In This Week’s Issue:
1. Reuters: CVS Drug Coverage Plan Based on Outside Pricing Review is Off to a Slow Start, see details below.
2. ICER Discriminates Against People with Rare Diseases, click here to read the article.
3. ICER Withdraws Draft Report on Rheumatoid Arthritis Therapies, click here to read more.
4. PCORI News and Updates, see details below.
5. Patient Advocacy Scholarships Available for Personalized Medicine Conference, click here to apply.
6. Cancer Support Community is Hosting a Summit on Utilization Management, click here to learn more and register.
7. Incorporating Patient Perspectives and Transparency for Patient-Centered Value Assessment, click here to read the article.
8. Not All QALYs are Created Equal, click here to read the article.
9. Proposed Changes to ICER Framework Available for Comment, click here to view the changes and to comment and see below for more.
10. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training, click here to learn more and to apply for the training.
11. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
12. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, click here to provide patient input.
13. Upcoming Events and Webinars, see details below.
14. Medical Journal Articles, see details below.
15. AHRQ Effective Program Updates, see details below.
1. Reuters: CVS Drug Coverage Plan Based on Outside Pricing Review is Off to a Slow Start, see details below.
2. ICER Discriminates Against People with Rare Diseases, click here to read the article.
3. ICER Withdraws Draft Report on Rheumatoid Arthritis Therapies, click here to read more.
4. PCORI News and Updates, see details below.
5. Patient Advocacy Scholarships Available for Personalized Medicine Conference, click here to apply.
6. Cancer Support Community is Hosting a Summit on Utilization Management, click here to learn more and register.
7. Incorporating Patient Perspectives and Transparency for Patient-Centered Value Assessment, click here to read the article.
8. Not All QALYs are Created Equal, click here to read the article.
9. Proposed Changes to ICER Framework Available for Comment, click here to view the changes and to comment and see below for more.
10. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training, click here to learn more and to apply for the training.
11. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
12. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, click here to provide patient input.
13. Upcoming Events and Webinars, see details below.
14. Medical Journal Articles, see details below.
15. AHRQ Effective Program Updates, see details below.
1. Reuters: CVS Drug Coverage Plan Based on Outside Pricing Review is Off to a Slow Start
Last week, a Reuters reporter published an article about CVS Caremark’s plan to work with the Institute for Clinical Economic Review (ICER) to limit benefits for employer clients to $100,000 per QALY. The article states, "CVS has limited sales and marketing for the plan while it talks to patient groups who oppose it. About 240,000 CVS employees and a few large clients’ employees are enrolled thus far. The company declined to comment on exact membership. 'We are not widely promoting this program,' Brennan said, adding that CVS is working to address patient groups’ concerns.” In response, PIPC Chairman Tony Coelho applauded this reporter for her work to confirm how CVS Caremark was rolling out their QALY-based plan that we opposed. Last year, 90 organizations signed a letter to CVS Caremark stating, "We all support access to high-quality, affordable care, but CVS’ reliance on a cost-effectiveness threshold is profoundly misguided.” While increasingly aware that policymakers, payers and PBMs are turning to one-size-fits-all tools to make decisions about our health care, PIPC will continue to educate policymakers about the discriminatory implications of QALYs and similar metrics that use averages to determine clinical benefit of treatments, especially as the House of Representatives considers drug pricing policies relying on such metrics. Click here to view the Reuters article. Click here to view the letter to CVS with over 90 signatures.
2. ICER Discriminates Against People with Rare Diseases
ICER's value assessment methodology inherently discriminates against people with rare diseases, writes Randy Rutta, board chairman of the Partnership to Fight Chronic Disease and former president and CEO of Easterseals, in the San Francisco Examiner. "If health plans follow ICER’s recommendations and limit or stop covering rare disease medicines, drug companies will be under pressure to stop developing those treatments. After all, it’d make no sense to spend billions creating a medicine if health plans won’t pay for it and patients won’t receive it. Scientists are currently developing more than 560 medicines to treat rare diseases. Many include potential cures for rare genetic diseases that disable and kill. That research will very likely come to a screeching halt — causing patients to lose access to lifesaving drugs — if insurers fail to recognize the faults in ICER’s reasoning and continue to adopt the group’s increasingly disputed recommendations," he writes. Click here to read the article.
3. ICER Withdraws Draft Report on Rheumatoid Arthritis Therapies
Last week, ICER withdrew its draft report on JAK inhibitor rheumatoid arthritis therapies, saying that it was reevaluating the modeling approach used in the draft report. It had released the draft report on September 26. The report sought to evaluate the cost-effectiveness of the new JAK inhibitor drugs vis-a-vis existing therapies and asserted that the newer drugs were unlikely to be cost-effective under its analysis. Click here to read more.
4. PCORI News and Updates
5. Patient Advocacy Scholarships Available for Personalized Medicine Conference
There are a limited number of travel scholarships available to patients, patient advocates, and caregivers to attend Personalized Medicine Coalition's (PMC) 15th Annual Personalized Medicine Conference November 13-14, 2019 at Harvard Medical School in Boston, MA. In addition to attending the conference, scholarship recipients will participate in a roundtable discussion on patients’ expectations for personalized medicine and its role in the future of health care. Applications are due October 11. Click here to apply.
6. Cancer Support Community Event on Utilization Management
The Cancer Support Community is holding a summit to discuss the future of utilization management strategies and practices. The event, which will be held on October 23, 2019 in Washington, D.C., will feature panel discussions, presentations, and patient perspectives on the trends, policies, and values that will shape utilization management going forward. Click here to learn more and register.
7. Incorporating Patient Perspectives and Transparency for Patient-Centered Value Assessment
A new article in the Journal of Clinical Pathways asserts that an overwhelming focus on cost containment in medicine without due attention to quality -- particularly from the patient's perspective -- can negatively impact patient outcomes. In particular, the authors write, the focus on rising pharmaceutical costs fails to take into account patient preferences and outcomes. "Better capturing the patient’s voice in care is the next step in the evolution of a patient-centered delivery system. Value assessment should incorporate the patient’s perspective and adopt transparent methods to be in step with this evolution," they write. Click here to read the article.
8. Not All QALYs are Created Equal
Different parameters used to calculate QALYs can produce wide variations in the measurement, show a team of Australian researchers. They find that different health state utility instruments (HSUIs) take into account different values and were constructed for varying purposes, however, once they are applied to produce a QALY they tend to be treated as equal by policymakers. "Developers recalled complex developmental processes, grounded in unique histories, and these backgrounds help to explain different pathways taken at key decision points during the HSUI development. The basis for the HSUIs was commonly not equivalent conceptually: differently valued concepts and goals drove instrument design and development, according to each HSUI's defined purpose," they write, adding that this means that "a QALY is not a QALY is not a QALY." Click here to read the article.
9. 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.
10. 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.
11. 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.
12. 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:
13. Upcoming Events and Webinars
ISPOR Summit 2019 on Building Trust in RWE – The Role of Study Registration
October 11, 2019
Click here for details.
Cancer Support Community Utilization Management Summit
October 23, 2019
Click here for details.
Webinar: Applying Real-World Evidence to Regulatory and Drug Development Challenges
October 25, 2019
Click here for details.
Personalized Medicine Conference
November 13-14, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
FT US Pharma and Biotech Summit 2020
May 14, 2020
Click here for details.
14. Medical Journal Articles
Incorporating Patient Perspectives and Transparency for Patient-Centered Value Assessment, click here to view.
Accounts from developers of generic health state utility instruments explain why they produce different QALYs: A qualitative study, click here to view.
The Shared Decision-Making Process in the Pharmacological Management of Depression, click here to view.
Training Patients to Review Scientific Reports for the Patient-centered Outcomes Research Institute: An Observational Study, click here to view.
Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology, click here to view.
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.
15. 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, a Reuters reporter published an article about CVS Caremark’s plan to work with the Institute for Clinical Economic Review (ICER) to limit benefits for employer clients to $100,000 per QALY. The article states, "CVS has limited sales and marketing for the plan while it talks to patient groups who oppose it. About 240,000 CVS employees and a few large clients’ employees are enrolled thus far. The company declined to comment on exact membership. 'We are not widely promoting this program,' Brennan said, adding that CVS is working to address patient groups’ concerns.” In response, PIPC Chairman Tony Coelho applauded this reporter for her work to confirm how CVS Caremark was rolling out their QALY-based plan that we opposed. Last year, 90 organizations signed a letter to CVS Caremark stating, "We all support access to high-quality, affordable care, but CVS’ reliance on a cost-effectiveness threshold is profoundly misguided.” While increasingly aware that policymakers, payers and PBMs are turning to one-size-fits-all tools to make decisions about our health care, PIPC will continue to educate policymakers about the discriminatory implications of QALYs and similar metrics that use averages to determine clinical benefit of treatments, especially as the House of Representatives considers drug pricing policies relying on such metrics. Click here to view the Reuters article. Click here to view the letter to CVS with over 90 signatures.
2. ICER Discriminates Against People with Rare Diseases
ICER's value assessment methodology inherently discriminates against people with rare diseases, writes Randy Rutta, board chairman of the Partnership to Fight Chronic Disease and former president and CEO of Easterseals, in the San Francisco Examiner. "If health plans follow ICER’s recommendations and limit or stop covering rare disease medicines, drug companies will be under pressure to stop developing those treatments. After all, it’d make no sense to spend billions creating a medicine if health plans won’t pay for it and patients won’t receive it. Scientists are currently developing more than 560 medicines to treat rare diseases. Many include potential cures for rare genetic diseases that disable and kill. That research will very likely come to a screeching halt — causing patients to lose access to lifesaving drugs — if insurers fail to recognize the faults in ICER’s reasoning and continue to adopt the group’s increasingly disputed recommendations," he writes. Click here to read the article.
3. ICER Withdraws Draft Report on Rheumatoid Arthritis Therapies
Last week, ICER withdrew its draft report on JAK inhibitor rheumatoid arthritis therapies, saying that it was reevaluating the modeling approach used in the draft report. It had released the draft report on September 26. The report sought to evaluate the cost-effectiveness of the new JAK inhibitor drugs vis-a-vis existing therapies and asserted that the newer drugs were unlikely to be cost-effective under its analysis. Click here to read more.
4. PCORI News and Updates
- New Executive Director: PCORI announced that Dr. Josie Briggs will step into the Executive Director role in an interim capacity effective November 1. Dr. Briggs is currently the Editor in Chief of the Journal of the American Society of Nephrology, the leading journal in kidney care. Her career includes nearly 20 years in leadership at the NIH, including key positions with NIH's Common Fund Health Systems Research Collaboratory and its Precision Medicine Initiative. Dr. Briggs while serve while a search committee works to find a permanent Executive Director.
- PCORI Engagement Awards: PCORI is accepting Letters of Inquiry for two Engagement Award special project funding announcements. Up to $1.6 million in funding will be awarded in two categories: Accelerating the Adoption of Tools and Resources, and Community Convening around Patient-Centered Outcomes Research. Click here to learn more.
- Advisory Panel Openings: PCORI is seeking nominations and applications for new members of its Advisory Panel on Rare Disease. Members help guide PCORI's work in patient-centered research in rare diseases and engagement with the rare disease research community. Click here to learn more and apply or submit a nomination.
5. Patient Advocacy Scholarships Available for Personalized Medicine Conference
There are a limited number of travel scholarships available to patients, patient advocates, and caregivers to attend Personalized Medicine Coalition's (PMC) 15th Annual Personalized Medicine Conference November 13-14, 2019 at Harvard Medical School in Boston, MA. In addition to attending the conference, scholarship recipients will participate in a roundtable discussion on patients’ expectations for personalized medicine and its role in the future of health care. Applications are due October 11. Click here to apply.
6. Cancer Support Community Event on Utilization Management
The Cancer Support Community is holding a summit to discuss the future of utilization management strategies and practices. The event, which will be held on October 23, 2019 in Washington, D.C., will feature panel discussions, presentations, and patient perspectives on the trends, policies, and values that will shape utilization management going forward. Click here to learn more and register.
7. Incorporating Patient Perspectives and Transparency for Patient-Centered Value Assessment
A new article in the Journal of Clinical Pathways asserts that an overwhelming focus on cost containment in medicine without due attention to quality -- particularly from the patient's perspective -- can negatively impact patient outcomes. In particular, the authors write, the focus on rising pharmaceutical costs fails to take into account patient preferences and outcomes. "Better capturing the patient’s voice in care is the next step in the evolution of a patient-centered delivery system. Value assessment should incorporate the patient’s perspective and adopt transparent methods to be in step with this evolution," they write. Click here to read the article.
8. Not All QALYs are Created Equal
Different parameters used to calculate QALYs can produce wide variations in the measurement, show a team of Australian researchers. They find that different health state utility instruments (HSUIs) take into account different values and were constructed for varying purposes, however, once they are applied to produce a QALY they tend to be treated as equal by policymakers. "Developers recalled complex developmental processes, grounded in unique histories, and these backgrounds help to explain different pathways taken at key decision points during the HSUI development. The basis for the HSUIs was commonly not equivalent conceptually: differently valued concepts and goals drove instrument design and development, according to each HSUI's defined purpose," they write, adding that this means that "a QALY is not a QALY is not a QALY." Click here to read the article.
9. 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.
10. 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.
11. 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.
12. 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: Draft Scoping Document available, comment period OPEN through 10/18/2019.
- Cystic Fibrosis: Draft Scoping Document available. Comment period OPEN through 10/21/2019. 10/29/2019: Revised Scoping Document.
- Sickle Cell Disease: Revised Scoping Document available. 11/5/2019: Research Protocol. 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: 10/2/2019: ICER pulled the draft report, saying it would reissue it with changes in the next several days. Its meeting to discuss the report has not been postponed. 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, evidence presentation, and revised voting questions. Midwest CEPAC met 9/26/2019 to deliberate and vote on ICER's report on evidence presented in ICER's report on additive CVD therapies. 10/17/2019: Final Evidence Report and Meeting Summary.
- Unsupported Price Increase Assessment: 10/8/2019: Final Report.
- Acute Migraine: Model Analysis Plan available. 11/7/2019: Draft Evidence Report. 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.
13. Upcoming Events and Webinars
ISPOR Summit 2019 on Building Trust in RWE – The Role of Study Registration
October 11, 2019
Click here for details.
Cancer Support Community Utilization Management Summit
October 23, 2019
Click here for details.
Webinar: Applying Real-World Evidence to Regulatory and Drug Development Challenges
October 25, 2019
Click here for details.
Personalized Medicine Conference
November 13-14, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
FT US Pharma and Biotech Summit 2020
May 14, 2020
Click here for details.
14. Medical Journal Articles
Incorporating Patient Perspectives and Transparency for Patient-Centered Value Assessment, click here to view.
Accounts from developers of generic health state utility instruments explain why they produce different QALYs: A qualitative study, click here to view.
The Shared Decision-Making Process in the Pharmacological Management of Depression, click here to view.
Training Patients to Review Scientific Reports for the Patient-centered Outcomes Research Institute: An Observational Study, click here to view.
Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology, click here to view.
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.
15. 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.
