​In a letter to the Institute for Clinical and Economic Review (ICER), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho offered feedback on ICER’s draft evidence report for Sickle Cell Disease (SCD) treatments. Chairman Coelho expressed concerns with ICER’s use of the QALY metric to assess SCD treatments, saying that the QALY is a particularly inappropriate method for evaluating any value accrued from interventions aimed at its alleviation. The letter also criticizes ICER for choosing to use claims data instead of listening to input from patient and clinician stakeholders. “ICER risks doing the SCD community a disservice by using the QALY, a metric highly inappropriate for the assessment of SCD treatments, and by failing to listen to the community about factors like standard of care and outcomes that matter to patients that should be meaningfully incorporated into its model,” wrote Chairman Coelho. ​

Twenty groups representing patients and people with disabilities submitted a comment letter to the Centers for Medicare & Medicaid Services (CMS) in response to Tennessee’s proposed amendment to the TennCare Demonstration, TennCare II Demonstration, Amendment 42. The groups expressed concern that adopting a closed formulary opens the door to evaluating the “value” of a drug using cost-effectiveness analyses based on the discriminatory quality-adjusted life year, which would lead to limited access to needed treatments for patients and people with disabilities. "Our goal is for TennCare to be centered on the needs, outcomes, and priorities of patients and people with disabilities; therefore, we oppose opening the door in Tennessee to limited formularies and the use of cost-effectiveness analyses based on the QALY and similar metrics, which would lead to discrimination and restricted access to care," the letter states. 

In a letter to Reps. Diana DeGette (D-CO) and Fred Upton (R-MI), the Partnership to Improve Patient Care offered feedback on the next iteration of the 21st Century Cures Act — “Cures 2.0.” PIPC Chairman Tony Coelho encouraged the lawmakers to consider that role that the Patient-Centered Outcomes Research Institute and high quality shared decision making can play in supporting high-value, personalized health care decision making in the legislation. He also urged consideration of the recent report issued by the National Council on Disability calling on policymakers to avoid use of the discriminatory quality-adjusted life years (QALY) metric. “We look forward to working with you to ensure that Cures 2.0 is centered on patients and people with disabilities and supports the goal of innovative treatments reaching those who need them most.,” wrote Chairman Coelho. “We are committed to working with you to advance a personalized, informed health system that works to ensure patients access treatments that work for them, and do not fail them.”

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 acute migraines. Chairman Coelho criticized the report for making an "oversimplified assumption" that there are no mortality effects in migraine treatment, citing that a number of people with more severe types of migraine have higher rates of all-cause mortality in both men and women. He also reiterated PIPC's concern with ICER's use of the  QALY, saying that it is not an appropriate methodology for use in assessments where the patient population is heterogeneous. "ICER continues to overlook outcomes that matter to patients in favor of overly simplistic QALY-based models," wrote Chairman Coelho. "We urge ICER to be more thoughtful in its model construction and take seriously the feedback from patients and clinicians who are experts in migraine attacks."

In a letter to Senators working to advance reauthorization of the Patient Centered Outcomes Research Institute (PCORI), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho provided feedback on a recent discussion draft of PCORI reauthorization. Chairman Coelho emphasized that this is a “crucial” time for Congress to build on the success of PCORI, noting that PIPC supports efforts to ensure that PCORI research is timely and responsive to the needs of those making decisions about new drugs and other treatment options. In addition to a fully funded reauthorization of PCORI for ten years, and Chairman Coelho offered suggestions pertaining to: (1) board composition; (2) methodology committee selection; (3) outcomes data; (4) high-impact research; and (5) enhancing statutes that protect PCORI’s patient-centered mission. “Now more than ever, we need solutions that are both evidence-based and patient-centered,” wrote Chairman Coelho. “The next 10 years of PCORI will be essential as the institute focuses on dissemination and implementation of its work."

On Friday, Oct. 18, the Partnership to Improve Patient Care joined over 50 leading patient advocacy groups in submitting a joint comment letter to the Institute for Clinical and Economic Review (ICER) on its draft 2020 Value Assessment Framework. The letter criticized ICER for defending its use of the QALY, saying that ICER’s framework ignores ethical principles that enjoy broad support among the general public. Instead of relying on metrics that treat patients as averages, the letter encouraged ICER to abandon it’s use of discriminatory value metrics and develop mechanisms that incorporate robust patient and clinician feedback. “Above all, we urge ICER to put patients and people with disabilities at the center of all of your assessments,” the letter states. “ICER’s value assessments do not promote affordability for patients, but instead give payers justification to create barriers to treatment coverage that benefit their own bottom line.”

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 Type 2 Diabetes Treatments. Chairman Coelho criticized ICER for omitting quality of life data deemed valuable by patients, pointing out that the institute continues to rely on faulty data in its assessments. The letter also condemns ICER for ignoring the heterogeneity of Type 2 Diabetes Patients in its report.  “ICER continues to use a flawed methodology, ignoring the reality of heterogeneous patient populations and quality of life outcomes that matter to patients in favor of data that easily crosswalks into the discriminatory QALY metric,” wrote Chairman Coelho. “We urge ICER to consider alternative methodologies that will foster improved health care decisions for individual patients.”

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 on treatments for Cardiovascular disease (CVD). Chairman Coelho argued that there are several key flaws with ICER's report, noting that their model uses inappropriate data for the population being targeted with CVD medications. He also criticized ICER for using an "artificially narrow" definition of a major adverse cardiovascular event. "ICER continues to use a flawed methodology, ignoring real-world data and quality of life outcomes that matter to patients in favor of data that easily crosswalks into the discriminatory QALY metric," wrote Chairman Coelho. "We urge ICER to reconsider both its data sources and its concerning theory that health care must be rationed to achieve savings and efficiency in our health care system." 

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 on treatments for Duchenne Muscular Dystrophy (DMD). Chairman Coelho offered criticism of ICER’s model for oversimplifying the disease, noting that ICER continues to overlook outcomes that matter to patients and caregivers. He also pointed out that ICER continues to use the flawed and discriminatory quality-adjusted-life-year (QALY) metric in its review. “ICER continues to overlook outcomes that matter to patients, families and caregivers in their haste to provide reports to payers,” wrote Chairman Coelho. “We encourage ICER to be more strategic and focus on producing complete and thoughtful analysis using high quality data incorporating a range of outcomes important to patients instead of rushing to complete reports that do not have appropriate scientific rigor."

​In a letter to the Institute for Clinical Economic Review (ICER), over 30 patient and disability groups joined the Partnership to Improve Patient Care (PIPC) in outlining concerns about ICER’s 2020 Value Assessment Framework. The letter calls on ICER to abandon its use of the quality-adjusted-life-years (QALY) metric, as well as other metrics that discriminate against patients and people with disabilities. PIPC also emphasized that ICER must develop novel measures of value to account for patient differences and priorities, as well as models that are open-source, transparent, and available to all patients and researchers. “Above all, we urge ICER to put patients and people with disabilities at the center of all of your assessments,” the letter states. “While we share your interest in lowering healthcare spending and addressing affordability, we do not believe that generating value assessments in a manner that leads to restricted access and discrimination is a necessary tactic or ethical strategy for achieving these goals.”