In a letter to the Institute for Clinical and Economic Review (ICER), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho provided feedback on ICER’s draft evidence report for high cholesterol treatments. 

Over 40 leading groups and individuals representing the patient and disability communities signed onto the Partnership to Improve Patient Care's (PIPC) comment letter to the Patient-Centered Outcomes Research Institute (PCORI) on its Proposed Principles for the Consideration of the Full Range of Outcomes Data. The letter applauds Executive Director Nakela Cook for recognizing the PCORI authorizing statue's prohibition on cost-effective analysis, thus protecting patients from harmful and restrictive coverage decisions. The letter also emphasizes three key recommendations to PCORI, including: (1) promote usability of collected information for decision-making, including patients with multiple chronic conditions and their caregivers; (2) contextualize the cost information being communicated to ensure it is not used against patients and providers; and (3) solicit and appoint new Methodology Committee members who have appropriate expertise in the collection and communication of patient-level data.

​Amidst the debate around value driven health care, it is important to understand what organizations can support such a system. Two prominent organizations, the Patient-Centered Outcomes Research Institute (PCORI) and the Institute for Clinical and Economic Review (ICER), are positioned to help decision makers compare available treatment options. However, their approaches differ significantly. 

The Partnership to Improve Patient Care (PIPC) submitted a comment letter to the Institute for Clinical and Economic Review (ICER) on its draft evidence report for bladder cancer treatments. PIPC Chairman Tony Coelho criticized ICER for continuing to conduct studies prematurely, as well as assessing the value-based price of these drugs in the absence of sufficient evidence. Chairman Coelho also noted that the mixed data sources for measures of effectiveness in the report are likely to lead to biased estimates in ICER's model. "Bladder cancer can present many challenges to a patient’s quality of life, and there are currently very few treatment options for patients with high-risk non-muscle invasive bladder cancer that is unresponsive to BCG," wrote Chairman Coelho. "It is critical that new treatments are evaluated carefully when there is appropriate available evidence."

As healthcare costs in the United States have continued to grow, there has been an increasing desire to move towards “value-based” care in which patients and payers would be paying for the “value” of the treatment patients receive. This idea has been gaining particular momentum as policymakers look for strategies to curtail spending on pharmaceuticals. While there is merit in paying for services and treatments that work and eliminating wasteful spending, it is important to step back and consider to whom “value” is being provided. As the ultimate beneficiary, we would advocate that the measure of “value” in a healthcare setting should focus on value to the patient, but currently, we are concerned that the trend is to look towards “value” to the payer by prioritizing reduced cost over care outcomes for patients in the form of cost-effectiveness analyses. 

​Cell and gene therapies (C&GTs) are revolutionary advancements that offer potentially life-altering therapies – and in some cases even cures – for patients with rare and severe diseases. Around the globe, various health technology assessment (HTA) and value assessment organizations are attempting to estimate the health and economic value of new C&GTs to better inform healthcare decision making. These organizations most commonly employ cost-effectiveness analysis (CEA), which seeks to determine whether the costs of a given therapy are justified by its benefits; that is, whether it is a “good buy.”

Tony Coelho sent a personal letter to the National Academies of Sciences, Engineering, and Medicine to amplify the comments submitted by the disability community in response to the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, commissioned by the Centers for Disease Control and the National Institutes of Health. He stated, "In my experience as a longtime disability rights advocate and an original of the Americans with Disabilities Act, I view this as a process that is aligned with our mantra of 'Nothing About Us Without Us' and therefore urge you to outreach directly to our disability community as you wrestle with difficult questions related to vaccine allocation even after the comment deadline.” He highlighted letters submitted by the Consortium for Citizens with Disabilities, the Association of University Centers on Disabilities, the American Association of People with Disabilities, and Not Dead Yet.