The Inflation Reduction Act of 2022, or IRA, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D, allowing the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of the HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge. V
All entries for: Immune Diseases
Equillium, Inc.
Negative Outlook
La Jolla, CA
1-50 employees
The Inflation Reduction Act of 2022, or IRA, which was passed into law in August 2022, included drug pricing reforms that have the potential to adversely impact our ability to successfully commercialize our product candidates and could lessen the real or perceived value of our product candidates, which would negatively impact our business.
Absci Corp/WA
Neutral Outlook
Vancouver, WA
201-500 employees
The IRA also enacted significant changes intended to reduce prescription drug spending and beneficiary out-of-pocket costs, including redesigning the Medicare Part D benefit beginning in 2025 (including a lower annual out-of-pocket threshold), replacing the prior coverage gap discount framework with a new Part D Manufacturer Discount Program, requiring inflation-based rebates in certain contexts, and establishing a Medicare Drug Price Negotiation Program that permits CMS to set a “maximum fair price” for certain qualifying single-source drugs and biologics reimbursed under Medicare Part B and/or Part D.
Avalo Therapeutics
Neutral Outlook
Wayne, PA
1-50 employees
The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program. The effects of the IRA on our business and the healthcare industry in general is not yet known.
Chemomab Therapeutics
Neutral Outlook
Tel Aviv, Israel
51-200 employees
In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs that have been on the market for at least 7 years and biologics that have been on the market for at least 11 years, and, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements; requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation; and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes.
InflaRx N.V.
Neutral Outlook
Jena, Germany
51-200 employees
In 2022, the Inflation Reduction Act, or the IRA, was enacted, which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms. Specifically, the IRA authorizes and directs the U.S. Department of Health and Human Services or the DHHS to set drug price caps for certain high-cost Medicare qualified drugs and the first year of maximum price applicability to begin in 2026. The IRA further authorizes the DHHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare drugs faster than the rate of inflation. Finally, the IRA creates significant changes to certain Medicare benefits by capping certain beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025.
ARGENX SE
Neutral Outlook
Amsterdam, Netherlands
501-1,000 employees
Beginning in 2025, the IRA eliminates the coverage gap phase and associated manufacturer discounts under Medicare Part D, significantly lowers the enrollee maximum out-of-pocket cost and establishes a new manufacturer discount program, which requires 10% discounts in the initial phase, and 20% discounts in the catastrophic phase. Although these discounts represent a lower percentage of enrollees’ costs than coverage gap discounts, the new manufacturer contribution during the catastrophic phase could be considerable for certain high-cost drugs and the total contributions by manufacturers to a Part D enrollee’s drug expenses may exceed those currently provided. The IRA also requires manufacturers to provide annual Medicare Part D rebates for single-source drugs and biological products with prices that increase faster than the rate of inflation.
Vyome Holdings
Neutral Outlook
Cambridge, MA
1-50 employees
Further, judicial challenges to the IRA may have an impact on the implementation of the IRA’s provisions; and the overall effects of the IRA on Bio’s business and the healthcare industry in general is not yet known.
Estrella Immunopharma
Neutral Outlook
Emeryville, CA
1-50 employees
Since its enactment, there have been judicial, congressional and executive branch challenges and amendments to certain aspects of the ACA. For example, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of pocket cost and through a newly established manufacturer discount program.