CurrentEmblemHealthPolicy MG.MM.PH.101

Provenge (sipuleucel-T) Intravenous

This policy governs medical necessity and coverage requirements for sipuleucel-T (Provenge) administration for EmblemHealth members with metastatic castration‑resistant prostate cancer. It applies to providers requesting authorization for Provenge infusions under EmblemHealth plans (excluding separate Medicare LCD/NCD criteria).

Policy Summary

PayerEmblemHealth

PolicyProvenge (sipuleucel-T) Intravenous

Policy CodePolicy MG.MM.PH.101

Change TypeNo material changes

Effective Date

Next Review DateFeb 25, 2025

Key ActionObtain prior authorization and submit clinical evidence that the member meets policy criteria for Provenge (coverage limited to 3 doses).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3maximum authorized doses

14ddosing interval

Q2043procedure code

ECOG 0-1performance status

No hepatic metsexclusion

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Initial Approval Criteria

Covered when ALL of the following are met:

Initial approval requirements: 1) Diagnosis of prostate cancer with castration-resistant metastatic disease; AND 2) ECOG performance status 0-1; AND 3) No hepatic metastases; AND 4) Not used in combination with chemotherapy; AND 5) Life expectancy estimated > 6 months; AND 6) Patient is asymptomatic or minimally symptomatic; AND 7) Patient has not previously received sipuleucel-T; AND 8) Coverage limited to 3 doses (1 billable unit every 14 days).

Provenge (sipuleucel‑T) is not considered medically necessary for indications other than those listed in the coverage criteria. Specifically, Provenge is excluded when the patient presentation does not meet the policy’s initial approval requirements (for example, presence of hepatic metastases or use in combination with chemotherapy), and separate Medicare LCD/NCD criteria apply for Medicare members.

Use of Provenge for off‑label or other unlisted indications is considered not medically necessary because there is insufficient evidence of therapeutic value to support coverage outside the enumerated criteria.

Regimen	Dosing schedule	Total doses
Sipuleucel‑T (Provenge)	1 billable unit every 14 days	3 doses (coverage provided for 3 doses only)

Applicable Codes and Billing

Applicable Procedure CodesHCPCSCovered

Q2043

land all other preparatory procedures,per infusion; 1 billable unit = 1 dose (Code Price is per 250 mL)

Applicable NDCsNDCCovered

30237-8900-XX

Provenge suspension for injection

Applicable ICD-10 DiagnosesICD-10

C61	Malignant neoplasms of prostate
R97.21	Rising PSA following treatment for malignant neoplasm of prostate
219.2	Hormone resistant malignancy status
285.46	Personal history of malignant neoplasm of prostate

inv-07: Dosing schedule

Dosing schedule1 billable unit every 14 days, total 3 doses (coverage provided for 3 doses only; may not be renewed)

Maximum authorized doses3 doses total

Interval per billable unitEvery 14 days

Prior Authorization, Documentation, and Administration

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is limited to 3 doses (1 billable unit every 14 days x 3). Coverage will be provided for 3 doses only and may not be renewed.

Prior authorization required.
Max units: 1 billable unit every 14 days x 3 doses only.
Length of authorization: 3 doses; not renewable.

Documentation Required

Clinical Documentation Required

The treating clinician must submit clinical evidence that the member meets the policy criteria to allow proper review of the preauthorization or post-payment request. Without this documentation EmblemHealth will not be able to properly review the request.

Submit documentation demonstrating diagnosis of castration‑resistant metastatic prostate cancer and that the patient meets all Initial Approval Criteria (ECOG 0–1; no hepatic metastases; not combined with chemotherapy; life expectancy >6 months; asymptomatic or minimally symptomatic; no prior sipuleucel‑T).
For Medicare members: refer to separate LCD/NCD Medicare criteria for Provenge.

Denial Risk

Documentation Submission Requirement

Failure to submit the required clinical documentation will prevent proper review of the preauthorization and may result in denial or delayed payment.

Provide complete clinical records and supporting documentation at time of preauthorization submission.
Missing or incomplete documentation may result in denial of the request or post‑payment recovery.

Background on sipuleucel‑T (Provenge)

Sipuleucel‑T (Provenge) is an autologous cellular immunotherapy intended for certain men with metastatic castration‑resistant prostate cancer. Coverage under this policy is aligned to patients who have castration‑resistant metastatic disease, an ECOG performance status of 0–1, no hepatic metastases, are not receiving concurrent chemotherapy, have an estimated life expectancy of >6 months, are asymptomatic or minimally symptomatic, and have not previously received sipuleucel‑T. For Medicare members, separate LCD/NCD criteria apply.

Key Definitions

inv-13: Castration‑resistant metastatic disease

DefinitionProstate cancer that progresses despite androgen deprivation therapy and has metastasized (castration‑resistant metastatic disease).

Policy contextRequired diagnosis for coverage under this policy (one of the initial approval criteria).

Exclusions relatedPatients with hepatic metastases are excluded from coverage even if castration‑resistant metastatic disease is present.

inv-14: ECOG Performance status 0-1

ECOG 0Fully active — able to carry on all pre‑disease performance without restriction.

ECOG 1Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.

Use in criteriaECOG performance status 0-1 is required for initial approval of sipuleucel‑T under this policy.

Revision History

2025-02-25Annual ReviewLatest

Annual review: added diagnosis codes R97.21, 219.2, and 285.46; no clinical criteria changes

2024-04-08Content Update

Added statement: 'For Medicare members: Provenge- please refer to our separate LCD/NCD Medicare criteria.'

2024-01-12Annual Review

Annual review with no criteria changes

2023-05-18Annual Revision

Annual revision: removed code Z85.46

2022-10-13Administrative Update

Policy transferred to new template

2020-01-01Annual Review

Annual review (no further detail provided in document)