CurrentmhnPolicy CP.PHAR.219

Factor IX Complex, Human (Profilnine)

Policy governing 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 providers submitting claims to the payer lines of business listed. Affects prescribing clinicians and prior authorization reviewers.

Policy Summary

Payermhn

PolicyFactor IX Complex, Human (Profilnine)

Policy CodePolicy CP.PHAR.219

Change TypeNo material change

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with supporting documentation including diagnosis, hematologist involvement, current weight, and dosing within FDA maximum.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J7194HCPCS code

≥18Min age

3 moApproval duration

500–1500 IUVial sizes

Coverage Criteria for Profilnine (Factor IX Complex)

Initial Approval — Congenital Hemophilia B

Policy Summary

Payermhn

PolicyFactor IX Complex, Human (Profilnine)

Policy CodePolicy CP.PHAR.219

Change TypeNo material change

Effective DateMay 1, 2016

Next Review Date

Key ActionSubmit prior authorization with supporting documentation including diagnosis, hematologist involvement, current weight, and dosing within FDA maximum.

SourceLink

On This Page

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Covered when ALL of the following are met

Initial Approval — 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

Continued Therapy — Congenital Hemophilia B

Continued therapy — Covered when ALL of the following are met

Continued Therapy — 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

For continued therapy, current weight required only if higher dose requested.

Other/Off-label Uses

Other indications

Other Diagnoses/Indications: 1. If the drug has had a recent label change not reflected in this policy, route to the applicable formulary/non-formulary policy for the relevant line of business; 2. If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53, or other applicable off-label policies).

See referenced policies CP.CPA.190, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

This policy applies to use of Profilnine (factor IX complex, human) for the prevention and control of bleeding in patients with factor IX deficiency (congenital hemophilia B). The product contains non‑therapeutic levels of factor VII and, consequently, is not indicated for treatment of factor VII deficiency and such requests are outside the scope of this policy. Coverage is limited to indications and clinical scenarios described in the approval criteria; requests for uses not covered here must follow the referenced off‑label and non‑formulary policies.

Requests for non‑FDA approved or off‑label uses of Profilnine are not authorized under this policy unless there is adequate documentation of efficacy and safety consistent with the payer’s off‑label use policies (for example, CP.CPA.09 for commercial lines and CP.PMN.53 for Medicaid). When sufficient evidence is not provided per those policies, coverage for off‑label indications will be denied.

Coding and Dosing Information

HCPCS CodesHCPCS

J7194

Factor IX complex, per IU

Maximum dose and dosing key facts (Hemophilia B)

Maximum dose (Hemophilia B)50 IU/kg

Minor–moderate bleeding dosing20–30 IU/kg IV every 16–24 hours

Major bleeding dosing30–50 IU/kg IV, then 20 IU/kg IV every 16–24 hours

Perioperative (surgery) dosing30–50 IU/kg IV prior to surgery, repeat same dose every 16–24 hours

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for requested therapy. Submit prior authorization requests per payer procedures and bill using HCPCS code J7194 (Factor IX complex, per IU) where applicable. Providers should verify benefit coverage and formulary status prior to submission.

Prior authorization required
Billing code: HCPCS J7194 (Factor IX complex, per IU)
Verify formulary/non-formulary status and follow non-formulary or off-label routing if applicable (see CP.CPA.190, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53)

Documentation Required

Documentation Required to Support Medical Necessity

Provider must submit documentation supporting that the member meets all approval criteria. Required documentation includes, but is not limited to, office/clinic notes, laboratory results, documentation of diagnosis, current body weight (kg), dosing information, and evidence of hematologist involvement when applicable.

Office chart notes and clinical progress notes
Relevant laboratory results
Documentation of diagnosis (e.g., congenital hemophilia B)
Current body weight in kilograms
Dose, dosing regimen, and justification if requesting dose increase
Documentation of prescribing by or in consultation with a hematologist

Denial Risk

Documentation Insufficiency May Result in Denial

Lack of the required documentation will result in denial or non-approval of the request. Incomplete information may delay processing and may require resubmission with complete clinical evidence.

Insufficient clinical documentation will lead to denial or non-approval
Incomplete requests may be returned for additional information or denied if criteria cannot be verified

Background

Profilnine is a human plasma‑derived factor IX complex containing factor IX, II, X and low levels of factor VII. It is FDA‑approved for the prevention and control of bleeding episodes in patients with factor IX deficiency (hemophilia B). Note the product’s limitation: because it contains only non‑therapeutic levels of factor VII, it is not indicated for treatment of factor VII deficiency.

Definitions

Profilnine — key product facts

Product typeFactor IX complex (human) — Profilnine

Factor compositionContains factor IX, II, X, and low (non-therapeutic) levels of factor VII

FDA 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