There have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA. For example, in August 2022, the 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 through a newly established manufacturer discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and healthcare reform measures will impact the ACA and our business.
All entries for: Dermatology
May 8, 2025
Corvus Pharmaceuticals
Neutral Outlook
Burlingame, CA
51-200 employees
While the impact of the IRA on the pharmaceutical industry cannot yet be fully determined, it is likely to be significant.
Disease Area: Dermatology, Immune Diseases, Multiple, Oncology
Drug Type: Biologic, Small Molecule
May 8, 2025
Vanda Pharmaceuticals
Negative Outlook
Washington DC
201-500 employees
We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, including our and our partners’ ability to continue to successfully commercialize our products, including activities related to Fanapt® for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults which was approved in April 2024 and acquired rights to PONVORY® in the U.S. and Canada in December 2023, the impact of the Medicare Part D benefit redesign effective January 1, 2025 under the Inflation Reduction Act of 2022, any possible payments made or received pursuant to license agreements, progress of our research and development efforts, the timing and outcome of clinical trials and related possible regulatory approvals and the status of existing and future potential litigation involving our products and intellectual property.
Disease Area: Dermatology, Gastrointestinal, Multiple, Neurological Diseases, Psychiatry
Drug Type: Biologic, Small Molecule
May 1, 2025
Bausch Health
Negative Outlook
Bridgewater, NJ
10,001-50,000 employees
These negotiations could, among other things, accelerate revenue erosion prior to the expiration of intellectual property protections. The effect of reducing prices and reimbursement for certain of our products could significantly impact our business and consolidated results of operations.
Disease Area: Dermatology, Gastrointestinal, Multiple, Neurological Diseases
Drug Type: Small Molecule
April 29, 2025
Terns Pharmaceutical
Negative Outlook
Foster City, CA
51-200 employees
Accordingly, while it is currently unclear how the IRA will be effectuated, we cannot predict with certainty what impact any federal or state health reforms will have on us, but such changes could impose new or more stringent regulatory requirements on our activities or result in reduced reimbursement for our products, any of which could adversely affect our business, results of operations and financial condition.
Disease Area: Dermatology, Immune Diseases, Multiple, Oncology
Drug Type: Small Molecule
April 29, 2025
Incyte Corp
Negative Outlook
Wilmington, DE
1,001-5,000 employees
We expect our sales allowances to fluctuate from quarter to quarter due to changes in the volume of purchases eligible for government mandated discounts and rebates as well as changes in discount percentages, which are impacted by potential future price increases, rate of inflation, and other factors, such as changes to the 340B drug pricing program. In 2025, we expect to see a reduction in our sales allowances owed under Medicare Part D, due to changes from the Inflation Reduction Act, which effective January 1, 2025, replaced the manufacturer’s coverage gap liability with a different discount structure.
Disease Area: Dermatology, Immune Diseases, Multiple, Oncology
Drug Type: Biologic, Small Molecule
April 29, 2025
Sol-Gel Technologies
Negative Outlook
Whippany, NJ
1-50 employees
In August 2022, the Inflation Reduction Act, or IRA, was signed into law. The IRA includes multiple provisions that may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. For example, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the product’s price increases faster than the rate of inflation. This calculation is made on a product-by-product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, starting in payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease. Any additional federal or state healthcare reform measures could limit the amounts that third-party payers will pay for healthcare products and services, and, in turn, could significantly reduce the projected value of certain development projects and reduce our profitability.
Disease Area: Dermatology
Drug Type: Small Molecule