Neighborhood Health Plan RI recombinant factor VIIa Coverage

Coverage Criteria

COVERAGE CRITERIA

Covered when ALL of the following indication-specific criteria are met (grouped by diagnosis):

Indications

Hemophilia A (congenital factor VIII deficiency): Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing; member has inhibitors to Factor VIII with a current or historical titer >= 5 Bethesda Units (BU); will NOT be used in combination with another agent used as prophylactic therapy for Hemophilia A; used as treatment for at least one of: treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage), perioperative management (authorizations valid for 1 month), OR routine prophylaxis when additional prophylaxis criteria are met (primary prophylaxis for severe deficiency: factor VIII level <1%; OR secondary prophylaxis with at least TWO documented episodes of spontaneous joint bleeding); OR member has documented trial and failure of Immune Tolerance Induction (ITI); AND member has documented trial and failure or contraindication to Hemlibra.inhibitor titer >=5 BU
Members with inhibitor titer levels >0.6 BU to <5 BU who are not responding to or are not a candidate for standard factor replacement will be evaluated on a case-by-case basis.
Hemophilia B (congenital factor IX deficiency): Diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing; member has inhibitors to Factor IX with a current or historical titer >= 5 Bethesda Units (BU); will NOT be used in combination with another agent used as prophylactic therapy for Hemophilia B; used as treatment for at least one of: treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage), perioperative management (authorizations valid for 1 month), OR routine prophylaxis when additional prophylaxis criteria are met (primary prophylaxis for severe deficiency OR secondary prophylaxis with at least two documented episodes of spontaneous joint bleeding); OR member has documented trial and failure of Immune Tolerance Induction (ITI).inhibitor titer >=5 BU
Acquired Hemophilia: Diagnosis of acquired hemophilia confirmed by blood coagulation testing; used as treatment for at least one of: treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage), OR perioperative management (authorizations valid for 1 month).
Congenital Factor VII Deficiency: Diagnosis of congenital factor VII deficiency confirmed by blood coagulation testing; used as treatment for at least one of: treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage), OR perioperative management (authorizations valid for 1 month).
Glanzmann's Thrombasthenia: Diagnosis of Glanzmann's Thrombasthenia confirmed by blood coagulation testing; used as treatment for at least one of: treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage), OR perioperative management (authorizations valid for 1 month); AND platelet transfusions are known or suspected to be ineffective or contraindicated.

Age requirement

Age requirement: Member is at least 12 years of age where specified for adolescent acute treatment and combined Hemophilia A/B criteria.age >=12 years

Specified in combined Hemophilia A/B section

General coverage criteria

Covered when ALL of the following are met (policy emphasizes FDA labeling, literature, and prescriber justification):

Indication: Use is for a medically accepted indication such as congenital hemophilia A/B with inhibitors, acquired hemophilia, congenital factor VII deficiency, Glanzmann's thrombasthenia, or perioperative management for these conditions (see covered ICD-10 codes).

See Appendix 1 for ICD-10 codes

Dosing conforms to labeling or literature: Requested dosing and administration align with FDA-approved labeling or established literature (examples: NovoSeven RT 90 mcg/kg IV every 2 hours for congenital hemophilia A/B with inhibitors; congenital FVII deficiency 15-30 mcg/kg IV every 4-6 hours; Sevenfact regimens as specified in dosing section).

Dosing examples in Dosage/Administration section

Documentation for prophylaxis renewals: For routine prophylaxis with NovoSeven RT, renewals will be approved for a 12-month authorization period only if the member has demonstrated a beneficial response to therapy (decrease in frequency of bleeding episodes from pre-treatment baseline).12-month renewal contingent on demonstrated benefit

Authorization for treatment of Hemophilia A or B with recombinant factor VIIa products will not be used to treat Congenital Factor VII Deficiency when the authorization request is specifically for acute Hemophilia A/B management. This cross‑indication exclusion is explicit: requests for Hemophilia A/B acute treatment must not be repurposed to cover congenital FVII deficiency under the same authorization.

Requests for use that are inconsistent with FDA‑approved labeling or that are not supported by relevant clinical literature and an adequate prescriber justification may be excluded from coverage. For Medicare members, policy criteria apply only when no applicable NCD/LCD exists; individual consideration will be given based on prescriber‑submitted information.

Perioperative management of bleeding with NovoSeven RT is a limited authorization circumstance: such perioperative authorizations may NOT be renewed. Renewal requests for perioperative use should be expected to be denied.

Indications that lack support from FDA labeling or relevant clinical literature and that are not accompanied by adequate prescriber justification may be considered not medically necessary and therefore denied. The plan will review each request individually using submitted clinical information and applicable Medicare NCD/LCDs.

Coding

Hemophilia-related HCPCS codesHCPCS

J7189	NovoSeven RT (Factor VIIa)
J7212	Sevenfact (Factor VIIa)
J7198	Feiba (Anti-Inhibitor Coagulant Complex)
J7192	Factor VIII products (Advate, Kogenate FS, Helixate FS, Recombinate)
J7211	Kovaltry
J7205	Eloctate
J7190	Koate / Hemofil M
J7182	Novoeight
J7209	Nuwiq
J7188	Obizur

1–10 of 23

1/3

HCPCS J-codesHCPCS

J7189	Novoseven RT, 1 mcg
J7212	Sevenfact, 1 mcg

NDCs listedNDC

00169-7010	Novoseven RT NDC 1 mg vial
00169-7020	Novoseven RT NDC 2 mg vial
00169-7050	Novoseven RT NDC 5 mg vial
00169-7040	Novoseven RT NDC 8 mg vial
00169-7201	Novoseven RT MixPro NDC 1 mg
00169-7202	Novoseven RT MixPro NDC 2 mg
00169-7205	Novoseven RT MixPro NDC 5 mg
00169-7208	Novoseven RT MixPro NDC 8 mg
71127-1000	Sevenfact NDC 1 mg
71127-5000	Sevenfact NDC 5 mg

Covered ICD-10 Diagnosis CodesICD-10Covered

D66	Hereditary factor VIII deficiency
D67	Hereditary factor IX deficiency
D68.0	Von Willebrand's disease
D68.2	Hereditary deficiency of other clotting factors
D68.311	Acquired hemophilia
D69.1	Qualitative platelet defects

Max billable units per 30 days

Maximum billable units120,000 billable units per 30-day supply

Unit basisHCPCS unit = 1 mcg for NovoSeven RT/Sevenfact per coding table

Billing periodLimit applies to cumulative billed units within any 30-day supply period

Doses by indication (selected examples)

NovoSeven RT — Hemophilia A/B with inhibitors90 mcg/kg IV every 2 hours until hemostasis (adjust dose based on severity); post‑hemostatic: 90 mcg/kg IV every 3–6 hours for severe bleeds

NovoSeven RT — Acquired hemophilia

Provider Actions and Requirements

Denial Risk

Inventory and dispensing risks

Authorizations and dispensing may be impacted by member on-hand inventory and dispensing practices. The cumulative amount of medication the member has on-hand will be considered when issuing authorizations; up to 5 on-hand doses for treatment of acute bleeding episodes are permitted at the time of authorization. Rendering providers must account for on-hand inventory when submitting monthly dispensing authorization requests and must not dispense quantities that would leave the member with more than five extra doses for acute bleeding treatment. Excess dispensing beyond allowed on-hand doses or failing to document on-hand inventory when requested may result in denial or modification of the authorization.

Cumulative on-hand inventory considered for authorizations; up to 5 on-hand doses permitted
Rendering provider must document member product inventory when requesting monthly dispensing authorization
Dispensing beyond allowed on-hand doses or failure to submit required dispensing authorization may risk denial

Documentation Required

Background

Recombinant factor VIIa products (Novoseven RT and Sevenfact) are indicated primarily for treatment of bleeding episodes in patients with hemophilia A or B with inhibitors. The policy bases coverage on adherence to FDA‑approved labeling and relevant clinical literature, and it requires documentation of the confirmed diagnosis by coagulation testing and, for inhibitor‑mediated hemophilia, a current or historical inhibitor titer of ≥ 5 Bethesda Units (BU). Requests will be evaluated in the context of the listed, covered diagnoses and the plan’s requirement that use align with labeling or cited literature; Medicare determinations follow NCD/LCD where applicable.

Definitions and Dosing

Measurement of inhibitor titer

DefinitionBethesda Unit (BU) — measurement of inhibitor titer used to define clinically significant inhibitors

Authorization thresholdInhibitor titer ≥ 5 BU (current or historical) required to meet Hemophilia A/B inhibitor criteria for authorization

Case‑by‑case noteMembers with titers >0.6 BU to <5 BU may be evaluated on a case‑by‑case basis if not responding to or not a candidate for standard factor replacement

Hemostatic dosing (NovoSeven RT)

Initial hemostatic regimenAdminister 90 mcg/kg IV every 2 hours (adjustable based on severity) until hemostasis is achieved or treatment judged inadequate

Post‑hemostatic dosingAfter hemostasis for severe bleeds: administer 90 mcg/kg IV every 3–6 hours

OpenPayer

Hemophilia Products – Recombinant Factor VIIa (NovoSeven RT, Sevenfact) Coverage Criteria

Coverage Criteria

Coding

Provider Actions and Requirements

Background

Definitions and Dosing