CurrentPeach State Health PlanPolicy CP.PHAR.220

Factor VIIa, Recombinant (NovoSeven RT, SevenFact)

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Defines medical necessity criteria, dosing limits, and authorization requirements for recombinant factor VIIa products (NovoSeven RT and SevenFact) for treatment of bleeding disorders across Peach State Health Plan lines of business.

Policy Summary

PayerPeach State Health Plan

PolicyFactor VIIa, Recombinant (NovoSeven RT, SevenFact)

Policy CodePolicy CP.PHAR.220

Change TypeNo material changes

Effective DateMay 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber specialty, current body weight (kg), and dosing to meet initial approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsapproval duration

90 mcg/kgmax dose (NovoSeven)

75 mcg/kgSevenFact dosing

J-codesbilling codes

Commercial, HIM, Medicaid

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CurrentPeach State Health PlanPolicy CP.PHAR.220

Factor VIIa, Recombinant (NovoSeven RT, SevenFact)

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Sign up for Peach State Health Plan Policy CP.PHAR.220 alerts

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Policy Summary

PayerPeach State Health Plan

PolicyFactor VIIa, Recombinant (NovoSeven RT, SevenFact)

Policy CodePolicy CP.PHAR.220

Change TypeNo material changes

Effective DateMay 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber specialty, current body weight (kg), and dosing to meet initial approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsapproval duration

90 mcg/kgmax dose (NovoSeven)

75 mcg/kgSevenFact dosing

J-codesbilling codes

Commercial, HIM, Medicaid

Coverage Criteria — Recombinant Factor VIIa (NovoSeven RT, SevenFact)

Initial Therapy (Hemophilia A/B with inhibitors; Congenital FVII deficiency; Acquired hemophilia)

Covered when ALL of the following are met for the listed diagnosis groups

Eligible Diagnoses: Member has one of: (a) congenital hemophilia A or B with inhibitors; (b) acquired hemophilia (NovoSeven RT requests only); (c) congenital factor VII deficiency (NovoSeven RT requests only)

SevenFact indication limited to hemophilia A/B with inhibitors and age ≥12 years

Prescriber and Documentation: Prescribed by or in consultation with a hematologist; documentation of member's current body weight (kg); provider submits supporting clinical documentation

Intended Use: Request is for treatment and control of bleeding episodes or perioperative management (perioperative management limited to NovoSeven RT)

SevenFact: treatment and control of bleeding episodes only

Dosing Limits: Dose does not exceed product-specific maxima: NovoSeven - hemophilia 90 mcg/kg every 2 hours; NovoSeven - congenital factor VII deficiency 30 mcg/kg every 4 hours; SevenFact - 75 mcg/kg every 2 hours

See Appendix D dosing tables for detailed regimens

Initial Therapy (Glanzmann's Thrombasthenia)

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

Diagnosis of Glanzmann's thrombasthenia

Product: Request is for NovoSeven RT

SevenFact is not listed for this indication

Refractory to Platelets: Condition is refractory to platelet transfusions

Prescriber: Prescribed by or in consultation with a hematologist

Dose Limit: Dose does not exceed 90 mcg/kg every 2 hours

Continued Therapy

Continued therapy covered when ALL of the following are met

Prior therapy or continuity: Member is currently receiving medication via Centene benefit OR member has previously met initial approval criteria OR continuity of care applies (state/product specific)

Refer to state-specific addendums for continuity provisions

Response: Member is responding positively to therapy

Documentation of member's current body weight (kg)

Weight documentation required to calculate dose

Dose increase limits: If increasing dose, the new dose must not exceed product-specific maxima: NovoSeven hemophilia 90 mcg/kg q2h; NovoSeven congenital FVII deficiency 30 mcg/kg q4h; SevenFact 75 mcg/kg q2h

See Appendix D for dosing specifics

Covered Uses and Dosing

Coverage and dosing are described per indication with specific regimens; SevenFact indications aligned to FDA label and acquired hemophilia indication applicable to NovoSeven RT only.

Indications: Use for treatment and control of bleeding episodes and perioperative hemostasis in: congenital hemophilia A or B with inhibitors (NovoSeven RT and SevenFact); congenital factor VII deficiency (NovoSeven RT only); Glanzmann's thrombasthenia refractory to platelet transfusion (NovoSeven RT); acquired hemophilia (NovoSeven RT only)

SevenFact coverage aligned to FDA label; acquired hemophilia limited to NovoSeven RT

Dosing examples by indication: NovoSeven for hemophilia with inhibitors — 90 mcg/kg IV every 2 hrs until hemostasis (then 90 mcg/kg every 3–6 hrs for severe bleeds); NovoSeven for congenital FVII deficiency — 15–30 mcg/kg IV every 4–6 hrs (30 mcg/kg q4h cited for some regimens); NovoSeven for acquired hemophilia — 70–90 mcg/kg IV every 2–3 hrs until hemostasis; NovoSeven for Glanzmann's — 90 mcg/kg IV every 2–6 hrs until hemostasis (surgical regimens up to 140 mcg/kg q2h noted); SevenFact for mild/moderate bleeds — 75 mcg/kg IV every 3 hrs or initial 225 mcg/kg (severe bleed dosing and subsequent 75 mcg/kg intervals per label)

Specific perioperative schedules and post-operative maintenance described in Appendix D; consult manufacturer PI for full details

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient supporting documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 for commercial lines of business, HIM.PA.154 for the health insurance marketplace, or CP.PMN.53 for Medicaid, or unless coverage is established by evidence of coverage documents.

The policy clarifies that the acquired hemophilia indication applies explicitly to NovoSeven RT only. Other product indications are aligned with each product's FDA‑labeled uses; SevenFact coverage was updated to align with the FDA label during prior reviews.

Initial Therapy — Authorization Rules by Diagnosis

Initial Therapy

Initial authorization rules by diagnosis group

Hemophilia A/B with inhibitors: Diagnosis of congenital hemophilia A or B with inhibitors; prescribed by or in consultation with a hematologist; request for treatment and control of bleeding episodes (SevenFact) or treatment/ perioperative management (NovoSeven RT); documentation of current body weight (kg); dose within product-specific limits

SevenFact requests require age ≥12 years

Acquired hemophilia: Diagnosis of acquired hemophilia; applicable to NovoSeven RT only; prescribed by or in consultation with a hematologist; documentation of current body weight (kg); dose within product-specific limits

Congenital factor VII deficiency: Diagnosis of congenital factor VII deficiency; applicable to NovoSeven RT only; prescribed by or in consultation with a hematologist; documentation of current body weight (kg); dose within product-specific limits

Continuation Therapy — Ongoing Authorization Conditions

Continuation Therapy

Continued therapy criteria for all indications in Section I

Eligibility: Member currently receiving medication via Centene benefit OR member previously met initial approval criteria OR continuity of care applies (state/product specific)

Refer to state-specific addendums for continuity provisions

Clinical response: Member is responding positively to therapy

Weight documentation: Documentation of current body weight (kg)

Weight required to support dosing

Continuation Therapy

Continuation dosing until hemostasis achieved and post-operative maintenance dosing when indicated.

Provider Actions — Prior Authorization, Documentation, and Billing

Prior Authorization

Prior authorization required with supporting clinical documentation

Prior authorization is required. Provider must submit documentation demonstrating the member meets the policy's initial approval criteria including diagnosis (eligible diagnosis per Section I), prescriber (prescribed by or in consultation with a hematologist), age requirement for SevenFact (≥12 years when applicable), intended use (treatment/control of bleeding episodes or perioperative management for NovoSeven RT), and documentation of the member's current body weight (kg).

Diagnosis must be one of: congenital hemophilia A or B with inhibitors; acquired hemophilia (NovoSeven RT only); or congenital factor VII deficiency (NovoSeven RT only).
Prescribed by or in consultation with a hematologist.
SevenFact requests: age ≥ 12 years.
Intended use must be treatment/control of bleeding episodes; perioperative management is limited to NovoSeven RT.
Documentation of current body weight (kg) is required.

Coding — HCPCS and Dosing Examples

HCPCS CodesHCPCS

J7189	Factor VIIa (antihemophilic factor, recombinant), (NovoSeven RT), per 1 mcg
J7212	Factor VIIa (antihemophilic factor, recombinant)-jncw (SevenFact), per 1 mcg

Dose examples — inv-08: Dose examples

Hemophilia A/B (with inhibitors)Example dosing: 90 mcg/kg IV every 2 hours for severe bleeds; after hemostasis 90 mcg/kg every 3–6 hours (NovoSeven RT)

Congenital factor VII deficiencyExample dosing: 15–30 mcg/kg IV every 4–6 hours until hemostasis; perioperative: 15–30 mcg/kg immediately before surgery and every 4–6 hours as needed (NovoSeven RT)

Glanzmann's thrombastheniaExample dosing: 90 mcg/kg IV every 2–6 hours until hemostasis; surgical: 90 mcg/kg immediately before surgery and repeat every 2 hours (NovoSeven RT)

Acquired hemophiliaExample dosing: 70–90 mcg/kg IV every 2–3 hours until hemostasis is achieved (NovoSeven RT)

SevenFact dosing examplesMild/moderate bleeds: 75 mcg/kg IV every 3 hours until hemostasis OR initial 225 mcg/kg; if no hemostasis within 9 hours, additional 75 mcg/kg doses (SevenFact)

Quantity Limits and Product Strengths

inv-24: Factor VIIa, recombinant (NovoSeven RT, SevenFact)

NovoSeven RT vial strengthsSingle-use vials: 1 mg, 5 mg, 8 mg (powder for reconstitution)

SevenFact vial strengthsLyophilized powder for reconstitution in single-use vials: 1 mg, 2 mg, 5 mg

Dosing units for billing/quantity limitsDosing and quantity limits are specified in mcg (e.g., dosing examples 75–225 mcg/kg); product availability reported in mg vial sizes for reconstitution

Site of Care and Administration

Note

Dosing assumes IV administration in acute/perioperative settings

Dosing described in the policy assumes intravenous administration in acute care or perioperative settings; the policy text does not limit use to a specific facility setting.

Example regimens (e.g., 90 mcg/kg IV every 2 hrs for NovoSeven) are given for IV administration in these settings.
No explicit site‑of‑care restriction is specified in the policy.

Background

Recombinant factor VIIa products are hemostatic agents used to treat bleeding in several settings, including congenital hemophilia A or B with inhibitors, congenital factor VII deficiency, Glanzmann's thrombasthenia refractory to platelet transfusion, and acquired hemophilia. The policy notes product‑specific indications and labeling differences between NovoSeven RT and SevenFact, and documents revisions over time including age and formulation updates as well as the requirement for documentation of member weight for dosing.

Definitions

inv-18: Hemophilia definitions

Congenital hemophilia ADeficiency of factor VIII

Congenital hemophilia BDeficiency of factor IX

Acquired hemophiliaPresence of coagulation factor inhibitors (autoantibodies)

inv-19: Acquired hemophilia

Definition — acquired hemophiliaBleeding due to coagulation factor inhibitors (autoantibodies); noted in Appendix D as evidence of acquired hemophilia

Product applicabilityAcquired hemophilia indication is applicable to NovoSeven RT only per dosing and indications sections

Clinical note

Revision History

2025-10-29Annual review

Clarified that acquired hemophilia indication is applicable to NovoSeven RT only; references reviewed and updated.

2025-10-17Annual review

Clarified terminology for congenital factor VII deficiency from 'prevention' to FDA-labeled 'control' of bleeding episodes; references reviewed and updated.

2024-07-08Template update/RT4

Added new vial strength (2 mg) and updated HCPCS codes.

Policy Summary

PayerPeach State Health Plan

PolicyFactor VIIa, Recombinant (NovoSeven RT, SevenFact)

Policy CodePolicy CP.PHAR.220

Change TypeNo material changes

Effective DateMay 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber specialty, current body weight (kg), and dosing to meet initial approval criteria.

SourceLink

On This Page

Glanzmann's thrombasthenia (reference): Diagnosis of Glanzmann's thrombasthenia refractory to platelet transfusions; NovoSeven RT only; prescribed by or in consultation with a hematologist; dose limit 90 mcg/kg q2h

Glanzmann's criteria listed separately in policy Section I.B

Initial Therapy

Initial dosing regimens for bleeding episodes and pre-operative use.

Initial dosing examples: Examples include: NovoSeven for congenital hemophilia A/B with inhibitors — 90 mcg/kg IV every 2 hrs until hemostasis; for minor surgery 90 mcg/kg IV immediately before surgery (repeat q2h during surgery and post-op per schedule); congenital FVII deficiency — 15–30 mcg/kg IV every 4–6 hrs until hemostasis (30 mcg/kg q4h noted); acquired hemophilia — 70–90 mcg/kg IV every 2–3 hrs until hemostasis; SevenFact for mild/moderate bleeds — 75 mcg/kg IV every 3 hrs or initial 225 mcg/kg (if needed follow with 75 mcg/kg), with product-specific intervals for severe bleeds

Refer to Appendix D for full perioperative and post-op dosing tables

Continue until hemostasis: Repeat dosing as specified (intervals vary by indication) until hemostasis is achieved; post-operative maintenance dosing described (e.g., NovoSeven: continue 90 mcg/kg q2h after surgery for specified period then spacing to q2–6 hrs or continuous infusion at 50 mcg/kg/hr as noted)

Specific intervals and durations depend on severity and indication — see Appendix D

Billing Rule

Include HCPCS codes, weight, and indication with PA

When requesting authorization, include the HCPCS billing codes and clinical details needed to support dosing: J7189 for NovoSeven RT and J7212 for SevenFact. Submission must include the member's current body weight (kg) and the indication to justify the requested mcg/kg dosing.

HCPCS: J7189 = Factor VIIa (NovoSeven RT), per 1 mcg.
HCPCS: J7212 = Factor VIIa (SevenFact), per 1 mcg.
Include member weight in kg and the specific indication to support the mcg/kg dose requested.

Note

Route unlisted uses to formulary/non‑formulary or off‑label policies

If the requested indication, age, or dosing regimen is not specifically listed in this policy, route the request per the formulary/non‑formulary or off‑label use policies for the applicable line of business (commercial, marketplace, or Medicaid) as referenced in this policy.

For recent label changes or if drug is on formulary/PDL, refer to the no coverage criteria policy for the relevant line of business (e.g., CP.CPA.190 commercial, HIM.PA.33 marketplace, CP.PMN.255 Medicaid).
If drug is NOT on formulary/PDL, refer to the non‑formulary policy for the relevant line of business (e.g., CP.CPA.190 commercial, HIM.PA.103 marketplace, CP.PMN.16 Medicaid).
If the requested use is not listed under Section III and criterion 1 above does not apply, refer to the off‑label use policy (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid).

Denial Risk

Verify coding to avoid claim denials

Ensure claims and requests use correct codes and descriptions; incorrect or outdated coding may result in denied claims. Verify coding against current professional coding guidance prior to submission.

Codes referenced in this policy are for informational purposes only and inclusion does not guarantee coverage.
Providers should reference the most up‑to‑date sources of professional coding guidance before submitting claims.

Documentation Required

Submit supporting clinical documentation (office notes, labs, consultations)

Provider must submit supporting clinical documentation with the prior authorization request, such as office chart notes, laboratory results, and any consultations (e.g., hematology) that demonstrate the member meets approval criteria.

Include office notes or other clinical information showing diagnosis and refractory status when applicable (e.g., refractory to platelet transfusions for Glanzmann's thrombasthenia).
Include evidence of hematology consultation when required.

Documentation Required

Provide current body weight (kg) for dose calculation

Document the member's current body weight in kilograms in the request and medical record; weight is required to calculate mcg/kg dosing and was added as a requirement in the 1Q2021 policy update.

Weight must be included in the prior authorization submission and in ongoing documentation for continuation requests.
Weight is necessary to verify that requested dose does not exceed product‑specific maxima.

Denial Risk

Non‑FDA indications require off‑label policy documentation or will risk denial

Coverage is limited to FDA‑approved or policy‑specified indications; requests for non‑FDA indications that are not addressed in this policy require documentation per the off‑label use policy for the applicable line of business or evidence of coverage documents, otherwise they risk denial.

Non‑FDA approved indications are not authorized unless sufficient documentation of efficacy and safety is provided per CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid).
Acquired hemophilia is covered only for NovoSeven RT per the policy.

Denial Risk

Coding errors may cause claim denials — confirm codes before submission

Claims may be denied if coding is incorrect; before submitting claims for reimbursement, providers should verify codes and descriptions against current professional coding guidance.

The policy notes codes are informational and do not guarantee coverage.
Confirm HCPCS units (per 1 mcg) and code mapping for NovoSeven RT (J7189) and SevenFact (J7212) prior to claim submission.

Acquired hemophilia dosing examples: 70–90 mcg/kg IV every 2–3 hours until hemostasis (NovoSeven RT)

2021-12-01Annual review

Added commercial line of business; required documentation of member's body weight for dosage calculation; clarified SevenFact indications to align with FDA label; updated references.

2026-02-26Annual reviewLatest

1Q2026 annual review: clarified congenital factor VII deficiency indication terminology to align with FDA label ('control' of bleeding episodes); references reviewed and updated.