Way now clear for use of costly breast cancer drug throughout UK

August 24, 2015

Government health secretary, Patricia Hewitt, said local health trusts must not refuse to fund the drug solely on the grounds of cost - ??21,800 a year - even if some might have to make trade-offs in their own priorities to find the money.

Hewitt says providing the drug to patients is dependent on doctors supporting the treatment.

Acknowledging the "huge frustration" of many women about delays in getting new cancer treatments, Ms Hewitt took the unusual step of backing widespread availability of a drug whose use is not expected to be licensed until next summer.

NICE, the government body that advises on effectiveness of treatments, is expected to rule about the same time.

Herceptin is said to have the potential to save 1,000 lives a year in England alone.

Results of trials published last week suggest the drug cuts by half the risk of cancer returning after a year among the 20% to 30% of women whose cancer is linked to the HER2 protein.

These results have prompted Ms Hewitt to fast track NICE appraisal and widen testing of women to ensure they might benefit.

Also to be announced soon are proposals to streamline NICE appraisals of a range of other drugs which many charities say are routinely delayed by bureaucratic bottlenecks.

Currently Herceptin is licensed only for late-stage breast cancer, but health authorities in Devon and Cornwall have already decided to fund Herceptin's use immediately for women who have their doctors' support.

Patients and campaigners at a London meeting of Breakthrough Breast Cancer were delighted by Hewitt's demand that the rest of the 300 primary care trusts must follow Devon and Cornwall's suit.

Herceptin's development costs have been suggested to be as high as ??500m, hence it's current pricing structure.

To find out, the CISNET groups used data that reflected "real life" use of screening and adjuvant therapy, including some population databases that had not been tapped before for this purpose. Their analysis relied on the incidence of breast cancer as reported by the Surveillance, Epidemiology, and End Results (SEER) program and the rate of death from breast cancer as reported by the National Center for Health Statistics (NCHS), as well as additional databases concerning uses of screening and treatment and their efficacy in the population.

The models reached somewhat different estimates. Dana-Farber's model found that screening mammography accounted for 65 percent of the reduced breast cancer death rate (with 35 percent due to use of chemotherapy and tamoxifen) while the M. D. Anderson model reached the opposite conclusion - that 65 percent of the mortality benefit is due to adjuvant chemotherapy and 35 percent is due to screening.

Berry has studied mammography and has focused on its downside. He says that the researchers in the study are comfortable with the level of disagreement concerning their point estimates and with the level of uncertainty reflected in their overall conclusions. In his opinion, "the evidence makes clear that the benefit of screening on breast cancer mortality is very likely while the benefit of providing adjuvant therapy is certain." He adds that he continues to feel strongly that women should be informed of the risks of screening as well as the benefits, and says he is "happy to have helped further quantify the latter."

The models now in place can be used to answer a number of questions related to screening and treatment, Berry says. "They provide a way for assessing the benefits of screening and treatment strategies different from the ones that were actually in place over the time period of the study," he says. "For example, our models can address what the effect on mortality would be if all women in particular age groups were to be screened at regular intervals. And it allows for addressing the impact on overall mortality if effective therapies were made available to particular types of patients with breast cancer."

In this way, the models may "help determine what strategies for delivering medical care are best for patients," Berry says. "And that is necessary, since our efforts, taken as a whole, haven't come close to eliminating breast cancer mortality."

Berry's co-authors include Eric J. Feuer, Ph.D, and Kathleen A. Cronin, Ph.D., from the National Cancer Institute; Sylvia K. Plevritis, Ph.D., from Stanford University; Dennis G. Fryback, Ph.D., from the University of Madison-Wisconsin; Lauren Clarke from Cornerstone Systems in Lynden, Washington; Marvin Zelen, Ph.D., from Dana-Farber Cancer Institute; Jeanne S. Mandelblatt, Ph.D., from Georgetown University; Andrei Y. Yakovlev, Ph.D., from the University of Rochester; and J. Dik F. Habbema, Ph.D., from Erasmus University in Rotterdam.

mdanderson/