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IRA – Saving Money, or Playing Politics?

IRA’s drug negotiation choices seem to be much more about the 2024 election than Medicare cost savings in 2026.

By Duane Schulthess, John Lamattina, and Harry P. Bowen

September 13th, 2023

On Tuesday August 29th, the Biden Administration and the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs to be selected as part of their signature legislation, the Inflation Reduction Act (IRA).

The linchpin of the IRA has been to lower total Medicare costs. The text of the IRA states clearly that the drugs to be chosen for negotiation are those, “… drugs with the highest total expenditures being ranked the highest.” This language is completely unambiguous; drugs with the greatest total expenditures for taxpayers are the ones to be negotiated.

The IRA also includes provisions that drugs soon to be subject to generic or biosimilar competition are excluded from negotiation. This is logical as once a drug loses its patent exclusivity its price falls rapidly.

Our firm, Vital Transformation (VT), has been at the center of the IRA debate for well over a year. Given the IRA’s clear objective to contain taxpayer costs, we conducted economic modeling which simulated the impact of 10 years of IRA negotiations on Medicare spending and biopharmaceutical company revenues.

Are CAR-T therapies living up to their hype? A study using real-world data in two cohorts to determine how well they are actually working in practice compared with bone marrow transplants

18th July 2019

With the increasing demands being placed on HTAs in Europe, a methodology allowing for a valid assessment of the clinical effectiveness and costs for indications targeting small patient populations and orphan conditions, such as ALL, at the time of a reimbursement decision is vital. This is particularly true when the costs of these interventions are significantly high, such as in the case of CAR-T, where costs exceed US$375 000. By extracting RWD from live hospital EHRs, we were able to demonstrate a novel methodology that allows us to move beyond the use of proxies for clinical effectiveness measures extrapolated from clinical trials to obtain an assessment of the long-term outcomes and total costs of new therapies, such as CAR-T, compared with the next-best legacy treatment option.

Azar’s Plan To Tie U.S. Drug Prices To Foreign Ones Will Impact Investments In R&D

Photographer: Al Drago/Bloomberg © 2019 BLOOMBERG FINANCE LP Publish date: June 21, 2019 By John LaMattina, Contributor for Forbes Azar claims that HHS can reduce spending on Medicare Part B drugs with little impact on biopharmaceutical R&D investment. Duane Schulthess, Managing Director at VitalTransformation, questioned Azar’s claim on this. As he delved into specific compounds on Azar’s list of 27, he found some startling data. One striking case is with Biogen’s Multiple Sclerosis drug, Tysabri.

Nashville.Bio Putting the REAL into RWE

Podcast with Nashville.Bio - Putting the REAL into RWE Nashville Biosciences and Vital Transformation are collaborating on a ground-breaking project to measure the impact of CAR-T on the total cost of treating cancer by harnessing RWE. The CEO of Nashville [...]

REPORTS

Better Science, Better Health
27-28th October 2015, US Congress, Washington DC
Resources now available

Reports, videos and more...

Universal health: Investing in Health and Wellbeing for All
June 29th-30th, RIGA
Resources now available

Videos and downloads

Webinar: MAPPs – New Tools for Decision Making
April 14th, 2015, 2-3pm CEST
Resources now available

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RWE and Health Data in the EU: viable public policy vs. political overreach
February 7, 2016 - by Duane Schulhtess, Managing Director, Vital Transformation

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