Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 154

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 154
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 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 of marketed drugs may be required
to provide discounts or rebates under government healthcare programs or to certain government and private purchasers in order to obtain
coverage under federal healthcare programs such as Medicaid. More generally, price concessions may need to be offered to third party payors
to obtain favorable coverage or to purchasers to achieve sales. Arrangements with third party payors or purchasers may include value-based
arrangements under which the amount paid for products depends on the performance of the product. Net prices for drugs may be further reduced
by mandatory discounts or rebates required by government healthcare programs or private payors and by any