In This Week’s Issue:
1. New York: Tell Legislators to Not Allow Use of Discriminatory Cost-Effectiveness Measures, click here for a tool to find your legislator and a template letter.
2. PIPC Chairman Tony Coehlo Writes: Rising Costs Must be Met with Patient-Centered Solutions, click here to read the article.
3. Morning Consult Poll Finds Americans Support Patient-Centered Solutions, click here to read the announcement and the survey results.
4. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy, click here to provide patient input.
6. AMA President: Prior Authorization Requirements Hurt Patients, click here to read the article.
7. PCORI Funds Studies on Shared Decision Making, click here to read the article.
8. Review and Comment! IVI Releases New Value Assessment Platform for Non-Small Cell Lung Cancer Therapy Sequences, see details below.
9. PCORI Advisory Panel Openings, see details below.
10. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus, click here to submit your events.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below.
1. New York: Tell Legislators to Not Allow Use of Discriminatory Cost-Effectiveness Measures, click here for a tool to find your legislator and a template letter.
2. PIPC Chairman Tony Coehlo Writes: Rising Costs Must be Met with Patient-Centered Solutions, click here to read the article.
3. Morning Consult Poll Finds Americans Support Patient-Centered Solutions, click here to read the announcement and the survey results.
4. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy, click here to provide patient input.
6. AMA President: Prior Authorization Requirements Hurt Patients, click here to read the article.
7. PCORI Funds Studies on Shared Decision Making, click here to read the article.
8. Review and Comment! IVI Releases New Value Assessment Platform for Non-Small Cell Lung Cancer Therapy Sequences, see details below.
9. PCORI Advisory Panel Openings, see details below.
10. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus, click here to submit your events.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below.
1. New York: Tell Legislators to Not Allow Use of Discriminatory Cost-Effectiveness Measures
The New York Executive and Assembly included a provision in their budget that would allow for the use of QALY-based value assessments to determine access and coverage, such as the assessments conducted by the Institute for Clinical Economic Review (ICER). Thankfully, the New York Senate bill incorporated provisions to address our concerns by banning use of discriminatory, biased value assessments that are not transparent. The Epilepsy Foundation is urging supporters to speak out against measures that discriminate against seniors and individuals with chronic conditions and disabilities. Patients are encouraged to share their stories with members of New York's legislature. If you live in New York or have a network of New Yorkers that oppose discrimination, please share and use the tool to find your state legislator and a template letter available here. As background, click here to view the joint letter sent to New York legislators opposing the Executive Budget provision.
2. PIPC Chairman Tony Coehlo Writes: Rising Costs Must be Met with Patient-Centered Solutions
PIPC Chairman Tony Coehlo published an opinion column in Morning Consult highlighting public concern about the use of QALYs and support for PCORI reauthorization. "The use of value assessment standards to determine health care coverage and payments are increasingly under consideration in the United States, even though these standards are not reasonable or fair solutions for patients. The reality is, these assessments employ the quality-adjusted-life-year (QALY) as a metric to determine the value of a treatment, and this assigns a value to patients’ lives based on their age, condition or disease to assess whether a treatment is cost-effective. As more patients and people with disabilities become familiar with cost-effectiveness assessments, the more Americans are reluctant to have our own government adopt this policy across the nation," he wrote. Click here to read the article.
3. Morning Consult Poll Finds Americans Support Patient-Centered Solutions
Morning Consult released a public opinion poll regarding the use of cost-effectiveness assessments to determine value of coverage and treatment costs. "This survey highlights the importance of PIPC’s long-standing efforts to support patient-centered approaches over cost-effectiveness assessments that determine the value of patient care in a one-size-fits-all approach. Patients should have the freedom to decide with their doctor, not the government, over which treatment or care is best suited for their situation and needs. PIPC has worked too long and too hard to support patients and provide them with a meaningful voice in determining their health care decisions," said PIPC Chairman Tony Coehlo. Click here to read the announcement and the survey results.
4. 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.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy
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:
6. AMA President: Prior Authorization Requirements Hurt Patients
Insurance plans' prior authorization requirements delay treatment and result in worse health outcomes, wrote American Medical Association President Dr. Barbara McAneny. "The AMA has and always will support the practice of evidence-based medicine tailored to the unique clinical characteristics of each patient. Physicians must be good stewards of limited health care resources in every situation. But the prior authorization process in place today must be overhauled to eliminate treatment delays that inflict tremendous harm and needless suffering on our patients. This is dysfunction in our health care system that interferes with patient care," she wrote in the Baltimore Sun. Click here to read the article.
7. PCORI Funds Studies on Shared Decision Making
PCORI has funded two studies on building shared decision-making processes into clinical care. "Shared decision making is a vital component of patient-centered care, and it’s also a channel building patient-centered evidence into an individual’s decision making about their treatment options. PCORI is dedicated to supporting research that improves the process by which patients, working with their clinicians, choose a treatment approach that works best for them. ‘Works best for them’ means that the decision is based to the greatest extent possible on patient-specific information. That is the kind of evidence PCORI aims to produce. These new awards will help bring this evidence directly to patients, to support them in making choices with their clinicians about their care," said PCORI Executive Director Dr; Joe Selby. Click here to read the article.
8. Review and Comment! IVI Releases New Value Assessment Platform for Non-Small Cell Lung Cancer Therapy Sequences
IVI recently released the initial version of its new Open-Source Value Platform (OSVP) model for non-small cell lung cancer. Specifically, the platform will be assessing the relative value of sequential treatments for epidermal growth factor receptor positive (EGFR+), non-squamous non-small cell lung cancer (NSCLC).
IVI, a nonprofit organization dedicated to advancing the science and improving the practice of value assessment in healthcare, has now developed two open-source platforms from which healthcare value assessment tools can be built and utilized. The entirety of IVI’s modeling package, including a dynamic and engaging user interface, can be found IVI’s website.
The public comment period will remain open until April 1, 2019 and IVI encourages stakeholder comment on their model. The feedback received during this public comment period will provide the basis for improving the model. IVI has engaged an external technical expert panel to synthesize comments and recommend prioritized modifications for inclusion in the second release of the IVI-NSCLC platform.
For more information contact IVI’s executive director, Jennifer Bright at [email protected].
9. PCORI Advisory Panel Openings
PCORI is now accepting nominations and applications for new members of four of its advisory panels: Health Delivery and Disparities Research, Patient Engagement, Clinical Trials, and Rare Disease. PCORI’s advisory panels provide important guidance on everything from refining and prioritizing research questions for potential funding, to offering feedback on the design of research studies, to engaging patients as partners throughout the research process. If you are interested in serving on a panel or would like to nominate a candidate, the deadline to submit applications and nominations is Friday, March 29. You can find details about each panel and the application process here: http://bit.ly/advisorypanels
10. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus
In the interest of amplified patient and stakeholder engagement, your organization may be interested that the House Majority Leader’s office is compiling a list of fly-ins, advocacy days, and conferences that will be taking place throughout the year. This information will be shared with all House Democratic offices and used for a variety of purposes including scheduling and messaging. Feel free to share any events you have planned. If we hear of similar efforts by the Minority Leader, we hope to share that as well. Please submit your events, here.
11. Upcoming Events and Webinars
NPC @ Health Datapalooza 2019
March 27-28, 2019
Click here for details.
Cycle 1 2019 Limited PCORI Funding Announcement: Partnerships To Conduct Research (PaCR) within PCORnet
April 3, 2019
Click here for details.
Webinar: MCDA - How to Guide Through the Application of Different Methods for Assessment and Prioritization of Rare Disease Health Technologies
April 4, 2019
Click here for details.
Big Data, RWD and RWE: What’s the Difference and How is it Changing the Research Landscape?
April 15, 2019
Click here for details.
PCORI Board of Governors Meeting
April 16, 2019
Click here for details.
17th Annual Eyeforpharma Philadelphia
April 16-17, 2019
Click here for details.
Cycle 2 2019 Improving Methods Applicant Town Hall
May 9, 2019
Click here for details.
Advisory Panel on Clinical Trials Spring 2019 Meeting
May 15, 2019
Click here for details.
Advisory Panel on Healthcare Delivery and Disparities Research Spring 2019 Meeting
May 16, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019,
Click here for details.
A New Path Forward for Using Real World Evidence in Randomized Clinical Trials
June 23, 2019,
Click here for details.
12. Medical Journal Articles
The Evolution of European HTA and Access to Innovative Medicines, click here to view.
Advocating for New Patient-Centered Tools for Value-Based Treatment Choices in Oncology, click here to view.
Toward a Strategy to Involve Patients in Health Technology Assessment in Spain, click here to view.
Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute, click here to view.
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies, click here to view.
Letter: Multi-Method Patient-Engagement Approach: A Case Example from a PCORI-Funded Training Project, click here to view.
Perspectives of Patients in Identifying Their Values-Based Health Priorities, click here to view.
How Patient's Access to Evidence-Based Medicine Provides Them with a New Hope "The 45 Min—An Insightful Round," click here to view.
Improving Patient-Reported Measures in Oncology, click here to view.
Moving Forward from Drug-Centred to Patient-Centred Research, click here to view.
13. AHRQ Effective Program Updates
Comment Period: Management of Primary Headaches in Pregnancy, click here to view.
Comment Period: Antipsychotics for the Prevention and Treatment of Delirium, click here to view.
Nonopioid Pharmacologic Treatments for Chronic Pain, click here to view.
Systematic Review Update: Noninvasive Nonpharmacologic Treatments for Chronic Pain, click here to view.
Treatment of Acute Pain: An Evidence Map, click here to view.
Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned, click here to view.
Standardized Library of Depression Outcome Measures, click here to view.
Patient Navigation Models for Lung Cancer, click here to view.
Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update, click here to view.
Long-term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review, click here to view.
The New York Executive and Assembly included a provision in their budget that would allow for the use of QALY-based value assessments to determine access and coverage, such as the assessments conducted by the Institute for Clinical Economic Review (ICER). Thankfully, the New York Senate bill incorporated provisions to address our concerns by banning use of discriminatory, biased value assessments that are not transparent. The Epilepsy Foundation is urging supporters to speak out against measures that discriminate against seniors and individuals with chronic conditions and disabilities. Patients are encouraged to share their stories with members of New York's legislature. If you live in New York or have a network of New Yorkers that oppose discrimination, please share and use the tool to find your state legislator and a template letter available here. As background, click here to view the joint letter sent to New York legislators opposing the Executive Budget provision.
2. PIPC Chairman Tony Coehlo Writes: Rising Costs Must be Met with Patient-Centered Solutions
PIPC Chairman Tony Coehlo published an opinion column in Morning Consult highlighting public concern about the use of QALYs and support for PCORI reauthorization. "The use of value assessment standards to determine health care coverage and payments are increasingly under consideration in the United States, even though these standards are not reasonable or fair solutions for patients. The reality is, these assessments employ the quality-adjusted-life-year (QALY) as a metric to determine the value of a treatment, and this assigns a value to patients’ lives based on their age, condition or disease to assess whether a treatment is cost-effective. As more patients and people with disabilities become familiar with cost-effectiveness assessments, the more Americans are reluctant to have our own government adopt this policy across the nation," he wrote. Click here to read the article.
3. Morning Consult Poll Finds Americans Support Patient-Centered Solutions
Morning Consult released a public opinion poll regarding the use of cost-effectiveness assessments to determine value of coverage and treatment costs. "This survey highlights the importance of PIPC’s long-standing efforts to support patient-centered approaches over cost-effectiveness assessments that determine the value of patient care in a one-size-fits-all approach. Patients should have the freedom to decide with their doctor, not the government, over which treatment or care is best suited for their situation and needs. PIPC has worked too long and too hard to support patients and provide them with a meaningful voice in determining their health care decisions," said PIPC Chairman Tony Coehlo. Click here to read the announcement and the survey results.
4. 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.
- New Zealand: Breast cancer patients are not receiving access to to life-saving medications. As a result of widespread criticism, PHARMAC is set to review its practices of breast cancer drug funding. Click here and here to read more. Patients in New Zealand also face barriers to access for treatment of spinal muscular atrophy. Click here to read more.
- Canada: Discriminatory cost effectiveness measures are blocking access to care for patients with spinal muscular atrophy patients. Click here and here to read more. Click here to view the story of a child with thyroid cancer forced to come to the U.S. for care, and here for an article about high costs of Parkinson's and MS treatments. Click here for a story about a patient with cystic fibrosis whose province does not cover the drug she needs.
- Netherlands: Cost effectiveness measures are blocking access to cystic fibrosis treatments for children. It also remains unavailable for adults because the government has failed to reach an agreement. Click here to read more.
- United Kingdom: English families are moving to Scotland and Ireland in an attempt to access MS drugs not covered by the NHS. Activists are fighting for access to treatments for cystic fibrosis and cancer. Click here, here, and here for articles related to cystic fibrosis. Click here and here to read about the fight for access to cancer drugs in Scotland. Click here for an article related to MS. Click here for more information on the NHS drug approval process.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy
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:
- Cardiovascular Disease : Comment period OPEN on Draft Scoping Document through 4/5/2019. 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.
- Spinal Muscular Atrophy: 3/28/2019: Final Evidence Report and Meeting Summary.
- Depression: Comment period on Draft Evidence Report OPEN through 4/17/2019. Meeting 5/23/2019: Midwest CEPAC to review evidence on esketamine as a therapy for treatment-resistant depression.
- Multiple Sclerosis: Public Comments OPEN through April 10, 2019 on the Draft Analysis Report. Meeting 5/23/2019: Midwest CEPAC to review ICER's assessment of siponimod (Novartis) for secondary progressive multiple sclerosis.
- Peanut Allergy: Draft Evidence Report: 4/9/2019. Meeting 6/11/2019: CTAF to review ICER's assessment of treatments for peanut allergy.
- Duchenne Muscular Dystrophy: Research protocol available. Meeting 7/25/2019: New England CEPAC to deliberate and vote on evidence presented in ICER's report on treatments for Duchenne muscular dystrophy.
- Unsupported Price Increase Assessment: Open Input Period through 4/19/2019.
6. AMA President: Prior Authorization Requirements Hurt Patients
Insurance plans' prior authorization requirements delay treatment and result in worse health outcomes, wrote American Medical Association President Dr. Barbara McAneny. "The AMA has and always will support the practice of evidence-based medicine tailored to the unique clinical characteristics of each patient. Physicians must be good stewards of limited health care resources in every situation. But the prior authorization process in place today must be overhauled to eliminate treatment delays that inflict tremendous harm and needless suffering on our patients. This is dysfunction in our health care system that interferes with patient care," she wrote in the Baltimore Sun. Click here to read the article.
7. PCORI Funds Studies on Shared Decision Making
PCORI has funded two studies on building shared decision-making processes into clinical care. "Shared decision making is a vital component of patient-centered care, and it’s also a channel building patient-centered evidence into an individual’s decision making about their treatment options. PCORI is dedicated to supporting research that improves the process by which patients, working with their clinicians, choose a treatment approach that works best for them. ‘Works best for them’ means that the decision is based to the greatest extent possible on patient-specific information. That is the kind of evidence PCORI aims to produce. These new awards will help bring this evidence directly to patients, to support them in making choices with their clinicians about their care," said PCORI Executive Director Dr; Joe Selby. Click here to read the article.
8. Review and Comment! IVI Releases New Value Assessment Platform for Non-Small Cell Lung Cancer Therapy Sequences
IVI recently released the initial version of its new Open-Source Value Platform (OSVP) model for non-small cell lung cancer. Specifically, the platform will be assessing the relative value of sequential treatments for epidermal growth factor receptor positive (EGFR+), non-squamous non-small cell lung cancer (NSCLC).
IVI, a nonprofit organization dedicated to advancing the science and improving the practice of value assessment in healthcare, has now developed two open-source platforms from which healthcare value assessment tools can be built and utilized. The entirety of IVI’s modeling package, including a dynamic and engaging user interface, can be found IVI’s website.
The public comment period will remain open until April 1, 2019 and IVI encourages stakeholder comment on their model. The feedback received during this public comment period will provide the basis for improving the model. IVI has engaged an external technical expert panel to synthesize comments and recommend prioritized modifications for inclusion in the second release of the IVI-NSCLC platform.
For more information contact IVI’s executive director, Jennifer Bright at [email protected].
9. PCORI Advisory Panel Openings
PCORI is now accepting nominations and applications for new members of four of its advisory panels: Health Delivery and Disparities Research, Patient Engagement, Clinical Trials, and Rare Disease. PCORI’s advisory panels provide important guidance on everything from refining and prioritizing research questions for potential funding, to offering feedback on the design of research studies, to engaging patients as partners throughout the research process. If you are interested in serving on a panel or would like to nominate a candidate, the deadline to submit applications and nominations is Friday, March 29. You can find details about each panel and the application process here: http://bit.ly/advisorypanels
10. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus
In the interest of amplified patient and stakeholder engagement, your organization may be interested that the House Majority Leader’s office is compiling a list of fly-ins, advocacy days, and conferences that will be taking place throughout the year. This information will be shared with all House Democratic offices and used for a variety of purposes including scheduling and messaging. Feel free to share any events you have planned. If we hear of similar efforts by the Minority Leader, we hope to share that as well. Please submit your events, here.
11. Upcoming Events and Webinars
NPC @ Health Datapalooza 2019
March 27-28, 2019
Click here for details.
Cycle 1 2019 Limited PCORI Funding Announcement: Partnerships To Conduct Research (PaCR) within PCORnet
April 3, 2019
Click here for details.
Webinar: MCDA - How to Guide Through the Application of Different Methods for Assessment and Prioritization of Rare Disease Health Technologies
April 4, 2019
Click here for details.
Big Data, RWD and RWE: What’s the Difference and How is it Changing the Research Landscape?
April 15, 2019
Click here for details.
PCORI Board of Governors Meeting
April 16, 2019
Click here for details.
17th Annual Eyeforpharma Philadelphia
April 16-17, 2019
Click here for details.
Cycle 2 2019 Improving Methods Applicant Town Hall
May 9, 2019
Click here for details.
Advisory Panel on Clinical Trials Spring 2019 Meeting
May 15, 2019
Click here for details.
Advisory Panel on Healthcare Delivery and Disparities Research Spring 2019 Meeting
May 16, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019,
Click here for details.
A New Path Forward for Using Real World Evidence in Randomized Clinical Trials
June 23, 2019,
Click here for details.
12. Medical Journal Articles
The Evolution of European HTA and Access to Innovative Medicines, click here to view.
Advocating for New Patient-Centered Tools for Value-Based Treatment Choices in Oncology, click here to view.
Toward a Strategy to Involve Patients in Health Technology Assessment in Spain, click here to view.
Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute, click here to view.
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies, click here to view.
Letter: Multi-Method Patient-Engagement Approach: A Case Example from a PCORI-Funded Training Project, click here to view.
Perspectives of Patients in Identifying Their Values-Based Health Priorities, click here to view.
How Patient's Access to Evidence-Based Medicine Provides Them with a New Hope "The 45 Min—An Insightful Round," click here to view.
Improving Patient-Reported Measures in Oncology, click here to view.
Moving Forward from Drug-Centred to Patient-Centred Research, click here to view.
13. AHRQ Effective Program Updates
Comment Period: Management of Primary Headaches in Pregnancy, click here to view.
Comment Period: Antipsychotics for the Prevention and Treatment of Delirium, click here to view.
Nonopioid Pharmacologic Treatments for Chronic Pain, click here to view.
Systematic Review Update: Noninvasive Nonpharmacologic Treatments for Chronic Pain, click here to view.
Treatment of Acute Pain: An Evidence Map, click here to view.
Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned, click here to view.
Standardized Library of Depression Outcome Measures, click here to view.
Patient Navigation Models for Lung Cancer, click here to view.
Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update, click here to view.
Long-term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review, click here to view.
