Obtain prior authorization and adhere to dosing limit

Prior authorization (PA) is required for Bavencio (avelumab). Initial approvals are valid for 6 months (180 days); renewals may be granted every 6 months thereafter. The policy limits dosing to a maximum of 80 billable units (800 mg) every 14 days for all indications.

• Initial PA length: 6 months (180 days)
• Renewal interval: every 6 months (180 days)
• Dosing limit: 80 billable units (800 mg) every 14 days

Expect PA consideration due to drug cost

The NQTL checklist identifies drug cost as a factor considered when applying prior authorization; providers should expect PA review may be used due to cost considerations.

• NQTL checklist flags Cost of drug = Yes: Consider for PA

Follow applicable Medicare NCD/LCD/LCA guidance for Part B claims

When billing under Medicare Part B, providers must follow applicable Medicare guidance — National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) — where relevant; noncompliance may affect coverage.

• Medicare Part B coverage is governed by Pub. 100-2, Chapter 15 §50 and applicable NCDs/LCDs/LCAs
• Medicare Part B Covered Diagnosis Codes listed as N/A in this excerpt, but NCD/LCD/LCA requirements still apply

Confirm no prior PD‑1/PD‑L1 therapy unless indication allows

Use of Bavencio is restricted if the member previously received PD-1/PD-L1–directed therapy unless an indication-specific exception applies; verify prior PD‑1/PD‑L1 therapy status before requesting PA.

• Universal criterion: Member has not received prior PD‑1/PD‑L1 therapy unless otherwise specified

Submit FDA‑approved or CLIA‑compliant tumor biomarker results

Document tumor biomarker results (MSI‑H/dMMR or POLE/POLD1 ultra‑hypermutated phenotype) from an FDA‑approved or CLIA‑compliant test; if using an immunotherapy companion assay, reference FDA companion diagnostic resources.

• MSI‑H/dMMR or POLE/POLD1 ultrahypermutated (e.g., TMB >50 mut/Mb) must be determined by an FDA‑approved or CLIA‑compliant test
• If confirmed using an immunotherapy assay, reference FDA companion diagnostics guidance

Document weight and dose calculation method

Calculate and document the dose using the patient’s actual body weight when applicable; state whether flat dosing (800 mg every 14 days) or weight‑based dosing (10 mg/kg, e.g., 600 mg if ≤66 kg) was used and provide the weight supporting the calculation.

• Dosing should be calculated using actual body weight and not flat dosing where applicable
• Standard flat dose: 800 mg IV every 14 days; Weight ≤66 kg: use 600 mg (10 mg/kg) IV every 2 weeks

Include a supported Appendix 1 ICD‑10 diagnosis code

Include an ICD‑10 diagnosis code from Appendix 1 with the PA submission and claim to support medical necessity; the Appendix 1 code list (chunks 36–38) contains the covered diagnosis codes to use.

• Claims and PA submissions must be associated with a diagnosis code listed in Appendix 1 (see chunks 36–38 for the code list)

Provide evidence of response and tolerability for renewal

Renewal requests may be denied if the member does not demonstrate disease stabilization or tumor decrease, or if unacceptable toxicity from the drug is present; provide objective evidence of clinical benefit and tolerability with renewal requests.

• Renewal requires continued meeting of criteria plus disease stabilization or decrease in tumor size/spread
• Renewal denied if unacceptable toxicity (e.g., severe infusion reactions, severe immune‑mediated AEs, MACE, HSCT complications) is present

Submit re‑biopsy and mutation change documentation for case‑by‑case review

If a tumor re‑biopsy demonstrates a change in an actionable mutation (for example, MSS initially and MSI‑H on subsequent biopsy), re‑initiation of PD‑directed therapy may be considered but will be evaluated on a case‑by‑case basis and is not automatic; document biopsy and mutation change details for review.

• Re‑initiation after re‑biopsy showing changed actionable mutation will be evaluated case‑by‑case
• Provide pathology and molecular results from re‑biopsy when requesting reconsideration

Ensure Medicare policy compliance for Part B billing

Noncompliance with Medicare NCD/LCD/LCA requirements where applicable may result in denial of coverage for Part B claims; ensure Medicare guidance is followed for beneficiaries and claims under Part B.

• Medicare NCDs/LCDs/LCAs may exist and must be followed where applicable
• Lack of compliance with Medicare guidance could trigger denial

Intravenous administration — infusion center setting

Avelumab is administered intravenously; follow the dosing and administration guidance provided for infusion delivery.