1. People with Disabilities Call for Nondiscrimination in the COVID-19 Crisis, see details below.
2. Don't Let Bureaucrats Deny Care for Kids with Cystic Fibrosis, click here to read the op-ed.
3. PIPC Submits Comment Letter to ICER on Draft Evidence Report for Cystic Fibrosis, click here to read the letter.
4. Advocacy Groups Seek COVID-19 Assistance, see details below.
5. Over 150 Groups Urge Congress to Erect Safeguards Around Medicare & Medicaid Demonstration Projects, click here to read the letter.
6. COVID-19 Has Highlighted the Need for Good Hygiene, and Cystic Fibrosis Patients Hope This Awareness Continues, click here to read the article.
7. PIPC Patient Blog: Migraine Patients Deserve Access to Needed Treatments, click here to read the blog.
8. Headache and Migraine Patients Speak Out on ICER's Acute Migraine Report, see details below.
9. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
10. ICER's QALY-Based Study Topics: Hemophilia A, Acute Migraine, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, click here to provide patient input.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below.
As the COVID-19 crisis escalates, people with disabilities have communicated a clear message against perpetuating discrimination in violation of the Americans with Disabilities Act (ADA). The New York Times published a response from PIPC Chairman Tony Coelho to a troubling opinion piece last week stating, "I did not fight for the Americans With Disabilities Act to let this country count people with disabilities as having less value than others. Those with underlying conditions should not allow self-appointed ‘experts' to instill fear.” The New York Daily News published a more expansive opinion by Chairman Coelho stating, "Right now, we need leadership directing resources to the most vulnerable populations, not away from them. Health officials in the administration are taking aggressive steps to ensure anyone with COVID-19 can access the care they need. Similarly, leaders in Congress like my friend Sen. Bob Casey and many of his Senate colleagues are getting this right by calling for steps to protect people in nursing homes, older adults and people with disabilities...People with disabilities understand very clearly what is at stake in this crisis. Will we as a nation rise above fear and reaffirm our value for every person, regardless of their age or abilities? Or give way to fear and retreat to self-preservation?” Click here to view Chairman Coelho’s Letter to the Editor and here to view his opinion.
The National Council on Disability has requested that the Office for Civil Rights (OCR) quickly issue a notice to physicians and hospitals specifying the applicability of non-discrimination requirements of the Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act, and Section 1557 of the Affordable Care Act in making treatment decisions. Today, Ari Ne’eman reiterated the importance of nondiscrimination in his opinion in the New York Times, stating, "At its core, these debates are about value — the value we place on disabled life and the value we place on disability nondiscrimination. When Congress passed the Americans With Disabilities Act 30 years ago, did it do so as a form of charity limited to times of plenty? Or was our country serious about disability as a civil rights issue? Charity can end when resources are scarce — civil rights must continue, even if doing so imposes a cost in time, money and even lives. People with disabilities have an equal right to society’s scarce resources, even in a time of crisis.” Click here to view the NCD letter. Click here to view the opinion by Ari Ne’eman.
2. Don't Let Bureaucrats Deny Care for Kids with Cystic Fibrosis
When the Affordable Care Act passed ten years ago, lawmakers made it clear that the government should not ration health care, wrote Boomer Esiason and Mary Vought in the New York Post. "Despite these clear prohibitions on rationing of care within Medicare, other government programs have taken it upon themselves to outsource their coverage decisions to an outside body—the Institute for Clinical and Economic Review (ICER). As parents of cystic fibrosis patients, we see obvious problems with the ICER approach. First, its QALY formula discounts the value, and the inherent worth, of individuals with disabilities. Our children deserve the right to a future just as much as other Americans—yet the QALY measure values their well being less than 'healthy' Americans. In fact, the National Council on Disability released a report last fall, noting that, 'QALY-based programs have been found to violate the Americans with Disabilities Act.' Second, ICER represents an unelected, unaccountable group of officials making decisions that influence the health coverage decisions—and thus the lives—of millions of Americans. ICER recently released draft recommendations regarding cystic fibrosis treatments. Despite finding 'substantial' evidence of net health benefits in several instances, the ICER draft branded treatments like the miracle drug, Trikafta, too expensive to justify coverage by insurers. But as parents who have seen the way that new medications like Orkambi and Symdeko have changed the lives of many with cystic fibrosis, we believe the entire ICER process undermines the value of not only our children, but also all Americans," they said. Click here to read the op-ed.
3. PIPC Submits Comment Letter to ICER on Draft Evidence Report for Cystic Fibrosis
In a letter to the Institute for Clinical and Economic Review (ICER), the Partnership to Improve Patient Care (PIPC) offered feedback on ICER’s draft evidence report for Cystic Fibrosis treatments. PIPC Chairman Tony Coelho was critical of ICER’s QALY-based approach in its assessment, noting that the QALY disservices those with chronic and disabling conditions such as CF. Chairman Coelho also took issue with ICER’s willingness to prioritize financial savings over patient life and well-being. “ICER needs to reconsider its use of the QALY and model construction to ensure it is capturing an accurate picture of the value of treatments to patients,” wrote Chairman Coelho. “We disagree, as do the patients and families impacted by your analysis, that ICER should have the authority to determine the value of a patient with cystic fibrosis. Click here to read the letter.
4. Advocacy Groups Seek COVID-19 Assistance
As Congress considers legislation providing relief for COVID-19, several groups and coalitions have put forward requests to Congress. Click here to view the priorities of Civil Rights and Disability organizations to address the needs of people with disabilities, their families, and the workforce that supports them. Click here to view the requests from the “Burrito Coalition” of advocacy organizations seeking assistance for charitable non-profits. Click here to view a toolkit for contacting Congress. Click here to view a Q&A resource created with the National Foundation for Infectious Diseases (NFID) for older adults and people with chronic health conditions and here to register for their webinar.
5. Over 150 Groups Urge Congress to Erect Safeguards Around Medicare & Medicaid Demonstration Projects
On Mar. 12, PIPC joined over 150 leading patient advocacy groups in signing on to a letter of support for the Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741). Sponsored by Reps. Terri Sewell (D-AL) and Adrian Smith (R-NE), this bill would make significant strides in addressing patient and provider concerns about the impact of the Center for Medicare and Medicaid Innovation (CMMI) demonstrations on access to care and the quality of care. “We are concerned that too many CMMI models endanger patient access to healthcare providers and medically necessary treatments and create unnecessary obstacles for vulnerable patients,” the letter states. “H.R. 5741 provides safeguards for CMMI to ensure CMMI demonstrations are patient-focused and benefit beneficiaries.” Click here to read the letter.
6. COVID-19 Has Highlighted the Need for Good Hygiene, and Cystic Fibrosis Patients Hope This Awareness Continues
Individuals living with cystic fibrosis and their families, among others with compromised immune systems, have been practicing the good hygiene needed to combat the novel coronavirus, COVID-19, for years. In USA Today, Boomer Esiason and Mary Vought, two parents of cystic fibrosis patients write that it is important for their children that people continue to practice good hygiene after the pandemic ends. "We know there is an eventual end in sight for the coronavirus pandemic, but vulnerable populations will continue to be just that: vulnerable. That means proper health hygiene should not disappear with the virus. Continuing to take the necessary steps to protect those around you is the considerate course of action. Please keep washing those hands and covering those coughs. It will not only help you, it helps protect the people we love, those who can’t protect themselves," they wrote. Click here to read the article.
7. PIPC Patient Blog: Migraine Patients Deserve Access to Needed Treatments
Jamie Sanders, who lives with intractable migraine, penned a PIPC patient blog about her experience and the importance of access to treatments for patients like her. "Patients like me should immediately access new treatments. To ensure this happens, it is vital that doctors’ assessments be widely accepted in determining which patients have failed or can’t use older medicines. Migraine disease is an incredibly personal journey and the clinician-patient relationship should be primary, not the academics over at ICER or their recommendations for prior authorization, in making treatment decisions," she wrote. Click here to read the blog.
8. Headache and Migraine Patients Speak Out on ICER's Acute Migraine Report
In response to ICER's revision to its acute migraine report reversing course on its determination that certain migraine drugs were not cost effective, migraine advocates continued to point out that ICER undervalues drugs' benefits and does not address the real economic costs of migraines, not to mention the patient perspective. The Headache and Migraine Policy Forum's Lindsay Vedinieks was quoted in multiple publications calling for ICER to revise its report taking into account societal factors to better reflect the actual impact that new medications can have on the lives of migraine patients. "Waiting is painful for migraine patients," she said, adding that there is an issue whenever an individual with migraine issues has to wait for care. Click here to read the Politico article. Click here to read the Inside Health Policy article. Click here to read the Bloomberg Law article.
9. 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.
- Canada: Cystic Fibrosis Canada asks Saskatchewan for help in advocating potential life-saving drug. Click here and here to read more. Newfoundland man recovering from second lung transplant that he had to get because Canada denies access to life-saving CF drugs.
- United Kingdom: Woman with life-threatening bowel cancer seeks help from NHS on drug that may save her. NHS finally approves life-changing injectable migraine drug. Click here and here to read more.
10. ICER's QALY-Based Study Topics: Hemophilia A, Acute Migraine, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments
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: Model Analysis Plan available. 4/1/2020: Draft Evidence Report and Draft Voting Questions. Meeting 6/30/2020: CTAF will convene to deliberate and vote on evidence presented in ICER's report on ulcerative colitis therapies.
- Cystic Fibrosis: Draft Evidence Report and Draft Voting Questions available. 4/23/2020: Evidence Report and Response to Comments. Meeting POSTPONED: CTAF will convene to deliberate and vote on evidence presented in ICER's report on treatments for cystic fibrosis.
- Sickle Cell Disease: Evidence Report and Responses to Comments AVAILABLE. Meeting POSTPONED: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for sickle cell disease.
- Non-Alcoholic Steatohepatitis: Draft Evidence Report and Voting Questions AVAILABLE, Comment Period OPEN through 4/15/2020. Meeting 5/28/2020: The Midwest CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for NASH.
- Hemophilia A: Revised Scoping Document available. 3/30/2020: Research Protocol. Meeting 8/3/2020: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for hemophilia.
- Bladder Cancer: Draft Scoping Document available. 4/10/2020: Revised Scoping Document.
- Opioids: Digital Apps: Draft Scoping Document available, Comment Period open through 4/2/2020. 4/10/2020: Revised Scoping Document.
- Opioids: Supervised Injection Centers: Open input period, no end date specified.
11. Upcoming Events and Webinars
PCORI Board of Governors Meeting
March 24, 2020
Click here for details.
Webinar: How Biopharma & MedTech Companies Can Demonstrate Value Under Recent ICER Updates
March 25, 2020
Click here for details.
Webinar: Adding Depth to Observational Research through Data Linkage
April 8, 2020
Click here for details.
Market Access USA at eyeforpharma Philadelphia
April 15, 2020
Click here for details.
Webinar: Unlocking Health Data to Improve Oncology Outcomes
April 28, 2020
Click here for details.
FT US Pharma and Biotech Summit 2020
May 14, 2020
Click here for details.
Advancing Value-Based Care
May 14, 2020
Click here for details.
12. Medical Journal Articles
Defining the Role of the Public in Health Technology Assessment (HTA) and HTA-Informed Decision-Making Processes, click here to view.
When Guidelines Recommend Shared Decision-Making, click here to view.
Upholding Trust in Therapeutic Trials and Evidence-Based Medicine: Need for Full Disclosure of Data, Crowdsourcing Data Analysis and Independent Review?, click here to view.
Physician and Patient Adjustment to Reference Pricing for Drugs, click here to view.
Patient-Centered Outcomes Research and the Injured Patient: A Summary of Application, click here to view.
Does the Use of Health Technology Assessment Have an Impact on the Utilisation of Health Care Resources? Evidence from Two European Countries, click here to view.
Patients, Clinicians and Researchers Working Together to Improve Cardiovascular Health: A Qualitative Study of Barriers and Priorities for Patient-Oriented Research, click here to view.
HTA Around the World: Broadening Our Understanding of Cross-Country Differences, click here to view.
Early Returns From the Era of Precision Medicine, click here to view.
Who Assigns Value in Value-Based Insurance Design?, click here to view.
Does the Institute for Clinical and Economic Review Revise Its Findings in Response to Industry Comments?, click here to view.
13. AHRQ Effective Program Updates
EPC Program Concludes Series on Improving Health Systems Use of Evidence Reviews. Click here to view.
Research Protocol: Prehospital Airway Management: A Systematic Review. Click here to view.
OPEN FOR COMMENT THROUGH MARCH 2: Technical Brief: Strategies for Patient, Family, and Caregiver Engagement. Click here to view.
Research Protocol: Pharmacologic and Nonpharmacologic Treatments of Posttraumatic Stress Disorder, click here to view.
2019 Year in Review—Accomplishments From the Evidence-based Practice Center Program, click here to view.
Research Protocol: Radiation Therapy for Brain Metastases: A Systematic Review, click here to view.
Research Protocol: Cervical Ripening in the Outpatient Setting, click here to view.
Research Protocol: Treatments for Acute Episodic Migraine, click here to view.
Research Protocol: Mixed Methods Review: Integrating Palliative Care With Chronic Disease Management in Ambulatory Care, click here to view.
Online Training for SRDR+ Now Available at the Evidence Synthesis Academy, click here to read more.