CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

CareSource utilization management policy defining prior authorization criteria, dosing limits, prescribing specialist requirements, approved indications, and non-recommended uses for NovoSeven RT for medical-benefit coverage.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual review — no criteria changes

Effective DateDec 4, 2024

Next Review Date

Key ActionPrior Authorization is recommended; approve only members who meet the policy's criteria and dosing limits.

SourceLink

POLICY UPDATE CHANGES

Annual revisions noted with 'No criteria changes' for 2023-08-14 and 2024-12-04.

5Covered Indications (listed)

1Not-recommended Indication (liver disease)

4Specialist requirement (prescriber types)

Coverage Summary & Authorization Criteria

NovoSeven RT (recombinant activated Factor VIIa) is indicated for treatment of bleeding episodes and perioperative management in congenital Factor VII deficiency, Glanzmann's thrombasthenia refractory to platelet transfusions, hemophilia A or B with inhibitors, and acquired hemophilia in adults. Evidence does not support general off-label hemostatic use outside these labeled indications.

Recommended Authorization Criteria - FDA-Approved Indications

Coverage of NovoSeven RT is recommended in those who meet one of the following criteria:

ANY of the following

Congenital Factor VII Deficiency
- Approval duration: 1 year if NovoSeven RT is prescribed by or in consultation with a hemophilia specialist
Glanzmann's Thrombasthenia
- Patient is refractory to platelet transfusions
- Medication is prescribed by or in consultation with a hematologist
- Approval duration: 1 year
Hemophilia, Acquired
- Patient meets clinical criteria as specified (policy does not enumerate additional diagnostic thresholds)
- Medication is prescribed by or in consultation with a hemophilia specialist
- Approval duration: 1 year
Hemophilia A or B with Inhibitors
- Medication is prescribed by or in consultation with a hemophilia specialist
- ONE of the following
  - Patient has a positive inhibitor titer ≥ 5 Bethesda Units≥ 5 Bethesda Units
  - Patient has history of an inhibitor with anamnestic response to Factor VIII (or IX for Hemophilia B) replacement therapy that precludes use of Factor replacement to treat bleeding episodes, according to the prescriber
  - Patient has history of an inhibitor with refractory hemostatic response to increased Factor VIII (or IX) dosing that precludes use of Factor replacement to treat bleeding episodes, according to the prescriber
Hemophilia B with Inhibitors (separate listing)
- Medication is prescribed by or in consultation with a hemophilia specialist
- ONE of the following
  - Patient has a positive inhibitor titer ≥ 5 Bethesda Units≥ 5 Bethesda Units
  - Patient has history of an inhibitor with anamnestic response to Factor IX replacement therapy which precludes use of Factor IX replacement to treat bleeding episodes, according to the prescriber
  - Patient has history of an inhibitor with refractory hemostatic response to increased Factor IX dosing which precludes use of Factor IX replacement to treat bleeding episodes, according to the prescriber

Prescribing & Approval Conditions

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical-benefit coverage of NovoSeven RT. Approval is recommended only for members who meet the policy’s listed clinical criteria and the dosing limits specified in the policy. Typical approval duration is 1 year.

Codes: NDC group (related drug)
Typical approval duration: 1 year

Documentation Required

Specialist prescribing/consultation requirement

NovoSeven RT must be prescribed by, or in consultation with, a physician who specializes in the condition being treated (for example, a hemophilia specialist or hematologist).

Billing Rule

Dose exceptions reviewed case-by-case

Requests for doses outside the dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Denial Risk

Non-recommended indications denial risk

Coverage is not recommended for bleeding associated with liver disease and for indications not listed in the Recommended Authorization Criteria; claims for these uses may be denied.

Dosing Considerations & Quantity Limits

Dosing Considerations (clinical guidance)

Dosing ranges described in policy and prescribing information; individualized per patient

Dosing Considerations

Glanzmann's Thrombasthenia dosing: Glanzmann's Thrombasthenia: dosing up to 90 mcg/kg every 2 hours for acute episodes or perioperative management (1,080 mcg/kg daily)
Congenital Factor VII Deficiency dosing: Congenital Factor VII Deficiency: routine prophylactic up to 30 mcg/kg three times weekly; for bleeding episodes and perioperative up to 30 mcg/kg every 4 hours (180 mcg/kg daily); policy approval limit 900 mcg/kg per 28 days≤ 900 mcg/kg per 28 days
Hemophilia, Acquired dosing: Hemophilia, Acquired: dosing similar to congenital hemophilia A/B with inhibitors; up to 90 mcg/kg every 2 hours for acute episodes or perioperative (1,080 mcg/kg daily)
Hemophilia A/B with Inhibitors dosing: Hemophilia A/B with Inhibitors: MASAC notes doses up to 270 mcg/kg per day effective; prescribing information allows up to 50 mcg/kg per hour by continuous infusion in perioperative setting (1,200 mcg/kg daily); policy approval limit 11,160 mcg/kg per 28 days≤ 11,160 mcg/kg per 28 days

Clinical Evidence & Rationale

Cochrane review (2012) concluded that the effectiveness of recombinant Factor VIIa as a general hemostatic drug in non-hemophiliac patients remains unproven and recommended limiting use outside licensed indications to clinical trials.

Randomized trials in cirrhosis-related bleeding (upper gastrointestinal and variceal bleeding) failed to show benefit of recombinant Factor VIIa; AASLD guidance states recombinant Factor VIIa should not be used to correct coagulopathy in this scenario.

Overall, available evidence does not support general off-label hemostatic use of NovoSeven RT outside its labeled indications.

Definitions & Background

Bethesda Units: laboratory measurement unit for inhibitor titer; this policy uses a threshold of ≥ 5 Bethesda Units to define inhibitor-positive status.

NovoSeven RT is labeled for treatment of bleeding episodes and perioperative management in congenital Factor VII deficiency, Glanzmann's thrombasthenia refractory to platelet transfusions, hemophilia A/B with inhibitors, and acquired hemophilia in adults.