On behalf of organizations representing health care stakeholders, we would like to express concern with SB 5020, as it relies directly on reports conducted by the Institute for Clinical and Economic Review (ICER), an entity that embraces the quality-adjusted life year (QALY) as the gold standard for value assessment.
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.
More than 40 Leading Patient and Disability Groups Join PIPC Comment Letter on PCORI Outcome Principles
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.
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."
Chairman Coelho Pens Letter to NASEM on Preliminary Framework for Equitable Allocation of COVID-19 Vaccine
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.
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 Ulcerative Colitis (UC) treatments. Chairman Coelho criticized ICER for its use of the quality-adjusted-life-years (QALY) metric, noting that ICER fails to capture the true meaning of “value” for patients in its assessment. The letter also knocks ICER for neglecting to account for the heterogeneity of the UC patient population. “UC is a condition that impacts a very heterogeneous patient population, and treatment can vary greatly from patient to patient,” wrote Chairman Coelho. “For this reason, it is imperative that ICER account for this heterogeneity within its model and consider improving its methods.”
In a letter to the Institute for Clincial and Economic Review (ICER), Partnership to Improve Patient Care Chairman (PIPC) Chairman Tony Coelho provided feedback on ICER's draft evidence report for Non-alcoholic Steatohepatitis (NASH). Chairman Coelho criticized ICER's model for continuing to rely on the discriminatory quality-adjusted-life-years (QALY) metric, writing that it is an inappropriate metric to accurately show health gains for NASH patients. The model also makes inaccurate assumptions about liver transplant procedures. "ICER’s model exacerbates the shortcomings of the QALY by discounting the future health gains incorrectly," the letter states. "NASH is a complex condition, and it is important ICER holistically capture the complexity and the impact the disease has on individual patients and public health."
More than 50 leading groups representing patients and people with disabilities joined the Partnership to Improve Patient Care’s (PIPC) comment letter to the Institute for Clinical and Economic Review (ICER) regarding its assessment of remdesivir and other treatments for the novel coronavirus (COVID-19). The letter offers strong criticism of ICER’s use of flawed methodologies in its assessment, noting that ICER has chosen to completely ignore vast array of stakeholder feedback it has received over the last five years on its framework and processes. The groups reiterate that it’s imperative that discriminatory assessment tools like the quality-adjusted-life-years (QALY) metric are not used in determining the price of treatments, especially during public health emergencies such as COVID-19. “We have consistently raised the red flag that ICER’s value assessments are methodologically flawed and not fit for the purpose of making decisions related to coverage, reimbursement and incentive programs by policymakers and payers,” the letter states. “ The latest assessment from ICER validates our concerns.”
Over 60 Leading Patient and Disability Groups Join PIPC in Letter to New ICER VP for Patient Engagement
More than 60 leading patient advocacy and disability groups signed onto the Partnership to Improve Patient Care’s (PIPC) outreach letter to the Institute for Clinical and Economic Review’s (ICER) new Vice President for Patient Engagement Yvette Venable. The undersigned groups applauded the creation of this new position, and look forward to working with Ms. Venable to ensure that ICER develops and implements a robust patient engagement framework. “As organizations that have worked across the spectrum of health care – including life sciences innovation, payer decision-making and value assessment – with missions to improve the quality of life for patients and people with disabilities, we hope that you will engage with us and take advantage of our real-world patient engagement experiences and lessons learned,” the letter states. “Do not hesitate to reach out to us and to the experts in this field described above as you consider patient engagement frameworks that may be fit for use within ICER.”