Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 145

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 145
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 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 future relaxation
of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

In addition, in some foreign countries, the
proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely
from country to country. For example, the EU provides options for its member states to restrict the range of medicinal products for which
their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain
reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness
of a particular medicinal