Kadcyla, made by Roche Pharmaceuticals, was rejected by the National Institute for Health and Care Excellence. It has the highest price tag ever for a cancer medicine and was turned down because its benefits did not justify its cost, Nice said.
Prof Carole Longson, director of the centre for health technology evaluation at Nice, said: “We know that people with cancer place great importance on drugs that can increase their life expectancy. For that reason we apply as much flexibility as we can when we look at new life-extending treatments.
“But the reality is that the price of trastuzumab emtansine [the generic name for Kadcyla] is currently too high in relation to the benefits it gives for it to be recommended for routine commissioning in the NHS, even taking into account the end-of-life criteria and the patient access scheme.”
The charity Breast Cancer Now launched a petition against what it called a disastrous decision and “a huge setback for the treatment of advanced breast cancer”, while Breast Cancer Care said the decision was unacceptable.
“Kadcyla can give people [on average] nine months longer to be there for the moments that matter – the first day at school, a wedding, a family birthday – with far fewer enduring severe side-effects like sickness and diarrhoea than with many other drugs,” Breast Cancer Care said.
Nice, which evaluates drugs for use in the NHS in England, originally turned down Kadcyla, but patients were able to get it anyway via the cancer drugs fund, a pot of money put aside for such circumstances by the coalition government.
However, the CDF massively overspent and is now under the control of Nice, which is re-examining the value for money of all the drugs it has been paying for.
Nice has now said in draft guidance that the price is too high even after a discount offered by Roche. The company had offered to foot the bill for any patients who needed to stay on the drug beyond 14 months.
About 1,200 patients could benefit from Kadcyla if it were to be funded by the NHS in England. Roche submitted data to Nice to show that the drug could give women on average nine months longer than the standard treatment currently available – a considerable amount of extra time for women suffering from a particularly aggressive type of breast cancer, Her2+, which often affects younger women.
Nice said it was not a final decision. It will be hoping that Roche brings down the price. However, it has not done so in Scotland, where the cancer drugs fund does not apply and women can only get Kadcyla in exceptional circumstances.
Breast cancer charities will campaign against the draft Nice decision in the hope of bringing about a U-turn when the assessment committee meets to make its final decision in February. The Breast Cancer Now petition calls on Sir Andrew Dillon, the chief executive of Nice, and Richard Erwin, general manager at Roche Products, to urgently return to the negotiating table.
Delyth Morgan, the chief executive of Breast Cancer Now, said: “This disastrous decision is a huge setback for the treatment of advanced breast cancer. Kadcyla offers significant and precious extra time for women with incurable cancer in great need of hope, and we mustn’t let it slip away.
“Nice and Roche’s inability to find a compromise is seeing secondary breast cancer patients left abandoned. Responsibility lies on both sides, and such reckless brinkmanship is unfortunately about to rip away one of the best breast cancer drugs in years from patients in desperate need of a lifeline.”
The charity argued that Nice had not compared Kadcyla with the appropriate alternative treatment when making its calculations of cost-effectiveness. “This outcome also speaks volumes about a drug appraisal system that is just not working for metastatic breast cancer patients. This targeted drug is available in many other countries, including France, Germany, Australia and Canada, and it is nowhere near good enough that women in England will be denied such an effective option,” Lady Morgan said.
Danni Manzi, of Breast Cancer Care, said: “While we understand the pressure around budgets, it is ultimately patients who suffer. We urge Nice, NHS England and Roche to work together to make Kadcyla available in England. Until then, these women cannot be certain they will get the drugs they need. They deserve better than this second-rate care.”
That's especially true when the surgeon doesn't offer a recommendation either way, the researchers said.
"We are seeing that one in six breast cancer patients are choosing bilateral mastectomy when this aggressive procedure is not going to benefit them in terms of survival," said Dr. Reshma Jagsi.
Jagsi, who led the study, is a professor and deputy chair of radiation oncology at the University of Michigan School of Medicine.
Cancer specialists say no compelling evidence suggests a survival advantage for most patients to chose a double mastectomy. Also, the risk of getting cancer in the opposite healthy breast is low for most patients, they note.
However, after actress Angelina Jolie publicized her decision to undergo removal of both breasts, more women became aware of the option. Perhaps they think more is better, the researchers said.
Jagsi said she is disturbed that so many women choose such a radical approach. However, she understands how they perceive they are doing everything they can to avoid cancer.
Women for whom the double procedure might be warranted, she said, include those who have a very high cancer risk, such as the BRCA 1 or BRCA 2 gene mutations.
However, "for women with garden-variety breast cancer in one breast, the medical risks [of a preventive mastectomy in the opposite breast] really seem to outweigh the medical benefit," Jagsi said.
In the study, Jagsi and her colleagues surveyed 2,400 women diagnosed with early stage breast cancer in one breast. The researchers asked how their surgeon's recommendation -- or lack of one -- affected their decision for or against removal of the healthy breast.
Overall, the researchers found, 44 percent of the patients said they had considered removal of the healthy breast, but only 38 percent knew the procedure does not improve survival for all women with breast cancer. Nearly one-quarter believed it did, while the others didn't know.
However, 47 percent of the average-risk women received no recommendation either way about removal of the healthy breast. Among these women, 19 percent decided to undergo a double mastectomy.
Nearly all who chose to have the unaffected breast removed cited peace of mind as the primary reason, the researchers found.
The study results were published Dec. 21 online in JAMA Surgery.
Surgeons need to communicate the risks and benefits with each patient, Jagsi said. "What we need to do as physicians is educate our patients," she said.
Other researchers have also found that women are increasingly opting for preventive mastectomy. What appears new in this study is the physicians' influence on patients' decision-making, said Dr. Courtney Vito. She's a breast surgeon and assistant clinical professor of surgical oncology at City of Hope Comprehensive Cancer Center in Duarte, Calif.
Helping patients make the right decision for their situation takes time and effort, said Vito, who wasn't involved in the study. It means developing a rapport and bond with a patient, she added.
"When you actually sit down and educate your patients, then they can make an appropriate decision," Vito said. In some cases, she hasn't agreed with a patient's choice, "but the woman made an informed decision," she added.
"My job is to demonstrate to the patient what the entire road map is," Vito said. In her opinion, with physician guidance, a woman undergoing breast cancer treatment "should be ultimately satisfied with her decisions, because they are truly hers and she is making them in an informed way."
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