Prior Authorization Criteria for Oncology Agents
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Defines prior authorization requirements and approval/renewal criteria for oncology drugs and related gene/cell therapies for Kansas Medicaid; requires prescribing per FDA-approved indications and package insert.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Criteria for Initial Approval for All Products
Covered when ALL of the following are met
Applies to all listed oncology products
inv-02: Criteria for Renewal for All Products
Covered when ALL of the following are met
Patient must continue to meet the criteria required for initial approval; length of approval: 12 months
Length of approval: 12 months
inv-03: PA Review for Newly Approved Indications/Dosages
Decision based on package insert
No specific exclusions are listed in this policy beyond the requirement that medications be prescribed in accordance with the FDA-approved indication and the product package insert. Providers must follow the FDA-approved labeling and package insert for each agent; uses that do not conform to those authorities are not supported by this coverage policy.
Use of a medication outside the FDA-approved indication, age, or dose, or without any prerequisite treatments specified in the product package insert, is not considered consistent with the policy’s coverage criteria and may result in denial of prior authorization.
Initial Therapy Criteria
inv-15: Initial Therapy
Initial approval requirements
Applies to all listed products
Continuation / Renewal Criteria
inv-16: Continuation Therapy
Renewal Requirements
Length of approval is 12 months
Step Therapy
| Step | Requirement |
|---|---|
| 1 | |
| Follow package insert prerequisite treatment requirements; medication must be prescribed according to the FDA‑approved indication, age, dose, and prerequisite treatments located in the package insert. |
Coding / Listed Agents
| Abraxane | paclitaxel protein-bound |
| Adcetris | brentuximab vedotin |
| Afinitor | everolimus |
| Akeega | niraparib tosylate and abiraterone acetate |
| Alecensa | alectinib hcl |
| Alimta | pemetrexed |
| Aliqopa | copanlisib |
| Alunbrig | brigatinib |
| ... (full drug list continues in source) | See listed brand and generic names in chunks 2-7 and 10-11 |
| Adstiladrin | nadofaragene firadenovec-vncg |
Provider Actions / Requirements
Prior authorization required for all dose forms; initial approval per FDA/package insert
Prior authorization is required for all current and future dose forms of the listed oncology agents. Initial approval requires the medication be prescribed according to the FDA-approved indication, age, dose, and any prerequisite treatments in the package insert.
Follow package-insert prerequisite treatments (product-specific step therapy)
PA criteria reference prerequisite treatments located in each product's package insert; product-specific step therapy requirements must be followed as described in the package insert for the requested indication.
- Follow package insert prerequisite treatment requirements for the specific drug and indication.
- For drugs with new indications/doses not previously covered, PA review will be based on the package insert: indication, age, dose, and any prerequisite treatments.
Submit package-insert evidence with initial request; prescriber must attest to benefit at renewal
Initial requests must include evidence that the medication is prescribed per the FDA-approved indication, age, dose, and any package-insert prerequisite treatments. At renewal, the prescriber must attest that the patient has experienced a positive clinical response and is tolerating therapy.
- Initial request: documentation showing alignment with FDA-approved indication, age, dose, and package-insert prerequisites.
- Renewal: prescriber attestation of positive clinical response and tolerability; patient must continue to meet initial approval criteria.
Nonconformance with FDA/package insert may lead to denial or additional documentation
If the medication is not prescribed according to the FDA-approved indication, age, dose, or the package-insert prerequisite treatments, the PA request may be denied or may require additional documentation.
- Uses outside the FDA-approved indication, age, or dose, or without required package-insert prerequisite treatments, are subject to being considered not medically necessary and may lead to PA denial.
- For newly approved indications/doses not previously in the PA, review is based on package insert; lack of required package-insert information may prompt denial or further information requests.
Definitions / Key Conditions
Background
This document lists oncology agents and related gene/cell therapies that are subject to prior authorization and sets general clinical requirements for initial and renewal approvals. For all listed products, prior authorization is required and initial approval is granted only when the medication is prescribed according to the FDA-approved indication, age, dose, and any prerequisite treatments in the package insert.
Revision History
Policy revised (document-level update).
Policy revised (document-level update).
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Policy revised (document-level update).
Policy revised (document-level update).
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Policy revised (document-level update).
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Policy revised (document-level update).
Policy revised (document-level update).
Policy revised (document-level update).
Policy revised (document-level update).
Policy revised (document-level update).
Policy revised (document-level update).
Policy revised (document-level update).
Policy initial approval date (policy established).
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