In This Week’s Issue:
1. Policymakers Should Avoid Importing Discrimination Through Foreign Reference Pricing, see details below.
2. Value Assessment Should be Expanded to Incorporate Health Inequality, click here to read the article.
3. Webinar: Unpacking ICER’s Models Assessing COVID-19 Treatments, click here to view the webinar.
4. Patients Know the Value of Medicines, click here to read the article.
5. OCR Continues its Work to Resolve COVID-19 Discrimination Cases, see details below.
6. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
7. 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.
8. Upcoming Events and Webinars, see details below.
9. Medical Journal Articles, see details below.
10. AHRQ Effective Program Updates, see details below.
1. Policymakers Should Avoid Importing Discrimination Through Foreign Reference Pricing, see details below.
2. Value Assessment Should be Expanded to Incorporate Health Inequality, click here to read the article.
3. Webinar: Unpacking ICER’s Models Assessing COVID-19 Treatments, click here to view the webinar.
4. Patients Know the Value of Medicines, click here to read the article.
5. OCR Continues its Work to Resolve COVID-19 Discrimination Cases, see details below.
6. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
7. 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.
8. Upcoming Events and Webinars, see details below.
9. Medical Journal Articles, see details below.
10. AHRQ Effective Program Updates, see details below.
1. Policymakers Should Avoid 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, but we know patients in other countries suffer from restrictions and delays in access to needed treatments. Importing international prices could have very negative implications for our nation’s most vulnerable. 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.
2. Value Assessment Should be Expanded to Incorporate Health Inequality
The value of reduced inequality should be factored into value assessment, write Jason Shafrin and Meena Venkatachalam in the Health Affairs blog. "In a time when calls for equity are ringing through all sectors of society, symbolized most prominently by the Black Lives Matter movement, value assessment frameworks must change," they write. "The solution to the problem is not to have the government favor treatments for one race compared to another. Rather, treatments developed for patient populations with disproportionately poor outcomes should be valued more than those for individuals who already can expect good health outcomes." Click here to read the article.
3. Webinar: Unpacking ICER’s Models Assessing COVID-19 Treatments
On July 9, the Partnership to Improve Patient Care held a webinar to discuss the implications of the Institute for Clinical and Economic Review's assessment on treatments for the novel coronavirus (COVID-19). 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 thatwould deny them care in a shortage. In the midst of this, 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. Participants discussed how this model exacerbates the existing challenges of using QALYs and “average” inputs to determine value, and its relation to the “QALY Logic” that disability lawyers are fighting to ensure civil rights laws are enforced against restricted access to COVID-19 care during the pandemic. Click here to view the webinar.
4. Patients Know the Value of Medicines
Patients should have a role in deciding the value of medicines, write Thomas Concannon and Lori Frank in STAT News. "Patients, their family members, and the general public have historically been excluded from contributing to value assessment models. We believe that their voices and views should be essential elements in measuring value," they write. "Their exclusion hasn’t been an oversight — it is by design. Setting aside the views of patients — who have the most to gain or lose from health care interventions — is standard operating procedure in pharmacoeconomic and policy research. Advocates of that approach say that summary, societal-level preferences are the only way to generate apples-to-apples comparisons of the benefits and costs of every health care option. We contend that obscuring patient perspectives hurts the long-term prospects of these methods and that limited resources will be allocated to interventions for a precisely but thinly conceived notion of 'the public.'" Click here to read the article.
5. OCR Continues its Work to Resolve COVID-19 Discrimination Cases
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. Click here to read a letter sent by AARP. Click here to read PIPC Chairman Coelho’s opinion in the New York Daily News.
To track nondiscrimination and civil rights activities related to COVID-19, click here to view information on the Center for Public Representation website.
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.
7. 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.
8. Upcoming Events and Webinars
PCORI Advisory Panel on Clinical Trials Summer 2020 Meeting
July 31, 2020
Click here for details.
PCORI Board of Governors Meeting
August 25, 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.
9. Medical Journal Articles
Engaging Patients and Stakeholders in Preresearch: Findings from the Pipeline to Proposal Awards Initiative, click here to view.
Why Clinical Trials May Not Help Patients Make Treatment Decisions: Results from Focus Group Discussions with 22 Patients, click here to view.
Defining Patient Engagement in Research: Results of a Systematic Review and Analysis: Report of the ISPOR Patient-Centered Special Interest Group, click here to view.
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.
10. AHRQ Effective Program Updates
OPEN FOR COMMENT THROUGH 8/13/2020: Key Questions: Management Strategies for Infantile Epilepsy. Click here to view.
Research Protocol: Prehabilitation and Rehabilitation for Major Joint Replacement. Click here to view.
Research Protocol: Disparities and Barriers for Pediatric Cancer Survivorship Care. 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.
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.
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, but we know patients in other countries suffer from restrictions and delays in access to needed treatments. Importing international prices could have very negative implications for our nation’s most vulnerable. 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.
2. Value Assessment Should be Expanded to Incorporate Health Inequality
The value of reduced inequality should be factored into value assessment, write Jason Shafrin and Meena Venkatachalam in the Health Affairs blog. "In a time when calls for equity are ringing through all sectors of society, symbolized most prominently by the Black Lives Matter movement, value assessment frameworks must change," they write. "The solution to the problem is not to have the government favor treatments for one race compared to another. Rather, treatments developed for patient populations with disproportionately poor outcomes should be valued more than those for individuals who already can expect good health outcomes." Click here to read the article.
3. Webinar: Unpacking ICER’s Models Assessing COVID-19 Treatments
On July 9, the Partnership to Improve Patient Care held a webinar to discuss the implications of the Institute for Clinical and Economic Review's assessment on treatments for the novel coronavirus (COVID-19). 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 thatwould deny them care in a shortage. In the midst of this, 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. Participants discussed how this model exacerbates the existing challenges of using QALYs and “average” inputs to determine value, and its relation to the “QALY Logic” that disability lawyers are fighting to ensure civil rights laws are enforced against restricted access to COVID-19 care during the pandemic. Click here to view the webinar.
4. Patients Know the Value of Medicines
Patients should have a role in deciding the value of medicines, write Thomas Concannon and Lori Frank in STAT News. "Patients, their family members, and the general public have historically been excluded from contributing to value assessment models. We believe that their voices and views should be essential elements in measuring value," they write. "Their exclusion hasn’t been an oversight — it is by design. Setting aside the views of patients — who have the most to gain or lose from health care interventions — is standard operating procedure in pharmacoeconomic and policy research. Advocates of that approach say that summary, societal-level preferences are the only way to generate apples-to-apples comparisons of the benefits and costs of every health care option. We contend that obscuring patient perspectives hurts the long-term prospects of these methods and that limited resources will be allocated to interventions for a precisely but thinly conceived notion of 'the public.'" Click here to read the article.
5. OCR Continues its Work to Resolve COVID-19 Discrimination Cases
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. Click here to read a letter sent by AARP. Click here to read PIPC Chairman Coelho’s opinion in the New York Daily News.
To track nondiscrimination and civil rights activities related to COVID-19, click here to view information on the Center for Public Representation website.
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.
- Canada: Canadians demand access to lifesaving cystic fibrosis drug recently approved in the UK. Toddler racing against time to get critical spinal muscular atrophy therapy, with NHL players and celebrities working to raise money and awareness.
- United Kingdom: After 11-year fight, "wonder drug" could finally be available on NHS. Newly available cystic fibrosis drug is changing lives, but highlights NHS' past failures.
7. 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 8/272020: 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: Research Protocol Available. 8/6/2020: Model Analysis Plan.
- Opioids: Digital Apps: Research Protocol Available. 8/3/2020: Model Analysis Plan.
- Opioids: Supervised Injection Centers: Revised Scoping Document AVAILABLE. 7/21/2020: Research Protocol.
- High Cholesterol: Draft Scoping Document Available. Public Comments Open through 7/24/2020.
- Anemia in Chronic Kidney Disease: Draft Scoping Document Available. Public Comments Open through 8/7/2020.
- Unsupported Price Increase Assessment: 1/8/2021: Final Assessment and Report.
8. Upcoming Events and Webinars
PCORI Advisory Panel on Clinical Trials Summer 2020 Meeting
July 31, 2020
Click here for details.
PCORI Board of Governors Meeting
August 25, 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.
9. Medical Journal Articles
Engaging Patients and Stakeholders in Preresearch: Findings from the Pipeline to Proposal Awards Initiative, click here to view.
Why Clinical Trials May Not Help Patients Make Treatment Decisions: Results from Focus Group Discussions with 22 Patients, click here to view.
Defining Patient Engagement in Research: Results of a Systematic Review and Analysis: Report of the ISPOR Patient-Centered Special Interest Group, click here to view.
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.
10. AHRQ Effective Program Updates
OPEN FOR COMMENT THROUGH 8/13/2020: Key Questions: Management Strategies for Infantile Epilepsy. Click here to view.
Research Protocol: Prehabilitation and Rehabilitation for Major Joint Replacement. Click here to view.
Research Protocol: Disparities and Barriers for Pediatric Cancer Survivorship Care. 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.
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.
