Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — HCPCS A9607

Radioligand class — A9607 (Pluvicto) vs A9513 (Lutathera) CMS HCPCS verified May 2026

Two Novartis Lu-177 radioligands. Same isotope, completely different targets and indications. Don't cross the wires on the HCPCS.

Lu-177-based radioligand therapy is a fast-growing therapeutic class. As of May 2026, two products are FDA-approved and routinely billed in U.S. nuclear medicine departments: Pluvicto (lutetium Lu 177 vipivotide tetraxetan, A9607) and Lutathera (lutetium Lu 177 dotatate, A9513). Both are manufactured by Novartis (via Advanced Accelerator Applications), share the same therapeutic isotope (Lu-177, beta-minus emitter, 6.7-day half-life), and use the same administration CPT (79101). They are not interchangeable.

Dosing & unit math FDA label verified May 2026

From the FDA-approved Pluvicto prescribing information (BLA 215833, March 2025 pre-taxane expansion). Unit-of-billing is the millicurie (mCi), not the milligram.

Approved indications

• Original indication (March 2022): adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition (ARPI) and taxane-based chemotherapy
• March 2025 expansion: adult patients with PSMA-positive mCRPC who have been treated with at least one ARPI and are considered appropriate to delay taxane-based chemotherapy — effectively a 2L (post-ARPI, pre-chemo) positioning that materially broadens the eligible population

Dosing & schedule

Worked example — full 6-cycle course

Dose modifications

Per FDA label, dose reductions (to 5.6 GBq / 150 mCi) or treatment delays apply for specific hematologic, renal, dry mouth (xerostomia), and AE-related toxicities. Each held or reduced cycle should be documented at the visit; billing reflects the actually-administered mCi (e.g., a 150 mCi reduced dose bills as A9607 × 150 units, not 200). Course discontinuation criteria include disease progression by PSA + imaging, unacceptable toxicity, or completion of 6 cycles.

Companion PSMA-PET imaging gate

Before cycle 1, PSMA positivity must be confirmed by PSMA-targeted PET imaging using an FDA-approved companion diagnostic: Pylarify (piflufolastat F 18, A9595), Illuccix (gallium Ga 68 gozetotide, A9596), Locametz (gallium Ga 68 gozetotide, A9800), or Posluma (flotufolastat F 18). At least one PSMA-positive metastatic lesion must be documented. This is the gating clinical eligibility criterion and the single most common cause of Pluvicto prior authorization denial. Note: Locametz was specifically co-approved alongside Pluvicto in March 2022 as the original FDA-paired companion diagnostic; Pylarify and Illuccix are practice-standard alternatives widely accepted by payers.

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Pluvicto is a radiopharmaceutical therapy. Use nuclear medicine therapy administration codes, not chemo or therapeutic infusion codes.

Modifiers CMS verified May 2026

JZ — routine on patient-specific radiopharmaceutical fills

Pluvicto ships as a patient-specific individualized fill calibrated to the administration time. In practice, there is rarely physical waste in the conventional vial sense — the entire shipped activity is administered. Bill JZ on A9607 to attest "no discarded amount from a single-dose container," consistent with CMS's July 2023 single-dose container policy.

JW — only if dose is held or partially administered

If a dose is partially administered (e.g., infusion-reaction stop, line failure) and the remaining activity is discarded, report the discarded mCi on a separate JW line. Document the actually-administered activity from the dose calibrator log and the difference from the shipped fill. Both administered and wasted activity are reimbursable for single-dose container radiopharmaceuticals.

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the radioligand administration. Routine pre-infusion clinical check (vitals, prior-cycle toxicity review, AU verification) is bundled into the admin code.

340B modifiers (JG, TB)

Pluvicto is dispensed by certified nuclear medicine departments. 340B-acquired Pluvicto in HOPD settings follows the current 340B modifier policy — verify against your MAC's published guidance and your hospital's 340B compliance team. Pass-through radiopharmaceuticals have specific 340B reporting nuances; do not assume parity with J-code biologics.

Modifier CT — companion PSMA-PET imaging

If the companion PSMA-PET scan is performed on a non-NEMA-XR-29 compliant CT (rare in 2026), modifier CT applies to the PET CPT code line. Most modern PET/CT scanners are compliant and modifier CT is not needed.

ICD-10-CM by indication FY2026 verified May 2026

Pluvicto is indicated for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Castration resistance and PSMA positivity must both be documented.

Site of care & place of service Verified May 2026

Pluvicto is administered exclusively in certified nuclear medicine departments within hospital outpatient settings. Unlike conventional infused biologics or chemo, radioligand therapy is restricted to sites with an authorized user (AU) credentialed per NRC or Agreement State licensure to handle Lu-177, shielded infusion stations, radiation safety officer (RSO) oversight, and protocols for radioactive waste handling. There is no office-based (POS 11) or ambulatory infusion center (POS 49) administration pathway.

Claim form field mapping Novartis Patient Support 2026

Pluvicto claims are typically submitted on UB-04 (837I) by the hospital outpatient department.

Payer policy snapshot Reviewed May 2026

All major payers require PA. PSMA-PET + prior ARPI history are universal gating requirements. Taxane status interpretation varies post-March-2025.

Step therapy & prior ARPI

Androgen receptor pathway inhibitor (ARPI) therapy — abiraterone, enzalutamide, apalutamide, or darolutamide — is the standard treatment in mCRPC (and increasingly in mHSPC and nmCRPC). Major payers require documentation of prior ARPI therapy and either PSA progression on ARPI or radiographic progression. Pluvicto does not replace ADT; per the FDA label, medical or surgical castration (LHRH agonist/antagonist — leuprolide / Lupron Depot or degarelix / Firmagon) must be maintained throughout the Pluvicto course. Document the prior ARPI regimen, duration, and reason for progression in the PA packet.

March 2025 label expansion — the new 2L positioning

The March 2025 FDA expansion removed the requirement for prior taxane chemotherapy, allowing Pluvicto in PSMA+ mCRPC after ARPI when taxane is being deferred or is inappropriate. This is a material payer-policy change: PA criteria that pre-date March 2025 will deny appropriate post-ARPI/pre-taxane patients. Through 2025 the major payers updated their policies; some BCBS regional plans and smaller commercial plans were slow to catch up. If a denial cites "no prior taxane" as the reason, cite the updated FDA label (BLA 215833 supplement, March 2025) and current NCCN GU guideline in the appeal. This is the #4 cause of Pluvicto denial in 2026.

NCCN compendium support

Pluvicto is included in the NCCN Prostate Cancer guideline as a recommended option for PSMA+ mCRPC after ARPI (with or without prior taxane per the current edition). Verify NCCN category against the current edition; pre-March-2025 NCCN editions required prior taxane.

Companion PSMA-PET pre-authorization

The companion PSMA-PET (Pylarify, Locametz, Illuccix, or Posluma) frequently requires its own PA, billed to the same payer typically on a separate authorization. Some payers will conditionally approve Pluvicto contingent on a satisfactory PSMA-PET report; others require the PET to be completed and submitted with the Pluvicto PA packet. Coordinate with the nuclear medicine and urologic oncology teams to sequence the PET pre-PA workflow.

Medicare reimbursement CMS Q2 2026 (live)

A9607 is paid under OPPS for HOPD administration. Pass-through payment status applies for high-cost radiopharmaceuticals; verify the current OPPS Addendum B status indicator.

Coverage

No NCD specific to Pluvicto or to PSMA radioligand therapy generally. Coverage falls under MAC LCDs for nuclear medicine therapy services and the radiopharmaceutical pass-through framework. All MACs cover A9607 for FDA-approved on-label indications with appropriate ICD-10 (C61 + Z19.2), PSMA positivity documented by Pylarify / Locametz / Illuccix / Posluma PSMA-PET, prior ARPI history, and concurrent ADT.

Code history

• A9607 — "Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie"; effective July 1, 2022 (post-FDA approval Q1 2022). Pre-permanent code period (Q2–Q3 2022) used C9399 / unclassified C-code or J3490.
• A9595 — "Piflufolastat F 18, diagnostic, 1 millicurie" (Pylarify, Lantheus); companion PSMA-PET diagnostic, FDA approved May 2021.
• A9596 — "Gallium Ga-68 gozetotide, diagnostic, (Illuccix), 1 millicurie" (Telix); PSMA-PET diagnostic, FDA approved December 2021.
• A9800 — "Gallium Ga-68 gozetotide, diagnostic, (Locametz), 1 millicurie" (Novartis); PSMA-PET diagnostic, co-approved with Pluvicto March 2022 as the FDA-paired companion diagnostic.
• Posluma (flotufolastat F 18, Blue Earth Diagnostics) — FDA approved May 2023; no dedicated permanent A-code at publication; bills via NOC code A9597 in most MACs.

Patient assistance — Novartis Patient Support Novartis verified May 2026

• Novartis Patient Support Center: 1-844-638-7222 / novartis.com/our-focus/patient-support — benefits investigation, prior authorization assistance, appeal support, site-of-care navigation
• Pluvicto Co-Pay Assistance Program: commercial copay support for eligible commercially-insured patients; subject to annual cap (excludes Medicare, Medicaid, federal program patients)
• Novartis Patient Assistance Foundation, Inc.: free product for uninsured / underinsured patients meeting income requirements (501(c)(3))
• Foundations (Medicare patients): PAN Foundation (Prostate Cancer fund), HealthWell Foundation, Patient Access Network, ZERO Prostate Cancer — verify open prostate cancer funds quarterly
• ZERO Prostate Cancer: patient navigation, peer support, copay assistance program (Patient Support Program); zerocancer.org
• Travel & lodging: Novartis Patient Support coordinates with Healthcare Hospitality Network and Hope Lodge for patients traveling to certified Pluvicto centers (many regions have only 1–3 sites)

Radiation safety & FDA-label warnings FDA label

FDA-label warnings & precautions

• Radiation exposure to patients, family, and caregivers: patients are radioactive for several days post-administration. Provide written discharge instructions on close-contact restrictions, sleeping arrangements, public transit, and pediatric exposure mitigation per FDA label and your institution's RSO guidance.
• Myelosuppression: grade 3+ thrombocytopenia / neutropenia / anemia observed in the pivotal VISION and PSMAfore trials. Monitor CBC at baseline, before each cycle, and 2–4 weeks post-cycle.
• Secondary MDS & acute leukemia: observed in published follow-up. Discuss in consent and monitor CBC long-term.
• Renal toxicity: monitor serum creatinine and eGFR; hold or dose-reduce per FDA label for creatinine clearance changes. (Note: amino acid co-infusion is not required for Pluvicto unlike Lutathera.)
• Dry mouth (xerostomia): PSMA is expressed in salivary glands; xerostomia is a known on-target off-tumor toxicity. Counsel patients on sialagogues, oral hygiene, dental follow-up.
• Embryo-fetal toxicity: can cause fetal harm in partners; counsel on contraception ×14 weeks post-treatment.
• Infertility: may impair fertility; discuss fertility preservation referral before cycle 1 (though most mCRPC patients are post-reproductive age).

Pluvicto carries no FDA Boxed Warning, but the cumulative radiation, secondary malignancy risk, and family/caregiver exposure considerations make the discharge instruction packet a critical workflow element. Document discharge counseling and provide the standardized written sheet at every cycle.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Pluvicto?

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is billed under HCPCS A9607 — "Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie." Note this is an A-code (radiopharmaceutical category), not a J-code. Each millicurie equals one billable unit and the standard 200 mCi dose bills as 200 units.

What administration CPT do I use for Pluvicto?

CPT 79101 — "Radiopharmaceutical therapy by intravenous administration." This is a nuclear medicine therapy code, NOT a chemotherapy or therapeutic infusion code. Do NOT bill 96365 (therapeutic IV), 96413 (chemo IV), or 96374 (IV push).

Is companion PSMA-PET imaging required before Pluvicto?

Yes. Per FDA label and all major payer policies, PSMA positivity must be documented by PSMA-targeted PET imaging using an FDA-approved companion diagnostic: Pylarify (piflufolastat F 18, HCPCS A9595), Illuccix (Ga-68 gozetotide, A9596), Locametz (Ga-68 gozetotide, A9800), or Posluma (flotufolastat F 18) before Pluvicto initiation. At least one PSMA-positive metastatic lesion must be documented. Missing or absent companion PSMA-PET documentation is the #1 cause of Pluvicto prior authorization denial.

How many doses are in a Pluvicto course?

Up to six doses of 7.4 GBq (200 mCi) administered approximately 6 weeks apart, for a maximum cumulative dose of 44.4 GBq (1,200 mCi). Each dose is billed separately as A9607 × 200 units on the day of administration. Course may be discontinued earlier for progression, toxicity, or patient preference.

Did the March 2025 label expansion change billing for Pluvicto?

The indication changed, not the HCPCS or admin code. The original March 2022 FDA approval required prior ARPI AND prior taxane chemotherapy. The March 2025 expansion broadened eligibility to PSMA+ mCRPC after ARPI without requiring prior taxane — effectively a 2L (post-ARPI, pre-chemo) positioning. Payers updated PA criteria through 2025; denials under the old criteria ("no prior taxane") are the #4 cause of Pluvicto denial in 2026. Cite the updated FDA label and current NCCN GU guideline in appeals.

What ICD-10 codes do I use for Pluvicto?

Indication is PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Primary: C61 (malignant neoplasm of prostate). Pair with Z19.2 (hormone-resistant) to document castration-resistant status, and with secondary metastatic codes (C77.x nodal, C78.x respiratory/digestive, C79.51 bone) as documented. Bone metastases are nearly universal in mCRPC at Pluvicto initiation. Pluvicto is NOT approved for mHSPC.

Is amino acid co-infusion required with Pluvicto?

No. Unlike Lutathera, Pluvicto does not require renal-protection lysine/arginine co-infusion — PSMA biodistribution does not concentrate in the proximal renal tubules the way DOTATATE does. Do not bill amino acid HCPCS lines or CPT 96365 amino-acid admin for Pluvicto.

What is the Medicare reimbursement for A9607?

A9607 is paid under the Medicare Hospital Outpatient Prospective Payment System (OPPS) for HOPD administration. As a high-cost radiopharmaceutical, A9607 has historically received OPPS pass-through payment (status indicator G) at ASP + 6%. Pass-through status is time-limited; for CY2026 OPPS, CMS finalized a high-cost radiopharmaceutical policy that affects packaging vs separate payment depending on per-day cost. Verify the current OPPS Addendum B status indicator for A9607 each calendar year. Manufacturer WAC is approximately $42,000 per dose; the six-dose maximum course costs approximately $252,000 in drug acquisition.

How is Pluvicto different from Lutathera?

Both are Novartis Lu-177 radioligand therapies. Pluvicto (A9607) targets prostate-specific membrane antigen (PSMA) using the PSMA-617 ligand for mCRPC. Lutathera (A9513) targets somatostatin receptor type 2 (SSTR2) using the DOTATATE peptide for GEP-NETs. Both require companion diagnostic PET (Pylarify / Illuccix / Locametz for Pluvicto; Ga-68 dotatate / Cu-64 dotatate for Lutathera), both use CPT 79101, and both follow OPPS pass-through frameworks. Pluvicto does NOT require amino acid co-infusion (Lutathera does). They are not interchangeable. See the radioligand class comparison.

Is Pluvicto given with ADT?

Yes. Continuous medical or surgical castration must be maintained throughout the Pluvicto course. Most patients are on leuprolide (Lupron Depot, J1950) or degarelix (Firmagon, J9155) on the standard q3-month / q1-month schedule. Surgical castration (bilateral orchiectomy) is an acceptable alternative. The concurrent ADT bills under its own HCPCS (J1950 for Lupron Depot; J9155 for Firmagon) on its own schedule, independent of the Pluvicto cycle.

Source documents

1. FDA — PLUVICTO prescribing information (BLA 215833)
   FDA-approved label including March 2025 pre-taxane expansion; full prescribing information including dosing, W&P, radiation safety
2. DailyMed — PLUVICTO (lutetium Lu 177 vipivotide tetraxetan)
   Setid 14908037-2892-4d98-a053-253ce35afb1a — labeler Novartis Pharmaceuticals Corporation; label revision verified April 7, 2026 (includes March 28, 2025 pre-taxane expansion)
3. Sartor O et al., NEJM 2021 — VISION phase 3 trial
   Pivotal RCT of 177Lu-PSMA-617 in post-ARPI + post-taxane mCRPC (DOI: 10.1056/NEJMoa2107322); supports original March 23, 2022 FDA approval
4. PSMAfore (NCT04689828) — phase 3 pre-taxane mCRPC trial
   177Lu-PSMA-617 vs ARPI switch in post-ARPI, pre-chemo mCRPC; supports March 28, 2025 FDA pre-taxane label expansion
5. Novartis — Pluvicto HCP site & Patient Support
   Manufacturer billing guide, claim form mapping, copay assistance program, AU/RSO resources
6. CMS — Medicare Part B Drug ASP Pricing File
   Quarterly ASP file; A9607 listed under radiopharmaceuticals (A-code series)
7. CMS — OPPS Addendum A / Addendum B
   Hospital outpatient status indicators; check A9607 status quarterly (pass-through vs packaged); CY2026 high-cost radiopharmaceutical policy applies
8. SEER CanMED — HCPCS A9607 reference
9. NCCN Clinical Practice Guidelines — Prostate Cancer
   Compendium support for Pluvicto in PSMA+ mCRPC post-ARPI (with or without prior taxane per current edition)
10. UnitedHealthcare — Oncology Medication Clinical Coverage Policy (PSMA radioligand)
11. U.S. NRC — Lu-177 medical use guidance & authorized user requirements
    Federal licensing and AU credentialing framework for Lu-177 therapy
12. FDA National Drug Code Directory
13. CMS — JW/JZ modifier policy (CR 12056, eff. July 2023)
14. FDA — March 2025 Pluvicto label expansion announcement
    Pre-taxane mCRPC indication expansion (PSMAfore trial data)

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 22, 2026 — SME audit pass. Corrected PSMA-PET tracer A-codes throughout (Pylarify A9595, Illuccix A9596, Locametz A9800); previous mapping inverted Pylarify/Illuccix and used wrong code for Locametz. Added DailyMed setid, VISION (NEJM 2021) and PSMAfore (NCT04689828) pivotal trial citations to source list. Verified March 28, 2025 pre-taxane expansion date.
• May 22, 2026 — Initial publication. ASP data: Q2 2026. Sister radioligand page to Lutathera (A9513). Includes March 2025 pre-taxane label expansion. Manufacturer source: Novartis Patient Support 2026.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File and the OPPS Addendum B status indicator. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list, dosing, and radiation safety guidance are verified against the current FDA label revision. Authorized user and licensing context is verified against NRC guidance for Lu-177 medical use. We do not paraphrase from billing-software vendor blogs.