In This Week’s Issue:
1. PIPC Urges House to Protect Patients and People with Disabilities in Title 1 of New House Bill, see details below.
2. NHC Patient Community Training on Value Assessment, click here to read more and to watch the training.
3. PCORI Advocacy 101: The Politics and Policy of PCORI Reauthorization, click here for a complete recording of the event and the slides used in the presentation.
4. New NQF Resource on Patient-Centered Renal Care, click here to read more.
5. Proposed Changes to ICER Framework Available for Comment, click here to view the changes and to comment and see below for more.
6. ICER Announces Possible 2020 Assessments, click here to see the list of possible assessments.
7. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training, click here to learn more and to apply for the training.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
9. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, 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. PIPC Urges House to Protect Patients and People with Disabilities in Title 1 of New House Bill, see details below.
2. NHC Patient Community Training on Value Assessment, click here to read more and to watch the training.
3. PCORI Advocacy 101: The Politics and Policy of PCORI Reauthorization, click here for a complete recording of the event and the slides used in the presentation.
4. New NQF Resource on Patient-Centered Renal Care, click here to read more.
5. Proposed Changes to ICER Framework Available for Comment, click here to view the changes and to comment and see below for more.
6. ICER Announces Possible 2020 Assessments, click here to see the list of possible assessments.
7. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training, click here to learn more and to apply for the training.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
9. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, 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. PIPC Urges House to Protect Patients and People with Disabilities in Title 1 of New House Bill
Last week, legislation was introduced in the House of Representatives which included certain provisions concerning patients and people with disabilities in Title 1. This section of the bill takes an approach that is entrenched in controversial comparative clinical and cost effectiveness standards that force patients and people with disabilities into “one-size-fits-all” decisions about their health. PIPC Chairman Tony Coelho expressed concern that these provisions place hard-fought existing patient protections under serious threat. First, it authorizes national determinations of value to be based on comparative or cost effectiveness standards that ignore differences in patient needs and discriminate against vulnerable subgroups of patients and people with disabilities, opening the door to reliance on assessments like those conducted by the Institute for Clinical and Economic Review (ICER). Second, it relies on policy decisions made in other countries that we know establish prices based on discriminatory cost-effectiveness standards (such as Quality-Adjusted Life Years or QALYs) and similar average metrics. Third, it lacks any reference to existing statutory safeguards against misuse of QALYs and similar average metrics. PIPC supports policies to improve care and affordability for patients, adopt and extend safeguards in current statute that prohibit application of discriminatory cost-effectiveness thresholds in Medicare (whether done overtly by Medicare or covertly via “comparative effectiveness analysis” or reference to foreign countries’ use of these thresholds) and codify criteria for patient-centeredness called for in CMMI’s statute. Click here to view the bill. Click here to view prior stakeholder letter on referencing International pricing. Click here to view information on Value Our Health.
2. NHC Patient Community Training on Value Assessment
On September 6, the National Health Council held a training for patients and organizations to learn about value assessment. Speakers covered a number of topics including the impacts of patient engagement on value assessment, how value assessment affects payer decision-making, and the importance of incorporating patient and caregiver experience. Click here to read more and to watch the training.
3. PCORI Advocacy 101: The Politics and Policy of PCORI Reauthorization
On September 13, 2019 the Partnership to Improve Patient Care (PIPC) held an 'Advocacy 101' webinar to help explain the Institute’s pending reauthorization and offer suggestions on how stakeholders can support patient-centered research. Topics covered in the webinar include a background related to PCORI’s creation, the legislative process that we anticipate for reauthorization in 2019, and appropriate tactics for outreach to legislators to ensure they understand the personal impact that PCORI’s work has on patients and other stakeholders. Click here for a complete recording of the event and the slides used in the presentation.
4. New NQF Resource on Patient-Centered Renal Care
The National Quality Forum (NQF) released a new NQF Playbook on renal care called Supporting Shared Decision Making for Individuals with Chronic Kidney Disease and End-Stage Renal Disease. "Developed with a diverse group of experts and patients, the latest NQP Playbook™ outlines evidence-driven strategies for critical stakeholders to adopt shared decision making as a proven, patient-centered approach to arrive at well-informed, optimal healthcare decisions by engaging patients as active partners in making decisions that align with personal goals, preferences, and values," NQF wrote in a press release announcing the release. Click here to read more.
5. Proposed Changes to ICER Framework Available for Comment
ICER has released its proposed changes to its value assessment framework for 2020. Public comment is open on the proposed changes through October 18, 2019. Click here to view the changes and to comment. Click here to view a comment letter signed by over 30 stakeholders. PIPC looks forward to working again with stakeholders to comment on this new opportunity. Click here and here to view videos about ICER's methodology.
6. ICER Announces Possible 2020 Assessments
The Institute for Clinical and Economic Research (ICER) published a list of possible assessments for 2020. The possible assessments include drugs to treat cystic fibrosis, breast cancer, multiple sclerosis, and HIV. ICER's QALY-based studies are not transparent, use discriminatory cost-effectiveness measures, and ignore patient preferences and input. Click here to see the list of possible assessments.
7. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training
Alliance for Aging Research’s Senior Patient and Family Caregiver Network (SP&FCN) is seeking advocates to participate in a research-advocacy training program designed to empower senior patients and their family caregivers to engage in patient-centered outcomes research (PCOR). The training will be held November 19-21, 2019 in Dallas, TX, and reimbursements for a hotel stay and travel expenses are available. In particular, the Alliance is looking for patients or caregivers of patients with Alzheimer’s disease, sarcopenia, atrial fibrillation, chronic pain, age-related macular degeneration, or heart valve disease. Click here to learn more and to apply for the training.
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 Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis
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. Please note the following upcoming formal ICER deadlines per their website:
10. Upcoming Events and Webinars
Health Spending: Moving from Theory to Action
September 11, 2019
Click here for details.
PCORI Improving Methods Applicant Town Hall
September 12, 2019
Click here for details.
ISPOR Latin America
September 12-14, 2019
Click here for details.
Advisory Panel on Rare Disease Fall 2019 Meeting
September 16, 2019
Click here for details.
PCORI Advisory Panel on Patient Engagement Fall 2019 Meeting
September 17, 2019
Click here for details.
ICER's Valuing Cures Summit
September 17, 2019
Click here for details.
IMPACCT: Real World Evidence
September 18-19, 2019
Click here for details.
2019 PCORI Annual Meeting
September 18-20, 2019
Click here for details.
CMS Public Stakeholder Meeting: Resources to Reduce Opioid Misuse
September 20, 2019
Click here for details.
Cycle 3 2019 Broad PFA Applicant Town Hall
September 25, 2019
Click here for details
FT Pharma Pricing and Value Summit 2019
September 26, 2019
Click here for details.
Data Capacity for Patient-centered Outcomes Research for People with Multiple Chronic Conditions
October 2-3, 2019
Click here for details.
ISPOR Summit 2019 on Building Trust in RWE – The Role of Study Registration
October 11, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
11. Medical Journal Articles
Prioritizing Evidence-Based Interventions for Dissemination and Implementation Investments: AHRQ's Model and Experience, click here to view.
Observational Studies Have a Critical Role to Play in Cancer Comparative Effectiveness Research, click here to view.
High-Quality Evidence to Inform Clinical Practice, click here to view.
An Ethical Analysis of Coverage With Evidence Development, click here to view.
How Different Is Research Done by the Patient-Centered Outcomes Research Institute, and What Difference Does it Make?, click here to view.
The Importance of Measuring the Impact of Patient-Oriented Research, click here to view.
Building Evidence and Measuring Clinical Outcomes for Genomic Medicine, click here to view.
Evidence-Based Medicine: A Data-Driven Approach to Lean Healthcare Operations, click here to view.
Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments, click here to view.
Commonly Used Definitions in Real-World Studies May Underestimate the Prevalence of Renal Disease Among Nonvalvular Atrial Fibrillation Patients, click here to view.
12. AHRQ Effective Program Updates
Research Protocol: Management of Colonic Diverticulitis, click here to view.
Research Protocol: Therapies for Clinically Localized Prostate Cancer, click here to view.
Research Report: Web Interactive Presentation of EPC Reports: A Foray Into Interactive Reports, click here to view.
Systematic Review: Antipsychotics for the Prevention and Treatment of Delirium, click here to view.
Systematic Review: Comparative Effectiveness of Analgesics To Reduce Acute Pain in the Prehospital Setting, click here to view.
Blog: Innovations to Foster Evidence-based Care in Learning Health Systems: Ideas from the AHRQ Evidence-based Practice Centers, click here to view.
Research Protocol: Prevention, Diagnosis, and Management of Opioids, Opioid Misuse and Opioid Use Disorder in Older Adults, click here to view.
AHRQ EPC Pilot Projects Summary: Improving Health Systems' Access to High Quality Evidence, click here to view.
Research Protocol: Care Interventions for People With Dementia (PWD) and Their Caregivers, click here to view.
Research Protocol: Impact of Community Health Worker Certification on Workforce and Service Delivery for Asthma and Other Selected Chronic Diseases, click here to view.
AHRQ EPC Program Helps Health Systems Use Evidence, click here to view.
Last week, legislation was introduced in the House of Representatives which included certain provisions concerning patients and people with disabilities in Title 1. This section of the bill takes an approach that is entrenched in controversial comparative clinical and cost effectiveness standards that force patients and people with disabilities into “one-size-fits-all” decisions about their health. PIPC Chairman Tony Coelho expressed concern that these provisions place hard-fought existing patient protections under serious threat. First, it authorizes national determinations of value to be based on comparative or cost effectiveness standards that ignore differences in patient needs and discriminate against vulnerable subgroups of patients and people with disabilities, opening the door to reliance on assessments like those conducted by the Institute for Clinical and Economic Review (ICER). Second, it relies on policy decisions made in other countries that we know establish prices based on discriminatory cost-effectiveness standards (such as Quality-Adjusted Life Years or QALYs) and similar average metrics. Third, it lacks any reference to existing statutory safeguards against misuse of QALYs and similar average metrics. PIPC supports policies to improve care and affordability for patients, adopt and extend safeguards in current statute that prohibit application of discriminatory cost-effectiveness thresholds in Medicare (whether done overtly by Medicare or covertly via “comparative effectiveness analysis” or reference to foreign countries’ use of these thresholds) and codify criteria for patient-centeredness called for in CMMI’s statute. Click here to view the bill. Click here to view prior stakeholder letter on referencing International pricing. Click here to view information on Value Our Health.
2. NHC Patient Community Training on Value Assessment
On September 6, the National Health Council held a training for patients and organizations to learn about value assessment. Speakers covered a number of topics including the impacts of patient engagement on value assessment, how value assessment affects payer decision-making, and the importance of incorporating patient and caregiver experience. Click here to read more and to watch the training.
3. PCORI Advocacy 101: The Politics and Policy of PCORI Reauthorization
On September 13, 2019 the Partnership to Improve Patient Care (PIPC) held an 'Advocacy 101' webinar to help explain the Institute’s pending reauthorization and offer suggestions on how stakeholders can support patient-centered research. Topics covered in the webinar include a background related to PCORI’s creation, the legislative process that we anticipate for reauthorization in 2019, and appropriate tactics for outreach to legislators to ensure they understand the personal impact that PCORI’s work has on patients and other stakeholders. Click here for a complete recording of the event and the slides used in the presentation.
4. New NQF Resource on Patient-Centered Renal Care
The National Quality Forum (NQF) released a new NQF Playbook on renal care called Supporting Shared Decision Making for Individuals with Chronic Kidney Disease and End-Stage Renal Disease. "Developed with a diverse group of experts and patients, the latest NQP Playbook™ outlines evidence-driven strategies for critical stakeholders to adopt shared decision making as a proven, patient-centered approach to arrive at well-informed, optimal healthcare decisions by engaging patients as active partners in making decisions that align with personal goals, preferences, and values," NQF wrote in a press release announcing the release. Click here to read more.
5. Proposed Changes to ICER Framework Available for Comment
ICER has released its proposed changes to its value assessment framework for 2020. Public comment is open on the proposed changes through October 18, 2019. Click here to view the changes and to comment. Click here to view a comment letter signed by over 30 stakeholders. PIPC looks forward to working again with stakeholders to comment on this new opportunity. Click here and here to view videos about ICER's methodology.
6. ICER Announces Possible 2020 Assessments
The Institute for Clinical and Economic Research (ICER) published a list of possible assessments for 2020. The possible assessments include drugs to treat cystic fibrosis, breast cancer, multiple sclerosis, and HIV. ICER's QALY-based studies are not transparent, use discriminatory cost-effectiveness measures, and ignore patient preferences and input. Click here to see the list of possible assessments.
7. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training
Alliance for Aging Research’s Senior Patient and Family Caregiver Network (SP&FCN) is seeking advocates to participate in a research-advocacy training program designed to empower senior patients and their family caregivers to engage in patient-centered outcomes research (PCOR). The training will be held November 19-21, 2019 in Dallas, TX, and reimbursements for a hotel stay and travel expenses are available. In particular, the Alliance is looking for patients or caregivers of patients with Alzheimer’s disease, sarcopenia, atrial fibrillation, chronic pain, age-related macular degeneration, or heart valve disease. Click here to learn more and to apply for the training.
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: MS patient forced to go to Russia to seek treatment that is not covered in Australia. While blood cancer rates are worse than previously thought in Australia, patients are having trouble accessing needed medications.
- New Zealand: Pharmac stops funding a drug that has successfully halted the seizures of a man living with epilepsy.
- Canada: Duchenne muscular dystrophy patients raise awareness of a lack of approved treatments in Canada.
- United Kingdom: Patients in Scotland can access a lifesaving cystic fibrosis treatment while their neighbors in England cannot. Click here and here to read more. A drug that could save a bowel cancer patient's life is unavailable on the NHS.
9. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis
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. Please note the following upcoming formal ICER deadlines per their website:
- Ulcerative Colitis: Open Input Period ends TOMORROW. 9/27/2019: Draft Scoping Document.
- Cystic Fibrosis: Open Input Period ends WEDNESDAY. 9/30/2019: Draft Scoping Document.
- Sickle Cell Disease: Draft Scoping Document and Stakeholder List available. 9/30/2019: Revised Scoping Document. Meeting 3/26/2020: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for sickle cell disease.
- Arthritis: Model Analysis Plan available. 9/24/2019: Draft Evidence Report. Meeting 11/19/2019: CTAF to an update to its 2017 rheumatoid arthritis assessment.
- Type 2 Diabetes: Draft Evidence Report and Voting Questions available. Public Comment period OPEN through 10/8/2019. Meeting 11/14/2019: The New England CEPAC will convene to deliberate on ICER's review of oral semaglutide for the treatment of type 2 diabetes.
- Cardiovascular Disease : Response to comments, evidence report, and revised voting questions AVAILABLE. 9/26/2019 Meeting: Midwest CEPAC to deliberate and vote on ICER's report on evidence presented in ICER's report on additive CVD therapies.
- Unsupported Price Increase Assessment: 10/8/2019: Final Report.
- Acute Migraine: Research Protocol available. 9/24/2019: Model Analysis Plan. Meeting 1/23/2020: Midwest CEPAC to review ICER's assessment of acute migraine treatments
- Valuing A Cure Project: White Paper AVAILABLE. Meeting 9/17/2019: Invited stakeholders to discuss single or short-term transformative therapies.
- 2020 Value Assessment Framework: Proposed changes AVAILABLE. Comment period open through 10/18/2019.
10. Upcoming Events and Webinars
Health Spending: Moving from Theory to Action
September 11, 2019
Click here for details.
PCORI Improving Methods Applicant Town Hall
September 12, 2019
Click here for details.
ISPOR Latin America
September 12-14, 2019
Click here for details.
Advisory Panel on Rare Disease Fall 2019 Meeting
September 16, 2019
Click here for details.
PCORI Advisory Panel on Patient Engagement Fall 2019 Meeting
September 17, 2019
Click here for details.
ICER's Valuing Cures Summit
September 17, 2019
Click here for details.
IMPACCT: Real World Evidence
September 18-19, 2019
Click here for details.
2019 PCORI Annual Meeting
September 18-20, 2019
Click here for details.
CMS Public Stakeholder Meeting: Resources to Reduce Opioid Misuse
September 20, 2019
Click here for details.
Cycle 3 2019 Broad PFA Applicant Town Hall
September 25, 2019
Click here for details
FT Pharma Pricing and Value Summit 2019
September 26, 2019
Click here for details.
Data Capacity for Patient-centered Outcomes Research for People with Multiple Chronic Conditions
October 2-3, 2019
Click here for details.
ISPOR Summit 2019 on Building Trust in RWE – The Role of Study Registration
October 11, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
11. Medical Journal Articles
Prioritizing Evidence-Based Interventions for Dissemination and Implementation Investments: AHRQ's Model and Experience, click here to view.
Observational Studies Have a Critical Role to Play in Cancer Comparative Effectiveness Research, click here to view.
High-Quality Evidence to Inform Clinical Practice, click here to view.
An Ethical Analysis of Coverage With Evidence Development, click here to view.
How Different Is Research Done by the Patient-Centered Outcomes Research Institute, and What Difference Does it Make?, click here to view.
The Importance of Measuring the Impact of Patient-Oriented Research, click here to view.
Building Evidence and Measuring Clinical Outcomes for Genomic Medicine, click here to view.
Evidence-Based Medicine: A Data-Driven Approach to Lean Healthcare Operations, click here to view.
Patient Registries: An Underused Resource for Medicines Evaluation: Operational Proposals for Increasing the Use of Patient Registries in Regulatory Assessments, click here to view.
Commonly Used Definitions in Real-World Studies May Underestimate the Prevalence of Renal Disease Among Nonvalvular Atrial Fibrillation Patients, click here to view.
12. AHRQ Effective Program Updates
Research Protocol: Management of Colonic Diverticulitis, click here to view.
Research Protocol: Therapies for Clinically Localized Prostate Cancer, click here to view.
Research Report: Web Interactive Presentation of EPC Reports: A Foray Into Interactive Reports, click here to view.
Systematic Review: Antipsychotics for the Prevention and Treatment of Delirium, click here to view.
Systematic Review: Comparative Effectiveness of Analgesics To Reduce Acute Pain in the Prehospital Setting, click here to view.
Blog: Innovations to Foster Evidence-based Care in Learning Health Systems: Ideas from the AHRQ Evidence-based Practice Centers, click here to view.
Research Protocol: Prevention, Diagnosis, and Management of Opioids, Opioid Misuse and Opioid Use Disorder in Older Adults, click here to view.
AHRQ EPC Pilot Projects Summary: Improving Health Systems' Access to High Quality Evidence, click here to view.
Research Protocol: Care Interventions for People With Dementia (PWD) and Their Caregivers, click here to view.
Research Protocol: Impact of Community Health Worker Certification on Workforce and Service Delivery for Asthma and Other Selected Chronic Diseases, click here to view.
AHRQ EPC Program Helps Health Systems Use Evidence, click here to view.
