CurrentMass General Brigham Health PlanPolicy 048

Provenge (sipuleucel-T) medical necessity and prior authorization criteria

Defines prior authorization requirements and coverage guidance for sipuleucel-T (Provenge) across Mass General Brigham Health Plan lines of business (Medicare Advantage, Mass General Brigham ACO, One Care/SCO, Commercial and Qualified Health Plans). Uses CMS NCDs/LCDs and MassHealth guidance where applicable.

Policy Summary

PayerMass General Brigham Health Plan

PolicyProvenge (sipuleucel-T) medical necessity and prior authorization criteria

Policy CodePolicy 048

Change TypeClarified / Added / Revised

Effective Date

Next Review Date

Key ActionProviders must obtain prior authorization before administering sipuleucel-T and follow the applicable PA process (Prime Therapeutics for Commercial/QHP), and support Medicare Advantage/One Care/SCO determinations with CMS NCDs/LCDs/LCAs or apply MassHealth criteria when CMS guidance is not met.

SourceLink

POLICY UPDATE CHANGES

Reformatted policy and clarified hierarchy of criteria in One Care and SCO variation (June 2026).

MassHealth variation added (September 2024) and One Care/SCO variation added (January 2026).

Updated prior authorization table and added variation for One Care and SCO members (January 2026 ad hoc).

4Lines of business explicitly addressed (Medicare Advantage, ACO, One Care/SCO, Commercial/QHP)

1Primary HCPCS code listed for sipuleucel-T

Multiple

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Medical Necessity and Coverage Rules

Medicare Advantage / One Care / SCO — Coverage rule

Coverage is determined using CMS guidance (NCD/LCD/LCA). Off-label indications beyond CMS NCD are not covered. For One Care/SCO, if Medicare criteria are not met, MassHealth criteria are applied.

ALL of the following

Member is a Medicare Advantage, One Care, or SCO plan member (as applicable to this rule).
The requested use of sipuleucel-T must meet the CMS National Coverage Determination (NCD) for Autologous Cellular Immunotherapy Treatment (110.22) and any applicable LCDs/LCAs.
Indication must be for metastatic castrate-resistant (hormone-refractory) prostate cancer that is asymptomatic or minimally symptomatic (as per NCD).

ALL of the following

Member is a Medicare Advantage, One Care, or SCO plan member (as applicable to this rule).
The requested use of sipuleucel-T must meet the CMS National Coverage Determination (NCD) for Autologous Cellular Immunotherapy Treatment (110.22) and any applicable LCDs/LCAs.
Indication must be for metastatic castrate-resistant (hormone-refractory) prostate cancer that is asymptomatic or minimally symptomatic (as per NCD).

Mass General Brigham ACO — Coverage rule

Coverage determinations follow MassHealth Drug List criteria.

ALL of the following

Prior authorization is required.
Criteria for Provenge are those found in MassHealth Drug List Table 57: Oncology Agents.

ALL of the following

Prior authorization is required.
Criteria for Provenge are those found in MassHealth Drug List Table 57: Oncology Agents.

Commercial and Qualified Health Plans — Prior authorization

Prior authorization requirements and clinical criteria are managed by the delegated pharmacy benefit manager.

ALL of the following

Prior authorization is required and managed by Prime Therapeutics.
Coverage is determined according to Prime Therapeutics' Provenge policy (provider must follow that process).

ALL of the following

Prior authorization is required and managed by Prime Therapeutics.
Coverage is determined according to Prime Therapeutics' Provenge policy (provider must follow that process).

Exclusions / Not covered

Limitations explicitly noted in the policy:

ANY of the following

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

What Providers Must Do

Prior Authorization

Prior authorization required (product-specific by line of business)

Providers must obtain prior authorization before administering sipuleucel-T for all listed lines of business. Prior authorization is required for Medicare Advantage, Mass General Brigham ACO, One Care/SCO, and Commercial/Qualified Health Plans; prior authorization for Commercial and Qualified Health Plan members is managed by Prime Therapeutics.

Q2043

Documentation Required

Documentation basis for medical necessity

Medical necessity determinations for Medicare Advantage and One Care/SCO must be supported by CMS National Coverage Determinations, Local Coverage Determinations/Articles, and documentation included in the Medicare manuals; when CMS guidance is absent or the Medicare criteria are not met for One Care/SCO, MassHealth criteria are applied.

Billing Codes

Provenge product code (informational)HCPCS

Q2043

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

Clinical and Administrative Background

Sipuleucel‑T (Provenge) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate‑resistant (hormone‑refractory) prostate cancer. Coverage and medical necessity determinations for Mass General Brigham Health Plan lines of business reference applicable CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and Medicare manuals where relevant; when CMS guidance is absent or not applicable for certain plan variations, MassHealth criteria are used as specified in the policy.

Defined Terms

Definitions

NCDNational Coverage Determination – CMS policy used to determine coverage for Medicare beneficiaries.

LCD/LCALocal Coverage Determination / Local Coverage Article – regional Medicare contractor guidance documents.

Policy Changes and Notes

2026-06Annual review / clarificationLatest

Annual review with reformatting of the policy and clarification of the hierarchy of criteria for One Care and SCO; updated prior authorization information for Commercial and Qualified Health Plan members.

2026-01Ad hoc update

Updated the prior authorization table and added a variation for One Care and SCO members; fixed code disclaimer.

2024-09Ad hoc update

Added a MassHealth variation to apply MassHealth criteria when CMS guidance is absent or not met for certain members.