1. Webinar: Unpacking ICER’s Models Assessing COVID-19 Treatments, see details below.
2. Dollars-and-Cents Calculations Should Not Figure in to Saving a Life, click here to read the full article from the Genetic Literacy Project.
3. OCR Settles Tennessee Case on COVID-19 Patient Non-Discrimination, see details below.
4. Morning Consult: Cost-Effectiveness in Health Care Is Racist, click here to read the op-ed.
5. PIPC Submits Comment Letter to ICER on Draft Evidence Report for NASH, click here to read the letter.
6. Experts and Advocates Oppose Importing Discrimination Through Foreign Reference Pricing, see details below.
7. Cost Assessors Must Consider Novel Value Elements, click here to read the article.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
9. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, click here to provide patient input.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
COVID-19 has presented an unprecedented challenge for our society. It has taken its toll on our health care system and ground much of society to a halt. It has also presented unique challenges for the patient and disability community that are at higher risk for complications should they contract the disease along with the added burden of attempts in many states to implement discriminatory crisis standards that would deny them care in a shortage.
In the midst of this, the Institute for Clinical and Economic Review (ICER) has released a model for determining the “value” of treatments for COVID-19. ICER has made clear they intend to continue using this model for future new treatments, making it seminally important that we understand the model and what it could mean for COVID-19 treatment access and future treatment development should it be relied on by policymakers and payers. Please join us for a discussion with a panel of experts on these topics on July 9, 2020 at 11 a.m. ET. Please RSVP to Thayer Surette at firstname.lastname@example.org.
2. Dollars-and-Cents Calculations Should Not Figure in to Saving a Life
A Boston-area mother was given dire news about her children, both of whom were diagnosed with Duchenne Muscular Dystrophy. "Her boys would stop walking by age 12 or 13 and, shortly thereafter, they would require nighttime ventilation. They would each need a tracheotomy, a feeding tube, or both by their late teens. Death would come a few years later. It hasn’t worked out that way, thanks to two new drugs that became available after the boys’ 2002 diagnosis....Austin now attends college and interns at a biotech company. Max attends his local high school in Newton, Massachusetts...,[I]n the eyes of some U.S. health economists, the drugs are not worth the price. That’s why [the boys' mother] hates the quality-adjusted life year (QALY), an economic calculation that attempts to quantify the value of a medical intervention, based in part on the quality of life it bestows on recipients." Click here to read the full article from the Genetic Literacy Project.
3. OCR Settles Tennessee Case on COVID-19 Patient Non-Discrimination
PIPC Chairman Tony Coelho is pleased to share that on June 26, 2020, the Office for Civil Rights announced a settlement with the State of Tennessee after it updated its crisis standards of care (“CSC”) plan to ensure that the criteria does not discriminate against persons based on disability or age. This is OCR’s fourth resolution with a state regarding disability discrimination concerns during COVID-19. According to the Center for Public Representation, "Medical rationing policies have disproportionately impacted Black people with disabilities, who have higher rates of COVID-19 infection and hospitalization. Today’s resolution sets a national precedent, with OCR building off earlier resolutions of complaints regarding Alabama’s and Pennsylvania’s plans and weighing in for the first time on the discriminatory impact of a number of provisions common in many states’ rationing plans.”
As background, on April 16, 2020, over 400 aging, disability, and patient organizations sent a letter urging the Department of Health and Human Services (HHS) to issue further guidance addressing the application of federal non-discrimination laws to plans to ration scarce health care resources during the COVID-19 pandemic. The letter led by the American Association of People with Disabilities, the Bazelon Center for Mental Health Law, the Center for Public Representation, and the Disability Rights, Education and Defense Fund called upon the HHS Office of Civil Rights to provide guidance clarifying, among other things, that federal law prohibits states and health care providers from making treatment allocation decisions based on assumptions that an individual’s disability or age will lessen the possibility of survival beyond the short-term or require the use of greater treatment resources. Click here to read the letter.
AARP wrote a letter to OCR Director Roger Severino thanking him for OCR's recent call for Alabama to "abandon guidelines calling for blunt age and disability cutoffs for their Crisis Standards of Care." Categorically excluding people with disabilities or seniors from care violates federal law, the letter said, and it is important that health care providers not discriminate in that way. Click here to read the AARP letter.
To track nondiscrimination and civil rights activities related to COVID-19, click here to view information on the Center for Public Representation website.
4. Morning Consult: Cost-Effectiveness in Health Care Is Racist
Systemic racism is often overlooked in health economics, writes the Alliance for Aging Research’s Sue Peschin. “Older people and people with disabilities or debilitating chronic conditions are discriminated against compared to younger, healthier people when it comes to QALY analyses,” she said in a Morning Consult op-ed. “Overall, QALYs distort our ethical instincts by placing a lower value on people’s lives due to having less ‘life years’ or ‘perfect health’ ahead of them. This is a particular issue for Black people, since QALYs dictate that worth is proportionate to life expectancy. Black Americans maintain a shorter life expectancy than whites, which forces the cost-effectiveness threshold for treatment to rise. QALYs also seek to generalize the population, which sounds like it would have an equalizing effect, but populations that experience social disadvantage are routinely considered more expensive to treat.” Click here to read the op-ed.
5. PIPC Submits Comment Letter to ICER on Draft Evidence Report for NASH
In a letter to the Institute for Clincial and Economic Review (ICER), Partnership to Improve Patient Care Chairman (PIPC) Chairman Tony Coelho provided feedback on ICER's draft evidence report for Non-alcoholic Steatohepatitis (NASH). Chairman Coelho criticized ICER's model for continuing to rely on the discriminatory quality-adjusted-life-years (QALY) metric, writing that it is an inappropriate metric to accurately show health gains for NASH patients. The model also makes inaccurate assumptions about liver transplant procedures. "ICER’s model exacerbates the shortcomings of the QALY by discounting the future health gains incorrectly," the letter states. "NASH is a complex condition, and it is important ICER holistically capture the complexity and the impact the disease has on individual patients and public health." Click here to read the letter.
6. Experts and Advocates Oppose Importing Discrimination Through Foreign Reference Pricing
Policymakers continue to propose foreign reference pricing as a tactic to lower drug prices within the United States. Though this policy may sound attractive on paper, experts and advocates worry that tis policy will hurt the nation’s most vulnerable causing restrictions and delays in access to needed treatments. The National Council on Disability made clear in a recent report that importing this type of QALY-based drug pricing that relies on prices set internationally would be contrary to United States civil rights law and disability policy.
7. Cost Assessors Must Consider Novel Value Elements
Writing in the Health Affairs blog, a group of researchers write that ICER's value assessment methodology is ill-suited to determining the value of drugs. Instead, they argue, the health system must consider additional elements of value, such as contextual considerations. "As scientists continue their efforts to develop new therapeutics and vaccines to treat and prevent COVID-19, other stakeholders—health technology assessment bodies, payers, policy makers, manufacturers, and health economists—have a responsibility to also ensure innovation in value assessment. The recent ICER analysis of remdesivir failed in this respect by not adequately addressing novel elements of value (even as contextual considerations) that are of particular relevance in the ongoing pandemic. While contentious debates surrounding the value and price of new therapies are likely to continue, the COVID-19 saga should make clear the importance of rethinking the existing paradigm and avoiding business as usual." Click here to read the article.
8. 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: Cystic fibrosis advocates campaign for access to life-saving drug. Compassionate care access to that drug saves Ottawa man's life. Cystic fibrosis is getting more common in Saskatchewan, while new treatments remain inaccessible. Click here to read more.
- New Zealand: Bus driver self-funds cancer drug after Pharmac postpones support. An unfunded drug is the last lifeline for a 27-year-old with bowel cancer.
- United Kingdom: Life-saving prostate cancer drug will be denied to those who need it because NHS says it's too expensive. Family is trying to raise money for leukemia treatment that is unavailable under the NHS.
9. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, High Cholesterol, Anemia in Chronic Kidney Disease
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. All of ICER’s current assessments have been put on hold for 2-3 months in response to COVID-19. We will continue to update below deadlines as we receive more information.
- Ulcerative Colitis: Draft Evidence Report and Draft Voting Questions AVAILABLE. Comment period open through 7/29/2020. Meeting 9/24/2020: CTAF will convene to deliberate and vote on evidence presented in ICER's report on ulcerative colitis therapies.
- Cystic Fibrosis: Evidence Report and Response to Comments AVAILABLE. Meeting POSTPONED: CTAF will convene to deliberate and vote on evidence presented in ICER's report on treatments for cystic fibrosis.
- Sickle Cell Disease: Evidence Report and Responses to Comments AVAILABLE. Meeting POSTPONED: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for sickle cell disease.
- Non-Alcoholic Steatohepatitis: 7/21/2020: Evidence Report and Responses to Comments. Meeting was cancelled due to FDA stating that current efficacy and safety data are not sufficient for accelerated approval.
- Hemophilia A: Model Analysis Plan AVAILABLE. 8/26/2020: Draft Evidence Report.
- Bladder Cancer: Revised Scoping Document AVAILABLE. 7/14/2020: Research Protocol.
- Opioids: Digital Apps: Revised Scoping Document AVAILABLE. 7/14/2020: Research Protocol.
- Opioids: Supervised Injection Centers: Revised Scoping Document AVAILABLE. 7/21/2020: Research Protocol.
- High Cholesterol: Draft Scoping Document Available TODAY, 7/6/2020. Public Comments Open through 7/24/2020.
- Anemia in Chronic Kidney Disease: Open input period through 7/15/2020.
- Unsupported Price Increase Assessment: Protocol Available. Public input through 7/17/2020.
10. Upcoming Events and Webinars
CER Data Linkage Seminar Series - Lessons Learned: Using Linked EHR and Claims Data at UNC to Examine Preoperative Gabapentinoids & Prolonged Opioid Use
July 8, 2020
Click here for details.
PCORI Advisory Panel on Clinical Trials Summer 2020 Meeting
July 31, 2020
Click here for details.
2020 PCORI Annual Meeting (A Virtual Event): Accelerating Impact on Care and Patient Outcomes
September 16-17, 2020
Click here for details.
11. Medical Journal Articles
The Impact of Drug Quality Ratings from Health Technology Assessments on the Adoption of New Drugs by Physicians in Germany, click here to view.
Developing a Patient- and Family-Centered Research Agenda for Hospital Medicine: The Improving Hospital Outcomes through Patient Engagement (i-HOPE) Study, click here to view.
Annals Clinical Decision Making: Communicating Risk and Engaging Patients in Shared Decision Making, click here to view.
Comparative Effectiveness Research in Critically Ill Patients: Risks Associated with Mischaracterising Usual Care, click here to view.
Unanticipated Therapeutic Value of the Patient-Centered Outcomes Research Institute (PCORI) Stakeholder Engagement Project for Homebound Older Adults, click here to view.
Impact of a Global Pandemic on Health Technology Assessment, click here to view.
How Are Incremental Cost-Effectiveness, Contextual Considerations, and Other Benefits Viewed in Health Technology Assessment Recommendations in the United States?, click here to view.
The Implementation of Health Technology Assessment Principles in Public Decisions Concerning Orphan Drugs, click here to view.
Decision-Making under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the US and Europe, click here to view.
What Types of Real-World Evidence Studies Do U.S. Commercial Health Plans Cite in Their Specialty Drug Coverage Decisions?, click here to view.
Defining the Role of the Public in Health Technology Assessment (HTA) and HTA-Informed Decision-Making Processes, click here to view.
12. AHRQ Effective Program Updates
Research Protocol: Disparities and Barriers for Pediatric Cancer Survivorship Care. Click here to view.
OPEN FOR COMMENT THROUGH JULY 17: Technical Brief: Automated-Entry Patient-Generated Health Data for Chronic Conditions: The Evidence on Health Outcomes. Click here to view.
OPEN FOR COMMENT THROUGH JULY 13: Maternal and Fetal Effects of Mental Health Treatments in Pregnant and Breastfeeding Women: A Systematic Review of Pharmacological Interventions. Click here to view.
Research Protocol: Breast Reconstruction after Mastectomy. Click here to view.
Rapid Evidence Report: Masks for Prevention of COVID-19 in Community and Healthcare Settings: A Living Rapid Review. Click here to view.
OPEN FOR COMMENT THROUGH JULY 6: Systematic Review: Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD Repository. Click here to view.
Systematic Review: Interventions for Substance Use Disorders in Adolescents. Click here to view.
White Paper: The Evidence Base for Telehealth: Reassurance in the Face of Rapid Expansion During the COVID-19 Pandemic. Click here to view.
White Paper: Standardized Library of Depression Outcome Measures. Click here to view.
Research Protocol: No-Touch Modalities for Disinfection of Hospital/Acute Care Settings: A Rapid Evidence Review. Click here to view.