CER Daily Newsfeed®

Articles

Virus Outbreak Sidelines Medicare's Push for Value-Based Care (4/3, Tony Pugh, Bloomberg Law) reports “...The flood of costly Covid-19 cases and fewer visits for elective services all but assures that many ACOs in the Medicare Shared Savings Program will take losses this year. Unless Congress agrees to forgive all ACO losses this year, the shared savings program—traditional Medicare's leading value-based care initiative—could face a massive exodus of providers.” Full

Alternative Drug Purchasing Arrangements Do Not Justify Raising The Prices Medicaid Pays For Brand Drugs (4/3, Edwin Park and Andrea Noda, Health Affairs Blog) comments “...The chief executive of Novartis—the maker of the $2.125 million pediatric gene therapy Zolgensma—has argued that Medicaid's best price requirement is obstructing the use of pay-over-time and outcome-based contracts to help certain payers better afford the cost of that drug. The claim was essentially that alternative purchasing arrangements could result in overly large best price discounts that deter manufacturers from making pay-over-time and outcome-based contracts available to private insurers and other payers.” Full

Massachusetts Blues Plan Signs Nation's First Value-Based Care Contract with Dental Management Group (4/2, Aine Cryts, Managed Healthcare Executive) reports “...Under the agreement, BCBSMA will pay an incentive payment to 42 North Dental in early 2021 in return for dental providers demonstrating measurable quality improvements in the oral and overall health of the payer's dental members, says Bob Lowando, DDS, executive director of Dental Blue at BCBSMA. The additional services for members include extra dental cleanings and periodontal treatments, which help patients manage their health conditions while reducing their medical costs, adds Lewando.” Full

Journals

Decision-Making under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the US and Europe Vreman RA, et al. April 1, 2020, Clinical Pharmacology and Therapeutics PubMed

V-BID X for Employers: A Framework Designed to Promote Employee Access to High-Value Drugs, Services Matthew Gavidia and Mary Caffrey April 2, 2020, The American Journal of Accountable Care AJMC

Leveraging Health Information Technology for ACO Success Tom Romeo April 2, 2020, The American Journal of Accountable Care AJMC

Articles

Trump's Pet Coronavirus Drug Ready for Trial in Health Workers (4/1, Jacquie Lee, Bloomberg Law) reports “...As part of the trial, health-care workers will take either hydroxychloroquine or a placebo for 30 days. They'll be followed for two months to test whether the drug prevents Covid-19 in people exposed to the virus and if it stunts the spread of coronavirus in those not yet showing symptoms. ‘This study's focus on high-risk healthcare workers is especially important given their vital role on the front lines of treating this novel infection,’ Josephine P. Briggs, interim executive director of the Patient-Centered Outcomes Research Institute, said in a statement Wednesday.” Full

Duke to Spearhead $50 Million Research Effort to Test Hydroxychloroquine in Preventing COVID-19 (4/2, Carter Forinash, The Chronicle) reports “...Hydroxychloroquine has limited clinical evidence but significant promise after doctors in China reported that the drug may help alleviate symptoms in coronavirus-positive people. Unlike in that study, the new Duke-led one will look at using the drug to prevent COVID-19 for healthcare workers and prevent new spread of the virus. While clinical trials for new disease treatments are usually lengthy processes, the new study is aiming for speed as well as success.” Full

Stanford Launches Data-Driven Model Evaluating COVID-19 Interventions (4/2, Jessica Kent, Health IT Analytics) reports “...The team aims to help users understand the benefits of delaying the peak of the epidemic and staying below a fixed healthcare capacity. Rather than trying to map the exact dynamics of a certain location, the model shows possible trajectories under different hypothetical scenarios. ‘We wanted to start a larger conversation about how our long-term response might look,’ said Erin Mordecai, Stanford biologist. ‘We're concerned about the potential for the disease to rapidly spread once we lift control measures.’” Full

UK: NICE Publishes Second Set of Rapid COVID-19 Guidelines (4/2, Selina McKee, PharmaTimes) reports “...The guidelines advise clinicians on modifying care to reduce patients' exposure to COVID-19 and how to balance the risks and benefits of treatment during the pandemic. For delivering radiotherapy, the guideline recommends avoiding treatment if the evidence suggests there will be little to no benefit or if an alternative treatment is available, to defer radiotherapy if clinically appropriate, and if radiotherapy treatment is unavoidable, to use the shortest safe form of treatment.” Full

Journals

Understanding Medical Student Evidence-Based Medicine Information Seeking in an Authentic Clinical Simulation Joey Nicholson, et al. 2020, Journal of the Medical Library Association Journal of the Medical Library Association

'The Problem Is Small Enough, the Problem Is Big Enough': A Qualitative Study of Health Technology Assessment and Public Policy on Drug Funding Decisions for Children Denburg AE, et al. March 30, 2020, International Journal for Equity in Health PubMed

Changes in Perception of Various Telehealth Topics Before and After a Patient-Centered Outcomes Research Institute Telehealth Research Dissemination Conference. Smith S, et al. March 31, 2020, Telemedicine Journal & E-Health PubMed

Events

Part 2 - Dealing with the Emergency Department Amid COVID-19 April 7, 2020 11:45AM - 12:45PM EDT PCORI

Articles

Efficacy-Effectiveness Gap, Outcomes Disparity in Clinical Trials vs Real-World Settings (4/1, Journal of Clinical Pathways) reports “...[Ian F Tannock, MD, PhD:] I have argued in the past that if a randomized control trial shows benefits for a certain type of treatment, then you may be able to test for real-world benefits by assessing health outcomes data in a registry...An example of clinical trial benefit matching registry-based real-world benefit is in adjuvant breast cancer therapy, where even in usual practice women tend to be relatively healthy aside from their diagnosis. But there are other disease states where the same cannot be said, such as outcomes from cystectomy for muscle-invasive bladder cancer, or most situations where the patients tend to be older and have more comorbidities.” Full

Answering the Call on COVID-19 (4/1, Josephine P. Briggs, MD, The PCORI Blog) comments “...[O]ur Board of Governors today approved up to $50 million to fund a healthcare workers registry and rapid-turnaround clinical trial of whether hydroxychloroquine can prevent healthcare workers at high risk of contracting COVID-19 from becoming infected and unintentionally spreading the virus to others...We also are providing funding for new research and programs seeking to improve COVID-19 care while making supplemental funds available to existing studies and projects that can address this issue. Altogether, PCORI is investing up to $110 million in high-quality, patient-centered research targeting coronavirus.” Full

Exclusive: Larry Ellison Reveals His Big Data Battle Plan To Fight Coronavirus In Partnership With Trump White House (4/1, Angel Au-Yeung, Forbes.com) reports “...Over the past eight years, [Oracle CEO Larry Ellison has] spent at least half a billion dollars on a Hawaiian island, Lanai, that he has turned into a laboratory for health and wellness powered by data...Without a vaccine, doctors around the world are experimenting with medicines to treat COVID-19...Ellison asked Trump if a clearinghouse existed for real-time data about treatment efficacies and outcomes. Trump said no...‘Larry said, “I will build you a system so doctors and patients can enter information, so we can know what's happening,”’ says David Agus, a cancer doctor...” Full

UK: A NICE Transformation? (4/2020, Nicola Boyd, PharmaTimes) comments “...The outcomes of the Review and subsequent reform will be a decider on the potential for NICE to deliver another exceptional 20 years of health technology assessment. The extent of reform to the HTA process that the Review will bring is uncertain but likely to be limited by its scope. Regardless of its outcome, the systemic issues that have led to this Review must continue to be addressed beyond its time frame if NICE is to pave the way to personalisation.” Full

Press Releases

PCORI Funds Registry and Large-Scale Study of Effectiveness of Hydroxychloroquine to Prevent COVID-19 Infection in U.S. Healthcare Workers (4/1, PCORI Press Release) “...The registry will create a community of healthcare workers (HCWs) interested in contributing to understanding the impact of COVID-19 on them and their colleagues, families and friends, and to determine their willingness to participate in clinical studies. The trial will evaluate the use of HCQ in addition to usual practice in both preventing COVID-19 infection in exposed healthcare workers and limiting the amount of virus HCWs without symptoms might spread and thus unintentionally disperse to others.” Full

Duke Clinical Research Institute to Expedite Study of COVID-19 Prevention in Healthcare Workers (4/1, Duke Clinical Research Institute Press Release) “...‘The HERO program offers an important opportunity for healthcare systems across the country to unite and use the national resources offered by PCORnet to answer some of the most critical questions facing our nation right now,’ said Judith Currier, MD, and Russell Rothman, MD, co-chairs of the program's steering committee. ‘The urgency of the questions we are asking and the need for speed cannot be overstated, and it's heartening to see the dedication being poured into this effort.’” Full

GAO Issues Call for Nominations to Fill Seats on PCORI's Board of Governors (4/1, PCORI Press Release) “...The GAO is accepting nominations for representatives in the following categories as required by the statute: a physician, a representative of patients and health care consumers, a representative of pharmaceutical manufacturers or developers, a representative of private payers who represents employers who self-insure employee benefits, and between one and three representatives of private payers who represent health insurance issuers.” Full

TFS Forms Partnership to Conduct a Global RWE Study on COVID-19 Pandemic (4/1, TFS Press Release) “...Neus Valveny, TFS Operational Strategy Lead Real World Evidence, addresses the importance of real world evidence to complement clinical trial results. ‘Similarities and differences with other viral infections as well as effectiveness and safety of current preventive or therapeutic measures are extremely important. Models assessing most relevant prognostic factors in the daily practice will be also crucial to help healthcare providers decide which subjects should be prioritized and given more intensive therapies. The full analysis needs to be adjusted for potential confounding and biases inherent to observational research.’”

Journals

Leveraging Digital Data to Inform and Improve Quality Cancer Care Tina Hernandez-Boussard, et al. April 2020, Cancer Epidemiology, Biomarkers & Prevention Cancer Epidemiology, Biomarkers & Prevention

How Are Incremental Cost-Effectiveness, Contextual Considerations, and Other Benefits Viewed in Health Technology Assessment Recommendations in the United States? LoganTrenaman, PhD, Steven D.Pearson, MD, MSc, Jeffrey S.Hoch, PhD April 1, 2020, Value in Health Value in Health

Events

Part 1 - Report from the Field: How We Are Managing Incident Command (Continued) April 2, 2020 11:45AM - 12:45PM EDT PCORI

Articles

The Argument for Evidence-Based Medicine and Why Employers Should Care (3/31, Scott Wooldridge, Benefits Pro) reports “...The new paper, ‘What Employers Need to Know about Evidence-Based Medicine and Clinical Guidelines,’ was released by Connections Health Care Cost Containment, a consulting firm that blends expertise from both the clinical and financial side of health care management. According to the report, providers are still lagging behind in using the best evidence-based practices when it comes to delivering health care. ‘While evidence-based medicine (EBM) is the gold standard taught to all clinicians and is widely accepted as important to drive superior outcomes, day to day decision-making in health care is slow to evolve from “opinion based” or ‘experience-based' to those based on sound scientific evidence,’ the report says in its introduction.” Full

Healthcare's Big Data Moment Can't Come At The Expense Of Our Privacy (3/31, Harold Li, Forbes.com) comments “...The emergence of digital healthcare innovation will undoubtedly contribute to future improvements across health and wellness. But that shouldn't have to come at the cost of our rights to privacy and security. Companies handling health data must take exceptional measures to protect it and commit to not sharing or selling it in a personally identifiable way without explicit, proactive consent. Otherwise, personalized healthcare is simply a form of surveillance.” Full

Press Releases

ISPOR Value of Information Task Force Publishes Two New Good Practices Reports (3/31, ISPOR Press Release) “...‘The first report is specifically aimed at those tasked with making decisions about the adoption of healthcare or the funding of healthcare research,’ noted Elisabeth Fenwick, PhD, Pharmerit International, Oxford, England, United Kingdom, lead author of the first report. ‘It demonstrates the importance of VOI to decision makers, introducing readers to the concepts of VOI analysis and outlining decisions that can be supported by VOI analysis.’” Full

Journals

Unrecognized Implementation Science Engagement Among Health Researchers in the USA: A National Survey Elizabeth R. Stevens, et al. March 30, 2020, Implementation Science Communications Springer

Spending Variation Among ACOs in the Medicare Shared Savings Program Michael Anne Kyle, MSN, MPH, et al. March 31, 2020, The American Journal of Managed Care AJMC

Reports

Value of Information Analysis for Research Decisions—An Introduction: Report 1 of the ISPOR Value of Information Analysis Emerging Good Practices Task Force March 31, 2020 ISPOR

Articles

Real-World Evidence Should Be Part of Clinical Trials in Oncology (3/28, Sarah Alwardt, PhD, OncLive) comments “...According to the National Cancer Institute, standard of care is defined as treatment that experts agree is appropriate, accepted, and widely used. If a study is comparing new treatment options with a standard treatment that has not changed for years, why not use historic RWE as the control? If multiple biopharma companies are developing new drugs for the treatment of renal cell carcinoma, and each is conducting trials with nearly identical control groups, the possibility exists for all to draw data from the same control group. This may present some risk to the biopharma companies but could be a major boost for patients in the form of faster access to promising new therapies.” Full

Clinical Pathways Lead to Reduction in Spending Within the Oncology Care Model (3/28, Hannah Slater, Cancer Network) reports “In a study, published in the Journal of Clinical Oncology: Oncology Practice, researchers demonstrated that the reduction of drug spending by using value-based clinical pathways to optimize chemotherapy utilization is possible and can increase the chances of a practice's success within the Oncology Care Model. Researchers indicated that misguided perceptions that drug prices are outside the control of oncologists has led to many OCM participants focusing their efforts on other areas to reduce costs, such as reducing preventable emergency department visits and hospital admissions.” Full

How Economists Calculate The Costs And Benefits Of COVID-19 Lockdowns (3/27, Chris Conover, Forbes.com) comments “...More concretely, a COVID-19 treatment that was found to save lives at a cost of $311,194/QALY would be quickly deemed ‘cost-ineffective’ by those in our health system in charge of allocating scarce resources...Yet if a hypothetical federal agency were to propose some public health regulation to ‘flatten the curve’ at a cost to the economy that was shown to be less than $311,000 per statistical life year for each of the unknown COVID-19 whose lives were estimated to be spared by such a rule, that would pass the [Value of a Statistical Life] sniff test.” Full

The Precision Medicine Revolution (3/27, Joel Diamond, MD, Medical Economics) comments “...Precision medicine is rapidly becoming recognized as the new standard of care. The potential for improving quality and safety of care—as well as patient loyalty—is tremendous. And because it empowers providers with new information and robust clinical decision support, it promises to enhance satisfaction as well.” Full

UK: COVID-19: NICE Updates Guideline as Sanofi Announces Vaccine Development (3/30, Anna Smith, PharmaTimes) reports “...As more pharmaceutical companies race to find a vaccine to the growing pandemic, Sanofi is the latest to offer its services in the form of a collaboration with Translate Bio to develop an mRNA vaccine. The French pharma giant announced that the partnership will use Translate Bio's mRNA platform to discover, design and manufacture a number of SARS-CoV-2 vaccine candidates, with Sanofi advancing them for further development.” Full

UK: Does NICE Hold the Cards to Drug Pricing and Reimbursement? (3/30, Rebecca Lanning, Pharmafield) comments “...President Trump is said to be actively taking advice on how the NHS can pay more for US medicines and NICE's price cap – usually beyond the reach of political interference – has been identified as a key target for US negotiators. However, as long as negotiators focus on the inflexibility of NICE's cost-effectiveness threshold, the threat to the NHS budget in a future trade deal is minimised. As the eventual approval of Orkambi – or the accelerated appraisal of Trikafta – shows, the role of NICE is changing but it isn't due to Brexit or the demands of a foreign president.” Full

People or Profit: What Is the Best System to Regulate Drug Prices? (3/30, Conor Kavanagh, Pharmafile) reports “...A key principle of the German drug pricing system that differentiates it from the US system is that there will be no increase in prices without incremental benefit. This is decided through the Gemeinsamer Bundesausschuss (G-BA) – a quasi-public entity governed by the national associations of physicians, dentists, hospitals, sickness funds, and patient advocates – carrying out assessments which are based on patient-relevant clinical endpoints such as overall survival, functional ability, and reduction in symptoms, rather than on intermediate endpoints such as reduced tumour size or a change in biomarker levels.” Full

Press Releases

NIH-Funded Studies Show Stents and Surgery No Better than Medication, Lifestyle Changes at Reducing Cardiac Events (3/30, National Institutes of Health Press Release) “Invasive procedures such as bypass surgery and stenting—commonly used to treat blocked arteries—are no better at reducing the risk for heart attack and death in patients with stable ischemic heart disease than medication and lifestyle changes alone. However, such procedures offer better symptom relief and quality of life for some patients with chest pain, according to two new, milestone studies.” Full

Journals

Utilization of Clinical Pathways Can Reduce Drug Spend Within the Oncology Care Model Hertler A, et al. March 20, 2020, JCO Oncology Practice PubMed

The Implementation of Health Technology Assessment Principles in Public Decisions Concerning Orphan Drugs Brenna E, et al. March 26, 2020, European Journal of Clinical Pharmacology PubMed

Matching-Adjusted Indirect Treatment Comparison of Siponimod and Other Disease Modifying Treatments in Secondary Progressive Multiple Sclerosis Imtiaz A. Samjoo, et al. March 27, 2020, Current Medical Research and Opinion Current Medical Research and Opinion

Extending an Open-Source Tool to Measure Data Quality: Case Report on Observational Health Data Science and Informatics (OHDSI) Brian E Dixon, et al. March 29, 2020, BMJ Health & Care Informatics BMJ Health & Care Informatics

What "Evidence" in Evidence-Based Medicine? Carlo Martini March 29, 2020, Topoi Springer

Real-World Direct Healthcare Costs of Treating Recurrent High-Grade Serous Ovarian Cancer with Cytotoxic Chemotherapy Lucy Gilbert, et al. March 30, 2020, Journal of Comparative Effectiveness Research Journal of Comparative Effectiveness Research

Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease John A. Spertus, M.D., M.P.H., et al. March 30, 2020, The New England Journal of Medicine NEJM

Articles

Could Real-World Evidence Help Shape the Future of Drug Development? (3/27, Rebecca Robbins, Adam Feuerstein and Damian Garde, STAT Plus) reports “...[Aetion CEO Carolyn Magill:] We see the role of real-world evidence as supplementing clinical trials. We don't believe that it makes sense to replace clinical trials with data studies. That said, the work that we're doing with the FDA and with other regulators … helps to underscore how critical it is to test how and when it's appropriate to use real-world evidence to drive decisions about labels, about safety, about potentially representing populations who are underrepresented in clinical trials.” Paid Subscription Required

Video: Dr. Freedland on Real-World Evidence vs PREVAIL Trial in mCRPC (3/26, Stephen J. Freedland, MD, OncLive) “Stephen J. Freedland, MD...discusses how real-world evidence with the use of enzalutamide (Xtandi) in patients with metastatic castration-resistant prostate cancer (mCRPC) compares with data from the phase III PREVAIL trial.” View Video

Measuring the Reach of PCORI's Funded Research Results (3/27, Robin Bloodworth, PhD, MPH, et al., The PCORI Blog) comments “...An analysis of PCORI's early funded studies found that almost 60 percent published results within 30 months of the project's completion date. In contrast, an analysis in The BMJ found that typically only about one-third of research studies publish their results over that same time period, and only about two-thirds of them ever publish their results. That lag in sharing results is what PCORI wants to change.” Full

To Help Develop The Safest, Most Effective Coronavirus Tests, Treatments, And Vaccines, Ensure Public Access To Clinical Research Data (3/26, Christopher J. Morten, Amy Kapczynski, Harlan M. Krumholz and Joseph S. Ross, Health Affairs Blog) comments “...As President Trump, Congress, the Food and Drug Administration, the Centers for Disease Control, the National Institutes of Health, and other parts of government move quickly to fight COVID-19, they should make clinical research data transparency a high-level priority and commit to data sharing as a condition of clinical research funding and product clearance and approval. Medical journals should help by mandating data sharing associated with publications on therapeutics, vaccines, and diagnostics. And companies can show their commitment to public health by voluntarily agreeing to share data at the time when products are approved.” Full

Expert Explains 'Downside Risk' in New Value-Based Health Care Models (3/27, Angela Gonzales, Phoenix Business Journal) reports “...[Reginald M. Ballantyne III, former chairman of the American Hospital Association:] I think it is safe to say that there is no common definition of downside risk yet in the value-based care arena. To the contrary, many professionals are still trying to come to agreement on exactly what value-based care means. Is it evidence-based medicine? Is the patient involved in determining value? Is the benchmark based on predictable outcomes? Or is achieved value the result of payer and provider negotiation?” Paid Subscription Required

England's NICE To Focus On COVID-19 And Other Critical Therapies (3/27, Neena Brizmohun, Pink Sheet) reports “...NICE has decided to prioritize and only publish work that is either therapeutically critical or relates to addressing COVID-19 diagnostic or therapeutic interventions...NICE clarified that essentially all technology appraisals involving a cancer medicine are considered therapeutically critical, except for Cancer Drugs Fund reviews. A small number of non-cancer medicines have also been designated as therapeutically critical.” Paid Subscription Required

UK: A Look At The New Leadership Team At NICE (3/27, Pink Sheet) reports “...Leng's appointment has not pleased everyone in industry. ‘I did think Leng would be a main contender for the chief executive role, simply because she has been deputy chief executive for so long,’ an industry insider told the Pink Sheet. ‘She is a safe pair of hands,’ the source said, adding: ‘This is not necessarily what NICE needs. The problem is this is not going to give the shake-up that NICE needs.’” Paid Subscription Required

Journals

What Types of Real-World Evidence Studies Do U.S. Commercial Health Plans Cite in Their Specialty Drug Coverage Decisions? Ari D. Panzer, et al. March 25, 2020, Pharmacoepidemiology & Drug Safety Wiley

The Importance of Considering Differences in Study and Patient Characteristics Before Undertaking Indirect Treatment Comparisons: A Case Study of Siponimod for Secondary Progressive Multiple Sclerosis Imtiaz A. Samjoo, et al. March 27, 2020, Current Medical Research and Opinion Current Medical Research and Opinion

Reports

Value-Based Care Assessment March 2020 Insights by Xtelligent Healthcare Media