Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 67

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 67
---
in approving a drug, then it forgoes 25% of the evaluation fee as a penalty. The sponsor concerned can also consider the outcome as a
“deemed refusal” and appeal to the Administrative Appeals Tribunal for a resolution. For variations to the registration of
a drug, the TGA must raise an objection within 45 working days, otherwise the application is deemed to be approved.

Pharmaceutical Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage
and reimbursement status of products approved by the FDA and other government authorities. Sales of products will depend, in part, on
the extent to which third-party payors, including government health programs in the United States such as Medicare and Medicaid, commercial
health insurers and managed care organizations, provide coverage, and establish adequate reimbursement levels for, such products. The
process for determining whether a payor will provide coverage for a product may be separate from the process for setting the price or
reimbursement rate that the payor will pay for the product once coverage is approved. Third-party payors are increasingly challenging
the prices charged, examining the medical necessity, and reviewing the cost-effectiveness of medical products and services and imposing
controls to manage costs. Third-party payors may limit coverage to specific products on an approved list, or formulary, which might not
include all of the approved products for a particular indication.

35

In order to secure coverage and reimbursement
for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic studies in order to demonstrate
the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain FDA or other comparable regulatory
approvals. Nonetheless, product candidates may not be considered medically necessary or cost effective. Additionally, a payor’s
decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s
determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product.
Third-party reimbursement may not be sufficient to maintain price levels high enough to realize an appropriate return on investment in
product development.

The containment of healthcare costs also has
become a priority of federal, state and foreign governments and the prices of drugs have been a focus in this effort. Governments have
shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements
for substitution of generic products. Adoption of price controls