere. Results 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 (NEJM) on 20 th October 2005. According to Dr Murray Brunt, a consultant clinical oncologist whose report was part of the evidence before me, the trials showed significant benefits to those patients who had been given Herceptin. Dr Brunt recognises the potential cardiac side effects of Herceptin and notes that of the 1694 patients who received the drug nine developed severe congestive heart failure although there were no deaths.
The National Cancer Research Institute (NCRI) is a coalition of cancer charities and research bodies in the UK. On 14 th December 2005 it published UK Clinical Guidelines for the Use of Adjuvant Trastuzamub (Herceptin) Following Chemotherapy in HER2-positive Early Breast Cancer. This document considered the trial reported in the New England Journal of Medicine and two other trials of Herceptin and concluded: "these trials have all reported considerable therapeutic benefit with around a 50% reduction in the risk of recurrence when trastumazub was given in combination with or following chemotherapy." The NCRI recommended that "women should be considered eligible for adjuvant trastumazub if they fit the following criteria:
a) Have primary invasive breast cancer that is confirmed as HER2 positive �
b) Are eligible for and receive adjuvant chemotherapy.
c) Have normal left ventricular ejection fraction (LVEF) (though particular care was recommended in the case of patients aged over 50 with an LVEF of 55% or less)�
d) Have none of the [listed] �. cardiac contraindications �
e) Have an adequate baseline heptatic, renal and haematological function.
f) Have no evidence of metastistic spread."
I will refer to patients who satisfy all these criteria as "the eligible group".
I have already noted that Herceptin is licensed for late stage breast cancer. At that stage Herceptin is given with a range of other treatments. Dr Brunt records that many of his patients who have relapsed received Herceptin for more than two years and he still has survivors from 2001/2002. The cost of treatment...
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