CurrentHealth NetPolicy CP.PHAR.219

Factor IX Complex, Human (Profilnine)

Policy governs medical necessity and prior authorization criteria for Profilnine (human factor IX complex) for prevention and control of bleeding in patients with factor IX deficiency; applies to Health Net lines of business including Commercial and Medicaid.

Policy Summary

PayerHealth Net

PolicyFactor IX Complex, Human (Profilnine)

Policy CodePolicy CP.PHAR.219

Change TypeNo material change

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must obtain prior authorization and submit documentation showing diagnosis, hematology consultation, age ≥18, current weight, and dosing within FDA maximum.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age ≥ 18minimum age for initial approval

3 monthsapproval duration

J7194billing code

500–1500 IUvial sizes

Coverage and Medical Necessity Criteria

Related Billing Codes

HCPCS-J7194-FACTOR-IX-COMPLEX-REPLACEMENT-IU

HCPCS J7194: Factor IX Complex, Per International Unit

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Initial Approval Criteria for Congenital Hemophilia B: 1. Diagnosis of congenital hemophilia B (factor IX deficiency); 2. Prescribed by or in consultation with a hematologist; 3. Age ≥ 18 years; 4. Request is for prevention and control of bleeding episodes; 5. Documentation of member's current body weight (in kg); 6. Dose does not exceed the FDA approved maximum recommended dose for the relevant indication.

Approval duration: 3 months

Continuation Therapy

Continued therapy covered when ALL of the following are met

Continued Therapy Criteria for Congenital Hemophilia B: 1. Member meets one of the following (a or b): (a) Currently receiving medication via Centene benefit or member has previously met initial approval criteria; (b) Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for a dose increase, both: (a) Documentation of member's current body weight in kg (if requesting a higher dose than previously requested); (b) New dose does not exceed the FDA approved maximum recommended dose for the relevant indication.

Approval duration: 3 months

Other Indications / Off-label routing

Other indications

Other uses: 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to the applicable no-coverage/ PD L or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary/PDL; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary). 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

See referenced policies for coverage determination

Requests for uses that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the request is supported by sufficient clinical documentation and justification per the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage.

Billing and Coding

HCPCS CodesHCPCS

J7194

Factor IX complex, per IU

Maximum dose (Hemophilia B)

Maximum dose (Hemophilia B)50 IU/kg

Dosing contextMajor bleeding and perioperative dosing guidance up to 30–50 IU/kg with maintenance dosing thereafter; maximum specified as 50 IU/kg.

Approval noteDose must not exceed the FDA-approved maximum for the indication; documentation of current body weight required for dosing calculations.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Profilnine (Factor IX Complex, Human). The request must document age and diagnosis and be prescribed by or in consultation with a hematologist when applicable. Requests are for prevention and control of bleeding episodes and must include current body weight and dosing that does not exceed the FDA‑approved maximum for the indication.

Prior authorization required for adults (age ≥ 18) with congenital Hemophilia B
Prescriber must be a hematologist or consult with one
Request must state intended use: prevention and control of bleeding episodes
Include current body weight (kg) and dose that does not exceed FDA maximum

Note

Formulary / Off‑Label Routing

If Profilnine is not on the member's formulary or PDL, follow the applicable non‑formulary policy for the member's line of business. If the requested use is not covered by this policy and is not listed in section III, refer to the off‑label use policy for the appropriate line of business.

Commercial non‑formulary: CP.CPA.190; Off‑label commercial: CP.CPA.09
Health insurance marketplace non‑formulary: HIM.PA.103; Off‑label marketplace: HIM.PA.154
Medicaid non‑formulary: CP.PMN.16; Off‑label Medicaid: CP.PMN.53

Documentation Required

Required Documentation

Provider must submit documentation (such as office/clinic notes, lab results, dosing history, and other clinical information) demonstrating that the member meets all approval criteria. For dose increase requests include documentation of current body weight (kg) and rationale that the new dose does not exceed FDA maximum. For continuation requests include evidence of prior approval or continuity of care and clinical response to therapy.

Office chart notes describing diagnosis and treatment plan
Laboratory results and factor activity levels when available
Documentation of prior authorization or proof of prior therapy if applying for continuation
Current body weight in kg for dose calculations and any dose‑increase requests
Clinical notes showing positive response to therapy or justification for continued use

Denial Risk

Non‑Covered Indications Risk

Requests for non‑FDA approved indications that are not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label policy or evidence of coverage. Providers should refer to the off‑label use policies listed above and submit supporting literature and rationale when seeking coverage for unlisted indications.

Non‑FDA indications require submission of supporting clinical evidence per CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid)
Absent sufficient evidence, coverage for non‑FDA indications is not authorized

Background

Profilnine is a plasma‑derived human factor IX complex product that contains factor IX, factor II, factor X and low (non‑therapeutic) levels of factor VII. It is labeled and indicated for the prevention and control of bleeding episodes in patients with factor IX deficiency (hemophilia B). Dosing varies by clinical scenario and should follow FDA‑approved recommendations.

Definitions

Profilnine

Product descriptionHuman factor IX complex (Profilnine) — plasma‑derived product containing factor IX, II, X and low levels of factor VII.

Primary indicationPrevention and control of bleeding episodes in patients with factor IX deficiency (hemophilia B).

Limitation of useNot indicated for treatment of factor VII deficiency due to non‑therapeutic levels of factor VII.

Vial sizes (available)500, 1000, 1500 IU vials (per product availability).