1. You're Invited! Value Our Health Briefings on Capitol Hill, see below for details.
2. PIPC, Patient and Disability Groups Highlight Concerns with ICER’s Value Assessment Framework, click here to read the letter.
3. PIPC Chairman Coelho and Doctors Caucus Co-Founder Dr. Phil Gingrey on PCORI, click here to read the article.
4. Institute for Patient Access: To Improve Framework, ICER Must Address Shortcomings, click here to read the full article.
5. Consortium for Citizens with Disabilities Opposes Use of QALYs and Discriminatory Benefit Design, click here to view the full recommendations.
6. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
7. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, Duchenne Muscular Dystrophy click here to provide patient input.
8. American Autoimmune Related Diseases Association: Let Doctors, Patients Decide Treatment, click here to read the article.
9. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus, click here to submit your events.
10 Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
Organizations calling on policymakers to Value Our Health are holding two briefings on value assessments on Capitol Hill on June 20. Please join our esteemed panel to learn about value assessments, their potential for discrimination against patients and people with disabilities, and related public policy threats at the federal and state level. Click here to RSVP for a breakfast briefing on the House side (for screen reader accessibility, click here) and click here to RSVP for a lunch briefing on the Senate side (for screen reader accessibility, click here).
2. PIPC, Patient and Disability Groups Highlight Concerns with ICER’s Value Assessment Framework
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.” Click here to read the letter.
3. PIPC Chairman Coelho and Doctors Caucus Co-Founder Dr. Phil Gingrey on PCORI
PIPC Chairman Tony Coelho and Doctors Caucus co-founder Dr. Phil Gingrey both served as health care advocates in Congress, and now they have written an op-ed together in Modern Healthcare about the successes of PCORI and the importance of continuing its work. "If we're to continue to make progress on improving patient care and outcomes, clinicians and patients must have access to more reliable, useful information to help determine which healthcare options are best for them. And in order to ensure that evidence is relevant and accessible to them, patients need a seat at the table in developing it....PCORI has lived up to its name and its mandate to drive patient-centeredness. We both feel strongly that the funding that supports its work should be reauthorized before it expires at the end of fiscal 2019, so the valuable investment in its efforts to date can produce even more useful evidence for healthcare decisionmakers well into the future," the duo wrote. Click here to read the article.
4. Institute for Patient Access: To Improve Framework, ICER Must Address Shortcomings
As ICER solicits public comments on modifications to its value assessment framework, the Institute for Patient Access made a number of recommendations to the group, including phasing out discriminatory quality measures like the QALY. "The metric is designed to gauge improvements provided by a given therapy. But it can favor life-saving therapies, whose impact can be more easily quantified, over life-enhancing therapies, whose impact may be equally valuable but more subjective and individualized....Not all social benefits are easily incorporated into a value framework. That’s understandable. But in scenarios where this is the case, ICER should offer a caveat along with its cost-effectiveness data. Or even refrain from providing a value-based price point. However ICER chooses to address the challenge, one thing is certain. It’s inappropriate and even detrimental to patients to provide an ostensibly precise cost-effectiveness report when important details have not, or cannot, be factored in. Attempting precise calculations with incomplete data isn’t just poor practice. It’s bad for patients, for whom medicine’s value is often personal, contextualized and deeply felt," the group wrote. Click here to read the full article.
5. Consortium for Citizens with Disabilities Opposes Use of QALYs and Discriminatory Benefit Design
The Consortium for Citizens with Disabilities (CCD) is the largest coalition of national organizations working together to advocate for federal public policy that ensures the self-determination, independence, empowerment, integration and inclusion of children and adults with disabilities in all aspects of society. Prescription drugs are an essential aspect of daily life for many people with disabilities and chronic conditions. Among its recommendations to ensure access to treatment that is affordable, accessible, easy to navigate, and based on a physician-directed and person-centered treatment plan determined by the individual and their health care providers, CCD has stated a clear opposition to the use of Quality Adjusted Life Years (QALYs), a discriminatory measure based on the idea that disabled lives are less valuable and less worth living than non-disabled lives, and related measures. CCD supports an explicit ban on the use of QALYs in new health care legislation, opposes discriminatory benefit designs and calls on policymakers not to use access to care as leverage in negotiations. Click here to view the full recommendations.
6. 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.
- Australia: Australians' lives have a price -- about $50,000 per QALY. PBS is making a woman pay $4,500 per month out of pocket for a breast cancer drug because she does not meet PBS's criteria.
- New Zealand: Breast cancer advocates say that human life is not prioritized by PHARMAC. Click here to read more. Advocates also call for greater funding for breast cancer drugs by PHARMAC. Lung cancer patients say similar things. Patients are fighting to have PHARMAC cover spinal muscular atrophy drug Spinraza, including through legal action.
- Canada: Patients call on Ontario to cover "miracle drugs." An Ontario woman living with CF advocates for greater access to lifesaving drugs.
- United Kingdom: Patients continue to fight for access to cystic fibrosis drugs. Click here and here to read more. NHS has doubled its cataract treatment rationing, ignoring evidence that surgery is effective. Click here to read more.
7. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy
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. Please note the following upcoming formal ICER deadlines per their website:
- Arthritis: Revised Scoping Document available. 6/21/2019: Research Protocol. Meeting 10/31/2019: CTAF to an update to its 2017 rheumatoid arthritis assessment.
- Type 2 Diabetes: 7/8/2019: Research Protocol. Meeting 11/14/2019: The New England CEPAC will convene to deliberate on ICER's review of oral semaglutide for the treatment of type 2 diabetes.
- Cardiovascular Disease : Model Analysis Plan available. 7/24/2019: Draft Evidence Report. 9/26/2019 Meeting: Midwest CEPAC to deliberate and vote on ICER's report on evidence presented in ICER's report on additive CVD therapies.
- Depression: Evidence Presentation available. 6/20/2019: Final Evidence Report and Meeting Summary.
- Multiple Sclerosis: Evidence Presentation available. 6/20/2019: Final Evidence Report and Meeting Summary.
- Peanut Allergy: Evidence Presentation and Report available. Meeting 6/11/2019: CTAF reviewed ICER's assessment of treatments for peanut allergy. 7/3/2019: Final Evidence Report.
- Duchenne Muscular Dystrophy: Public comment period OPEN on Draft Evidence Report and Draft Voting Questions through 6/18/2019. Meeting 7/25/2019: New England CEPAC to deliberate and vote on evidence presented in ICER's report on treatments for Duchenne muscular dystrophy.
- Unsupported Price Increase Assessment: 10/8/2019: Final Report.
- Acute Migraine: Open Input Period through 6/25/2019. Meeting 1/23/2020: Midwest CEPAC to review ICER's assessment of acute migraine treatments
- Valuing A Cure Project: White Paper available 8/6/2019. Comment period open 8/6/2019-9/3/2019.
8. American Autoimmune Related Diseases Association: Let Doctors, Patients Decide Treatment
Virginia Ladd, Executive Director of the American Autoimmune Related Diseases Association, writes that health plans place unnecessary burdens on a variety of medications that help patients manage their conditions, taking decisions out of the hands of doctors and patients and giving them instead to pharmacy benefit managers and insurance companies. "This new research and prior studies indicate that the burdensome health insurance practice of step therapy is disproportionately affecting patients whose conditions require specialty medicines. All patients deserve access to all available medicines. They also deserve to receive the treatment their doctors determine is best for them in a timely manner — regardless of their medical condition....There are solutions to ensure that step therapy practices are applied only when appropriate and avoid unnecessary patient suffering. It is time to start examining these alternatives and letting doctors and their patients decide the best possible solution," she wrote. Click here to read the article.
9. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus
In the interest of amplified patient and stakeholder engagement, your organization may be interested that the House Majority Leader’s office is compiling a list of fly-ins, advocacy days, and conferences that will be taking place throughout the year. This information will be shared with all House Democratic offices and used for a variety of purposes including scheduling and messaging. Feel free to share any events you have planned. If we hear of similar efforts by the Minority Leader, we hope to share that as well. Please submit your events here.
10. Upcoming Events and Webinars
PCORI at AcademyHealth 2019 Research Meeting
June 2-4, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019
Click here for details.
Getting Real: The Changing Tide on Real-World Evidence in Drug Development
June 5, 2019
Click here for details.
Advisory Panel on Rare Disease Summer 2019 Webinar
June 12, 2019
Click here for details.
Advisory Panel on Clinical Effectiveness, and Decision Science Spring 2019 Meeting
June 14, 2019
Click here for details.
PCORI Board of Governors Meeting
June 18, 2019
Click here for details.
What’s in a Number? It Matters in Health Policy Conversations
June 18, 2019
Click here for details.
Understanding FDA’s Real-World Evidence Program: A Presentation of the AMIA Public Policy Committee
June 21, 2019
Click here for details.
A New Path Forward for Using Real World Evidence in Randomized Clinical Trials
June 23, 2019
Click here for details.
Improvements to Rural Health Care Through Patient-Centered Research
June 26, 2019
Click here for details.
PCORI Advisory Panel on Patient Engagement Summer 2019 Meeting
June 27-28, 2019
Click here for details.
Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes
July 11-12, 2019
Click here for details.
NVHR Hepatitis C Patient Summit
July 29-30, 2019
Click here for details.
2019 PCORI Annual Meeting
September 18-20, 2019
Click here for details.
FT Pharma Pricing and Value Summit 2019
September 26, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
11. Medical Journal Articles
Navigating Joint HTA, Procurement, and Fair Pricing: Evidence-Based Insights and Practical Recommendations - A Meeting Report from ISPOR Regional Conference in Warsaw, 2019, click here to view.
Health Technology Assessment as Part of a Broader Process for Priority Setting and Resource Allocation, click here to view.
Improving Quality Measure Maintenance: Navigating the Complexities of Evolving Evidence, click here to view.
A Tool for Empirical Equipoise Assessment in Multigroup Comparative Effectiveness Research, click here to view.
As Health Technology Assessment Evolves So Must its Approach to Patient Involvement, click here to view.
Evaluation of Value-Based Insurance Design for Primary Care, click here to view.
Leveraging Patient/Community Partnerships to Disseminate Patient Centered Outcomes Research in Geriatrics, click here to view.
Enabling Individualised Health in Learning Healthcare Systems, click here to view.
Analysis of Sponsor Hearings on Health Technology Assessment Decision Making, click here to view.
Study Verifies Value of Real-World Evidence, click here to view.
A Framework for Aiding the Translation of Scientific Evidence into Policy: The Experience of a Hospital-Based Technology Assessment Unit, click here to view.
12. AHRQ Effective Program Updates
Research Protocol: Impact of Community Health Worker Certification on Workforce and Service Delivery for Asthma and Other Selected Chronic Diseases, click here to view.
Systematic Review: Treatment of Depression in Children, click here to view.
AHRQ EPC Program Helps Health Systems Use Evidence, click here to view.
Technical Brief: Pharmacological and Nonpharmacological Treatments for Post-Traumatic Stress Disorder, click here to view.
Systematic Review: Management of Infertility, click here to view.
Key Questions: Cervical Ripening in the Outpatient Setting, click here to view.
Key Questions: Radiation Therapy for Brain Metastases, click here to view.
Protocol: A Rapid Evidence Review of Retention Strategies for Medications for Addiction Treatment (MAT) in Adults with Opioid Use Disorder, click here to view.
Systematic Review: Diagnosis and Treatment of Clinical Alzheimer's-type Dementia (CATD), click here to view.
Systematic Review: Comparative Effectiveness of Analgesics to Reduce Acute Pain in the Prehospital Setting, click here to view.
Systematic Review: Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention, click here to view.
Systematic Review: Telehealth for Acute and Chronic Care Consultations, click here to view.
White Paper: Standardized Library of Asthma Outcome Measures, click here to view.
Research Protocol: Characteristics of Existing Asthma Self-Management Education Packages, click here to view.
Systematic Review: Can Physical Activity Improve the Health of Wheelchair Users?, click here to view.