CER Daily Newsfeed®
Articles
Partnerships in Action: Advancing Healthcare through Collaborative Science in Emerging Markets (2/20, Salman Rizvi, MD, MBA, et al., CIO Applications) comments “...RWE offers tremendous possibilities to translate data into meaningful health outcomes, particularly through observational studies, patient-reported outcomes, clinical trial optimization, synthetic control arm construction and pragmatic trials. As analytic capabilities and digital innovation mature, we see new opportunities to harness computational power, artificial intelligence, and high volumes of data in an efficient way.” Full
ACOs Ask CMMI for More Shared Savings in Direct Contracting Model (2/21, Shannon Muchmore, Healthcare Dive) reports “...[The National Association of Accountable Care Organizations] said ACOs weighing participation need more information about the program's benchmarking, risk adjustment and capitated payments. ‘Without these details, it's impossible for the healthcare community to make informed decisions about program participation,’ NAACOS wrote. The group also wants CMS to include more clinical metrics in the list of measures used to determine quality scores and to rely less on Consumer Assessment of Health Providers and Systems surveys.” Full
UK: NICE Gives Green Light to Multiple Sclerosis Drug (2/21, Pavankumar Kamat, Medscape) reports “[NICE] has recommended peginterferon beta-1a (Plegridy, Biogen Idec) as a treatment option for relapsing-remitting multiple sclerosis for routine use within NHS England...Clinical trial evidence has shown peginterferon beta-1a to slow disease progression and decrease the frequency of relapses compared with placebo. Indirect comparison of peginterferon beta-1a with other beta interferons and glatiramer acetate has shown comparable effectiveness; however, peginterferon beta-1a needs to be injected less frequently than other beta interferons.” Full
Exclusive: Canadian Regulator Considers Changes to New Drug Pricing Plan (2/20, Allison Martell, Reuters) reports “Canada's drug pricing agency is contemplating significant changes to how it will apply new regulations aimed at lowering costs, Reuters has learned, as drugmakers unhappy with the policy delay introducing new medicines in the country and blame it for job cuts...[Patented Medicine Prices Review Board] Executive Director Doug Clark told Reuters companies could be given an 18-month grace period to comply with parts of the regulation, and that cost-effectiveness measures may be applied to fewer treatments.” Full
Press Releases
ICER to Assess Treatments for Bladder Cancer (2/20, ICER Press Release) “The Institute for Clinical and Economic Review announced today that it plans to assess the comparative clinical effectiveness and value of nadofaragene firadenovec (Instiladrin®, FKD Therapies Oy and Ferring Pharmaceuticals) for the treatment of bladder cancer. Nadofaragene firadenovec has received a fast track and breakthrough therapy designation from the FDA, with an anticipated decision expected in mid-2020.” Full
ICER to Assess Evidence on Supervised Injection Facilities and Digital Apps for Opioid Use Disorder (2/21, ICER Press Release) “...‘Opioid misuse continues to ravage American communities,’ said Steven D. Pearson, MD, MSc, President of ICER. ‘Clinicians, industry, government, and non-profit organizations are all trying to figure out how best to help affected individuals and communities. ICER is joining the fight in the best way we know how: by providing an independent and rigorous analysis of the data, and by working with all stakeholders to evaluate the broader health and economic effects of different care and policy options.’” Full
Articles
Medical: Pharma's New North Star (2/20, Paul Simms, Eye for Pharma) reports “...The transition to value-based care, in its myriad forms, is the primary driver behind this evolution, says [Eddie Power, Vice President, North America Medical Affairs, Hospital Business at Pfizer]. Stakeholders now need a deep understanding of how a new product will add value. In the case of health systems, it isn't just about comparative effectiveness, it is about looking more broadly at health system outcomes and determining whether a product contributes a net gain, or loss. This is a trend which isn't going away. Across stakeholders of all shapes and sizes, institutions are increasingly allocating resource to determine the benefit of medicines.” Full
Fact Check: HCCI Analysis Overstates Medicine Spending and Prices (2/19, Katie Koziara, PhRMA: The Catalyst) comments “A recent analysis from the Health Care Cost Institute on health care spending overestimates medicine spending and pricing and mischaracterizes the true drivers of health care spending in the commercial market. The analysis significantly overstates commercial medicine spending and growth by failing to account for rebates, discounts and other price concessions, which have doubled since 2012, and now lower the list price of brand medicines by 40% on average.” Full
How Administrative Spending Contributes To Excess US Health Spending (2/20, Laura Tollen, Elizabeth Keating and Alan Weil, Health Affairs Blog) comments “...[M]any council members noted—as have others before them—that the piecework, fee-for-service nature of health care drives an enormous amount of administrative spending in the form of documentation, coding, billing, and re-billing. Capitation and other forms of outcomes-based payment would reduce the need for these types of activities, but only once the system has reached a point where fee-for-service represents just a negligible sliver of the overall payment landscape. Until then, it will be necessary for providers to keep the administrative infrastructures to support fee-for-service, even as alternative payment models expand.” Full
PBM Industry Report Claims Greater Use of Tools Can Generate $1T in Savings Over next Decade (2/19, Robert King, Fierce Healthcare) reports “...The study, published Wednesday by pharmacy consulting firm Visante and funded by PBM lobbying group Pharmaceutical Care Management Association, argues for greater use of a collection of PBM tools to save money for commercial, managed care and Part D plans as well as beneficiaries...The tools the study examined include rebates and discounts PBMs negotiate from drugstores and manufacturers, mail-service and specialty pharmacies, drug utilization programs, adherence programs to improve care management and formulary management tools such as step therapy and prior authorization.” Full
Press Releases
ICER Releases Draft Evidence Report on Therapies for Cystic Fibrosis (2/20, ICER Press Release) “...ICER's report focuses on elexacaftor/tezacaftor/ivacaftor (TrikaftaTM, Vertex). ICER also examined new data that has become available since its May 2018 review of three other cystic fibrosis treatments already approved by the FDA: tezacaftor/ivacaftor (Symdeko®, Vertex), lumacaftor/ivacaftor (Orkambi®, Vertex), and ivacaftor (Kalydeco®, Vertex).This preliminary draft marks the midpoint of ICER's eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER's final conclusions.” Full
Journals
Development of the WHO-INTEGRATE Evidence-to-Decision Framework: An Overview of Systematic Reviews of Decision Criteria for Health Decision-Making Stratil JM, et al. February 11, 2020, Cost Effectiveness and Resource Allocation PubMed
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies Bujar M, et al. March 2020, Therapeutic Innovation and Regulatory Science PubMed
Reports
Pharmacy Benefit Managers (PBMs): Generating Savings for Plan Sponsors and Consumers February 2020 PCMA
CF Update: Draft Evidence Report February 20, 2020 ICER
Articles
Could ICER Outreach To US FDA Lead To Better Cost Effectiveness Analyses? (2/18, Cathy Kelly, Pink Sheet) reports “...ICER will invite participating patient groups to a formal debriefing session at the conclusion of each cost effectiveness review and ‘offer to co-write and promote a letter to FDA and other stakeholders with proposals for improving generation of patient-relevant data as part of the drug development process,’ the value framework says. The proposals might also address ways FDA could shape clinical trials to facilitate efforts to compare the cost effectiveness of competing agents, an ICER spokesman noted. The goal would be to make the available information better suited to ICER's value determinations.” Paid Subscription Required
How Much Will Drug Price Controls Harm Innovation? It Depends (2/20, Alaric Dearment, MedCity News) reports “...‘What has happened is that the U.S. has been subsidizing innovation for the rest of the world,’ said Pascal Prigent, CEO of Lille, France-based drugmaker Genfit...Were the U.S. to pay the same amount for drugs as France, it would harm innovation, he said. France spent $653 per capita in 2018, according to the OECD. The bigger question is how much lowering prices would affect innovation and how much spending would need to come down for there to be a significant impact.” Full
Medication Adherence Falters as Out-of-Pocket Patient Costs Soar (2/19, Sara Heath, Patient Engagement HIT) reports “...The data, published in the Surescripts Prescription Price Transparency and Patient Experience survey, specifically shows that 53 percent of patients have chosen not to obtain a prescription because of cost. Twenty-nine percent said they did not take a medication because it took too long to fill. This comes as the healthcare industry continues to zero in on medication adherence, a key factor to quality patient outcomes. When a patient doesn't take her medication for any reason, she is more likely to see a chronic illness deteriorate, potentially resulting in a costly acute care episode.” Full
Out-of-Network Primary Care Linked to Higher ACO Costs (2/19, Emily Sokol, MPH, RevCycle Intelligence) reports “Patients receiving primary care outside of their defined accountable care organization network drive up costs for ACOs, a recent study from Portland State University said...[F]or every one percentage point increase in an ACO's out-of-network primary care visits rate, the ACO paid an extra $43 a year per patient, the study published in Health Affairs showed. ‘Primary care has the potential to unlock the key to reducing healthcare costs,’ said Sunny Lin, PhD, MS, assistant professor at OHSU-PSU School of Public Health and co-author of the study.” Full
Population-Based Payments May Help Ensure Access To Life-Saving Antibiotics For Medicare Beneficiaries (2/18, Monika Schneider, Nicholas R. Harrison and Mark B. McClellan, Health Affairs Blog) comments “...Duke-Margolis and other groups have called for alternative value-based payment reforms that align and augment incentives for the development, availability, and appropriate use of priority antibiotics. Similarly, former [FDA] Commissioner Scott Gottlieb and other public officials have called for the development of ‘subscription,’ population-based payment, or licensing models for priority antibiotics. In the United Kingdom, a new subscription payment arrangement is being piloted as a set fee paid to manufacturers based on the availability of a drug to help protect a population and not the volume of the drug actually used. This subscription payment approach could better reflect the value of the antibiotic to the population being covered...” Full
Press Releases
UPMC Receives $3.7 Million PCORI Award to Improve Care for Patients with Sepsis and Pneumonia (2/19, UPMC Health Plan Press Release) “...The PCORI funding will support one of the largest clinical trial of sepsis and pneumonia survivors to date, aiming to enroll more than 1,600 participants. While most research in this field is focused on implementing care for survivors in an outpatient clinic setting, this study will bring care into the home with a remote patient monitoring platform, which uses the patient's smartphone to track vitals and alert clinicians to changes. Patients will be enrolled in different degrees of monitoring and types of interventions, including palliative care to improve quality of life.” Full
Journals
Clinical Pathways: A Critical Component of Success in Episodes of Care Lili Brillstein, MPH, and Brian Currie February 2020, Evidence-Based Oncology AJMC
Reports
Prescription Price Transparency and the Patient Experience February 2020 Surescripts
Articles
How Can We Effectively Spend Our Health Care Dollars? (2/18, Going Below the Surface) comments “Health care policy experts gathered for a panel discussion at the AcademyHealth National Health Policy Conference on Feb. 11 to tackle how we can more effectively spend our health care dollars and understand possible tradeoffs. The panel, moderated by National Pharmaceutical Council Chief Science Officer Robert Dubois, featured Stacie Dusetzina, associate professor, Vanderbilt University; Katie Martin, senior fellow, Health Care Cost Institute; Michael Thompson, president and CEO, National Alliance of Healthcare Purchaser Organizations; and Joel White, president, Council for Affordable Health Coverage.” Full
How Important Are the Indirect Benefits of Health Care Innovation? (2/18, Katie Kuehner-Hebert, Benefits Pro) reports “...Employers also care about whether adopting an innovation within their health care plan would result in reduced absenteeism and caregiver burden, as well as increased presenteeism and quality of life. However, payers place a low priority on such ‘indirect benefits,’ according to new study published in the Journal of Occupational and Environmental Medicine by researchers at the National Pharmaceutical Council and RTI Health Solutions. ‘Several factors may explain this disconnect, including the fact that employers can shift the cost and risk of health care to payers, but they cannot shift broader impacts of lost productivity and functional status outside of their organizational boundaries,’ Michael Ciarametaro, vice president of research at NPC and one of the study's authors, says...” Full
Video: Real-World Data Can Make Up for Clinical Trial Weaknesses, Says Viraj Narayanan (2/17, The American Journal of Managed Care) “Real-world data can help resolve some challenges commonly faced in clinical trails, said Viraj Narayanan, MBA, vice president of Life Sciences at COTA Healthcare.” View Video
RWE: Cost and Time Savings Entice Sponsors as Pitfalls Linger (2/14, Zachary Brennan, Regulatory Focus) reports “...The NEJM article, meanwhile, titled ‘The Magic of Randomization versus the Myth of Real-World Evidence,’...notes that ‘because of the potential biases inherent in observational studies, such studies cannot generally be trusted when — as is often the case — the effects of the treatment of interest are actually null or only moderate (i.e., less than a twofold difference in the incidence of the health outcome between using and not using the treatment).’ ‘In those circumstances, large observational studies may yield misleading associations of a treatment with health outcomes that are statistically significant but noncausal, or that are mistakenly null when the treatment really does have clinically important effects,’ they write.” Full
The Role of the Accountable Care Organization in Value-Based Care (2/17, Emily Sokol, MPH, RevCycle Intelligence) reports “...True value, though, looks different depending on the patient and the ACO...Markets with a diverse payer mix are left to the mercy of their payers to define success. ‘We really don't define value. The payers define what they see as value,’ argued [Coastal Carolina Quality Care, Inc. CEO Stephen Nuckolls]. ‘We move and adhere to the contractual provisions that they give us in these various programs. A payer has some control over what we put on our dashboards because they're the ones paying the bills.’” Full
UK: NICE Recommends New Therapy for Hyperkalaemia (2/17, Pavankumar Kamat, Medscape) reports “The National Institute for Health and Care Excellence has recommended patiromer (Veltassa, Vifor Fresenius Medical Care Renal Pharma) as a treatment option for hyperkalaemia.” Full
UK: NICE Recommends Wireless Device for Overactive Bladder (2/14, Anna Smith, PharmaTimes) reports “...Meindert Boysen, director of the centre for health technology evaluation at NICE, said: ‘Clinical trial evidence seen by our independent committee shows that Axonics can help improve quality of life for people with symptoms caused by an overactive bladder. This device will last longer than the current non-rechargeable system, resulting in a cost saving for the NHS after six years of use, and, importantly for patients, fewer replacement surgeries.’” Full
Press Releases
CEADM Applauds CADTH's Decision to Recommend an Innovative Depression Medication for Publicly-Funded Drug Plans in Canada (2/18, Canadians for Equal Access to Depression Medication Press Release) “...Dr. Sidney Kennedy...responded to CADTH's recent recommendation. ‘Historically, assessing the effectiveness of a depression medication is based on an antiquated approach – “Does this make you feel better?” The 40-percent of people with depression who don't respond to the standard medications need access to a variety of medications. I am hopeful CADTH's recent recommendation that vortioxetine be reimbursed for the treatment of MDD is an acknowledgement that given the 227 combinations of the symptoms of depression, one size of [treatment] does not fit all,’ Dr. Kennedy said.” Full
Journals
Out-Of-Network Primary Care Is Associated With Higher Per Beneficiary Spending In Medicare ACOs Sunny C. Lin, et al. February 2020, Health Affairs Health Affairs
The Magic of Randomization Versus the Myth of Real-World Evidence Rory Collins, F.R.S., et al. February 13, 2020, The New England Journal of Medicine NEJM
Does Consumer Engagement in Health Technology Assessment Enhance or Undermine Equity? Ghinea N, Lipworth W, Kerridge I. February 14, 2020, Journal of Bioethical Inquiry PubMed
Comparative Effectiveness of Long-Acting GLP-1 Receptor Agonists in Type 2 Diabetes: A Short Review on the Emerging Data Chudleigh RA, Platts J, Bain SC February 18, 2020, Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy Dove Press
Articles
Prices Drove Spending Growth: Trends In Employer-Sponsored Insurance Costs, 2014-2018 (2/13, Niall Brennan, Jean Fuglesten Biniek and John Hargraves, Health Affairs Blog) comments “...Drawing on 2.5 billion medical and pharmacy claims from four of the largest national health insurers, the latest annual report from the Health Care Cost Institute shows that average health care spending climbed to an all-time high in 2018 of $5,892 per person for individuals with health insurance coverage through an employer. That amounts to an average annual growth rate of 4.3 percent between 2014 and 2018...The increase in health care spending is particularly concerning because nearly three-quarters of the increase in inflation-adjusted spending was due to rising prices.” Full
Supporting the Safety Net through Research Training and Engagement (2/14, Adney Rakotoniaina, The PCORI Blog) comments “...Health center patients often have chronic health issues that are compounded by difficulties resulting from social factors. FQHCs, and the state Primary Care Associations which support them, face challenges in meeting the complex health needs of their patients. Given this, Eugene Washington PCORI Engagement Awards teams across the country are helping health center patients and clinicians drive research important to them to better meet these needs.” Full
Morningstar's Report on Socially Conscious Investment Strategies (2/14, David Whitrap, ICER Blog) comments “...Increasingly, the more forward-thinking biopharma companies are rolling up their sleeves to engage fully in ICER's assessments. They're aware that a favorable ICER report provides 1) a reputational boost for their company among legislators and the general public, 2) improved leverage when negotiating with payers, and 3) a progressive pitch to investors who are looking to put their money behind socially responsible companies.” Full
Scotland Recommends Interim Funding For Regeneron/Sanofi's Libtayo (2/14, Francesca Bruce, Pink Sheet) reports “...Scotland's health technology assessment body, the Scottish Medicines Consortium, has accepted Regeneron Pharmaceuticals Inc. / Sanofi's conditionally approved skin cancer treatment, Libtayo (cemiplimab), for interim funding on the Scottish National Health Service. Other treatments that recently got the thumbs up from the SMC include Pierre Fabre Group's Braftovi (encorafenib), also for skin cancer, and Takeda Pharmaceutical Co. Ltd.'s Revestive (teduglutide) for short bowel syndrome.” Paid Subscription Required
Journals
Physician and Patient Adjustment to Reference Pricing for Drugs James C. Robinson, PhD, et al. February 5, 2020, JAMA Network Open JAMA Network Open
Establishment of a Patient-Centered Outcomes Research Network for Individuals with TBI and Neuropsychiatric Symptoms Rao VA, et al. February 12, 2020, Brain Injury PubMed
CAR-T Therapy and Historical Trends in Effectiveness and Cost–Effectiveness of Oncology Treatments James R Baumgardner, et al. February 14, 2020, Journal of Comparative Effectiveness Research Journal of Comparative Effectiveness Research
Adding Pertuzumab to Adjuvant Therapy for High-Risk HER2-Positive Early Breast Cancer in APHINITY: A GRADE Analysis Alberto Zambelli, et al. February 14, 2020, Journal of Comparative Effectiveness Research Journal of Comparative Effectiveness Research
Reports
2018 Health Care Cost and Utilization Report February 2020 Health Care Cost Institute
Events
PCORI Board of Governors Meeting March 2, 2020 2:30 - 7:30PM EST PCORI
Articles
Expand Predeductible Coverage Without Increasing Premiums or Deductibles (2/13, A. Mark Fendrick, MD, The American Journal of Managed Care) comments “...V-BID X plans demonstrate that coverage can lower consumer out-of-pocket costs for high-value services without increasing deductibles or premiums. Applying targeted cost sharing based on the clinical value—not the price—of a service will give consumers improved access to high-value care, reduce cost-related nonadherence, and decrease exposure to harmful care. Actuarial estimates are used to match the incremental spending on high-value services dollar for dollar with the cost savings resulting from higher cost sharing on, and the resultant decreased use of, low-value care.” Full
Laying the Groundwork for Better Heart Health in 2020 and Beyond (2/13, Bob McNellis, M.P.H., P.A., and Michael I. Harrison, Ph.D., AHRQ Views) comments “...In the coming days, AHRQ will launch a new initiative to build on lessons learned from EvidenceNOW that will be focused on improving the heart health of people in communities with the greatest need. Project participants will be developing State-level capacity to broaden the dissemination and implementation of patient-centered outcomes research findings into even more primary care practices throughout the United States. This effort to further improve heart health and capitalize on new multi-organizational partnerships is designed to establish and expand the capacity of sustainable, primary care quality improvement. Stay tuned!” Full
CMS Needs to Provide More Support to Small, Physician-Led ACOs or Risk Drop-Outs: Report (2/13, Joanne Finnegan, Fierce Healthcare) reports “Small physician-led Accountable Care Organizations have shown success in reducing costs while improving quality. But they need more support to continue down that road, according to a new report. Those ACOs would benefit from more guidance and support from [CMS], private insurers and other sources as they take on greater financial risk and move farther away from traditional fee-for-service payments, according to a new report from the Duke-Margolis Center for Health Policy.” Full
Journals
The Magic of Randomization Versus the Myth of Real-World Evidence Rory Collins, F.R.S., et al. February 13, 2020, The New England Journal of Medicine NEJM
Reports
How to Better Support Small Physician-Led Accountable Care Organizations: Recent Program Updates, Challenges, and Policy Implications February 2020 Duke Margolis Center for Health Policy