CurrentMass General Brigham Health PlanPolicy N/A

Provenge (sipuleucel-T) — Coverage Criteria for Metastatic Castrate-Resistant Prostate Cancer

Governs prior authorization, medical necessity criteria, and coverage conditions for sipuleucel-T (Provenge) for members of Mass General Brigham Health Plan and specified product lines.

Policy Summary

PayerMass General Brigham Health Plan

PolicyProvenge (sipuleucel-T) coverage criteria — metastatic castrate-resistant prostate cancer

Policy CodePolicy N/A

Change TypeAd hoc update — added OneCare & SCO variationupdated PA table

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, testosterone level, ECOG 0-1, life expectancy >6 months, absence of hepatic metastases, and prescribing clinician specialty.

SourceLink

POLICY UPDATE CHANGES

Added variation language for OneCare and Senior Care Options (SCO) members and updated prior authorization table.

MassHealth variation criteria were added to policy.

3total doses/infusions per treatment course

ECOG 0-1required performance status

<50 ng/dLtestosterone threshold

No hepatic metsabsence required

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Coverage & Medical Necessity Criteria

Initial Approval

Covered when ALL of the following are met

Initial Approval Criteria: Member has a diagnosis of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer

Absence of hepatic metastases

Testosterone level <50 ng/dl

Life expectancy greater than 6 months

Performance status: ECOG performance status 0 or 1

Combination therapy restriction: Not receiving combination chemotherapy or immunosuppressive medications

Prescribing clinician: Prescribed by an oncologist or urologist

Treatment course: Planned treatment consists of 3 complete autologous cell infusions administered at approximately two-week intervals3 doses/infusions

Additional courses of therapy beyond the initial 3-dose course are considered investigational.

Provenge (sipuleucel-T) must not be administered in combination with chemotherapy or other immunosuppressive medications. Requests for concurrent use with these agents do not meet the policy's coverage criteria and will not be approved.

The approved course of therapy is a single treatment course consisting of three complete doses/infusions. Additional courses of therapy beyond the initial 3-dose course are considered investigational and are not covered under this policy.

Patients with any of the following clinical factors do not meet medical necessity criteria for Provenge: presence of hepatic metastases; serum testosterone ≥ 50 ng/dL; Eastern Cooperative Oncology Group (ECOG) performance status greater than 1; or estimated life expectancy of ≤ 6 months.

Regimen	Dosing schedule	Coverage stance
Sipuleucel-T (Provenge) autologous cellular immunotherapy for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer
Three complete doses/infusions administered as the total treatment course; administer doses at approximately two-week intervals
Initial 3‑dose course covered when criteria met; additional courses investigational

Codes & Clinical Thresholds

Included HCPCS Codes (informational)HCPCS

Q2043

Sipuleucel-T, minimum of 50 million autologous cd54+ cells activated with PAP-GM-

inv-06: Testosterone level — required threshold

Testosterone thresholdSerum testosterone <50 ng/dl

Source contextRequired as part of initial approval criteria for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer

Measurement unitsng/dl

inv-07: Life expectancy — required threshold (>6 months)

Life expectancy requirement>6 months

Policy consequenceLife expectancy <=6 months does not meet medical necessity criteria

Context

Prior Authorization, Documentation & Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required for sipuleucel‑T (Provenge) for applicable lines of business. Ensure authorization is obtained before administration.

Applies to Commercial, Qualified Health Plans (QHP), Mass General Brigham ACO, Medicare Advantage, OneCare, Senior Care Options (SCO)

Denial Risk

Combination Therapy Restriction

Provenge must not be used in combination with cytotoxic chemotherapy or immunosuppressive medications.

Do not administer concurrently with chemotherapy or immunosuppressive agents

Use in Therapy Sequence

Salvage

Indication: Asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer; intended as active therapy delivered as a 3-dose course3 doses

Regimen Details

Regimen	Dosing schedule	Coverage stance
Sipuleucel-T (Provenge) autologous cellular immunotherapy for asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer
Three complete doses/infusions administered as the total treatment course; administer doses at approximately two-week intervals
Initial 3‑dose course covered when criteria met; additional courses investigational

Definitions & Key Terms

inv-13: Provenge (sipuleucel-T) — autologous cellular immunotherapy definition

DefinitionProvenge (sipuleucel-T) is an autologous cellular immunotherapy for treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

Course of therapyAdminister three complete autologous activated‑cell infusions approximately two weeks apart (total of 3 doses).

Combination therapyNot to be used in combination with chemotherapy or immunosuppressive medications.

inv-14: ECOG performance status 0-1 definitions

ECOG 0Fully active, able to carry on all pre-disease performance without restriction.

ECOG 1Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work (e.g., light housework, office work).

Background

Provenge (sipuleucel-T) is an autologous cellular immunotherapy indicated for treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. The treatment is prepared from the patient’s own cells and administered as three complete doses/infusions, given at approximately two-week intervals. Therapy should be prescribed by or administered under the direction of an oncologist or urologist.