NovoSeven RT (coagulation factor VIIa [recombinant]) coverage under the pharmacy benefit
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Defines Mass General Brigham Health Plan pharmacy benefit coverage and prior authorization requirements for NovoSeven RT (recombinant factor VIIa) for specified bleeding disorders and compendial uses; applies to Commercial/Exchange pharmacy benefit members and specialty pharmacy processes.
Policy updated to apply only to the pharmacy benefit (no longer applies to the medical benefit).
Approval length for initial reauthorization approvals updated to 12 months.
Language for members new to the plan updated to require medical records showing current treatment when coverage effective date is ≤ 90 days.
SevenFact (an alternative agent) was removed from the policy.
Coverage and Authorization Criteria
Diagnosis-specific coverage criteria
Authorization may be granted when the member meets diagnosis-specific criteria below.
ALL of the following
ONE of
- Inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL).
- Member has a history of inhibitor titer ≥ 5 BU.
ALL of the following
ONE of
- Inhibitor titer is ≥ 5 Bethesda units per milliliter (BU/mL).
- Member has a history of inhibitor titer ≥ 5 BU.
Initial therapy criteria
Initial authorization is granted when diagnosis-specific criteria are met.
Continuation of therapy
Continuation and reauthorization criteria
Continuation of Therapy (reauthorization requirements)
Reauthorization requirements
Limits
Limitations
Billing, Codes, and Lab Thresholds
| No codes listed |
Prior Authorization and Documentation Requirements
Prior authorization required; documentation for new members
Prior authorization is required under the pharmacy benefit and specialty distribution must be through a contracted specialty pharmacy. For members new to the plan (coverage effective date ≤ 90 days), submit medical records documenting that the member is currently receiving treatment with the requested drug; documentation does not need to include therapies obtained as samples or through manufacturer patient assistance programs. Authorization may be granted when diagnosis-specific criteria are met.
- Submit medical records for new-to-plan members with coverage effective date ≤ 90 days to document current treatment.
- Do not submit records for therapies obtained as samples or via manufacturer patient assistance programs.
- Ensure prior authorization request is for a diagnosis that meets the policy's diagnosis-specific criteria.
Specialty Pharmacy and Benefit Designation
Specialty distribution and pharmacy benefit
This medication is designated as a specialty product and must be dispensed through a contracted specialty pharmacy; coverage is provided under the pharmacy benefit.
- Arrange fulfillment through the contracted specialty pharmacy listed by the plan.
- Billing and benefits are managed under the pharmacy benefit (not medical).
Key Definitions
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