US PBM Bill Markup Hearing Postponed Until May 11th
US Senators were geared up for a hearing to markup a bill targeting practices of the pharmacy benefit manager (PBM) industry that are alleged to be anticompetitive and drive up drug prices. However, this meeting has been delayed until May 11th so that the markup can occur after a May 10th hearing featuring testimony from major pharma and PBM leaders.
US Senators Weighing Approaches to Lowering Insulin Prices for All
As US Senators continue to debate over plans to lower insulin prices for all Americans, two bills have taken the forefront. One, by Sen. Susan Collins (R-ME) and Sen. Jeanne Shaheen (D-NH) would cap monthly cost-sharing at 25% of list price or $35. It would also force pharmacy benefit managers (PBMs) to make sure 100% of manufacturer rebates and discounts go to payers.
Medicaid Redetermination Process to Take Coverage from Millions of Children
With the COVID-19 public health emergency on its way out, states are set to start up the redetermination for Medicaid beneficiaries. Among the millions who will lose healthcare coverage in this process are children, who make up the majority of Medicaid recipients. The number of children to be dropped is still uncertain, but it is estimated to be around 1/3 of kids on the program.
Integrating Behavioral Health and Primary Care Through Value-Based Payment Models
To improve patient mental health outcomes and reduce healthcare costs, behavioral health needs to move to a value-based payment model and be better integrated into primary care. However, significant hurdles stand in the way. Payers could play a pivotal role in addressing the problem, but this will require careful cooperation with providers.
US Senate Finance Committee Unveils Plan to Regulate PBMs
A group of US senators in the Senate Finance Committee have released their plan to implement regulation targeting the pharmacy benefit manager (PBM) industry. The plan proposes changing how PBMs get compensated for drug sales, increasing transparency, and holding them financially and legally accountable for violations.
US Supreme Court Extends Mifepristone Access Temporarily with 2-Day Pause on Lower Court Ruling
The US Supreme Court has issued a 2-day pause on a lower ruling that would revoke the decades-old approval of mifepristone, a key component of the abortion pill. The stay would end at midnight this Friday, April 21st. The ruling has drawn substantial criticism, not the least of which is that allowing a judge to overturn approval by the US Food and Drug Administration (FDA) would undermine the agency’s authority to regulate medications.
ICER Issues Final Report on Alzheimer’s Drug Leqembi
Following a session of public comments, the Institute for Clinical and Economic Review (ICER) has issued its final evidence report on Eisai’s Alzheimer’s drug Leqembi (lecanemab). The independent organization valued the treatment between $8,900 - $21,500 per year. This is notably lower than the current list price of $26,500 per year set by the manufacturer.
Danco Laboratories and DOJ ask for US Supreme Court Action on Conflicting Mifepristone Rulings
Both the US Department of Justice (DOJ) and the mifepristone distributor Danco Laboratories have called upon the US Supreme Court to act quickly to hold back the effects of dueling federal court cases regarding the drug. The Fifth Circuit Court of Appeals temporarily paused last week’s ruling that mifepristone, a key drug used in the abortion pill, was inappropriately approved. Although mifepristone can stay on the market for now, expanded access to the drug would be cut, putting manufacturers and the FDA in conflict with another ruling last Friday.
US Senators Looking to Make Changes to Upcoming Legislation on Generics and PBMs
US Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA) are looking to April 19th when they can start deliberating on changes to an upcoming piece of legislation about generic drugs and the pharmacy benefit manager (PBM) industry. The bipartisan effort comes after increasing public and congressional pressure on PBMs and drug prices.
US Senators Propose Bill to Cap Insulin Costs for Every Patient
US Senators Raphael Warnock (D-GA) and John Kennedy (R-LA) have advanced a new bill that would lock the max price of insulin at $35 a month for all patients. The bill, entitled the Affordable Insulin Now Act of 2023, comes after manufacturers have voluntarily lowered insulin prices following price caps for Medicare patients in the Inflation Reduction Act.
28 US States Will See Medicaid Enrollment Drop to Near Pre-Pandemic Levels
Just as US states begin the Medicaid redetermination process, a new report by Moody’s Investors Services finds that 28 states will see enrollment drop to numbers equivalent to pre-pandemic levels. Some states, the report notes, will settle on enrollment levels higher than those seen before the pandemic-era Medicaid redetermination pause.
State Level Look at Who’s About to Lose Medicaid Coverage
With the imminent end to the COVID-19 public health emergency looming large, pandemic-era Medicaid expansions are set to kick millions off the program in the US. A newly published report from the Urban Institute and Robert Wood Johnson Foundation predicts that up to 18 million people are set to be dropped from Medicaid in the coming weeks and months. Examine this at the state-by-state level in a new Becker’s Payer Issues article.
Darwin EU Seeks New Partnerships After Successful First Year
The European Medicines Agency (EMA) has issued a call for applications for new partnerships with Darwin EU. The move comes after a successful first year that saw the implementation of four real-world data (RWD) projects that investigated rare blood cancers, the use of certain medications tied to pregnancy issues, antibiotic prescription patterns, and severe asthma.
US FDA Releases Draft Guidance on Oncology Clinical Trials Seeking Accelerated Approval
In a new draft guidance, the US FDA proposes two strategies to make clinical trials for cancer drugs better support accelerated approval applications for cancer drugs. Such applications are expected to be followed by confirmatory studies that often don’t materialize or yield negative results. The first suggestion is to move to a single trial for accelerated approval that also confirms potential health benefits.
India Shoots Down Application for J&J’s Tuberculosis Drug Patent Extension
Johnson & Johnson notched a loss today as India’s patent office refused to extend the patent on bedaquiline, a drug for treatment-resistant tuberculosis. The company was looking to extend the patent to 2027, but the patent office’s refusal means J&J will lose the patent by July, ending the company’s monopoly of the drug and opening the door for cheaper generics.
Sanofi Cuts Insulin Prices and Sets Out-of-Pocket Price Cap
Hot on the heels of Novo Nordisk and Eli Lilly, Sanofi announced it will cut the price of its main insulin formulation, Lantus, in January of next year. Just outstripping the others, the cuts amount to a 78% price drop for the life-saving drug used by millions of people with diabetes. In addition, Sanofi set an out-of-pocket cap of $35 a month for patients.
US CMS Releases Guidance on Upcoming Drug Price Negotiations
The pharma and biotech industry has waited with bated breath for more information on impending drug price negotiations with the US Centers for Medicare and Medicaid Services (CMS) that begin in 2026. The agency released its guidance on the process, laying out the process in detail. CMS has also put out a call for feedback. Responses are due by April 14th.
EMA and FDA Parallel Review Program Sees Slow Uptake
Pharma and biotech companies seeking entry into the US and EU markets may request advice from both agencies through the Food and Drug Administration (FDA) and European Medicines Agency (EMA) Parallel Scientific Advice (PSA) Program. However, few companies seem to be opting for the program, with only 22 drugs getting simultaneous review in the past five years.
Biden Administration Looks into Expanding Reach of Medicare Drug Pricing Negotiations
During a statement about his administrations budgetary plans, US president Joe Biden argued that more drugs should undergo Medicare pricing negotiations. In addition, he called on the process to go more quickly, considering that only a small number of drugs will be negotiated starting in 2026 under the Inflation Reduction Act.
HealthCore Changes Name to Carelon Research
The healthcare data company HealthCore announced today, March 1st, that it has undergone a name change. The company, now dubbed Carelon Research, will continue its dedication to providing its healthcare data and evidence generation services to its clients across industry, academia, and other life science stakeholders. The change marks the company’s entrance into the broader Carelon family.
Do Commercial Payers Rely on ICER Assessments During Specialty Drug Coverage Deliberations?
The Institute for Clinical and Economic Review (ICER) releases value assessment reports that determine cost-effectiveness ratios (CERs) for new and existing therapeutics. A newly published study in the Journal of Managed Care + Specialty Pharmacy, examines whether and how commercial insurance plans in the US incorporate these reports into their reimbursement decision-making process.
CDC Launches Initiative to Accelerate Health Data Modernization Efforts
The US Centers for Disease Control and Prevention (CDC) has announced a new initiative to modernize its public health data infrastructure. The Initiative, announced today, February 27th, will be a cooperative public-private effort led by the agency, the National Coordinator for Health Information Technology (ONC), and the CDC Foundation, an independent non-profit started by Congress.
Clinical Trials Must Include Diversity Plan in FDA Applications
Many patients from rural areas and marginalized backgrounds are severely underrepresented in many clinical trials. To address this problem, the US Food and Drug Administration (FDA) has announced that in the near future, all clinical trials registered through the agency must contain a plan to ensure diversity in the participant population. The plan will take time, however, as the agency must issue a final guidance and wait for public input.
FDA Lays Out Three Ways to Fight US Opioid Crisis in New Report
The US Food and Drug Administration (FDA) has outlined three steps in a newly released report that it can take to help combat the ongoing opioid crisis. The report, entitled the External Review of FDA Regulation of Opioid Analgesics Final Report, examines how the agency acted upon the 2017 findings of the National Academies for Sciences, Engineering, and Medicine (NASEM). The first is to evaluate study designs that consider public health for regulatory decision-making. In addition,
Moderna CEO Will Testify Before Senate Committee Headed by Sanders Over COVID Vaccine Price Hike
Stéphane Bancel, CEO of Moderna, will speak before a US Senate committee headed by Sen. Bernie Sanders (I-VT) over planned price hikes for the company’s COVID-19 vaccine. The shot, which the US federal government paid around $30 per dose for during the pandemic, will jump in price to $130 as it enters the market.
