1. Key Issues with ICER's Report on COVID-19, click here to read PIPC's one-pager.
2. Beware Undervaluing COVID-19 Drugs, click here to read the op-ed.
3. New Survey: Majority of Americans Don't Know Healthcare Rationing Takes Place in Their Own Backyard, click here to read more.
4. Over 60 Leading Patient and Disability Groups Join PIPC in Letter to New ICER VP for Patient Engagement, click here to read the letter.
5. ICER’s Cost Model Is Not Only Wrong It’s Also Dangerous, click here to read the article.
6. Gunnar Esiason: A Flawed Economic Model Should Not Be Used to Deny Access to a Miracle Medication, click here to read the op-ed.
7. In Letter to PCORI, PIPC Offers Input on Next 10 Years, click here to read the letter.
8. ICER Report Adds Insult to Injury for Cystic Fibrosis Patients, click here to read the blog.
9. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
10. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, click here to provide patient input.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below.
The Institute for Clinical and Economic Review (ICER) recently released a model it intends to use to evaluate treatments for COVID-19, along with its results for remdesivir, the first drug shown to be efficacious against the virus. A thorough review of the model shows it to contain many concerning assumptions and to discriminate against older patients. In the height of this global crisis, it would be irresponsible, and put older Americans, patients, and people with disabilities as risk for policymakers to rely on ICER’s flawed model. Click here to read PIPC's one-pager on the issue.
2. Beware Undervaluing COVID-19 Drugs
Writing in the Washington Post, Northwestern University Professor Craig Garthwaite reminds us that there will be an enormous societal benefit to effective COVID-19 drugs and vaccines -- a factor that ICER does not consider. "Everyone benefits from the product’s existence — even if they never catch COVID-19," he writes. "This happens in two ways: First, it reduces the spread of the disease. Every person who doesn’t get sick or who gets better faster is someone who is less able to transmit the virus to others. We all value that. Second, it creates value by transforming the existing uninsurable health risk into an insurable financial risk. Just as homeowners willingly pay premiums for insurance even if their houses don’t burn down, we all value the existence of innovative treatments that can cure us even if we don’t get sick." Click here to read the op-ed.
3. New Survey: Majority of Americans Don't Know Healthcare Rationing Takes Place in Their Own Backyard
The Alliance for Aging Research released new survey findings regarding the public perception of healthcare rationing in the United States. Amid the COVID-19 crisis, healthcare rationing has become a serious concern, especially surrounding ventilator access and hospital admissions. But as results of the nationwide survey show, many Americans do not realize this type of rationing has been encouraged and orchestrated by one particular organization, the Institute for Clinical and Economic Review, or ICER, for some time. 58 percent of Americans are unaware of an organization like ICER that promotes health care rationing, the survey found. Click here to read more.
4. Over 60 Leading Patient and Disability Groups Join PIPC in Letter to New ICER VP for Patient Engagement
More than 60 leading patient advocacy and disability groups signed onto the Partnership to Improve Patient Care’s (PIPC) outreach letter to the Institute for Clinical and Economic Review’s (ICER) new Vice President for Patient Engagement Yvette Venable. The undersigned groups applauded the creation of this new position, and look forward to working with Ms. Venable to ensure that ICER develops and implements a robust patient engagement framework. “As organizations that have worked across the spectrum of health care – including life sciences innovation, payer decision-making and value assessment – with missions to improve the quality of life for patients and people with disabilities, we hope that you will engage with us and take advantage of our real-world patient engagement experiences and lessons learned,” the letter states. “Do not hesitate to reach out to us and to the experts in this field described above as you consider patient engagement frameworks that may be fit for use within ICER.” Click here to read the letter.
5. ICER’s Cost Model Is Not Only Wrong It’s Also Dangerous
Writing in Forbes, the Pacific Research Institute's Wayne Winegarden says that ICER's model for the antiviral Remdesivir, which may help in treating COVID-19, is "precisely wrong." "Should policymakers listen to ICER, they will be punishing the private companies and individuals who are stepping up to help solve this pandemic," he writes. "The basic logic of incentives tells us that fewer people will do what is right if you punish them for doing the right thing. Essentially, this is what ICER’s cost model does." Click here to read the article.
6. Gunnar Esiason: A Flawed Economic Model Should Not Be Used to Deny Access to a Miracle Medication
ICER's QALY-based models should not be used to deny lifesaving drugs to patients like him, writes Gunnar Esiason, who is living with cystic fibrosis. "The medication that has turned my life around has, however, come under the suspicious eye of a watchdog group called the Institute for Clinical and Economic Review," he writes. "ICER uses a discriminatory cost-effectiveness model called Quality-Adjusted Life Years to determine the value of different medications. QALY, which ICER calls the 'gold standard' to determine cost-effectiveness, is a utility analysis that evaluates the price of a particular drug against its efficacy in improving a person’s life, or according to the model, the utility value recovered by the drug. It is discriminatory because it does not value years of life equally for people who are terminally ill compared with people who are healthy." Click here to read the op-ed.
7. In Letter to PCORI, PIPC Offers Input on Next 10 Years
In a letter to the Patient-Centered Outcomes Research Institute (PCORI), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho offered input on the next 10 years of PCORI. Chairman Coelho framed PIPC’s recommendations around three core principles: relevance, timeliness, and trust. Specifically, he encouraged PCORI to: (1) create a national agenda for research priorities; (2) expand collection of and access to patient-centered outcomes; (3) advance use of patient-centered outcomes in value assessment; and (4) promote patient-centered methodologies. “This is a crucial moment to build on PCORI’s success for another 10 years,” wrote Chairman Coelho. “Success, we believe, will entail effectively connecting PCORI and its research strengths to the current, pressing needs of our health care system and the patients and caregivers it serves. Click here to read the letter.
8. ICER Report Adds Insult to Injury for Cystic Fibrosis Patients
In the latest PIPC Patient Blog, Siri Vaeth writes that ICER's evaluation of breakthrough cystic fibrosis (CF) drugs does not value the lives and wellbeing of people living with CF, such as her daughter. "ICER’s reports are based on a discriminatory metric, the Quality-Adjusted Life Year, which quite simply measures the lives of people with disabilities and chronic illnesses, like my daughter, as less valuable than those of “healthy” people," she writes. "ICER’s report found that Trikafta had clear clinical benefit. Indeed, they gave Trikafta an 'A,' their highest rating for comparative clinical effectiveness....Without question, this drug is a breakthrough. For many patients it can turn CF from a definitive death sentence into a chronic life-threatening disease. Despite this clear clinical benefit, ICER also found that the drug is 'not worth the cost,' even if it were a curative therapy. Put bluntly, ICER believes that my daughter is not worth treating." Click here to read the blog.
9. 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: COVID-19 pandemic is extra difficult for cystic fibrosis patients, and the government still will not provide access to life-changing drugs. Mom starts petition to repeal new rules that make it more difficult for her child to access cystic fibrosis medication he needs. Click here to read more about the changes.
- New Zealand. The government's new funding boost for Pharmac does not do enough to help cancer patients. Click here and here to read more.
10. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments
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: MARCH 2020: DEADLINES PUSHED BACK 2-3 MONTHS. Draft Evidence Report and Voting Questions AVAILABLE, Comment Period OPEN through 6/24/2020. Meeting 8/13/2020: The Midwest CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for NASH.
- Hemophilia A: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Revised Scoping Document available. 6/15/2020: Research Protocol. Meeting 11/5/2020: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for hemophilia.
- Bladder Cancer: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Draft Scoping Document available, comment period open through 6/1/2020.
- Opioids: Digital Apps: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Draft Scoping Document available, Comment Period open through 6/1/2020.
- Opioids: Supervised Injection Centers: Draft Scoping Document AVAILABLE, Comment period open through 6/9/2020.
11. Upcoming Events and Webinars
PCORI Advisory Panel on Patient Engagement Spring 2020 Meeting
June 4-5, 2020
Click here for details.
PCORI Advisory Panel on Healthcare Delivery and Disparities Research Spring 2020 Meeting
June 11, 2020
Click here for details.
PCORI Board of Governors Meeting
June 23, 2020
Click here for details.
12. Medical Journal Articles
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.
When Guidelines Recommend Shared Decision-Making, click here to view.
13. AHRQ Effective Program Updates
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.
OPEN FOR COMMENT THROUGH JUNE 12: Technical Brief: Prevention, Diagnosis, and Management of Opioids, Opioid Misuse and Opioid Use Disorder in Older Adults. Click here to view.
Research Protocol: No-Touch Modalities for Disinfection of Hospital/Acute Care Settings: A Rapid Evidence Review. Click here to view.
Research Protocol: Masks for Prevention of COVID-19 in Healthcare and Community Settings. Click here to view.
Systematic Review: Labor Dystocia. Click here to view.
Systematic Review: Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia. Click here to view.
Technical Brief: Characteristics of Existing Asthma Self-Management Education Packages. Click here to view.
Systematic Review: Opioid Treatments for Chronic Pain. Click here to view.