Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 147

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 147
---
 trend in the U.S. healthcare industry
and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage
and the amount of payments for particular products. For example, payors may limit coverage to specific drug products on an approved list,
also known as a formulary, which might not include all of the FDA-approved drugs for a particular indication. Payors may require use
of alternative therapies or a demonstration that a product is medically necessary for a particular patient before use of a product will
be covered. Additionally, payors may seek to control utilization by imposing prior authorization requirements.

Increasingly,
third-party payors are requiring that drug companies provide predetermined discounts from list prices and are challenging the prices
charged for products. We cannot be sure that coverage will be available for any drug candidate that we commercialize and, if coverage
is available, what the level of reimbursement will be. Reimbursement may impact the demand for, or the price of, any drug candidate for
which we obtain marketing approval. Patients are unlikely to use our products, if they are approved for marketing, unless coverage is
provided, and reimbursement is adequate to cover a significant portion of the cost of such products.

There
may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the
purposes for which the drug is approved by the FDA, EMA, MHRA or other comparable regulatory agencies. Moreover, eligibility for reimbursement
does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture,
sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may
not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may
be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.
Net prices for drugs may be reduced by mandatory discounts or rebates required by federal 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 the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting
their own reimbursement policies. In the European Union, reference pricing systems and other measures may lead to cost containment and
reduced prices.