CurrentMass General Brigham Health PlanPolicy 048

Medical Necessity Guidelines — Provenge (sipuleucel-T)

Defines medical necessity, prior authorization requirements, and payer-specific criteria for use of sipuleucel-T (Provenge) for metastatic castrate‑resistant prostate cancer across Mass General Brigham Health Plan product lines.

Policy Summary

PayerMass General Brigham Health Plan

PolicyProvenge (sipuleucel-T) medical necessity and prior authorization

Policy CodePolicy 048

Change TypeRevision with material updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization for sipuleucel‑T; follow CMS NCD 110.22 for Medicare Advantage and MassHealth Table 57 for ACO members when applicable.

SourceLink

POLICY UPDATE CHANGES

Reformatted policy and clarified hierarchy of criteria in One Care and SCO variation; updated prior authorization information for Commercial and QHP members.

MassHealth variation language (Table 57: Oncology Agents) was added for ACO members.

Hierarchy of criteria for One Care and SCO members clarified to use CMS guidance first, then MassHealth when Medicare criteria are not met.

PA requiredCommercial and Medicare Advantage

Q2043HCPCS code

110.22CMS NCD

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Coverage and Medical Necessity Criteria

Plan-specific coverage criteria

Covered when coverage aligns with CMS NCD and applicable plan-specific criteria are met:

Medicare Advantage coverage: Medical necessity determinations must follow CMS NCD 110.22 and any applicable LCDs/LCAs/Medicare manual documentation

Off-label indications beyond those described in the NCD are not covered

Mass General Brigham ACO coverage: Prior authorization required; determinations use the MassHealth Drug List (Table 57: Oncology Agents)

One Care and SCO coverage hierarchy: Use CMS guidance first; if Medicare criteria are not met or no CMS guidance, apply MassHealth criteria

Prior authorization required

Commercial and QHP coverage: Prior authorization required and managed by Prime Therapeutics; follow the Prime Therapeutics policy for medical necessity determinations

Off-label indications beyond those described in the CMS National Coverage Determination NCD 110.22 (Autologous Cellular Immunotherapy Treatment) are not covered. Coverage is limited to indications and uses specified within the NCD; requests for Provenge (sipuleucel‑T) for indications outside that NCD may be denied.

Covered Regimens and Administration

Regimen	HCPCS code	Description	Coverage status
Sipuleucel‑T infusion series as described in product labeling	Q2043	Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP‑GM‑CSF, including leukapheresis and all other preparatory procedures, per infusion	Covered with criteria (see policy)

Billing Codes

Informational HCPCS codeHCPCS

Q2043

Sipuleucel-T, minimum of 50 million autologous cd54+ cells activated with PAP- GM-CSF, including leukapheresis and all other preparatory procedures, per infusion

Prior Authorization, Documentation, and Plan Variations

Prior Authorization

Prior Authorization Required

Prior authorization is required for Provenge across Medicare Advantage, Mass General Brigham ACO, One Care/SCO, and Commercial/QHPs. Providers must obtain prior authorization before administration.

Medicare Advantage: prior authorization required
Mass General Brigham ACO: prior authorization required
One Care and SCO: prior authorization required
Commercial and Qualified Health Plans: prior authorization required (managed by Prime Therapeutics)

Note

MassHealth / ACO Variation

Mass General Brigham ACO members' medical necessity determinations follow the MassHealth Drug List. Criteria for Provenge are located in Table 57: Oncology Agents — adjudicators and providers should reference that table when requesting coverage for ACO members.

MassHealth Drug List — Table 57: Oncology Agents (Provenge criteria)

Placement in Therapy

Salvage

Indication: Asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer

Per Overview and compendia references

Key Definitions

Definition — Provenge (sipuleucel‑T)

AgentProvenge (sipuleucel‑T)

Therapy typeAutologous cellular immunotherapy

IndicationTreatment of asymptomatic or minimally symptomatic metastatic castrate‑resistant (hormone‑refractory) prostate cancer

Product characteristicPatient‑specific (autologous) cellular product manufactured from leukapheresed peripheral blood mononuclear cells

Series descriptionAdministered as an infusion series per product labeling (leukapheresis, cell processing, reinfusion)

Background and Clinical Context

Provenge (sipuleucel‑T) is an autologous cellular immunotherapy prepared from a patient’s own peripheral blood mononuclear cells and activated ex vivo for reinfusion. It is intended for the treatment of asymptomatic or minimally symptomatic metastatic castrate‑resistant (hormone‑refractory) prostate cancer, consistent with CMS guidance. Medical necessity determinations for Medicare Advantage members follow CMS policy sources (NCDs, LCDs, LCAs, and Medicare manuals); when CMS guidance is not available, the plan’s medical policies are used.