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: Biologic
Takeda
Layoffs
Cambridge, MA
50,001+ employees
Takeda has announced a significant restructuring to streamline corporate functions and generate more than $1.25 billion in savings by fiscal year 2028, though the full workforce impact has not yet been disclosed.
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.
Xilio Therapeutics
Neutral Outlook
Waltham, MA
51-200 employees
On August 16, 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law. The new legislation has implications for Medicare Part D, which is a program available to individuals who are entitled to Medicare Part A or enrolled in Medicare Part B, to give them the option of paying a monthly premium for outpatient prescription drug coverage. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023); and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025). The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
Bionano Genomics
Neutral Outlook
San Diego, CA
201-500 employees
The Inflation Reduction Act of 2022 (“IRA”) also eliminates the coverage gap 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.