Neighborhood Health Plan RI Factor VIIa Coverage Prior Auth

Coverage Criteria and Clinical Requirements

Initial Therapy — Hemophilia A with inhibitors

Covered when ALL of the following are met for Hemophilia A with inhibitors

Hemophilia A (congenital factor VIII deficiency): Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing

Inhibitor titer: Current or historical titer >= 5 Bethesda Units (BU)>= 5 BU

Patients with inhibitor titer >0.6 BU and <5 BU will be evaluated on a case-by-case basis

Permitted uses: Treatment and control of acute bleeding episodes OR Perioperative management (authorizations valid for 1 month) OR Routine prophylaxis when prophylaxis-specific criteria are also met

Prophylaxis criteria: primary prophylaxis for severe factor VIII deficiency (factor VIII level < 1%), OR secondary prophylaxis for ≥2 documented spontaneous joint bleeds, OR documented trial and failure of immune tolerance induction (ITI) and trial/failure/contraindication to Hemlibra

Initial Therapy — Hemophilia B with inhibitors

Covered when ALL of the following are met for Hemophilia B with inhibitors

Hemophilia B diagnosis: Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing

Inhibitor titer: Current or historical titer >= 5 Bethesda Units (BU)>= 5 BU

Permitted uses: Treatment and control of acute bleeding episodes OR Perioperative management (authorizations valid for 1 month) OR Routine prophylaxis when prophylaxis-specific criteria are met

Prophylaxis criteria similar to Hemophilia A, including ITI failure

Initial Therapy — Congenital Factor VII Deficiency

Covered when ALL of the following are met for Congenital Factor VII deficiency

Diagnosis of congenital factor VII deficiency has been confirmed by blood coagulation testing

Permitted uses: Treatment and control of acute bleeding episodes OR Perioperative management

Authorizations for perioperative management valid for 1 month

Initial Therapy — Glanzmann's Thrombasthenia

Covered when ALL of the following are met for Glanzmann's Thrombasthenia

Diagnosis of Glanzmann's Thrombasthenia has been confirmed by blood coagulation testing

Platelet transfusion failure: Platelet transfusions are known or suspected to be ineffective or are contraindicated

Permitted uses: Treatment and control of acute bleeding episodes OR Perioperative management

Authorizations for perioperative management valid for 1 month

Initial Therapy — Hemophilia A/B age 12+ with inhibitors

Covered when ALL of the following are met for age 12+ with inhibitors (Hemophilia A or B)

Age: Patient is at least 12 years of age>= 12 years

Diagnosis of congenital factor VIII or IX deficiency has been confirmed by blood coagulation testing

Inhibitor titer: Patient has inhibitors to factor VIII or IX with a current or historical titer >= 5 Bethesda Units (BU)>= 5 BU

Indication limited to treatment and control of acute bleeding episodes; will not be used for treatment of congenital factor VII deficiency

General Coverage Criteria

Covered when use aligns with FDA-approved labeling, MASAC recommendations, and the plan's P&T Committee criteria:

General coverage requirements: Use is for a medically accepted indication consistent with FDA labeling or relevant clinical literature; documentation supports the indication and dosing; prescriber justification provided for non-standard use

Neighborhood will give individual consideration to each request; for INTEGRITY members NCD/LCD take precedence

Dosing and Administration

Dosing guidance (per product labeling):

Perioperative dosing - congenital Factor VII deficiency: Administer 15-30 mcg/kg IV immediately before surgery and every 4-6 hours during surgery until hemostasis achieved

From product labeling

Perioperative dosing - Glanzmann's Thrombasthenia: Initial 90 mcg/kg IV immediately before surgery, repeat every 2 hours during procedure; post-op 90 mcg/kg IV every 2-6 hours to prevent postoperative bleeding

From product labeling

Bleed control - Hemophilia A/B with inhibitors (Sevenfact dosing examples): Mild/moderate: 75 mcg/kg IV every 3 hours until hemostasis OR initial 225 mcg/kg with additional 75 mcg/kg every 3 hours if needed after 9 hours; Severe: 225 mcg/kg IV initially, then 75 mcg/kg every 2 hours after 6 hours until hemostasis

From product labeling

Perioperative authorizations for bleeding management with NovoSeven RT are limited to the initial authorization period specified for the indication and may NOT be renewed. Documented perioperative use should be requested only for the defined surgical timeframe and renewal requests for perioperative management will not be approved.

For Medicare Part B members, coverage of outpatient drugs is governed by the Medicare Benefit Policy Manual and by any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs). Where NCDs/LCDs/LCAs apply, compliance with those documents is required and they may supersede this policy for Part B claims.

When applying the criteria for patients aged ≥12 years with hemophilia A or B and inhibitors, NovoSeven RT will not be used for the treatment of Congenital Factor VII deficiency. Requests for congenital factor VII deficiency should be evaluated under the specific criteria for that diagnosis rather than the Hemophilia A/B with inhibitors criteria set.

Billing Codes, NDCs, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J7189

NovoSeven RT (1 mcg = 1 billable unit)

NDCs / Vial sizesNDC

00169-7010	NovoSeven RT 1 mg NDC
00169-7020	NovoSeven RT 2 mg NDC
00169-7050	NovoSeven RT 5 mg NDC
00169-7040	NovoSeven RT 8 mg NDC
N/A	Sevenfact NDCs and specific codes listed elsewhere in document

Covered HCPCS CodesHCPCSCovered

J7189	Novoseven RT (recombinant activated factor VII)
J7212	Sevenfact (eptacog beta)

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

Product NDCsNDC

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)

inv-16: Inhibitor titer threshold — >= 5 Bethesda Units (BU) for eligibility for inhibitors-related indications

Threshold>= 5 Bethesda Units (BU)

Applies toCurrent or historical inhibitor titer for Factor VIII or Factor IX (Hemophilia A or B)

Use in criteriaRequired eligibility criterion for inhibitors-related indications (acute bleeding, perioperative management, or prophylaxis when other criteria met)

Case-by-case notePatients with titers >0.6 BU to <5 BU may be evaluated on a case-by-case basis

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Authorization period and step therapy exception

Initial authorizations are generally provided for 3 months unless otherwise specified. For members of the Medicare‑Medicaid Plan (MMP) who have received the requested medication within the past 365 days, step therapy requirements do not apply (these members are exempt from step therapy). The cumulative amount of medication the patient has on‑hand will be considered when authorizing; up to 5 on‑hand doses for treatment of acute bleeding episodes may be permitted for the duration of the authorization.

Initial authorization period: 3 months (unless specified otherwise)
Step therapy exception: MMP members with prior receipt within past 365 days are exempt
On‑hand inventory: up to 5 extra doses allowed for acute bleeding episodes

Documentation Required

Monthly dispensing authorization documentation

Monthly dispensing by the rendering provider requires prior submission of documentation before delivering factor product. The rendering provider must provide the original prescription, requested dispense amount, vial sizes available to order from the manufacturer, patient clinical history including product inventory and bleed history, and any other information requested to justify the monthly dispense quantity. Prescriptions cannot be auto‑filled; dispensing must reflect an expressed need from the patient, caregiver, or prescriber. The cumulative on‑hand amount will be considered and patients should not have more than 5 extra doses on‑hand.

Background and Clinical Context

Recombinant activated factor VIIa products (eg, NovoSeven RT and related agents) are indicated primarily for control and treatment of bleeding in patients with hemophilia A or B with inhibitors. These agents have demonstrated hemostatic efficacy in clinical studies and are also used in other hemostatic disorders such as congenital factor VII deficiency, acquired hemophilia, and Glanzmann's thrombasthenia. Adverse events reported include headache, dizziness, infusion site reactions and thrombotic events; these safety considerations should be documented and monitored when seeking coverage.

Key Terms and Definitions

inv-26: Bethesda Units (BU) — measurement of neutralizing antibody titer against factor VIII or IX

DefinitionBethesda Units (BU) — measurement of neutralizing antibody titer against factor VIII or IX

ContextUsed to confirm presence of inhibitors in patients with hemophilia A or B

Interpretation guidanceCurrent or historical titer >= 5 BU is required for coverage in inhibitor-related indications; lower titers (>0.6 to <5 BU) considered case-by-case

inv-27: Bypass and hemostatic agents (e.g., recombinant activated factor VII, eptacog beta) — definition of bypass agent

DefinitionBypass and hemostatic agents — agents such as recombinant activated factor VII (e.g., NovoSeven RT) and eptacog beta (Sevenfact) used to achieve hemostasis by bypassing inhibited clotting factors

Examples

Policy Revision History

08/14/2024last_reviewLatest

Policy last reviewed by the plan (P&T Committee rationale and criteria reaffirmed).

01/01/2020effective_date

Policy became effective for coverage of recombinant activated factor VII products (NovoSeven RT; Sevenfact).

OpenPayer

Hemophilia Products - Factor VIIa: NovoSeven RT; Sevenfact

Coverage Criteria and Clinical Requirements

Billing Codes, NDCs, and Diagnosis Codes

Prior Authorization, Documentation, and Provider Requirements

Background and Clinical Context

Key Terms and Definitions

Policy Revision History