Patient is to appeal High Court ruling on breast cancer drug

A woman with early stage breast cancer is to appeal against a refusal by the High Court in London last week to order Swindon Primary Care Trust to pay for treatment with the mono-clonal antibody trastuzumab (Herceptin).

As Ann Marie Rogers prepared to make the appeal, the drug's maker, Roche, announced that it was applying to the European Medicines Agency for the drug to be licensed for the early stage of HER2 positive cancer.

Roche said its application was based on data from an international study involving 12 000 women showing that treatment with trastuzumab after standard chemotherapy reduced the risk of recurrence by 46%.

The drug, which costs around £26 000 ($45 000; €38 000) for a course of treatment, is already licensed and approved for the late stage of HER2 positive cancer, a type in which tumours overexpress the human epidermal growth factor receptor 2. Use in the early stage could be authorised by June, but assessment for cost effectiveness by the National Institute for Health and Clinical Excellence (NICE) could take a further two months.

Meanwhile, many NHS trusts are funding treatment with the drug for the early stage of HER2 positive cancer, which affects around one in five women with breast cancer. But others, including the Swindon trust, are waiting for regulatory approval and paying for treatment only in exceptional cases.

Ms Rogers, 53, who has three grown children, was the first patient to go to court to challenge a primary care trust's refusal to pay for the drug.

Mr Justice Bean said it was a matter for political debate whether the trusts that provided the drug for all eligible women had a better policy than Swindon's, but it was not an issue for a judge.

Swindon's policy was not unlawful, said the judge, because it was not “arbitrary or irrational.” Nor was it a breach of Article 2 of the European Convention on Human Rights—that covering the right to life—because it was not denying a person health care that the state had undertaken to make available to the public at large.

The judge gave Ms Rogers permission to appeal, with a request that the appeal be heard and decided on before Easter.

In the meantime, he ruled, Swindon must continue to pay for her treatment on an interim basis, pending the appeal court's decision.

Yogi Amin, Ms Rogers's solicitor, said: “It has been a matter of public record that Roche would apply for this early stage licence, and that NICE will fast track appraisal, since late last year. However, this does not help the women who are currently living under a `death sentence' from being denied this potentially life saving drug on account of where they live in England and Wales.”

Figure 1.

Ann Marie Rogers called Swindon Primary Care Trust's decision to refuse her treatment with trastuzumab a “death sentence”

Credit: FIONA JANSON/PA/EMPICS