ModifiedAnthemPolicy CC-0134

Provenge (sipuleucel-T)

Defines medical-benefit clinical criteria, exclusions, and applicable procedure and diagnosis codes for coverage of Provenge (sipuleucel-T) for metastatic castrate-resistant prostate cancer under the plan's prior authorization/medical necessity process.

Policy Summary

PayerAnthem

PolicyProvenge (sipuleucel-T)

Policy CodePolicy CC-0134

Change TypeNCCN-based criteria update (exclusions added)

Effective Date

Next Review Date

Key ActionDocument progressive disease, ECOG 0-1, life expectancy >6 months, absence of liver/visceral metastases, and that the patient has not progressed on both docetaxel and a novel hormone therapy when submitting prior authorization for Provenge.

SourceLink

POLICY UPDATE CHANGES

Added criteria to exclude individuals with liver metastases and those who had prior treatment and progressed with both docetaxel and novel hormone therapy.

Updated description for HCPCS Q2043.

Removed criteria regarding baseline testosterone levels and prior chemotherapy within 3 months (per 08/16/2019 committee).

Q2043Primary HCPCS code

5Key clinical approval criteria

2Major exclusions

2025

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Coverage Summary

Provenge (sipuleucel-T) is an autologous cellular immunotherapy indicated for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer. The IMPACT trial demonstrated a survival benefit (mean survival 25.8 months treatment vs 21.7 months control) and the PROCEED registry reported a median overall survival of 30.7 months. NCCN recommends Provenge only for asymptomatic or minimally symptomatic patients without liver metastases and with ECOG performance status 0-1. The policy's coverage stance is covered_with_criteria and the scope defines medical-benefit clinical criteria, exclusions, and applicable procedure and diagnosis codes for Provenge under the plan's prior authorization/medical necessity process.

Initial Therapy Criteria

Approval Criteria

Requests for Provenge (sipuleucel-T) may be approved if the following criteria are met:

ALL of the following

ALL of the following
- Individual has a diagnosis of prostate cancer (Label, NCCN 1, 2A)
- Individual has metastatic castrate-resistant or hormone refractory disease
- All of the following (Kantoff 2010)
  - Asymptomatic or minimally symptomatic with no liver metastases
  - B: ECOG (Eastern Cooperative Oncology Group) performance status 0-1
  - C: No visceral metastasis
  - D: No pathologic long bone fracture, or spinal cord compression within the last 3 months
  - E: Life expectancy of greater than 6 months

Continuation / Ongoing Treatment Criteria

No separate continuation-specific criteria are provided in the brief. Ongoing dosing and administration should follow the product labeling and treating clinician assessment. The policy approval criteria that apply across treatment include documented life expectancy of > 6 months and ECOG performance status 0-1, which remain requirements throughout the course of therapy.

Exclusions / Not Approved

Requests for Provenge (sipuleucel-T) may not be approved for the following:

ANY of the following

Small cell/neuroendocrine prostate cancer (NCCN Prostate Cancer Guidelines)
When the above criteria are not met and for all other indications

The policy explicitly excludes individuals with liver metastases and patients who have progressed after receiving both docetaxel and a novel hormone therapy (examples: abiraterone, enzalutamide, darolutamide, apalutamide) per the material change recorded 08/16/2025.

Applicable Codes

HCPCS - Provenge productHCPCSCovered

Q2043

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

ICD-10 Diagnosis codes (informational)ICD-10

C61	Malignant neoplasm of prostate
R97.20	Elevated prostate specific antigen [PSA]
R97.21	Rising PSA following treatment for malignant neoplasm of prostate
Z19.2	Hormone resistant malignancy status
Z51.12	Encounter for antineoplastic immunotherapy

Provider Actions

Prior Authorization

Prior authorization for Provenge required

Requests for Provenge (sipuleucel-T) require prior authorization and clinical review. Approval is contingent on documentation that all clinical approval criteria are met, including diagnosis of metastatic castrate-resistant prostate cancer, ECOG 0-1, absence of visceral/liver metastases, no recent pathologic long bone fracture or spinal cord compression, life expectancy >6 months, no progression on both docetaxel and a novel hormone therapy, and documented progressive disease by rising PSA or objective osseous progression. Affected codes: - Q2043 - C61 - R97.20 - R97.21 - Z19.2 - Z51.12

Q2043
C61
R97.20
R97.21
Z19.2
Z51.12

Documentation Required

Document progressive disease and prior treatment history

Clinical Evidence

25.8 vs 21.7IMPACT trial mean overall survival: 25.8 months (treatment) vs 21.7 months (control); 22% reduction in mortality risk

30.7PROCEED registry median overall survival: 30.7 months (95% CI, 28.6-32.2)

Evidence cited in the brief includes the IMPACT phase 3 trial (Kantoff et al., 2010) showing an overall survival benefit (mean survival 25.8 vs 21.7 months; 22% reduction in mortality risk) and the PROCEED prospective registry reporting median overall survival of 30.7 months (95% CI, 28.6-32.2). NCCN guidance emphasizes patient selection: use only in asymptomatic or minimally symptomatic patients without liver/visceral metastases and with ECOG 0-1.

Definitions

Key definitions used in the policy:

ECOG performance status: a 0–5 scale describing functional status where 0 = fully active and 1 = restricted in strenuous activity but ambulatory; the policy requires ECOG 0-1 for Provenge approval.

Progressive disease: cancer that is growing, spreading, or getting worse; acceptable documentation includes a rising PSA or objective imaging evidence of osseous progression.

Novel hormone therapy: examples include abiraterone, enzalutamide, darolutamide, and apalutamide.

Revision History

08/16/2025annual_review/material_updateLatest

Annual review updated criteria to align with NCCN: added exclusions for individuals with liver metastases and for those who had prior treatment and progressed with both docetaxel and a novel hormone therapy; coding description for HCPCS Q2043 was also updated.

08/16/2019select_review/material_removal

Select review removed criteria regarding baseline testosterone levels (<50 ng/mL) and prior chemotherapy within 3 months; language around progressive disease was updated.

05/19/2023

Policy Summary

PayerAnthem

PolicyProvenge (sipuleucel-T)

Policy CodePolicy CC-0134

Change TypeNCCN-based criteria update (exclusions added)

Effective Date

Next Review Date

SourceLink

On This Page

F: Individual has not had prior treatment or progressed with both docetaxel and a novel hormone therapy (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide)

Progressive disease must be documented by ONE of the following

1: Serum prostate-specific antigen (PSA) level increasing
2: Osseous metastases on imaging with objective evidence of progression regardless of PSA levels

Providers must document evidence of progressive disease and prior treatment history. Progressive disease must be documented by either a rising serum PSA level or objective evidence of osseous metastasis progression on imaging. Additionally, document that the patient has not had prior treatment or progressed with both docetaxel and a novel hormone therapy (examples: abiraterone, enzalutamide, darolutamide, apalutamide).

Progressive disease: rising PSA OR objective osseous progression on imaging
No prior treatment or progression on both docetaxel and a novel hormone therapy (abiraterone, enzalutamide, darolutamide, apalutamide)

Documentation Required

Document ECOG and life expectancy

Providers must document the patient’s ECOG performance status and estimated life expectancy. ECOG must be 0-1, and estimated life expectancy should be greater than 6 months for approval.

ECOG performance status documented as 0 or 1
Estimated life expectancy documented as > 6 months

annual_review/revised

Annual review with minor wording and formatting updates; coding reviewed with no changes.

08/16/2024annual_review/no_change

Annual review: no changes; coding reviewed: no changes.

05/15/2020annual_review/revised

Annual review updated 'may not be approved' criteria to exclude use in those with small cell/neuroendocrine prostate cancer; coding reviewed: no changes.

05/17/2019annual_review/initial

First review of Provenge clinical criteria with wording and formatting updates and addition of reference for off-label criteria; coding reviewed: no changes.