CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hemophilia Products -Factor VIII/VWF Complex: Alphanate, Humate-P, Wilate (Intravenous)

Policy governs medical benefit coverage, authorization, dispensing, dosing guidance, renewal criteria, and billing/NDC information for intravenous factor VIII/VWF complex products (Alphanate, Humate-P, Wilate) for Medicaid, Commercial, and Medicare-Medicaid members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products -Factor VIII/VWF Complex: Alphanate, Humate-P, Wilate (Intravenous)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review Date

Key ActionRequesters must obtain authorization (initial typically 3 months) and provide indication-specific documentation; cumulative on-hand inventory will be reviewed and up to 5 on-hand doses allowed.

POLICY UPDATE CHANGES

No material clinical or coverage changes were made to this policy.

3Products covered (Alphanate, Humate-P, Wilate)

9Covered ICD-10 diagnosis codes listed

5On-hand doses allowed

55,200Max units (example per product)

Coverage Summary

This coverage criteria (effective 01/01/2020, last reviewed 08/14/2024) governs medical benefit coverage for intravenous factor VIII/VWF complex products: Alphanate, Humate-P, and Wilate. The policy status is CURRENT and the coverage stance is covered_with_criteria for Medicaid, Commercial, and Medicare-Medicaid members. Covered diagnoses include listed ICD-10 codes (e.g., D66; D68.01–D68.03; D68.04; D68.09). Operational rules include prior authorization (initial authorization typically 3 months), cumulative on-hand inventory review with up to 5 on-hand doses allowed at authorization, and product-specific maximum billable unit limits (e.g., 55,200 billable units per 28 days for Alphanate and Humate-P; 55,200 per 90 days for Wilate). Dispensing rules require monthly authorization submission from the rendering provider and limits on vial/assay variance when dispensing.

Thresholds

On-hand doses permitted at authorizationUp to 5 doses

Initial authorization duration3 months

Alphanate/Humate-P max units per 28 days55,200 billable units per 28 day supply

Wilate max units per 90 days55,200 billable units per 90 day supply

Minimally treated patient definition< 50 exposure days to factor products

Dispensing vial variance limitFactor dose should not exceed +1% of prescribed dose and maximum three vials dispensed per dose

Medical-Necessity / Coverage Criteria

Alphanate and Humate-P - Covered Indications

Coverage is provided when ALL of the following are met:

ALL of the following

Diagnosis of congenital hemophilia A (factor VIII deficiency) confirmed by blood coagulation testing
Used as treatment in one of the following
- Treatment and control of acute bleeding episodes (episodic treatment of acute hemorrhage)
- Perioperative management (Authorization valid for 1 month)
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Prophylaxis qualifiers
- Used as primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level of <1%)
- Used as secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints

Alphanate - von Willebrand disease (vWD) coverage

Coverage is provided when ALL of the following are met:

ALL of the following

Diagnosis of von Willebrand disease confirmed by blood coagulation and von Willebrand factor testing
Used as treatment in one of the following
- Spontaneous and trauma-induced bleeding episodes
- Surgical bleeding prophylaxis during major or minor procedures in patients with vWD in whom desmopressin is ineffective or contraindicated (Authorization valid for 1 month)
Alphanate is NOT indicated for patients with severe (type 3) vWD undergoing major surgery OR treatment of spontaneous/trauma-induced bleeding episodes

Humate-P and Wilate - Covered Indications (vWD and Hemophilia A)

Coverage is provided when ALL of the following are met:

ALL of the following

Diagnoses covered
- Congenital hemophilia A (diagnosis confirmed by testing)
- von Willebrand disease (diagnosis confirmed by appropriate testing)
Used as treatment in one of the following
- Control and prevention of bleeding episodes (episodic treatment of acute hemorrhage/on-demand treatment)
- Perioperative management of bleeding (Authorization valid for 1 month for surgical prophylaxis when indicated)

Hemophilia Management Program Requirements

Hemophilia Management Program requirements

Program requirements that are part of coverage:

ALL of the following

Half-life study and inhibitor tests are required as part of hemophilia management program when specified
For minimally treated patients (< 50 exposure days) previously on a different factor product: inhibitor testing is required at baseline and at every comprehensive care visit (yearly for mild/moderate; semi-annually for severe)
If request for routine prophylaxis exceeds dosing limits under dosing guidance, a half-life study should be performed
For members with BMI ≥ 30, a half-life study should be performed to determine dose and interval

Definitions relevant to program requirements: Minimally treated patient is defined as a patient with < 50 exposure days to factor products. On-hand doses denotes additional doses in the patient's possession beyond immediate need (policy permits up to 5 for acute bleeding).

Evidence and guidance supporting these requirements include the product package inserts (Alphanate, Humate-P, Wilate) and expert guidance bodies referenced in the policy (e.g., MASAC, World Federation of Hemophilia (WFH), ASH/ISTH/NHF/WFH guidelines), which form the rationale for inhibitor testing schedules, half-life study recommendations, and other hemophilia management program elements.

Dispensing / Authorization Limits and Requirements

Dispensing/Authorization limits and requirements

Coverage and dispensing require adherence to the following:

ALL of the following

Initial authorization provided for 3 months (may vary by indication); renewals per section V
Cumulative amount on-hand considered for authorizations; up to 5 on-hand doses for acute bleeding permitted at authorization
Prescriptions cannot be auto-filled; must have expressed need from patient/caregiver/prescriber
Monthly, rendering provider must submit authorization for dispensing before delivering factor product including original prescription, requested amount, vial sizes available, patient clinical history (including product inventory and bleed history)
Factor dose should not exceed +1% of prescribed dose and a maximum of three vials may be dispensed per dose; if unable to meet threshold, dispense lowest possible dose above +1% and do not increase prescribed dose to meet assay management requirements
Patients should not have more than 5 extra doses on-hand for treatment of acute bleeding episodes

Prior Authorization

Initial and renewal authorization requirements

Requesters must obtain prior authorization before initiating therapy. Initial authorizations are typically provided for 3 months (unless otherwise specified). Documentation should include indication-specific clinical information and the member’s current on-hand inventory; up to 5 on-hand doses for acute bleeding may be allowed and cumulative on-hand supply will be reviewed at authorization.

Provide indication-specific documentation per the covered indication criteria
Report current patient product inventory (cumulative on-hand supply will be considered)
Initial authorization duration: typically 3 months
Up to 5 on-hand doses for acute bleeding permitted at authorization

Documentation Required

Monthly dispensing authorization submission

Rendering providers must submit authorization monthly before dispensing. The submission must include the original prescription and clinical details to justify the requested dispensing quantity.

Original prescription information
Requested amount to be dispensed
Vial sizes available to be ordered from the manufacturer
Patient clinical history including product inventory
Bleed history

Billing Rule

Dispensing quantity and vial rules

Dispensing must follow dose variance, vial-count, and on-hand limits to align with assay and inventory management.

Factor dose should not exceed +1% of the prescribed dose
Maximum of three vials may be dispensed per dose
Do not increase the prescribed dose to meet assay management requirements; if threshold cannot be met, dispense the lowest possible dose above +1%
Patients should not have more than 5 extra doses on-hand for acute bleeding

Prior Authorization

Perioperative authorization limit

Authorizations for perioperative/surgical bleeding prophylaxis are limited to a 1-month authorization period and coverage for surgical prophylaxis may not be renewed.

Perioperative/surgical prophylaxis authorization valid for 1 month
Coverage for surgical prophylaxis may NOT be renewed

Denial Risk

Renewal denial conditions

Renewal requests may be denied if there is evidence of unacceptable toxicity or if dose increases lack acceptable clinical rationale.

Unacceptable toxicity examples: anaphylaxis, hypersensitivity reactions, thromboembolic events, development of neutralizing antibodies (inhibitors)
Dose increases must have acceptable clinical rationale (e.g., weight gain, half-life study results, increased breakthrough bleeding when adherent); otherwise renewal may be denied

Documentation Required

Inhibitor testing schedule for minimally treated patients

For minimally treated patients (<50 exposure days) previously on a different factor product, inhibitor testing is required at baseline and then at every comprehensive care visit. Testing cadence differs by severity.

Baseline inhibitor test prior to switching products
Comprehensive care visit testing schedule:
Yearly for mild and moderate patients
Semi-annually for severe patients

Background, Evidence & Definitions

Background: The policy summarizes clinical dosing guidance from package inserts for Alphanate, Humate-P, and Wilate — including weight-based dosing formulas and target FVIII or VWF:RCo levels for minor, moderate, and major bleeding and perioperative management — to inform appropriate dose selection. The hemophilia management program requires pharmacokinetic considerations such as half-life studies (especially when requested routine prophylaxis exceeds dosing limits or for members with BMI ≥ 30) and routine inhibitor monitoring for minimally treated patients (<50 exposure days) at baseline and at every comprehensive care visit (yearly for mild/moderate; semi-annually for severe). Coverage is aligned with diagnosis confirmation via laboratory testing (blood coagulation testing for hemophilia A and von Willebrand factor testing for vWD) as a prerequisite for authorization. Operational dispensing and authorization rules include an initial authorization default of 3 months, monthly submission requirements from rendering providers before dispensing (original prescription, requested amount, vial sizes, patient inventory and bleed history), limits on dispensing variance (factor dose should not exceed +1% of prescribed dose and a maximum of 3 vials per dose), and consideration of cumulative on-hand supply (patients should not have more than 5 extra doses on-hand).

Evidence: Primary references include the package inserts for Alphanate, Humate-P, and Wilate (product prescribing information) and guidance documents from authoritative bodies such as MASAC, the World Federation of Hemophilia (WFH), and the combined ASH/ISTH/NHF/WFH guideline publications, which are cited in the policy references and underpin clinical dosing, prophylaxis, and monitoring recommendations.

Definitions

Minimally treated patientDefined as fewer than 50 exposure days to factor products

On-hand dosesAdditional doses in patient's possession beyond immediate need; policy permits up to 5 for acute bleeding

D66	Hereditary factor VIII deficiency.
D68.01	Von Willebrand disease, type 1.
D68.020	Von Willebrand disease, type 2A.
D68.021	Von Willebrand disease, type 2B.
D68.022	Von Willebrand disease, type 2M.
D68.023	Von Willebrand disease, type 2N.
D68.03	Von Willebrand disease, type 3.
D68.04	Acquired von Willebrand disease.
D68.09	Other von Willebrand disease.

68516-4601	Alphanate NDC (vial info listed)
68516-4611	Alphanate NDC
68516-4602	Alphanate NDC
68516-4612	Alphanate NDC
68516-4603	Alphanate NDC
68516-4613	Alphanate NDC
68516-4604	Alphanate NDC
68516-4614	Alphanate NDC
68516-4609	Alphanate NDC
68516-4615	Alphanate NDC

Name / Number / Type	Effective Date / Notes
Billing and Coding: Hemophilia Factor Products (reference) — A56482 / A56433	Effective 2023-10-01 — LCD local coverage articles referenced for billing and coding guidance
Anti-Inhibitor Coagulant Complex (AICC) guidance reference — NCD 110.3 (A56065)	Effective 2022-11-24 — National Coverage Determination for AICC referenced

OpenPayer

Hemophilia Products -Factor VIII/VWF Complex: Alphanate, Humate-P, Wilate (Intravenous)

Coverage Summary

Medical-Necessity / Coverage Criteria

Hemophilia Management Program Requirements

Dispensing / Authorization Limits and Requirements

Coding

Background, Evidence & Definitions

Medicare Determinations

Revision History