Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 151

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 151
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. Our ability to successfully commercialize our product candidates will depend
in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government
health authorities or programs, private health insurers and other organizations. Even if coverage is provided, the approved reimbursement
amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

Government authorities and other third-party
payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish
reimbursement levels. Additionally, coverage and reimbursement for drug products can differ significantly from payor to payor. One third-party
payor’s decision to cover a particular drug product or service does not ensure that other payors will also provide coverage for
the drug product, or will provide coverage at an adequate reimbursement rate. Coverage policies and third-party reimbursement rates may
change at any time. Even if favorable coverage and reimbursement status is attained for one or more product candidates for which we receive
regulatory approval from one or more third party payors, less favorable coverage policies and reimbursement rates may be implemented
in the future. Additionally, if a companion diagnostic test is developed for use with a drug product, any coverage and reimbursement
for that test would be separate and apart from the coverage and reimbursement sought for such product. A lack of coverage or adequate
reimbursement for such a test could adversely affect access to a drug product.

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Within the U.S., third-party payors are increasingly
seeking to control drug costs by examining the cost-effectiveness of new products and services in addition to their safety and efficacy;
managing drug utilization and challenging the price of drugs. To obtain or maintain coverage and reimbursement for any future product,
we may need to conduct expensive pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of our product.
These studies will be in addition to the studies required to obtain regulatory approvals. Third-party payors may limit coverage of product
by, for example, only covering specific products on an approved list, or formulary, which might not include all of the FDA-approved products
for a particular indication. Some third-party payors may manage utilization of a particular product by requiring pre-approval (known
as “prior authorization”) for coverage of particular prescriptions (to allow the payor to assess medical necessity) or otherwise
restricting coverage of a product even if used consistent with its approved indication. Manufacturers