CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hemophilia Products Factor VIII (Advate, Adynovate, Afstyla, Eloctate, Hemofil M, Koate/Koate DVI, Kogenate FS, Kovaltry, Novoeight, Nuwiq, Obizur, Recombinate, Xyntha/Xyntha Solofuse, Jivi, Esperoct, Altuviiio)

Governs authorization, dosing limits, hemophilia management program requirements, dispensing and renewal criteria, perioperative and prophylaxis indications, and billing/J-code/NDC mappings for multiple factor VIII products across Medicaid, Commercial, and Medicare-Medicaid Plan populations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products Factor VIII (Advate, Adynovate, Afstyla, Eloctate, Hemofil M, Koate/Koate DVI, Kogenate FS, Kovaltry, Novoeight, Nuwiq, Obizur, Recombinate, Xyntha/Xyntha Solofuse, Jivi, Esperoct, Altuviiio)

Policy CodePolicy N/A

Change TypeClarified (no material change)

Effective Date01/01/2020

Next Review DateN/A

Key ActionMonthly, rendering providers must submit authorization of dispensing quantity (original prescription, requested amount, vial sizes, patient history and inventory); initial authorizations typically 3 months and renewals require meeting criteria.

POLICY UPDATE CHANGES

Document lists multiple revision dates (12/14/2023, 01/10/2024, 05/15/2024, 08/14/2024) with change history present; no material clinical/coverage change indicated (Part 1 of 2).

16Products listed

Up to 5Allowed on-hand extra doses

3 monthsInitial auth

6 months

Coverage Summary

This coverage policy governs authorization, dosing, dispensing, and renewal for a comprehensive list of factor VIII replacement products used for congenital and acquired Hemophilia A across Medicaid, Commercial, and Medicare-Medicaid populations. Operationally, initial prior authorization is generally issued for 3 months (unless otherwise specified), with renewals typically processed for 6 months except routine prophylaxis which may be renewed for 12 months. The Hemophilia Management Program requirements (half-life studies, inhibitor testing) and dispensing controls (monthly authorization before delivery, vial/rounding rules, and inventory limits) are enforced at authorization and refill. Cumulative on-hand medication is considered for approvals; members may have up to 5 on-hand doses permitted for acute bleeding episodes at the time of authorization.

Key thresholds

On-hand doses allowedUp to 5 extra doses for acute bleeding episodes

Initial authorization period3 months (unless otherwise specified)

Renewal authorization period (general)6 months

Renewal authorization period (routine prophylaxis)12 months

Obizur inhibitor titer limitBaseline anti-porcine FVIII inhibitor titer ≤20 BU

Example EHL dosing threshold (Eloctate)50 IU/kg every 4 days (example regimen)

Typical initial auth3 months

Typical renewal auth6 months (routine prophylaxis: 12 months)

Medical-Necessity Criteria

General Authorization and Coverage

Covered when ALL of the following are met:

ALL of the following

Products: Advate; Adynovate; Afstyla; Eloctate; Hemofil M; Koate/Koate DVI; Kogenate FS; Kovaltry; Novoeight; Nuwiq; Obizur; Recombinate; Xyntha/Xyntha Solofuse; Jivi; Esperoct; Altuviiio (intravenous) - any listed product is eligible under the Hemophilia Management Program.
Diagnosis: Hemophilia A (congenital factor VIII deficiency) confirmed by appropriate blood coagulation testing when indication is congenital Hemophilia A; OR acquired Hemophilia A confirmed by blood coagulation testing when indication is acquired Hemophilia A.
Indication-specific use: Product use must be for on-demand treatment and control of bleeding episodes, perioperative management, routine prophylaxis, or other FDA/compendia-supported Hemophilia A indications as described in product-specific criteria.

Provider Actions and Dispensing Requirements

Prior Authorization

Authorization required before dispensing

Authorization required before dispensing. Monthly, the rendering provider must submit an authorization request for the dispensing quantity before delivering factor product. Include original prescription information, the requested amount to be dispensed, vial sizes available, patient clinical history (including product inventory and bleed history). Initial authorization is typically 3 months and renewals require meeting criteria.

Original prescription
Requested amount
Vial sizes available
Patient clinical history
Inventory (on-hand doses)
Bleed history

Coding

Covered HCPCS/J-codes by product (billing unit = 1 IU unless noted)mixedCovered

J7192	Advate; Kogenate FS; Recombinate; multiple products listed under J7192 (1 billable unit = 1 IU for many products)
J7205	Eloctate (1 IU)
J7211	Kovaltry (1 IU)

J-Codes and product mappings (by product)HCPCS|NDC

J7192	Advate, Kogenate FS, Recombinate, Recombinate and others mapped to J7192 with listed NDCs and vial sizes per source
J7211	Kovaltry mapped to J7211 with multiple NDCs referenced (00944-2844-10, 00944-2845-10, 00026-3821-25, 00026-3822-25, 00026-3824-25, 00026-3826-50, 00026-3828-50)
J7205	Eloctate mapped to J7205 with NDCs including 00944-2844-10, 00944-2845-10 and 71104-0801-01 through 71104-0810-01 (various vial sizes)
J7190	Koate/Koate DVI and Hemofil M mapped to J7190 with multiple NDCs for Koate and Hemofil M (see source)
J7182	Novoeight mapped to J7182 with NDCs 00169-7825-01, 00169-7850-01, 00169-7810-01, 00169-7815-01, 00169-7820-01, 00169-7830-01
J7209	Nuwiq mapped to J7209 with NDCs 68982-0140-01, 68982-0142-01, 68982-0144-01, 68982-0146-01, 68982-0148-01, 68982-0150-01
J7188	Obizur mapped to J7188 with NDC referenced 00944-5001-xx
J7185	Xyntha / Xyntha Solofuse mapped to J7185 with NDCs such as 58394-0012-01, 58394-0022-03, 58394-0013-01, 58394-0014-01, 58394-0024-03, 58394-0015-01, 58394-0025-03, 58394-0016-03
J7210	Afstyla mapped to J7210 with NDCs 69911-0474-02, 69911-0475-02, 69911-0476-02, 69911-0480-02, 69911-0477-02, 69911-0481-02, 69911-0478-02
J7207	Adynovate mapped to J7207 with NDCs 00944-4622-01, 00944-4623-01, 00944-4626-01, 00944-4624-01, 00944-4627-01, 00944-4625-01, 00944-4628-01

1–10 of 13

1/2

Product NDC mappings (selected examples)NDC

00944-3051-02	Advate 250 units vial NDC
00944-3052-02	Advate 500 units vial NDC
00944-3054-02	Advate 1500 units vial NDC
00944-3045-10	Advate 2000 units vial NDC
00944-3046-10	Advate 3000 units vial NDC
0944-3047-10	Advate 4000 units vial NDC (format in doc)
00026-3782-25	Kogenate FS 250 units NDC
00026-3783-35	Kogenate FS 500 units NDC
00026-3785-55	Kogenate FS 1000 units NDC
00026-3786-65	Kogenate FS 2000 units NDC

1–10 of 14

1/2

Billable unit equivalencies and vial sizes (selected examples)mixed

1 IU	Many products: 1 billable unit equivalent = 1 IU (explicit for Advate, Recombinate, others)
Vial sizes	Multiple vial sizes listed per product (see NDC group for examples)

ICD-10 diagnosis mappingsICD-10

D68.311	Acquired hemophilia
D66	Hereditary factor VIII deficiency

Background

The policy sets clinical and operational rules as part of a Hemophilia Management Program to ensure appropriate use of factor VIII products for both congenital Hemophilia A and acquired Hemophilia A. It requires diagnostic confirmation by coagulation testing, specifies inhibitor testing schedules (including baseline testing for minimally treated patients), and requires half-life studies when initiating or switching to extended half-life (EHL) products or for patients with BMI ≥30. Covered product types include a broad roster of factor VIII replacement therapies (standard and extended half-life brands and Obizur for acquired Hemophilia A) with associated billing mappings (J‑codes and NDCs) listed for provider billing. The policy applies to members enrolled under Medicaid, Commercial, and Medicare‑Medicaid (MMP) plans.

Definitions

Minimally treated patientsDefined as <50 exposure days to factor products

EHLExtended half-life factor VIII product

Billable Unit Equiv.One billable unit equivalent = 1 International Unit (IU) for the listed factor products

Medicare Determinations

Name	Effective Date	Type/Number
Hemophilia Factor Products (Local Coverage Articles referenced)	2023-10-01	LCD

Revision History

12/14/2023revision_date

Document lists revision date 12/14/2023; Part 1 of 2 indicates change history present without material clinical changes noted in this part.

01/10/2024revision_date

Document lists revision date 01/10/2024; Part 1 of 2 indicates change history present without material clinical changes noted in this part.

05/15/2024revision_date

Document lists revision date 05/15/2024; Part 1 of 2 indicates change history present without material clinical changes noted in this part.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policy CodePolicy N/A

Change TypeClarified (no material change)

Effective Date01/01/2020

Next Review DateN/A

On This Page

Age constraints: Jivi is approved only for patients aged 12 years and older (when request is for Jivi).

Von Willebrand disease: Factor VIII products will not be used for treatment of von Willebrand disease in this policy unless specifically indicated by compendia or FDA labeling.

Products with inhibitors: Use of products intended for inhibitor patients (e.g., Obizur for acquired Hemophilia A) must follow inhibitor-specific criteria and testing requirements in the Inhibitor and testing requirements group.

Hemophilia A (congenital factor VIII deficiency) - product-specific core criteria

Preserve nested logic for product-specific core criteria; ONE of the usage reasons and population constraints must be met.

ALL of the following

Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing.
ONE of
- On-demand treatment and control of bleeding episodes.
- Perioperative management of bleeding (per authorization length noted in procedure-specific guidance).
- Routine prophylaxis to reduce frequency of bleeding episodes.
Population-specific constraints
- Primary prophylaxis in patients with severe factor VIII deficiency (FVIII level ≤1%).
- Secondary prophylaxis in patients with documented recurrent spontaneous joint bleeding (history of ≥2 documented spontaneous joint bleeds).
- Use in children to reduce frequency of bleeding episodes and reduce risk of joint damage (Kogenate FS specific wording applies where indicated).
Jivi: patient must be at least 12 years of age.
Exclusion: Not for treatment of von Willebrand disease unless specifically supported by labeling/compendia.

Acquired Hemophilia A (acquired factor VIII deficiency) - Obizur

Acquired Hemophilia A (Obizur) — include inhibitor titer requirement and usage constraints.

ALL of the following

Diagnosis: Acquired factor VIII deficiency confirmed by blood coagulation testing.
Indication: Use is limited to on-demand treatment and control of bleeding episodes in acquired Hemophilia A (not for congenital Hemophilia A or von Willebrand disease).
Baseline anti-porcine factor VIII inhibitor titer must be ≤20 Bethesda Units (BU).
Patients with baseline anti-porcine factor VIII inhibitor titer >20 BU are not eligible for Obizur under this policy.

Extended half-life (EHL) product criteria (Eloctate, Adynovate, Jivi, Esperoct, Altuviiio)

Extended half-life (EHL) product criteria (Eloctate, Adynovate, Jivi, Esperoct, Altuviiio).

ALL of the following

Candidate selection: Patient must not be a suitable candidate for a standard (non-EHL) factor VIII product. Clinical rationale must be documented (e.g., inadequate trough/clinical control, dosing frequency constraints, adherence issues).
Half-life study requirement: A formal half-life study must be scheduled (and results provided) to determine appropriate dose and dosing interval for the EHL product when initiated.
Prior half-life on non-EHL product: Prior to switching to an EHL product (Eloctate, Adynovate, Jivi, Esperoct, Altuviiio), a half-life study should be performed on the current non-EHL factor VIII product to demonstrate likely clinical benefit from switching.
BMI note: For members with BMI ≥30, a half-life study should be performed to determine the appropriate dose and interval.
Dose limits and suitability: If the requested dose exceeds the protocol-specific dosing limits for the named EHL product, documentation must be submitted specifying why the member is not a suitable candidate for Hemlibra and for alternative EHL factor VIII products. Examples of referenced dosing thresholds include regimen equivalents (e.g., Eloctate ~50 IU/kg every 4 days; Adynovate ~40 IU/kg twice weekly; Jivi ~60 IU/kg every 5 days; Esperoct ~50 IU/kg every [specified interval]; refer to product dosing guidance).
Dosing and documentation expectations: Requests must include complete dosing rationale, weight, calculated IU/kg dosing, frequency, recent bleeding history, prior factor exposure and half-life study results. For minimally treated patients (<50 exposure days), inhibitor testing is required at baseline and at every comprehensive care visit (yearly for mild/moderate, semi-annually for severe).

Inhibitor and testing requirements

Inhibitor and testing requirements.

ALL of the following

Minimally treated patients (<50 exposure days to factor products): inhibitor testing required at baseline, then at every comprehensive care visit — yearly for mild/moderate patients and semi-annually for severe patients.
Baseline testing rules: For patients previously receiving a different factor product, baseline inhibitor testing must be obtained prior to initiating a new factor product; additional testing cadence follows the minimally treated patient schedule above.
Renewal and monitoring: Development of neutralizing antibodies (inhibitors) is a reason to reassess therapy; presence of inhibitors may require product change and will affect ongoing coverage decisions per inhibitor-specific criteria.

Dispensing requirements for rendering providers (Hemophilia Management Program)

Dispensing requirements for rendering providers (Hemophilia Management Program).

ALL of the following

Prescriptions cannot be filled without an expressed need from the patient, caregiver, or prescribing practitioner; rendering provider must document expressed need prior to dispensing.
Monthly authorization for dispensing quantity: Rendering provider must submit an authorization request each month before delivering factor product. Submission must include original prescription information, requested amount to be dispensed, available vial sizes, patient clinical history (including product inventory and bleed history), and dosing calculations.
Dispensed vial tolerance: Factor dose dispensed should not exceed +1% of the prescribed dose and a maximum of three vials may be dispensed per dose. If exact dosing within +1% cannot be met due to vial sizes, the lowest possible dose above +1% should be dispensed; prescribed dose must not be increased to meet assay management requirements.
On-hand inventory limits: The cumulative amount of medication the patient has on-hand will be taken into account when dispensing. Patients should not have more than 5 extra doses on-hand for the treatment of acute bleeding episodes at the time of authorization/dispensing.
Rendering provider documentation: Monthly submissions must include patient product inventory, bleed history, and justification for requested quantities. Dispensing requirements are part of the Hemophilia Management Program and noncompliance may affect authorization.

Renewal criteria

Renewal criteria — include period differences, toxicity/antibody considerations, dosing increases justification, and on-hand inventory consideration.

ALL of the following

Continuing eligibility: Patient continues to meet the universal and indication-specific criteria identified in the policy (e.g., section III relevant criteria).
Toxicity and antibodies: Absence of unacceptable toxicity (examples include anaphylaxis/hypersensitivity, thromboembolic events) and absence of clinically significant neutralizing antibodies (inhibitors). Development of inhibitors may lead to non-renewal or change in product per inhibitor criteria.
Dose changes: Any increases in dose must be supported by acceptable clinical rationale such as weight gain, half-life study results, or increased breakthrough bleeding despite adherence; documentation must be provided.
On-hand inventory: The cumulative amount of medication the patient has on-hand will be considered at renewal; authorizations will allow up to 5 doses on-hand for treatment of acute bleeding episodes for the duration of the authorization.
Renewal periods: Standard renewals will be approved for a 6-month authorization period for most indications. Routine prophylaxis renewals will be approved for a 12-month authorization period provided the patient has demonstrated a beneficial response (e.g., decreased bleeding frequency from baseline). Perioperative management requests are not eligible for renewal under routine renewal provisions.

Documentation Required

Hemophilia management program documentation

Hemophilia Management Program documentation required. Providers must document half-life studies and inhibitor testing results when required (e.g., for EHL products, minimally treated patients, and patients with BMI ≥30). Also provide clinical rationale for dose increases or high requested doses.

Billing Rule

Vial dispensing and dose rounding rules

Vial dispensing and dose rounding rules for dispensing rendering providers. Factor dose should not exceed +1% of the prescribed dose; a maximum of three vials may be dispensed per dose. If exact vial match is unavailable, dispense the lowest possible dose above the +1% threshold (do not increase prescribed dose to meet assay or vial constraints).

+1% rounding rule
max three vials per dose
If exact vial match unavailable, dispense lowest possible dose above +1% (do not increase prescribed dose to meet assay management)

Denial Risk

On-hand inventory limitation enforcement

On-hand inventory limitation enforcement: cumulative on-hand medication is considered for authorizations and dispensing. Patients should not have more than 5 extra doses on-hand for treatment of acute bleeding episodes; having more than this may lead to limitation or denial of authorization or dispensing.

Documentation Required

Inhibitor testing schedule

Inhibitor testing schedule required for minimally treated patients (<50 exposure days). Testing cadence: baseline inhibitor test at initiation, then at every comprehensive care visit — yearly for mild and moderate patients, and semi-annually for severe patients.

Baseline (at initiation) for minimally treated patients (<50 exposure days)
Yearly for mild/moderate patients
Semi-annually for severe patients

Billing Rule

Report units and vial/NDC mappings

Report units and vial/NDC mappings when billing. For each billed J-code, report the applicable NDC(s) for the vial size billed and the unit equivalency (1 IU = 1 billable unit for the listed products). Billed vial size must use the specific product NDC corresponding to that vial.

Report J-code
Report applicable NDC(s) for billed vial size
Unit equivalency: 1 IU = 1 billable unit
Billed vial size must use the product's NDC

Billing Rule

Use ICD-10 diagnosis mapping

Use ICD-10 diagnosis mapping when billing. Include the appropriate ICD-10 code for the indication (examples: D68.311 for acquired hemophilia; D66 for hereditary factor VIII deficiency) when billing Obizur and listed factor products as applicable.

Example: D68.311 (Acquired hemophilia) for Obizur
Example: D66 (Hereditary factor VIII deficiency) for congenital Hemophilia A

08/14/2024revision_dateLatest

Document lists revision date 08/14/2024 and last_review 2024-08-14; Part 1 of 2 indicates change history present without material clinical changes noted in this part.