1. National Viral Hepatitis Roundtable Calls for Removed HCV Treatment Barriers, click here to view the letter.
2. NCD Letter on H.R. 3, click here to read the letter.
3. PIPC Chairman, Tony Coelho, reiterates PIPC’s Commitment to Nondiscrimination, see details below.
4. Over 85 Disability and Patient Groups Sign Open Letter: Reject Health Policies that Discriminate, see details below.
5. IVI to Hold Second Methods Summit, click here to learn more.
6. States Rely on Template Legislation that References ICER and Discriminatory Metrics, see details below.
7. IVI Value Model on Major Depressive Disorder, see details below.
8. Emerging Threats in States like CO and ME for Use of Discriminatory Metrics, see details below.
9. Vaccination Equity and Communication, see details below.
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, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease, Asthma, 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.
The Provider Advocates Network of the National Viral Hepatitis Roundtable (NVHR) sent a letter to the newly appointed Assistant Secretary for Health at HHS, calling for facilitating removal of all remaining barriers to coverage and access. The letter references on-going barriers in restrictive policies and prior authorization requirements that limit patient access based on unjustified criteria including disease severity, provider type, and arbitrary sobriety restrictions. The letter also calls on HHS to to prioritize federal efforts across agencies to promote the implementation and uptake of CDC Hepatitis C virus (HCV) screening guidelines, work across federal agencies to ensure a coordinated response to improving maternal and child health that recognizes and responds to missed opportunities in addressing Hepatitis B and HCV, and champion the expansion and sustainability of harm reduction services. Click here to view the letter.
2. NCD Letter on H.R. 3
The National Council on Disabilities (NCD) wrote to Congressional leaders sharing its concerns with Democrats' bill that would set drug prices referencing countries that use discriminatory QALYs to determine the "value" of lifesaving treatments. NCD wrote that, as Congress's disability advisor, it urged "policymakers not to rely on foreign drug prices set in reliance on the quality adjusted life year (QALY), a cost-effectiveness measure that devalues the lives of people with disabilities and chronic illnesses, when pursuing legislative solutions to high drug prices, as has been envisioned in the newly reintroduced H.R. 3"
NCD continues, "based on the discriminatory design and impact of the QALY, resulting in restricted access to life-sustaining and lifesaving drugs for persons with disabilities, and in recognition of the concerns that led to the prohibition of its use under the ACA, NCD recommends that Congress consider alternative ways to lower drug costs that do not rely on this discriminatory metric."
Click here to read the letter.
3. PIPC Chairman, Tony Coelho, reiterates PIPC’s Commitment to Nondiscrimination
PIPC Chairman Tony Coelho issued a statement expressing disappointment that the House reintroduced legislation - modeled on what was known as H.R. 3 when it was introduced in 2019 - that would rely on quality-adjusted life years (QALYs) to value health care, which are well known to discriminate against people with disabling and chronic conditions, especially in communities of color that are not well represented in the research literature. Chairman Coelho stated that the patient and disability community is united in amplifying the work of the National Council on Disability, an independent federal agency that has warned policymakers on the implications of referencing QALYs directly and by reference to third parties and foreign countries, noting that the patient and disability community stand ready to work with Congress on solutions that address the cost of care that do not discriminate.
4. Over 85 Disability and Patient Groups Sign Open Letter: Reject Health Policies that Discriminate
On April 14, 2021, over 85 groups representing people with disabilities, chronic conditions and older adults stated to policymakers, "Every life is valuable. We strongly urge policymakers to reject policies that discriminate against people with disabilities and chronic conditions, older adults, and reinforce health inequities.” In releasing the Open Letter, Maria Town, President and CEO of the American Association of People with Disabilities, expressed disappointment that the disability community still has to fight policies that discriminate by referencing discriminatory metrics to value health care, whether directly or indirectly from foreign governments. Other disability groups including Autistic Self Advocacy Network, the Disability Rights Education & Defense Fund, National Council on Independent Living, and Not Dead Yet expressed similar concerns about the use of discriminatory metrics to value health care, and particularly the quality-adjusted life year (QALY) which devalues lives lived with a disability. Organizations representing patients and people with chronic conditions also joined the Open Letter, with accompanying statements from Genetic Alliance, CancerCare, Alliance for Aging Research and the Cystic Fibrosis Research Institute expressing deep concerns with short-sighted drug pricing policies that rely on QALYs and highlighting their united front opposing their use by policymakers.
Click here to view the Open Letter. Click here to view the statements from disability groups and here to view the statements from patient groups.
5. 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.
6. 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.
7. IVI Value Model on Major Depressive Disorder
The Innovation and Value Initiative (IVI) is holding a public comment period on its draft model scope for its major depressive disorder value model through May 14, 2021. IVI is seeking feedback on factors most important to include, missing data elements, and recommendations for specific use cases in the model. Please send comments and questions to firstname.lastname@example.org or respond to the survey here. IVI will hold an informational webinar on Monday, May 3, from 1:00-2:00 PM to provide more detailed information about the MDD Model Scope. Registration information is available here.
8. Emerging State Bills Reference the QALY and Value Assessments
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 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.
SB844 establishes a Prescription Drug Affordability Board in the Department of Consumer and Business Services to review prices for prescription drug products meeting specified cost criteria. It is based on the NASHP template legislation and states, "The board may enter into a contract with a qualified, independent third party for any service necessary to carry out the powers and duties of the board.” Based on past experience, the expectation is that the third party would likely be an entity such as the Institute for Clinical and Economic Review (ICER) which continues to call QALY’s the gold standard for assessing cost effectiveness of new treatments. A robust QALY ban would address these shortcomings. The Oregon Medicaid and EPSDT waiver is up for renewal this year, providing an opportunity to address the state’s possible use of QALYs.
The Colorado state legislature has introduced SB 21-175 creating a prescription drug affordability review board. 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. An amendment to SB 21-75 was adopted that prohibits the use of QALYs in the section of the bill that determines an upper payment limit. A similar amendment 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. The bill passed the Senate and but could be amended in the House to bar QALYs in section 10-16-1306, which would then prevent the medications subject to the UPL from unfairly representing treatments for people with disabilities that are devalued under the QALY metric (consistent with language in the Value Our Health legislative template).
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 in mid-June. 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.
Maine has introduced a bill, S.P. 262, which would rely solely on the Institute for Clinical and Economic Review, ICER, to determine whether a price increases on certain therapies were supported by additional evidence. We remain concerned about states referencing ICER, particularly as a sole source of information, and will be watching developments in Maine closely.
9. Vaccination Equity and Communication
There is critical ongoing work to assure equity in the prioritization of vaccinations, as well as communication to address reluctance and ensure access to information and systems. PIPC Steering member the Association of University Centers on Disabilities (AUCD) aggregated the following resources that we wanted to share:
- Elevated COVID-19 Mortality Risk Among Recipients of Home and Community-Based Services: A Case for Prioritizing Vaccination for This Population
- National Council on Disability letter to Governors Association
- COVID-19 Vaccine Prioritization Dashboard
- Measuring the impact of COVID-19 vaccine misinformation on vaccination intent in the UK and USA
- COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination — United States, September and December 2020
- KFF COVID-19 Vaccine Monitor: What Do We Know About Those Who Want to “Wait and See” Before Getting a COVID-19 Vaccine?
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: Patient says Canada's health care system is "incredibly flawed" when it comes to accessing life-saving medication.
- France: Father wonders when life-saving cystic fibrosis drug will be available to his daughter.
- New Zealand: Pharmac has a budget "hole" and will not fund life-saving treatments. Pharmac is likely to end blanket funding for cancer drugs for kids.
11. ICER's QALY-Based Study Topics: Hypertrophic Myocardiopathy, Myasthenia Gravis, Atopic Dermatitis, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease, Asthma
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.
- Hypertrophic Cardiomyopathy: Revised Scoping Document available. 5/14/2021: Research Protocol. Meeting 8/22/2021: CTAF will deliberate and vote on evidence presented in ICER’s report on therapies for obstructive hypertrophic cardiomyopathy.
- Myasthenia Gravis: Research Protocol available. 6/7/2021: Model Analysis Plan. 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: Model Analysis Plan available. 5/14/2021: Draft Evidence Report. Meeting 7/23/2021: An assessment of treatments for atopic dermatitis by the New England CEPAC.
- Multiple Myeloma: Meeting 4/16/2021: An assessment of idecabtagene vicleucel, ciltacabtagene autoleucel, and belantamab mafodotin for the treatment of multiple myeloma. 5/11/2021: Final Evidence Report
- Hereditary Angioedema: 7/27/2021: Final Updated Assessment with RWE Update.
- Unsupported Price Increase: Research Protocol available, public input OPEN through TODAY, 5/10/2021.
- Asthma: Draft Scoping Document available, comment period OPEN through 5/27/2021. 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: Draft Evidence Report AVAILABLE, comment period OPEN through 6/2/2021. Meeting 7/15/2021: CTAF will deliberate and vote on evidence presented in ICER’s report on Alzheimer’s disease.
12. Upcoming Events and Webinars
Engagement Awardee Lunch and Learn Engagement in Practice: Success Stories Across PCORI-funded Projects
June 9, 2021
Click here to view.
Building Data Capacity for Patient Centered Outcomes Research: A Comprehensive Ecosystem for PCOR - Workshop 3
June 14, 2021
Click here to view.
PCORI Advisory Panel on Patient Engagement Summer 2021 Meeting
July 15-16, 2021
Click here to view.
13. Medical Journal Articles
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.
Health Technology Assessment With Diminishing Returns to Health: The Generalized Risk-Adjusted Cost-Effectiveness (GRACE) Approach, click here to view.
Comparative Effectiveness Research Needs to Consider Optimal Dosing and Scheduling, click here to view.
14. AHRQ Effective Program Updates
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.
OPEN FOR COMMENT THROUGH MAY 13, 2021: Interventional Treatments for Acute and Chronic Pain. Click here to view.
OPEN FOR COMMENT THROUGH MAY 14, 2021: Key Questions: Accelerated Partial Breast Irradiation for Breast Cancer. 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.
Surveillance Report: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Rapid Evidence Review: Antibody Response Following SARS-CoV-2 Infection and Implications for Immunity. Click here to view.
White Paper: Standardized Library of Lumbar Spondylolisthesis Outcome Measures. Click here to view.