CER Daily Newsfeed®
Articles
Addressing Low-Value Care in the Time of COVID-19 (8/3, National Pharmaceutical Council: E.V.I.dently Today) comments “...It's time for us to take that step and prioritize high-value care at a time when health care costs are reaching new levels. That's why the Going Below the Surface Forum developed the Roadmap for Addressing Low-Value Care, a step-by-step guide to assist health care stakeholders in determining opportunities to address unnecessary care and improve patient outcomes. The GBTS Forum – a group of experts representing payers, provider groups and patient advocacy organizations – designed the guide to spotlight the key considerations stakeholders should note in their efforts to reduce spending and utilization of low-value treatments and services. The Roadmap outlines key goals, questions and tactics to consider and provides stakeholder-specific examples for potential interventions to reduce low-value care. This document is informed by both real-world experience and academic expertise of a GBTS Forum task force.” Full
COVID-19, Market Consolidation, And Price Growth (8/3, Laura Tollen and Elizabeth Keating, Health Affairs Blog) comments “...Taken together, though, the body of research on price variation suggests that there may be opportunities to reduce health spending by reining in some private payer prices—and that post-consolidation price increases may be a target of opportunity. The difficulty is in discerning when such price increases are associated with better value. If, for example, prices go up, but improved clinical integration leads to reductions in unnecessary use (fewer repeated tests, and so forth), value increases, and total spending may be moderated. Consolidation could have such an impact when it involves clinical integration and associated investments in quality and care coordination.” Full
Health Technology Assessment Post-COVID (8/3, Claudia Rubin, Pharmafield) comments “...The most clear and present challenge HTA bodies will face following the resumption of operations is a backlog in appraisals – this may lead to decision outcome delays, further hindering patient access to latest treatments. Increasing internal capacity could allow HTA bodies to ramp up operations while maintaining gold-standard appraisals. This would require more financial backing though and whether there is the appetite for this additional investment from budget-holders remains to be seen.” Full
Press Releases
ISPOR Announces Virtual ISPOR Asia Pacific 2020 (8/3, ISPOR Press Release) “ISPOR—The Professional Society for Health Economics and Outcomes Research announced its Virtual ISPOR Asia Pacific 2020 event programming today. Registration is now open for the virtual event that will be held 14-16 September 2020. Virtual ISPOR Asia Pacific 2020, ‘Next Generation Healthcare in Asia Pacific: Where Technology Meets Patients to Improve Care,’ is offering more than 25 hours of content that registrants can attend live and/or as on-demand recordings for 30 days after the event concludes.” Full
Commonly Used Treatments for Chronic Pain Can Do More Harm than Good and Should Not Be Used, Says NICE in Draft Guidance (8/3, NICE Press Release) “...The draft guideline recommends that some antidepressants can be considered for people with chronic primary pain. However, it says that paracetamol, non-steroidal anti-inflammatory drugs (these include aspirin and ibuprofen), benzodiazepines or opioids should not be offered. This is because, while there was little or no evidence that they made any difference to people's quality of life, pain or psychological distress, there was evidence that they can cause harm, including possible addiction. The draft guideline also says that antiepileptic drugs including gabapentinoids, local anaesthetics, ketamine, corticosteroids and antipsychotics should not be offered to people to manage chronic primary pain. Again, this was because there was little or no evidence that these treatments work but could have possible harms.” Full
Darolutamide in Prostate Cancer: Indication of Considerable Added Benefit (8/3, IQWiG Press Release) “Up to now, adult men with non-metastatic castration-resistant prostate cancer at high risk of developing metastatic disease usually continued their conventional androgen deprivation therapy while the cancer was observed for the occurrence of metastases (so-called watchful waiting). The German Institute for Quality and Efficiency in Health Care now examined in an early benefit assessment whether adding the drug darolutamide offers an added benefit for patients in comparison with the appropriate comparator therapy.” Full
Journals
NxGen Evidence: Redesigning the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Website to Promote Engagement, Interactivity and Usability of Systematic Reviews Ed Reid, et al. July 31, 2020, Research Synthesis Methods Wiley
Events
Webinar: Reducing Low-Value Care Roadmap: How AMGA Is Charting A Course To Change Health Care August 5, 2020 2:00 - 3:00PM ET Going Below the Surface
Webinar: Increasing Access to Necessary Care During the COVID-19 Pandemic & Beyond August 13, 2020 12:00 - 1:30PM ET Center for Value-Based Insurance Design
Articles
Viewpoint: Weighing the Benefits and Risks of Proliferating Observational Treatment Assessments: Observational Cacophony, Randomized Harmony (7/31, Robert M. Califf, MD; Adrian F. Hernandez, MD, MHS; Martin Landray, MBChB, JAMA) comments “...In some situations, observational findings about treatment effects associated with specific interventions merit adoption in practice, but in most cases this learning system should identify promising treatments and approaches for designing proper large-scale trials or should supplement RCT findings by modeling effects seen in RCTs in broader populations. Rather than promoting inconclusive observational findings in medical journals and the press, a repository could be created to register results in a manner less apt to inappropriately influence practice. In addition, it seems prudent to place a moratorium on reporting observational studies that could mislead the public.” Full
Trump's Kinda Sorta War with Pharma (7/31, Sarah Owermohle, Politico Prescription Pulse) reports “...‘For us, it's not an ”either or,” but a “yes and,”’ Carolyn Magill told Prescription Pulse in a phone interview. She noted that RWE are meant to supplement RCTs and better understand what's occurring in under-represented populations...‘Let's not try to boil the ocean,’ Magill said. ‘We don't need to extend [RWE] to every use case but absolutely there are cases where it can be critical to getting a better understanding for certain patient populations.’” Full
Strength in Numbers: LTC Might Finally Be Getting Some (7/31, James M. Berklan, McKnight's Long-Term Care News) reports “...Earlier this month, PCC launched its Lighthouse initiative. It will provide de identified data on COVID 19 diagnosed patients, including demographics, vitals, medications and health related outcomes to help better understand their health and outcomes post ICU. ‘The COVID-19 pandemic has introduced unprecedented challenges to healthcare systems worldwide, but we live in a more connected world and we must work together and learn from each other's experiences to help reduce the severity of the impact,’ said Rahul Kashyap, M.B.B.S., MBA...‘This dissemination of aggregated knowledge shared in a single database in a timely manner will be essential for comparative effectiveness studies. It will be a game-changer,’ Kashyap added.” Full
AAFP Advocacy Visible in Value-Based Payment Legislation (7/30, American Academy of Family Physicians) comments “The AAFP's repeated calls for Congress and regulators to ensure that family physicians can successfully participate in value-based payment models and accountable care organizations resonate in a new bill applauded by the Academy and 12 other health care organizations...A number of key AAFP priorities are included in the bill, which would: increase Medicare Shared Savings Program Basic-track ACO shared-savings rates...provide advance funding to ACOs to ensure access to capital for initial infrastructure investments...” Full
UK: 5 Questions for the New Chair of NICE Sharmila Nebhrajani (7/31, Siobhan Harris, Medscape) reports “...[Sharmila Nebhrajani:] Three main challenges spring immediately to mind. Firstly, the health advances promised by personalised medicine are extraordinary...Secondly is the rise of AI and machine learning impacting all branches of medicine. NICE methods will need to adapt to assess these sorts of dynamic interventions which, rather than fixed, are learning in real time, using messy real-world data and with software that updates rapidly.” Full
UK: NICE Backs Bavencio Combo for Kidney Cancer (7/31, Selina McKee, PharmaTimes) reports “The National Institute for Health and Care Excellence has recommended NHS use of Merck and Pfizer's immunotherapy Bavencio (avelumab) in combination with axitinib as a first-line treatment for kidney cancer. Specifically, the drug's use will be funded via the Cancer Drugs Fund when used for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).” Full
Journals
Are Observational, Real-World Studies Suitable to Make Cancer Treatment Recommendations? Rahul Banerjee, MD; Vinay Prasad, MD, MPH July 30, 2020, JAMA Network Open JAMA Network Open
Events
ICER Colloquium Series, Pricing in a Pandemic: Options, Debate, a Path Forward: Session Three: Monetary Prizes, Compulsory Licensing, Advanced Market Commitments August 7, 2020 12:00 - 1:30PM ET ICER
Webinar: Support Your Clinical and Economic Value Proposition with Real World Data: Data and Technology-Enabled Evidence Generation August 20, 2020 2:00PM ET IQVIA
Articles
High-Value Care Every Time: Recommendations From The National Quality Task Force (7/30, Ayesha D'Avena, Shantanu Agrawal and Kenneth Kizer, Health Affairs Blog) comments “...Consistent with the 2002 NQF National Framework for Healthcare Quality Measurement and Reporting, the Task Force specified the need to capture accurate data at the point of care to improve data veracity and reduce administrative burden. Timely transparency of valid data is necessary for comparative benchmarking and continuous improvement. Data standardization is also necessary to reduce duplicative measures and administrative burden and bolster measure alignment and development. The Task Force validated the need to align stakeholders to a universal, limited set of identical measures, allowing for additional measure sets as necessary to account for geographic and population-specific variation.” Full
Viewpoint: Integrating Personalized Medicine With Population Health Management: The Path Forward (7/30, David C. Grossman, MD, MPH; Eric B. Larson, MD, MPH; Harold C. Sox, MD, JAMA) comments “...In the near future, genome-wide DNA sequencing will likely become a part of regular medical practice and represents an era of ‘personalized medicine’...However, while personalized medicine may be a key to population health, the way forward will be costly, wasteful, and potentially harmful without the establishment of priorities, adherence to rules of evidence, and the patience to wait for outcomes to unfold over years of observation.” Full
A Military-Civilian Perspective on Real-World Evidence to Support Regulatory Decision Making (7/29, Todd E. Rasmussen, MD, and Brian J. Young, MBA, Regulatory Focus) reports “...This article summarizes the framework promoting the collection and analysis of real-world data in the healthcare system. The authors emphasize how the US Military Health System used RWD during the Iraq and Afghanistan Wars to achieve historic rates of survival and describe a new era of collaboration between the US Department of Defense and the US Food and Drug Administration. The article reviews the FDA evidentiary standards for medical product approval and gives examples of how RWE can help meet those standards.” Full
Journals
Incorporating Value-Based Care Into Oncology Seymour, Erlene K. MD, et al. July/August 2020, The Cancer Journal The Cancer Journal
A Crisis in US Drug Pricing: Consequences for Patients with Neuromuscular Diseases, Physicians, and Society, Part 2 Ted M. Burns, MD, et al. July 29, 2020, Muscle & Nerve Wiley
Evaluation of the Use of Cancer Registry Data for Comparative Effectiveness Research Abhishek Kumar, MD, MAS; Zachary D. Guss, MD; Patrick T. Courtney, BA, et al. July 30, 2020, JAMA Network Open JAMA Network Open
Uterine-Artery Embolization or Myomectomy for Uterine Fibroids Isaac Manyonda, Ph.D., et al. July 30, 2020, The New England Journal of Medicine NEJM
Articles
GBTS Forum Launches Tool To Support Effective Resource Utilization During The Global Pandemic And Beyond (7/29, Going Below the Surface) comments “...To improve how we use our resources in a way that maximizes high-value services and minimizes low-value ones, the Going Below The Surface Forum – a group of experts across the health care sector, including payers, provider groups and patient advocacy organizations – developed a guide, Roadmap for Addressing Low-value Care...Robert Dubois, MD, PhD, Chief Science Officer and Executive Vice President, National Pharmaceutical Council, said, ‘If we are going to address how we spend our health care resources, tackling low-value care is a good place to start. Through the Roadmap, we want to help organizations develop strategies to prioritize high-value care that will improve patient health outcomes.’” Full
Video: Formulary Consideration and Clinical Impact of Cost (7/29, The American Journal of Managed Care) “Steven Peskin, MD, MBA, FACP provides the tiers in formulary for CDK4/6 inhibitors and William J. Gradishar, MD shares the clinician's considerations on cost for therapy.” View Video
Opaque Pricing Could Protect Europe From US Policy (7/28, Francesca Bruce, Pink Sheet) reports “...[Anna Bucsics, project advisor at the Mechanism of Coordinated Access to Orphan Medicinal Products,] said she would like to see the European Commission's stalled plans for greater cooperation on HTA proceed. The commission's draft legislation on increasing cooperation on HTA, which was first presented in January 2018, included controversial proposals for mandatory joint clinical assessments. This draft regulation is currently stuck at the Council of the EU, where member state ministers are unable to agree on issues such as whether joint assessments should be mandatory.” Paid Subscription Required
Press Releases
Alliance for Regenerative Medicine Calls for Multi-Stakeholder Pan-European Initiative to Fast-Track Real World Evidence in Support of Patient Access to Advanced Therapies (7/29, The Alliance for Regenerative Medicine) “...ARM calls on the European Commission to fast-track the use of RWE for ATMPs, by convening a multi-stakeholder forum, including subject matter experts from ARM, manufacturers and patient advocacy groups, to set up a European infrastructure for regular RWE use. ARM believes this collaborative approach will benefit regulators, HTA bodies, payors, manufacturers, healthcare professionals and, most importantly, patients.” Full
Journals
Golimumab Improves Patient-Reported Outcomes in Daily Practice of Inflammatory Rheumatic Diseases in Germany Klaus Krueger, Sven Remstedt, Astrid Thiele, Susanne Hohenberger July 29, 2020, Journal of Comparative Effectiveness Research Journal of Comparative Effectiveness Research
Reports
Roadmap for Addressing Low-Value Care July 29, 2020 Going Below the Surface
Events
Webinar: Reducing Low-Value Care Roadmap: How AMGA Is Charting A Course To Change Health Care August 5, 2020 2:00 - 3:00PM ET Going Below the Surface
Articles
How Next Generation VBAs Can Put Patients Front and Center (7/28, Eli Lilly) comments “...We also need collaboration across the health care system. Collaboration means more than just sharing data. It means payers, manufacturers, employers, and patients need to get more comfortable and willing to share data generated from VBAs, including real world usage of innovative therapies, anonymized patient-reported outcomes data, and other RWE. ‘Above all, improvements to VBAs require that the “value” represents value to patients and reflect improvements in meaningful clinical outcomes and quality of life metrics,’ said Erin Huntington, Lilly senior director, PRA strategy & marketing.” Full
Study Confirms Safety and Efficacy of BI's Humira Biosimilar (7/27, Skylar Jeremias, The Center for Biosimilars) ...A phase 3b clinical trial assessing Boehringer Ingelheim's adalimumab biosimilar (Cyltezo) demonstrated that the safety, efficacy, and immunogenicity of the drug were comparable to that of the reference product (Humira, AbbVie). The results of the study were published as part of the American Academy of Dermatology Virtual Meeting Experience 2020 that was held from June 12-14.” Full
AcademyHealth Annual Research Meeting: Virtual, but Vital as Ever (7/28, Gopal Khanna, M.B.A., AHRQ Blog) comments “...More than ever we need to challenge ourselves to make sure our research is relevant and timely, and serves the needs of our stakeholders. That was confirmed by findings in the independent report, conducted by Rand, to assess federally funded HSR and primary care research conducted between 2012 and 2018. The goal was to increase the impact of research by identifying research gaps and proposing strategies for better coordination across the Federal enterprise. AHRQ contracted with the RAND Corporation to conduct this independent analysis.” Full
White House Cancels Meeting With Pharma On Tuesday About Executive Order (7/27, Ariel Cohen, InsideHealthPolicy.com) reports “...The White House blamed drug companies for the failed meeting. ‘The White House has been more than accommodating in attempts to schedule this meeting,’ a White House official said. ‘We remain willing to discuss ways to lower costs for patients at the pharmacy counter. However, we remain steadfastly opposed to policies that would allow foreign governments to set prices for medicines in the United States,’a PhRMA spokesperson said when asked about the White House meeting.” Paid Subscription Required
Journals
Effect of Intravenous Acetaminophen on Postoperative Hypoxemia After Abdominal Surgery: The FACTOR Randomized Clinical Trial Alparslan Turan, MD, et al. July 28, 2020, JAMA JAMA
Reports
Health Services and Primary Care Research Study: Comprehensive Report June 2020 AHRQ
Articles
The Need to Expand Coverage and Enhance Access to Essential Services on a Predeductible Basis Following COVID-19 (7/24, A. Mark Fendrick, MD, JAMA Network Open) comments “...Moving forward, health benefit designers must ensure that people with COVID-19 and other chronic conditions can manage to pay for evidence-based medical services. Enhanced coverage of essential services prior to meeting the plan deductible is fiscally feasible and can be paid entirely by reducing a small portion of the billions of dollars spent annually in the US on low-value or wasteful clinical services.” Full
MA Stakeholders, Hospices At Odds Over VBID Demo Delay (7/25, Michelle M. Stein, Inside Health Policy) reports “Medicare Advantage and hospice stakeholders say legislation could be introduced soon that would push back until 2023 the option for MA plans to add hospice to the Value-Based Insurance Design demonstration run through the innovation center -- but while hospice providers say a delay is needed, the Better Medicare Alliance says plans have prepped for the demo and a two-year delay is untenable.” Paid Subscription Required
New Bill Seeks to Boost Participation in Advanced Payment Models, ACOs via Several Reforms (7/27, Robert King, Fierce Healthcare) reports “...The Value in Health Care Act introduced on July 24 proposes several changes to Medicare's alternative payment models. It would boost payments for not only ACOs but also extend bonus payments to clinicians working in advanced APMs. ‘To increase the quality of care across the country we need to encourage value, not volume,’ said Rep. Peter Welch, D-Vt., one of the co-sponsors, in a statement Friday. ‘These commonsense changes will reward providers for delivering the value that patients need and expect.’” Full
New IQVIA, JDRF Platform Will Use Real-World Data to Address T1D Diagnosis Gaps (7/24, Gianna Melillo, The American Journal of Managed Care) reports “...Data included in the new platform will be amassed from US ambulatory electronic medical records of 5.1 million people with diabetes over the past 5 years, collected from more than 100,000 physicians; 60% of whom are specialists treating diabetes, while the remaining 40% are primary care providers, [Jon Morris, vice president and general manager of healthcare solutions at IQVIA,] explained. IQVIA and JDRF's combination of ‘advanced analytics with unparalleled data and deep domain expertise,’ will assist in moving both the care and eventual cure of diabetes forward for individuals of all ages. ‘This first project with JDRF…will lay the foundation for a series of clinical research collaborations utilizing IQVIA's real world data and analytical expertise to derive insights about T1D,’ Morris said.” Full
Low-Value Virus Research Clogging Federal Database, Study Says (7/27, Jeannie Baumann, Bloomberg Law) reports “...Only 29% of more than 1,500 studies listed on ClinicalTrials.gov met a threshold of high quality, based on an Oxford University Centre for Evidence-Based Medicine scale, according to the study published Monday in JAMA Internal Medicine...Fewer than half of the studies were randomized controlled trials, which are considered the gold standard. Just 75 randomized controlled trials included a placebo, more than 100 participants, and more than one research institution. Nearly 1,200 of the studies took place at just one site, which previous research shows can exaggerate the effectiveness of a treatment.” Full
As FDA Approaches Next PDUFA Iteration, Industry Offers its Wish List (7/24, Mark Terry, BioSpace) reports “...And, consistent with the last few years, PhRMA is hoping for greater support for real world evidence in FDA's decision-making. ‘PhRMA believes that real world evidence, for example, can be used for demonstrating effectiveness either on its own in some circumstances or in combination with other data,’ [PhRMA vice president of science and regulatory advocacy Lucy Vereshchagina] said.” Full
Supplemental Process Can Aid in Assessing Value of Rare Disease Treatments (7/25, Skylar Jeremias, The American Journal of Managed Care) reports “The implementation of supplemental processes is helpful to assess the true value of rare disease treatments, according to a study published in the Orphanet Journal of Rare Disease. RDTs can make it difficult to justify reimbursements as cost-effectiveness analyses often result in much higher willingness-to-pay thresholds than common diseases and they are only applied to a small population of patients within each country. However, researchers noted that there has been an increase in the opinion that conventional appraisal approaches aren't appropriate for assessing the value of RDTs.” Full
Trump Signs Series of Executive Orders Aimed at Lowering Drug Costs (7/24, Noah Higgins-Dunn, Jasmine Kim, and Berkeley Lovelace Jr., CNBC) reports “...The fourth order, which Trump said he may not need to implement, would allow Medicare to purchase drugs at the same price other countries pay. The order would specifically allow Medicare to implement a so-called international pricing index to bring drug prices in line with what other nations pay...Trump signed the fourth order, but said he was holding it until Aug. 24 to give the industry time to ‘come up with something’ to reduce drug prices. Pharmaceutical company executives are scheduled to meet at the White House on Tuesday, he said.” Full
Trump Targets High Prices Just When He Needs Drugmakers the Most (7/25, Margot Sanger-Katz, Noah Weiland, Katie Thomas, The New York Times) reports “...[PhRMA president Stephen J. Ubl], the main trade group for the industry, noted Mr. Trump's dilemma. ‘In the middle of a global pandemic, when nearly 145,000 Americans have lost their lives and millions of others have suffered untold economic hardships, this administration has decided to pursue a radical and dangerous policy to set prices based on rates paid in countries that he has labeled as socialist,’ Mr. Ubl said in a statement.” Full
EU's Joint Regulatory/HTA System Praised, But Improvements Needed (7/27, Ian Schofield, Pink Sheet) reports “...‘Today we do have differences in what type of evidence is looked at in the different countries, and among the regulatory and HTA agencies,’ said Edith Frénoy, director of market access and HTA policy lead at the European pharmaceutical industry federation EFPIA. ‘We see different health care system organizations, different remits and different objectives of decision making, which translates into different evidence requirements,’ she said. Frénoy noted that companies have only one drug development plan, and one set of data generated by clinical trials, but then ‘they have to answer different questions with the same dataset.’ The different technical requirements of regulators and HTA bodies need to be put into ‘the political context of access to innovative treatments,’ she said.” Paid Subscription Required
Press Releases
Tulane Awarded Funding to Bring Patient Perspective to COVID-19 Research (7/27, Tulane University News Release) “Tulane University has been awarded $150,000 from the Patient-Centered Outcomes Research Institute to use equity-focused design to improve community participation in public health research against COVID-19. The Eugene Washington PCORI Engagement Award will fund an equity focused, human centered design process to understand the needs and values of underrepresented stakeholders around patient-centered outcomes research and produce an equity-centered design thinking toolkit for communities to improve engagement in research.” Full
NICE Publishes New COVID-19 Rapid Guideline on Arranging Planned Care in Hospitals and Diagnostic Services (7/27, NICE Press Release) “...The latest in its series of COVID-19 rapid guidelines, the guideline makes recommendations about how these services should be organised in order to balance the risks associated with COVID-19 with the potential harms that can arise from delays in elective treatment and diagnostic procedures. It promotes a flexible approach based on individual circumstances and the type of procedure and aims to support the prompt recovery of elective care, while advocating shared decision-making, balancing the risks and benefits.” Full
Journals
Are Supplemental Appraisal/Reimbursement Processes Needed for Rare Disease Treatments? An International Comparison of Country Approaches Elena Nicod, et al. July 20, 2020, Orphanet Journal of Rare Diseases Orphanet Journal of Rare Diseases
Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis Peter C. Minneci, MD, MHSc, et al. July 27, 2020, JAMA JAMA
Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov Krishna Pundi, MD, et al. July 27, 2020, JAMA Internal Medicine JAMA Internal Medicine
Reports
RCTs to Scale: Comprehensive Evidence from Two Nudge Units July 2020 The National Bureau of Economic Research
Events
ICER Colloquium Series, Pricing in a Pandemic | Session Two: Cost-Effectiveness and Value-Based Pricing July 31, 2020 12:00 - 1:30PM ET ICER