Sipuleucel-T (Provenge) — CPB 0802 | AETNA Coverage Update

TL;DR: Aetna, a CVS Health company, modified CPB 0802 governing sipuleucel-T (Provenge) coverage, effective January 5, 2026. Billing teams that handle Q2043 for metastatic castrate-resistant prostate cancer need to confirm their prior authorization workflows and ICD-10 coding are tight before claims go out.

---

Aetna modified CPB 0802, the Aetna sipuleucel-T (Provenge) coverage policy, effective January 5, 2026. The policy governs HCPCS code Q2043—the primary billing code for Provenge—under commercial medical plans. This is a GCIT-designated therapy, meaning Aetna routes it through a dedicated review team, and the prior authorization requirements are non-negotiable.

---

Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Sipuleucel-T (Provenge) — CPB 0802
Policy Code	CPB 0802
Change Type	Modified
Effective Date	January 5, 2026
Impact Level	High — six-figure therapy with strict medical necessity gatekeeping
Specialties Affected	Oncology, Urology, Infusion
Key Action	Precertify Q2043 before administration using (866) 752-7021; confirm patient meets all three eligibility criteria

---

Aetna Sipuleucel-T Coverage Criteria and Medical Necessity Requirements 2026

The Aetna sipuleucel-T coverage policy under CPB 0802 limits medically necessary coverage to one course of therapy—exactly three doses, no more. The patient must meet all of the following criteria simultaneously. Miss any one of them, and you're looking at a claim denial.

Three requirements for initial approval:

#	Covered Indication Copy
1	The member has metastatic castrate-resistant (hormone-refractory) prostate cancer
2	The member is asymptomatic or minimally symptomatic with an ECOG performance status of 0 or 1
3	The member does not have liver metastases

That liver metastases exclusion is a hard stop. Aetna does not treat it as a clinical gray area. If your oncology team hasn't documented the absence of liver involvement, your authorization request will fail before a reviewer reads the rest of the chart.

The primary billing code for Provenge is HCPCS Q2043—"Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis." That's a mouthful, but it's the only HCPCS code in CPB 0802 designated as covered when selection criteria are met. Make sure Q2043 appears in your charge capture with clean ICD-10 support from the first claim.

Precertification is mandatory. This isn't a soft requirement. All Aetna participating providers must precertify sipuleucel-T before administration, regardless of plan design. Call (866) 752-7021 or fax (888) 267-3277. For Statement of Medical Necessity forms, pull them from the Aetna Specialty Pharmacy Precertification page. Don't start the leukapheresis process without an authorization number in hand—the reimbursement risk is too high.

Aetna routes all Provenge requests through its GCIT team—Gene-based, Cellular & Other Innovative Therapies. This is not a standard prior authorization review. Plan for longer turnaround times and more detailed clinical documentation than you'd see for a conventional chemotherapy PA.

The continuation of therapy rule is simple: one course, three doses, done. Aetna does not cover a second course under this policy. Document this clearly in your treatment plan so patients and referring physicians understand the limit upfront.

For Medicare patients, this policy does not apply. Aetna directs Medicare coverage questions to its Part B criteria page. If your patient mix includes Medicare Advantage members under an Aetna plan, verify which set of criteria applies before you submit.

---

Aetna Sipuleucel-T Exclusions and Non-Covered Indications

Aetna classifies all uses of sipuleucel-T outside of the criteria above as experimental, investigational, or unproven. There are no other approved indications under this policy.

The real issue here is what doesn't qualify. Symptomatic patients with an ECOG score of 2 or higher are excluded. Patients with liver metastases are excluded. Any off-label use—whether for a different cancer type or a second course of treatment for prostate cancer—is excluded.

Several immunization administration CPT codes appear in the policy as explicitly not covered for the indications listed in CPB 0802. These include 90460, 90461, 90471, 90472, 90473, and 90474. Provenge is not a conventional vaccine, and Aetna is drawing a hard line against billing it under immunization administration codes. If your billing team has historically reached for the 904xx range for any infusion or cellular therapy, stop. Those codes will deny.

---

Coverage Indications at a Glance

---

Aetna Sipuleucel-T Billing Guidelines and Action Items 2026

The sipuleucel-T billing process has several distinct failure points. Here's where to focus your team's attention now—before a claim goes out under the January 5, 2026 effective date.

Copy Action Items

---

CPT, HCPCS, and ICD-10 Codes for Sipuleucel-T (Provenge) Under CPB 0802

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
Q2043	HCPCS	Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis

Not Covered CPT and HCPCS Codes

Key ICD-10-CM Diagnosis Codes

The policy lists 164 ICD-10-CM codes. The primary code for this indication is listed below, along with the other cancer categories included in the policy. Note that coverage under CPB 0802 is specific to prostate cancer (C61) meeting all stated criteria—the other codes below appear in the policy but do not represent additional covered indications for Provenge.

For the full list of all 164 ICD-10-CM codes referenced in CPB 0802, see the full policy on PayerPolicy.

---