Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 54

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 54
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 to penalize manufacturers for pricing drugs
above a certain threshold or limit spending on biopharmaceutical products. States are also seeking to change the way they pay for drugs
for patients covered by state programs. New York has established a Medicaid drug spending cap, and Massachusetts implemented a new review
and supplemental rebate negotiation process. Six states (Colorado, Maine, New Hampshire, Maryland, Oregon and Washington) have enacted
laws that establish Prescription Drug Affordability Boards (“PDABs”) to study drug prices and identify drugs that pose affordability
challenges, and in three states (Colorado, Maryland and Washington) include authority for the state PDABs to set upper payment limits
on certain drugs in state regulated plans. Other states may consider implementing similar policies and laws. Additionally, Colorado,
Florida, Maine, New Hampshire, New Mexico and Vermont have enacted laws, and several other states have proposed bills, to implement importation
of drugs from Canada. The FDA has met with representatives from Colorado, Florida, Maine and New Mexico to discuss those states’
proposed importation programs, and the FDA may be working towards approving such plans. Other states could adopt similar approaches or
could pursue different policy changes in a continuing effort to reduce their costs. Ultimately, as with U.S. federal government actions,
existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business
and results of operations.

U.S. commercial payor
actions have affected and may continue to affect access to and sales of our products

Payors, including healthcare
insurers, pharmacy benefit managers (“PBMs”), integrated healthcare delivery systems (vertically-integrated organizations
built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, increasingly seek ways to reduce their
costs. With increasing frequency, payors are adopting benefit plan changes that shift a greater proportion of drug costs to patients.
Such measures include more limited benefit plan designs, high deductible plans, higher patient co-pay or coinsurance obligations and
more significant limitations on patients’ use of manufacturer commercial co-pay assistance programs. Further, government regulation
of payors may affect these trends. For example, CMS finalized a policy for plan years starting on or after January 1, 2021 that has caused
commercial payors to more widely adopt co-pay accumulator adjustment programs. Payors, including PBMs, have sought, and continue to seek,
price discounts or rebates in connection with the placement of our branded products on their formularies