Sipuleucel‑T (Provenge) for Metastatic Castrate‑Resistant Prostate Cancer
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Defines Highmark Pennsylvania coverage criteria for sipuleucel‑T (Provenge) for adults with metastatic castrate‑resistant prostate cancer and operational payment/applicability rules for providers and claims.
No material clinical or coverage changes in this revision.
Coverage Criteria for Sipuleucel-T (Provenge)
Medically Necessary Criteria
Covered when ALL of the following are met:
mCRPC defined as above
Use of sipuleucel-T for any indication not listed in this policy is considered experimental/investigational and non‑covered.
Any use of sipuleucel‑T outside the specified indications and criteria in this policy (including indications not listed) is non‑covered as experimental/investigational.
Covered Regimens and Indications
| Regimen | Indication / Eligibility | Coverage Status |
|---|---|---|
| Sipuleucel-T (Provenge) | Asymptomatic or minimally symptomatic adults with metastatic castrate-resistant prostate cancer (mCRPC) who meet ALL of the following: serum testosterone < 50 ng/dL; PSA >= 5.0 ng/mL; ECOG performance status 0 or 1; no visceral (liver, lung, or brain) metastases; no use of narcotics for cancer-related pain; life expectancy > 6 months. mCRPC is defined as disease progression with a PSA rise of >= 2 ng/mL above nadir or increased tumor mass on imaging despite castrate testosterone <50 ng/dL. | Covered |
Coding and Clinical Thresholds
| No codes listed |
Provider Actions, Billing, and Review
Pre-payment diagnosis codes; post-payment retrospective review
Coverage determination and diagnosis codes are applied on a pre-payment basis. Professional and facility services are processed initially (post-payment) and are subject to retrospective review; diagnosis codes remain a pre-payment application within the policy.
- Diagnosis codes are applied on a pre-payment basis.
- Professional claims: policy applied on a post-payment basis — services pay on initial processing and are subject to retrospective review.
- Facility claims: policy applied on a post-payment basis — services pay on initial processing and are subject to retrospective review.
No step therapy requirement
No step therapy or prerequisite trials are specified in this policy; eligibility is determined solely by the clinical coverage criteria listed (e.g., mCRPC status, PSA, testosterone, ECOG, absence of visceral metastases, life expectancy, and narcotic use).
- Eligibility must meet the clinical criteria in the COVERAGE CRITERIA section (PSA ≥ 5.0 ng/mL, testosterone <50 ng/dL, ECOG 0–1, etc.).
Signed advance notice and member agreement for E/I services; document eligibility
If a provider intends to bill the member for a service deemed experimental/investigational, they must give advance written notice, obtain a signed cost‑agreement from the member, and retain that signed agreement in the provider’s records; medical records should support eligibility criteria (ECOG, PSA, testosterone, absence of visceral metastases, life expectancy, narcotic use).
- Provide advance written notice to the member that the service is deemed experimental/investigational and include an estimate of cost.
- Obtain the member’s written agreement to assume financial responsibility before delivering the service and maintain the signed agreement in the medical record.
- Document clinical eligibility criteria in the medical record (ECOG, PSA, testosterone, absence of visceral metastases, life expectancy, narcotic use).
Denial risk for non-concordant indications; member billing permitted with advance agreement
Services that do not meet the policy’s coverage criteria will be considered experimental/investigational and may be denied; network providers may bill the member only after providing advance written notice and obtaining the member’s signed cost agreement.
- Any use outside the specified indications and criteria is non-covered as experimental/investigational.
- If service is E/I, obtain advance written notice with cost estimate and signed member agreement prior to providing the service.
Definitions
Background
Sipuleucel‑T is an autologous cellular immunotherapy composed of patient‑derived antigen‑presenting cells exposed ex vivo to prostate antigen–containing fusion proteins intended to stimulate the patient’s immune system to resist spread of metastatic castrate‑resistant prostate cancer. It is indicated for asymptomatic or minimally symptomatic adult patients with mCRPC who meet the physiologic and disease‑specific criteria listed in this policy (including serum testosterone < 50 ng/dL, PSA ≥ 5.0 ng/mL, ECOG 0–1, absence of visceral metastases, no narcotic use for cancer‑related pain, and life expectancy > 6 months).
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