In This Week’s Issue:
1. 60 Patient and Disability Groups Join PIPC in Comment Letter to HHS Opposing Most Favored Nations Rule, see details below.
2. Emerging Threats in States for Use of Discriminatory Metrics, see details below.
3. ICER Hosts Public Meeting for its Assessment of Treatments for High Cholesterol, see details below.
4. IVI Welcomes New Chief Scientific Officer, see details below.
5. NCD Letter on 'Most Favored Nations' Rule, click here to read the letter.
6. COVID-19 Response for Vulnerable Patients, see details below.
7. PCORI Seeks Nominations for Advisory Panels, click here to learn more, submit a nomination, or apply to be on an advisory panel.
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: Atopic Dermatitis, Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's 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.
1. 60 Patient and Disability Groups Join PIPC in Comment Letter to HHS Opposing Most Favored Nations Rule, see details below.
2. Emerging Threats in States for Use of Discriminatory Metrics, see details below.
3. ICER Hosts Public Meeting for its Assessment of Treatments for High Cholesterol, see details below.
4. IVI Welcomes New Chief Scientific Officer, see details below.
5. NCD Letter on 'Most Favored Nations' Rule, click here to read the letter.
6. COVID-19 Response for Vulnerable Patients, see details below.
7. PCORI Seeks Nominations for Advisory Panels, click here to learn more, submit a nomination, or apply to be on an advisory panel.
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: Atopic Dermatitis, Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's 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.
1. 60 Patient and Disability Groups Join PIPC in Comment Letter to HHS Opposing Most Favored Nations Rule
60 leading groups and individuals representing the patient and disability communities signed onto the Partnership to Improve Patient Care's (PIPC) comment letter to the Department of Health and Human Services (HHS) opposing the Trump administration's Most Favored Nations (MFN) rulemaking.
The letter outlines several concerns with the regulation, chiefly that it would: (1) rely on the discriminatory quality-adjusted-life-year (QALY) metric and other means of cost-effectiveness assessment that would harm patients; (2) lead to discrimination that is in direct conflict with American civil rights and disability policy; and (3) cause undue disruption in the health care system that will result in immediate access issues for patients.
"We support the agency’s goal of lowering drug prices for all Americans, but it is critical that it is done in ways that work for all Americans," the letter states. "The MFN rule ignores the boundaries of statute creating the Center for Medicare and Medicaid Innovation that were put in place to protect patients, would import discriminatory standards for policymaking used in MFN nations, and lead directly to lack of access to needed treatments for many Americans. "
Click here to read the letter. In addition, the Alliance for Aging Research (AAR) submitted its own letter opposing MFN. Click here to read AAR's letter.
2. Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment or are considering policies to import QALY-based decisions from other countries. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. Click here to view the Value Our Health state template legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making. Click here to view a one pager about the flaws in ICER’s methodology. Click here to view information from experts on the downside of referencing foreign countries. Click here to learn about statutory protections against use of QALYs.
Washington State
Washington State bill SB 5020 was recently introduced for the 2021 session. The legislation states, "In order to determine whether a price increase for a prescription drug is unsupported by new clinical evidence, the state must utilize and rely upon the analyses of prescription drugs prepared annually by the institute for clinical and economic review and published in its annual unsupported price increase report.” Treatments identified by ICER would then be subject to the penalties outlined in the legislation despite ICER’s reliance on quality-adjusted life years (QALYs) which is known to be a discriminatory metric. Federal policymakers on both sides of the aisle have expressed concern that measures that would unlawfully discriminate on the basis of disability or age are subject to section 504 of the Rehabilitation Act, the Americans with Disabilities Act, the Age Discrimination Act, and section 1557 of the Affordable Care Act - including state Medicaid agencies. PIPC provided written testimony on this bill on January 19 in advance of the hearing on Friday, January 22, 2021. Click here to read PIPC’s testimony. Click here to read testimony from Epilepsy Foundation. Testimony submitted by AAPD and AUCD will be made available on their websites.
New Mexico
The legislature in the State of New Mexico has introduced HOUSE BILL 154 which would create a prescription drug affordability board. The proposed law would authorize the board to review the cost of prescription drugs and vote on whether to impose an upper payment limit on purchases and payer reimbursements of prescription drug products in the state, similar to the State of New York. We are concerned that, also similar to New York, the bill explicitly authorizes the board to enter into contracts with qualified, independent third parties (such as the Institute for clinical and Economic Review) for services necessary to carry out the powers and duties of the board. New York explicitly references ICER which is known to refer to the quality-adjusted life year (QALY) as the “gold standard” for value assessment. Organizations supporting Value Our Health have developed a template for state legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making.
Pennsylvania
In the past, we have reported that Pennsylvania is considering the establishment of a Health Policy Committee, modeled after Massachusetts. The Pennsylvania State Treasurer is proposing to create a Drug Affordability Review Board and to institute “value-based purchasing” of pharmaceuticals. Interestingly, the Treasurer specifically references VBP arrangements in Oklahoma but does not mention that the Oklahoma state legislature subsequently barred the use of QALYs. We will follow these developments closely to see if Pennsylvania similarly seeks to bar QALYs as part of their considerations.
Vermont
At a recent meeting of the Vermont Green Mountain Care Board’s (GMCB) pharmaceutical technical advisory group, it came to light that the state is considering legislative initiatives similar to New York that would potentially rely heavily on the work of ICER. GMCB provided a link to a summary of state actions that advanced legislative initiatives from the National Association of State Health Policy (NASHP), including initiatives to reference QALY-based decisions in foreign countries such as Canada and referencing ICER studies. We will follow these developments closely. Click here to learn more about the how patients with cystic fibrosis are impacted by Canadian reimbursement and coverage policies.
Tennessee
We understand that patient and disability advocates are deeply concerned - for a variety of reasons - about the recently approved TennCare waiver. PIPC and other stakeholders sent a letter to CMS opposing the waiver application due to its implications for discrimination as it would likely utilize QALYs to determine cost effectiveness of treatments as part of limited formulary determinations. Unfortunately, CMS approved the waiver. They included a statement that the state should ensure that non-discrimination clauses as provided in 45 CFR 156.125 and 45 CFR 156.225, which prevent discrimination on the basis of a number of factors, including health conditions, are applied to the formulary. But they did not go so far as to explicitly call out that discriminatory measures such as QALYs fall into the category of violating these laws. Instead, they explicitly allow for limited formularies and increased barriers to receiving the right treatment at the right time. We believe that this waiver approval serves as an invitation to incorporate discriminatory cost and clinical effectiveness measures based on averages that will not take into account the unique characteristics and priorities of people with disabilities and serious chronic conditions. Click here to view the waiver approval. Click here to view the stakeholder letter opposing the waiver application. Click here to view Chairman Coelho’s blog stating "it is not enough to have CMS point out anti-discrimination laws such as the Americans with Disabilities Act if the federal government is going to give states explicit authority in an approved waiver to do just that - discriminate."
3. ICER Hosts Public Meeting for its Assessment of Treatments for High Cholesterol
On February 5, 2021, ICER will host is public meeting for its assessment evaluating treatments for high LDL or “bad” cholesterol. ICER’s review is examining medications that treat an inherited form of high cholesterol as well as secondary prevention of ASCVD. Increasingly, questions of access and coverage to new medications are influenced by ICER’s assessments, so it is imperative the patient voice is heard. Click here to learn more and get involved by reviewing resources from the Partnership to Advance Cardiovascular Health.
4. IVI Welcomes New Chief Scientific Officer
The Innovation and Value Initiative (IVI) – a nonprofit organization dedicated to advancing the science, practice, and use of value assessment in healthcare – announced that Rick Chapman, Ph.D., will be its next Chief Scientific Officer. “As value assessment plays an increasingly important role in healthcare – and as the number of assessment organizations grows – we’re thrilled Rick is joining the IVI team,” said Jennifer Bright, IVI’s Executive Director. “His wealth of health economics and outcomes research experience will guide IVI’s contributions to research and methods that ensure patient-centricity, transparency, and flexibility in economic modeling and value assessment.”
“I’m excited to join this expanding value assessment nonprofit at such a pivotal time,” Chapman said. “If value frameworks are to be used to enhance patients’ lives, improving the design of value assessments to better incorporate patient perspectives and lived experiences at the onset of model construction is paramount. I’m looking forward to helping IVI apply its patient-centric and transparent approach to additional disease-state models.”
5. NCD Letter on 'Most Favored Nations' Rule
The National Council on Disability sent a letter to the administration criticizing the "Most Favored Nations" rule which would import discriminatory QALYs to the U.S. "The need to control Medicare prescription drug costs is important to seniors and the Federal Government alike, but the MFN Rule is highly problematic on several levels," NCD states. "It runs contrary to federal law by adopting foreign drug prices set in reliance on the quality adjusted life year (QALY), a cost-effectiveness measure that devalues the lives of people with chronic illnesses and limits their access to highly effective drugs and treatments; it will cause doctors to stop providing necessary care, thereby worsening chronic diseases and increasing deaths of seniors; and it is a major policy change developed and implemented without providing the opportunity for public comment from affected stakeholders." Click here to read the letter.
6. COVID-19 Response for Vulnerable Patients
In March, the National Council on Disability requested the quick issuance of guidance to make clear that, under federal law, people with disabilities had the right to receive nondiscriminatory care. HHS' Office of Civil Rights (OCR) issued a bulletin on March 28 on the civil rights responsibilities of healthcare providers during the COVID-19 pandemic that detailed responsibilities for non-discrimination under the Americans with Disabilities Act (the ADA) and other federal laws. OCR made clear that treatment decisions must be made consistent with federal law - based on an individualized assessment of the patient based on objective medical evidence – not influenced by stereotypes, assessments of quality of life, or judgments about a person’s relative “worth” based on the presence or absence of disabilities. This guidance served an important purpose, but even its issuance has not completely stopped the development of discriminatory COVID-19 policies across the nation, and OCR continues to receive complaints alleging that states and hospitals across the nation are discriminating in access to COVID-19 care under the ADA, Section 504 of the Rehabilitation Act (Section 504), and the Affordable Care Act (the ACA). Several federal lawsuits have also been filed alleging discrimination in access to COVID-19 care for people with disabilities. In a comment letter, NCD expresses its concerns on a vaccine allocation framework developed by the National Academies, particularly that it should include a clear statement that people with disabilities have a federally protected right to equally access healthcare. Click here to read the comments.
The Consortium for Citizens with Disabilities (CCD) sent a letter to President Biden's COVID-19 Advisory Board calling for individuals with disabilities to be treated equitably in the response to the virus. Many individuals with disabilities have underlying health conditions that make them more vulnerable to the disease, and CCD is calling for that to be taken into account when the initial doses of COVID-19 vaccine are allocated. In addition, the group warned against rationing care or putting individuals with disabilities at a disadvantage when it comes to receiving COVID-19 treatment. Click here to read the letter.
The Advisory Committee on Immunization Practices (ACIP) announced in late November that residents of “long-term care facilities” were included in Phase 1a of allocation in their framework, alongside health care workers. The definition of long-term care facilities is very broad and includes individuals who are, for whatever reason, unable to live independently. However, the real decisionmakers are the states, and ACIP's recommendations provide a guide to governors as they decide how to allocate vaccines.
The Association of University Centers on Disabilities (AUCD) sent a letter to ACIP calling for people with disabilities to be included in phase 1 of ACIP's distribution framework. It also called for caregivers to be included in phase 1. "It is both an ethical imperative to reduce harm and health inequities for this vulnerable population, and a practical measure to mitigate the spread of the novel coronavirus," the letter read. AUCD also issued an FAQ document about vaccine distribution concerns for the disability community. Click here to read the letter. Click here to read the FAQ.
7. PCORI Seeks Nominations for Advisory Panels
PCORI is currently seeking nominations for appointments to its advisory panels. The advisory panels must include patients or patient advocates. PCORI's staff, board, and methodology committee take advisory panels' recommendations into account when making decisions and determinations. PIPC encourages patients and patient advocates to submit nominations to serve on PCORI's advisory panels, including on the Advisory Panel on Clinical Effectiveness and Decision Science, Advisory Panel on Patient Engagement, and Advisory Panel on Rare Disease. Nominations are open through March 31, 2020. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
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: Atopic Dermatitis, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's 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.
10. Upcoming Events and Webinars
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 2, 2021
Click here for details.
Webinar: The Value and Effective Use of RWE in Pricing and Market Access
February 4, 2021
Click here for details.
PCORI Board of Governors Meeting
February 9, 2021
Click here for details.
11. Medical Journal Articles
Experiences of an HCV Patient Engagement Group: A Seven-Year Journey, click here to view.
Choosing Important Health Outcomes for Comparative Effectiveness Research: 6th Annual Update to a Systematic Review of Core Outcome Sets for Research, click here to view.
Health Technology Assessment With Diminishing Returns to Health: The Generalized Risk-Adjusted Cost-Effectiveness (GRACE) Approach, click here to view.
Comparative Effectiveness Research Needs to Consider Optimal Dosing and Scheduling, click here to view.
Are Patients More Adherent to Newer Drugs?, click here to view.
Improving the Quality of Person-Centred Healthcare from the Patient Perspective: Development of Person-Centred Quality Indicators, click here to view.
Six Ways to Foster Community-Engaged Research During Times of Societal Crises, click here to view.
Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI), click here to view.
Improving Access and Quality of Health Care in the United States: Shared Goals Among Patient Advocates, click here to view.
Using Electronic Health Record Data to Identify Comparator Populations for Comparative Effectiveness Research, click here to view.
Pharmaceutical Pricing Benchmarks: Governmental Versus Private Sector, click here to view.
12. AHRQ Effective Program Updates
Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Research Protocol: Improving Rural Health Through Telehealth-Guided Provider-to-Provider Communication. Click here to view.
Systematic Review: Treatments for Acute Pain. Click here to view.
Systematic Review: Acute Treatments for Episodic Migraine. Click here to view.
Research Protocol: Interventional Treatments for Acute and Chronic Pain: Systematic Review. Click here to view.
Research Protocol: Diagnostic Errors in the Emergency Department. Click here to view.
Research Protocol: Maternal and Childhood Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Click here to view.
White Paper: Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression. Click here to view.
Research Protocol: Maternal and Childhood Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Click here to view.
60 leading groups and individuals representing the patient and disability communities signed onto the Partnership to Improve Patient Care's (PIPC) comment letter to the Department of Health and Human Services (HHS) opposing the Trump administration's Most Favored Nations (MFN) rulemaking.
The letter outlines several concerns with the regulation, chiefly that it would: (1) rely on the discriminatory quality-adjusted-life-year (QALY) metric and other means of cost-effectiveness assessment that would harm patients; (2) lead to discrimination that is in direct conflict with American civil rights and disability policy; and (3) cause undue disruption in the health care system that will result in immediate access issues for patients.
"We support the agency’s goal of lowering drug prices for all Americans, but it is critical that it is done in ways that work for all Americans," the letter states. "The MFN rule ignores the boundaries of statute creating the Center for Medicare and Medicaid Innovation that were put in place to protect patients, would import discriminatory standards for policymaking used in MFN nations, and lead directly to lack of access to needed treatments for many Americans. "
Click here to read the letter. In addition, the Alliance for Aging Research (AAR) submitted its own letter opposing MFN. Click here to read AAR's letter.
2. Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment or are considering policies to import QALY-based decisions from other countries. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. Click here to view the Value Our Health state template legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making. Click here to view a one pager about the flaws in ICER’s methodology. Click here to view information from experts on the downside of referencing foreign countries. Click here to learn about statutory protections against use of QALYs.
Washington State
Washington State bill SB 5020 was recently introduced for the 2021 session. The legislation states, "In order to determine whether a price increase for a prescription drug is unsupported by new clinical evidence, the state must utilize and rely upon the analyses of prescription drugs prepared annually by the institute for clinical and economic review and published in its annual unsupported price increase report.” Treatments identified by ICER would then be subject to the penalties outlined in the legislation despite ICER’s reliance on quality-adjusted life years (QALYs) which is known to be a discriminatory metric. Federal policymakers on both sides of the aisle have expressed concern that measures that would unlawfully discriminate on the basis of disability or age are subject to section 504 of the Rehabilitation Act, the Americans with Disabilities Act, the Age Discrimination Act, and section 1557 of the Affordable Care Act - including state Medicaid agencies. PIPC provided written testimony on this bill on January 19 in advance of the hearing on Friday, January 22, 2021. Click here to read PIPC’s testimony. Click here to read testimony from Epilepsy Foundation. Testimony submitted by AAPD and AUCD will be made available on their websites.
New Mexico
The legislature in the State of New Mexico has introduced HOUSE BILL 154 which would create a prescription drug affordability board. The proposed law would authorize the board to review the cost of prescription drugs and vote on whether to impose an upper payment limit on purchases and payer reimbursements of prescription drug products in the state, similar to the State of New York. We are concerned that, also similar to New York, the bill explicitly authorizes the board to enter into contracts with qualified, independent third parties (such as the Institute for clinical and Economic Review) for services necessary to carry out the powers and duties of the board. New York explicitly references ICER which is known to refer to the quality-adjusted life year (QALY) as the “gold standard” for value assessment. Organizations supporting Value Our Health have developed a template for state legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making.
Pennsylvania
In the past, we have reported that Pennsylvania is considering the establishment of a Health Policy Committee, modeled after Massachusetts. The Pennsylvania State Treasurer is proposing to create a Drug Affordability Review Board and to institute “value-based purchasing” of pharmaceuticals. Interestingly, the Treasurer specifically references VBP arrangements in Oklahoma but does not mention that the Oklahoma state legislature subsequently barred the use of QALYs. We will follow these developments closely to see if Pennsylvania similarly seeks to bar QALYs as part of their considerations.
Vermont
At a recent meeting of the Vermont Green Mountain Care Board’s (GMCB) pharmaceutical technical advisory group, it came to light that the state is considering legislative initiatives similar to New York that would potentially rely heavily on the work of ICER. GMCB provided a link to a summary of state actions that advanced legislative initiatives from the National Association of State Health Policy (NASHP), including initiatives to reference QALY-based decisions in foreign countries such as Canada and referencing ICER studies. We will follow these developments closely. Click here to learn more about the how patients with cystic fibrosis are impacted by Canadian reimbursement and coverage policies.
Tennessee
We understand that patient and disability advocates are deeply concerned - for a variety of reasons - about the recently approved TennCare waiver. PIPC and other stakeholders sent a letter to CMS opposing the waiver application due to its implications for discrimination as it would likely utilize QALYs to determine cost effectiveness of treatments as part of limited formulary determinations. Unfortunately, CMS approved the waiver. They included a statement that the state should ensure that non-discrimination clauses as provided in 45 CFR 156.125 and 45 CFR 156.225, which prevent discrimination on the basis of a number of factors, including health conditions, are applied to the formulary. But they did not go so far as to explicitly call out that discriminatory measures such as QALYs fall into the category of violating these laws. Instead, they explicitly allow for limited formularies and increased barriers to receiving the right treatment at the right time. We believe that this waiver approval serves as an invitation to incorporate discriminatory cost and clinical effectiveness measures based on averages that will not take into account the unique characteristics and priorities of people with disabilities and serious chronic conditions. Click here to view the waiver approval. Click here to view the stakeholder letter opposing the waiver application. Click here to view Chairman Coelho’s blog stating "it is not enough to have CMS point out anti-discrimination laws such as the Americans with Disabilities Act if the federal government is going to give states explicit authority in an approved waiver to do just that - discriminate."
3. ICER Hosts Public Meeting for its Assessment of Treatments for High Cholesterol
On February 5, 2021, ICER will host is public meeting for its assessment evaluating treatments for high LDL or “bad” cholesterol. ICER’s review is examining medications that treat an inherited form of high cholesterol as well as secondary prevention of ASCVD. Increasingly, questions of access and coverage to new medications are influenced by ICER’s assessments, so it is imperative the patient voice is heard. Click here to learn more and get involved by reviewing resources from the Partnership to Advance Cardiovascular Health.
4. IVI Welcomes New Chief Scientific Officer
The Innovation and Value Initiative (IVI) – a nonprofit organization dedicated to advancing the science, practice, and use of value assessment in healthcare – announced that Rick Chapman, Ph.D., will be its next Chief Scientific Officer. “As value assessment plays an increasingly important role in healthcare – and as the number of assessment organizations grows – we’re thrilled Rick is joining the IVI team,” said Jennifer Bright, IVI’s Executive Director. “His wealth of health economics and outcomes research experience will guide IVI’s contributions to research and methods that ensure patient-centricity, transparency, and flexibility in economic modeling and value assessment.”
“I’m excited to join this expanding value assessment nonprofit at such a pivotal time,” Chapman said. “If value frameworks are to be used to enhance patients’ lives, improving the design of value assessments to better incorporate patient perspectives and lived experiences at the onset of model construction is paramount. I’m looking forward to helping IVI apply its patient-centric and transparent approach to additional disease-state models.”
5. NCD Letter on 'Most Favored Nations' Rule
The National Council on Disability sent a letter to the administration criticizing the "Most Favored Nations" rule which would import discriminatory QALYs to the U.S. "The need to control Medicare prescription drug costs is important to seniors and the Federal Government alike, but the MFN Rule is highly problematic on several levels," NCD states. "It runs contrary to federal law by adopting foreign drug prices set in reliance on the quality adjusted life year (QALY), a cost-effectiveness measure that devalues the lives of people with chronic illnesses and limits their access to highly effective drugs and treatments; it will cause doctors to stop providing necessary care, thereby worsening chronic diseases and increasing deaths of seniors; and it is a major policy change developed and implemented without providing the opportunity for public comment from affected stakeholders." Click here to read the letter.
6. COVID-19 Response for Vulnerable Patients
In March, the National Council on Disability requested the quick issuance of guidance to make clear that, under federal law, people with disabilities had the right to receive nondiscriminatory care. HHS' Office of Civil Rights (OCR) issued a bulletin on March 28 on the civil rights responsibilities of healthcare providers during the COVID-19 pandemic that detailed responsibilities for non-discrimination under the Americans with Disabilities Act (the ADA) and other federal laws. OCR made clear that treatment decisions must be made consistent with federal law - based on an individualized assessment of the patient based on objective medical evidence – not influenced by stereotypes, assessments of quality of life, or judgments about a person’s relative “worth” based on the presence or absence of disabilities. This guidance served an important purpose, but even its issuance has not completely stopped the development of discriminatory COVID-19 policies across the nation, and OCR continues to receive complaints alleging that states and hospitals across the nation are discriminating in access to COVID-19 care under the ADA, Section 504 of the Rehabilitation Act (Section 504), and the Affordable Care Act (the ACA). Several federal lawsuits have also been filed alleging discrimination in access to COVID-19 care for people with disabilities. In a comment letter, NCD expresses its concerns on a vaccine allocation framework developed by the National Academies, particularly that it should include a clear statement that people with disabilities have a federally protected right to equally access healthcare. Click here to read the comments.
The Consortium for Citizens with Disabilities (CCD) sent a letter to President Biden's COVID-19 Advisory Board calling for individuals with disabilities to be treated equitably in the response to the virus. Many individuals with disabilities have underlying health conditions that make them more vulnerable to the disease, and CCD is calling for that to be taken into account when the initial doses of COVID-19 vaccine are allocated. In addition, the group warned against rationing care or putting individuals with disabilities at a disadvantage when it comes to receiving COVID-19 treatment. Click here to read the letter.
The Advisory Committee on Immunization Practices (ACIP) announced in late November that residents of “long-term care facilities” were included in Phase 1a of allocation in their framework, alongside health care workers. The definition of long-term care facilities is very broad and includes individuals who are, for whatever reason, unable to live independently. However, the real decisionmakers are the states, and ACIP's recommendations provide a guide to governors as they decide how to allocate vaccines.
The Association of University Centers on Disabilities (AUCD) sent a letter to ACIP calling for people with disabilities to be included in phase 1 of ACIP's distribution framework. It also called for caregivers to be included in phase 1. "It is both an ethical imperative to reduce harm and health inequities for this vulnerable population, and a practical measure to mitigate the spread of the novel coronavirus," the letter read. AUCD also issued an FAQ document about vaccine distribution concerns for the disability community. Click here to read the letter. Click here to read the FAQ.
7. PCORI Seeks Nominations for Advisory Panels
PCORI is currently seeking nominations for appointments to its advisory panels. The advisory panels must include patients or patient advocates. PCORI's staff, board, and methodology committee take advisory panels' recommendations into account when making decisions and determinations. PIPC encourages patients and patient advocates to submit nominations to serve on PCORI's advisory panels, including on the Advisory Panel on Clinical Effectiveness and Decision Science, Advisory Panel on Patient Engagement, and Advisory Panel on Rare Disease. Nominations are open through March 31, 2020. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
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.
- Australia: Cancer patient recovers after receiving drug that the government refuses to fund.
- New Zealand: The Diabetes Foundation accuses Pharmac of "penny pinching" and encourages it to cover life-changing drugs for all patients with Type 2 diabetes.
- United Kingdom: Dad runs every street in his city to raise awareness of NHS not covering a life-changing PKU drug. Parents call for NHS to cover a PKU drug so that their children can eat normally.
9. ICER's QALY-Based Study Topics: Atopic Dermatitis, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's 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.
- Atopic Dermatitis: Research Protocol available. 3/22/2021: Model Analysis Plan.
- High Cholesterol: Evidence Report and Response to Public Comments AVAILABLE. Meeting 2/5/2021: The Midwest CEPAC will convene to review treatments for high cholesterol.
- Anemia in Chronic Kidney Disease: Evidence Report and Response to Public Comments AVAILABLE. Meeting 2/11/2021: CTAF will deliberate and vote on evidence presented in ICER’s report on therapies for anemia in chronic kidney disease.
- Lupus Nephritis: Draft Evidence Report AVAILABLE, Comment Period OPEN through 2/8/2021. Meeting 3/26/2021: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for lupus nephritis.
- Multiple Myeloma: Model Analysis Plan available. 2/11/2021: Draft Evidence Report. Meeting 4/16/2021.
- Alzheimer's Disease: Model Analysis Plan available. 3/1/2021: Draft Evidence Report. Meeting 5/7/2020: CTAF will convene virtually to deliberate and vote on evidence presented in ICER's report on Alzheimer's disease.
10. Upcoming Events and Webinars
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 2, 2021
Click here for details.
Webinar: The Value and Effective Use of RWE in Pricing and Market Access
February 4, 2021
Click here for details.
PCORI Board of Governors Meeting
February 9, 2021
Click here for details.
11. Medical Journal Articles
Experiences of an HCV Patient Engagement Group: A Seven-Year Journey, click here to view.
Choosing Important Health Outcomes for Comparative Effectiveness Research: 6th Annual Update to a Systematic Review of Core Outcome Sets for Research, click here to view.
Health Technology Assessment With Diminishing Returns to Health: The Generalized Risk-Adjusted Cost-Effectiveness (GRACE) Approach, click here to view.
Comparative Effectiveness Research Needs to Consider Optimal Dosing and Scheduling, click here to view.
Are Patients More Adherent to Newer Drugs?, click here to view.
Improving the Quality of Person-Centred Healthcare from the Patient Perspective: Development of Person-Centred Quality Indicators, click here to view.
Six Ways to Foster Community-Engaged Research During Times of Societal Crises, click here to view.
Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI), click here to view.
Improving Access and Quality of Health Care in the United States: Shared Goals Among Patient Advocates, click here to view.
Using Electronic Health Record Data to Identify Comparator Populations for Comparative Effectiveness Research, click here to view.
Pharmaceutical Pricing Benchmarks: Governmental Versus Private Sector, click here to view.
12. AHRQ Effective Program Updates
Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Research Protocol: Improving Rural Health Through Telehealth-Guided Provider-to-Provider Communication. Click here to view.
Systematic Review: Treatments for Acute Pain. Click here to view.
Systematic Review: Acute Treatments for Episodic Migraine. Click here to view.
Research Protocol: Interventional Treatments for Acute and Chronic Pain: Systematic Review. Click here to view.
Research Protocol: Diagnostic Errors in the Emergency Department. Click here to view.
Research Protocol: Maternal and Childhood Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Click here to view.
White Paper: Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression. Click here to view.
Research Protocol: Maternal and Childhood Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Click here to view.
