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.”

​In a letter to the Patient-Centered Outcomes Research Institute (PCORI), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho offered input on the next 10 years of PCORI. Chairman Coelho framed PIPC’s recommendations around three core principles: relevance, timeliness, and trust. Specifically, he encouraged PCORI to: (1) create a national agenda for research priorities; (2) expand collection of and access to patient-centered outcomes; (3) advance use of patient-centered outcomes in value assessment; and (4) promote patient-centered methodologies. “This is a crucial moment to build on PCORI’s success for another 10 years,” wrote Chairman Coelho. “Success, we believe, will entail effectively connecting PCORI and its research strengths to the current, pressing needs of our health care system and the patients and caregivers it serves.

​In a letter to the Institute for Clinical and Economic Review (ICER), the Partnership to Improve Patient Care (PIPC) offered feedback on ICER’s draft evidence report for Cystic Fibrosis treatments. PIPC Chairman Tony Coelho was critical of ICER’s QALY-based approach in its assessment, noting that the QALY disservices those with chronic and disabling conditions such as CF. Chairman Coelho also took issue with ICER’s willingness to prioritize financial savings over patient life and well-being. “ICER needs to reconsider its use of the QALY and model construction to ensure it is capturing an accurate picture of the value of treatments to patients,” wrote Chairman Coelho. “We disagree, as do the patients and families impacted by your analysis, that ICER should have the authority to determine the value of a patient with cystic fibrosis.

On Mar. 12, PIPC joined nearly 150 leading patient advocacy groups in signing on to a letter of support for the Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741). Sponsored by Reps. Terri Sewell (D-AL) and Adrian Smith (R-NE), this bill would make significant strides in addressing patient and provider concerns about the impact of the Center for Medicare and Medicaid Innovation (CMMI) demonstrations on access to care and the quality of care. ​“We are concerned that too many CMMI models endanger patient access to healthcare providers and medically necessary treatments and create unnecessary obstacles for vulnerable patients,” the letter states. “H.R. 5741 provides safeguards for CMMI to ensure CMMI demonstrations are patient-focused and benefit beneficiaries.” 

​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.”