CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy for Alhemo (concizumab-mtci)

Defines step therapy requirements for coverage of Alhemo for routine prophylaxis in patients ≥12 years with hemophilia A or B without inhibitors; applies to pharmacy benefit adjudication and prescribers seeking prior authorization.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Alhemo (concizumab-mtci)

Policy CodePolicy N/A

Change TypeNew step therapy program

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionProviders must document why Hympavzi is not an appropriate candidate when requesting Alhemo without a prior trial of Hympavzi.

SourceLink

POLICY UPDATE CHANGES

New step therapy program requiring trial of Hympavzi (marstacimab-hncq) prior to coverage of Alhemo (concizumab-mtci) unless the provider documents the patient is not an appropriate candidate for Hympavzi.

Authorization duration for Alhemo set to 12 months for covered indications and other approved uses.

12 monthsauthorization duration

≥12 yrsage for indications

1new program

Coverage Criteria for Alhemo (concizumab-mtci)

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Hemophilia A without inhibitors - initial: Provider documents patient is not an appropriate candidate for Hympavzi based on clinical assessment (provider must document reason)

Document reason for inappropriateness

Hemophilia A without inhibitors - continuation/established: Both: (1) patient is currently on Alhemo therapy AND (2) patient has not received a manufacturer‑supplied sample at no cost in the prescriber office or any form of assistance from NovoCare to establish current use

Patients established via free samples or NovoCare assistance are treated as new-to-therapy and must meet initial criteria

Hemophilia B Without Inhibitors

Covered when ONE of the following is met:

Hemophilia B without inhibitors - initial: Provider documents patient is not an appropriate candidate for Hympavzi based on clinical assessment (provider must document reason)

Document reason for inappropriateness

Hemophilia B without inhibitors - continuation/established: Both: (1) patient is currently on Alhemo therapy AND (2) patient has not received a manufacturer‑supplied sample at no cost in the prescriber office or any form of assistance from NovoCare to establish current use

Patients established via free samples or NovoCare assistance are treated as new-to-therapy and must meet initial criteria

Other Indications

Covered when approved per program rules:

Other Indications: Alhemo will be approved for other indications as specified by the program or applicable mandates

Authorization will be issued for 12 months; state mandates, federal requirements, and member benefit plan may apply

Members who appear to be "currently on Alhemo therapy" but who were established on that therapy solely through receipt of manufacturer-supplied free samples in the prescriber's office or via any NovoCare assistance (for example, a sample card redeemable at a pharmacy for free medication) are not treated as established users for continuation criteria. Such members must meet the initial authorization requirements and cannot rely on prior-use status when requesting coverage.

If a provider requests authorization for a member who was started on Alhemo through samples or NovoCare assistance, treat the request as an initial authorization and document the member's clinical status accordingly; the policy explicitly states these patients "shall be required to meet initial authorization criteria as if patient were new to therapy."

Provider Requirements and Step-Therapy Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Alhemo. Prior authorization will be granted when the member meets the coverage criteria for hemophilia A or B without inhibitors and either (a) the provider documents a clinical reason why Hympavzi (marstacimab-hncq) is inappropriate for the patient, or (b) the patient is already established on Alhemo therapy and meets the manufacturer-sample/assistance exception conditions. Authorization, when approved, will be issued for 12 months.

Affected products: Alhemo (concizumab-mtci); Step alternative: Hympavzi (marstacimab-hncq)
Authorization duration: 12 months

Step Therapy

Step Therapy Requirement

Step therapy applies: members with hemophilia A or B without inhibitors must trial Hympavzi (marstacimab-hncq) before coverage of Alhemo (concizumab-mtci), unless the provider documents that Hympavzi is not an appropriate option.

Step requirement applies to hemophilia A and hemophilia B without inhibitors

Documentation Required

Documentation of Contraindication or Inappropriateness

Provider must document the clinical assessment and the specific reason why the patient is not an appropriate candidate for Hympavzi when requesting coverage of Alhemo under the contraindication/inappropriateness exception. Documentation should explain the medical rationale (for example, prior intolerance, contraindication, lack of efficacy, or other clinical considerations).

Document reason in the clinical record when invoking the Hympavzi inappropriateness exception

Denial Risk

Step Therapy Denial Risk

Denial risk: requests for Alhemo will be denied if the member has not first trialed Hympavzi and the provider has not documented a valid clinical reason why Hympavzi is inappropriate or contraindicated.

Denial may occur for failure to meet step therapy or documentation requirements

Note

Current User Exception and Manufacturer Sample Consideration

Exception for current Alhemo users: Alhemo may be approved without a prior Hympavzi trial when the patient is currently on Alhemo therapy and either (a) was not established on therapy solely via a manufacturer-supplied sample or NovoCare assistance, or (b) meets documentation showing ongoing use despite prior assistance. Patients who were established on Alhemo only through a manufacturer sample or NovoCare assistance must meet initial authorization criteria as if new to therapy.

If patient received a free manufacturer sample in the prescriber's office or assistance from NovoCare to establish use, initial authorization criteria apply as if new to therapy

Definitions and Background

TFPI antagonist — definition for class of medications

ClassTissue factor pathway inhibitor (TFPI) antagonists

MechanismInhibit tissue factor pathway inhibitor to reduce bleeding in patients with hemophilia

ExamplesAlhemo (concizumab-mtci); Hympavzi (marstacimab-hncq)

Indicated populationRoutine prophylaxis to prevent or reduce bleeding in patients 12 years of age and older with hemophilia A or B

Label distinctionsAlhemo: indicated for hemophilia A or B with or without inhibitors; Hympavzi: indicated for hemophilia A or B without inhibitors

Alhemo (concizumab-mtci) and Hympavzi (marstacimab-hncq) are members of the tissue factor pathway inhibitor (TFPI) antagonist class and are indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients 12 years and older with hemophilia A or B. Hympavzi's FDA-labeled indication is limited to patients without factor VIII or IX inhibitors, whereas Alhemo is indicated for hemophilia A or B with or without inhibitors.

This policy establishes a step-therapy requirement: coverage of Alhemo for hemophilia A or B without inhibitors generally requires a trial of Hympavzi first unless the provider documents that Hympavzi is not an appropriate option for the patient. Authorizations for approved uses of Alhemo are issued for 12 months.

Initial Therapy

Initial authorization conditions:

Initial Authorization: Approval if provider documents patient is not an appropriate candidate for Hympavzi (provider must document reason)

Documentation of clinical assessment and reason required when requesting Alhemo without prior trial of Hympavzi

Initial Authorization for current user: Both: (1) patient is currently on Alhemo therapy AND (2) patient has not received a manufacturer‑supplied sample at no cost in the prescriber office or any form of assistance from NovoCare to establish current use

Patients established via samples or NovoCare assistance are treated as new-to-therapy and must meet initial criteria

Continuation Therapy

Continuation/maintenance coverage for members already on Alhemo:

Continuation: Member is currently on Alhemo therapy and was not established on therapy via manufacturer‑supplied samples at no cost in the prescriber office or via NovoCare assistance

Authorization issued for 12 months