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  • Home
  • About
    • Mission and Priorities
    • Meet the Chairman
    • Steering Committee
    • PIPC Member List
    • Contact
  • The Issues
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    • Nevada AB 259
    • QALY Panel
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The PIPC Blog

PIPC Weekly Update: June 3, 2019

6/3/2019

 
Picture
In This Week’s Issue:
 
1. PIPC Blog: ICER's SMA Study Falls Short on Data Accuracy, click here to read the full post.
2. ICER Seeks Public Input for 2020 Value Assessment Framework - Contact PIPC to Sign On!, click here to read more and see below for details.
3. Shared Decision-Making: Sign Comment Letter on Interoperability Rule, see below for details.
4. The Perils of QALYs Event at the Coelho Center, click here to read more.
5. Coelho Center Celebrates its First Year, click here to read more about the Center.
6. You're Invited! Value Our Health Briefings on Capitol Hill, see below for details.
7. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more. 
8. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, Duchenne Muscular Dystrophy click here to provide patient input.
9. AACR Briefing on e-Cigarettes and Nicotine Addiction, click here for more information.
10. STAT Op-Ed: Critics of SMA Gene Therapy are Missing the Point, click here to read the article.
11. PPVF Initiative Releases Survey Results on SDM Tool, White Paper on Patient-Centered Value Assessment, click here to see the survey results and click here to read the white paper.
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. 

​1. PIPC Blog: ICER's SMA Study Falls Short on Data Accuracy
 
PIPC published a blog post this week outlining how ICER failed to consider sufficient data in its recent study on SMA and how the study and its use of the QALY hurts patients. From the blog: "ICER’s recently-released final report was disappointing in several ways, including the lack of sufficient data, disregard for outcomes that matter to patients, lack of understanding and oversimplification of the condition, and the inherit weaknesses of the quality-adjusted-life-year (QALY) measure. This is particularly concerning given the real-world consequences we are observing in the U.K. and other countries, which have utilized QALYs to limit patient access. As one mother of a child with SMA living in the U.K. shared: “It’s an abomination of human rights that the drug isn’t available… I've seen children in America who had it when they were first diagnosed and they're walking. To be put in a position where you have to consider moving abroad to keep your son alive is dreadful.” With such clear consequences for children and their families, it is alarming to see ICER ignore patients’ voices and produce such a flawed and short-sighted assessment of these important, breakthrough therapies." Click here to read the full post.
 
2. ICER Seeks Public Input for 2020 Value Assessment Framework - Contact PIPC to Sign On!
 
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 and its partners have developed 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 submit comments to ICER. Click here to view PIPC's letter, and please contact [email protected] for additional information about the letter being developed by PIPC and others.
 
3. Shared Decision-Making: Sign Comment Letter on Interoperability Rule
 
The Alliance for Aging Research, National Partnership for Women and Families, National Patient Advocate Foundation, the Partnership to Improve Patient Care and EBSCO Health collaborated to draft a response to CMS related to their comments on the implications of interoperability for advancing shared decision-making. The current rulemaking on Interoperability has comments due TODAY, Monday, June 3, 2019. Please contact [email protected] to sign on by 4pm EST today. The comment letter narrows down for CMS simple concrete steps for advancing shared decision-making:
 
  • CMS should reinforce the importance of person-centered communication skills development among providers. 
  • CMS should work with stakeholders, including patient representatives, to establish appropriate standards for achieving high quality shared decision-making. 
  • CMS should work with stakeholders with expertise on shared decision-making and the patient advocacy community to identify a path forward for the certification of patient decision aids. 
 
CMS should consider many common preference sensitive conditions as priorities for building communication skills among relevant providers and certification of decision aids for those conditions.  Click here to view the letter.
 
4. The Perils of QALYs Event at the Coelho Center
 
The Coelho Center on Disability Law, Policy, and Innovation held an event this week to discuss the shortcomings of QALYs and how they discriminate against people with disabilities. A panel including PIPC Chairman Tony Coelho and Executive Director Sara van Geertruyden spoke about how cost-effectiveness analyses all too often treat patients as averages, not as individuals. "I started PIPC in an effort to make research more patient-centered, with patient and people with disabilities at the table throughout the process so that it answered questions that matter to us. Over the years, PIPC has grown to bring that same passion to engaging patients and people with disabilities in Medicare and Medicaid decisions about access to care," said Chairman Coelho. Click here to read more.
 
5. Coelho Center Celebrates its First Year
 
The Coelho Center on Disability Law, Policy, and Innovation at Loyola Law School in Los Angeles celebrated the end of its inaugural academic year. The Center, founded by and named for PIPC Chairman Tony Coelho, serves to collaborate with the disability community to cultivate leadership and advocate innovative approaches to advance the lives of people with disabilities. Over its first year, the Center held a number of events to engage people with disabilities and the broader community in breaking down barriers for the disabled community. Click here to read more about the Center.
 
6. You're Invited! Value Our Health Briefings on Capitol Hill
 
Value Our Health, a coalition including PIPC and a wide variety of groups advocating for patients and people with disabilities, is holding two briefings on value assessments on Capitol Hill on June 20. Please join our esteemed panel to learn about value assessments, their potential for discrimination, and related public policy threats at the federal and state level. Click here to RSVP for a breakfast briefing on the House side and click here to RSVP for a lunch briefing on the Senate side.
 
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: An immigrant child with cystic fibrosis and his family may face deportation due to the cost of treating the disease.
 
  • New Zealand: Patients can face long waits for new drugs, or never gain access to them at all. Click here to read more. Patients fear that PHARMAC will switch to offering only a less-effective epilepsy drug. Patients are fighting to have PHARMAC cover spinal muscular atrophy drug Spinraza. Click here for more.
 
  • Canada: An Ontario woman living with CF advocates for greater access to lifesaving drugs.
 
  • United Kingdom: Child with CF's classmates send a letter to CF to try to get it to cover a lifesaving drug. Chronic migraine sufferers call for the NHS to cover a breakthrough drug. A "breakthrough" multiple sclerosis drug will be covered by the NHS only after 21,000 patients petitioned the group.
 
  • France: Patients are alarmed as a multiple sclerosis drug will no longer be covered.
 
8. 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:
 
  • Spinal Muscular Atrophy: Updated Final Evidence Report Available.
 
  • Arthritis: Revised Scoping Document available. 6/14/2019: Research Protocol. Meeting 10/31/2019: CTAF to an update to its 2017 rheumatoid arthritis assessment.
 
  • Type 2 Diabetes: Revised Scoping Document available. 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 :  Research Protocol now available. 6/6/2019: Model Analysis Plan. 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: Evidence Presentation available. 6/20/2019: Final Evidence Report and Meeting Summary.
 
  • Multiple Sclerosis: Evidence Presentation available. 6/20/2019: Final Evidence Report and Meeting Summary.
 
  • Peanut Allergy: Responses to Public Comments and Evidence Report available. Meeting 6/11/2019: CTAF to review ICER's assessment of treatments for peanut allergy. 7/3/2019: Final Evidence Report.
 
  • Duchenne Muscular Dystrophy: Public comment period OPEN on Draft Evidence Report and Draft Voting Questions through 6/18/2019. 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.
 
9. AACR Briefing on e-Cigarettes and Nicotine Addiction
 
On June 12, 2019, the American Association for Cancer Research (AACR) will host a Capitol Hill briefing to educate Congressional staff and the public on the potential public health crisis of e-cigarette use and nicotine addiction in youth and young adults. Government officials and public health experts will share their knowledge on regulatory efforts, new data around nicotine addiction, and usage trends. Click here for more information.
 
10. STAT Op-Ed: Critics of SMA Gene Therapy are Missing the Point
 
A patient with spinal muscular atrophy (SMA) wrote an op-ed in STAT News saying that ICER-style "value assessment," placing a price tag on human life, should be unacceptable to our society. "We should not put a price tag on life, though. “$2.1 million is too much to spend for that baby’s survival” isn’t the kind of 'value assessment' we should ever accept as a society. Instead, think about the parents who will no longer have to receive the heartbreaking news that my parents were given 29 years ago: 'Your child has spinal muscular atrophy, and there’s nothing we can do. Survival beyond early childhood is unlikely.' The price of Zolgensma seems insignificant now, don’t you think?" wrote Nathan Yates, who lives with SMA and teaches finance and economics at Southern New Hampshire University. Click here to read the op-ed.
 
11. PPVF Initiative Releases Survey Results on SDM Tool, White Paper on Patient-Centered Value Assessment
 
PIPC is a member of the Patient-Perspective Value Framework (PPVF) Initiative led by Avalere Health. As a part of the initiative, Avalere partnered with CancerCare and Dr. Gabrielle Rocque, an oncologist at the University of Alabama Birmingham School of Medicine, to develop the Preparation for Shared Decision Making (PFSDM) tool. The purpose of PFSDM is to help women with advanced breast cancer feel better prepared to communicate with their clinicians and engage in decision making that aligns with their personal preferences. The PPVF Initiative also published a new white paper featuring consensus-based recommendations to improve the patient-centeredness of value assessment frameworks. The paper provides recommendations on how stakeholders can adjust their frameworks to better incorporate patient-oriented aspects of value in both the short and long term. Click here to see the survey results and click here to read the white paper.
 
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 
  
PCORI at AcademyHealth 2019 Research Meeting
June 2-4, 2019
Click here for details.
 
2019 NEC Symposium
June 2 - 5, 2019
Click here for details.
 
Getting Real: The Changing Tide on Real-World Evidence in Drug Development
June 5, 2019
Click here for details.
 
Advisory Panel on Clinical Effectiveness, and Decision Science Spring 2019 Meeting
June 14, 2019
Click here for details.
 
PCORI Board of Governors Meeting
June 18, 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.
 
Improvements to Rural Health Care Through Patient-Centered Research
June 26, 2019
Click here for details.
 
PCORI Advisory Panel on Patient Engagement Summer 2019 Meeting 
June 27-28, 2019
Click here for details.
 
Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes
July 11-12, 2019
Click here for details.
 
NVHR Hepatitis C Patient Summit
July 29-30, 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 Tool for Empirical Equipoise Assessment in Multigroup Comparative Effectiveness Research, click here to view.
 
As Health Technology Assessment Evolves So Must its Approach to Patient Involvement, click here to view.
 
Evaluation of Value-Based Insurance Design for Primary Care, click here to view.
 
Leveraging Patient/Community Partnerships to Disseminate Patient Centered Outcomes Research in Geriatrics, click here to view.
 
Enabling Individualised Health in Learning Healthcare Systems, click here to view.
 
Analysis of Sponsor Hearings on Health Technology Assessment Decision Making, click here to view.
 
Study Verifies Value of Real-World Evidence, click here to view.
 
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.
 
15. AHRQ Effective Program Updates
 
Technical Brief: Pharmacological and Nonpharmacological Treatments for Post-Traumatic Stress Disorder, click here to view.
 
Systematic Review: Management of Infertility, click here to view.
 
Key Questions: Cervical Ripening in the Outpatient Setting, click here to view.
 
Key Questions: Radiation Therapy for Brain Metastases, click here to view.
 
Protocol: A Rapid Evidence Review of Retention Strategies for Medications for Addiction Treatment (MAT) in Adults with Opioid Use Disorder, click here to view.
 
Systematic Review: Diagnosis and Treatment of Clinical Alzheimer's-type Dementia (CATD), click here 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. 

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