Neighborhood Health Plan RI Factor IX Coverage

Coverage Criteria for Factor IX (Hemophilia B)

Initial Therapy — Hemophilia B

Covered when ALL of the following are met

Universal: Patient or request meets Hemophilia Management Program requirements (including required half-life study and inhibitor testing when applicable); therapy is not being used for induction of immune tolerance for Hemophilia B for the listed products; MMP members who received the medication within the past 365 days are exempt from step therapy

See Hemophilia Management Program for half-life and inhibitor testing requirements

Diagnosis of congenital factor IX deficiency (Hemophilia B) confirmed by blood coagulation testing

Indication: Request is for one of the following: on-demand treatment to control bleeding episodes; OR perioperative management (authorizations valid for 1 month); OR routine prophylaxis to prevent or reduce bleeding frequency

If prophylaxis dose exceeds dosing limits a half-life study should be performed; half-life study required for Alprolix, Idelvion, or Rebinyn

Severity requirement: Patient has severe hemophilia B (factor IX level < 1%) OR has at least two documented episodes of spontaneous joint bleeding

Renewal Criteria

Renewal covered when ALL of the following are met

Continuation requirements: Patient continues to meet universal and indication-specific criteria and has absence of unacceptable toxicity to the drug

Unacceptable toxicity examples include anaphylaxis, hypersensitivity, thromboembolic events, development of neutralizing antibodies (inhibitors), nephrotic syndrome

Dose changes and on-hand supply: Any increases in dose must be supported by acceptable clinical rationale (e.g., weight gain, half-life study results, increase in breakthrough bleeding when adherent); cumulative on-hand medication will be considered and authorization may allow up to 5 doses on-hand for acute bleeding during the authorization period

On-demand renewal: Renewals for on-demand treatment will be approved for a 6-month authorization period

Perioperative renewal: Perioperative management coverage may NOT be renewed

Product Dosing Guidance

Dosing guidance by product and scenario (on-demand, perioperative, prophylaxis)

Alprolix dosing: Provides recovery estimates and suggested dosing for minor/moderate/major bleeds, perioperative management, and routine prophylaxis (e.g., adults/adolescents ≥12: 50 IU/kg once weekly or 100 IU/kg every 10 days; circulating factor IX rise ≈1% per IU/kg in adults/children ≥6)

Half-life study required to justify extended-interval dosing (100 IU x10 days) and before switching from non‑EHL products

AlphaNine SD dosing: Dosing by bleed severity and prophylaxis (e.g., minor 20–30 IU/kg; moderate 25–50 IU/kg; major up to 30–50 IU/kg with repeats; routine prophylaxis 25–40 IU/kg twice weekly or 15–30 IU/kg twice weekly); perioperative targets 50–100% as specified

Adjust regimen based on individual response

BeneFIX dosing: Provides recovery and dosing by bleed severity and prophylaxis (recovery ≈0.8 IU/dL per IU/kg in ≥12y); examples include minor bleed target 20–30% dosed every 12–24 hours, major 50–100% for 7–10 days, routine prophylaxis example 100 IU/kg once weekly

Dose and duration depend on severity, location of bleed, age, and observed recovery

Indication-based coverage

Covered when product is used for ANY of the following FDA-indicated uses with dosing per product labeling:

Indications: On-demand treatment and control of bleeding episodes; OR perioperative management; OR routine prophylaxis when supported by the product's FDA labeling

Rebinyn is not approved for routine prophylaxis per summary of evidence; follow product labeling for prophylaxis indications

Dosing criteria

Dosing must follow product-specific calculations and target activity levels:

Dosing logic: Initial dose should be calculated using product-specific recovery and the formula: Required Dose (IU) = Body Weight (kg) x Desired Factor IX rise (% of normal or IU/dL) x reciprocal of product recovery (IU/kg per IU/dL), except where product labeling specifies fixed dosing (e.g., Rebinyn 40 IU/kg for minor/moderate; 80 IU/kg for major)

Target circulating Factor IX activity ranges vary by product and scenario (examples: BeneFIX minor 20–30%; Idelvion minor/moderate 30–60%; perioperative targets commonly 50–100% depending on surgery)

General Coverage Criteria

Covered when consistent with FDA-approved labeling and relevant clinical literature and when clinical information submitted supports medical necessity.

General coverage requirements: Use consistent with FDA-approved labeling and/or relevant clinical literature; prescriber must provide clinical information to support medical necessity; Neighborhood will give individual consideration to each request based on submitted information and applicable coverage determinations

CMS NCDs/LCDs supersede plan criteria for Medicare members; criteria adopted to align use of named products (Alprolix, Idelvion, Rebinyn) with labeling and literature

Therapy for induction of immune tolerance in patients with Hemophilia B is not an approved use for the listed factor IX products. The policy explicitly excludes induction of immune tolerance for the following products: Alprolix, Rixubis, Ixinity, Idelvion, Rebinyn, AlphaNine SD, Mononine, and BeneFIX.

The evidence summary and product labeling indicate that Rebinyn is not approved for routine prophylaxis in patients with Hemophilia B. Clinical trial data summarized in the evidence section evaluated Rebinyn for on‑demand treatment and perioperative management, but routine prophylaxis is not an approved indication for Rebinyn per the document.

Medicare (Part B) coverage determinations take precedence where applicable. Providers should follow any relevant National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs); compliance with those CMS policies is required for Medicare members and supersedes the plan criteria when applicable.

Authorizations issued for perioperative management are time‑limited and may not be renewed. Perioperative approvals are intended to cover the immediate surgical period only; ongoing refill or renewal requests for a perioperative indication should not be granted under the perioperative authorization rules.

Within the provided document fragments there are no explicit statements labeling specific uses as 'not medically necessary.' The policy instead documents approved indications, exclusions, and the clinical evidence supporting product uses without categorically designating additional uses as not medically necessary in these excerpts.

Although a formal denial rationale is not listed in the supplied fragments, requests that do not align with FDA‑approved labeling or the relevant clinical literature (as adopted by the plan’s P&T Committee) may be denied. The plan states it will give individual consideration to requests and may deny coverage if submitted information does not support medical necessity per the adopted criteria.

Coding, Units, and Diagnosis Codes

Max Units per 28-day supply (by product)mixed

Alprolix	34,500 billable units per 28-day supply
Idelvion	18,400 billable units per 28-day supply
Rebiyn	18,400 billable units per 28-day supply
Ixinity	64,000 billable units per 28-day supply
AlphaNine SD	36,800 billable units per 28-day supply
Profilnine	36,800 billable units per 28-day supply
Mononine	36,800 billable units per 28-day supply
BeneFIX	46,000 billable units per 28-day supply
Rixubis	55,200 billable units per 28-day supply

HCPCS codes listed for productsHCPCS

J7193	Mononine
J7194	Profilnine
J7200	Rixubis
J7201	Alprolix
J7202	Idelvion
J7203	Rebinyn

NDCs citedNDC

68516-3601	NDC listed (vial NDC for a product)
00053-6232	Mononine NDC
71104-0933	Alprolix NDC (example)

Billing/CPT/HCPCS Codes for Factor IX ProductsHCPCS

J7200	Rixubis (factor IX) — 1 IU (billing code listed)
J7202	Idelvion (factor IX) — 1 IU (billing code listed)
J7203	Rebinyn (factor IX) — 1 IU (billing code listed)

Covered Diagnosis Codes (ICD-10)ICD-10Covered

D67	Hereditary factor IX deficiency

Exposure days (minimally treated)

Minimum exposure daysMembers with < 50 exposure days to factor products are considered minimally treated and require baseline inhibitor testing and periodic testing

Baseline testing frequencyInhibitor testing required at baseline for minimally treated patients (<50 exposure days)

Ongoing testing frequencyRepeat inhibitor testing at every comprehensive care visit: yearly for mild/moderate and semi‑annually for severe patients

Target circulating Factor IX activity

BeneFIX (example targets)Minor bleed target 20–30% of normal; moderate 25–50%; major 50–100% (recovery ~0.8 IU/dL per IU/kg in ≥12 y).

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required and must specify the exact HCPCS code/product and the clinical indication for use. Requests should reference the named factor IX product (e.g., Alprolix, Idelvion, Rebinyn, Rixubis, Ixinity, AlphaNine SD, Mononine, BeneFIX) and the corresponding HCPCS code(s) to ensure correct routing and review.

Prior authorization must reference specific HCPCS/product and indication.
Prior authorization criteria adopted for Alprolix, Idelvion, and Rebinyn to align with FDA labeling and literature.

Documentation Required

Prescriber Clinical Information Considered

Prescriber-submitted clinical information will be considered in individual coverage decisions. Submitters should provide patient clinical history, bleed history, current product inventory on-hand, rationale for product selection, and any supporting documentation to justify use of a specific factor IX product.

Background and Rationale

Hemophilia B (congenital factor IX deficiency) is managed primarily with intravenous factor IX replacement therapy to treat acute bleeds, provide perioperative hemostatic control, and, where supported by labeling, to provide routine prophylaxis to reduce bleed frequency. Severity (for example, severe disease defined by factor IX activity <1% or recurrent spontaneous joint bleeds), patient age, and the clinical scenario determine target circulating factor IX activity levels and dosing regimens. Product‑specific recovery and dosing guidance are used to calculate initial and maintenance doses to reach the desired percent activity or IU/dL targets for minor, moderate, or major bleeding and for perioperative management.

Key Definitions and Clinical Thresholds

Severe hemophilia B — definition/threshold

Factor IX level thresholdSevere hemophilia B defined as circulating Factor IX level < 1% of normal

Clinical severity alternativeOr at least two documented episodes of spontaneous joint bleeding

Use in criteriaSeverity requirement applied to initial therapy eligibility for Hemophilia B

IU per kg recovery — expected rise in circulating Factor IX activity

BeneFIX recoveryApproximately 0.8 IU/dL increase in circulating Factor IX per IU/kg infused in adolescents/adults (≥12 years)

Idelvion recoveryApproximately 1.3 IU/dL increase in circulating Factor IX per IU/kg infused in adolescents/adults

OpenPayer

Intravenous Factor IX (Hemophilia B) — Coverage Criteria

Coverage Criteria for Factor IX (Hemophilia B)

Coding, Units, and Diagnosis Codes

Provider Requirements, Prior Authorization, and Billing Guidance

Background and Rationale

Key Definitions and Clinical Thresholds