CurrentEmblemHealthPolicy N/A

Provenge (sipuleucel‑T) — Coverage Criteria

Defines Evolent Clinical Guideline criteria for Provenge (sipuleucel‑T) use, applicability to providers processing medication requests, and acceptable evidence sources for coverage decisions. Affects network ordering providers and member medication authorization decisions.

Policy Summary

PayerEmblemHealth

PolicyProvenge (sipuleucel‑T) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent and include supporting evidence per FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not supportedCoverage stance

Q2043HCPCS code

3Max doses

Commercial/Exchange/MedicaidLines of business

Coverage Criteria for Provenge (sipuleucel-T)

Coverage stance and continuation criteria

Evolent does not support Provenge for metastatic castrate-resistant prostate cancer; continuation requests may be exempt under specific conditions.

Primary stance: Provenge (sipuleucel-T) is not supported by Evolent for metastatic castrate-resistant prostate cancer due to lack of Level 1 evidence showing superiority in progression-free or overall survival compared with Evolent-recommended alternative agents/regimens.

Continuation exception: Continuation requests are exempt from this policy provided ALL of the following are met:

Continuation criteria - member status: The member has not experienced disease progression on the requested medication.

Continuation criteria - timing:

Policy Summary

PayerEmblemHealth

PolicyProvenge (sipuleucel‑T) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent and include supporting evidence per FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature.

SourceLink

On This Page

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The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.

Continuation criteria - regimen changes: No additional medication(s) are being added to the continuation request.

Requests will be excluded (denied) when any of the following exclusion criteria are met: disease progression while taking Provenge (sipuleucel‑T); concurrent use with other anticancer therapies; or dosing that exceeds 3 doses, given at approximately 2‑week intervals. The policy also excludes investigational or off‑label uses that lack sufficient supporting evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature.

Evolent does not support Provenge (sipuleucel‑T) for metastatic castrate‑resistant prostate cancer because there is a lack of Level 1 evidence (randomized clinical trials and/or meta‑analyses) demonstrating superiority in progression‑free survival (PFS) or overall survival (OS) compared with Evolent‑recommended alternatives. Requests for investigational or off‑label indications are similarly not approvable when they do not meet the policy's evidence standards, which require CMS‑recognized compendia or acceptable peer‑reviewed literature and consideration of clinically meaningful outcomes (for example, ASCO‑recommended thresholds such as a hazard ratio < 0.80 or ≥3‑month survival benefit).

Billing and Coding

Covered HCPCS CodesHCPCSCovered

Q2043

Sipuleucel-t, minimum of 50 million autologous cd54+ cells activated with pap-gm-csf, including leukapheresis and all other preparatory procedures, per infusion

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization and Required Supporting Evidence

Evolent processes all medication requests from network ordering providers and prior authorization is required for Provenge (sipuleucel-T). The use of this drug must be supported by one of the following sources: FDA-approved product labeling, CMS-approved compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Required supporting evidence: FDA labeling, CMS compendia, NCCN/ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.
Prior authorization: All medication requests for Provenge must be submitted to Evolent for authorization prior to administration.

Note

Therapy Positioning vs Alternatives

Provenge (sipuleucel‑T) is not supported by Evolent for metastatic castrate‑resistant prostate cancer (mCRPC). This position is based on the lack of Level 1 evidence (randomized clinical trials and/or meta-analyses) demonstrating superiority of Provenge over alternative agents or regimens recommended by Evolent with respect to progression-free survival (PFS) or overall survival (OS). Providers should consider and document alternative, evidence-based therapies in accordance with Evolent Pathways and applicable guidelines when treating mCRPC.

Therapy positioning: Not supported for mCRPC due to insufficient Level 1 evidence of PFS/OS benefit versus recommended alternatives.
When considering Provenge for other indications, documentation must reference one of the acceptable evidence sources listed above.

Background

Provenge (sipuleucel‑T) is an autologous cellular immunotherapy developed for prostate cancer that uses a patient’s own antigen‑presenting cells activated ex vivo against prostatic acid phosphatase. Evolent references the IMPACT trial and the product labeling in its review but does not support routine use for metastatic castrate‑resistant prostate cancer due to insufficient Level 1 evidence showing superior PFS or OS compared with alternative regimens.

Definitions and Code Descriptions

HCPCS code description for sipuleucel‑T (Q2043)

HCPCS codeQ2043

Description (short)Sipuleucel‑T, minimum of 50 million autologous CD54+ cells activated with PAP‑GM‑CSF

Includes proceduresIncludes leukapheresis and all other preparatory procedures, per infusion

Minimum cell count per infusionMinimum of 50 million autologous CD54+ cells

Activation methodActivated with PAP‑GM‑CSF