CurrentViva HealthPolicy IC-0100

Provenge (sipuleucel‑T) — Coverage Criteria and Administration

Coverage criteria and administration rules for sipuleucel‑T (Provenge) for members with castration‑resistant metastatic prostate cancer; applies to Viva Health benefit determinations for non‑Medicare populations with referenced CMS guidance noted.

Policy Summary

PayerViva Health

PolicyProvenge (sipuleucel‑T) — Coverage Criteria and Administration

Policy CodePolicy IC-0100

Change TypeNo material clinical or coverage changes

Effective Date

Next Review DateMar 4, 2025

Key ActionObtain prior authorization limited to three doses (HCPCS Q2043), one billable unit every 14 days.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 dosesauthorized number of doses

1 unit/14ddosing interval

ECOG 0-1required performance status

>6 monthsminimum life expectancy

No liver metsexclusion for metastatic site

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: Patient has castration-resistant metastatic prostate cancer; Patient has an ECOG performance status of 0-1; Patient does not have liver metastases; Sipuleucel‑T is not used in combination with chemotherapy; Patient's life expectancy is estimated to be greater than 6 months; Patient is asymptomatic or minimally symptomatic; Patient has not previously received therapy with sipuleucel‑T

Authorization limited to 3 doses; coverage will be provided for 3 doses only and may not be renewed.

Patients with liver metastases are excluded from coverage for sipuleucel‑T. This exclusion is part of the required eligibility criteria for treatment of castration‑resistant metastatic prostate cancer and must be documented in the prior authorization request.

Sipuleucel‑T is considered not medically necessary and will not be covered when any of the following apply: the patient is symptomatic beyond minimal symptoms, has an ECOG performance status >1, has an estimated life expectancy of ≤ 6 months, or has previously received sipuleucel‑T. These conditions are exclusionary for initial therapy and should be clearly documented in the clinical record and authorization submission.

Regimen	Schedule	Billing unit	Coverage notes
Sipuleucel‑T (Q2043) — autologous cellular immunotherapy (Provenge)
Three infusions administered approximately every 2 weeks (infuse contents of one pre‑made bag over ~60 minutes)
1 billable unit per infusion (Q2043; 1 unit = 1 dose; code price per 250 mL)
Do not administer concurrently with chemotherapy; prior authorization limited to 3 doses total (authorization may not be renewed)

Billing and Code Information

Covered HCPCS CodesHCPCSCovered

Q2043

Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GMCSF, including leukapheresis and all other preparatory procedures, per infusion

Covered Diagnosis CodesICD-10Covered

C61	Malignant neoplasm of prostate
Z85.46	Personal history of malignant neoplasm of prostate

NDCNDC

30237-8900-xx

Provenge suspension for injection (NDC)

Minimum autologous CD54+ cells per infusion

Threshold>= 50 million autologous CD54+ cells per infusion

Administration detailInfuse the contents of 1 pre-made bag containing at least 50 million CD54+ cells activated with PAP-GM-CSF over 60 minutes

Dosing scheduleThree infusions administered approximately every 2 weeks (1 billable unit per infusion)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for sipuleucel-T. Coverage is limited to a maximum of 3 doses (3 infusions) total; authorization will not be renewed beyond three doses.

PA required — maximum 3 doses
Authorization length: 3 doses only; may not be renewed
Billing: 1 billable unit = 1 dose (HCPCS Q2043)

Denial Risk

Concurrent Therapy Restriction

Sipuleucel-T must not be administered concurrently with cytotoxic chemotherapy.

Do not use in combination with chemotherapy (concurrent therapy restriction)

Documentation Required

Required documentation must be submitted with the prior authorization request to support medical necessity.

Diagnosis code consistent with prostate cancer (e.g., C61; Z85.46 as applicable)
Documentation of castration‑resistant metastatic prostate cancer
ECOG performance status (must be 0-1)
Estimated life expectancy (> 6 months)
Prior treatment history (including prior sipuleucel‑T; patient must not have received sipuleucel‑T previously)
Symptoms status (asymptomatic or minimally symptomatic)
Evidence that there are no liver metastases

Denial Risk

Eligibility-related Denial Triggers

Eligibility-related denial triggers (examples): presence of liver metastases, ECOG > 1, life expectancy ≤ 6 months, symptomatic disease beyond minimal symptoms, or prior receipt of sipuleucel‑T.

Do not approve if liver metastases are present
Do not approve if ECOG > 1
Do not approve if life expectancy ≤ 6 months
Do not approve if patient is more than minimally symptomatic
Do not approve if patient previously received sipuleucel‑T

Definitions and Product Details

inv-13: sipuleucel‑T (Provenge)

Product descriptionAutologous cellular immunotherapy (sipuleucel‑T, Provenge) prepared from the patient’s leukapheresed cells

Minimum cellular contentAt least 50 million CD54+ cells activated with PAP‑GM‑CSF per infusion

Per‑infusion codingHCPCS Q2043 — Sipuleucel‑T, minimum of 50 million autologous CD54+ cells activated with PAP‑GMCSF, including leukapheresis and all preparatory procedures

AdministrationInfuse one pre‑made bag (containing the required CD54+ cells) over 60 minutes; repeat for a total of three doses approximately 2 weeks apart

Covered Regimens and Administration

Dose number	Timing	Administration details	Billing action
Dose 1
Day 0 (first infusion)
Infuse contents of 1 pre‑made bag containing ≥ 50 million CD54+ cells over ~60 minutes
Bill 1 unit of Q2043
Dose 2
~14 days after Dose 1
Infuse contents of 1 pre‑made bag containing ≥ 50 million CD54+ cells over ~60 minutes
Bill 1 unit of Q2043
Dose 3
~14 days after Dose 2
Infuse contents of 1 pre‑made bag containing ≥ 50 million CD54+ cells over ~60 minutes
Bill 1 unit of Q2043; total maximum 3 billable units per authorization

Background

Sipuleucel‑T (Provenge) is an autologous cellular immunotherapy indicated for certain patients with metastatic castration‑resistant prostate cancer. Per the coverage criteria, eligible patients must have castration‑resistant metastatic disease, an ECOG performance status of 0–1, be asymptomatic or minimally symptomatic, have an estimated life expectancy of greater than 6 months, not have liver metastases, not have received prior sipuleucel‑T, and must not receive sipuleucel‑T in combination with chemotherapy. Therapy is administered as part of the approved regimen consistent with these eligibility requirements.

Revision History

06/21/2011policy_origination

Document originated (Date of Origin).

2011-09review

Policy reviewed (dates listed include 09/2011).

2012-03review

Policy reviewed (dates listed include 03/2012).

2013-03review

Policy reviewed (dates listed include 03/2013).

2014-03review

Policy reviewed (dates listed include 03/2014).

2015-03review

Policy reviewed (dates listed include 03/2015).

2016-02review

Policy reviewed (dates listed include 02/2016).

2017-02review

Policy reviewed (dates listed include 02/2017).

2018-02review

Policy reviewed (dates listed include 02/2018).

2019-04review

Policy reviewed (dates listed include 04/2019).

2020-04review

Policy reviewed (dates listed include 04/2020).

2021-04review

Policy reviewed (dates listed include 04/2021).

2022-04review

Policy reviewed (dates listed include 04/2022).

2023-04review

Policy reviewed (dates listed include 04/2023).

2024-04review

Policy reviewed (dates listed include 04/2024).

2025-03-04last_reviewLatest

Last review date recorded for the policy; document marked with Last Review Date 03/04/2025.