1. ICER Seeks Public Input for 2020 Value Assessment Framework, click here for more information and to comment.
2. You're Invited! The Perils of QALYs Event at the Coehlo Center in Los Angeles May 20, click here for more information and click here to RSVP.
3. Policy Briefing in Sacramento on May 15: Are Value Assessments In Healthcare a New Form of Discrimination?, click here for more information and click here to RSVP.
4. Last Call for Signatures on Letters supporting PCORI Reauthorization!, email [email protected] to sign on and click here to view updates and access advocacy tools related to PCORI reauthorization.
5. PIPC Advises California LAO to Avoid Discriminatory Value Assessment Metrics, click here to read the letter.
6. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
7. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy, click here to provide patient input.
8. NVHR Hepatitis C Patient Summit, click hereto apply to the patient summit.
9. NPC: Public Input Key for Improving Value Assessment, click here to read the article.
10. AAMC on PCORI's Contributions, click here to read the article.
11. AUCD: Submit a Proposal for 2019 Conference! Click here for more information.
12. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus, click here to submit your events.
13. Upcoming Events and Webinars, see details below.
14. Medical Journal Articles, see details below.
15. AHRQ Effective Program Updates, see details below.
As part of its biannual process of revising its value assessment framework, ICER is seeking public comment on potential changes to improve its process. This is an important opportunity for patients and people with disabilities to tell ICER that one-size-fits-all conceptions of "value" ignore what is important to them. Specifically, the use of QALYs discriminates against older people and people with disabilities, and it has no place in determining the value of treatments. ICER is specifically seeking comment on the QALY and its cousin, the equal-value life year gained (evLYG) metric. PIPC looks forward to working with its partners to develop comments that will highlight for ICER how the use of QALYs and evLYGs devalues their lives, with suggestions on addressing the methodological flaws in its current model. ICER is accepting comments through June 10, 2019, and plans to publish draft changes to its framework based on comments received on August 16th. Click here for more information and to comment.
2. You're Invited! The Perils of QALYs Event at the Coehlo Center in Los Angeles on May 20
On Monday, May 20, PIPC and the Coehlo Center on Disability Law, Policy, and Innovation will host an event in Los Angeles entitled "The Perils of QALYs: Addressing discrimination against people with disabilities and serious chronic conditions." PIPC and the Coehlo Center invite people with disabilities, patients, seniors, families, individuals experiencing disparities in care, providers and advocates to join our esteemed panel to learn about value assessments, their potential for discrimination, and related public policy threats at the federal and state level. "This event will arm advocates with the information they need to oppose discriminatory measures in public programs, like Medicaid, and defend access to care for all. We hope you will join us in advocating for policymakers to Value Our Health!" wrote PIPC Chairman Tony Coehlo. Click here for more information and click here to RSVP.
3. Policy Briefing in Sacramento on May 15: Are Value Assessments In Healthcare a New Form of Discrimination?
The Partnership to Improve Patient Care (PIPC), California Partnership for Access to Treatment (CPAT), and the ALS Association (Greater Sacramento Chapter), invites people with disabilities, patients, seniors, families, individuals experiencing disparities in care, providers, advocates, and any interested groups to join our experts to learn about value assessments, their potential for discrimination, and related public policy threats at the federal and state level. The briefing will be held on May 15, 2019 at the Sheraton Grand Sacramento Hotel in Sacramento, California. Click here for more information and click here to RSVP.
4. Last Call for Signatures on Letters supporting PCORI Reauthorization!
Friends of PCORI Reauthorization has extended the deadline for signing letters to House and Senate leaders supporting PCORI reauthorization, including support for a full ten year reauthorization with current funding and extending PCORI’s mission to conduct comparative clinical effectiveness research, until Wednesday, May 8. For more information and to sign on, please email [email protected] and click here to view updates and access advocacy tools related to PCORI reauthorization.
5. PIPC Advises California LAO to Avoid Discriminatory Value Assessment Metrics
In a letter to the California Legislative Analyst’s Office (LAO), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho provided feedback on the LAO’s recent report entitled “The 2019-20 Budget: Analysis of the Carve Out of Medi-Cal Pharmacy Services From Managed Care.” While PIPC shares concerns emphasized in the report about affordability of health care for patients and people with disabilities, Chairman Coelho strongly encouraged the state to avoid the use of discriminatory cost-effectiveness analysis for preference of drugs and as reference for spending caps. He emphasized that these analyses ultimately employ discrimination and restricted access as a means to lower costs. “In the end, policies that prevent patients and people with disabilities from getting the right care at the right time based on their unique characteristics and priorities adversely impact health and increase costly adverse events such as hospitalizations,” wrote Chairman Coelho. “Therefore, we reject any approach that fails to consider the implications for discrimination and adverse health outcomes in its analysis of the formal use of cost-effectiveness analysis for preference of drugs in Medi-Cal and use of a drug spending cap, similar to the State of New York.” Click here to read the letter.
6. 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: An immigrant child with cystic fibrosis and his family may face deportationdue to the cost of treating the disease.
- New Zealand: Patients are losing hope that "life-changing" breast cancer drugs will be covered by PHARMAC. Click here, here, and here for more. Patients with lung cancer are being denied drugs that will prolong their lives.
- Canada: Although Ontario said it would cover Orkambi for patients who need it, very few patients will be eligible. Click here to read more. Click here for a story about a patient with spinal muscular atrophy 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: Click here, here, and herefor articles on the impact of the NHS's denial of needed cystic fibrosis drugs. English families are moving to Scotland in an attempt to access needed cystic fibrosis drugs. Patients are fighting for access to multiple sclerosis drugs in Scotland. Click here for an article about the fight for access to spinal muscular atrophy drugs. Click here for an article about a patient who was denied access to a treatment that she helped test. Click here for an article about the need for NHS to fund drugs to treat rare diseases.
- France: Patients are alarmed as a multiple sclerosis drug will no longer be covered.
7. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, 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:
- Arthritis: 5/9/2019: Revised Scoping Document. Meeting 10/31/2019: CTAF to an update to its 2017 rheumatoid arthritis assessment.
- Type 2 Diabetes: Draft Scoping Document now available, public comment open through 5/22/2019. 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 : 5/20/2019: Research Protocol. 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.
- Depression: 5/9/2019: Evidence Report. Meeting 5/23/2019: Midwest CEPAC to review evidence on esketamine as a therapy for treatment-resistant depression.
- Multiple Sclerosis: Evidence Report now available. Meeting 5/23/2019: Midwest CEPAC to review ICER's assessment of siponimod (Novartis) for secondary progressive multiple sclerosis.
- Peanut Allergy: Draft Evidence Report available. Public Comments OPEN through May 8, 2019. Meeting 6/11/2019: CTAF to review ICER's assessment of treatments for peanut allergy.
- Duchenne Muscular Dystrophy: 5/22/2019: Draft Evidence Report. 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: 10/8/2019: Final Report.
8. NVHR Hepatitis C Patient Summit
The National Viral Hepatitis Roundtable (NVHR) will be hosting a hepatitis C patient summit July 29-30th 2019 in Atlanta, timed with World Hepatitis Day on July 28th. The summit - NVHR’s first national patient gathering - will bring together 100 patients recently cured of or currently living with Hepatitis C who have had limited experience engaging in other advocacy programs. Click here to apply to the patient summit.
9. NPC: Public Input Key for Improving Value Assessment
As ICER prepares to review its value assessment process, it is critical to place greater weight on patient input to understand what patients value, writes the National Pharmaceutical Council. "Stakeholder input and feedback — especially from patients — should be meaningfully incorporated throughout the assessment process, from the selection of topics to be examined through the entire review cycle. Today, frameworks still vary widely in the extent to which they embed patients in the process. Patients are ultimately the ones affected by the value-based decisions of other stakeholders, so it is critically important to engage with patients and consider their perspectives throughout the framework development and assessment processes," wrote the organization. Click here to read the article.
10. AAMC on PCORI's Contributions
Doctors have long relied on what other doctors have done before to decide on what care is best for their patients. The Association of American Medical Colleges writes that PCORI's contribution of comparative clinical effectiveness research has given doctors new tools to understand which interventions are best for which patients. The article notes that patient input, a cornerstone of PCORI's research, has been shown to objectively improve the quality of research and result in better outcomes. "PCORI’s emphasis on patient engagement marks a shift in how research is being carried out, with greater emphasis placed on listening to the patient voice and treating them as experts. It’s also helped researchers think differently about desired outcomes," writes the AAMC's Julia Haskins. "But that could come to a halt before the year ends, with PCORI’s budget up for reauthorization in Congress. Researchers, clinicians, patients, and other stakeholders who have benefited from PCORI want to keep the momentum going." Click here to read the article.
11. AUCD: Submit a Proposal for 2019 Conference!
The AUCD Conference welcomes proposals to highlight the work of the disability community. Over 200 different presentations will be accepted to the conference in several different types of sessions, formatted for maximum visibility and interaction with attendees. Proposals are encouraged from students, self-advocates, family leaders, clinicians, and researchers in over 25 topics. Click here for more information.
12. 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.
13. Upcoming Events and Webinars
UPMC Conference on Accelerating Stakeholder-Driven Patient-Centered Outcomes Research and Comparative Effectiveness Research (PCOR/CER) in a Learning Health System
May 7, 2019
Click here for details.
2019 Triangle Comparative Effectiveness Symposium
May 7, 2019
Click here for details.
Cycle 2 2019 Improving Methods Applicant Town Hall
May 9, 2019
Click here for details.
PCORI Board of Governors Meeting
May 13, 2019
Click here for details.
Policy Briefing: Are Value Assessments in Healthcare A New Form of Discrimination?
May 15, 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 ISPOR Conference
May 18-22, 2019
Click here for details.
The Perils of QALYs: Addressing discrimination against people with disabilities and serious chronic conditions
May 20, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019
Click here for details.
Advisory Panel on Clinical Effectiveness, and Decision Science Spring 2019 Meeting
June 14, 2019
Click here for details.
Understanding FDA’s Real-World Evidence Program: A Presentation of the AMIA Public Policy Committee
June 21, 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.
2019 PCORI Annual Meeting
September 18-20, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
14. Medical Journal Articles
A Framework for Aiding the Translation of Scientific Evidence into Policy: The Experience of a Hospital-Based Technology Assessment Unit, click here to view.
Multi-Criteria Decision Analysis for Health Technology Assessment: Addressing Methodological Challenges to Improve the State of the Art, click here to view.
Novel Therapies for an Aging Population: Grappling With Price, Value, and Affordability, click here to view.
How Well Does the Patient-Centered Outcomes Research Institute Fund Primary Care and Comparative Effectiveness Research?, click here to view.
Addressing Health System Values in Health Technology Assessment: The Use of Evidence-Informed Deliberative Processes, click here to view.
Launch of AHRQ's Systematic Review Data Repository (SRDR)+, click here to view.
Knowledge and Use of Evidence-Based Medicine in Daily Practice by Health Professionals: A Cross-Sectional Survey, click here to view.
Quantifying Preferences in Drug Benefit-Risk Decisions, click here to view.
Raising the Impact of Real World Evidence, click here to view.
Why and How to Use Patient-Oriented Research to Promote Translational Research, click here to view.
15. AHRQ Effective Program Updates
Systematic Review: Diagnosis and Treatment of Clinical Alzheimer's-type Dementia (CATD), clickhere to view.
Systematic Review: Comparative Effectiveness of Analgesics to Reduce Acute Pain in the Prehospital Setting, click here to view.
Systematic Review: Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention, click here to view.
Systematic Review: Telehealth for Acute and Chronic Care Consultations, click here to view.
White Paper: Standardized Library of Asthma Outcome Measures, click here to view.
Research Protocol: Characteristics of Existing Asthma Self-Management Education Packages, click here to view.
Systematic Review: Can Physical Activity Improve the Health of Wheelchair Users?, click here to view.
Comment Period: Registries for Evaluating Patient Outcomes: A User's Guide: Fourth Edition, click here to view.
Treatment of Acute Pain: An Evidence Map, click here to view.
Systematic Review: Pharmacologic and Non-pharmacologic Therapies in Adult Patients with Acute Exacerbation of COPD, click here to view.
Integrating Palliative Care With Chronic Disease Management in Ambulatory Care, click here to view.
Systematic Review: Adverse Effects of Pharmacological Treatments of Major Depression in Older Adults, click here to view.
Key Questions: Management of Primary Headaches in Pregnancy, click here to view.
Systematic Review Update: Noninvasive Nonpharmacologic Treatments for Chronic Pain, click here to view.