Criteria for Prior Authorization — Oncology: Auxiliary Treatment Agents
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Defines prior authorization requirements, initial approval and renewal criteria, and length of approval for specified oncology supportive care and auxiliary drugs for members covered by the payer.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Approval for All Products
Covered when ALL of the following are met
Applies to all listed agents
Renewal Criteria for All Products
Covered when ALL of the following are met
Length of approval: 12 months
Review Process for Newly Approved Uses
Applies when new FDA approvals occur for drugs already on the PA list
This policy does not include product-specific, off-label, or compendia-driven criteria within the coverage criteria text. Initial approval for any listed oncology auxiliary agent is limited to use that is concordant with the FDA-approved indication, age, dose, and prerequisite treatments as specified in the manufacturer's package insert. Additionally, when a preferred PDL drug exists that treats the PA indication, that preferred agent is required unless the patient meets the non-preferred PDL PA criteria.
Listed Agents and Codes
| Atgam | Anti-thymocyte globulin (Atgam®) |
| Aranesp | Darbepoetin alfa (Aranesp®) |
| Denosumab | Denosumab (Aukelso ™ , Bildyos®, Bilprevda®, Bomyntra®, Bosaya ™ , Conexxence®, Enoby ™ , Jubbonti®, Osenvelt®, Prolia®, Stoboclo®, Wyost®, Xgeva®, Xtrenbo ™ ) |
| Elliotts B solution | (chemotherapy diluent) (Elliotts B® solution) |
| Ryzneuta | Efbemalenograstim alfa-vuxw (Ryzneuta®) |
| Rolvedon | Eflapegrastim-xnst (Rolvedon ™ ) |
| Epogen/Procrit/Retacrit | Epoetin alfa (Epogen®, Procrit®, Retacrit®) |
| Neupogen/Nivestym/Nypozi/Releuko/Zarxio | Filgrastim (Neupogen®, Nivestym®, Nypozi®, Releuko®, Zarxio®) |
| Focinvez | Fosaprepitant (Focinvez ™ ) |
| Akynzeo IV | Fosnetupitant/palonosetron (Akynzeo® IV) |
Provider Actions and Requirements
Prior authorization required for listed agents
Prior authorization is required for all current and future dose forms of the listed oncology auxiliary agents. Initial approval requires that the medication is prescribed according to the FDA‑approved indication, age, dose, and prerequisite treatments and that the preferred PDL drug (if applicable) has been used unless the patient meets non‑preferred PDL PA criteria.
- Applies to all listed agents and all dose forms
- Initial approval requires meeting all general criteria in the policy
Preferred PDL drug required when available
If a preferred PDL drug that treats the PA indication is available, that preferred agent must be used unless the patient meets the non‑preferred PDL PA criteria; step‑therapy toward the preferred agent is mandated when applicable.
- Requirement applies to all agents when a preferred PDL alternative exists
- Exemption only when the patient meets documented non‑preferred PDL PA criteria
Prescriber attestation required for renewal
For renewal, the prescriber must attest that the patient has experienced a positive clinical response from continuous treatment with the requested medication and is tolerating therapy; the patient must also continue to meet the criteria required for initial approval.
- Attestation of positive clinical response and tolerability is required for renewal
- Patient must continue to meet initial approval criteria
Review PA requests against package insert for new uses
PA requests for newly approved indications, dosages, or age changes for drugs that already have a PA requirement will be reviewed based on the package insert information, including indication, age, dose, and any prerequisite treatment requirements for that indication.
- Applies when FDA approves new indications, dosages, or age expansions for drugs already on the PA list
- Reviewer will use package insert details to evaluate the request
Non‑FDA‑concordant prescribing risks denial
Requests will be denied if the medication is not prescribed according to the FDA‑approved indication, age, dose, and prerequisite treatments as specified in the package insert.
- Prescribing that deviates from FDA‑approved indication/age/dose/prerequisite treatments risks denial
Denial risk when preferred drug not tried or criteria unmet
Requests will be denied if a preferred PDL drug that treats the PA indication is available and the patient does not meet the non‑preferred PDL PA criteria (i.e., the preferred agent has not been tried and no exception criteria are met).
- Denial applies when a preferred PDL alternative exists and non‑preferred criteria or exceptions are not documented
Definitions
Background
This policy establishes prior authorization requirements for supportive oncology and auxiliary agents listed by the payer. Prior authorization is required for all current and future dose forms of the listed agents. For initial approval, the medication must be prescribed according to the FDA-approved indication, age, dose, and prerequisite treatments in the package insert, and a preferred PDL drug that treats the PA indication must be used when applicable unless the patient qualifies for non-preferred PDL criteria.
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