Concizumab-mtci (Alhemo) prophylaxis for hemophilia A and B
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Defines medical necessity and prior authorization criteria for Alhemo (concizumab-mtci) when used for routine prophylaxis to prevent or reduce bleeding in patients ≥12 years with hemophilia A or B, with or without inhibitors. Applies to Health Net lines of business listed in the policy.
HCPCS code J7173 (Injection, concizumab-mtci, 0.5 mg) was added to the policy.
Requirements for documentation and provider attestations of Concizumab ELISA were removed.
Initial and continued approval durations were modified for Medicaid/HIM and Commercial lines of business.
New indication added for hemophilia A and B without inhibitors.
Provider confirmation of discontinuation of prophylactic hemophilia agents changed to an exclusion for concurrent use, with examples for on-demand use.
Coverage Criteria for Concizumab-mtci (Alhemo)
Initial Therapy - Without Inhibitors
Covered when ALL of the following are met for congenital hemophilia A or B without inhibitors (initial therapy):
See Appendix D for definitions of serious bleed and spontaneous bleed.
Prior authorization may be required for comparator products.
Prior authorization may be required for comparator products.
Initial Therapy - With Inhibitors
Covered when ALL of the following are met for congenital hemophilia A or B with inhibitors (initial therapy):
Prior authorization may be required for Hemlibra.
Continued Therapy
Covered when ALL of the following are met for continued therapy (with or without inhibitors):
Refer to state-specific addendums.
If plasma concentration is < 200 ng/mL at two consecutive measurements, benefits should be reevaluated (see Appendix D).
Dose individualization per Concizumab ELISA (Appendix D).
Initial and ongoing coverage criteria
Covered when ALL of the following are met
Policy added indication for hemophilia without inhibitors.
Plasma concentration thresholds detailed in Appendix D; ELISA monitoring documentation requirements were removed in 2Q2026.
Provider confirmation of discontinuation of prophylactic agents was revised to be an exclusion for concurrent use.
Non‑FDA approved (off‑label) indications that are not specifically addressed in this policy are not authorized unless the prescriber provides sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid.
Concurrent prophylactic use of other hemophilia prophylaxis agents while a member is receiving Alhemo is expressly excluded and will preclude coverage; the policy clarifies that on‑demand use of factor or bypassing agents is allowable as described elsewhere in the policy.
The policy does not allow concurrent use of Alhemo with other prophylactic hemophilia agents (for example, Hemlibra, prophylactic FVIII/FIX products, or bypassing agents). Concurrent prophylactic therapy is an exclusion and may result in denial if not discontinued prior to authorization.
Coding and Laboratory Thresholds
| J7173 | Injection, concizumab-mtci, 0.5 mg |
Provider Requirements, Prior Authorization, and Billing
Prior authorization required
Prior authorization is required. Prescribers must document the diagnosis, prescriber specialty (hematologist or in consultation with a hematologist), member age (≥12 years), current body weight (kg), dosing (loading and maintenance) and prior therapy failures or contraindications for both initial and continued therapy per the policy.
- Document diagnosis (hemophilia A or B, with or without inhibitors).
- Document prescriber specialty or consultation with a hematologist.
- Include current body weight (kg), dosing plan, and prior therapy failures or reasons alternatives are not used.
Prior authorization and billing code
Submit claims using HCPCS code J7173 (Injection, concizumab-mtci, 0.5 mg) and ensure the prior authorization follows the clinical coverage criteria in this policy.
- Code to use: J7173 = Injection, concizumab-mtci, 0.5 mg.
- Follow the policy coverage criteria when submitting PA and claims.
Step therapy / prior treatment requirements
Step therapy requires prescriber-documented failure of specified prior therapies unless contraindicated: for hemophilia A without inhibitors, documented failure of an FVIII product used for routine prophylaxis and failure of Hemlibra; for hemophilia B without inhibitors, documented failure of a FIX product.
- Document clinical failure or contraindication to FVIII (and Hemlibra for hemophilia A) or FIX (for hemophilia B).
- Prior authorization may be required for comparator products.
Step therapy bypass for Illinois HIM
Illinois HIM requests are exempt from the step therapy requirement effective 1/1/2026 per IL HB 5395; include state-specific exception when processing IL HIM prior authorizations.
- Step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395.
- Apply the IL HIM bypass when applicable to the member's line of business.
Required documentation for prior authorization
Provide supporting documentation with the prior authorization request, including office chart notes and laboratory results, evidence of hematologist involvement or consultation, current body weight in kg, and documentation of prior therapy failures or contraindications.
- Office chart notes and lab results supporting the diagnosis and clinical course.
- Evidence of hematologist involvement or that treatment was prescribed in consultation with a hematologist.
- Prior therapy details: failures, adverse effects, or contraindications, and current body weight (kg).
Failure to submit required documentation may result in denial
Failure to submit required documentation (office notes, labs, or other clinical information) demonstrating the member meets all approval criteria may result in denial of the prior authorization request.
Concurrent prophylactic therapy excluded
Concurrent prophylactic use of Hemlibra, bypassing agents, prophylactic FVIII, or prophylactic FIX products while on Alhemo is an exclusion and may trigger denial if not discontinued; on‑demand use of FVIII, FIX, or bypassing agents is allowable.
- Concurrent prophylactic Hemlibra, bypassing agents, FVIII, or FIX is excluded and will preclude coverage.
- On‑demand use of FVIII, FIX, or bypassing agents may continue as described in the policy.
Initial Therapy Criteria and Dosing
Initial Therapy (drug-specific)
Initial therapy criteria for patients with and without inhibitors:
Prior authorization may be required for comparator products.
Initial therapy
Initial dosing and billing
Appendix D provides plasma concentration-based adjustments; historical ELISA monitoring noted but documentation requirements removed later.
Providers should reference most up-to-date coding guidance prior to claim submission.
Criteria for Continued Therapy
Continuation Therapy
Continuation requires evidence of benefit and monitoring of plasma concentrations.
Dose adjustments according to plasma concentration ranges (see Appendix D).
Continued therapy and monitoring
Continued therapy requirements and durations as updated in 2Q2026
Initial approval durations were also modified; see policy revision history.
Policy previously required ELISA at 4-8 weeks and routine monitoring thereafter; these specific documentation requirements have been removed.
Step Therapy Requirements and Exceptions
| Step | Requirement (documented failure unless contraindicated) | Notes / Exceptions |
|---|---|---|
| 1 | ||
| For hemophilia A without inhibitors: Failure of a FVIII product used for routine prophylaxis as assessed and documented by prescriber. | ||
| Prior authorization may be required for comparator FVIII products; IL HIM step therapy requirement does not apply as of 1/1/2026 per IL HB 5395. |
| Line of Business / Program | Step Therapy Bypass Rule | Supporting Reference |
|---|---|---|
| Illinois HIM | ||
| Step therapy requirements are bypassed for Illinois HIM requests effective 1/1/2026 per IL HB 5395; step therapy bypass was added to policy for IL HIM. | ||
| IL HB 5395 operational exception; referenced in policy coding/operational notes. |
Product Strengths and Quantity Information
Site of Care and Administration
Product supplied as prefilled pens; no site restriction specified
Product is supplied as single‑patient‑use prefilled pens and the policy does not specify an administration site restriction; providers may note product availability when planning treatment.
- Available as single‑patient‑use prefilled pens in 60 mg, 150 mg, and 300 mg strengths.
- Administration setting is not specified as a restriction in the policy.
Prefilled pens suitable for self‑administration (home use)
Concizumab is provided in single‑patient‑use prefilled pens suitable for self‑administration; the policy notes suitability for self‑administration and does not restrict site of care.
- Prefilled pens intended for single‑patient use and suitable for self‑administration.
- No site‑of‑care restriction is specified in the policy.
Definitions and Clinical Terms
Billing and Code Summary
Background Information
Concizumab‑mtci (Alhemo) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients aged ≥ 12 years with hemophilia A or B, with or without inhibitors. The usual regimen includes a one‑time loading dose of 1 mg/kg subcutaneously followed by daily maintenance dosing (typical maintenance start 4 weeks after initiation); maintenance dosing may be individualized using plasma concentration guidance. The policy notes product availability as single‑patient‑use prefilled pens in multiple strengths and specifies billing using HCPCS code J7173 for concizumab‑mtci (0.5 mg) claims.
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