CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hemophilia Products -Factor IX: AlphaNine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Mononine, Profilnine, Rebinyn, and Rixubis (Intravenous)

Coverage and utilization management policy for intravenous Factor IX products for Hemophilia B across Medicaid, Commercial, and Medicare-Medicaid Plan members, including authorization lengths, quantity/unit limits, hemophilia management program requirements (half-life and inhibitor testing), dispensing requirements for rendering providers, renewal criteria, indication-specific dosing guidance, and billing/NDC/HCPCS mapping.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products -Factor IX: AlphaNine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Mononine, Profilnine, Rebinyn, and Rixubis (Intravenous)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review Date

Key ActionSubmit authorization requests per indication-specific windows (initial 3 months; on-demand renewals 6 months; routine prophylaxis renewals 12 months; perioperative authorizations 1 month) and include requested dispensing details, vial sizes, patient inventory and bleed history.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

9Listed Factor IX products covered

1Covered diagnosis codes listed

5Maximum on-hand doses permitted

Typical renewal periods (months)

Coverage Summary

This policy defines coverage and utilization management for intravenous Factor IX products used to treat Hemophilia B across Medicaid, Commercial, and Medicare-Medicaid Plan members. Covered products include: AlphaNine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Mononine, Profilnine, Rebinyn, and Rixubis. The policy's overall coverage stance is covered_with_criteria and specifies authorization lengths, quantity/unit limits, hemophilia management program requirements, dispensing controls, renewal criteria, and HCPCS/NDC billing mappings.

Key thresholds & quick facts

On-hand doses permitted at authorizationUp to 5 doses

Severe hemophilia B definitionFactor IX level <1%

Alprolix preferred dosing50 IU/kg every 7 days (to obtain 100 IU/kg every 10 days, submit half-life study)

Effective date01/01/2020

Last review08/14/2024

Initial Therapy Criteria (Medical Necessity)

Universal Criteria

Therapy excluded: The products listed below are NOT to be used for immune tolerance induction (ITI) in patients with Hemophilia B. These products are allowed for other indicated uses but are explicitly excluded for ITI.

ALL of the following

Therapy is NOT used for induction of immune tolerance in patients with Hemophilia B.
Products not to be used for immune tolerance induction
- Alprolix
- Rixubis
- Ixinity

Continuation / Renewal Criteria

Denial Risk

Renewal Denial Conditions

Renewal may be denied if the patient has unacceptable toxicity or no longer meets universal or indication-specific criteria. Any dose increases must be supported by an acceptable clinical rationale.

Examples of unacceptable toxicity: anaphylaxis, hypersensitivity, thromboembolic events, neutralizing antibodies/inhibitors, nephrotic syndrome

Provider Actions & Documentation Requirements

Documentation Required

Hemophilia Management Program data submission

For monthly dispensing authorization, the rendering provider must submit original prescription information, the requested amount to be dispensed, vial sizes available from the manufacturer, and patient clinical history including product inventory and bleed history. The cumulative on-hand inventory will be considered when authorizing dispensing.

Submit original prescription and requested amount
Provide vial sizes available, product inventory and bleed history
Cumulative on-hand inventory will be considered

Documentation Required

Half-life study and inhibitor testing requirements

Half-life studies are required when prophylaxis requests exceed dosing limits, for requests involving Alprolix, Idelvion, or Rebinyn, prior to switching to those EHL products, and for members with BMI ≥ 30. Inhibitor testing is required for minimally treated patients (<50 exposure days) at baseline and then at comprehensive care visits (yearly for mild/moderate; semi-annually for severe).

Applicable Codes (ICD-10, HCPCS, NDC)

Covered ICD-10 Diagnosis CodesICD-10Covered

D67	Hereditary factor IX deficiency

HCPCS / Billing mappings and NDCs (product-level)mixed

J7193	AlphaNine SD; 1 IU = 1 billable unit (vial sizes: 1000 units NDC 68516-3602; 500 units NDC 68516-3601; 1500 units NDC 68516-3603; 1000 units mapping shown)
J7194	Unspecified product mapping referenced (NDCs 68516-3201, 68516-3202, 68516-3203 etc.)
J7195	Unspecified product mapping referenced (NDCs 58394-0633, 58394-0634, 58394-0635, 58394-0636)
J7201	HCPCS code referenced in document (specific product not clear from text)
J7202	Rixubis / Rebinyn mapping appears in segments (NDCs 69911-0864/0865/0866/0867 etc.)
J7213	Product mapping (Medexus Pharma) NDCs 70504-0283, 70504-0284, 70504-0288
J7203	Rebinyn HCPCS mapping referenced (1 IU = 1 billable unit; Novo Nordisk)

NDC list (sampled from document)NDC

68516-3601	AlphaNine SD 500 units
68516-3602	AlphaNine SD 1000 units
68516-3603	AlphaNine SD 1500 units
68516-3607	AlphaNine SD (alternate pack)
68516-3608	AlphaNine SD (alternate pack)
68516-3609	AlphaNine SD (alternate pack)
00053-6232	Mononine 500 units
00053-6233	Mononine 1000 units
71104-0966	Listed product NDC (document contains multiple unnamed NDCs)
71104-0911	Listed product NDC

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Clinical Evidence & References

Dosing and hemophilia management program requirements in this policy are informed by product package inserts for AlphaNine SD, Alprolix, BeneFIX, Ixinity, Mononine, Profilnine, Rebinyn, Rixubis, and Idelvion, and by hemophilia guideline sources including MASAC recommendations and the World Federation of Hemophilia (WFH) Guidelines.

Background

This policy governs intravenous Factor IX replacement products for Hemophilia B and defines medical necessity and program requirements. It requires hemophilia management program elements such as half-life studies in specific situations (prophylaxis exceeding dosing limits, requests for Alprolix/Idelvion/Rebinyn, switching to those EHL products, and for members with BMI ≥ 30) and inhibitor testing for minimally treated patients (<50 exposure days) at baseline and at specified intervals. Dispensing controls require rendering providers to submit prescription details and patient inventory monthly, limit dose vial tolerance to +1% of prescribed dose with a maximum of three vials per dose, and cap extra on-hand doses at up to 5 for acute bleeding. Dosing guidance is derived from product package inserts and hemophilia guidelines and includes product-specific dosing and perioperative/prophylaxis recommendations.

Definitions

Minimally treated patient<50 exposure days to factor products

Severe hemophilia BFactor IX level of <1%

Medicare Determinations / Local Coverage References

Medicare-related references for claims review and mapping include the NCD titled "Hemophilia clotting factors billing/coding guidance references" and Local Coverage Articles A56482, A56065, and A56433, which are referenced for claims review and billing/coding mapping.

Revision History

2020-01-01Effective date

Policy effective date

2024-08-14Last reviewLatest

Most recent review date

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products -Factor IX: AlphaNine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Mononine, Profilnine, Rebinyn, and Rixubis (Intravenous)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review Date

SourceLink

On This Page

Universal Criteria: All other universal criteria (1-5,7-9) apply as relevant to the member and indication.

Hemophilia B (congenital factor IX deficiency) - Indication-specific criteria

Coverage for Hemophilia B (congenital factor IX deficiency) is provided when the following indication-specific criteria are met.

ALL of the following

Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing.
Allowed uses
- On-demand treatment and control of bleeding episodes.
- Perioperative management (Authorizations valid for 1 month).
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Severity requirement
- Patient has severe hemophilia B (factor IX level < 1%).
- Patient has at least two documented episodes of spontaneous bleeding into joints.

Note: Authorizations for perioperative management are valid for 1 month and are not renewable.

Hemophilia Management Program requirements

Hemophilia Management Program requirements that must be met or documented with requests for prophylaxis, product switches, and for certain patient populations.

ALL of the following

Half-life study requirements
- If the request is for prophylaxis and the requested dose exceeds dosing limits under part II, a half-life study should be performed to determine the appropriate dose and dosing interval.
- If the request is for Alprolix, Idelvion, or Rebinyn, a half-life study should be performed to determine the appropriate dose and dosing interval.
- Prior to switching to Alprolix, Idelvion, or Rebinyn, a half-life study should also be performed on the current non-EHL factor IX product to ensure a clinical benefit will be achieved.
- For members with a BMI ≥ 30, a half-life study should be performed to determine the appropriate dose and dosing interval.
Operational note: For Alprolix, 50 IU/kg every 7 days is the preferred regimen; to obtain 100 IU/kg every 10 days, a half-life study must show significant clinical benefit over 50 IU/kg every 7 days.
Operational note: Prior-to-switch requirement — submit half-life study on current product when switching to Alprolix, Idelvion, or Rebinyn.
Inhibitor testing for minimally treated patients
- For minimally treated patients (< 50 exposure days to factor products) previously receiving a different factor product, inhibitor testing is required at baseline.
- Subsequent inhibitor testing is required at every comprehensive care visit (yearly for mild and moderate patients, semi-annually for severe patients).
Requests will be reviewed to applicable National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) when relevant.

Prior Authorization

Authorization required and duration

Initial authorization provided for 3 months (may vary by indication); perioperative authorizations valid for 1 month.

On-demand: initial 3-month auth
Perioperative: 1-month auth (not renewable)
Routine prophylaxis: initial 3-month auth then see renewal criteria
Renewal denial conditions: Renewal will be denied if the patient does not continue to meet universal and indication-specific criteria; if there is unacceptable toxicity (including hypersensitivity/anaphylaxis, thromboembolic events, development of neutralizing antibodies/inhibitors, nephrotic syndrome); if increases in dose lack acceptable clinical rationale; or if documentation shows the member has more than the allowed on-hand doses (more than 5 extra doses).

Half-life study for prophylaxis beyond dosing limits, for Alprolix/Idelvion/Rebinyn requests, prior-to-switch, and for BMI ≥30
Inhibitor testing for minimally treated patients at baseline and per visit schedule (yearly for mild/moderate; semi-annually for severe)

Billing Rule

Dispensing dose vial tolerance

Factor dose should not exceed +1% of the prescribed dose and a maximum of three vials may be dispensed per dose. If exact matching within the threshold is not possible, dispense the lowest possible dose above +1%. Prescribed dose should not be increased to meet assay management requirements.

Factor dose should not exceed +1% of prescribed dose; max three vials per dose
If exact match unavailable, dispense lowest possible dose above +1%
Prescribed dose should not be increased to meet assay management requirements

Billing Rule

On-hand inventory limit for dispensing

Authorizations and dispensing will account for the cumulative amount of medication the patient has on-hand. Patients should not have more than 5 extra doses on-hand for treatment of acute bleeding episodes.

Up to 5 extra doses on-hand allowed at authorization

Prior Authorization

Authorization required and duration

Initial authorizations are typically provided for 3 months and may be renewed as specified by indication. On-demand renewals are approved for 6 months, routine prophylaxis renewals for 12 months (requires demonstrated benefit), and perioperative authorizations are valid for 1 month and are not renewable. The cumulative on-hand medication is considered when authorizing.

Initial: 3 months
On-demand renewals: 6 months
Routine prophylaxis renewals: 12 months (requires demonstrated benefit)
Perioperative: 1 month; not renewable