In This Week’s Issue:
1. Nearly 150 Groups Urge Congress to Erect Safeguards Around Medicare & Medicaid Demonstration Projects, click here to read the letter.
2. PIPC Patient Blog: Migraine Patients Deserve Access to Needed Treatments, click here to read the blog.
3. Washington Post: Protecting Older People Amidst Coronavirus, click here to read the article.
4. Headache and Migraine Patients Speak Out on ICER's Acute Migraine Report, see details below.
5. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
6. 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.
7. Upcoming Events and Webinars, see details below.
8. Medical Journal Articles, see details below.
9. AHRQ Effective Program Updates, see details below.
1. Nearly 150 Groups Urge Congress to Erect Safeguards Around Medicare & Medicaid Demonstration Projects, click here to read the letter.
2. PIPC Patient Blog: Migraine Patients Deserve Access to Needed Treatments, click here to read the blog.
3. Washington Post: Protecting Older People Amidst Coronavirus, click here to read the article.
4. Headache and Migraine Patients Speak Out on ICER's Acute Migraine Report, see details below.
5. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
6. 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.
7. Upcoming Events and Webinars, see details below.
8. Medical Journal Articles, see details below.
9. AHRQ Effective Program Updates, see details below.
1. Nearly 150 Groups Urge Congress to Erect Safeguards Around Medicare & Medicaid Demonstration Projects
On Mar. 12, PIPC joined nearly 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.
2. 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.
3. Washington Post: Protecting Older People Amidst Coronavirus
In the Washington Post this week, Lateshia Beachum wrote about how people can protect others who are less able to cope with the emerging coronavirus epidemic, including older people and others with compromised immune systems. Beachum's advice includes using technology for care to minimize spread, having a care plan in place, and being prepared. Click here to read the article.
4. 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.
5. 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.
6. 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:
7. Upcoming Events and Webinars
Webinar: Communicating Real-World Evidence in the Medical Literature
March 18, 2020
Click here for details.
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.
8. 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.
9. 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.
On Mar. 12, PIPC joined nearly 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.
2. 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.
3. Washington Post: Protecting Older People Amidst Coronavirus
In the Washington Post this week, Lateshia Beachum wrote about how people can protect others who are less able to cope with the emerging coronavirus epidemic, including older people and others with compromised immune systems. Beachum's advice includes using technology for care to minimize spread, having a care plan in place, and being prepared. Click here to read the article.
4. 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.
5. 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: Government will not sponsor life-changing treatment of migraine treatment.
- Canada: Parents whose daughter died of CF give $100,000 in medication to Truro woman.
- New Zealand: Sixth death linked to government-forced epilepsy drug switch leads to calls for expanded inquiry. Click here and here to read more. Harm reports from forced epilepsy drug switch increase thirty-fold. Mother fights for her son to access a lifesaving CF drug.
- United Kingdom: NHS comes back to the negotiating table for a "miracle" PKU drug, and patients are petitioning for its inclusion on the NHS. Click here and here to read more.
6. 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, comment period OPEN through 3/18/2020. Meeting 4/30/2020: 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 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.
- Non-Alcoholic Steatohepatitis: Model analysis plan available. 3/19/2020: Draft Evidence Report. 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.
7. Upcoming Events and Webinars
Webinar: Communicating Real-World Evidence in the Medical Literature
March 18, 2020
Click here for details.
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.
8. 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.
9. 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.
