After Patient Pressure, NHS England Strikes Kadcyla Deal With Roche, Wales Follows Suit

After negotiations with drug manufacturer Roche, England’s National Health Service (NHS) has approved the routine use of trastuzumab emtansine (Kadcyla) for the treatment of HER2-positive metastatic breast cancer in patients for whom trastuzumab (Herceptin) treatment has failed.

England’s National Institute for Health and Care Excellence (NICE) had previously rejected the drug for use under the government-paid health system in 2014, saying that trastuzumab emtansine—with its list price of £90,000 (approximately $114,000) per patient per year—failed its cost-benefit analysis. The center’s director for health technology evaluation, Carole Longson, MBE, said at the time, “The reality is that the price of 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.”

After NICE’s recommendation, a limited number of patients could access trastuzumab emtansine through England’s Cancer Drugs Fund, a fixed-budget fund that pays for access to more expensive drugs not approved for NHS use.

Patient groups, including Breast Cancer Now, voiced their frustration with such restricted access to the life-extending drug, saying, “The Government promised to fix this problem but they just haven’t done that. And that’s why we’re going to be calling on them to think again, and to work together with NICE and the pharmaceutical industry to find a way to make these drugs available to women who need them, across the whole of the [United Kingdom], in a way which is sustainable for the NHS in the long term.” In 2016, Breast Cancer Now launched a petition to make trastuzumab emtansine available under the NHS in an effort to bring patient access to the forefront of NICE’s mind.

All indications are that Breast Cancer Now’s strategy worked; last week, the NHS announced a price deal with Roche that will make trastuzumab emtansine available to approximately 1200 patients per year in England. In its official remarks, the center noted the outpouring of patient concern, and said that “The committee acknowledged the comments received from patients during the consultation on the draft recommendations for trastuzumab emtansine, in particular that 115,000 people had signed a Breast Cancer Now petition urging NICE and the company to ensure that it remains available. We are therefore very pleased that [Roche] and NHS England have been able to agree [to] a deal that will achieve this.”

Chief executive of NHS England, Simon Stevens, hinted that the NHS had undertaken hard negotiation with Roche in seeking to make the drug more widely available, saying, “Today’s announcement on Kadcyla shows that for companies who are willing to work with us, there are concrete gains for them, for the NHS, and most importantly, for patients able to get new and innovative drugs.”

Benefits of England’s deal appear to have repercussions for other area in the United Kingdom; Welsh NHS announced on Tuesday that it had reached an agreement with Roche with the terms as England had. It remains to be seen whether NHS Scotland, which had previously approved the use of trastuzumab emtansine in its health system, may be in a position to reach a better price agreement in light of the English and Welsh deals.

While this recent win is welcome news to patient groups in the United Kingdom who seek to improve the nation’s worst-in-Europe survival rates for many common cancers, new challenges loom for patients with HER2-positive metastatic breast cancer. Last week, the Scottish Medicines Consortium (SMC) announced that it would not allow patients to be treated with Roche’s pertuzumab (Perjeta) under NHS Scotland, saying that the monoclonal antibody’s “costs were too high and would not have been a good use of NHS resources.”

It remains to be seen whether Roche will offer a price deal on pertuzumab in the face of continued pressure from groups like Breast Cancer Now, though the organization seems poised to intensify its pressure on policy makers and manufacturers alike in the quest for more accessible oncology drugs. The organization has asked both Scottish authorities and Roche to meet with its representatives to discuss what it calls “a way forward.”