Health Policy Weekly: 9-22-2023: IVI previews major depressive disorder (MDD) value model

September 22, 2023

Health Policy Weekly

IVI previews major depressive disorder (MDD) value model

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Sept. 22, 2023

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Legislative update

Legislative bytes

Rep. John Joyce (R-PA) introduced HR 5539 that would expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program. The bill would remove the Inflation Reduction Act (IRA) provision that orphan medicines will not lose their exemption from price controls if they gain a second orphan drug designation.
The House Committee on Oversight and Accountability examined the role of pharmacy benefit managers (PBMs) in prescription drug markets.
- See Committee Chair James Comer’s (R-KY) opening statement
- See testimony of JC Scott, President and CEO, PCMA
- See testimony of Lori Reilly, Esq., Chief Operating Officer, PhRMA
- See testimony of Craig Burton, Executive Director, Biosimilars Council, and Senior Vice President, Association for Accessible Medicines
- See testimony of Hugh Chancy, RPh, President, NCPA
- See testimony of Rena M. Conti, PhD, Associate Professor, Department of Markets, Public Policy, and Law, Questrom School of Business
The House Energy and Commerce Committee Health Subcommittee examined policies to improve seniors’ access to innovative drugs, medical devices, and technology.
- See hearing memo
- See Committee Chair Cathy McMorris Rodgers’ (R-WA) opening statement
- See Subcommittee Chair Brett Guthrie’s (R-KY) opening statement
- See statement of Michael Chernew, PhD, Chair, Medicare Payment Advisory Commission
- See testimony of Dora Hughes, MD, Chief Medical Officer and Director, Centers for Medicare & Medicaid Services
- See testimony of John Dicken, Director, Health Care — Public Health and Private Markets, Government Accountability Office
The House Energy and Commerce Committee examined how the IRA’s price-setting scheme means fewer cures for patients.
- See hearing memo
- See Committee Chair Cathy McMorris Rodgers’ (R-WA) opening statement
- See testimony of John Czwartacki, Founder, Survivors for Solutions
- See testimony of Steve Potts, PhD, MBA, Chair, Drug Development Council, International Cancer Advocacy Network
- See testimony of John Crowley, Executive Chairman, Amicus Therapeutics, Inc
- See testimony of Aaron S. Kesselheim, MD, JD, MPH, Professor of Medicine at Harvard Medical School, and Director, PORTAL, Brigham and Women’s Hospital

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Inflation Reduction Act (IRA) center

IRA snippets

A JAMA Viewpoint reviewed the impact of the IRA and access to high-cost cardiovascular therapies.
Another JAMA Viewpoint evaluated the legal claims and policy implications of Medicare’s drug-price negotiations.

Value corner

ICER delays report, ceding this week’s Value Corner spotlight to IVI

On Tuesday, the Innovation and Value Initiative (IVI) held its 2023 Annual Meeting. Attendees received a preview of IVI’s open-source major depressive disorder (MDD) value model, which will be released for public comment in early October. To accommodate the complexity of MDD, the model uses a patient-simulation approach rather than the traditional health-state model, which tends to oversimplify complex processes. The meeting also included illuminating discussions about:

Fulfilling the promise of equity in value-based care
The role of value assessment in an evolving policy landscape, with a focus on the implementation of the Medicare drug-price negotiation provisions of the IRA
Considerations for assessing the value of rare disease
The relationship between quality and value in healthcare

IVI also announced the winning papers from its Valuing Innovation Project (VIP), which will be published in PharmacoEconomics:

“Incorporating Real Option Value in Valuing Innovation: A Way Forward,” by Meng Li, ScM, PhD, and Louis P. Garrison, PhD
“The Value of Flexible Vaccine Manufacturing Capacity: Value Drivers, Estimation Methods, and Approaches to Value Recognition in Health Technology Assessment,” by Fiona McElwee, PhD, and Anthony T. Newall, PhD
“Estimating and Rewarding the Value of Healthcare Interventions Beyond the Healthcare Sector: A Conceptual Framework,” by Askal Ayalew Ali, Amit Kulkarni, Sandipan Bhattacharjee, and Vakaramoko Diaby

Last week, the Institute for Clinical and Economic Review (ICER) delayed the release date for its forthcoming report, “Special Assessment to Inform CMS Drug Price Negotiation: Eliquis and Xarelto,” from September 20 to October 2, 2023. Next week, ICER will release the final changes for its 2024 value assessment framework on Monday and host a webinar to present the adaptations on Thursday.

If you need assistance with all things value assessment, IVI, or ICER-related, please contact Kimberly Westrich.

Regulatory update

Information buffet (AKA, other stuff that caught our attention)

The Food and Drug Administration released new guidance on biosimilar and interchangeable product labeling.
The Government Accountability Office found payments by beneficiaries were more than plan sponsor payments, after accounting for rebates, for 79 of the 100 drugs receiving the most rebates. As a result, the government agency recommended that Medicare monitor how rebates affect drug coverage and spending.
The CPT Editorial Panel is meeting this week in New Orleans; here is the agenda.
A Nephron Research analysis of the primary sources of PBM profitability found that fees and specialty pharmacy now drive a greater share of PBM profits, with estimated PBM profits derived from fees increasing approximately 400% and specialty pharmacy more than doubling since 2012.
Cigna faces a second class-action lawsuit over its use of software to automate claims processing. The plaintiffs alleged Cigna’s “procedure-to-diagnosis” or PxDx software reviewed and denied customer claims in batches without a medical professional reviewing those decisions.
PBM MedImpact has partnered with GoodRx on a new program that offers drug discounts “seamlessly” at the pharmacy counter. Under the initiative, when a MedImpact member fills a prescription, the cost will automatically be compared to GoodRx’s price, with the lower option automatically applied. What members pay will apply to their deductibles.
The Mark Cuban Cost Plus Drug Company (MCCPDC) makes a positive appearance in the literature. The Frontiers in Pharmacology study found “enormous potential for cost savings in the US market” for generic cardiology drugs. Savings were calculated by encouraging increased competition, decreasing administrative costs, and advocating for patients to compare prices between the MCCPDC and other generic pharmaceutical dispensers.
The American Enterprise Institute released a report that estimated the cost of new treatments for diabetes and obesity.

Heard on the street

“Congress should know patients, employers, and plans can thrive in a transparent, competitive, and efficient PBM market. We embrace critical reforms to a costly and misaligned drug pricing market. In fact, most of these reforms are already reflected in the business and innovations of transparent PBMs.”

– LeAnn Boyd, CEO of Liviniti, discussing Transparency-Rx, a not-for-profit coalition led by transparent PBM executives. The initial coalition members represent 14.5 million lives across all 50 states. Founding members include AffirmedRx, Liviniti, MedOne Pharmacy Benefit Solutions Rx, Navitus Health Solutions, RxPreferred Benefits, and SmithRx.

Source: “New coalition of transparent PBM companies seeks to fix nation’s broken drug pricing system,” Business Wire, September 19

Policy by numbers

5.4% to 8.5%

Benefit consultants from Mercer, Aon, and Willis Towers Watson see employer healthcare costs jumping 5.4% to 8.5% in 2024 due to medical inflation, soaring demand for weight-loss drugs, and wider availability of gene therapies.

Source: “US employers to see biggest healthcare cost jump in a decade in 2024,” Reuters, September 21

AMCP Nexus 2023

Join us in Orlando, FL on October 16-19, 2023, as we proudly support AMCP Nexus 2023. Our lineup of contributions to this year’s event features 5 posters, including gold and bronze medal winners, plus CPE and podium presentations.

Learn more

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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Featured contributors

Interim Editor-in-chief

Corey Ford

Vice President, Reimbursement and Policy Insights

Managing editor

Scott Shields

Associate Director, Health Policy

Contributing editor

Kimberly Westrich

Director, Value and Access Strategy

Advisory board:

Willis Chandler
President, Global Pharma Services | Cencora

Tommy Bramley, PhD, RPh
Senior Vice President, Market Access and Global Consulting | Cencora

Ana Stojanovska
Vice President, Commercialization Strategy Consulting | Cencora

Contributing authors:

Scott Shields | Kimberly Westrich

Production:

Laurie Kozbelt | Frank Jorfi