Altuviiio (antihemophilic factor [recombinant]) prior authorization
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Defines prior authorization, renewal, and coverage limitations for Altuviiio (intravenous antihemophilic factor recombinant) for members with hemophilia A; applies to providers submitting PA requests to Maryland Physicians Care.
No material clinical or coverage changes in this revision.
Coverage Criteria for Altuviiio
inv-01: Initial Authorization Criteria
Covered when ALL of the following are met:
inv-02: Reauthorization Criteria
Covered when ALL of the following are met for continuation:
Altuviiio is considered investigational or experimental for any use other than the listed indications and will not be covered.
Use of Altuviiio for von Willebrand disease is not an approved indication and is excluded from coverage.
Coding and Clinical Thresholds
| J7214 | Injection, factorviii/von willebrand factor complex, recombinant (altuviiio), per factor viii |
Prior Authorization, Documentation, and Provider Requirements
Document prior-agent failure rationale
If the member has a prior trial and failure with other Factor VIII agents, the provider must document that the failure was not due to a decreased clinical response to that product (e.g., clinical signs or symptoms).
- Applies to prior agents such as Adynovate, Eloctate, Jivi, etc.
- Documentation must attribute failure to reasons other than decreased response to the prior product
Required documentation to support authorization
Include documentation of the diagnosis, indication, and supporting clinical data: documented severe hemophilia A (endogenous Factor VIII <1%), the specific indication (treatment of bleed, surgical prophylaxis, or routine prophylaxis), prescriber specialty or hematology consultation, and evidence of positive clinical response for renewals.
- Documented diagnosis: endogenous Factor VIII <1% (severe hemophilia A)
- Indication: treatment of bleeding episodes, surgical prophylaxis, or routine prophylaxis
- Prescribed by or in consultation with a hematologist
- For renewals from a previous insurer: documentation of positive clinical response from baseline
- For reauthorizations: platelet count >100,000 cells/µL within 60 days
Prohibited uses and concomitant therapy
Use of Altuviiio for von Willebrand disease is not an approved indication and will be excluded; concurrent use with other factor VIII products or with emicizumab (Hemlibra) is prohibited and will trigger denial.
- Do not prescribe Altuviiio for von Willebrand disease
- Do not use Altuviiio concurrently with other factor VIII products
- Do not use Altuviiio concurrently with Hemlibra (emicizumab-kxwh)
Surgical prophylaxis reauthorization not permitted
Requests for reauthorization when the original indication is surgical prophylaxis are not allowed; surgical prophylaxis is not eligible for renewal.
- Initial authorization for surgical prophylaxis may be granted per criteria, but renewals for surgical prophylaxis will be denied
Background
Altuviiio (antihemophilic factor [recombinant], Fc‑VWF‑XTEN fusion protein) is a recombinant Factor VIII concentrate indicated for members with Hemophilia A (congenital Factor VIII deficiency) for routine prophylaxis, treatment of bleeding episodes, and perioperative (surgical) management. Key clinical considerations in the policy include a requirement for a documented diagnosis of severe Hemophilia A (endogenous Factor VIII < 1%), hematologist prescribing or consultation, avoidance of concurrent use with other Factor VIII products or emicizumab (Hemlibra), monitoring for development of neutralizing antibodies/inhibitors to Factor VIII throughout treatment, and specific documentation and dosing requirements for initial authorization and renewals.
Definitions
Initial Therapy Criteria
inv-15: Initial Therapy
Initial therapy coverage criteria
Continuation / Reauthorization Criteria
inv-16: Continuation / Reauthorization
Reauthorization requirements for continuation of Altuviiio therapy
Step Therapy / Prior-Agent Failure
| Step | Requirement |
|---|---|
| 1 | If member has a past trial and failure with other Factor VIII agents (e.g., Adynovate, Eloctate, Jivi), provider must submit documentation that the failure was not due to a decreased response (clinical signs or symptoms) to that prior product. |
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