While CAP is seeking to address an important issue – affordability – its proposals to focus CER on payer needs would have serious, negative consequences for patients. First, it relies on methods such as those used by the Institute for Clinical and Economic Review (ICER), which uses cost-effectiveness standards and payer-focused budgeting as the basis for making average determinations about the value of treatments. Far from an independent, patient-centered approach, ICER’s model represents a non-transparent process with little or no patient input or review of its potential impact on care. Second, it threatens to refocus the work of the Patient-Centered Outcomes Research Institute (PCORI) to make national payment policy recommendations based on average value assessments. Yet, no patient is average.
Congress recognized this fact when it created PCORI, determining rightly that CER should inform patient decisions, not limit patient choice. Congress agreed with the Partnership to Improve Patient Care (PIPC), as well as many other stakeholders and the American public, that instead of funding government research to strictly answer payer policy needs, the new institute should conduct patient-centered outcomes research that prioritizes questions from patients and measures outcomes that matter to patients so the information supports better – and more personal – decisions.
PIPC’s recent public survey underscores the popularity, and importance, of keeping PCORI true to its mission and keeping CER focused on the patient. A strong majority of survey respondents (62 percent) continued to express support for an institute that conducts CER and that studies delivery systems as long as results are used to support and empower patient decision-making. Most respondents (69 percent) also said that research should only be used to give doctors and patients more information about which options are right for individual patients.
At the same time, respondents expressed opposition to using CER results in ways that restrict access or limit treatment choices. Most of those polled (72 percent) opposed allowing Medicare to compare the efficacy of treatment options, and upon deeming them similarly effective, only covering the less-expensive option.
The good news is that we are building a strong infrastructure for prioritizing the patient experience and perspective. PCORI emphasizes patient engagement in the prioritization and conduct of CER, empowering patients and caregivers with information, not misusing it to restrict access and choice. The Food and Drug Administration (FDA) increasingly incorporates patient perspectives into its regulatory processes through the Patient-Focused Drug Development program.
So we again face a choice. Will we continue conduct CER to support patient needs and the science of personalized and “precision” medicine, or are we going back to the paternalistic days of patting patients on the head, telling them to take two pills and call back in the morning. I cannot imagine patients want to be sidelined in their own care decisions based on centralized value assessments from CER studies that are meaningless to them personally. We’ve come too far in building the research and innovation infrastructure that enables personalized decisions to throw it all away because we do not systematically believe patients should be driving their own care. As PIPC’s Chairman and a patient with a disability myself, I would urge policymakers to move forward – not backward – and to embrace the ideals of patient-centered, personalized medicine.