Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 233

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 233
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 Such a law, when applicable to Kadimastem’s products, could increase the company’s regulatory liability
through the imposition of additional reporting and regulatory requirements. There are also an increasing number of state laws that require
manufacturers to make similar reports to states on pricing and marketing information.

Reimbursement

We face uncertainties
over the pricing of pharmaceutical products. Sales of a product candidate will depend, in part, on the extent to which the costs of a
product candidate will be covered by third-party payors, such as federal health programs, commercial insurance and managed care organizations.
These third-party payors are increasingly challenging the prices charged for medical products and services. Additionally, the containment
of healthcare costs has become a priority of federal and state governments and the prices of drugs have been a focus in this effort.
The U. S. government, state legislatures, foreign governments and third party payors have shown significant interest in implementing
cost-containment programs, including price controls, pricing transparency disclosure obligations, restrictions on reimbursement and requirements
for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies
in jurisdictions with existing controls and measures, could further limit Kadimastem’s net revenue and results. If these third-party
payors do not consider Kadimastem’s product candidates to be cost-effective compared to other therapies, they may not cover Kadimastem’s
product candidates after approved as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow
Kadimastem to sell any other product candidate on a profitable basis.

The Medicare Modernization
Act imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries under Part D. Under
Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities that provide coverage of outpatient
prescription drugs. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug
plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. However, Part D prescription
drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all
the drugs in each category or class. The Centers for Medicare & Medicaid Services published a final rule in 2014 implementing
the Medicare Modernization Act. Contrary to the proposed rule, which would have enabled Part D plans to offer fewer drugs, the final
rule