Ann: Ryoncil Published in All Four Major Drug Pricing Compendia, page-18

Here is something from Chat GPT regarding next steps.
I'm not familiar with the US health care system, so viewer discretion is required to judge the accuracy and completeness of the information.

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Now that Ryoncil's pricing has been published in the four major U.S. drug pricing compendia, the next steps primarily involve commercialization and market uptake. Here's what comes next:

1. Ordering Process by Transplant Centers

• With pricing and NDC codes available in the compendia, transplant centers and hospitals can now place orders for Ryoncil.
• The product is distributed in different kit sizes based on patient weight-bands, ensuring tailored dosing.
• Hospitals and transplant centers typically work with group purchasing organizations (GPOs), wholesalers, and specialty distributors to procure the drug.

2. Inclusion in Hospital Formularies

• Many hospitals and transplant centers require a formulary review before a new drug can be routinely ordered and administered.
• The Pharmacy & Therapeutics (P&T) Committee at each center evaluates the drug’s clinical and economic benefits before approving it for use.
• The revised FDA label (which includes new supply and handling instructions) will also play a role in this approval process.

3. Reimbursement and Coverage by Payers

• Now that pricing is listed, private and government insurers (e.g., Medicare, Medicaid, and private insurers) will assess reimbursement policies.
• Mesoblast may negotiate with payers to secure favorable coverage terms.
• The Centers for Medicare & Medicaid Services (CMS) may need to issue reimbursement codes and guidance.

4. Billing and Claims Submission

• Hospitals and transplant centers will bill insurers and government payers for Ryoncil under the appropriate coding and pricing structure.
• The Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) codes for administration must align with reimbursement policies.

5. Distribution and Revenue Recognition

• Once orders are placed, Mesoblast can begin recognizing revenue as shipments are made to hospitals and treatment centers.
• The company's logistics team must coordinate product availability to meet demand.

6. Monitoring Real-World Use & Post-Marketing Commitments

• The company may be required to track safety and efficacy through post-marketing surveillance (Phase IV studies).
• Any adverse events will be reported to the FDA’s MedWatch system.