PiaSky (crovalimab-akkz) — HCPCS J1307

Crovalimab vs Soliris vs Ultomiris — the three anti-C5 mAbs FDA verified May 2026

Same biological target (terminal complement C5), three very different administration burdens, three different indication footprints, three separate REMS enrollments.

Crovalimab (PiaSky, J1307) joined the anti-C5 class on June 20, 2024 as the first Genentech / Roche entrant alongside Alexion's Soliris (eculizumab, J1299, originator 2007) and Ultomiris (ravulizumab-cwvz, J1303, longer-acting follow-on 2018). All three are monoclonal antibodies that bind C5 and prevent its cleavage to C5a and C5b, blocking terminal complement activation. The clinical rationale for adding PiaSky is primarily route and frequency: crovalimab is the only anti-C5 with a q4wk subcutaneous maintenance regimen after a single IV load — enabling at-home self-injection after training and reducing infusion-center volume.

Dosing & unit math FDA label current

Weight-banded loading and maintenance per the 2024 PiaSky USPI (BLA 761388). Single IV load, then weekly SC loading, then q4wk SC maintenance.

Dose schedule by body weight

• 1 unit = 10 mg under J1307
• Per dose, by vial count (340 mg / 2 mL SDV at 170 mg/mL): 340 mg = 1 vial · 680 mg = 2 vials · 1,000 mg = 3 vials with ~20 mg discarded · 1,020 mg = 3 vials · 1,500 mg = 5 vials with ~200 mg discarded
• IV dilution: Day 1 dose diluted in 0.9% NaCl per label and infused over 60 to 90 minutes
• SC administration: undiluted at 170 mg/mL; 1 mL per injection site — 340 mg = 2 sites; 680 mg = 4 sites; 1,020 mg = 6 sites (abdominal rotation recommended)
• Pediatric dosing (≥13 years and ≥40 kg): identical to adult weight-banded schedule above
• NOT studied / not approved: patients <13 years, <40 kg, or in aHUS / gMG / NMOSD

Worked example — year-1 billing, 75 kg adult with PNH

Required pre-administration checks (per PIASKY REMS)

• Confirm meningococcal vaccination status (MenACWY + MenB) per ACIP, completed at least 2 weeks before first dose (or antibacterial prophylaxis if therapy cannot wait)
• Document PIASKY REMS prescriber certification on file
• No active or untreated infection (especially meningococcal)
• Patient has received the PIASKY Patient Safety Card and counseling on signs / symptoms of meningococcal infection
• Confirm the patient is ≥13 years and ≥40 kg (label inclusion criteria)

NDC reference FDA NDC Directory verified May 2026

PIASKY REMS — mandatory enrollment Genentech verified May 2026

PiaSky is available only through the PIASKY REMS program because of the boxed warning for serious infections caused by Neisseria meningitidis.

Crovalimab, like the other anti-C5 monoclonal antibodies, inhibits terminal complement and dramatically increases susceptibility to meningococcal disease — including life-threatening and fatal cases, even in vaccinated patients. The PIASKY REMS is operated by Genentech and is separate from the Alexion Soliris / Ultomiris REMS framework: a prescriber or site that already participates in the Alexion-side REMS must enroll independently in PIASKY REMS to prescribe or dispense crovalimab.

Who must enroll

• Prescribers: certified through PIASKY REMS; must complete training and agree to counseling and reporting obligations
• Pharmacies / specialty distributors: only REMS-certified channels may dispense
• Infusion and home-infusion sites: must verify REMS certification before administering or supporting self-injection
• Patients: must receive the PIASKY Patient Safety Card and counseling; must complete vaccination per ACIP

Vaccination requirement

• MenACWY (quadrivalent meningococcal conjugate vaccine) per ACIP schedule
• MenB (serogroup B meningococcal vaccine) per ACIP schedule
• Both must be completed at least 2 weeks before the first crovalimab dose
• If urgent crovalimab therapy is required and the patient is unvaccinated: administer antibacterial prophylaxis (typically penicillin-class) and vaccinate as soon as feasible
• Booster doses per ACIP recommendations while on therapy
• Patient counseling on signs / symptoms of meningococcal infection at every visit

Patient Safety Card

Every patient must receive (and carry) a PIASKY Patient Safety Card that describes the boxed warning, vaccination history, prescriber contact information, and instructions to seek immediate medical care for fever or other signs of infection. Documentation that the card was provided is a frequent payer-audit target.

Billing implications

There is no separate REMS HCPCS code — REMS enrollment is not billable. However, documentation of PIASKY REMS enrollment and meningococcal vaccination status is required by virtually every payer's prior authorization. Notes should reference PIASKY REMS prescriber certification on each administration encounter, and the vaccination completion dates should be in the chart at induction and at each renewal.

Contact: PIASKY REMS — 1-866-469-7599 · PiaSkyREMS.com. Genentech Medical Information also operates a separate clinical-question line at 1-800-821-8590 (M–F, 5 am to 5 pm PT).

Administration codes CPT verified May 2026

PiaSky is non-chemotherapeutic and uses a mixed IV / SC schedule — two different admin CPTs are in play across the regimen.

Modifiers CMS verified May 2026

JZ — whole-vial use, default expectation for SC doses

Effective July 1, 2023, CMS requires JZ on all claims for single-dose container drugs when no drug is discarded. The PiaSky 340 mg vial paired with the SC regimen yields whole-vial multiples for the standard doses: 340 mg SC = 1 vial, 680 mg SC = 2 vials, 1,020 mg SC = 3 vials. JZ is the expected modifier on all standard SC doses. Verify against the current CMS single-dose container list at billing time — J1307 was added to the list with the April 2025 update cycle.

JW — vial waste on the IV loading dose

The Day 1 IV loading doses do not divide cleanly into the 340 mg vial: 1,000 mg requires 3 vials (1,020 mg drawn, 20 mg discarded); 1,500 mg requires 5 vials (1,700 mg drawn, 200 mg discarded). Bill the discarded mg on a separate line with the JW modifier and document the wasted volume in the medical record.

Worked JW example — 1,000 mg IV load (40 to <100 kg)

Modifier 25 — situational

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as administration. Routine pre-administration REMS / vaccination verification is bundled into the admin code.

340B modifiers (JG, TB)

For 340B-acquired PiaSky, follow your MAC's current 340B modifier policy. Crovalimab is a newer, higher-WAC product than Soliris (reference) or its biosimilars, so 340B economics on PiaSky may be more favorable for eligible centers than on the eculizumab products — check site-specific contract terms before electing.

ICD-10-CM diagnosis codes FY2026 verified May 2026

Crovalimab is PNH-only — the diagnosis space is narrow.

Site of care & place of service Verified May 2026

PiaSky's regimen is bimodal: the Day 1 IV load needs an infusion-capable setting (HOPD, freestanding ambulatory infusion suite, or hematology office), while the recurring SC doses (loading and maintenance) can be administered in a much wider range of settings — including the patient's home after training. UHC, Aetna, Cigna, and Anthem all operate site-of-care UM programs for high-cost biologics; expect those programs to steer crovalimab maintenance away from HOPD toward AIC or home as soon as the patient is stable.

Claim form field mapping Verified May 2026

CMS-1500 / 837P (physician office, AIC, home; POS 11/49/12). UB-04 / 837I for HOPD (POS 19/22).

Form references: NUCC (CMS-1500).

Payer policy snapshot Reviewed May 2026

PA universal; step therapy through Soliris or Ultomiris common at new start; site-of-care steering active.

What to document for approval

• Confirmed PNH diagnosis with flow cytometry (GPI-deficient clone with quantification)
• Evidence of intravascular hemolysis (LDH typically >1.5× ULN, low haptoglobin, indirect hyperbilirubinemia)
• Patient age ≥13 years and body weight ≥40 kg
• PIASKY REMS prescriber certification on file
• MenACWY + MenB vaccination completion dates ≥2 weeks before first dose (or antibacterial prophylaxis documentation)
• Step-therapy evidence (eculizumab / biosimilar or ravulizumab trial and outcome), OR clinical justification for first-line PiaSky (e.g., demonstrated intolerance, vascular access, route preference)
• Baseline labs: LDH, haptoglobin, CBC, reticulocyte count, transfusion history

Medicare reimbursement CMS Q2 2026 (live)

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

Per-dose reimbursement — Q2 2026

Coverage

No NCD specific to crovalimab. Coverage falls under the generic drug-coverage LCD framework, with commercial and Medicare Advantage payers applying their complement-inhibitor / anti-C5 medical policies. All MACs cover J1307 for FDA-approved on-label PNH when the standard PA and REMS criteria are met. The CMS Part B Drug ASP Pricing File first listed J1307 in Q1 2026 at the same per-10-mg payment rate as Q2 2026 ($551.512); the J-code was assigned with the January 2026 HCPCS quarterly update.

Code history

• June 20, 2024 — FDA approval (BLA 761388); initially billed under unclassified codes (J3490 / J3590 / C9399 depending on setting)
• January 1, 2026 — J1307 assigned, "Injection, crovalimab-akkz, 10 mg" (10 mg = 1 unit), effective with the Q1 2026 HCPCS update
• April 1, 2026 (Q2 2026) — First quarter with a stable ASP-based payment rate: $551.512 per 10 mg unit
• Next ASP update: July 1, 2026 for Q3

Patient assistance — Genentech Access Solutions / PiaSky Access Solutions Genentech verified May 2026

Genentech's standard hub serves the PiaSky program with co-pay support, foundation referral, and PAP for eligible uninsured patients.

• PiaSky Access Solutions: (855) 274-2759
• Genentech Access Solutions (general): (877) GENENTECH / (877) 436-3683 (6 am to 5 pm PT, M–F)
• PiaSky Co-pay Program: commercial copay assistance for eligible patients — learn more at (800) 888-8051. Excludes Medicare, Medicaid, and other federal-program patients per federal anti-kickback rules.
• Independent foundation referral: Genentech routes Medicare and Medicaid patients to independent co-pay foundations (PAN, HealthWell, NORD) as funding allows
• Genentech Patient Foundation (GPF): free drug for eligible uninsured patients (income / clinical-need criteria apply); the PAP arm of Genentech Access Solutions
• PIASKY REMS clinical / safety contact: 1-866-469-7599 · PiaSkyREMS.com
• Genentech Medical Information: 1-800-821-8590 (5 am to 5 pm PT, M–F)
• Web: genentech-access.com/patient/brands/piasky

Independent foundations (for Medicare / Medicaid / uninsured)

• NORD (National Organization for Rare Disorders) — PNH fund opens intermittently
• PAN Foundation — PNH fund opens as funding allows; check status before each enrollment cycle
• HealthWell Foundation — periodic disease-specific funds for complement-mediated PNH
• Good Days — occasional rare-disease funds applicable to PNH

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for PiaSky (crovalimab)?

PiaSky (crovalimab-akkz) is billed under HCPCS J1307 — "Injection, crovalimab-akkz, 10 mg." Each 10 mg equals one billable unit, so the 1,000 mg IV loading dose (40 to <100 kg patients) is 100 units, the 1,500 mg IV loading dose (≥100 kg) is 150 units, the 340 mg weekly SC loading dose is 34 units, and the 680 mg or 1,020 mg q4wk SC maintenance dose is 68 or 102 units respectively. The product ships as a 340 mg / 2 mL (170 mg/mL) single-dose vial under NDC 50242-115-01.

Crovalimab vs Soliris vs Ultomiris — when to choose which anti-C5?

All three target complement C5 but differ on burden, indication breadth, and route. Soliris (eculizumab, J1299) is the reference C5 inhibitor and the only product approved for NMOSD; IV q2wk maintenance (~26 infusions/year). Ultomiris (ravulizumab-cwvz, J1303) is the longer-acting Alexion product with IV or SC OnBody q8wk maintenance (~6–7 doses/year); covers PNH, aHUS, gMG, NMOSD. PiaSky (crovalimab-akkz, J1307) is the only anti-C5 with a primarily SC regimen after a single IV load — q4wk SC maintenance enables a self-administration / at-home pathway after training; FDA approval is limited to PNH in patients ≥13 years and ≥40 kg. Choice usually turns on indication (NMOSD = Soliris or Ultomiris), route preference (SC convenience = PiaSky), and payer steering on cost-minimization.

Does PiaSky have a REMS program?

Yes. PiaSky is available only through the PIASKY REMS program because of the boxed warning for serious infections caused by Neisseria meningitidis. Prescribers and pharmacies must enroll. Patients must complete MenACWY plus MenB vaccination per ACIP at least 2 weeks before the first dose; if urgent therapy cannot wait, antibacterial prophylaxis must be administered while the patient is vaccinated. The PIASKY REMS is separate from the Soliris REMS / Ultomiris REMS framework operated by Alexion — prescribers and sites that treat across the C5 inhibitor class must enroll in each product's REMS independently. PIASKY REMS contact: 1-866-469-7599 or PiaSkyREMS.com.

What is PiaSky's loading and maintenance schedule?

Weight-banded, with a one-time IV load followed by weekly SC loading and q4wk SC maintenance. For body weight 40 to <100 kg: Day 1 = 1,000 mg IV; Days 2, 8, 15, 22 = 340 mg SC each; then 680 mg SC every 4 weeks starting Day 29. For body weight ≥100 kg: Day 1 = 1,500 mg IV; Days 2, 8, 15, 22 = 340 mg SC each; then 1,020 mg SC every 4 weeks starting Day 29. The Day 1 IV infuses over approximately 60 to 90 minutes (after dilution); subsequent SC doses inject at multiple sites (340 mg = 2 sites; 680 mg = 4 sites; 1,020 mg = 6 sites; 1 mL per site at 170 mg/mL undiluted).

What is the administration CPT for PiaSky?

Two codes apply across the regimen. CPT 96365 — "Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour" — for the Day 1 IV loading dose. CPT 96372 — "Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular" — for every other dose in the regimen (Days 2, 8, 15, 22 loading plus all q4wk maintenance). Crovalimab is non-chemotherapeutic, so 96413 (chemo administration) is NOT appropriate.

Can PiaSky be self-administered at home?

Per the FDA label, PiaSky SC injections may be administered by a healthcare professional or, after appropriate training, by the patient or caregiver. In practice, the Day 1 IV loading dose and the early SC loading doses (Days 2, 8, 15, 22) are administered in a clinical setting under direct observation, and the q4wk SC maintenance phase is the realistic self-administration window. Payer policies vary widely on whether home self-injection is reimbursed under the medical benefit or whether the product moves to the specialty pharmacy / pharmacy benefit at maintenance; verify with each plan before the first home dose. REMS counseling and vaccination currency must be maintained whether administration happens in clinic or at home.

What ICD-10 codes apply to PiaSky?

PiaSky is FDA-approved only for PNH, so the primary code is D59.5 (Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli]). Payer policies typically require flow-cytometry confirmation of a GPI-deficient clone (CD55 / CD59-negative) with quantification of clone size, plus evidence of intravascular hemolysis (elevated LDH, decreased haptoglobin) for prior authorization. Crovalimab does NOT carry approval for aHUS, gMG, or NMOSD — patients with those diagnoses should be considered for Soliris or Ultomiris instead.

What is the Medicare reimbursement for J1307?

For Q2 2026, the Medicare Part B payment limit for J1307 is $551.512 per 10 mg unit (ASP + 6%). The 1,000 mg IV load (40 to <100 kg) reimburses at approximately $55,151.20 (100 units); the 1,500 mg IV load (≥100 kg) at approximately $82,726.80 (150 units); the 340 mg SC weekly load at approximately $18,751.41 per dose (34 units); the 680 mg q4wk SC maintenance at approximately $37,502.82 (68 units); and the 1,020 mg q4wk SC maintenance at approximately $56,254.22 per dose (102 units), all before sequestration (~2%). ASP is updated quarterly by CMS; the next refresh is July 1, 2026 for Q3.

What are the most common PiaSky denials?

The single most common denial driver is missing or insufficient meningococcal vaccination documentation — both MenACWY and MenB completion dates at least 2 weeks before the first dose must be in the chart and frequently submitted with the prior authorization. Other top denial reasons: PNH diagnosis not fully documented (flow cytometry / clone size missing, no evidence of hemolysis); step therapy through Soliris or Ultomiris not met or failure not documented; PIASKY REMS prescriber / site not enrolled; site-of-care mismatch (e.g., HOPD admin when payer requires AIC or home for SC maintenance); and NDC-to-HCPCS misalignment when dispensing the 340 mg vial.

Source documents

1. FDA — PiaSky (crovalimab-akkz) Prescribing Information, 2024
   FDA-approved label (BLA 761388), with boxed warning, weight-banded dosing, REMS framework
2. DailyMed — PIASKY (crovalimab) Prescribing Information
   SetID 2597efc2-a97b-487c-b500-a67fd282a73b (Genentech, Inc.)
3. FDA — PiaSky Approval Letter, June 20, 2024
   BLA 761388 approval letter; PNH indication for patients ≥13 years and ≥40 kg
4. PIASKY REMS — Genentech REMS portal
   Prescriber and pharmacy enrollment, patient counseling, vaccination requirements · 1-866-469-7599
5. PiaSky Access Solutions — Genentech patient support
   Co-pay program, foundation referral, Genentech Patient Foundation (PAP) · (855) 274-2759
6. Genentech — PiaSky information for healthcare providers
   Manufacturer HCP hub with REMS, dosing, and access resources
7. COMMODORE 2 — Phase III randomized trial of crovalimab vs eculizumab in complement-inhibitor-naive PNH
   Pivotal trial supporting FDA approval (NEJM and Blood publications, 2024)
8. COMMODORE 1 — Phase III trial of crovalimab vs eculizumab in C5-inhibitor-experienced PNH
   Switch-from-eculizumab trial supporting FDA approval (2024)
9. NORD — Paroxysmal Nocturnal Hemoglobinuria (PNH)
   Patient-facing PNH overview; foundation funding contacts
10. CDC / ACIP — Meningococcal Vaccination Recommendations
    MenACWY + MenB schedule referenced by the anti-C5 REMS framework (incl. PIASKY REMS)
11. AAFP — Meningococcal Vaccination: Guidance for Eculizumab and Anti-C5 Therapy
    Primary-care guidance on anti-C5 REMS vaccination workflow
12. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026
13. CMS — HCPCS quarterly update file (canonical J-code source)
    J1307 assigned with the January 2026 HCPCS update
14. FDA National Drug Code Directory
    NDC 50242-115-01 (Genentech labeler 50242)

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 — Initial publication. ASP data: Q2 2026 (J1307 = $551.512 per 10 mg unit). FDA approval verified June 20, 2024 (BLA 761388). NDC verified 50242-115-01. Dose schedule verified against the 2024 FDA label (40 to <100 kg: 1,000 mg IV day 1 / 340 mg SC weekly × 4 / 680 mg SC q4wk; ≥100 kg: 1,500 mg IV day 1 / 340 mg SC weekly × 4 / 1,020 mg SC q4wk). PIASKY REMS contact verified 1-866-469-7599. Genentech Access Solutions / PiaSky Access Solutions: (855) 274-2759. Class context: positioned vs Soliris (J1299, eculizumab + biosimilars Bkemv Q5152 / Epysqli Q5151) and Ultomiris (J1303, ravulizumab-cwvz).

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. We do not paraphrase from billing-software vendor blogs. The weight-banded dose schedule is taken from the 2024 PiaSky USPI (BLA 761388) and cross-checked against the COMMODORE 1 and COMMODORE 2 pivotal trial publications. Vial-waste calculations are derived from the FDA-labeled doses combined with the 340 mg / 2 mL single-dose vial. When payer guidance is inconsistent (as with per-injection-site SC billing under 96372), we surface the ambiguity rather than asserting a definitive answer.