Hemlibra (emicizumab-kxwh) — HCPCS J7170

About Hemlibra (emicizumab-kxwh) FDA verified May 2026

Bispecific FIXa/FX humanized antibody — FVIIIa cofactor mimetic, hemophilia A prophylaxis (with or without inhibitors), all ages.

Hemlibra (emicizumab-kxwh) is a humanized bispecific IgG4 monoclonal antibody manufactured by Genentech, Inc. (a member of the Roche Group) that simultaneously binds activated factor IX (FIXa) and factor X (FX). By bridging these two coagulation factors, emicizumab functionally substitutes for the cofactor activity of activated factor VIII (FVIIIa) and restores thrombin generation through the intrinsic coagulation pathway. Because the mechanism is FVIII-independent, Hemlibra works in patients with congenital factor VIII deficiency regardless of whether they have neutralizing FVIII inhibitors.

The FDA approved Hemlibra on November 16, 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have FVIII inhibitors. On October 4, 2018, the FDA approved a label expansion to include hemophilia A patients without FVIII inhibitors. Both approvals cover patients of all ages, including newborns. As of Q2 2026, Hemlibra is the dominant non-factor prophylactic for hemophilia A and has the broadest label and longest real-world experience of any agent in its class.

Hemlibra is administered by subcutaneous injection from a single-dose vial. Loading is 3 mg/kg once weekly for the first 4 weeks; maintenance starts at week 5 with one of three equivalent regimens: 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks. The flexibility to choose a monthly maintenance schedule materially improves adherence and is the principal reason most hemophilia A patients are on Hemlibra rather than Alhemo, which requires daily SC injection. The HAVEN clinical trial series (HAVEN 1–5) established efficacy in inhibitor and non-inhibitor adult and pediatric populations.

Hemlibra vs. Alhemo — class context FDA verified May 2026

Both are non-factor prophylactics; they target different proteins, are dosed at different cadences, and cover different populations.

Hemlibra (emicizumab, J7170) and Alhemo (concizumab-mtci, J7173) are the two FDA-approved non-factor hemophilia prophylactics as of Q2 2026. They are frequently grouped together in payer policies but they are NOT interchangeable. Hemlibra is a bispecific antibody that mimics FVIIIa by bridging activated FIX and FX — it cannot help a hemophilia B patient because there is no FIX to bridge. Alhemo's anti-TFPI mechanism is FVIII/FIX-independent and therefore covers both A and B. Hemlibra dosing is weekly to monthly; Alhemo is strictly daily. Hemlibra has the longer real-world experience window (US approval 2017 for inhibitors; 2018 expansion to non-inhibitors), broadest label (all ages, with or without inhibitors), and is typically first-line for hemophilia A in most payer policies.

Dosing & unit math FDA label current

Per FDA prescribing information — weight-based loading + 3 equivalent maintenance options.

FDA-labeled dosing

• Loading dose: 3 mg/kg SC once weekly × 4 weeks (4 loading doses)
• Maintenance options (choose ONE, starting week 5):
  • 1.5 mg/kg SC once weekly, OR
  • 3 mg/kg SC every 2 weeks, OR
  • 6 mg/kg SC every 4 weeks
• All three maintenance regimens are FDA-approved and equivalent in efficacy per HAVEN trial data
• Total mg per 4 weeks is approximately equal across all three regimens (1.5 × 4 = 6, 3 × 2 = 6, 6 × 1 = 6 mg/kg/month)
• Missed dose: per label — administer as soon as possible up to 1 day prior to the next scheduled dose, then resume the original schedule. Do not double-dose to make up.
• Storage: refrigerated; out-of-fridge tolerance per the PI

Unit math — 0.5 mg per billable unit

Worked example — 80 kg hemophilia A patient, monthly maintenance regimen

Required pre-initiation checks

• Confirm hemophilia A diagnosis (D66) with FVIII activity assay (<1% severe; 1–5% moderate; 5–40% mild)
• Inhibitor titer documentation (Nijmegen-modified Bethesda assay preferred) if inhibitor patient
• Baseline VTE risk assessment — boxed warning population, especially if aPCC use anticipated
• Bypassing-agent management plan — prefer recombinant FVIIa (NovoSeven RT) over aPCC (Feiba) for breakthrough; if aPCC required, use minimum dose <100 U/kg/24h
• Patient/caregiver SC injection training (vial draw-up technique)
• Choice of maintenance cadence (1.5 mg/kg q1w, 3 mg/kg q2w, 6 mg/kg q4w) — patient preference, document on chart
• Counseling on coagulation lab interference (Hemlibra interferes with aPTT-based assays; chromogenic Bethesda assay required for inhibitor titer)

NDC reference FDA NDC Directory verified May 2026

Genentech labeler 50242. All five presentations are single-dose vials (SDV).

Administration codes CPT verified May 2026

Hemlibra is almost always home self-administered — no admin code is billed. HTC office injection bills 96372.

Modifiers CMS verified May 2026

SDV format means JW/JZ apply per CMS single-dose container rule; HTC 340B drives JG/TB.

JG — 340B-acquired drug (Medicare)

Most hemophilia treatment centers are 340B-eligible covered entities. When the HTC acquires Hemlibra at 340B ceiling pricing and bills Medicare Part B, append modifier JG to the J7170 line for outpatient hospital claims (HOPD) per current CMS OPPS rules. JG identifies the drug as 340B-acquired and historically triggered the OPPS payment reduction (note: payment-reduction policy has been litigated and adjusted — verify the current OPPS rule for the date of service).

TB — 340B-acquired drug (some Medicare Advantage / commercial)

Beginning in 2025, CMS adopted modifier TB as the "no-pay" 340B identification modifier in certain payment scenarios, while JG retained payment-reduction implications in others. For some Medicare Advantage and commercial payers, TB is the requested identifier. Confirm payer-by-payer which 340B modifier applies; submitting the wrong one can trigger an automatic edit or recoupment audit.

JZ — no waste from single-dose container

Hemlibra vials are single-dose containers (SDV) on the CMS single-dose container list. CMS requires JZ on J7170 lines when the full vial is administered with no discarded drug. The default Hemlibra coding scenario where the patient draws up the entire vial contents (e.g., 150 mg dose from a 150 mg/1 mL vial, no residual) is a JZ scenario.

JW — documented wastage

Use JW on a separate line for the discarded mg when a patient-specific dose does not match a vial size exactly and the remaining vial contents must be discarded (SDV cannot be reused). Example: a 120 mg dose from one 150 mg vial discards 30 mg → bill 240 units of J7170 on the administered line and 60 units of J7170-JW on the wastage line. Document vial size, calculated dose, mg administered, and mg wasted in the chart.

Worked example — HOPD HTC dispensing 480 mg monthly maintenance, 340B-acquired

• Patient: 80 kg hemophilia A non-inhibitor, monthly maintenance 6 mg/kg = 480 mg every 4 weeks
• Vial combination: 1 × 300 mg + 1 × 150 mg + 1 × 30 mg = 480 mg exact (no waste)
• Line 1: J7170 × 960 units with modifiers JG (Medicare HOPD, 340B) and JZ (no waste)
• NDCs reported: 50242-0924-01 (300 mg), 50242-0923-01 (150 mg), 50242-0920-01 (30 mg) with N4 qualifier — one composite or separate lines per payer convention
• No JW (no waste because vial combo matches dose exactly)

Worked example — same patient on weekly maintenance, partial-vial waste

• Patient: 80 kg hemophilia A non-inhibitor, weekly maintenance 1.5 mg/kg = 120 mg per dose
• Vial used: 1 × 150 mg vial; 120 mg administered, 30 mg discarded (SDV cannot be reused)
• Line 1: J7170 × 240 units with modifier JG (administered)
• Line 2: J7170 × 60 units with modifiers JG + JW (wastage)
• Document calculated dose, mg administered, mg wasted, vial size in chart

ICD-10-CM diagnosis codes FY2026 verified May 2026

D66 primary on every claim; pair with D68.311 for inhibitor patients.

Site of care & place of service Verified May 2026

Hemlibra's weekly-to-monthly SC self-injection rhythm pushes site of care toward the patient's home for maintenance. The relevant decision is whether the dispensing channel is pharmacy benefit (specialty pharmacy fills) or medical benefit (HTC buy-and-bill). HOPD administration is uncommon for Hemlibra because it is not infused — the most common reasons for an in-clinic dose are loading injections, training, or breakthrough-bleed management at an HTC.

Claim form field mapping Verified May 2026

CMS-1500 / 837P for HTC office or home dispensing under medical benefit. NCPDP D.0 for pharmacy-benefit specialty pharmacy fills.

Medical benefit (J7170) — CMS-1500 / 837P

Pharmacy benefit (NDC) — NCPDP D.0

Specialty pharmacy dispensing under the pharmacy benefit submits NCPDP D.0 with the Hemlibra NDC, days supply, DAW code, and prescriber NPI. Specialty pharmacy benefits investigation typically precedes the first fill; the pharmacy handles PA and copay assistance enrollment with Genentech Access Solutions. Days supply is calculated from the patient's maintenance cadence (e.g., a 30-day fill on the q4wk regimen is one dose; on the weekly regimen is 4–5 doses).

Form references: NUCC (CMS-1500); NCPDP (D.0 pharmacy claim standard).

Payer policy snapshot Reviewed May 2026

Universal prior authorization. Hemlibra is first-line non-factor prophylactic for hemophilia A at most plans.

What to document for approval

• Confirmed hemophilia A (D66) diagnosis with FVIII activity assay and severity classification
• Inhibitor status: titer in BU (Nijmegen-modified chromogenic Bethesda; Hemlibra interferes with aPTT-based assays), with date and lab, if inhibitor patient
• Inhibitor history: high-responder vs low-responder status, dates of first detection
• Prior prophylactic and on-demand regimen (factor concentrates, bypassing agents) with response
• VTE risk assessment (boxed warning compliance)
• aPCC (Feiba) management plan — prefer recombinant FVIIa (NovoSeven RT) for breakthrough; if aPCC required, limit dose <100 U/kg/24h
• Body weight (within 30 days) for accurate loading and maintenance dose calculation
• Patient/caregiver training completion or scheduled training plan for SC self-injection from vial
• Maintenance cadence selection (1.5 mg/kg q1w / 3 mg/kg q2w / 6 mg/kg q4w) documented in chart

Medicare reimbursement CMS Q2 2026 (live)

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

Part B vs Part D

For Medicare beneficiaries, Hemlibra can be billed under Part B when administered or dispensed under a provider's "incident to" framework at an HTC (medical benefit, J7170) or under Part D when dispensed by a Medicare-contracted specialty pharmacy for home self-administration (pharmacy benefit). Part B coinsurance is 20% (after deductible) with no annual cap unless covered by Medigap or other secondary; Part D has plan-specific cost-sharing tiers and (post-2025) a $2,000 annual OOP cap under the Inflation Reduction Act — highly relevant at Hemlibra's price point.

Coverage

No NCD specific to emicizumab-kxwh. Coverage falls under the generic drug-coverage LCD framework (e.g., LCD L33394). All MACs cover J7170 for FDA-approved on-label indications. Bill with appropriate ICD-10. Next CMS ASP update: July 1, 2026 for Q3 2026 (effective Jul 1 – Sep 30, 2026).

Code history

• November 16, 2017 — FDA approval (hemophilia A with FVIII inhibitors)
• October 4, 2018 — FDA label expansion to hemophilia A without inhibitors
• Pre-J7170 effective date — claims under unclassified J3590 with NDC
• J7170 permanent code, "Injection, emicizumab-kxwh, 0.5 mg" (0.5 mg = 1 unit)
• Q2 2026 ASP+6% = $55.640 per 0.5 mg unit ($111.28/mg)

Patient assistance — Genentech Access Solutions Genentech verified May 2026

• Genentech Access Solutions: 1-866-422-2377 — central hub for benefits investigation, PA support, copay assistance enrollment, and shipment coordination across the Genentech rare disease portfolio
• Hemlibra Co-pay Program: commercial patients only. Pays out-of-pocket drug cost up to program limits per calendar year. Excludes Medicare, Medicaid, TRICARE, VA, CHIP, and other federal program patients. Enrollment via Genentech Access Solutions or HemlibraCopay.com.
• Genentech Patient Foundation (GPF): free product for uninsured / functionally uninsured patients who meet financial criteria. Application via prescriber through Genentech Access Solutions; income threshold typically ≤500% FPL.
• Bridge program: interim free supply available while coverage is being pursued (eligibility criteria apply, time-limited).
• Case managers: Genentech Access Solutions assigns a dedicated case manager at enrollment for ongoing coverage troubleshooting and reauthorization support.
• Patient enrollment form: Genentech Access Solutions Hemlibra forms and documents
• Web: hemlibra.com (patient site) · hemlibra-hcp.com (HCP site) · genentech-access.com
• Foundation backup (federal program patients): Patient Access Network Foundation (PAN), HealthWell Foundation, National Bleeding Disorders Foundation (NBDF, formerly NHF) financial assistance programs — verify open funds quarterly.
• Hemophilia Federation of America (HFA): Helping Hands financial assistance for hemophilia-related out-of-pocket costs.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Hemlibra?

Hemlibra (emicizumab-kxwh) is billed under HCPCS J7170 — "Injection, emicizumab-kxwh, 0.5 mg." One billable unit equals 0.5 mg of drug, so a 60 mg dose bills as 120 units, a 150 mg dose bills as 300 units, and a 300 mg dose bills as 600 units. J7170 is used when Hemlibra is dispensed and billed through the medical benefit (typical for hemophilia treatment centers operating under buy-and-bill). Most commercial and Medicare Part D plans route home-administered Hemlibra through the pharmacy benefit using the NDC instead.

Hemlibra vs Alhemo — which one should I bill?

Hemlibra (emicizumab, J7170) and Alhemo (concizumab-mtci, J7173) are NOT interchangeable. Hemlibra is a bispecific FIXa/FX humanized antibody dosed once weekly, every two weeks, or every four weeks SC; it is FDA-approved for hemophilia A only (FVIII deficiency) with or without inhibitors, all ages from birth. Alhemo is a first-in-class anti-TFPI antibody dosed once DAILY SC; it covers hemophilia A and B (with or without inhibitors), age ≥12 years only. For hemophilia A patients, Hemlibra is first to market and is typically first-line. Alhemo is the only labeled non-factor option for hemophilia B with inhibitors. Both use 0.5 mg = 1 unit.

How is Hemlibra dosed — loading vs maintenance?

Loading dose: 3 mg/kg subcutaneous once weekly for the first 4 weeks (4 loading doses total). Maintenance starts at week 5 with one of three FDA-approved options: 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks. All three regimens are equivalent in efficacy per HAVEN trial data; choice is patient preference and adherence-driven. Round each dose to the nearest vial-deliverable combination. The total mg per maintenance interval is approximately the same across all three regimens (~6 mg/kg/month).

What maintenance cadence flexibility do I have on the claim?

The maintenance cadence (q1w, q2w, q4w) is a patient-preference choice, not a clinical one — all three deliver the same monthly mg/kg. Document the chosen cadence on the chart and in the NTE segment of the claim. Payers reconcile per-dose units against the cadence (e.g., 480 mg q4wk vs 120 mg q1w). The annualized drug spend is essentially the same across the three regimens, but the days-supply calculation and number of vials per fill differ significantly — affects JW/JZ exposure and dispensing logistics.

Is Hemlibra billed under pharmacy or medical benefit?

Both pathways are in use. When the patient self-administers at home from a specialty pharmacy fill, most commercial plans and Medicare Part D adjudicate the claim under the pharmacy benefit using the NDC. When the patient receives drug through an HTC under buy-and-bill, the claim runs under the medical benefit using HCPCS J7170. Verify the assigned channel BEFORE the first fill — wrong-benefit routing is the single most common Hemlibra denial.

Can hemophilia treatment centers bill 340B for Hemlibra?

Yes. HTCs that participate in the 340B Drug Pricing Program are eligible to acquire Hemlibra at 340B ceiling pricing. For Medicare Part B claims, use modifier JG on the J7170 line to indicate 340B-acquired drug. Some Medicare Advantage plans and a handful of commercial payers require modifier TB instead for 340B identification — confirm with each payer. Hemophilia clotting factors and non-factor prophylactics have historically been carved out of certain HOPD 340B payment reductions; verify the current CMS OPPS rule and your MAC's policy for the dispensing date of service.

Is Hemlibra approved for pediatric patients?

Yes — all ages, including newborns. The Hemlibra FDA label covers hemophilia A patients of any age from birth onward, with or without FVIII inhibitors. This is a significant differentiator from Alhemo (J7173), which is labeled ≥12 years only. Pediatric hemophilia A patients under 12 with or without inhibitors should be on Hemlibra (or factor concentrate where appropriate); Alhemo is not a labeled option in this age group.

Why is the Feiba/aPCC combination a boxed warning?

Hemlibra carries a boxed warning for thrombotic microangiopathy (TMA) and thromboembolic events in patients receiving activated prothrombin complex concentrate (aPCC, brand name Feiba) at average cumulative amounts of greater than 100 U/kg/24 hours for 24 hours or more. The mechanism is Hemlibra's FVIIIa-mimetic activity stacking on top of aPCC's procoagulant effect. For breakthrough bleeds, use the minimum bypassing-agent dose; prefer recombinant FVIIa (NovoSeven RT) over aPCC when possible. This warning is unique to Hemlibra and does not apply to Alhemo (different mechanism, separate boxed warning).

What is the Medicare reimbursement for J7170?

For Q2 2026, the Medicare Part B payment limit for J7170 is $55.640 per 0.5 mg unit (ASP + 6%) — equivalent to $111.28 per mg. A 150 mg dose reimburses at approximately $16,692.00 before sequestration; a 480 mg monthly maintenance dose (80 kg patient at 6 mg/kg q4wk) reimburses at approximately $53,414.40. ASP is updated quarterly by CMS; next update July 1, 2026 for Q3 2026.

Source documents

1. FDA — HEMLIBRA (emicizumab-kxwh) Prescribing Information (current revision)
   FDA-approved label, BLA 761083 (initial approval November 16, 2017; non-inhibitor label expansion October 4, 2018)
2. DailyMed — HEMLIBRA emicizumab-kxwh injection, solution
   Current FDA label (canonical Genentech SPL); NDC details for 30 / 60 / 105 / 150 / 300 mg single-dose vials
3. FDA — News Release on Emicizumab Approval for Hemophilia A without FVIII Inhibitors
   FDA announcement of October 4, 2018 label expansion to non-inhibitor population
4. FDA — News Release on Initial Hemlibra Approval (Nov 16, 2017)
   Initial FDA approval for hemophilia A with FVIII inhibitors
5. hemlibra.com — patient site
   Vial formats, support program details, patient enrollment, copay program
6. hemlibra-hcp.com — HCP site
   Dosing references, HAVEN trial data, reimbursement and coding guides
7. Genentech Access Solutions — Hemlibra HCP resources
   Copay assistance, Patient Foundation, bridge program, benefits investigation (1-866-422-2377)
8. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026 (J7170 = $55.640 per 0.5 mg unit)
9. CMS — HCPCS quarterly update file
   J7170 permanent code (canonical J-code source)
10. CMS — JW Modifier and JZ Modifier policy
    Single-dose container reporting requirements (effective July 1, 2023). Hemlibra vials are SDVs on the CMS list.
11. HRSA — 340B Drug Pricing Program
    HTC eligibility and 340B ceiling price reference (JG / TB modifier framework)
12. National Bleeding Disorders Foundation (NBDF) — clinical and patient resources
    MASAC (Medical and Scientific Advisory Council) treatment recommendations, including Hemlibra positioning and inhibitor management guidance
13. Hemophilia Federation of America (HFA) — patient support
    Helping Hands financial assistance for hemophilia-related out-of-pocket costs
14. New England Journal of Medicine — HAVEN trial series (HAVEN 1, 2, 3, 4, 5)
    Pivotal Phase 3 trials supporting the 2017 inhibitor approval (HAVEN 1, 2) and 2018 non-inhibitor label expansion (HAVEN 3, 4). HAVEN 4 established the q4wk maintenance option; HAVEN 5 supported pediatric <12 yr safety/efficacy.
15. FDA National Drug Code Directory
    All Genentech labeler 50242 emicizumab-kxwh NDCs
16. Genentech, Inc. (Roche)
    Manufacturer (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 (J7170 = $55.640 per 0.5 mg unit; $111.28/mg). FDA approval November 16, 2017 (hemophilia A with FVIII inhibitors); October 4, 2018 label expansion to non-inhibitor hemophilia A. NDCs: 50242-920-01 (30 mg), 50242-921-01 (60 mg), 50242-922-01 (105 mg), 50242-923-01 (150 mg), 50242-924-01 (300 mg). Manufacturer support program: Genentech Access Solutions (1-866-422-2377). Payer policies: UHC, Aetna, Cigna, Carelon/Anthem, BCBS, Medicare, Medicaid — Hemlibra is first-line non-factor prophylactic for hemophilia A across the board.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for J7170 (Q2 2026 = $55.640 per 0.5 mg unit). Dosing reflects the current FDA prescribing information. The 0.5-mg-per-unit HCPCS convention is the most common Hemlibra coding error and is emphasized in multiple sections rather than buried. The Hemlibra vs Alhemo disambiguation is also emphasized because the two drugs are frequently confused in payer policy auto-edits despite covering different hemophilia populations at different cadences.