— A Step Backward: No Voice for Stakeholders in Updated Reconciliation Provisions. Click here to read the blog.
— Disability and Patient Advocacy Groups Raise Concerns Over CHCF's Decision to Fund ICER. Click here to read the letter.
— PCORI Engagement Award Program Offers New Funding to Build Capacity for Small Organizations to Engage in PCOR/CER.
— PIPC Submits Comments on ICER's Assessment of ALS Treatments. Click here to read the letter.
— Could Person-Centered Care Be the Secret to Achieving the Triple Aim? Click here to read the article.
— Senate Makes Public Legislative Language That Again Fails to Extend QALY Ban Across Federal Programs. See details below.
— HHS Report Highlights Progress on PCOR Data Infrastructure. Click here to read the article.
— Don’t Let Payer Investments in QALYs Undermine California’s Health Equity Goals. Click here to read the blog.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— AHRQ Effective Program Updates. See details below.
1. Chairman's Corner: A Step Backward — No Voice for Stakeholders in Updated Reconciliation Provisions. PIPC Chair Tony Coelho published a new blog that criticizes the updated reconciliation package's provisions for being unresponsive to "calls from the disability community to unambiguously bar the use of discriminatory value metrics like the quality-adjusted life year (QALY) across federal programs." Additionally, he raised that the new provisions also fail to provide opportunities for affected stakeholders to provide input.
The Chairman added, "The disability community was already disappointed that each iteration of this legislation has failed to incorporate the recommendations of the National Council on Disability. When provisions to reform how Medicare pays for prescription drugs were debated as part of H.R. 3, the National Council on Disability urged Congress not to rely on QALYs and later strongly encouraged the “inclusion of an unambiguous ban on the QALY within the text of the Build Back Better Act (H.R. 5367) in such a way as to convey unequivocal application to the drug price negotiation process” and further recommended extending the QALY ban in Medicare across federal programs as part of their Health Equity Framework." Click here to read the full blog piece.
2. Disability and Patient Advocacy Groups Raise Concerns Over CHCF's Decision to Fund ICER. On July 19th, PIPC joined the Cystic Fibrosis Research Institute (CFRI), Disability Rights California, DREDF, the Coelho Center, and Familia Unida, among others, on a letter to the California Health Care Foundation (CHCF) to (1) applaud the Foundation on its focus on fair access to health care and (2) raise concerns about the equity implications of the Foundation's recent announcement to fund ICER. The letter explains that ICER uses "discriminatory and flawed comparative effectiveness metrics such as the QALY to assess the value of medicines." The undersigned organizations are urging the Foundation to "ensure that ICER does not use discriminatory, biased value assessments or comparative effectiveness measures as they complete CHCF-funded work" and "to assure Californians that the work it is funding will not be used against patients and people with disabilities to drive health policy." Click here to view the letter.
3. PCORI Engagement Award Program Offers New Funding to Build Capacity for Small Organizations to Engage in PCOR/CER. The October 2022 Cycle of the Eugene Washington PCORI Engagement Award Program is now open. This funding cycle has a new funding opportunity for small groups: Building Capacity for Small Organizations to Engage in Patient-Centered Outcomes Research (PCOR)/Comparative clinical Effectiveness Research (CER). This cycle also offers funding for three other Engagement Award (EA) opportunities: Capacity Building, Dissemination Initiative, and Stakeholder Convening Support. Learn about all four funding opportunities below. Since 2014, the EA Program has awarded over $140 million to more than 680 projects. All of these projects help build communities ready to take part in PCOR, which is a type of CER. Click here to view the blog.
4. PIPC Submits Comments on ICER's Assessment of ALS Treatments. In a letter to the Institute for Clinical and Economic Review (ICER), the Partnership to Improve Patient Care (PIPC) submitted feedback on ICER's assessment of treatments for amyotrophic lateral sclerosis (ALS). The letter is critical of ICER's model structure for failing to appropriately represent a progressive disease such as ALS. PIPC also encourages ICER to factor in caregiver burden, as well as abandon the use of the discriminatory quality-adjusted life years (QALY) metric. "Given the severity of the disease, it is imperative that patients are able to access treatments as they become available," wrote PIPC Chair Tony Coelho. "PIPC encourages ICER to revisit its modeling choices to ensure that the model accurately represents the needs of and treatment value to the ALS patient population."
5. Could Person-Centered Care Be the Secret to Achieving the Triple Aim? As detailed in an article in Health Affairs, "Person-centered care refers to “providing care that is respectful of and responsive to individual patient preferences, needs and values, and ensuring that patient values guide all clinical decisions.” Person-centered care is a core pillar of quality health care, and there have been a number of efforts to expand it, including work on goal-directed care and the “Age-Friendly” movement’s emphasis on identifying what matters most for patients and caregivers. Despite these efforts, the value of person-centered care is still underappreciated when it comes to performance measurement." The article further discusses how person-centered care has powerful effects on health and projected costs, how it adds to preventative care, and how it could redefine the triple aim of addressing care, health, and cost.
6. Senate Makes Public Legislative Language That Again Fails to Extend QALY Ban Across Federal Programs. The recent draft reconciliation legislation creating new health care payment policies did not include the provisions recommended by the National Council on Disability extending the Affordable Care Act’s ban on use of QALYs in Medicare across federal programs or an unambiguous QALY ban. The legislation also omitted an earlier provision to allow affected stakeholders to provide input in the negotiation provisions outlined in Section 1194. PIPC Chairman Tony Coelho stated in November of 2021, "Unfortunately, the Build Back Better Act currently being debated by Congress misses the opportunity to strengthen current safeguards in its drug pricing provisions, giving Medicare new powers to make judgments regarding the value of treatments with little assurance that it will seek and incorporate patient perspectives on the value of their care. While I strongly agree that it is important to take action to improve drug affordability, I have always believed just as strongly that this must not be done at the expense of patients and people with disabilities.” Click here to view Chairman Coelho’s 2021 opinion. Click here to view the new legislative text. Click here to view the NCD letter to Congress. Click here to view the NCD Health Equity Framework, recommendation #8.
7. HHS Report Highlights Progress on PCOR Data Infrastructure. An article in Healthcare Innovation discusses a recent report of the U.S Department of Health & Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that "highlights progress on the collection, linkage, and analysis of data for patient-centered outcomes research. The ASPE annual report highlights the accomplishments of 34 multi-agency projects to build data capacity and support the HHS mission to advance science and improve knowledge about the comparative effectiveness of health care interventions. In fiscal year 2021, the report focuses on projects aligned with four national health priorities—COVID-19, maternal health, health equity and social determinants of health (SDOH), and the opioid crisis. The section on social determinants and health equity gives a flavor of the type of projects being supported." Click here to read the article.
8. Chairman's Corner: Don’t Let Payer Investments in QALYs Undermine California’s Health Equity Goals. PIPC Chair Tony Coelho published a new blog that outlines concerns about the use of ICER's discriminatory value assessment metrics in California. In March 2022, ICER received a grant from the California Health Care Foundation, including support for its work to develop value assessments relying on QALYs. As part of this grant announcement, ICER recognized proudly that policymakers are now “regularly referencing ICER’s health-benefit price benchmarks” and made no reference to the potential for discrimination from use of an inherently discriminatory metric to drive health care decisions.
As Chair Coelho astutely points out, California’s diversity is among its greatest strengths, yet ICER has been strongly critiqued for its reliance on average metrics that fail to represent diverse populations. ICER touts how its value assessments can be leveraged to reduce costs, but in reality, its value assessments developed for use by payers will benefit payers at the expense of access to care for patients and people with disabilities — not their benefit.
"I urge California policymakers not to ignore the recommendations of so many disability rights leaders on this issue and to be skeptical about the ability of ICER to make fair health care recommendations on this vital issue," wrote Chair Coelho. "Reducing people to a one-size-fits-all standard of health care is not the equitable way to reduce health costs."
Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. We encourage you to keep track of all state-based threats using this new website tracking state activities. Key issues are highlighted below.
- Click here to learn more about the potential for Prescription Drug Affordability Boards to discriminate by incorporating the use of QALYS.
- Click here to view the Value Our Health state template legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making.
- Click here to view a one pager about the flaws in ICER’s methodology.
- Click here to view information from experts on the downside of referencing foreign countries.
- Click here to learn about statutory protections against use of QALYs.
ICER has received a grant from the California Health Care Foundation to develop annual unsupported price increase reports as well as a policymaker guide for using its research to determine “fair” access and pricing to drugs. Advocates are concerned of the implications of this grant given ICER’s reliance on QALYs. Simultaneously, the California legislature is considering AB 1130, which would establish the Office of Health Care Affordability to develop policies for lowering health care costs for consumers, set and enforce cost targets, and create a state strategy for controlling the cost of health care. This bill does not currently contain a ban on the use of the QALY.
On April 27, 2022, SB 8901 was introduced in the New York Senate, which would import QALYs from Canada by directly referencing the QALY-based prices paid for prescription drugs in four Canadian provinces. It has passed out of the Finance Committee and been referred to the Rules Committee. Click here to view the bill. Click here to learn more about state efforts to import discriminatory QALYs from Canada.
Oregon's waiver application, submitted to CMS on February 18, 2022 defended the state’s use of QALYs and continues to request authority to conduct reviews of drugs approved through FDA’s accelerated pathway to allow for restricted coverage. Disability and patient stakeholders have submitted comments to CMS asking that it reject Oregon’s use of the discriminatory QALY. Click here to read comments submitted by PIPC along with 62 other groups. Click here to view letters from Disability Rights Oregon and Paul Terdal. Click here to view the letter from Patients Rights Action Fund.
The Massachusetts House and Senate have each taken the positive step of introducing An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, H.201 and S.753. This bill would enshrine essential patient protections including a ban on the use of the QALY, a requirement for research to meet patient-centeredness criteria, and robust engagement of the patient and disability communities in health care decision making. Governor Charlie Baker filed his health care bill, SB 2774, An Act Investing in the Future of our Health, on March 17, 2022. The bill expands the Health Policy Commission’s authority to determine the value of a drug beyond Medicaid to private payers. As written, the bill allows for use of cost-effectiveness assessments and analysis by a third-party, and it does not include a QALY ban. The bill requires disclosure of methods used by third parties and disclosures of potential limitations of that research. In a hearing on SB 2774 on April 11, patient advocates testified that the bill as written has the potential to discriminate and must include a QALY ban.
International News: What Happens in Countries Using QALYs and Cost-Based Thresholds?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- Canada: CF patients are rejoicing after the government finally lifted restricted access to Trikafta, a life-saving drug, however, the government still restricts access to CF drugs Kalydeco and Orkambi for meeting eligibility criteria.
- United Kingdom: Breast cancer patients are thankful for the NHS' decision to finally give Alpelisib and Trodelvy, life-extending drugs, the green light after it was rejected in April.
ICER's QALY-Based Study Topics
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Click here to view the topics and deadlines.
- Amyotrophic Lateral Sclerosis (ALS): Draft Evidence Report available. Public comments closed. 8/4/2022: Evidence Report. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- Menopause: Vasomotor Symptoms: Research Protocol available. Revised Scoping Document available. Draft Scoping Document available. Public comments closed. 8/23/2022: Model Analysis Plan.
- Alzheimer's Disease: 10/5/2022: Model Analysis Plan. Research Protocol available. Revised Scoping Document available.
- Beta Thalassemia: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- COVID-19: Final Evidence Report and Meeting Summary available. Evidence Presentation and Report available. Draft Evidence Report Available. Public comments closed. Model Analysis Plan available. Draft Scoping Document and Research Protocol available.
- Obesity Management: Draft Evidence Report available. Public comments open until 8/8/2022. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available. Draft Scoping Document available. 8/31/2022: Evidence Report.
- Multiple Sclerosis: CIS, RRMS, and SPMS: Research Protocol available. 8/17/2022: Model Analysis Plan. Revised Scoping Document available. Draft Scoping Document available. Public comments closed.
- Gene Therapies for Hemophilia A and B: Revised Scoping Document available. 7/28/2022: Model Analysis Plan. Draft Scoping Document available. Public comments closed.
- Unsupported Price Increases Occurring in 2020 in California: Protocol available. 10/13/2022: Final Report.
- Type 2 Diabetes: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Evidence Report available. Draft Scoping Document and Research Protocol available.
- Hypertrophic Cardiomyopathy: Final Evidence Report and Meeting Summary available. Evidence Report Available. Evidence Presentation available.
- Asthma: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Evidence Report available.
Upcoming Events and Webinars
Board of Governors Meeting
July 26, 2022
Click here for details.
Medical Journal Articles
Challenges and Opportunities for Advancing Patient-Centered Clinical Decision Support: Findings from a Horizontal Scan, click here to view.
Can Alternative Payment Models and Value-Based Insurance Design Alter the Course of Diabetes in the United States? Click here to view.
A Pragmatic Guide to Assessing Real Option Value for Medical Technologies, click here to view.
Stakeholder Engagement Infrastructure to Support Multicenter Research Networks: Advances from the Clinical Research Networks Participating in PCORnet, click here to view.
Use of Pragmatic and Explanatory Trial Designs in Acute Care Research: Lessons from COVID-19, click here to view.
Impact of the COVID-19 Pandemic on Healthcare Resource Utilization Across Selected Disease Areas in the USA, click here to view.
Total Cost of Care Differences in National Comprehensive Cancer Center (NCCN) Concordant and Non-Concordant Breast Cancer Patients, click here to view.
The Role Of Prices In Excess US Health Spending, click here to view.
Application of Quantitative Bias Analysis for Unmeasured Confounding in Cost–Effectiveness Modelling, click here to view.
Seriously Ill Individuals—A Canary in the Coal Mine for Medicare’s Transition to Accountable Health Care, click here to view.
Perceptions and Use of Telehealth Among Mental Health, Primary, and Specialty Care Clinicians During the COVID-19 Pandemic, click here to view.
Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial, click here to view.
AHRQ Effective Program Updates
- Systematic Review: Schedule of Visits and Televisits for Routine Antenatal Care. Click here to view.
- Systematic Review: Telehealth for Women's Preventive Services. Click here to view.
- Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
- Systematic Review: Maternal and Child Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Click here to view.
- Research Report: Research Gaps in Women’s Health: 2022. Click here to view.
- Systematic Review: Treatments for Acute Pain. Click here to view.
- Systematic Review: Models of Care That Include Primary Care for Adult Survivors of Childhood Cancer: A Realist Review. Click here to view.
- Integrated and Comprehensive Pain Management Programs: Effectiveness and Harms. Click here to view.