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Pertuzumab may not be cost-effective for treatment of HER-2–positive breast cancer
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Despite a significant survival benefit, the addition of pertuzumab to docetaxel and trastuzumab for the treatment of HER-2–positive breast cancer appears unlikely to be cost-effective in the U.S., according to results of a study conducted by researchers at Stanford University.
Results of the CLEOPATRA study showed the addition of pertuzumab (Perjeta, Genentech) to trastuzumab (Herceptin, Genentech) and docetaxel (THP) for the first-line treatment of metastatic HER-2–positive breast cancer conferred a 15.7-month improvement in OS (HR = 0.68; P < .001). Based on these data, guidelines from the National Comprehensive Cancer Network recommend the combination for treatment of HER-2–positive metastatic breast cancer.
“Pertuzumab plus docetaxel and trastuzumab is unlikely to provide reasonable value for money in the U.S. for patients with HER-2–positive metastatic and locally recurrent breast cancer,” Ben Y. Durkee, MD, PhD, resident in the department of radiation oncology at Stanford University, told HemOnc Today. “Our findings are the same as those generated by the manufacturer for multiple countries. Even so, the results are thought-provoking because THP is clinically a highly effective regimen.”
Researchers in Canada previously evaluated the cost-effectiveness of pertuzumab in locally advanced, inflammatory or early HER-2–positive breast cancer and showed pertuzumab would be cost-effective between $25,388 and $46,196 per quality-adjusted life year (QALY) gained (Attard CL, et al. J Med Econ. 2015;doi:10.3111/13696998.2014.979938.).
Durkee and colleagues sought to conduct the first U.S.-based cost-effectiveness study of pertuzumab in the treatment of HER-2–positive metastatic breast cancer.
Researchers developed a decision-analytic Markov model to measure the cost-effectiveness of pertuzumab added to trastuzumab and docetaxel, following patients weekly over their remaining lifetimes. Patients’ health states included stable disease, progressing disease, hospice and death. Researchers based costs on the 2014 Medicare rates and expressed cost-effectiveness as an incremental cost-effectiveness ratio.
The researchers assumed a willingness-to-pay threshold of $100,000 per QALY gained, but also explored the possibilities of up to $500,000 per QALY gained.
Median survival was 39.4 months for patients assigned TH and 56.9 months for patients assigned THP. The addition of pertuzumab resulted in 1.82 life-years gained, or 0.64 QALYs at a cost of $713,219 per QALY gained.
Results of a sensitivity analysis showed that even in the most favorable cases, THP was not cost-effective. A probabilistic sensitivity analysis predicted a 0% chance of cost-effectiveness if the willingness-to-pay threshold was $100,000 per QALY gained. This result remained unchanged even with a willingness-to-pay threshold of up to $500,000.
The researchers found that widespread use of this new regimen in the population with metastatic disease could contribute an additional $8 billion to health care spending.
“We do not necessarily expect these findings to change decision-making at an individual patient–doctor level,” Durkee said. “Certainly, we all want the best for our patients and acknowledge that it is difficult for us to objectively weigh the abstract opportunity cost against the human patient in front of us.
Peter B. Bach
“That being said, from a societal perspective, it is imperative that we consider costs of treatment. In 2014, all newly FDA-approved cancer drugs were priced at more than $120,000 per year of use. It is hard to imagine that our nation can sustain these costs forever.”
The study by Durkee and colleagues is “one of the clearest” cost-effectiveness reports, Peter B. Bach, MD, director of the center for health policy and outcomes at Memorial Sloan Kettering Cancer Center in New York, wrote in an accompanying editorial.
The report comes at a time when cost is being increasingly discussed, Bach wrote.
“One of the inscrutable aspects of the article … is that the problem with unappealing levels of cost per unit of benefit is not, in this case, entirely driven by the price of the drugs,” Bach wrote. “In fact, it is because of the problematic paradox that treatment overall is costly, and so, when it is highly-effective and ongoing (like THP), this adds enormous costs in addition to, in this case, important benefits.
“By definition, we cannot economically afford a larger and larger pool of people receiving expensive maintenance treatments, although the last thing we would want would be to not provide this lifesaving therapy to anyone who could derive benefit from it.” – by Anthony SanFilippo
Disclosure: Durkee reports no relevant financial disclosures. One researcher reports stock or other ownership in ViewRay. Bach reports leadership and consultant/advisory roles with, travel accommodations and honoraria from, and stock or other ownership in DefinedHealth, Exam Works, Foundation Medicine, Genentech and The American Journal of Managed Care.
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