1. IVI Webinar: How Should Policy Uphold Equity in Value Assessment?, click here to learn more and register.
2. Value Assessment in the News, see details below.
3. Public Comment on PCORI Proposed National Priorities for Health, see details below.
4. KQED: Step Therapy Protocols Keep Patients from Accessing Post-Partum Depression Treatment, click here to read the story.
5. PIPC Submits Comment Letter to ICER on Draft Evidence Report for Atopic Dermatitis, see details below.
6. RECORDING AVAILABLE -- Discrimination and Health Care: How it Impacts You, click here to view the webinar.
7. States Rely on Template Legislation that References ICER and Discriminatory Metrics, see details below.
8. Emerging Threats in States for Use of Discriminatory Metrics, see details below.
9. IVI to Hold Second Methods Summit, click here to learn more.
10. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
11. ICER's QALY-Based Study Topics: Hypertrophic Cardiomyopathy, Myasthenia Gravis, Atopic Dermatitis, Alzheimer's Disease, Asthma, Type 2 Diabetes, click here to provide patient input.
12. Upcoming Events and Webinars, see details below.
13. Medical Journal Articles, see details below.
14. AHRQ Effective Program Updates, see details below.
This Wednesday, July 14, the Innovation and Value Initiative (IVI) will hold a webinar discussing how public policy can address equity concerns in value assessment. IVI will welcome experts, including Cancer Support Community's Phylicia Woods, to speak during the session. During the webinar, panelists will seek to answer the following questions and more: What policy actions are needed to incentivize changes in the behavior of organizations and individuals that will reduce disparities – and what are the key decisions to target? What role should value assessments play in shaping the decisions that determine access and outcomes?
This webinar, the third in a series on equity in value assessment, will take place July 14 at 1:00 p.m. Click here to learn more and register.
2. Value Assessment in the News
Federal policymakers are considering value assessment options, from domestic reference pricing to foreign reference pricing. As policymakers consider alternatives to QALYs and the evLYG which is derived from a QALY, it is important that policymakers to understand value assessment, how discriminatory metrics are used in value assessment and how innovators like PCORI and IVI are developing new methods for assessing cost and economic data related to care and treatment. For more information about evLYG, please view this PIPC Chairman blog and this Twitter thread that explains the evLYG method in more detail. We urge you to share widely the concerns from the National Council on Disability related to QALYs and evLYG (p. 61) and CBO’s use of QALYs to score H.R. 3 as a reminder that patients and people with disabilities oppose the use of this metric and metrics related to it like evLYG. Click here to view principles for value assessment centered on patients and people with disabilities.
3. Public Comment on PCORI Proposed National Priorities for Health
In 2020, PCORI started an initiative to identify new priorities to direct its work in the coming years. PCORI's Board of Governors approved posting for public comment of five proposed National Priorities for Health developed in consultation with stakeholders, advisors, and experts. Public comment on the priorities began June 28 and will run through August 27. The five priorities are:
- Increase Evidence for Existing Interventions and Emerging Innovations in Health
- Enhance Infrastructure to Accelerate Patient-Centered Outcomes Research
- Advance the Science of Dissemination, Implementation, and Health Communication
- Achieve Health Equity
- Accelerate Progress Toward an Integrated Learning Health System
Click here to read more and to submit comments.
4. KQED: Step Therapy Protocols Keep Patients from Accessing Post-Partum Depression Treatment
A story from KQED exposed the practices of insurers in California that impose step therapy protocols on new moms with post-partum depression. Rather than allowing patients to access treatments recommended by their doctors, one insurer required that a patient fail on four different medications before being allowed to get what doctors knew would work.
From the story -- “People walk out of the hospital, wanting to be with their child, wanting to return home,” said Dr. Riah Patterson, who has been treating women with brexanolone at the University of North Carolina at Chapel Hill since it became available in summer 2019. “There is a hopefulness, a brightness. You can really see that transformation in the hospital room over those 60 hours. It’s pretty miraculous.”
Click here to read the story.
5. PIPC Submits Comment Letter to ICER on Draft Evidence Report for Atopic Dermatitis
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 atopic dermatitis (AD) treatments. The report on which PIPC commented is now available here. PIPC offered strong criticism of ICER's model for its use of the discriminatory quality-adjusted-life-years (QALY) metric, relying on population averages, and not taking patient heterogeneity. The letter also takes issue with ICER's model for not being sensitive to or reflective of outcomes that matter most to patients. "It is imperative that the needs of these patients and the value treatments bring to them are being considered in any value assessment for AD," wrote PIPC Chairman Tony Coelho. "PIPC echoes some of our consistent feedback in this comment letter urging ICER to be more transparent, incorporate outcomes that truly matter to patients, and account for patient heterogeneity." Click here to read the letter.
6. RECORDING AVAILABLE -- Discrimination and Health Care: How it Impacts You
The Bonnell Foundation: Living with Cystic Fibrosis held a webinar discussing the ways that policymakers and payers make decisions about whether or to cover a given treatment. The system being proposed to state and federal policymakers was put forth by a self-appointed group that uses Quality Adjusted Life Years (QALY). The process for valuing treatments using QALYs puts a lower value on lives lived with a disability or chronic disease. The webinar also covered the existing civil and disability rights laws that have created precedent against using QALYs in public health programs, as well as threats at the state and federal level for incorporating the use of QALYs. Click here to view the webinar.
7. States Rely on Template Legislation that References ICER and Discriminatory Metrics
We are seeing many states reference pieces of template legislation put forward by the National Association of Health Policy (NASHP). Though the intent of these bills is to lower healthcare costs, several implicate the discriminatory Quality-Adjusted Life Year (QALY) and others rely on the Institute for Clinical and Economic Review (ICER) as the sole source for evidence. The three primary bills are:
- Canadian Reference Pricing -- This piece of template legislation directly references the prices paid for drugs in five Canadian provinces. Before applying for coverage by the provinces, all drugs must complete a Common Drug Review by CADTH, which uses QALYs. The result of this is that in Canada is that many individuals living with disabilities are unable to receive the treatments and care they need. The National Council on Disability (NCD) warned in its 2019 report that similar coverage denials and loss of access to care could also be the outcome if the United States if we reference other countries.
- Unsupported Price Increase -- This piece of template legislation relies on one report by ICER to determine whether a price increase on certain therapies were supported by additional evidence. This is concerning as it codifies reference to an independent entity lacking oversight and accountability as a sole source of information. ICER is the sole arbiter as to what evidence it uses to develop this report, and patients have consistently expressed concern with ICER’s lack of transparency and omission of real-world evidence. ICER also has the ability to change the inputs and methodology of the report without oversight. Though the 2020 report does not use the QALY, it is possible that future reports will.
- Drug Pricing Review Board -- This piece of template legislation establishes a drug review board or commission. The goal of the board is to allow the state to review and evaluate the reimbursement rate and/or coverage for pharmaceuticals. Most have fairly broad parameters of how they can assess a drug’s value, and specifically permit the state to rely on third-party research or contract directly with a third-party for the purpose of fulfilling its duties. As has happened in other states such as New York and Massachusetts, without patient protections, these bills allow the new state board or commission to reference value assessments that rely on QALY and similar metrics. It is imperative that these boards has patient and disability representation and that a QALY ban is included in the legislation.
8. 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 or are considering policies to import QALY-based decisions from other countries. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. 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. Other states are taking positive steps to ban the use of the QALY and other discriminatory metrics.
The Maryland legislature passed legislation earlier this year creating a Prescription Drug Affordability Board. The legislation did not include protections for patients and people with disabilities such as barring the use of discriminatory QALYs. The Board has begun meeting to hear from stakeholders, including hearing a presentation from the Institute for Clinical and Economic Review which relies on QALYs to assess treatment value. Legislation was introduced this year to bar the use of QALYs and implement patient protections that has not advanced in the legislature. Click here to view the Board meeting agenda and here to view reference to the discussion on how to leverage ICER studies. Click here to view HB 1167 which would bar the use of QALYs in Maryland.
The Governor of Colorado has signed into law SB 21-175, which creates a prescription drug affordability review board. SB 21-75 did include an amendment that prohibits the use of QALYs in the section of the bill that determines an upper payment limit, but it does not include similar protections in the sections establishing the commission’s authority to perform value assessments for treatments would prevent QALYs from being used to target treatments for people with disabilities and older adults. In some states these types of boards and commissions have led to referencing value assessments based on QALYs from the Institute for Clinical and Economic Review (ICER). In Massachusetts, the Health Policy Commission went so far as to contract with ICER. In order to mitigate this, it is important that the Board has representation from patients and people with disabilities. The Governors office is currently accepting applications for both the Colorado Prescription Drug Affordability Review Board and the Colorado Prescription Drug Affordability Advisory Council.
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.
CA AB 1130, the California Health Care Quality and Affordability Act, is being considered in California to create an Office of Health Care Affordability. Similar to the Massachusetts Health Policy Commission, the legislation would authorize reviewing health costs and "require the office to set priority standards for various health care metrics.” In Massachusetts, the Health Policy Commission went so far as to contract with ICER. We understand the legislation is likely to pass the Appropriations Committee this session, and amendments to protect patients from discrimination has not been considered. It was originally proposed by Governor Gavin Newsom in the California Budget for 2021-22 which included a proposal for a new Office of Health Care Affordability to be housed within the Office of Statewide Health Planning and Development (OSHPD) that would seek to promote “cost efficient” care. It is anticipated that this office could advance as an independent bill, or as part of the California budget. The Value Our Health template language has not been introduced or passed in California to protect patients from the use of QALYs and discriminatory considerations of cost effectiveness.
9. IVI to Hold Second Methods Summit
The Innovation and Value Initiative (IVI) announced that it will hold a second methods summit to drive patient-centered value assessment. The multi-stakeholder event is intended to drive consensus on priority patient inputs, methods, and research that more fully represent the patient perspective in comparative effectiveness research and economic evaluations of health care interventions. The three-part series will take place in Fall 2021. Overall, the goal of IVI’s summit is to define an action agenda for patient-centered outcomes research and cost-effectiveness research by exploring patient outcomes, beyond traditional clinical factors, that represent important impacts to patients and must be accounted for in economic analyses. Click here to learn more.
10. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- Canada: Although Health Canada has approved a lifesaving cystic fibrosis drug, patients still have to fight to access it. Click here to learn more.
- France: Delayed approval of lifesaving cystic fibrosis drug took too long for many families. Click here to learn more.
- United Kingdom: PKU patient tells government to keep its promise to make PKU medications available to all.
11. ICER's QALY-Based Study Topics: Hypertrophic Myocardiopathy, Myasthenia Gravis, Atopic Dermatitis, Alzheimer's Disease, Asthma, Type 2 Diabetes
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.
- Type 2 Diabetes: Draft Scoping Document available, comment period open through 7/21/2021.
- Hypertrophic Cardiomyopathy: Model Analysis Plan available. 8/18/2021: Draft Evidence Report. Meeting 10/22/2021: CTAF will deliberate and vote on evidence presented in ICER’s report on therapies for obstructive hypertrophic cardiomyopathy.
- Myasthenia Gravis: Model Analysis Plan available. 7/22/2021: Draft Evidence Report. Meeting 9/24/2021: New England CEPAC will deliberate and vote on evidence presented in ICER’s report on therapies for myasthenia gravis.
- Atopic Dermatitis: Evidence Report AVAILABLE. Meeting 7/23/2021: An assessment of treatments for atopic dermatitis by the New England CEPAC.
- Hereditary Angioedema: 7/27/2021: Final Updated Assessment with RWE Update.
- Unsupported Price Increase: 11/16/2021: Final Report.
- Asthma: Research Protocol available. 8/2/2021: Model Analysis Plan. Meeting 11/19/2021: New England CEPAC will deliberate and vote on evidence presented in ICER’s report on therapies for severe asthma.
- Alzheimer's Disease: Evidence Report available. Meeting 7/15/2021: CTAF will deliberate and vote on evidence presented in ICER’s report on Alzheimer’s disease.
- Fair Access: Coverage Policies in 2020: Protocol Available. 10/20/2021: Final Report.
12. Upcoming Events and Webinars
PCORI Advisory Panel on Patient Engagement Summer 2021 Meeting
July 15-16, 2021
Click here to view.
Real World Evidence in the COVID Era: The National COVID Cohort Collaborative
July 28, 2021
Click here to view.
Whistleblowers of America: Workplace Promise Institute 2021 Conference
September 9-10, 2021
Click here to view.
13. Medical Journal Articles
Association of Co-Pay Elimination With Medication Adherence and Total Cost, click here to view.
The Utility of Patient Engagement in Drug Research and Development, click here to view.
Patient-Powered Research Networks of the Autoimmune Research Collaborative: Rationale, Capacity, and Future Directions, click here to view.
Enhancing Patient Research Partner Engagement: Research in Psoriatic Arthritis, click here to view.
Patient Voices in Value-Based Cancer Care: Priorities for the Biden Administration, click here to view.
The Dollar or Disease Burden: Caps on Healthcare Spending May Save Money, but at What “Cost” to Patients?, click here to view.
Embedding Clinical Trials Within Routine Health-Care Delivery: Challenges and Opportunities, click here to view.
Approval and Coverage of Cancer Drugs in England, Canada, and the US, click here to view.
Experiences of an HCV Patient Engagement Group: A Seven-Year Journey, click here to view.
Choosing Important Health Outcomes for Comparative Effectiveness Research: 6th Annual Update to a Systematic Review of Core Outcome Sets for Research, click here to view.
14. AHRQ Effective Program Updates
Surveillance Report: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Systematic Review: Prehospital Airway Management. Click here to view.
Systematic Review: Radiation Therapy for Brain Metastases. Click here to view.
Systematic Review: Safety of Vaccines Used for Routine Immunization in the United States: An Update. Click here to view.
Research Protocol: Evaluation of Mental Health Applications. Click here to view.
Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Systematic Review of Perinatal Pharmacologic Interventions. Click here to view.
Rapid Evidence Product: Improving Pain Management in the Context of America's Opioid and Substance Use Disorders Crisis. Click here to view.
Systematic Review: Cervical Ripening in the Outpatient Setting. Click here to view.