How value assessment tools enhance decision-making in oncology.
Value assessments are a new and evolving area, and have the potential to make a tremendous impact on patient treatment decisions, as well as on coverage and reimbursement decisions, according to a statement from the National Pharmaceutical Council (NPC).
In recent years, according to the information from NPC, a number of organizations have developed frameworks to assess new treatments (Fig. 1).
Fig. 1“Value assessment may become more important as the health-care market shifts to outcomes and value-based reimbursement models,” said Jeremy Schafer, PharmD, MBA, Senior Vice President and Director for Payer Access Solutions at Precision for Value. It’s important for the oncology pharmacist to be familiar with each of the existing tools, including the methods through which value frameworks reach their conclusions and the way in which each framework is intended to be used, he added.
“We have done a significant amount of market research in this area and found that the majority of payers are at least familiar with value frameworks and many are using them”, said Schafer. The National Comprehensive Cancer Network’s (NCCN) Evidence Blocks tend to be the most popular frameworks, he said, since payers already rely on NCCN for oncology coverage decisions. “Our research has also found that payers currently not using value frameworks either anticipate doing so in the future or are relying on internal cost-effective analyses within their organizations,” he said.
“The most common way payers are using value frameworks is in choosing preferred therapies, comparing products within a class, and policy/pathway development,” Schafer told Drug Topics. Since head-to-head trials are generally lacking among similar agents in oncology, the value frameworks provide payers with a way to make these comparisons, although not necessarily in the most scientific rigorous way.
“Many of the methodologies and thresholds used in the frameworks have not been tested or vetted, which not only causes uncertainty about the validity of the results but creates uncertainty about whether the frameworks are useful for their intended purpose. The evidence base for many of the frameworks is quite limited,” said NPC in its statement.
It’s critical for pharmacists to be involved in the creation of value frameworks,” said Rowena Schwartz, PharmD, BCOP, Associate Professor of Pharmacy Practice at the University of Cincinnati in Cincinnati. “Pharmacists with the right skill sets, such as a knowledge of clinical practice and economics, need to be included,” she said.
In developing value frameworks NPC feels that all aspects of care should be considered, not just drugs. Additionally, all relevant stakeholders should be included, and economic models should be readily available, it stated. Transparency should be maintained at every step.
Existing frameworks incorporate safety and efficacy data from clinical trials into the valuation process, said Schafer. However, the current models may be lacking in some areas that are important to patients and providers. For example, “quality of life changes may not be addressed by all frameworks and the benefit to society of extended life for individual patients may be missing, as well,” he said.
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“I worry that health systems will [use value frameworks] to look at the cost of drugs, but cost is not the only factor,” Schwartz said. “As many disease states shift to chronicity,” quality of life issues are important. And in measuring quality of life, “toxicity is not the only factor,” she said. For example, a decision to use an oral form of a drug that a person can receive at home rather than an IV that must be administered in a physician’s office may enhance that patient’s quality of life, and should be considered. She also noted that value frameworks do not address the disparity in insurance coverage that exists in the United States without a single-payer system.
Part of the payer choice in choosing a value framework is based on what the payer is looking for, Schafer added. Payers interested in cost-effectiveness assessments that provide a “hard number” of value will be drawn to frameworks from the Institute for Clinical and Economic Review (ICER) or DrugAbacus, both of which recommend estimated value prices. Payers looking for a general impression of how cost compares across the class or cost compared with existing therapies may find the framework from the American Society on Clinical Oncology (ASCO) helpful. “It is important to note,” he said, “that payers do not have to limit themselves to one tool and may use multiple tools.”
Oncology pharmacists can refer to a value framework in discussions with providers involving the selection of therapies, Schafer said. “New initiatives around value, such as one currently under development from the Innovation and Value Initiative, may also help to add transparency by allowing pharmacists and other stakeholders to measure value from a variety of perspectives within a single tool. They may also allow value measurement to be adjusted based on different methodological assumptions,” he said.
Schwartz told Drug Topics that value frameworks are one step in reining in the escalating cost of oncology drugs, but just as important, she said, is the impact a treatment decision has on an individual patient.
“If value frameworks encourage providers to support evidence-based cost-effective treatments and avoid costly, unproven regimens, we may see enhanced value in the marketplace, even if treatment costs continue to rise,” said Schafer. “However, there are still questions regarding value frameworks on whether they will be widely adopted and if the organizations creating them will continue to update them to maintain relevancy. If not, frameworks may have little impact on the overall cost in oncology,” he concluded.