CER Daily Newsfeed

The Comparative Effectiveness Research Daily Newsfeed®, known for short as the CER Daily Newsfeed®, offers the latest news, research and related information on comparative effectiveness research, real-world data and evidence, value assessment and other important health care topics. 

News from Thursday, February 22, 2024

Articles

Biden's Coming For Your Cures

(2/21, Rep. Brett Guthrie, R-KY., The Hill) comments “...Recent data shows net prices for branded drugs, the most expensive therapies, have steadily declined since 2017. This data shows that more targeted solutions are needed to truly lower the costs of everyday medications and continue to promote access to innovative products. Unfortunately, President Biden has resorted to price controls and removing incentives for innovation by taking the intellectual property of innovators.” Full

 

Pharmaceutical Giants Unite Against Government in Landmark IRA Price-Setting Challenge

(2/21, BNN) reports “...Many see the IRA's price negotiation provisions as a lifeline, a means to access life-saving medications without the burden of exorbitant costs...Pharmaceutical executives, however, warn that stringent price controls could hamper innovation, potentially slowing the development of new drugs. ‘We're fighting to ensure that patients continue to have access to groundbreaking treatments,’ a spokesperson for one of the suing companies stated, framing their legal challenge as a defense of future medical breakthroughs.” Full

 

US Prices of Some Psoriasis Drugs Need to Be Lowered to Match Benefits, New Study Says

(2/22, Katherine Lewin, Endpoints News) reports “The prices of drugs for psoriasis need to be reduced by about 71% to match their efficacy, researchers from Harvard Medical School and the Brigham and Women’s Hospital said in a study published in JAMA Dermatology on Wednesday...Researchers concluded that using a new approach to calculating cost effectiveness and negotiating prices, known as the ‘efficiency frontier’ approach, ‘could lead to substantial price reductions and better align prices with clinical benefits.’” Full

 

340B Audit ‘Protections' Needed Prior To Dispute Resolution Final Rule, Lilly Tells OMB

(2/21, Cathy Kelly, Pink Sheet) reports “...A final rule revising the 340B administrative dispute resolution process should not be released until federal regulators issue guidance or regulations affirming manufacturer protections against providing duplicate 340B and Medicaid discounts on the same drug and providing discounts on drugs diverted to ineligible patients, Eli Lilly and Company urged the White House Office of Management and Budget during a January 22, meeting.” Subscription Required

 

UK: Pfizer’s Litfulo Recommended by NICE as First Treatment for Severe Alopecia Areata

(2/22, Emily Kimber, PMLiVE) reports “Pfizer’s Litfulo (ritlecitinib) has been recommended by the National Institute for Health and Care Excellence to treat severe alopecia areata in patients aged 12 years and older. NICE’s decision, which could benefit up to 14,000 patients, makes Litfulo the first treatment for severe alopecia areata to be recommended by the agency for use on the NHS.” Full

Journals

Comparative Effectiveness of Daptomycin Versus Vancomycin Among Patients with Methicillin-Resistant Staphylococcus Aureus (MRSA) Bloodstream Infections: A Systematic Literature Review and Meta-Analysis

Yau Adamu, et al.

February 21, 2024, PLoS One

PubMed

 

Use of Efficiency Frontiers to Align Prices and Clinical Benefits of Biologic Therapies for Plaque Psoriasis

Alexander C. Egilman, BA; Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD; et al

February 21, 2024, JAMA Dermatology

JAMA Dermatology

 

Synthesis Methods Used to Combine Observational Studies and Randomised Trials in Published Meta-Analyses

Cherifa Cheurfa, et al.

February 21, 2024, Systematic Reviews

PubMed

 

Comparative Effectiveness and Safety of Direct Oral Anticoagulants Compared with Warfarin in Patients with Low Bodyweight who have Atrial Fibrillation: A Systematic Review and Meta-analysis

Mohamed Nabil Elshafei, et al.

February 22, 2024, American Journal of Cardiovascular Drugs

PubMed

News from Wednesday, February 21, 2024

Articles

In New $7 Million, 5-Year Trial, Researchers Are Studying How to Connect Patients with Most Effective Heart Failure Medications

(2/21, Tyler Smith, UCHealth Today) reports “...[Dr. Larry Allen], a cardiologist at UCHealth University of Colorado Hospital on the Anschutz Medical Campus and medical director of the Advanced Heart Failure Program at the University of Colorado School of Medicine, recently secured a five-year, $7 million grant from [PCORI]. The goal: to study the power of electronic health records and innovative tools to increase the number of the most seriously ill heart failure patients who receive the proper doses of effective but underused classes of medications to improve their health.” Full

 

Eczema Counts Wraps Up

(2/20, National Eczema Association) comments “Eczema Counts, an innovative project that was run as a partnership between the National Eczema Association and the Pediatric Dermatology Research Alliance (PeDRA), concluded in early 2024. The goal of Eczema Counts was to educate and connect eczema patients and researchers with the goal of advancing patient centered outcomes research and comparative effectiveness research in the field of pediatric eczema. The project was funded by an Engagement Award from [PCORI].” Full

 

Surprise! Thanks to the IRA, Part D Plans Will Prefer High-List, High-Rebate Drugs

(2/21, Adam J. Fein, Ph.D, Drug Channels) comments “...Making manufacturers pay 20% of Part D catastrophic coverage costs probably seemed like a great idea when the IRA was rushed through Congress. Alas, this new structure will create an unintended formulary tension. The government and brand-name manufacturers will do better with low-list-price products, while plans will do better with high-list-price products. While I have changed my views on the outlook for the gross-to-net bubble in Part D, my assessment of the IRA remains the same: Legislate in haste, repent at leisure.” Full

 

Why Affordability Is the Big Tent

(2/20, Drew Altman, KFF) comments “...Much of the R&D enterprise now in health services research and health policy focuses on ways to change payment and delivery to get more value for the health spending we do. The primary constituencies for this work are payers, purchasers, and providers, all looking for ways to lower costs and improve quality. However, the polling suggests there is a ways to go before people see ‘value’ as relevant to them. This matters as long as value-based payment remains a central strategy in health care. If consumers do not see these efforts as lowering their costs and improving their care, they will see only high prices and continue to believe no effort is being made to make health care more affordable for them by the institutions that serve them.” Full

 

Video: Dr James Robinson on the Impact of 340B Programs and Drug Pricing Policies

(2/20, The American Journal of Managed Care) “In part 2 of our interview with Robinson, he addresses the potential for exacerbated health care disparities in the aftermath of hospital price markups and how insurance plan design often disadvantages the patients who most need expensive infusion therapies but cannot afford them.” View Video

 

ACOs Want Increased Participation of Long-Term and Post-Acute Care Providers

(2/21, Noah Tong, Fierce Healthcare) reports “...‘If CMS is to achieve its goal of having all Medicare beneficiaries in an accountable care relationship by 2030, then it must take steps to better include provider types less represented in ACOs, including SNFs,’ said National Association of ACOs (NAACOS) Senior Vice President of Government Affairs Aisha Pittman. ‘We hope our recommendations spark attention to this area, because patients served by LTPAC providers deserve the higher quality, lower cost care we know value-based care delivers.’” Full

 

Proposals to CMS Could Bring More Nursing Homes into ACOs

(2/21, Diane Eastabrook, Modern Healthcare) reports “...Only about 2,000 nursing homes are participating in ACOs. But a white paper, published by the American Health Care Association and the National Association of ACOs, said nursing homes could play a critical role in value-based care if the Center for Medicare and Medicaid Services were to better line up incentives for community-based and institutional providers.” Subscription Required

 

Pooled Procurement Of Cancer Drugs In India: Is Pharma Game For More?

(2/20, Anju Ghangurde, Pink Sheet) reports “...Negotiation on a national level could also address the challenges of ‘vendor monopoly’ or patented drugs supplied by a single vendor, the 2023 paper on the NCG initiative published in the Bulletin of the World Health Organization said. ‘Furthermore, to determine the final price for innovator and single vendor drugs, a comprehensive evaluation of the available literature on efficacy and safety data is crucial. If a drug meets the threshold for significant clinical benefits, cost–effectiveness assessment using adaptive health technology can provide guidance for negotiating prices,’ the authors said.” Subscription Required

Press Releases

Most Effective Atopic Dermatitis Treatments May Also Be Most Harmful

(2/21, The American Academy of Allergy, Asthma & Immunology Press Release) “...‘Atopic dermatitis is the most common inflammatory skin condition with an increasing number of available systemic interventions. We systematically reviewed and meta-analyzed the comparative benefits and harms of the available options and appraised the evidence using robust and standardized approaches. Our findings have important and immediate implications for achieving optimal outcomes in patients with eczema requiring advanced therapy’ says primary author Alexandro Chu, BHSc.” Full

Journals

Comparative Safety and Effectiveness of Reduced Doses of Direct Acting Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation

Flemming Skjøth, MSc, PhD, et al.

February 20, 2024, The American Journal of Medicine

The American Journal of Medicine

 

A Comprehensive Review and Shiny Application on the Matching-Adjusted Indirect Comparison

Ziren Jiang, et al.

February 21, 2024, Research Synthesis Methods

PubMed

News from Tuesday, February 20, 2024

Articles

New Report Makes Recommendations for Advancing Health Equity and Fostering Patient Engagement in the Implementation of CMS’ Drug Price Negotiation Program

(2/16, Joanne Walker, The Evidence Base) reports “The recent collaboration between The Innovation and Value Initiative, Alliance for Aging Research, Leavitt Partners, LLC, and National Pharmaceutical Council has shed light on critical health equity issues and patient engagement within the Drug Price Negotiation Program context...Based on the insights shared, critical recommendations for CMS include: Establishing a robust patient and health equity stakeholder engagement program. Ensuring transparency in goals, intentions, practices, and uncertainties. Implementing continuous quality measurement and improvement mechanisms.” Full

 

Value-Based Payment Models Can Improve Appropriate And Equitable Use Of Prescription Drugs

(2/20, Christina Bush, et al., Health Affairs Forefront) comments “...Currently, VBP models do provide incentives for appropriate use of clinician-administered drugs but often exclude pharmacy-dispensed drugs. VBP reforms can be advanced by strategies such as data to inform clinician-administered drug prescribing and inform specialty referrals, more meaningful quality measures assessing the outcomes from drugs, and engaging specialists in total cost of care models. For pharmacy-dispensed drugs, short-term strategies that can provide a path to more significant reforms include strategies to better align prescribing incentives with total costs of care and outcomes, especially for conditions where innovative but costly drugs can make a difference.” Full

 

Knowing Actual Prices Will Help HHS Set The Maximum Fair Price Under The Inflation Reduction Act

(2/16, Steven M. Lieberman and Paul B. Ginsburg, Health Affairs Forefront) comments “...From our perspective, policy decisions benefit from having more rather than less information, so requiring data on actual net costs will improve MFP negotiations. Having appropriate data will enhance the likelihood of a secretary making analytically sound decisions rather than reacting without adequate information to popular pressures to lower drug prices for Medicare beneficiaries or lobbying by manufacturers for a higher MFP.” Full

 

HHS Needs More Rebate Information To Negotiate Medicare Drug Prices, Say USC Experts

(2/19, Peter Wehrwein, Managed Healthcare Executive) reports "...The problem, according to [Steven Lieberman, M.Phil., M.S., and Paul Ginsburg, Ph.D.], is that neither the non-FAMP nor net Part D price captures the true price of what a drugmaker is receiving for a drug from a variety of different payers once rebates and discounts get factored in. They cite a 2017 Congressional Budget Office report that shows, for example, that Medicaid net prices are considerably lower than non-FAMP and net Part D prices. If HHS were to use the 75% of non-FAMP benchmark to set the price it pays for a drug that is heavily rebated, it would likely wind up paying a higher price than other payers pay because of the substantial rebates, even factoring in the 25% cut from non-FAMP, they say." Full

 

How Will Medicare Negotiate Drug Prices, And What Impact Will It Have?

(2/16, Marc A. Rodwin, John D. Lantos, Health Affairs Forefront) comments "...To close a negotiated Medicare deal under the IRA, manufacturers could offer a confidential discount in exchange for CMS accepting a higher MFP than it proposed. If negotiations play out this way, Medicare could see a net savings, but that savings would not necessarily lead to reduced prices for other payers. Instead, the published MFP (but not the net price) will become the benchmark that manufacturers could use to lock in higher prices from other payers...Under this scenario, CMS’s gain won’t help other purchasers and would actually help manufacturers charge them higher prices." Full

 

The Inflation Reduction Act Adds New Barriers to Curing Rare Disease

(2/19, Eric Dube, The Hill) comments “...The possibility that a line of research might produce a treatment for more than one disease helps reduce some of that risk, making it easier to attract investors. So by discouraging work on multiple rare diseases, the IRA creates significant new obstacles to developing innovative new medicines. The provision actually deters companies from searching for new uses for drugs they’ve already developed. After all, why would a company perform expensive clinical trials to investigate new potential uses in a rare disease if a second approval from the FDA will only lead to price controls?” Full

 

AHRQ’s Digital Healthcare Research Program: 20 Years of Innovation

(2/20, Robert Otto Valdez, Ph.D., M.H.S.A., Chris Dymek, Ed.D. and Kevin Chaney, M.G.S., AHRQ Blog) comments “...In its early years, computerized [clinical decision support] was confined to large systems that could not communicate among their care providers. AHRQ spurred a change in 2007 when it began funding CDS demonstration projects that emphasized a centralized web-based service approach to bedside decision support on a large scale. Then, in 2016, AHRQ launched a program of grants and contracts to help move patient-centered outcomes research evidence into practice through CDS. Today, AHRQ advances the science of CDS by supporting implementers, clinicians, and vendors in developing shareable, standards-based, publicly available, and patient-centered tools.” Full

 

Houston ACO Tells Fifth Circuit It Should Have Non-Exempt Status

(2/16, Shweta Watwe, Bloomberg Law) reports “...Memorial Hermann asserts that when enacting the ACA, Congress knew that accountable care organizations would have to service patients with private insurance to successfully improve the cost and quality of medical services and a “necessary consequence rather than a purpose.’ ‘Benefiting private insurance companies was no more Petitioners’ purpose than it was Congress’ in the first place when it made ACOs an instrument to advance ACA’s goals,’ the organization said.” Subscription Required

 

UK: GSK’s Omjjara Recommended by NICE to Treat Myelofibrosis Patients with Anaemia

(2/19, Emily Kimber, PMLiVE) reports “GSK’s Omjjara (momelotinib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a treatment option for myelofibrosis-related splenomegaly or symptoms in adults with moderate-to-severe anaemia.” Full

Press Releases

ICER Appoints New Members to Each of Its Three Independent Evidence Appraisal Councils

(2/20, ICER Press Release) “The Institute for Clinical and Economic Review has appointed new members to each of its three independent evidence appraisal councils: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC).” Full

Journals

Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes: A Large-Scale, Multinational, Federated Analysis of the LEGEND-T2DM Study

Rohan Khera, et al.

February 8, 2024, medRxiv

PubMed

 

Comparative Effectiveness of Tofacitinib and Tumour Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis in Real-World Practice: A Prospective Observational Study

Soo-Kyung Cho, et al.

February 15, 2024, Rheumatology

PubMed

 

Acceptability of Using Real-World Data to Estimate Relative Treatment Effects in Health Technology Assessments: Barriers and Future Steps

Manuel Gomes, et al.

February 16, 2024, Value in Health

PubMed

 

Comparative Effectiveness of Azathioprine and Mycophenolate Mofetil for Myasthenia Gravis (PROMISE-MG): A Prospective Cohort Study

Pushpa Narayanaswami, et al.

March 2024, The Lancet Neurology

PubMed

News from Friday, February 16, 2024

Articles

EU Regulators Make Finding & Using RWD Easier

(2/15, Neena Brizmohun, Pink Sheet) reports “...Two new electronic catalogs of real-world data sources and studies offer an improved and more efficient service to help drug companies, regulators and researchers find adequate data sources to generate real-world evidence for regulatory purposes, says the European Medicines Agency.” Subscription Required

 

EMA and HMA Launch Real-Word Data Catalogues

(2/16, Susan Haigney, BioPharm International) reports “...Created to promote transparency, encourage good practices, and build trust in RWD, the catalogues build on former databases developed by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The RWD sources catalogue replaces the ENCePP Resources Database. The RWD studies catalogue replaces the European Union electronic register of post-authorization studies. The ENCePP website has been renewed. Data sources, centers, and networks have migrated to the new catalogues; however, some content will remain on the renewed ENCePP website.” Full

 

UK: NICE Guidance on Momelotinib for the Treatment of Myelofibrosis

(2/16, MPN Voice) comments “We are delighted to announce that NICE (the National Institute for Health and Care Excellence) has recently released guidance recommending momelotinib as an option within the NHS for treating myelofibrosis-related splenomegaly (enlarged spleen) or symptoms in adults with intermediate-2 or high-risk myelofibrosis (MF) with moderate to severe anaemia, who have not had a JAK inhibitor or have had ruxolitinib.” Full

Journals

Comparison of Pharmacological Treatments for Agitated Delirium in the Last Days of Life

Natsuki Kawashima, et al.

February 12, 2024, Journal of Pain and Symptom Management

PubMed

 

Real-World Comparative Effectiveness of Dalteparin and Enoxaparin for Venous Thromboembolism Prophylaxis

Anna L Di Mauro, et al.

February 16, 2024, Blood Coagulation & Fibrinolysis

PubMed

News from Thursday, February 15, 2024

Articles

The End for QALYs in Federal US Drug Value Assessments?

(2/12, Joanne Walker, The Evidence Base) reports “...Kim Westrich (Chief Strategy Officer, National Pharmaceutical Council), in her interview with The Evidence Base, agreed a more holistic approach to value assessment was needed. ‘All these measures have trade-offs, which is why I believe it is critical that they are only one component of a more comprehensive approach to value assessment that captures the patient-centered value elements which are challenging to incorporate into a measure like the QALY.’” Full

 

Innovation in Value-Based Care Requires More Data, Patient-Centered Thinking

(2/14, Rose McNulty, The American Journal of Managed Care) reports “...‘What we can’t seem to crack is that what’s driving the cost in oncology, particularly for medical oncology, is the cost of the drugs,’ [Tracy Spinks, director of value-based care at Optum Health,] said. ‘And so that’s where we start to think about, well, should they be bifurcated? Should we be focusing on quality separately from cost?’ There may be a different way to look at this issue without making things harder on providers or patients, she added.” Full

 

States Get in on the Prior Authorization Crackdown

(2/15, Bram Sable-Smith, The Washington Post: The Health 202) reports “...Prior authorization, sometimes called pre-certification, requires patients to endure their health insurers' reviewing some medical treatments before deciding to cover them - or not. It's a tool the plans say reins in costs and protects patients from unnecessary or ineffective medical treatment. Patients and doctors hate it. But the new [CMS] rules are limited. So, doctors and hospitals are backing efforts by states to pass their own restrictions. Last year, lawmakers in 29 states and District of Columbia considered some 90 bills to limit prior authorization requirements, according to the American Medical Association, with notable victories in New Jersey and D.C. The physicians association expects more bills this year.” Sub. Req’d

Press Releases

Report Highlights 30 Years of AHRQ’s Primary Care Research

(2/15, AHRQ) “A new report from AHRQ’s National Center for Excellence in Primary Care Research describes three decades (1990–2020) of AHRQ’s primary care research and highlights how that research has impacted delivery of primary care. The report details AHRQ’s investments in research to improve primary care organization, workforce, quality and safety, digital healthcare, finance and cost, and prevention. These investments have positively impacted research, policy, clinical practice, and health outcomes.” Full

Journals

Comparative Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) for Depression in 43,061 Older Adults with Chronic Somatic Diseases: a Danish Target Trial Emulation Study

Kazi Ishtiak-Ahmed, et al.

February 7, 2024, General Hospital Psychiatry

PubMed

 

Comparative Effectiveness of Azathioprine and Mycophenolate Mofetil for Myasthenia Gravis (PROMISE-MG): A Prospective Cohort Study

Pushpa Narayanaswami, MD, et al.

March 2024, The Lancet Neurology

The Lancet Neurology

Reports

Policy Symposium: Ensuring Equity in Implementation of Ira Drug Price Negotiations: Convening Proceedings Report

December 2023

Innovation and Value Initiative

 

Mapping AHRQ's 30-Year Investment in Primary Care Research (1990-2020)

February 2024

AHRQ

 

HTA Policy and Methods Review – Draft Paper: Emerging Health Technologies

February 15, 2024

Australian Government Department of Health and Aged Care

News from Wednesday, February 14, 2024

Articles

ANALYSIS: Drug Price Fights Still Have Shot After One Suit Axed

(2/14, Alexis Kramer, Bloomberg Law) reports “...A federal district court in Texas Feb. 12 dismissed a lawsuit brought by the National Infusion Center Association and other industry groups for lack of jurisdiction. NICA's claims revolved around Medicare reimbursement for providers, and that led to its downfall. The eight other lawsuits winding their way through the courts don't involve providers, so even if they hit a roadblock, it likely won't be for the same reason.” Full

 

Video: Utilizing Real-World Data for Informed Decision-Making in CLL

(2/14, Cancer Network) “Sikander Ailawadhi, MD, review real-world data findings recently presented at ASH 2023, highlighting their potential implications on the treatment landscape.” View Video

 

Epic to Showcase New Evidence-Based Medicine Tool, EHR Improvements at HIMSS24

(2/14, Bill Siwicki, Healthcare IT News) reports “...Q. What are some of the additions or changes you will be making to your EHR? [Seth Hain, senior vice president of research and development at Epic:] One exciting example is Best Care Choices for My Patient, which will support evidence-based medicine by giving providers insights into how patients like theirs have responded to the different treatment options they're considering. It’s rolling out in its early stages this year.” Full

 

From Buzzword to Action: Addressing SDOH to Advance Health Equity

(2/14, Hillit Meidar-Alfi, MedCity News) comments “...Further, for groups to shift from buzzword to action on health equity, they must implement new workflows that are specifically designed to address the challenges of collecting and analyzing data related to SDoH. By adopting new workflows and leveraging technology, ACO REACH groups can empower providers and care team members to make informed decisions based on a more holistic view of the patient and seamlessly connect them with personalized intervention services, ensuring SDoH becomes an integral part of the healthcare delivery model.” Full

 

BMS Secures Better HTA Result In Germany With Additional Data for Camzyos

(2/14, Francesca Bruce, Pink Sheet) reports “...A revised benefit rating for BMS’ cardiomyopathy drug Camzyos will be good news for the product’s pricing in Germany.” Subscription Required

Journals

Comparative Effectiveness and Tolerability of Dual and Triple Combination Inhaler Therapies for Adolescents and Adults with Asthma

Fares Dashti, Ian Gregory

February 2024, Clinical and Experimental Allergy

PubMed

 

Tools for Assessing Quality of Studies Investigating Health Interventions Using Real-World Data: A Literature Review and Content Analysis

Li Jiu, et al.

February 13, 2024, BMJ Open

BMJ Open

 

Comparative Efficacy and Safety of Sofosbuvir/Velpatasvir and Danoprevir for the Treatment of Chronic Hepatitis C: The Real-World Data in China

Yunjing Zhou, et al.

February 14, 2024, BMC Gastroenterology

BMC Gastroenterology

 

Future Directions for Patient Engagement in Research: A Participatory Workshop with Canadian Patient Partners and Academic Researchers

Anna Maria Chudyk, et al.

February 14, 2024, Health Research Policy and Systems

Health Research Policy and Systems

Events

NPC's John O'Brien to Speak at the ACCESS 2024 International Meeting & Expo

February 24, 2024

10:00AM - 11:00PM

Miami, FL

National Pharmaceutical Council

 

NPC's Jon Campbell to Present at the 5th Annual IVI Methods Summit

March 14, 2024

9:30AM - 3:00PM

National Pharmaceutical Council

News from Tuesday, February 13, 2024

Articles

Pharmaceutical Group's Lawsuit Over Medicare Drug Price Program Dismissed

(2/13, Nate Raymond, Reuters) reports “...U.S. District Judge David Ezra in Austin, Texas, sided with President Joe Biden's administration in dismissing a lawsuit by the Pharmaceutical Research and Manufacturers of America and two other groups that argued the program was unconstitutional...The ruling marked another victory for the administration in its defense of the negotiation program, one of Biden's signature initiatives and part of the Inflation Reduction Act that the Democratic president signed into law in 2022.” Full

 

Judge Dismisses PhRMA Challenge to Medicare Drug Negotiations

(2/12, Maya Goldman, Axios) reports “...PhRMA could appeal to the 5th U.S. Circuit Court of Appeals. But if it prevailed, the trade group would likely have to go back to the district court to litigate its arguments, said Zachary Baron, director of the Health Policy and the Law Initiative at Georgetown University's O'Neill Institute.” Full

 

FTC Supports NIST Framework, Urges Further Action On Patent Reform

(2/12, Gabrielle Wanneh, InsideHealthPolicy) reports “...FTC says the existence of dense patent thickets impedes competition in the drug industry by delaying generics and biosimilars from entry into the market even when some component patents are deemed to be faulty...FTC also says the issue with patent thickets may weaken the utility of march-in rights to beef up affordable public access to drugs because certain drugs may be protected by privately-funded blocking patents in addition to government-funded patents subject to march-in rights.” Subscription Required

 

“Nudging” Doctors to Reduce Overuse

(2/13, Judith Garber, Lown Institute) comments “...While the policy landscape undoubtedly creates incentives for overuse, overuse rates often come down to the differences in behavior among individual physicians. Like all of us, physicians are vulnerable to cognitive biases, like availability bias (when we give more importance to examples we more readily remember), confirmation bias (when we give more importance to information that confirms our existing beliefs), and loss aversion (when we fear the outcome of losing something more than anticipate the value of gaining something). These can all impact decisions to offer low-value services to patients.” Full

 

Precision Medicine Tool May Personalize Pediatric Cancer Treatment

(2/13, Shania Kennedy, Health IT Analytics) reports “...Specifically, the tool focuses on investigating factors that influence drug movement, flagging early signs of drug toxicity, and exploring drug-chemotherapy interactions. The platform is connected to the health system’s electronic health record (EHR) system to identify when a blood draw is taken from a pediatric cancer patient. Using data from these blood draws, the research team can conduct analyses to gather information about potential drug interactions, the impact of certain drugs on patients with other medical conditions alongside their cancer, and how long medications remain in a patient’s bloodstream.” Full

Journals

Cardiovascular Outcomes in GRADE (Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness Study)

Jennifer B Green, et al.

February 12, 2024, Circulation

PubMed

News from Monday, February 12, 2024

Articles

Value Viewpoint: February 9, 2024

(2/9, Kimberly Westrich, LinkedIn) comments “On Monday, Health Affairs Forefront published an article by Peter Neumann and Joshua Cohen questioning whether, given the limitations of current economic analyses, we are valuing prescription drugs appropriately...As Neumann and Cohen note, we also need reform to PBM and health insurer practices and policies to support competition. Why does this matter? According to the authors: prices are critical because they send signals to innovators that influence allocation of private research and development resources. Appropriately calculated value-based prices can help achieve an allocation aligned with societal preferences to ensure the best uses of resources to improve people’s health and well-being.” Full

 

Podcast: From Fee-for-Service to Value-Based Care

(2/9, KevinMD.com) comments “Join Michael Poku, a physician executive, as we delve into the challenges and solutions for transforming the U.S. health care system. Explore how the fee-for-service model perpetuates health inequities, the importance of value-based care, and the impact on patient outcomes. Discover how prioritizing patients and making strategic investments can lead to a more equitable and cost-effective health care model.” Full

 

CBO Still Weighing IRA's Effect On Drug Innovation, Economic Outlook Omitted Issue

(2/9, Gabrielle Wanneh, InsideHealthPolicy) reports “...The Congressional Budget Office is continuing to assess new data on the Inflation Reduction Act's impact on pharmaceutical innovation after its latest 10-year economic outlook looked at projections for the IRA's clean vehicle and energy-related tax credits but not its drug price controls. CBO staff told Inside Drug Pricing the agency continues to receive and evaluate new research on drug innovation and how changes drug companies are expected to see in their future profits due to policies like drug price negotiation in Medicare will affect the development of drugs.” Subscription Required

 

Alaska Provider Network Achieving Value-Based Care Success with SDOH and Claims Data

(2/9, Bill Siwicki, Healthcare IT News) reports “...‘With each of the providers on the network able to create their own dashboard of metrics specific to their practice – for example, referral management, clinical care, revenue cycle – EHR, SDOH and claims data is an invaluable asset,’ [Alaska Provider Network president Jason Haugen] concluded. ‘While data doesn't treat patients, it's a tool to arm clinicians with the information needed for high-quality patient care efforts. My advice is to see what the options are that fit your practice best and trust the data for the benefit of your practice and patients.’” Full

Journals

Comparative Effectiveness of Biologics in Patients with Rheumatoid Arthritis Stratified by Body Mass Index: A Cohort Study in a Swiss Registry

Enriqueta Vallejo-Yagüe, et al.

February 8, 2024, BMJ Open

PubMed

Reports

NPC Comments Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights

February 6, 2024

National Pharmaceutical Council

News from Friday, February 9, 2024

Articles

PBMs Take Bulk of Blame as Senators Question BMS, J&J and Merck CEOs on High Drug Prices in US

(2/8, Kevin Dunleavy, Fierce Pharma) reports “...Sen. Rand Paul, R-Kentucky, used his allotted time to support the current healthcare system in the U.S. and railed against Senate Democrats for conducting ‘a show trial to harangue companies (who are) challenging the Inflation Reduction Acts' price controls in court.’ ‘One reason the U.S. leads in pharmaceutical innovation is because while the U.S. adhered to more market-based pricing and rewarded innovators, Europe adopted stringent price controls,’ Paul added. ‘It’s not surprising that we lead the world in innovation and Europe does not.’” Full

 

States Tackle Prior Authorizations Amid Outcry

(2/9, Michael McAuliff, Modern Healthcare) reports “...Advocates for limits on prior authorizations, such as the AMA, pressed state legislatures to act. The AMA drafted model legislation to shorten prior authorization timelines to 24 hours for urgent care and 48 hours for other requests, which New Jersey and Washington largely adopted. The New Jersey and Washington statutes are among the most extensive of the recent measures. In addition to deadlines, the laws set standards that insurers must follow, such as abiding by established clinical guidelines, sharing data on denials and disclosing their requirements to providers and policyholders in plain English.” Subscription Required

 

Regulatory Tracker: Stada, Calliditas’ Kinpeygo Picks Up NICE Recommendation

(2/9, Fraiser Kansteiner, Fierce Pharma) reports “England's [NICE] has endorsed Stada and Calliditas Therapeutics Kinpeygo for certain adults with primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression. To be eligible, patients must have a urine protein-to-creatinine ratio of 1.5 g/g or more. With the recommendation, Kinpeygo, or targeted-release budesonide, becomes the first-ever drug for primary IgA nephropathy to gain a NICE endorsement.” Full

 

EMA’s Cancer ‘Pathfinder’ Project Targets Conditional Approvals, Endpoints & RWE

(2/9, Ian Schofield, Pink Sheet) reports “...This second of a two-part article on the EU’s “Cancer Medicines Pathfinder” initiative looks at the trade-off between the benefits and risks of conditional drug approvals and differing perceptions of progression-free survival as a validated endpoint in cancer drug trials.” Subscription Required

Press Releases

New Research Finds Patient Access to Drugs Selected for IRA Is Often High (JAMA Health Forum)

(2/9, National Pharmaceutical Council Press Release) “A new research letter published in JAMA Health Forum found that current Medicare beneficiary access to many of the drugs selected for the first round of the Inflation Reduction Act’s Medicare Drug Price Negotiation Program (DPNP) was high in 2019 and 2023, supporting concerns that the unintended consequences of the IRA may include harm to patient access...‘Our research showed beneficiary access to the first ten selected drugs was high in 2019 and 2023: most of these drugs were on formularies without prior authorization or step therapy requirements,’ said co-author Dr. O’Brien, NPC’s President and CEO. ‘This is important to note before the DPNP prices go into effect as the IRA creates strong perverse incentives for plans to maximize rebates by potentially using utilization management and adverse tiering for the drugs selected.’” Full

Journals

Medicare Part D Coverage of Drugs Selected for the Drug Price Negotiation Program

Julie A. Patterson, PharmD, PhD; Tyler D. Wagner, PharmD, PhD; John M. O’Brien, PharmD, MPH; et al

February 9, 2024, JAMA Health Forum

JAMA Health Forum

 

Expanding the Catalog of Patient and Caregiver Out-of-Pocket Costs: A Systematic Literature Review

Theresa Schmidt, Christine Juday, Palak Patel, Taruja Karmarkar, Esther Renee Smith-Howell, and A. Mark Fendrick

February 6, 2024, Population Health Management

Population Health Management

 

Cardiorenal Effectiveness of Empagliflozin Vs. Glucagon-like Peptide-1 Receptor Agonists: Final-Year Results from the EMPRISE Study

Phyo T. Htoo, et al.

February 8, 2024, Cardiovascular Diabetology

Cardiovascular Diabetology

 

Value-Based Pricing: A Potential Solution to Difficult Pricing Discussions and Payers’ Negotiations

G. Tremblay, A. Poirier &L. Monfort

February 9, 2024, Journal of Medical Economics

Journal of Medical Economics

News from Thursday, February 8, 2024

Articles

It’s Time to Stop Talking Past Each Other on Drug Pricing

(2/8, John M. O'Brien, PharmD, MPH, National Pharmaceutical Council: E.V.I.dently Today) comments “...What is good in politics is not the same thing as good policy. I wish that we could have an honest conversation to understand better how the healthcare system in the U.S. works and ways that we can help it work better for patients. While we are unlikely to get that today, here are a few things I wish would get the attention they deserve...For over thirty years, drug companies have given the Medicaid program the best price among nearly all purchasers. Safety net hospitals and others accessing drugs via the 340B program get similar discounts. For many drugs, the size of this discount is so large that states get them free or, starting in 2024, will be paid for using them. Medicare drug plans are also able to tap into discounts that average 23% but, in many instances, are 50-80% of the list price.” Full

 

In a Showy Hearing, Bernie Sanders Gets Few Answers about Lower Drug Prices

(2/8, Rachel Cohrs, STAT) reports “...The CEOs agreed that their dramatically lower prices in other countries are still profitable, but contended that there is less patient access for medications in health care systems in other countries...[Sen. Bill Cassidy (La.)] told the story of a woman who traveled to the United States to pay out of pocket for a cancer treatment after coverage for the treatment was rejected in Canada.” Full

 

House Passes QALY Ban Bill

(2/7, Peter Wehrwein, Managed Healthcare Executive) comments “...Republicans favoring the bill spoke strongly. ‘QALY metrics intentionally devalue treatment for disabled and chronically ill patients in determining whether a treatment is cost effective. In other words, telling the patient, “you’re not worth it.”’ Rep. Brad Wenstrup, one of the Republican co-sponsors of the bill, said today on the floor of the House before the vote. Wenstrup, a podiatrist, represents a district in in southern Ohio. Another sponsor, Rep. Buddy Carter, said the legislation will ‘expand access to life-saving treatments and prevent discrimination against American with disabilities.’” Full

 

House Republicans Vote to Ban Certain Pricing Metrics in Federal Programs

(2/7, Noah Tong, Fierce Healthcare) reports “...[Rep. Cathy McMorris Rodgers, R-Washington] said that QALY assigns a dollar value to determine whether a treatment is cost-effective, potentially denying necessary healthcare. QALY, she added, removes the unique circumstances a patient faces. She also argued that Democrats previously have supported banning QALY indexes—both when the Affordable Care Act was first passed and banned QALY in Medicare, and again in 2020 as part of the Democratic National Committee platform.” Full

 

House Approves Ban on Disputed Measure for Valuing Treatments

(2/8, Victoria Knight, Axios) reports “...Rep. Frank Pallone, the top Democrat on the House Energy and Commerce Committee, argued on Wednesday that the ban would undermine federal efforts to lower prescription drug costs and give drug companies an opening to legally challenge efforts to reduce costs. Such opposition could doom the ban's prospects of being taken up in the Senate.” Full

 

Backlash Builds Over Biden Plan for Seizing Drug Patents

(2/8, Ian Lopez, Bloomberg Law) reports “...The Innovation Alliance...wrote to express its concern the plan ‘will erode the immeasurable success of the Bayh-Dole Act in driving U.S. private-sector innovation’ and ‘jeopardize U.S. global technological leadership.’ ‘Encouraging government agencies to exercise march-in rights based on an administration’s policy preferences, and adding consideration of pricing, which is not in the statute, would significantly disincentivize companies from applying for federal R&D grants and from licensing inventions created with federal R&D funds,’ the Innovation Alliance wrote.” Subscription Required

 

Physician Leaders Propel Privia ACOs’ Perennial High Performance

(2/8, Andis Robeznieks, American Medical Association) comments “Physician-led accountable care organizations have consistently been ranked among the best-performing organizations in the Medicare Shared Savings Program (MSSP). The ACOs that collectively constitute Privia Quality Network are among the best of those...Since 2014, Privia Quality Network has delivered total shared savings across government and commercial ACO programs of more than $890 million, including more than $510 million through participation in the MSSP. The amount of Medicare MSSP health care expenses included in Privia Quality Network has grown from $111 million in 2014, to $1.8 billion in 2022, according to a Privia news release.” Full

Journals

Long-Term Benefits of Dapagliflozin on Renal Outcomes of Type 2 Diabetes under Routine Care: A Comparative Effectiveness Study on Propensity Score Matched Cohorts at Low Renal Risk

Gian Paolo Fadini, et al.

February 2024, The Lancet Regional Health Europe

PubMed