Home › Drugs › Alhemo (J7173)

Alhemo (concizumab-mtci) — HCPCS J7173

Novo Nordisk Inc. · 60 / 150 / 300 mg prefilled pens · First-in-class anti-TFPI mAb · FDA-approved December 20, 2024

Alhemo is Novo Nordisk's first-in-class anti-tissue factor pathway inhibitor (anti-TFPI) monoclonal antibody for once-daily subcutaneous prophylaxis of bleeding episodes in adults and pediatric patients (≥12 years) with hemophilia A or B. The December 20, 2024 FDA approval was specifically for the inhibitor population (FVIII or FIX inhibitors); the label was subsequently expanded in 2025 to include patients without inhibitors. HCPCS J7173 bills at 0.5 mg = 1 unit, so a 150 mg dose bills as 300 units. Q2 2026 Medicare: $166.944/mg ($25,041.60 per 150 mg fill). Daily SC self-administration means the claim typically routes through the pharmacy benefit via NDC; hemophilia treatment centers (HTCs) operating under buy-and-bill use J7173 on the medical benefit with the JG (Medicare) or TB (some commercial) 340B modifier where applicable.

✓ASP data:Q2 2026 (live)
✓Payer policies:verified May 2026
✓Manufacturer guide:Novo Nordisk 2025
✓FDA label:Jul 2025 revision
✓Page reviewed:

Instant Answer — the 5 things you need to bill J7173

HCPCS
J7173
0.5 mg = 1 unit (not 1 mg)
Daily dose
0.2 mg/kg
SC once daily, individualized
340B Modifier
JG / TB
JG = Medicare · TB = some MA/comm
Admin CPT
None / 96372
Home self-inj · 96372 if HTC office
Medicare ASP+6%
$166.944
per mg, Q2 2026 · $25,041.60/150 mg
HCPCS descriptor
J7173 — "Injection, concizumab-mtci, 0.5 mg" Permanent Eff. Q4 2025
Loading dose
1 mg/kg SC on day 1 (single dose)
Initial daily dose
0.2 mg/kg SC once daily starting day 2 — individualize by plasma concentration at 4 weeks (no later than 8 weeks)
Pen sizes
60 mg / 1.5 mL (40 mg/mL, brown label) · 150 mg / 1.5 mL (100 mg/mL, gold) · 300 mg / 3 mL (100 mg/mL, white)
Primary NDCs
0169-2084-15 (60 mg) · 0169-2080-15 (150 mg) · 0169-2081-03 (300 mg) — Novo Nordisk labeler 0169
Route
Subcutaneous self-injection (abdomen, thigh, upper arm) via 32G × 4 mm needle — once daily, at home
Benefit channel
Pharmacy benefit primary (specialty pharmacy via NDC). HTC buy-and-bill bills medical benefit under J7173.
Class
First-in-class humanized anti-tissue factor pathway inhibitor (anti-TFPI) IgG4 monoclonal antibody
Boxed warning
Yes — thromboembolic events. Hypersensitivity also flagged. Discontinue if symptomatic thrombosis occurs.
FDA approval
December 20, 2024 (initial — inhibitor population); 2025 label expansion to non-inhibitor hemophilia A/B
Calculate patient estimate → Read full reference Alhemo vs Hemlibra →
ℹ️
HCPCS unit is 0.5 mg, not 1 mg. J7173's official descriptor is "Injection, concizumab-mtci, 0.5 mg" — the smallest reportable increment. To convert mg to billable units, multiply mg by 2. A 60 mg dose = 120 units, 150 mg = 300 units, 300 mg = 600 units. This is the most common Alhemo coding error: clerks accustomed to "1 mg = 1 unit" J-codes will under-bill by half. Hemlibra (J7170) uses the same 0.5 mg unit convention, so the rule is consistent within the anti-TFPI/non-factor prophylaxis class.
⚠️
Boxed warning: thromboembolic events. Alhemo's mechanism (TFPI blockade) restores a procoagulant tilt that can predispose to thrombosis. The label includes a boxed warning for thromboembolic events and hypersensitivity reactions. Patients with risk factors for venous thromboembolism or with concomitant bypassing agent use require additional monitoring. Confirm payer PA language regarding thrombosis-risk attestation.
✓
Only non-factor prophylactic covering hemophilia B with inhibitors. Hemlibra (emicizumab, J7170) is approved only for hemophilia A (FVIII deficiency). For hemophilia B inhibitor patients, Alhemo and bypassing agents (FEIBA, NovoSeven RT for breakthrough) are the principal pharmacologic options. Bills for hemophilia B inhibitor patients should not be subject to a Hemlibra-first step requirement — document the indication clearly to avoid an inappropriate denial.
Phase 1 Identify what you're billing Confirm the benefit channel (pharmacy vs medical), HTC vs community fill, indication, and weight-based dose before submitting.

About Alhemo (concizumab-mtci) FDA verified May 2026

First-in-class anti-tissue factor pathway inhibitor for once-daily subcutaneous hemophilia prophylaxis.

Alhemo (concizumab-mtci) is a humanized IgG4 monoclonal antibody manufactured by Novo Nordisk Inc. that binds and inhibits tissue factor pathway inhibitor (TFPI). By blocking TFPI's regulatory braking action on factor Xa generation, concizumab restores thrombin generation through the extrinsic coagulation pathway — bypassing the need for functional factor VIII (hemophilia A) or factor IX (hemophilia B). Because the mechanism is independent of the deficient clotting factor, Alhemo works regardless of inhibitor status.

The FDA approved Alhemo on December 20, 2024 under BLA 761315 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (≥12 years) with hemophilia A with FVIII inhibitors or hemophilia B with FIX inhibitors. This original inhibitor-only approval was specifically targeted at a population with very limited prophylactic options — hemophilia B inhibitor patients in particular have no other non-factor prophylactic on the market (Hemlibra/emicizumab covers FVIII deficiency only). In 2025 the FDA approved a label expansion to include hemophilia A or B without inhibitors, broadening the addressable population significantly while preserving the inhibitor-population coding pathway.

Alhemo is the only currently marketed anti-TFPI monoclonal antibody. The pivotal Phase 3 explorer7 trial established efficacy in hemophilia A and B inhibitor patients, and explorer8 supported the label expansion to non-inhibitor patients. Alhemo is administered once daily by subcutaneous injection via a single-patient-use prefilled, premixed pen (60 mg, 150 mg, or 300 mg) using a 32-gauge, 4 mm needle — the daily dosing rhythm is the principal differentiator versus weekly-to-monthly Hemlibra, and it materially affects adherence, dispensing channel, and benefit-routing decisions.

Why this matters for billing: daily SC self-administration shifts the default benefit channel toward the pharmacy benefit (specialty pharmacy fills NDC, patient self-injects at home). Hemophilia treatment centers operating under buy-and-bill keep dispensing under the medical benefit using HCPCS J7173. The routing decision is made BEFORE the first fill and is sticky — verify with the payer.

Alhemo vs. Hemlibra — class context FDA verified May 2026

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

Alhemo and Hemlibra 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 (emicizumab) is a bispecific antibody that mimics the cofactor activity of 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 a longer real-world experience window (US approval 2017 for inhibitors; 2018 expansion to non-inhibitors). Alhemo is the newer option with a narrower track record but unique B-inhibitor coverage.

Alhemo (J7173)Hemlibra (J7170)
Genericconcizumab-mtciemicizumab-kxwh
ClassAnti-TFPI mAb (IgG4, first-in-class)Bispecific FIXa/FX humanized mAb
ManufacturerNovo NordiskGenentech (Roche)
FDA approval (initial)December 20, 2024 (inhibitor pop)November 16, 2017 (FVIII inhibitor)
HCPCS unitJ7173 — 0.5 mgJ7170 — 0.5 mg
Covered hemophiliaA and B — with or without inhibitors (per current label)A only — FVIII deficiency, with or without inhibitors
Age≥12 years (adult + adolescent)All ages (newborn through adult)
RouteSC self-injectionSC self-injection
CadenceOnce DAILYQ1wk, Q2wk, or Q4wk (load-then-maintenance)
Loading dose1 mg/kg SC day 13 mg/kg SC weekly × 4 weeks
Maintenance0.2 mg/kg SC daily, individualized1.5 mg/kg weekly OR 3 mg/kg q2wk OR 6 mg/kg q4wk
Form60 / 150 / 300 mg prefilled pen30 / 60 / 105 / 150 / 300 mg vials
Boxed warningThromboembolic events; hypersensitivityThrombotic microangiopathy + thromboembolism with concurrent aPCC (FEIBA) >100 U/kg/24h
Q2 2026 ASP+6%$83.472 per 0.5 mg ($166.944/mg)$55.640 per 0.5 mg ($111.28/mg)
Practical decision tree: Is the patient hemophilia B (with or without inhibitors)? → Alhemo is the relevant non-factor option; Hemlibra is not labeled. Is the patient hemophilia A WITHOUT inhibitors with adequate response to weekly/biweekly dosing? → Hemlibra is typically first-line in most payer policies (longer real-world track record, less frequent dosing). Is the patient hemophilia A with inhibitors who has breakthrough bleeding on Hemlibra or cannot tolerate it? → Alhemo with documented Hemlibra failure or intolerance.
Step therapy is asymmetric. Most commercial plans require Hemlibra trial before approving Alhemo for hemophilia A inhibitor patients — but Hemlibra cannot be required for hemophilia B inhibitor patients (it is not FDA-labeled for FIX deficiency). Document the deficient factor and inhibitor status on every PA; a hemophilia B inhibitor PA should not generate a Hemlibra step requirement.

Dosing & unit math FDA label current

Per FDA prescribing information — weight-based loading dose, individualized maintenance.

FDA-labeled dosing

  • Loading dose: 1 mg/kg SC on day 1 (single dose)
  • Initial daily dose: 0.2 mg/kg SC once daily starting day 2
  • Plasma concentration measurement: at 4 weeks (no later than 8 weeks) after initiation to individualize maintenance
  • Typical individualized maintenance options: 0.15, 0.20, or 0.25 mg/kg SC once daily, rounded to a pen-deliverable amount
  • Missed dose: per label — take as soon as remembered same day; if remembered next day, skip and resume schedule
  • Storage: refrigerated; room-temperature out-of-fridge tolerance is specified in the PI

Unit math — 0.5 mg per billable unit

Dose (mg)J7173 unitsTypical pen drawDaily ASP+6% (Q2 2026)
15 mg30 units0.15 mL from 100 mg/mL pen$2,504.16
20 mg40 units0.20 mL from 100 mg/mL pen$3,338.88
40 mg80 units0.40 mL from 100 mg/mL pen (or full 60 mg pen = 1.5 mL @ 40 mg/mL contains 40 mg deliverable per pen label)$6,677.76
60 mg (loading or daily)120 unitsOne 60 mg pen (1.5 mL × 40 mg/mL pen format)$10,016.64
100 mg (loading or daily)200 units1.0 mL from 100 mg/mL pen (or one 150 mg pen partial)$16,694.40
150 mg300 unitsOne 150 mg pen (1.5 mL)$25,041.60
300 mg600 unitsOne 300 mg pen (3.0 mL)$50,083.20

Worked example — 80 kg hemophilia B inhibitor patient

# Day 1, loading: 1 mg/kg × 80 kg = 80 mg
Pen deliverable: round to 80 mg (one 150 mg pen, deliver 80 mg, ~70 mg residual).
Bill J7173 with 160 units administered. Discard remaining drug — see #modifiers for JW.

# Day 2 onward, initial daily: 0.2 mg/kg × 80 kg = 16 mg
Pen deliverable: round to 15 mg (per label; pen dosing increments).
Bill 30 units of J7173 per daily dose (pharmacy benefit) or aggregate per fill (medical benefit).

# 30-day supply at 15 mg daily: 30 × 15 mg = 450 mg
Total billable: 900 units per 30-day fill. @ Q2 2026 ASP+6%, drug spend ≈ $75,124.80.

# Annualized (365 d) at 15 mg daily: 365 × 15 mg = 5,475 mg = 10,950 units = ~$913,600/yr drug spend (pre-sequestration) at current ASP.
Maintenance dose may up- or down-titrate after 4-week plasma concentration check.

Required pre-initiation checks

  • Confirm hemophilia A or B diagnosis with factor activity assay
  • Inhibitor titer documentation (Nijmegen-modified Bethesda assay preferred)
  • Baseline VTE risk assessment — boxed warning population
  • Counseling on hypersensitivity recognition (anaphylaxis can occur)
  • Plan for bypassing-agent use during breakthrough bleeds (avoid concomitant aPCC at high dose given thrombosis signal)
  • Plan for 4-week plasma concentration sampling for maintenance individualization

NDC reference FDA NDC Directory verified May 2026

Novo Nordisk labeler 0169. All three presentations are single-patient-use prefilled pens.

NDCStrengthPackage SizeUnits/Pen (0.5 mg = 1 unit)
0169-2084-15 40 mg/mL (60 mg total) 60 mg / 1.5 mL single-patient-use prefilled pen (brown label) 120 units per pen
0169-2080-15 100 mg/mL (150 mg total) 150 mg / 1.5 mL single-patient-use prefilled pen (gold label) 300 units per pen
0169-2081-03 100 mg/mL (300 mg total) 300 mg / 3 mL single-patient-use prefilled pen (white label) 600 units per pen
11-digit NDC required on most claim forms. Pad the labeler segment to 5 digits: 00169-2084-15, 00169-2080-15, 00169-2081-03. Use the N4 qualifier in CMS-1500 Box 24A shaded area and UB-04 Box 43. The cardboard cartons and patient-facing materials often show the 10-digit form; these reference the same product.
Pen color coding: brown label = 60 mg, gold label = 150 mg, white label = 300 mg. This is a patient-safety distinction — pen mix-ups are a known issue with hemophilia self-injectables. Pharmacies should fill the smallest pen size that covers the patient's daily dose to minimize waste; HTCs dispensing in-clinic should match pen size to patient weight.
Phase 2 Code the claim No admin code for home self-injection. 96372 for in-office HTC injection. Modifier JG (Medicare) or TB (some commercial) for 340B HTCs.

Administration codes CPT verified May 2026

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

CodeDescriptionWhen to use
none Patient home self-injection (typical) Default scenario. The patient or caregiver injects daily at home. No CPT admin code is billed. The drug bills through pharmacy benefit (NDC) or, less commonly, medical benefit (J7173 alone) per dispensing-channel rules.
96372 Therapeutic, prophylactic, or diagnostic SC or IM injection (non-chemo) HTC office injection (occasional). Use when a hemophilia treatment center clinic nurse administers the dose in person — typically the loading dose or during training. One unit per injection.
96401 Chemotherapy SC/IM, non-hormonal anti-neoplastic Not appropriate. Concizumab is non-chemotherapeutic.
S9357 / S9542 Home infusion / home injection services HCPCS Some commercial payers reimburse a per-diem home-administration management code where a home-infusion vendor supplies training/oversight. Verify payer-specific applicability.
99211 – 99215 E/M visit codes (HTC clinic) Use the appropriate E/M level for the HTC visit when a separately identifiable evaluation occurs (initial training, dose individualization review, breakthrough-bleed management). Bundle pre-injection vitals.
Default: no admin code. The overwhelming majority of Alhemo doses are patient-injected at home from a specialty pharmacy fill. The pharmacy submits an NCPDP D.0 claim for the days supply; no CPT admin code is appropriate. The dispensing fee on the pharmacy side is the operational equivalent of an admin code.
96372 only when the HTC actually administers. Do not bill 96372 simply because the prescription originated at the HTC. The patient must receive the injection from a clinic staff member during a face-to-face encounter. Documentation must specify injection administered by [credential], site, dose, and patient observation period.

Modifiers CMS verified May 2026

Pen format reduces JW/JZ traffic; HTC 340B drives JG/TB; thrombotic-event tracking can trigger payer-specific reporting.

JG — 340B-acquired drug (Medicare)

Most hemophilia treatment centers are 340B-eligible covered entities. When the HTC acquires Alhemo at 340B ceiling pricing and bills Medicare Part B, append modifier JG to the J7173 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.

JW — documented wastage

Less common with Alhemo because the pen format is designed for variable-volume dosing — the patient or clinic uses only the prescribed mg from each pen, and the remainder of the pen is retained for the next dose (single-patient-use). True JW wastage is rare. Where JW applies (e.g., a partial pen is discarded because the patient discontinues mid-fill or a pen is contaminated), bill the discarded mg on a separate line with the wasted units and document vial/pen size, calculated dose, mg administered, and mg wasted.

JZ — no waste from single-dose container

CMS's JZ requirement applies to single-dose containers on the CMS single-dose container list. Alhemo pens are labeled single-patient-use rather than single-dose — the pen is reused by the same patient for multiple daily injections until empty. Verify against the current CMS single-dose container list for J7173 at billing time; many MACs treat multi-use single-patient-use pens differently than single-dose vials for JZ purposes.

Worked example — HOPD HTC dispensing 30-day supply, 340B-acquired

  • Patient: 80 kg hemophilia B inhibitor, individualized maintenance 0.15 mg/kg = 12 mg daily, rounded to 15 mg pen-deliverable
  • 30-day supply: 30 × 15 mg = 450 mg administered
  • Pens dispensed: 3 × 150 mg pens (450 mg total, no residual)
  • Line 1: J7173 × 900 units with modifier JG (Medicare HOPD, 340B)
  • NDC reported: 00169-2080-15 (150 mg pen) with N4 qualifier
  • No JW (no waste)
  • JZ applicability: per current MAC policy — verify
JG vs TB — check the payer. Submitting JG to a payer that requires TB (or vice versa) will trigger a 340B audit flag. The two modifiers are not interchangeable for payment purposes. Build the payer-specific 340B modifier rule into the HTC billing template — this is a high-recoupment area.
Hemophilia clotting-factor 340B carve-out history: hemophilia clotting factors have historically been exempt from certain HOPD 340B payment reductions because of the unique cost-and-access structure of HTCs. Non-factor prophylactics like Alhemo and Hemlibra are NEW enough that their classification under that exemption is not yet settled at every MAC. Track the current OPPS rule for Alhemo (J7173) classification at the dispensing date of service.

ICD-10-CM diagnosis codes FY2026 verified May 2026

Pair hereditary deficiency code with inhibitor code D68.311 for the original-label inhibitor population.

ICD-10DescriptionUse for Alhemo
D66Hereditary factor VIII deficiency (hemophilia A, classical)Primary for hemophilia A patients
D67Hereditary factor IX deficiency (hemophilia B, Christmas disease)Primary for hemophilia B patients — Alhemo is the only labeled non-factor prophylactic option
D68.311Acquired hemophilia / hemorrhagic disorder due to intrinsic increase in anti-FVIII, anti-FIX, or other anti-coagulant antibodies / inhibitorsPair with D66 or D67 to document inhibitor status — required by most PA edits for inhibitor-population claims even when the diagnosis is congenital
D68.312Antiphospholipid antibody with hemorrhagic disorderNot typical for Alhemo PA
D68.318Other hemorrhagic disorder due to intrinsic circulating anticoagulants, antibodies, or inhibitorsUse when D68.311 specificity is unavailable
D68.4Acquired coagulation factor deficiencyOff-label for Alhemo — not for congenital hemophilia inhibitor population
Z79.899Other long-term (current) drug therapyOptional secondary code for prophylaxis context
Z85.6 / Z85.79Personal history of leukemia / other lymphatic and hematopoietic neoplasmsNot for Alhemo
Inhibitor code on every line: for inhibitor-population claims, append D68.311 even when the hereditary code (D66 or D67) is already present. Many payer edits look specifically for the inhibitor diagnosis to authorize J7173 at the labeled population price point. Without D68.311, the claim may be edited to suggest factor-concentrate therapy as the standard of care.
Acquired (non-congenital) hemophilia is OFF-LABEL. Patients with acquired hemophilia (D68.311 alone, no hereditary D66/D67) are NOT in the FDA-approved Alhemo population as of Q2 2026. Off-label use requires medical-necessity documentation and is at high denial risk.
Pediatric <12 years is OFF-LABEL. Alhemo is approved for ≥12 years only. Pediatric hemophilia inhibitor patients under 12 use Hemlibra (FDA-labeled all ages) for A-inhibitor, or factor concentrate / bypassing agents for B-inhibitor.

Site of care & place of service Verified May 2026

Alhemo's daily SC self-injection rhythm pushes site of care toward the patient's home almost by default. The relevant decision is whether the dispensing channel is pharmacy benefit (specialty pharmacy fills) or medical benefit (HTC buy-and-bill). HOPD is rare for Alhemo because it is not infused — the only common reason to administer Alhemo in a hospital outpatient setting is during inpatient or HTC training before the patient transitions to home self-injection. Office-based HTC administration of the loading dose is more common.

SettingPOSClaim formChannel
Patient home (self-inject, specialty pharmacy fill)n/a (pharmacy benefit)NCPDP D.0 from specialty pharmacyDefault — most common
Patient home (HTC buy-and-bill medical benefit, shipped to patient)12CMS-1500 / 837PHTC-managed medical benefit
HTC office (loading dose or training injection)11CMS-1500 / 837PMedical benefit + 96372 admin
Hospital outpatient (rare)19 or 22UB-04 / CMS-1450Medical benefit; 340B JG/TB modifier if applicable
Inpatient (training before discharge)21UB-04 / CMS-1450Bundled into DRG; drug not separately billable
Pharmacy vs medical benefit decision is sticky. Once a Medicare or commercial payer routes Alhemo through pharmacy or medical benefit for a given patient, switching channels mid-year typically requires a new PA and benefits investigation. Verify the channel BEFORE the first fill. NovoCare benefits investigation (1-844-668-6732) handles this prospectively.
HTC enrollment matters for buy-and-bill. HTCs that meet the Maternal and Child Health Bureau federally funded hemophilia treatment center criteria have a specific 340B and reimbursement framework that community specialty pharmacies do not. Non-HTC sites attempting to buy-and-bill Alhemo on the medical benefit face higher acquisition cost and tighter payer scrutiny.

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 (J7173) — CMS-1500 / 837P

InformationCMS-1500 boxNotes
NPI17b / 24JRendering HTC provider or supervising hematologist
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaExample: N400169208015ML1.5 for the 150 mg pen
HCPCS J7173 + admin CPT (if applicable)24DDrug on its own line; 96372 only if in-office injection. Modifier JG / TB / JW as appropriate.
Drug units24Gmg administered × 2 (because 0.5 mg = 1 unit). 150 mg = 300 units.
Patient weightBox 19 / NTE segmentCritical — supports the weight-based loading and maintenance dose calculation
ICD-1021D66 or D67 + D68.311 (inhibitor pop) — on every claim
PA number23Required by virtually all payers; include the PA expiration date
Bethesda titer (lab value)NTE / attached PA documentationMany payers require titer documentation accompanying the claim or with PA renewal

Pharmacy benefit (NDC) — NCPDP D.0

Specialty pharmacy dispensing under the pharmacy benefit submits NCPDP D.0 with the Alhemo 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 NovoCare. Days supply is calculated from the patient's individualized daily dose and the pen size dispensed.

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

Phase 3 Get paid Universal PA. Bethesda titer documentation required for inhibitor PA. Hemlibra-first step typical for hemophilia A inhibitor (not for B).

Payer policy snapshot Reviewed May 2026

Universal prior authorization. Bethesda titer documentation. Hemlibra-first step common for A-inhibitor; not applicable to B-inhibitor.

PayerPA?Step therapyBenefit routingRe-auth
UnitedHealthcare
Specialty pharmacy / OptumRx		 Yes For hemophilia A inhibitor: Hemlibra trial typically required. For hemophilia B inhibitor: no Hemlibra step. Pharmacy benefit via OptumRx specialty primary; HTC medical benefit possible 12 mo with bleed-log review
Aetna
Hemophilia products policy		 Yes A inhibitor: Hemlibra inadequate response or contraindication. B inhibitor: factor concentrate / bypassing agent context required. Specialty pharmacy preferred; HTC medical benefit reviewed 12 mo with annualized bleed rate (ABR) data
Anthem / Carelon
Specialty drug program		 Yes A inhibitor: Hemlibra-first standard. B inhibitor: no step. Specialty pharmacy primary; HTC carve-out where applicable w/ documented response
Cigna
Express Scripts / Accredo specialty		 Yes A inhibitor: documented Hemlibra failure. B inhibitor: factor / bypassing agent history. Accredo specialty pharmacy primary 12 mo
BCBS / Blue Plans
Plan-specific (varies by Blue)		 Yes Variable by plan; A-inhibitor Hemlibra step common Plan-specific; HTC medical benefit accepted at many Blues w/ documented response
Medicare (Part B / Part D)
No NCD; LCD framework		 Plan-specific (Part D) Part D plans may apply step therapy; Part B does not for medically necessary on-label use Part B at HTC; Part D for home self-administration where applicable Plan-specific
Medicaid
State PDL varies		 Yes Most state PDLs require A-inhibitor Hemlibra trial; B-inhibitor often direct access State-specific; many states route through HTCs State-specific (typically 12 mo)
Key finding — B-inhibitor patients have a cleaner path. Because Hemlibra is not FDA-labeled for hemophilia B, payers cannot lawfully require a Hemlibra trial for B-inhibitor patients before approving Alhemo. PA submissions for B-inhibitor patients should document the FIX deficiency clearly and reference the Hemlibra label limitation if the payer's automated edit attempts to enforce a step. For A-inhibitor patients with established Hemlibra use, document specific breakthrough bleed history with dates, locations, and management.

What to document for approval

  • Confirmed hemophilia A (D66) or B (D67) diagnosis with factor activity assay
  • Current Bethesda inhibitor titer (Nijmegen-modified preferred), with date and lab
  • Inhibitor history: high-responder vs low-responder status, dates of first detection
  • Prior prophylactic and on-demand regimen (factor concentrates, bypassing agents, Hemlibra) with response
  • For A-inhibitor: Hemlibra trial details — dose, duration, ABR, reason for discontinuation
  • VTE risk assessment (boxed warning compliance)
  • Plan for breakthrough-bleed management with bypassing agents (FEIBA, NovoSeven RT)
  • Body weight (within 30 days) for accurate loading and daily dose calculation
  • Patient/caregiver training completion or scheduled training plan for SC self-injection

Medicare reimbursement CMS Q2 2026 (live)

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

Q2 2026 payment snapshot — J7173

Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions · Unit is 0.5 mg

ASP + 6% per 0.5 mg unit
$83.472
per billable unit ($166.944/mg)
150 mg dose
$25,041.60
300 units × ASP+6%
After sequestration
~$24,541
~2% reduction (actual paid)
Annualized drug cost example (80 kg patient, 15 mg daily individualized maintenance): 15 mg/day × 365 days = 5,475 mg/year ≈ 10,950 billable units. At Q2 2026 ASP+6% of $83.472/unit, the annual Medicare drug spend is approximately $914,000 per patient per year before sequestration. This is high even within the hemophilia non-factor class — Alhemo is more expensive per mg than Hemlibra ($83.472 vs $55.640 per 0.5 mg unit, Q2 2026), but Hemlibra's weekly-to-monthly dosing means total annualized spend depends heavily on regimen choice.

Part B vs Part D

For Medicare beneficiaries, Alhemo can be billed under Part B when administered or dispensed under a provider's "incident to" framework at an HTC (medical benefit, J7173) 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 — relevant given Alhemo's price point.

Coverage

No NCD specific to concizumab-mtci. Coverage falls under the generic drug-coverage LCD framework (e.g., LCD L33394). All MACs cover J7173 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

  • December 20, 2024 — FDA approval (initial; inhibitor population)
  • 2025 — FDA label expansion to non-inhibitor hemophilia A and B
  • Pre-J7173 effective date — claims under unclassified J3590 with NDC
  • Q4 2025 — J7173 permanent code, "Injection, concizumab-mtci, 0.5 mg" (0.5 mg = 1 unit) — first appearance in CMS Q4 2025 ASP file
  • Q2 2026 ASP+6% = $83.472 per 0.5 mg unit

Patient assistance — NovoCare Novo Nordisk verified May 2026

  • NovoCare Bleeding Disorders: 1-844-668-6732 — central support hub for benefits investigation, PA, copay, and patient education across Novo Nordisk hemophilia portfolio
  • NovoCare Copay Assistance: commercial patients only. Up to $12,000 per calendar year in copay/coinsurance assistance per Novo Nordisk hemophilia or rare bleeding disorder product. Excludes Medicare, Medicaid, TRICARE, VA, CHIP, and other federal program patients.
  • Novo Nordisk Patient Assistance Program (PAP): free product for uninsured / underinsured patients meeting income criteria (typically ≤400% FPL). Application via prescriber through the NovoCare patient enrollment form.
  • Trial Prescription Program: interim supply available through NovoCare while coverage is being pursued (eligibility criteria apply).
  • Patient Liaisons: dedicated case managers assigned at enrollment for ongoing coverage troubleshooting.
  • Patient enrollment form: novocare.com BD enrollment form
  • Web: alhemo.com · novomedlink HCP site · novocare.com (patient/HCP)
  • Foundation backup (federal program patients): Patient Access Network Foundation, 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.
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J7173 and Alhemo specialty pharmacy benefit modeling pre-loaded.
Copay program excludes federal program patients. Medicare, Medicaid, TRICARE, VA, CHIP, and other government-insured patients are not eligible for NovoCare copay assistance. For these patients, route to Novo Nordisk PAP (income-based free drug) or independent disease-specific foundations (PAN, HealthWell, NBDF, HFA Helping Hands) for copay assistance. Foundation fund availability fluctuates — build the check into the benefits-investigation workflow.
Phase 4 Fix problems Bethesda titer documentation gaps, benefit-channel routing errors, Hemlibra step misapplied to B-inhibitor, and 0.5 mg unit math are the top denials.

Common denials & how to fix them

Denial reasonCommon causeFix
Wrong benefit channel Claim submitted to medical benefit when payer assigned pharmacy benefit (or vice versa) Run a fresh benefits investigation through NovoCare (1-844-668-6732). If pharmacy benefit, route to assigned specialty pharmacy with NCPDP D.0 claim; if medical benefit, bill J7173 on CMS-1500/837P. Channel assignment is sticky — do not flip-flop without payer confirmation.
Missing Bethesda inhibitor titer documentation PA submitted without lab report showing positive FVIII or FIX inhibitor titer Attach the Bethesda titer lab report (Nijmegen-modified preferred), with assay date, titer value in BU, and lab CLIA ID. Many payers require titer documentation at every re-auth, not just initial PA.
Units billed at 1 mg = 1 unit (under-billing) Clerk used mg as units; should be mg × 2 because HCPCS unit is 0.5 mg Correct to mg × 2. A 150 mg dose = 300 units, not 150. Resubmit with corrected unit count. This is the most common Alhemo coding error.
Hemlibra-first step applied to hemophilia B inhibitor patient Payer auto-edit treated all hemophilia inhibitor PAs identically; missed that Hemlibra is not labeled for FIX deficiency Appeal with FDA label citation showing Hemlibra (J7170) is approved only for hemophilia A (FVIII deficiency). Reference the Alhemo label, which covers both A and B. For B-inhibitor patients, document FIX deficiency clearly with D67 + D68.311 ICD-10 pairing.
Hemlibra-first step applied to hemophilia A inhibitor without prior Hemlibra trial PA missing Hemlibra trial documentation for hemophilia A inhibitor patient Submit Hemlibra trial details: dose, duration, ABR before/during, reason for inadequate response or intolerance. Most A-inhibitor payers require this step. New-start A-inhibitor patients commonly initiate Hemlibra first; Alhemo positioned for Hemlibra failures.
340B modifier mismatch (JG vs TB) JG submitted to payer requiring TB, or vice versa Confirm the payer's current 340B modifier policy. Resubmit with correct modifier. Build payer-specific 340B rules into the HTC billing template.
NDC mismatch with HCPCS Wrong Alhemo NDC paired with J7173 (e.g., legacy 10-digit when payer requires 11-digit, or wrong pen-size NDC for the dose dispensed) Use the 11-digit NDC corresponding to the pen actually dispensed: 00169-2084-15 (60 mg), 00169-2080-15 (150 mg), 00169-2081-03 (300 mg). Pair with the N4 qualifier in 24A.
Off-label pediatric (<12 yr) denial Alhemo billed for hemophilia patient under 12 years Switch to age-appropriate alternative: Hemlibra for hemophilia A (all ages); factor concentrate / bypassing agent for hemophilia B inhibitor (<12 yr has no labeled non-factor option). Alhemo <12 yr requires off-label justification and high-bar appeal.
Off-label acquired hemophilia denial D68.311 alone (no D66/D67) submitted for non-congenital acquired hemophilia Alhemo's FDA label covers congenital hemophilia A and B with inhibitors (post-2025 expansion: with or without inhibitors). Acquired hemophilia is OFF-LABEL. Appeal requires strong medical-necessity rationale, prior treatment failures, and prescriber attestation.
VTE risk / boxed warning flag Patient has documented VTE history or concomitant high-dose bypassing agent use Submit VTE risk assessment, concomitant bypassing-agent management plan, and prescriber attestation acknowledging boxed warning. Document monitoring plan for thromboembolic signs/symptoms.
Formulary preference for Hemlibra (A-inhibitor patient) PBM steered to Hemlibra as preferred non-factor prophylactic For A-inhibitor patients with appropriate Hemlibra trial history showing inadequate response, submit ABR documentation and bleed log. For new starts, payer formulary preference is hard to overturn without trial documentation.
Missing patient weight on claim Box 19 / NTE weight not populated; weight-based dose calculation cannot be validated Add patient weight (within 30 days of fill) in Box 19 or NTE segment. Required for both loading dose (1 mg/kg) and individualized maintenance (0.15–0.25 mg/kg).
JW modifier denied / unsupported Wastage billed without documentation Document pen size, calculated dose, mg administered, mg wasted, reason for waste. Single-patient-use pens typically have minimal true waste because residual is retained for the next daily dose — verify the wastage scenario before appending JW.

Frequently asked questions

What is the HCPCS code for Alhemo?

Alhemo (concizumab-mtci) is billed under HCPCS J7173 — "Injection, concizumab-mtci, 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. J7173 is used when Alhemo 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 Alhemo through the pharmacy benefit using the NDC instead.

How is Alhemo different from Hemlibra?

Alhemo (concizumab-mtci, J7173) is a first-in-class anti-tissue factor pathway inhibitor (anti-TFPI) monoclonal antibody dosed once daily by subcutaneous injection. Hemlibra (emicizumab, J7170) is a bispecific factor IXa/X antibody dosed once weekly to once every four weeks SC. Alhemo's FDA-labeled population is hemophilia A or B with FVIII or FIX inhibitors (the December 2024 initial approval) and has since been expanded; Hemlibra is approved for hemophilia A patients with or without FVIII inhibitors and does not cover hemophilia B. Alhemo is the only non-factor prophylactic option that covers hemophilia B with inhibitors.

Is Alhemo billed under pharmacy or medical benefit?

Both pathways are in use, and the routing depends on payer policy, dispensing channel, and whether the patient is enrolled at a hemophilia treatment center (HTC). 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 J7173. Verify the assigned channel BEFORE the first fill — wrong-benefit routing is the single most common Alhemo denial.

What inhibitor titer documentation do payers require for Alhemo?

For the original inhibitor-population label, payers commonly require Bethesda assay documentation of a positive FVIII or FIX inhibitor titer — most policies set the threshold at greater than 5 Bethesda Units (BU) or any history of high-responder inhibitors. Some plans accept a current titer above 0.6 BU with documented bleeding while on bypassing agents (FEIBA, NovoSeven RT) or factor concentrate. Submit the lab report with date, assay type (Nijmegen-modified Bethesda preferred), and titer value. After the label expansion to non-inhibitor patients, payers may also require documentation of inadequate response to or contraindication for factor concentrates or other non-factor prophylactics — verify current PA criteria.

Can hemophilia treatment centers bill 340B for Alhemo?

Yes. HTCs that participate in the 340B Drug Pricing Program are eligible to acquire Alhemo at 340B ceiling pricing. For Medicare Part B claims, use modifier JG on the J7173 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.

What ICD-10 codes support Alhemo coverage?

For hemophilia A with inhibitors, use D66 (hereditary factor VIII deficiency) plus D68.311 (acquired hemorrhagic disorder due to intrinsic circulating inhibitors) when the inhibitor is documented. For hemophilia B with inhibitors, use D67 (hereditary factor IX deficiency) plus D68.311. Use D68.311 to flag the inhibitor status on every claim even if it appears redundant — many payer edits look specifically for the inhibitor code to authorize J7173. Acquired hemophilia (not congenital) uses D68.311 alone but is OFF-LABEL for Alhemo as of Q2 2026.

How is Alhemo dosed?

Alhemo is dosed by body weight in two phases. Loading dose: 1 mg/kg subcutaneous on day 1. Initial daily dose: 0.2 mg/kg subcutaneous once daily starting day 2. Maintenance dose: individualized based on plasma concizumab concentration measured at 4 weeks (not later than 8 weeks) after initiation. Typical maintenance options are 0.15, 0.20, or 0.25 mg/kg once daily, with the dose rounded to a pen-deliverable amount. The label-recommended target plasma concentration window guides the titration.

What is the Medicare reimbursement for J7173?

For Q2 2026, the Medicare Part B payment limit for J7173 is $83.472 per 0.5 mg unit (ASP + 6%) — equivalent to $166.944 per mg. A 150 mg dose reimburses at approximately $25,041.60 before sequestration. ASP is updated quarterly by CMS; next update July 1, 2026 for Q3 2026.

Is Alhemo covered after Hemlibra breakthrough bleeding?

Most payers will consider Alhemo for patients who have breakthrough bleeding on Hemlibra, but specific PA documentation is usually required: (1) documented adequate trial of Hemlibra at appropriate maintenance dose, (2) bleed log showing ongoing annualized bleed rate (ABR) above plan threshold, and (3) prescriber attestation. For hemophilia B inhibitor patients, Hemlibra is not an option (Hemlibra covers FVIII deficiency only) — Alhemo is typically a first-line non-factor prophylactic choice. Document the indication clearly: B-inhibitor patients should not be required to fail Hemlibra.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

  1. FDA — ALHEMO (concizumab-mtci) Prescribing Information (current revision)
    FDA-approved label, BLA 761315 (initial approval December 20, 2024; label expansion 2025)
  2. DailyMed — ALHEMO concizumab injection, solution
    Current FDA label; NDC details for 60 mg / 150 mg / 300 mg prefilled pens
  3. FDA — BLA 761315 Approval Letter (December 20, 2024)
    Initial FDA approval letter for the inhibitor population
  4. FDA — News Release on Concizumab Approval
    FDA announcement of Alhemo approval for hemophilia A or B with inhibitors
  5. alhemo.com — patient site
    Pen formats, support program details, patient enrollment
  6. NovoMedLink — Alhemo HCP site
    Dosing references, individualization protocol, reimbursement guides
  7. NovoCare — Bleeding Disorders patient support
    Copay assistance, PAP, trial program, patient enrollment (1-844-668-6732)
  8. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026 (J7173 = $83.472 per 0.5 mg unit)
  9. CMS — HCPCS quarterly update file
    J7173 effective Q4 2025 (canonical J-code source)
  10. CMS — JW Modifier and JZ Modifier policy
    Single-dose container reporting requirements (effective July 1, 2023)
  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 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 — explorer7 (concizumab in hemophilia A or B with inhibitors)
    Pivotal Phase 3 trial supporting the December 2024 inhibitor-population FDA approval; explorer8 supported the non-inhibitor label expansion
  15. FDA National Drug Code Directory
    All Novo Nordisk labeler 0169 concizumab-mtci NDCs
  16. Novo Nordisk Inc.
    Manufacturer (labeler 0169)

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

ElementCadenceHow it's refreshed
Medicare ASP pricing (J7173)QuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (UHC, Aetna, Cigna, Anthem, BCBS, Medicaid)Semi-annualManual review against published payer policy documents.
HCPCS / CPT / modifier rules (incl. JG/TB 340B framework)Quarterly340B modifier policy continues to evolve; verify at billing time.
NDC, dosing, FDA labelEvent-drivenTied to FDA label revision date (last verified July 2025 revision).
Pharmacy-benefit specialty pricing (WAC / net)AnnualWAC changes reviewed annually; specialty net pricing varies and is not published.
Class landscape (Hemlibra comparison, new entrants)QuarterlyTrack new non-factor prophylactic approvals (e.g., Mim8 in development).

Reviewer

Pending SME review. This page is staff-authored from primary sources (FDA, CMS, manufacturer, DailyMed, NovoCare — all linked above). Editorial review by a hemophilia treatment center billing specialist is in progress. Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes claims.

Change log

  • — Initial publication. ASP data: Q2 2026 (J7173 = $83.472 per 0.5 mg unit; $166.944/mg). FDA approval December 20, 2024 (inhibitor population); 2025 label expansion to non-inhibitor hemophilia A/B. NDCs: 0169-2084-15 (60 mg), 0169-2080-15 (150 mg), 0169-2081-03 (300 mg). Manufacturer support program: NovoCare (1-844-668-6732), up to $12,000/yr copay assistance for commercial patients. Payer policies: UHC, Aetna, Cigna, Carelon/Anthem, BCBS, Medicare, Medicaid — A-inhibitor Hemlibra-first step common; B-inhibitor direct access.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File for J7173 (Q2 2026 = $83.472 per 0.5 mg unit). Dosing reflects the current FDA prescribing information. The 0.5-mg-per-unit HCPCS convention is the most common Alhemo coding error and is emphasized in multiple sections rather than buried. The pharmacy-vs-medical benefit routing decision is similarly emphasized because it drives the largest single category of Alhemo denials.

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