The U.K. agency charged with reviewing medicines for use by the National Health Service (NHS) rejected its eighth straight breast cancer drug when it issued draft guidance today stating it would turn down the use of Roche’s Kadcyla (trastuzumab emtansine) because its benefits did not in its view outweigh its per-patient cost of £90,831 (about $153,000) per course of treatment.
The National Institute for Health and Care Excellence (NICE) concluded that the price of Kadcyla was too costly for NHS access given the drug’s extension of life by a median of 5.8 months in trials compared with the current U.K. standard of care, a combination of lapatinib plus capecitabine.
At issue was the use of Kadcyla, an antibody-drug conjugate consisting of trastuzumab linked to maytansine in women with human epidermal growth factor receptor 2 (HER2) positive, unresectable locally advanced or metastatic breast cancer who were previously treated with trastuzumab and a taxane.
"The Committee concluded that trastuzumab emtansine does not represent a cost effective use of NHS resources," NICE stated in its draft appraisal consultation document, posted on its website. "The incremental cost-effectiveness ratio (ICER) for lapatinib plus capecitabine compared with capecitabine alone was £49,798 per quality-adjusted life year (QALY) gained (incremental costs £20,997 [$35,249], incremental QALYs 0.42). The ICER for trastuzumab emtansine compared with lapatinib plus capecitabine was £167,236 [$280,739] per QALY gained (incremental costs £76,992 [$129,251], incremental QALYs 0.46)."
That ICER rose to £185,600 [$311,559] per QALY gained when calculated for Kadcyla compared with lapatinib plus capecitabine, NICE added.
Roche told NICE that lapatinib plus capecitabine should be excluded from the analysis because the ICER for lapatinib plus capecitabine compared with capecitabine alone is above the normally acceptable maximum ICER. In a pairwise comparison of Kadcyla with capecitabine, the ICER was £111,095 per QALY gained (incremental costs £97,989, incremental QALYs 0.88).
Roche also used a 10-year time horizon, which showed that 3% of patients were alive after 10 years. At the request of NICE’s Evidence Review Group, Roche also presented cost-effectiveness results using a 15-year time horizon. An incremental analysis showed that the ICER for Kadcyla compared with lapatinib plus capecitabine was £160,070 per QALY gained—and that just 1% of patients were alive at the end of the 15-year period.
"Roche is extremely disappointed that NICE has failed to safeguard the interests of patients with this advanced stage of aggressive disease," Jayson Dallas, general manager, Roche Products Limited, said today in a company statement."
NICE Chief Executive Sir Andrew Dillon countered in an institute statement: "We had hoped that Roche would have recognised the challenge the NHS faces in managing the adoption of expensive new treatments by reducing the cost of Kadcyla to the NHS."
"We apply as much flexibility as we can in approving new treatments, but the reality is that given its price and what it offers to patients, it will displace more health benefit which the NHS could achieve in other ways, than it will offer to patients with breast cancer," Dillon said, insisting: "We are very aware of the importance that people place on life-extending cancer drugs and a decision not to recommend a cancer treatment for routine NHS funding is never taken lightly."
Dillon noted that the U.K. already pays for use of Kadcyla through the government’s Cancer Drugs Fund, established so that women with advanced stages of breast cancer could use drugs either not approved for NHS by NICE or awaiting a decision from the institute.
"A negative NICE appraisal on trastuzumab emtansine will not affect the availability of this drug via the Cancer Drugs Fund," an unnamed spokesperson for the fund told The Guardian.
Availability may be an issue in two years, however, since the cancer fund is set to go out of existence in March 2016.