Perjeta (pertuzumab) — HCPCS J9306

Perjeta IV vs. Phesgo SC FDA verified Apr 2026

Same active ingredient (pertuzumab), very different billing. Phesgo bundles pertuzumab + trastuzumab into one SC injection.

Genentech offers pertuzumab in two formats: the original intravenous Perjeta (J9306, since 2012) and the fixed-dose subcutaneous combination Phesgo (BLA 761170, approved June 29, 2020). Phesgo is pertuzumab + trastuzumab + hyaluronidase-zzxf in a single SC injection — replacing two IV infusions with one 5–8 minute SC injection.

Dosing & unit math FDA label Mar 2026

From the FDA prescribing information, label revised March 2026 (BLA 125409). Pertuzumab is a fixed flat dose — NOT weight-based.

Adult dosing — HER2+ metastatic and early breast cancer (all indications)

• Loading dose: 840 mg IV over 60 minutes on cycle 1, day 1 — bill 840 units of J9306 (uses 2 vials)
• Maintenance dose: 420 mg IV over 30–60 minutes every 3 weeks thereafter — bill 420 units of J9306 (uses 1 vial)
• 1 mg = 1 unit — NOT 10 mg per unit (a frequent denial cause; see Denials)
• Always co-administered with trastuzumab (Herceptin) — never billed as monotherapy
• Observation: 30–60 minutes after first infusion; 30 minutes after subsequent infusions (infusion-reaction surveillance)

Pediatric dosing

• Not approved. Perjeta has no pediatric indication. Pediatric weight-based dosing scenarios do not occur for J9306.

Combination regimens (per FDA label and NCCN)

• HER2+ metastatic breast cancer (1L, CLEOPATRA): Perjeta + Herceptin + docetaxel — until disease progression or unacceptable toxicity
• HER2+ early breast cancer, neoadjuvant (NeoSphere/TRYPHAENA): Perjeta + Herceptin + chemo (TCH-P or AC-THP) — 3–6 cycles before surgery
• HER2+ early breast cancer, adjuvant (APHINITY): Perjeta + Herceptin (with or without chemo backbone) — total of 1 year of HER2-targeted therapy

Worked example — first-year billing for HER2+ metastatic breast (CLEOPATRA regimen)

No premedication routinely required (for Perjeta itself)

Perjeta does not require pre-infusion methylprednisolone or antihistamine. The Herceptin/chemo backbone may carry its own premedication requirements (corticosteroid + H1/H2 blockers for docetaxel; etc.). Manage infusion reactions per FDA label if they occur during or after pertuzumab administration.

Herceptin combo — always required FDA label verified Apr 2026

Perjeta is never administered or billed as monotherapy. The dual HER2 blockade mechanism requires trastuzumab co-administration in every approved indication.

Per the FDA label, Perjeta must be administered in combination with trastuzumab (Herceptin). Pertuzumab binds HER2 at a different domain (subdomain II) than trastuzumab (subdomain IV), blocking HER2 dimerization with HER3 — the dual blockade mechanism studied in the CLEOPATRA, APHINITY, NeoSphere, and TRYPHAENA pivotal trials.

Sequential infusion order

• Cycle 1 (loading): Perjeta 840 mg over 60 min, then Herceptin 8 mg/kg over 90 min, then chemo (if applicable). Observe 30–60 min after Perjeta.
• Cycles 2+: Perjeta 420 mg over 30–60 min, then Herceptin 6 mg/kg over 30–90 min, then chemo. Observe 30 min after each.
• Some institutions reverse order (Herceptin first); FDA label permits either sequence. Document the order in the chart.

Sequential admin CPT (when billed together)

• First drug (typically Perjeta): 96413 (chemo IV, up to 1 hour, single or initial substance)
• Second drug (sequential, Herceptin): 96417 (each additional sequential infusion of a different substance, up to 1 hour)
• If a drug's infusion exceeds 1 hour, add 96415 (each additional hour, same drug)
• Do NOT bill two 96413 codes for the same DOS; only one initial-infusion code per encounter

HER2 biomarker requirement NCCN + payer policy verified May 2026

HER2 positivity must be documented in the PA. All major payers enforce this hard requirement.

HER2 status must be confirmed positive before any pertuzumab claim. Payer PA criteria, NCCN Breast Cancer guidelines, and the FDA label all require HER2-positive disease defined per the ASCO/CAP joint guideline.

Acceptable HER2-positive criteria

• HER2 IHC 3+ (uniform, intense membrane staining of >10% of invasive tumor cells) — HER2-positive without further testing
• HER2 IHC 2+ (equivocal) AND in situ hybridization (FISH/CISH/SISH) confirming amplification:
  • HER2/CEP17 ratio ≥2.0, OR
  • HER2 gene copy number ≥6.0 signals/cell (regardless of ratio)
• HER2 IHC 0 or 1+ — HER2-negative; not eligible for Perjeta

HER2 test billing (separate from drug claim)

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Pertuzumab is billed as chemotherapy administration (complex monoclonal antibody). With Herceptin co-administration, sequential infusion code 96417 is required for the second drug.

Modifiers CMS verified May 2026

JZ — required on virtually every adult claim

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The 420 mg Perjeta maintenance dose uses exactly one 420 mg single-dose vial with zero waste; the 840 mg loading dose uses exactly two vials with zero waste. Because pertuzumab is a fixed flat dose (not weight-based), there is essentially never partial-vial waste. JZ applies to virtually every adult Perjeta claim.

JW — only for the rare waste scenario

JW reports the discarded portion of a single-dose vial. For Perjeta, JW would only apply in the rare scenario where a portion is discarded (spoilage during preparation, dose modification mid-prep, dropped vial, etc.). When this occurs, bill JW with the actual discarded units on a separate claim line. One of JZ or JW must be on every J9306 claim.

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 infusion (e.g., LVEF result review and dose decision). Routine pre-infusion clinical assessment is bundled.

340B modifiers (JG, TB)

For 340B-acquired Perjeta, follow your MAC's current 340B modifier policy. Genentech's billing guide does not provide 340B-specific instructions; Hospital Outpatient Prospective Payment System (OPPS) hospitals typically append JG (340B-acquired drug) or TB (340B-acquired drug, no payment adjustment) per their MAC instructions.

ICD-10-CM by indication FY2026 verified May 2026

Perjeta is approved exclusively for HER2+ breast cancer. Use the most specific C50.x code supported by encounter documentation.

Site of care & place of service Verified May 2026

UnitedHealthcare, Aetna, and most major BCBS plans run aggressive site-of-care UM for HER2-targeted therapies. Aetna and UHC explicitly steer Perjeta + Herceptin out of HOPD in maintenance phase unless on combo chemo or active toxicity management. Phesgo (SC) is even more office-friendly.

Claim form field mapping Genentech Mar 2026

From Genentech Access Solutions HCP coding & coverage page (Genentech Codes & Coverage 2026).

Payer policy snapshot + HER2 requirements Reviewed May 2026

All major payers require HER2 testing for Perjeta. Get the test result in hand before submitting PA. Combo PA usually covers both Perjeta and Herceptin.

Step therapy

Generally NOT required for FDA-labeled 1L HER2+ metastatic and early breast cancer. Perjeta is the first-line standard of care in combination with Herceptin per NCCN. Some payers may require documented HER2+ status and disease stage; verify per-payer.

Combo PA pattern

Because Perjeta is never billed without Herceptin, almost all payers issue a single PA covering both drugs in the regimen. Submit Perjeta + Herceptin (and the chemo backbone, if applicable) as one PA package with the HER2 test result, ICD-10, and intended regimen documented.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to pertuzumab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9306 for FDA-approved on-label HER2+ breast cancer indications with appropriate ICD-10, HER2 documentation, and Herceptin co-administration.

Code history

• J9306 — permanent code, effective January 1, 2014 (initial FDA approval was June 2012; pre-permanent-code period used unclassified J3490 / J9999)
• J9316 — Phesgo SC combination code, effective post-2020 approval

Patient assistance — Genentech Access Solutions Genentech verified May 2026

• Genentech Access Solutions: 1-866-422-2377 / genentech-access.com — benefits investigation, prior authorization assistance, appeal support
• Genentech Oncology Co-pay Assistance Program: commercial copay support up to $25,000/year, $0 out-of-pocket for eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients, including TRICARE and VA)
• Genentech Patient Foundation: free product for uninsured / underinsured patients meeting income requirements (1-888-941-3331)
• Foundations: for Medicare patients, refer to PAN Foundation, HealthWell, CancerCare — verify open HER2+ breast cancer or general oncology funds quarterly
• Web: genentech-access.com/hcp/brands/perjeta

LVEF monitoring — required during combo therapy FDA label + ASCO verified May 2026

Pertuzumab adds to the cardiotoxicity risk of trastuzumab (which carries its own Boxed Warning for cardiomyopathy). Echocardiogram (CPT 93306) or MUGA scan (CPT 78472/78473) is the standard LVEF assessment. Document baseline LVEF in the PA submission — many payers will not approve initiation without it.

LVEF test billing (separate from drug claim)

• Echocardiogram (transthoracic, complete): CPT 93306
• Echocardiogram (transthoracic, limited): CPT 93308
• MUGA scan (multigated equilibrium): CPT 78472 (single study) / 78473 (multiple studies)

Other Warnings & Precautions

• Embryo-fetal toxicity (Boxed Warning) — verify pregnancy status before initiation; effective contraception during therapy + 7 months after last dose
• Infusion reactions — observe 30–60 min after first infusion, 30 min after subsequent
• Hypersensitivity / anaphylaxis — permanent discontinuation if severe
• Pulmonary toxicity — rare interstitial lung disease; discontinue for severe pulmonary symptoms

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Perjeta?

Perjeta (pertuzumab IV) is billed under HCPCS J9306 — "Injection, pertuzumab, 1 mg." Each milligram equals one billable unit (NOT 10 mg per unit — a common error). The 840 mg loading dose is billed as 840 units; the 420 mg q3-week maintenance dose is billed as 420 units. J9306 has been effective since January 1, 2014. The fixed-dose subcutaneous combination Phesgo (pertuzumab + trastuzumab + hyaluronidase) uses HCPCS J9316 — separate code, different billing.

How many units do I bill for a Perjeta dose?

Bill 840 units of J9306 for the loading dose (cycle 1) and 420 units for each maintenance dose (q3 weeks thereafter). The 840 mg loading dose uses two 420 mg single-dose vials. The 420 mg maintenance dose uses one 420 mg single-dose vial. Pertuzumab is a fixed flat dose — NOT weight-based — so the unit math is the same for every adult patient.

What administration CPT do I use for Perjeta?

CPT 96413 — "Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug" for the first hour. The loading dose infuses over 60 minutes; subsequent doses infuse over 30–60 minutes. When co-administered with Herceptin (the standard combo), bill 96413 for the first drug and 96417 ("each additional sequential infusion of a different substance/drug, up to 1 hour") for the second drug. Do NOT bill 96365.

Do I bill JZ or JW for Perjeta?

Bill JZ on virtually every adult Perjeta claim. The 420 mg maintenance dose uses exactly one 420 mg single-dose vial with zero waste; the 840 mg loading dose uses exactly two vials with zero waste. Because pertuzumab is a fixed flat dose (not weight-based), there is essentially never partial-vial waste. JW only applies in the rare scenario where a portion is discarded. One of JZ or JW must be on every J9306 claim per CMS's July 2023 single-dose container policy.

What is the Medicare reimbursement for J9306?

For Q2 2026, the Medicare Part B payment limit for J9306 is $17.016 per mg (ASP + 6%). The 840 mg loading dose reimburses at approximately $14,293.44 per infusion; the 420 mg q3-week maintenance dose at approximately $7,146.72 per infusion. Annualized cost (Medicare ASP+6%) for a year of q3w maintenance (~17 doses + loading): approximately $128,000 in pertuzumab drug cost alone, before adding Herceptin and chemotherapy. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.

Is Perjeta always given with Herceptin?

Yes — the FDA label requires Perjeta to be administered in combination with trastuzumab (Herceptin), per the dual HER2 blockade mechanism studied in the CLEOPATRA, APHINITY, NeoSphere, and TRYPHAENA trials. Perjeta is never indicated as monotherapy. The standard regimens are: 1L HER2+ MBC (Perjeta + Herceptin + docetaxel), HER2+ early breast neoadjuvant (Perjeta + Herceptin + chemo), and HER2+ early breast adjuvant (Perjeta + Herceptin). Payer PA criteria almost always require co-prescription of Herceptin in the same submission.

Does Perjeta require HER2 testing for prior auth?

Yes — HER2 positivity must be documented in the PA via either IHC 3+ or IHC 2+ confirmed by FISH/ISH amplification (HER2/CEP17 ratio ≥2.0 or HER2 gene copy number ≥6.0). All major payers (UHC, Aetna, BCBS) require the HER2 result on the PA. Bill HER2 IHC under CPT 88360 (manual) or 88361 (computer-assisted); HER2 FISH/ISH under CPT 88374, 88377, or 88368/88369 depending on probe and methodology. Schedule HER2 testing before submitting the Perjeta PA — denial rates are high when biomarker results are not in hand at submission.

What is Phesgo and how does it differ from Perjeta?

Phesgo is the fixed-dose subcutaneous combination of pertuzumab + trastuzumab + hyaluronidase-zzxf, FDA-approved June 29, 2020 under BLA 761170. It is administered SC in 5–8 minutes (vs the IV combo's 60–150 minutes total chair time across two infusions), at fixed doses: 1,200 mg pertuzumab / 600 mg trastuzumab loading, then 600 mg pertuzumab / 600 mg trastuzumab q3 weeks. Phesgo uses HCPCS J9316 — a single combo code that replaces both J9306 (Perjeta) and J9355 (Herceptin) on the claim. Phesgo cannot be substituted for IV Perjeta + Herceptin without payer authorization — different BLA, different NDCs, different billing pathway.

What is the LVEF monitoring requirement?

Per FDA label, assess LVEF at baseline before initiating Perjeta/Herceptin combo, then every 3 months during therapy for metastatic disease, and every 3 months during therapy + every 6 months for 24 months after completion for early breast cancer adjuvant therapy. Echocardiogram (CPT 93306) or MUGA scan (CPT 78472/78473) is the standard LVEF assessment. Withhold pertuzumab and trastuzumab for symptomatic LVEF decline or LVEF <40% (or LVEF 40–45% with ≥10 percentage-point absolute decrease from baseline).

Source documents

1. Genentech Access Solutions — Perjeta Coding & Coverage HCP page
   Document footers: Genentech Codes & Coverage 2026
2. DailyMed — PERJETA (pertuzumab) Prescribing Information
   FDA-approved label, revised March 2026 (BLA 125409)
3. DailyMed — PHESGO (pertuzumab + trastuzumab + hyaluronidase-zzxf)
   SC combo formulation, FDA-approved June 2020 (BLA 761170)
4. FDA Perjeta label PDF (s139, 2024)
5. Genentech press releases — Perjeta indication expansions
6. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
7. SEER CanMED — HCPCS J9306 reference
8. UnitedHealthcare — Oncology Medication Clinical Coverage Policy (covers Perjeta + Herceptin combo)
9. Aetna CPB — HER2-Targeted Therapies for Breast Cancer (covers Perjeta, Herceptin, Phesgo)
10. NCCN Clinical Practice Guidelines in Oncology — Breast Cancer
11. FDA National Drug Code Directory

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.

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Change log

• May 2, 2026 — Initial publication. ASP data: Q2 2026. Manufacturer source: Genentech Access Solutions Mar 2026. FDA label: Mar 2026 revision (BLA 125409). HER2+ breast cancer indications (1L MBC, neoadjuvant early breast, adjuvant early breast). Phesgo SC combo (J9316, BLA 761170, June 2020 approval) referenced as sister product.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list is verified against the current FDA label revision and NCCN Breast Cancer guidelines. We do not paraphrase from billing-software vendor blogs.