CurrentMass General Brigham Health PlanPolicy N/A

Profilnine (factor IX complex) — Pharmacy Benefit Prior Authorization

Defines prior authorization requirements for Profilnine (factor IX complex) under the pharmacy benefit for Commercial/Exchange members of Mass General Brigham Health Plan; specialty pharmacy fill and hematologist involvement requirements apply.

Policy Summary

PayerMass General Brigham Health Plan

PolicyProfilnine (factor IX complex) — Pharmacy Benefit Prior Authorization

Policy CodePolicy N/A

Change TypeBenefit assignment clarified (medical → pharmacy)

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization under the pharmacy benefit and document diagnosis and hematologist involvement.

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate it no longer applies to the medical benefit and is under the pharmacy benefit only.

12 monthsApproval duration

90 daysNew-to-plan window

3Covered indications

YesSpecialty fill

Coverage Criteria for Profilnine (factor IX complex)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy — Covered when ALL of the following are met for the requested diagnosis-specific indication

Covered when ALL of the following are met for the requested diagnosis-specific indication

Diagnosis requirement: Member has a diagnosis of the specific condition: Hemophilia B OR bleeding due to low levels of liver-dependent coagulation factors OR Factor II deficiency (see separate nodes).

Each diagnosis is an alternative option; see children.

Indication-specific nodes: One of the following diagnosis-specific nodes must be met:

Hemophilia B criteria: Member has a diagnosis of Hemophilia B AND the requested medication is prescribed by or in consultation with a hematologist.

Bleeding due to low levels of liver-dependent coagulation factors criteria: Member has a diagnosis of bleeding due to low levels of liver-dependent coagulation factors AND the requested medication is prescribed by or in consultation with a hematologist.

Factor II deficiency criteria: Member has a diagnosis of Factor II deficiency AND the requested medication is prescribed by or in consultation with a hematologist.

Continuation/ Reauthorization — criteria for ongoing therapy and renewal

Continuation of therapy

Clinical benefit: Member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds).

Reauthorization approvals granted when benefit demonstrated.

Authorization duration: Initial approvals and reauthorizations will be granted for 12 months.12 months

Requests for uses of Profilnine (factor IX complex) outside the FDA-approved indication and listed compendial uses are not covered. Specifically, all indications other than Hemophilia B or the compendial uses (bleeding due to low levels of liver-dependent coagulation factors; Factor II deficiency) are considered experimental/investigational and not medically necessary.

In addition to the FDA-approved indication for Hemophilia B, this policy permits use only for the compendial indications listed: bleeding due to low levels of liver-dependent coagulation factors and Factor II deficiency. Any request for Profilnine for indications beyond these specified uses may be denied as not medically necessary per compendial limits.

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization required through the pharmacy benefit. This product is designated as a specialty medication and must be dispensed via a contracted specialty pharmacy. New-to-plan continuity: members who joined the plan within the past 90 days may be eligible for authorization to continue an existing course of treatment with the requested medication (excludes samples and manufacturer patient assistance program supplies).

Pharmacy prior authorization required
Specialty pharmacy dispensing required
New-to-plan continuity window: 90 days (existing therapy only; excludes samples and manufacturer PAP)

Step Therapy

There are no step therapy requirements for this medication.

Documentation Required

Required Documentation to Support Authorization

Authorization requests must include supporting documentation: relevant diagnosis, documentation that the medication is prescribed by or in consultation with a hematologist, and treatment history demonstrating current use or benefit when applicable.

Diagnosis documentation (e.g., Hemophilia B; bleeding due to low levels of liver-dependent coagulation factors; Factor II deficiency)
Specialist involvement: prescribed by or in consultation with a hematologist
For continuation: evidence of clinical benefit (e.g., reduced frequency or severity of bleeds)
For new-to-plan continuity: documentation of active treatment within 90 days prior to plan enrollment (exclude samples/PAP)

Denial Risk

Not Covered Indications

Requests for use outside of FDA-approved or compendial indications (all indications other than Bleeding due to low levels of liver-dependent coagulation factors, Hemophilia B, and Factor II deficiency) are considered experimental/investigational and are not medically necessary.

Not covered: all non-FDA and non-compendial indications

Key Definitions

Hemophilia B — definition of the condition

DefinitionAn inherited bleeding disorder caused by deficiency of clotting factor IX (Hemophilia B).

Typical causeGenetic deficiency or dysfunction of coagulation factor IX leading to impaired clot formation.

Clinical implicationPatients are at increased risk of spontaneous or trauma-related bleeding and may require factor IX replacement therapy.

Compendial uses — compendia-supported indications

Compendial-supported use 1Bleeding due to low levels of liver-dependent coagulation factors.

Compendial-supported use 2Factor II deficiency.

Coverage noteAll other indications not listed are considered experimental/investigational and not medically necessary.