In This Week’s Issue:
1. Webinar on Protecting Patients with Cystic Fibrosis, click here for more information and to register.
2. IVI: COVID-19 Forces a Reassessment of Measuring Value, click here to read the article.
3. The Prior Authorization Process Must be Reformed, click here to read the op-ed.
4. Key Issues with ICER's Report on COVID-19, click here to read PIPC's one-pager.
5. Beware Undervaluing COVID-19 Drugs, click here to read the op-ed.
6. New Survey: Majority of Americans Don't Know Healthcare Rationing Takes Place in Their Own Backyard, click here to read more.
7. Over 60 Leading Patient and Disability Groups Join PIPC in Letter to New ICER VP for Patient Engagement, click here to read the letter.
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, 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.
1. Webinar on Protecting Patients with Cystic Fibrosis, click here for more information and to register.
2. IVI: COVID-19 Forces a Reassessment of Measuring Value, click here to read the article.
3. The Prior Authorization Process Must be Reformed, click here to read the op-ed.
4. Key Issues with ICER's Report on COVID-19, click here to read PIPC's one-pager.
5. Beware Undervaluing COVID-19 Drugs, click here to read the op-ed.
6. New Survey: Majority of Americans Don't Know Healthcare Rationing Takes Place in Their Own Backyard, click here to read more.
7. Over 60 Leading Patient and Disability Groups Join PIPC in Letter to New ICER VP for Patient Engagement, click here to read the letter.
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, 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.
1. Webinar on Protecting Patients with Cystic Fibrosis
On June 9, Cystic Fibrosis advocates Gunnar Esiason and Siri Vaeth will be featured on a webinar focusing on protecting patients with cystic fibrosis from discrimination by ICER and its QALY-based studies. The webinar will be hosted by the Pioneer Institute and feature the Institute’s Dr. William Smith and will be moderated by Mary Vought. Click here for more information and to register.
2. IVI: COVID-19 Forces a Reassessment of Measuring Value
The Innovation and Value Initiative (IVI) writes that the ongoing COVID-19 pandemic is forcing stakeholders to reassess how value can be measured. "Many have commented on the work of the Institute for Clinical and Economic Review (ICER) in conducting a first cost-effectiveness analysis of the product, with an eye toward informing its potential 'value-based price,'" it says in an article. "As companies tackle rapid investigations into therapies—including yet-unrealized vaccines and potential cures—we think it crucial to take a broader perspective in defining value....How 'value' is determined will have long-term consequences on the future investments in COVID-19 treatments. The unintended impact of narrow assessments could create disincentives for investment in novel treatments that could offer improvements or even a cure." Click here to read the article.
3. The Prior Authorization Process Must be Reformed
Writing in The Hill, Occam Health's Vincent J. Rogusky says that insurers' prior authorization processes are in dire need of reform. "First and foremost, the states should suspend all insurance companies' prior authorization programs for the pandemic duration. But after the pandemic subsides, it does not make sense to return to the status quo," he writes. "[T]he costs of prior authorizations — from the impact on patients' health to a vastly increased administrative burden for physicians — was reaching a breaking point even before the dawn of the pandemic. Now is the time for permanent reform." Click here to read the op-ed.
4. Key Issues with ICER's Report on COVID-19
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.
5. 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.
6. 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.
7. 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.
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.
9. 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.
10. 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.
11. 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.
12. 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.
On June 9, Cystic Fibrosis advocates Gunnar Esiason and Siri Vaeth will be featured on a webinar focusing on protecting patients with cystic fibrosis from discrimination by ICER and its QALY-based studies. The webinar will be hosted by the Pioneer Institute and feature the Institute’s Dr. William Smith and will be moderated by Mary Vought. Click here for more information and to register.
2. IVI: COVID-19 Forces a Reassessment of Measuring Value
The Innovation and Value Initiative (IVI) writes that the ongoing COVID-19 pandemic is forcing stakeholders to reassess how value can be measured. "Many have commented on the work of the Institute for Clinical and Economic Review (ICER) in conducting a first cost-effectiveness analysis of the product, with an eye toward informing its potential 'value-based price,'" it says in an article. "As companies tackle rapid investigations into therapies—including yet-unrealized vaccines and potential cures—we think it crucial to take a broader perspective in defining value....How 'value' is determined will have long-term consequences on the future investments in COVID-19 treatments. The unintended impact of narrow assessments could create disincentives for investment in novel treatments that could offer improvements or even a cure." Click here to read the article.
3. The Prior Authorization Process Must be Reformed
Writing in The Hill, Occam Health's Vincent J. Rogusky says that insurers' prior authorization processes are in dire need of reform. "First and foremost, the states should suspend all insurance companies' prior authorization programs for the pandemic duration. But after the pandemic subsides, it does not make sense to return to the status quo," he writes. "[T]he costs of prior authorizations — from the impact on patients' health to a vastly increased administrative burden for physicians — was reaching a breaking point even before the dawn of the pandemic. Now is the time for permanent reform." Click here to read the op-ed.
4. Key Issues with ICER's Report on COVID-19
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.
5. 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.
6. 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.
7. 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.
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: MP is working to get a lifesaving cystic fibrosis drug approved by Health Canada. The "new normal" with COVID-19 doesn't work for people with cystic fibrosis.
- New Zealand: Cystic fibrosis patient raises money for hospital that saved her life.
9. 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 TODAY, 6/1/2020.
- Opioids: Digital Apps: MARCH 2020: REVIEW PAUSED 2-3 MONTHS. Draft Scoping Document available, Comment Period open through TODAY, 6/1/2020.
- Opioids: Supervised Injection Centers: Draft Scoping Document AVAILABLE, Comment period open through 6/9/2020.
10. 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.
11. 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.
12. 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.
