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Congress is out of session until after Labor Day.
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Inflation Reduction Act (IRA) center
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IRA snippets
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- The Drug Price Negotiation Data Elements Information Collection Request Form is now final and available for viewing on the Office of Management and Budget’s website. (Protip: In the box labeled “Display additional information by clicking on the following,” click “IC List” to view the link for the Negotiation Data Elements Form.)
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Top 4 current economic challenges faced by biopharma companies
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With the dynamic nature of the current economic climate, biopharma companies must seek out strategic solutions to maximize the value of their investments and enhance communications with healthcare decision makers. This article details challenges and provides potential solutions.
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Societal perspective in value assessment: Can you hear me now?
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Last week, PharmacoEconomics released its August issue, which includes a collection of articles aimed at improving the methods for incorporating the societal perspective in value assessments. Value Corner’s regular readers know that US stakeholders consistently call for the Institute for Clinical and Economic Review (ICER) to expand its use of the societal perspective, which ICER only elevates to a co-base case “on rare occasions.”
The societal perspective includes broader societal benefits such as workforce productivity and caregiver impact that can more fully inform value-based decision-making. Amidst the continued debates on the inclusion and impact of the societal perspective, the themed issue is intended to guide decision makers to “make allocation decisions in healthcare while being fully informed about the health, welfare, and distributional implications of their choices.” The articles are grouped into 3 categories:
- Productivity:
- Caregiver/informal care:
- Future costs:
With all this guidance, surely ICER can rise to the challenge of greater incorporation of the societal perspective in its value assessments. We will find out next month, as ICER is slated to present its updated 2024 value assessment framework via webinar on September 28.
If you need assistance with all things value assessment or ICER-related, please contact Kimberly Westrich.
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Information buffet (AKA, other stuff that caught our attention)
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- The Centers for Medicare & Medicaid Services (CMS) announced that the projected average total Part D beneficiary premium will decrease by 1.8% in 2024, from $56.49 in 2023 to $55.50 in 2024. CMS also announced that the Part D national average monthly bid amount for 2024 is $64.28, the 2024 Part D base beneficiary premium is $34.70, and the de minimis amount for low-income beneficiaries is $2.00.
- A Kaiser Family Foundation analysis of preliminary rates found marketplace insurers are proposing to increase premiums by an average 6% for 2024, driven primarily by higher medical costs due to inflation.
- Colorado’s Prescription Drug Affordability Board met to decide which prescription drugs it should review to cap prices. The 5 drugs it selected are Amgen’s ENBREL (etanercept), Gilead’s GENVOYA (elvitegravir / cobicistat / emtricitabine / tenofovir AF), Novartis’ COSENTYX (secukinumab), Johnson & Johnson’s (J&J’s) STELARA (ustekinumab), and Vertex’s TRIKAFTA (elexacaftor / tezacaftor / ivacaftor and ivacaftor).
- Starting September 1, UnitedHealthcare announced it will drop prior authorization requirements for a number of procedures, including dozens of radiology services and genetic tests. The health insurance giant acknowledged that, “While prior authorization remains an important tool to address clinical quality and safety, as well as fraud, waste, and abuse, we also know that fewer prior authorizations can help streamline care delivery.”
- The American Hospital Association (AHA) filed its comment letter on the Department of Health and Human Services’ (HHS’) proposed remedy for the payment cuts to 340B hospitals that the Supreme Court deemed unlawful. The AHA supported HHS’ proposal to make a 1-time lump-sum repayment to hospitals for the amounts they were underpaid from 2018 to 2022, as well as the proposal to pay 340B hospitals what they would have received in beneficiary cost-sharing had the unlawful 340B payment policy not been in effect. At the same time, the AHA pressed HHS not to finalize its proposal to recoup funds from hospitals as a “budget neutrality adjustment.”
- The American Journal of Managed Care published an article “doubling up” on Donald Berwick by discussing the Quintuple Aim of Healthcare, cemented by CMS establishing a Health Equity Index (HEI) measure within the Medicare Advantage Star Ratings.
- Formycon and Fresenius Kabi announced a settlement with J&J to allow their STELARA (ustekinumab) experimental biosimilar candidate to launch in the US by April 15, 2025. J&J also reached a settlement with Amgen in May to allow its STELARA biosimilar to begin marketing by January 1, 2025, and with Teva and Alvotech to allow a launch of their candidate by February 21, 2025.
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“The lack of a global budget for the US healthcare system has made it possible to deny the need for technology assessment and prioritization despite the obvious truth that resources are finite, even in the US. The rise of expensive treatments for highly prevalent conditions such as AD (and obesity, among others) that could quickly swell public and private healthcare budgets may finally force a reconsideration of this position. A new era in which the US healthcare reimbursement system explicitly considers cost, effectiveness, and distributional effects of paying for prescription drugs may have arrived.”
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– Meredith B. Rosenthal, PhD, Department of Health Policy and Management, Harvard School of Public Health
Source: “Novel Alzheimer Disease Treatments and Reconsideration of US Pharmaceutical Reimbursement Policy,” JAMA, August 8
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Managed Care Network Forum
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Get exclusive access to payer insights at the Managed Care Network (MCN) Forum being held in Fall 2023.
Our exclusive, bi-annual event is for pharmaceutical manufacturers focused on market access, commercial development, HEOR, and clinical/medical affairs and brings together a broad mix of national and regional payers / formulary decision makers from AmerisourceBergen’s proprietary Managed Care Network.
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Count on Health Policy Weekly for an at-a-glance view of legislative and regulatory developments and news that impacts the healthcare industry.
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Interim Editor-in-chief
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Corey Ford
Vice President, Reimbursement and Policy Insights
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Managing editor
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Scott Shields
Associate Director, Health Policy,
Xcenda
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Contributing editor
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Kimberly Westrich
Director, Value and Access Strategy
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Advisory board:
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Willis Chandler
President, Global Pharma Services | AmerisourceBergen
Tommy Bramley, PhD, RPh
Senior Vice President, Market Access and Global Consulting | AmerisourceBergen
Ana Stojanovska
Vice President, Commercialization Strategy Consulting | AmerisourceBergen
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Contributing authors:
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Jane Ha | Scott Shields | Kimberly Westrich
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Production:
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Laurie Kozbelt | Frank Jorfi
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Copyright © 2023 AmerisourceBergen. All Rights Reserved.
1 West First Avenue, Conshohocken, PA 19428
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