1. ICER's Methodology Fails to Properly Value Treatments, click here to read the article.
2. Making the Patient Voice Matter In Value Assessment, click here to read the article.
3. Disruptive Proposals May Undermine Medicare Part D’s Success, see below for more.
4. Proposed Changes to ICER Framework Available for Comment, click here to view the changes and to comment and see below for more.
5. ICER Announces Possible 2020 Assessments, click here to see the list of possible assessments.
6. AAR Seeks Recruits for Annual Senior Patient and Family Caregivers Network Training, click here to learn more and to apply for the training.
7. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
8. ICER Studies: Acute Migraine, Type 2 Diabetes, Arthritis, Cardiovascular Disease, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, click here to provide patient input.
9. Upcoming Events and Webinars, see details below.
10. Medical Journal Articles, see details below.
11. AHRQ Effective Program Updates, see details below.
Writing in Forbes, Pacific Research Institute Senior Fellow Wayne Winegarden says that ICER's methodology confuses price and value and fails to account for differences among patients. "The evidence on value are based on broad averages that, by definition, will be inapplicable to large numbers of individual patients whose particular circumstances vary...from these population averages. More fundamentally, the value of any medicine cannot be determined without accounting for the needs of individual patients that ICER’s population perspective is incapable of incorporating. Worsening this problem, while ICER’s reports discuss qualitative benefits from medicines (such as reduced pain or less absenteeism from work or school), the analyses do not incorporate these considerations into their quantitative calculations....Since ICER calculations don’t include the qualitative considerations that are essential in determining a medicine’s value to patients, the assessments underestimate the value of medicines by definition," he writes. Click here to read the article.
2. Making the Patient Voice Matter In Value Assessment
The University of Maryland's Susan Dorseis writes in Managed Care Magazine about the Patient-Driven Values in Healthcare Evaluation (PAVE) Center, which seeks to take a patient-centered view on value assessment. "Conversations about the value of health care treatments have not traditionally included the patient perspective. In the past, value has been measured through cost-effectiveness analyses that weigh the clinical benefits of a treatment against its costs without a consideration of how those benefits align with what patients want from a treatment. Value-assessment efforts often included highly qualified health care providers and health economists. But there has been no seat at the table for individuals who live day to day with the condition being assessed. We have begun to recognize the importance of having patients more consistently engaged both in the generation of evidence and in the determination of what is of value to patients in health care decision making. Including the patient voice in value assessment can ensure that health care decisions do not overlook the aspects of treatment that are truly important to patients," she writes. Click here to read the article.
3. Disruptive Proposals May Undermine Medicare Part D’s Success
Former Senator Blanche Lincoln, a champion in the creation of medicare’s Part D benefit, penned an opinion in Morning Consult calling on policymakers to look to its historical success as a guide to its future. She stated, "A troublesome proposal currently being discussed involves government arbitration within Part D. With this type of system, the government would select a panel to decide the price of a drug. If an agreeable price is not assigned, it is entirely possible that the manufacturer could reduce or stop production of that drug, causing seniors to lose access to many of the prescription drugs they currently rely on — particularly the more modern, innovative treatments approved in recent years...Ultimately, when designing Part D, we took the best of what the government can do and the best of what the private sector can do, and guess who the winner was: seniors....Today we barely pause to marvel at Medicare Part D’s achievement. The program has come in more than 40 percent under budget, while remaining incredibly popular with enrollees.” PIPC also has significant concerns about these policy ideas, which would assign a value to treatments that inherently discriminates against people with disabilities and serious chronic conditions by impeding access to care, whether through non-coverage or through the barriers put in place through utilization management such as step therapy. Putting patients and people with disabilities in the middle is not a solution. Overriding the judgement of clinicians and patients is not the answer. Click here to view the Senator’s opinion. Click here for resources to Value Our Health.
4. 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.
5. 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.
6. 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.
7. 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: While blood cancer rates are worse than previously thought in Australia, patients are having trouble accessing needed medications.
- New Zealand: Following outcry from patients, Pharmac is allocated an addition $60 million in funding. Advocates say that the government's plan for managing cancer is not adequate. Lung cancer advocates call for treatments to be guaranteed for New Zealanders.
- Canada: Canadian government continues to refuse to fund lifesaving cystic fibrosis treatments.
- United Kingdom: Parents take fight for access to Batten Disease medication to court. Two siblings with cystic fibrosis, one of whom received treatment while the other did not, reveal the lottery of receiving treatment.
8. 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 through 9/24/2019. 9/27/2019: Draft Scoping Document.
- Cystic Fibrosis: Open Input Period through 9/25/2019. 9/30/2019: Draft Scoping Document.
- Sickle Cell Disease: Draft Scoping Document and Stakeholder List available, comment period OPEN through 9/20/2019. 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: Model Analysis Plan available. 9/11/2019: Draft Evidence Report. 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 : 9/12/2019: Response to comments, evidence report, and revised voting questions. 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.
9. 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.
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.
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.
10. Medical Journal Articles
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.
Factors Associated with Evidence-Based Decision-Making Among Patients and Providers, click here to view.
11. AHRQ Effective Program Updates
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.
Technical Brief: Pharmacological and Nonpharmacological Treatments for Post-Traumatic Stress Disorder, click here to view.
Systematic Review: Management of Infertility, click here to view.