Howard Kaufman, MD
A group of doctors and other healthcare industry professionals have set out to develop a more efficient tool for assessing the true value of immuno-oncology (I/O) drugs. They note that these drugs often come with high prices that may distract from their advantages over other types of therapy. For example, Kroger Pharmacy is selling the checkpoint inhibitor ipilimumab (Yervoy) for $140 per mg. At the recommended dose of 3 mg/kg for melanoma patients, the total expense can be high. However, ipilimumab is one of the class of I/O drugs that have improved expectations on supportive care costs and survival benefit. The old measures of value may not apply. Therefore, how does one determine whether $140/mg is a fair price for the drug?
Howard Kaufman, MD, chief surgical officer and associate director for clinical science, Rutgers Cancer Institute, helped to organize a Value Summit on the issue at the November 2016 annual meeting of the Society for Immunotherapy of Cancer (SITC). Those who participated have now developed an action plan to improve the valuation of I/O drugs. Kaufman said that although currently available oncology drug valuation tools do not fully account for the unique benefits of I/O drugs, organizers hope to build on the capabilities of existing tools rather than “reinvent the wheel.”
A Summary of Concerns Has Been Drafted
The group has already drafted a manuscript that summarizes the conclusions that were drawn at the SITC conference. This will be submitted for publication in an upcoming issue of the Journal for ImmunoTherapy of Cancer, SITC’s peer-reviewed publication. The value summit brought together not just oncologists, but also patient advocates, pharma representatives, drug makers, and payers. The group decided to open a dialogue with groups that have already developed drug valuation tools, engage the assistance of one or more health economists, and decide whether to initiate further research. In addition, Kaufman said, “We’re hoping to develop a perspective piece for The New England Journal of Medicine in terms of highlighting why we need to have a separate value platform developed for immunotherapy.”
Kaufman said talks are underway with ASCO and that an invitation for discussion will be extended to the Institute for Clinical and Economic Review (ICER). ASCO has developed a prototype valuation tool that can evaluate the relative merits of drugs that are compared in the same trial. This model takes cost into account but has limitations that affect its utility in patient-doctor discussions about affordability. ICER has developed a system for use by payers in their negotiations with drug makers over what to pay for drugs, but the system has drawn criticism because of its emphasis on meeting payers’ needs rather than those of other stakeholders. Doctors at Memorial Sloan Kettering Cancer Center have developed a rudimentary tool that purportedly shows whether oncology drugs are priced fairly. “It’s possible that we could get working with one of these organizations to push the value piece and take one of the frameworks and add in some things that are specific to immunotherapy,” Kaufman said. However, they may also decide to develop an entirely new system of valuation.
Kaufman said none of the existing tools has exactly what is needed to address the unique benefits and risks of I/O drugs in a cost context. “There are advantages and disadvantages of each,” he said. For example, the National Comprehensive Cancer Network (NCCN) provides an affordability rating on a scale of 1 to 5 with its Evidence Block tools for evaluating therapy choices, but “I don’t think they are geared to considering the cost issue on a larger level. I think it’s one thing to put the drug costs in, but that’s not necessarily the only cost associated with treatment.”
There is also what Kaufman described as amortized cost, which is additional expense related to follow-up care. In first-line melanoma treatment, patients on I/O drugs are getting long-term survival benefits and don’t need to continue with tyrosine kinase inhibitors or chemotherapy. “We need some economic understanding to figure out how to best incorporate this,” he said.
The NCCN Defends its Evidence Blocks
Although the SITC group sees a need for improvement in I/O drug valuation, NCCN officials stated their Evidence Blocks embody sufficient flexibility for doctors to make adequate value determinations insofar as I/O drugs are concerned. “The Evidence Blocks are uniquely situated to consider the different profiles of these agents individually and in the context of traditional systemic therapies,” said Robert W. Carlson, MD, CEO of NCCN, and Joan McClure, MS, senior vice president of clinical information and publications for NCCN, in a statement.