In This Week's Issue:
1. Inside Health Policy: PCORI Announces Funding To Compare Hep C Rx, Diagnostics, click hereto view the full article (subscription required).
2. PCORI Blogs: Funding, Heart Disease, Subject Protection, Missing Data, see below for details.
3. Brookings: How Hepatitis C is Shining a Light on Critical Gaps in Payment Reform, click here to view the full article.
4. Boston Globe: Portal Promotes Patient-Centered Multiple Sclerosis Research, click here to view the full article.
5. Brookings: The Significance of President Obama's Precision Medicine Initiative, click here to view the full article.
6. CEA: New Paper: Medicare Is Scrutinizing Evidence More Tightly for National Coverage Determinations, click here to view the full post.
7. Medical Journal Articles, see below for details.
8. AHRQ Effective Program Updates, see below for details.
1. Inside Health Policy: PCORI Announces Funding To Compare Hep C Rx, Diagnostics, click hereto view the full article (subscription required).
2. PCORI Blogs: Funding, Heart Disease, Subject Protection, Missing Data, see below for details.
3. Brookings: How Hepatitis C is Shining a Light on Critical Gaps in Payment Reform, click here to view the full article.
4. Boston Globe: Portal Promotes Patient-Centered Multiple Sclerosis Research, click here to view the full article.
5. Brookings: The Significance of President Obama's Precision Medicine Initiative, click here to view the full article.
6. CEA: New Paper: Medicare Is Scrutinizing Evidence More Tightly for National Coverage Determinations, click here to view the full post.
7. Medical Journal Articles, see below for details.
8. AHRQ Effective Program Updates, see below for details.
1. Inside Health Policy: PCORI Announces Funding To Compare Hep C Rx, Diagnostics
On the heels of PCORI’s announcement about Hep C funding, Inside Health Policy wrote, “A day after Gilead Sciences executives projected larger than expected discounts on hepatitis C medications, Obamacare's comparative-effectiveness research panel on Wednesday (Feb. 4) offered $50 million to compare diagnostics and drugs for hepatitis C, according to a release from the Patient-Centered Outcomes Research Institute.[…]The hepatitis C funding is part of $138 million worth of research grants. The other $88 million funds a range of projects, $12 million of which is for rare diseases research. […][Paul Carter, Gilead's executive vice president] said pharmacy benefit managers are lifting restrictions on the drugs in return for rebates, and he even expects professional societies to change guidelines that call for only giving the drugs to the sickest patients. However, the rebates do not always mean that everyone infected with the virus gets the drugs, and patient advocates are still up in arms over restrictions.” Click here to view the full article (subscription required).
2. PCORI Blogs: Funding, Heart Disease, Subject Protection, Missing Data
What's New in Our Spring 2015 Funding Announcements?
Kara Odom Walker, Deputy Chief Science Officer, Tsahai Tafari, Associate Director of Science, and James Hulbert, Pre-Award Contracts Manager, announced new funding for the spring at PCORI last week, “PCORI is especially interested in the investigation of strategies that address care for patients with life-threatening or chronically debilitating rare diseases. These illnesses are of such low prevalence—defined as conditions that affect fewer than 200,000 people in the United States (i.e., less than 1 in 1,500 persons)—that special efforts, such as combining data across large populations, may be needed to address them.” Click here to view the full announcement.
Research Aims to Continue Reducing Toll of Heart Disease
Early last week, Dr. Diane E. Bild, Senior Program Officer for Science commented on the PCORI Blog, “PCORI's investment in its national data research network, PCORnet, is designed to support studies that will address important health challenges, including cardiovascular disease. The Health eHeart Alliance, one of the Patient-Powered Research Networks funded by PCORnet, supports studies that leverage big data and are aimed at heart disease prevention and management.” Click here to view the full post.
Addressing Protection of Human Subjects in PCORI Applications and Merit Review
Cary Scheiderer, Merit Review Officer, Marina Broitman, Senior Merit Review Officer, and Tsahai Tafari, Associate Director of Science said in a PCIRO Blog post last week, “Research Integration and Evaluation At PCORI, we are always working to improve the way we do our work. As part of that work, we are now providing additional guidance and resources or applicants and reviewers to ensure that applications for our research funding and review of applications appropriately address the protection of human subjects.” Click here to view the full post.
Now Accepting Letters of Intent for Latest Funding Cycle, including Hepatitis C Announcement
Specifically citing funding grants for Hep C, Last week PCORI announced, “We issued six new PCORI Funding Announcements (PFAs) today. Five offer up to $88 million in support for a range of patient-centered comparative effectiveness research (CER) proposals under our national research priorities, with a pool of up to $12 million set aside for rare disease-focused studies. We also issued a new PFA targeting hepatitis C virus (HCV) infection, offering up to $50 million for up to four studies of key research questions in HCV diagnosis and treatment. Required Letters of Intent (LOIs) are due by 5 p.m. ET Friday, March 6. Find out more on the Funding Opportunities page on our website.” Clickhere to view the announcement.
3. Brookings: How Hepatitis C is Shining a Light on Critical Gaps in Payment Reform
Also commenting last week on Hep C, Kavita Patel, Morgan H. Romine and Gregory W. Daniel, write for The Brookings Institution, “In virtually all other aspects of health care, payment and delivery reforms are achieving a palpable shift away from volume and intensity toward patient-centered, higher value care...In this blog post, we consider alternative payment policies that could help to ensure that – despite their potentially high cost – breakthrough treatments are consistently delivering value to patients and that the health care system is addressing inefficiencies in the delivery and total costs of care.” Click here to view the full article.
4. Boston Globe: Portal Promotes Patient-Centered Multiple Sclerosis Research
Robert Weisman of The Boston Globe wrote, “[PCORI] last year issued $100 million in grants to health care providers and patient networks to get patients more involved in medical research and to promote studies that compare the effectiveness of various drugs for individual patients...The grants are part of a broader shift in medicine to customize the diagnosis and treatment of each patient on diseases from cancers to cystic fibrosis to multiple sclerosis. Having large databases of patients' records and therapies is critical to that effort.” Click here to view the full article.
5. Brookings: The Significance of President Obama's Precision Medicine Initiative
Additionally from The Brookings Institution, Gregory W. Daniel and Morgan Romine comment, “Traditional drug development programs have relied on a ‘one-size-fits-all’ approach, which tests drugs for specific therapeutic areas and uses a representative sample of patients with that disease. The promise of increasingly-targeted, precision medicine is in moving beyond that approach by using available science to deliver the most effective treatment possible, while also minimizing the potential for patients to receive unnecessary treatments that do not benefit them.” Click here to view the full article.
6. CEA: New Paper: Medicare Is Scrutinizing Evidence More Tightly for National Coverage Determinations
Writing for The CEA Registry Blog, James D. Chambers commented recently, “We found that when holding constant the level of supporting evidence, more recent coverage determinations (from mid-March 2008 through August 2012) were approximately twenty times less likely to be positive than earlier coverage determinations (from February 1999 through January 2002). In other words, the evidentiary bar for medical intervention coverage under Medicare national coverage determinations became higher between 1999 and 2012.” Click here to view the full post.
7. Medical Journal Articles
Caring for Patients with Kidney Disease: Shifting the Paradigm from Evidence-Based Medicine to Patient-Centered Care: Click here to view.
Topotecan, Pegylated Liposomal Doxorubicin Hydrochloride, Paclitaxel, Trabectedin and Gemcitabine for Advanced Recurrent or Refractory Ovarian Cancer: A Systematic Review and Economic Evaluation: Click here to view.
Comparative Effectiveness of Cefazolin Versus Cloxacillin as Definitive Antibiotic Therapy for MSSA Bacteraemia: Results from a Large Multicentre Cohort Study: Click here to view.
Building Efficient Comparative Effectiveness Trials Through Adaptive Designs, Utility Functions, and Accrual Rate Optimization: Finding the Sweet Spot: Click here to view.
The Promise Of Biomedical Innovation: Click here to view.
Improving Pharmaceutical Innovation By Building A More Comprehensive Database On Drug Development And Use: Click here to view.
Medicare Is Scrutinizing Evidence More Tightly For National Coverage Determinations: Click here to view.
Evaluating Possible Confounding by Prescriber in Comparative Effectiveness Research: Click here to view.
8. AHRQ Effective Program Updates
Management and Outcomes of Binge-Eating Disorder (BED): click here to comment by February 25, 2015
Diagnosis of Celiac Disease: click here to comment by February 25, 2015
Strategies Used by Adults to Reduce Their Prescription Drug Costs: United States, 2013: Click here to view.
Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma: Click here to review comments.
Imaging Techniques for the Diagnosis and Staging of Hepatocellular Carcinoma: Click here to review comments.
The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain: Click here to review comments.
EPC Methods: An Exploration of Methods and Context for the Production of Rapid Reviews: Click here to view the white paper.
On the heels of PCORI’s announcement about Hep C funding, Inside Health Policy wrote, “A day after Gilead Sciences executives projected larger than expected discounts on hepatitis C medications, Obamacare's comparative-effectiveness research panel on Wednesday (Feb. 4) offered $50 million to compare diagnostics and drugs for hepatitis C, according to a release from the Patient-Centered Outcomes Research Institute.[…]The hepatitis C funding is part of $138 million worth of research grants. The other $88 million funds a range of projects, $12 million of which is for rare diseases research. […][Paul Carter, Gilead's executive vice president] said pharmacy benefit managers are lifting restrictions on the drugs in return for rebates, and he even expects professional societies to change guidelines that call for only giving the drugs to the sickest patients. However, the rebates do not always mean that everyone infected with the virus gets the drugs, and patient advocates are still up in arms over restrictions.” Click here to view the full article (subscription required).
2. PCORI Blogs: Funding, Heart Disease, Subject Protection, Missing Data
What's New in Our Spring 2015 Funding Announcements?
Kara Odom Walker, Deputy Chief Science Officer, Tsahai Tafari, Associate Director of Science, and James Hulbert, Pre-Award Contracts Manager, announced new funding for the spring at PCORI last week, “PCORI is especially interested in the investigation of strategies that address care for patients with life-threatening or chronically debilitating rare diseases. These illnesses are of such low prevalence—defined as conditions that affect fewer than 200,000 people in the United States (i.e., less than 1 in 1,500 persons)—that special efforts, such as combining data across large populations, may be needed to address them.” Click here to view the full announcement.
Research Aims to Continue Reducing Toll of Heart Disease
Early last week, Dr. Diane E. Bild, Senior Program Officer for Science commented on the PCORI Blog, “PCORI's investment in its national data research network, PCORnet, is designed to support studies that will address important health challenges, including cardiovascular disease. The Health eHeart Alliance, one of the Patient-Powered Research Networks funded by PCORnet, supports studies that leverage big data and are aimed at heart disease prevention and management.” Click here to view the full post.
Addressing Protection of Human Subjects in PCORI Applications and Merit Review
Cary Scheiderer, Merit Review Officer, Marina Broitman, Senior Merit Review Officer, and Tsahai Tafari, Associate Director of Science said in a PCIRO Blog post last week, “Research Integration and Evaluation At PCORI, we are always working to improve the way we do our work. As part of that work, we are now providing additional guidance and resources or applicants and reviewers to ensure that applications for our research funding and review of applications appropriately address the protection of human subjects.” Click here to view the full post.
Now Accepting Letters of Intent for Latest Funding Cycle, including Hepatitis C Announcement
Specifically citing funding grants for Hep C, Last week PCORI announced, “We issued six new PCORI Funding Announcements (PFAs) today. Five offer up to $88 million in support for a range of patient-centered comparative effectiveness research (CER) proposals under our national research priorities, with a pool of up to $12 million set aside for rare disease-focused studies. We also issued a new PFA targeting hepatitis C virus (HCV) infection, offering up to $50 million for up to four studies of key research questions in HCV diagnosis and treatment. Required Letters of Intent (LOIs) are due by 5 p.m. ET Friday, March 6. Find out more on the Funding Opportunities page on our website.” Clickhere to view the announcement.
3. Brookings: How Hepatitis C is Shining a Light on Critical Gaps in Payment Reform
Also commenting last week on Hep C, Kavita Patel, Morgan H. Romine and Gregory W. Daniel, write for The Brookings Institution, “In virtually all other aspects of health care, payment and delivery reforms are achieving a palpable shift away from volume and intensity toward patient-centered, higher value care...In this blog post, we consider alternative payment policies that could help to ensure that – despite their potentially high cost – breakthrough treatments are consistently delivering value to patients and that the health care system is addressing inefficiencies in the delivery and total costs of care.” Click here to view the full article.
4. Boston Globe: Portal Promotes Patient-Centered Multiple Sclerosis Research
Robert Weisman of The Boston Globe wrote, “[PCORI] last year issued $100 million in grants to health care providers and patient networks to get patients more involved in medical research and to promote studies that compare the effectiveness of various drugs for individual patients...The grants are part of a broader shift in medicine to customize the diagnosis and treatment of each patient on diseases from cancers to cystic fibrosis to multiple sclerosis. Having large databases of patients' records and therapies is critical to that effort.” Click here to view the full article.
5. Brookings: The Significance of President Obama's Precision Medicine Initiative
Additionally from The Brookings Institution, Gregory W. Daniel and Morgan Romine comment, “Traditional drug development programs have relied on a ‘one-size-fits-all’ approach, which tests drugs for specific therapeutic areas and uses a representative sample of patients with that disease. The promise of increasingly-targeted, precision medicine is in moving beyond that approach by using available science to deliver the most effective treatment possible, while also minimizing the potential for patients to receive unnecessary treatments that do not benefit them.” Click here to view the full article.
6. CEA: New Paper: Medicare Is Scrutinizing Evidence More Tightly for National Coverage Determinations
Writing for The CEA Registry Blog, James D. Chambers commented recently, “We found that when holding constant the level of supporting evidence, more recent coverage determinations (from mid-March 2008 through August 2012) were approximately twenty times less likely to be positive than earlier coverage determinations (from February 1999 through January 2002). In other words, the evidentiary bar for medical intervention coverage under Medicare national coverage determinations became higher between 1999 and 2012.” Click here to view the full post.
7. Medical Journal Articles
Caring for Patients with Kidney Disease: Shifting the Paradigm from Evidence-Based Medicine to Patient-Centered Care: Click here to view.
Topotecan, Pegylated Liposomal Doxorubicin Hydrochloride, Paclitaxel, Trabectedin and Gemcitabine for Advanced Recurrent or Refractory Ovarian Cancer: A Systematic Review and Economic Evaluation: Click here to view.
Comparative Effectiveness of Cefazolin Versus Cloxacillin as Definitive Antibiotic Therapy for MSSA Bacteraemia: Results from a Large Multicentre Cohort Study: Click here to view.
Building Efficient Comparative Effectiveness Trials Through Adaptive Designs, Utility Functions, and Accrual Rate Optimization: Finding the Sweet Spot: Click here to view.
The Promise Of Biomedical Innovation: Click here to view.
Improving Pharmaceutical Innovation By Building A More Comprehensive Database On Drug Development And Use: Click here to view.
Medicare Is Scrutinizing Evidence More Tightly For National Coverage Determinations: Click here to view.
Evaluating Possible Confounding by Prescriber in Comparative Effectiveness Research: Click here to view.
8. AHRQ Effective Program Updates
Management and Outcomes of Binge-Eating Disorder (BED): click here to comment by February 25, 2015
Diagnosis of Celiac Disease: click here to comment by February 25, 2015
Strategies Used by Adults to Reduce Their Prescription Drug Costs: United States, 2013: Click here to view.
Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma: Click here to review comments.
Imaging Techniques for the Diagnosis and Staging of Hepatocellular Carcinoma: Click here to review comments.
The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain: Click here to review comments.
EPC Methods: An Exploration of Methods and Context for the Production of Rapid Reviews: Click here to view the white paper.