CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hemlibra (emicizumab-kxwh) for hemophilia A prophylaxis — Coverage Criteria

Policy governs prior authorization, continuation, dosing, and coverage criteria for Hemlibra used as routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A; affects prescribers, pharmacists, and members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemlibra (emicizumab-kxwh) for hemophilia A prophylaxis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document benefit for continuation; authorization up to 12 months may be granted when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

3dosing schedules

Newborn+age range

Hematologistprescriber

Desmopressin listAppendix B

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Hemlibra (emicizumab-kxwh)

Initial and continuation therapy criteria

Covered when ALL of the following are met

Overall: Member is using Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes for hemophilia A (congenital factor VIII deficiency); the indication is FDA‑approved or compendial; prescriber is a hematologist or in consultation with a hematologist; dosing does not exceed listed induction and maintenance regimens; authorization up to 12 months may be granted

Based on Sections I, FDA‑approved indications, Dosage and Administration, and Authorization

Disease severity criteria: Member meets one of the following: (1) mild hemophilia A with insufficient response to desmopressin or a documented clinical reason for not using desmopressin (see Appendix B); OR (2) moderate or severe hemophilia A

See Appendix A and Appendix B; per policy Section IV.B

Concomitant therapy: Prophylactic use of factor VIII products (e.g., Advate, Adynovate, Eloctate) will be discontinued after the first week of starting Hemlibra; Hemlibra must not be used in combination with factor VIII products for prophylactic use for authorization or reauthorization

Continuation requires documented benefit and no concurrent prophylactic factor VIII use

Dosing limits: Induction: 3 mg/kg subcutaneously once weekly for the first 4 weeks; Maintenance: 1.5 mg/kg once weekly, or 3 mg/kg once every 2 weeks, or 6 mg/kg once every 4 weeks

Per Dosage and Administration (Section VI)

Authorization and benefit documentation: Prior authorization is required; authorization of up to 12 months may be granted for initial therapy and for continued treatment when the member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds)

See Authorization of 12 months (Sections IV and VI)

Hemlibra (emicizumab-kxwh) is covered only for its FDA‑approved and compendial indications. All other indications beyond FDA‑approved indications and compendial uses are considered experimental/investigational and not medically necessary.

Use of Hemlibra for indications that are not FDA‑approved or supported by recognized compendia is not medically necessary and will not be covered.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 months may be granted when approval criteria are met for initial therapy and for continuation. For continuation requests, chart notes documenting benefit from therapy (e.g., reduced frequency or severity of bleeds) must be submitted.

Prior authorization required for Hemlibra (emicizumab-kxwh)
Authorization duration: up to 12 months for initial and continuation when criteria met
Continuation requests must include chart notes documenting clinical benefit (e.g., reduced frequency or severity of bleeds)
Requests for indications other than FDA‑approved indications and compendial uses are considered experimental/investigational and not medically necessary
For members with mild hemophilia A, documentation of insufficient response to desmopressin or a documented clinical reason for not using desmopressin is required (see Appendix B for acceptable clinical reasons)
Continuation requests where the member is using Hemlibra in combination with factor VIII products for prophylactic use may be denied
Prophylactic use of factor VIII products should be discontinued after the first week of starting Hemlibra

Background on Hemlibra

Hemlibra (emicizumab-kxwh) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients, including newborns, with hemophilia A (congenital factor VIII deficiency), both with and without factor VIII inhibitors. Coverage under this policy applies to that indication; other uses are considered experimental/investigational and not medically necessary.

Hemophilia Severity Definitions

Severe hemophilia

DefinitionSevere hemophilia: clotting factor level <1% activity; spontaneous bleeding episodes, predominantly into joints and muscles; severe bleeding with trauma, injury, or surgery.

Factor VIII activity threshold<1% activity.

Typical bleeding patternPredominantly spontaneous bleeds into joints and muscles.

Bleeding risk with trauma/surgeryAlso associated with severe bleeding in the setting of trauma, injury, or surgery.

Moderate hemophilia

DefinitionModerate hemophilia: clotting factor level 1% to 5% activity; occasional spontaneous bleeding episodes; severe bleeding with trauma, injury, or surgery.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemlibra (emicizumab-kxwh) for hemophilia A prophylaxis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document benefit for continuation; authorization up to 12 months may be granted when criteria are met.

SourceLink

On This Page

Documentation Required

Desmopressin Trial or Contraindication for Mild Disease

Document insufficient response to desmopressin or a clinical reason for not using desmopressin for members with mild disease. Acceptable clinical reasons include age < 2 years, pregnancy, fluid/electrolyte imbalance, high cardiovascular/cerebrovascular risk, predisposition to thrombus formation, trauma requiring surgery, life‑threatening bleed, contraindication or intolerance to desmopressin, or unavailability of Stimate Nasal Spray due to backorder/shortage.

Document trial of desmopressin with insufficient response OR
Document one of the clinical reasons from Appendix B for not using desmopressin

Documentation Required

Required Documentation for Prior Authorization/Renewal

Continuation requests require submission of chart notes demonstrating clinical benefit from therapy, such as reduced frequency or severity of bleeding episodes. Requests lacking documentation of benefit may be denied.

Chart notes showing reduced bleed frequency or severity
Evidence member is not using Hemlibra concurrently with factor VIII products for prophylactic use
If member is using Hemlibra with prophylactic factor VIII products, include justification; continuation may be denied

Denial Risk

Non‑FDA/Compendial Indications

Requests for uses other than FDA‑approved indications for Hemlibra are considered experimental/investigational and not medically necessary.

Hemlibra FDA‑approved indication: routine prophylaxis to prevent or reduce bleeding in hemophilia A (with or without inhibitors)
All other indications: experimental/investigational and not medically necessary

Denial Risk

Concurrent Prophylactic Factor VIII Use

Continuation requests where the member is using Hemlibra in combination with factor VIII products for prophylactic use may be denied. Prophylactic factor VIII products should be discontinued after the first week of starting Hemlibra per authorization criteria.

Examples of factor VIII products: Advate, Adynovate, Eloctate
If combination prophylactic therapy is documented, include clinical justification; otherwise authorization may be denied

Factor VIII activity threshold1% to 5% activity.

Typical bleeding patternOccasional spontaneous bleeding episodes.

Bleeding risk with trauma/surgeryRisk of severe bleeding with trauma, injury, or surgery.

Mild hemophilia

DefinitionMild hemophilia: clotting factor level 6% to 40% activity; severe bleeding mainly with serious injury, trauma, or surgery.

Factor VIII activity threshold6% to 40% activity.

Typical bleeding patternSevere bleeding usually only with serious injury, trauma, or surgery.

Spontaneous bleedsSpontaneous bleeding is uncommon in mild disease.