CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Factor VIII and related hemophilia factor products (intravenous) — Coverage Criteria

Covers medical and pharmacy authorization, dosing limits, and program requirements for intravenous factor VIII and related products used to treat congenital and acquired hemophilia A for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFactor VIII and related hemophilia factor products (intravenous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization with documentation of indication, dosing rationale (desired FVIII rise and IU/kg calculation), and required hemophilia management studies (half-life and inhibitor testing when indicated).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial auth period

up to 5on-hand extra doses allowed

6 mo / 12 morenewal periods

multipledistinct products

25+references cited

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Congenital Hemophilia A (initial coverage criteria)

Covered when ALL of the following are met for congenital Hemophilia A

Hemophilia A coverage: Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing

Age for Jivi: If the request is for Jivi, patient must be at least 7 years of age

Not for vWD: Will not be used for the treatment of von Willebrand's disease

Indication types: Used as treatment in at least one of: on-demand treatment and control of bleeding episodes; perioperative management (authorizations valid for 1 month); routine prophylaxis

No combination prophylaxis: Will not be used in combination with another agent used as prophylactic therapy for Hemophilia A

Prophylaxis intent: Used to reduce frequency of bleeding episodes OR used to reduce frequency and risk of joint damage in children without pre-existing joint damage (Kogenate-FS only)

Primary/secondary prophylaxis: Primary prophylaxis for severe FVIII deficiency (FVIII <1%) OR secondary prophylaxis in patients with at least TWO documented spontaneous joint bleeds OR patient previously treated with valoctocogene roxaparvovec with decreased FVIII activity/bleeding not controlled

Acquired Hemophilia A (initial coverage criteria)

Covered when ALL of the following are met for acquired Hemophilia A

Age: Patient is at least 18 years of age

Diagnosis confirmation: Diagnosis of acquired factor VIII deficiency confirmed by blood coagulation testing

Indication: Used as on-demand treatment and control of bleeding episodes

Exclusions: Is NOT being used for congenital Hemophilia A OR von Willebrand disease

Obizur inhibitor titer: Patient does not have baseline anti-porcine factor VIII inhibitor titer >20 Bethesda Units (BU) (relevant for Obizur)

Renewal Criteria and Duration

Renewal coverage logic

Universal renewal criteria: Patient continues to meet universal and indication-specific criteria; absence of unacceptable toxicity (examples: anaphylaxis, thromboembolic events, development of neutralizing antibodies); dose increases must have clinical rationale; on-hand dose limits considered (authorization may allow up to 5 doses on-hand)

On-demand renewals: Renewals for on-demand treatment approved for a 6-month authorization period

Perioperative renewals: Perioperative management coverage may NOT be renewed

Routine prophylaxis renewals: Renewals for routine prophylaxis approved for a 12-month authorization period and patient must have demonstrated beneficial response (decrease in bleeding frequency from baseline)

Product-specific dosing criteria

Covered when dosing follows product‑specific calculations and target factor VIII activity ranges for the clinical context

On‑demand treatment

Minor bleed dosing examples: Target FVIII 20-40%; dosing may use formula Dose (IU/kg)=Body weight (kg) x Desired factor VIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL) or product-specific fixed IU/kg (see product sections)20-40%
chunks 18,19,21,27,30,33
Moderate bleed dosing examples: Target FVIII 30-60%; repeat dosing commonly every 12-48 hours as specified per product until resolution30-60%
chunks 18,21,27,30,33
Major bleed dosing examples:

Covered indications and dosing guidance

Coverage is framed by indication and established dosing regimens per product for on-demand treatment, perioperative management, and routine prophylaxis.

{\"operator\":\"any\",\"n\":0,\"label\":\"Indications covered\",\"text\":\"On-demand treatment and control of bleeding episodes for congenital Hemophilia A and acquired Hemophilia A; perioperative management; routine prophylaxis\",\"threshold\":\"\",\"note\":\"Product-specific dosing and target FVIII levels provided in product sections\",\"children\":[]}

{\"operator\":\"all\",\"n\":0,\"label\":\"Dose calculation and targets\",\"text\":\"Dose calculations must reference desired FVIII rise (IU/dL) and use 0.5 IU/kg per IU/dL or follow product-specific loading/maintenance regimens; target FVIII levels vary by bleed severity: minor 20-40%, moderate 30-60%, major 60-100% (and Obizur guidance for acquired Hemophilia A specifying troughs 50-100 IU/dL and 100-200 IU/dL during acute bleed)",\"threshold\":\"\",\"note\":\"See product dosing lines\",\"children\":[]}

This policy specifies exclusions for product use in certain diagnoses. For congenital Hemophilia A, products intended for acquired Hemophilia A must not be used to treat congenital disease and vice versa as described in the criteria. The policy explicitly states products will not be used for von Willebrand's disease. For Obizur (porcine-derived recombinant factor VIII), use is excluded when the patient has a baseline anti-porcine factor VIII inhibitor titer > 20 Bethesda Units (BU).

Within the provided excerpts there are no additional exclusion conditions listed for the products beyond those noted elsewhere (for example, Obizur’s baseline anti-porcine inhibitor titer limitation).

The referenced portions of the document and package insert list do not state explicit exclusion conditions for the remaining products in these excerpts; the reference list supports that further product-specific contraindications are detailed in the respective package inserts.

Requests that exceed stated dosing limits for extended half-life (EHL) factor VIII products (examples: Eloctate, Adynovate, Jivi, Esperoct, Altuviiio) require submission of documentation explaining why the member is not a suitable candidate for Hemlibra or alternative EHL products. The policy lists explicit dosing limits (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 4 days) and states additional justification is required when those limits are exceeded.

No explicit statements in these excerpts label particular uses as universally “not medically necessary.” However, the policy indicates that requests exceeding EHL dosing limits without required documentation (including reasons the member is not appropriate for alternative agents) may be considered inappropriate and could be denied under program rules. Documentation requirements and testing obligations are described elsewhere in the policy.

These sections do not include explicit blanket “not medically necessary” declarations for specific product indications. Instead, coverage is defined by meeting indication-specific criteria and appropriate dosing—examples include product dosing tables for on-demand, perioperative, and prophylaxis use that must be followed to support medical necessity.

Coding and Billing

Factor product HCPCS/J-codes (listed in policy)HCPCS

J7192	Advate, Kogenate FS, Helixate FS, Recombinate (Factor VIII)
J7205	Eloctate
J7182	Novoeight
J7209	Nuwiq
J7188	Obizur
J7185	Xyntha / Xyntha Solofuse
J7210	Afstyla
J7207	Adynovate
J7208	Jivi
J7204	Esperoct

1–10 of 22

1/3

Maximum units per product (HCPCS units)mixed

MaxUnits

Per-product maximum billable HCPCS units per supply period as listed (e.g., Advate: 64,400 per 28 days; Adynovate: 46,000 per 28 days; Afstyla: 69,000 per 28 days; Eloctate: 74,750 per 30 days; Kogenate: 64,400 per 28 days; Kovaltry: 55,200 per 28 days; Novoeight: 69,000 per 28 days; Nuwiq: 64,4000 per 28 days; Hemofil M: 55,200 per 28 days; Koate DVI: 55,200 per 28 days; Recombinate: 64,400 per 28 days; Xyntha/Xyntha Solofuse: 41,400 per 28 days; Obizur: 115,000 per 90 days; Jivi: 41,400 per 30 days; Esperoct: 40,250 per 28 days; Altuviiio: 23,000 per 28 days)

Listed HCPCS/J-Codes for factor productsHCPCS

J7192	Advate, Kogenate FS, Recombinate (multiple products listed with J7192 mapping in document)
J7211	Kovaltry
J7205	Eloctate
J7188	Obizur
J7185	Xyntha/Xyntha Solofuse
J7182	Novoeight
J7209	Nuwiq
J7210	Afstyla
J7207	Adynovate
J7208	Jivi

1–10 of 11

1/2

Relevant ICD-10 codesICD-10

D68.311	Acquired hemophilia
D66	Hereditary factor VIII deficiency (Hemophilia A)

EHL dosing limits examples

Eloctate regimen50 IU/kg every 4 days (total weekly ~87.5 IU/kg)

Adynovate regimen40 IU/kg twice weekly (total weekly 80 IU/kg)

Jivi regimen60 IU/kg every 5 days (total weekly ~84 IU/kg)

Esperoct regimen50 IU/kg every 4 days (total weekly ~87.5 IU/kg)

Target FVIII levels for different bleed severities

Minor bleed targetTarget FVIII ~20-40% (20-40 IU/dL)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for factor products as specified in the policy. Initial authorizations are generally provided for 3 months and may be renewed if renewal criteria are met. Renewal requires continued meeting of universal and indication-specific criteria, absence of unacceptable toxicity, and clinical justification for any dose increases. The cumulative medication on-hand will be considered for both initial and renewal authorizations; up to 5 doses on-hand for acute bleeding episodes may be permitted.

Initial authorization default duration: 3 months (may vary by specific indication)
Renewal requires: continued meeting of universal and indication-specific criteria; absence of unacceptable toxicity; clinical rationale for dose increases; and review of on-hand inventory (≤5 extra doses permitted)
Cumulative on-hand inventory considered for authorization decisions

Documentation Required

Hemophilia Management Program Documentation

Background

Background: This policy governs authorization and clinical use of intravenous factor VIII and related factor products for both congenital Hemophilia A and acquired Hemophilia A. It defines eligibility (diagnosis confirmation by coagulation testing; age requirements for acquired disease ≥ 18 years and for certain products such as Jivi ≥ 7 years), frames covered indications (on‑demand treatment, perioperative management, routine prophylaxis), and references product-specific dosing guidance and package inserts for detailed contraindications and dosing regimens.

Definitions

Hemophilia A (congenital) — definition and typical uses

DefinitionCongenital Hemophilia A: congenital factor VIII deficiency confirmed by blood coagulation testing

Typical usesOn‑demand treatment and control of bleeding episodes; perioperative management (authorizations valid for 1 month); routine prophylaxis

Age note for JiviIf request is for Jivi, patient must be at least 7 years of age

Acquired Hemophilia A — definition and age criteria; use not for congenital cases

DefinitionAcquired Hemophilia A: acquired factor VIII deficiency confirmed by blood coagulation testing

Age criterionPatient must be at least 18 years of age

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFactor VIII and related hemophilia factor products (intravenous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2020

Next Review DateN/A

SourceLink

On This Page

Target FVIII 60-100%; repeat dosing every 8-24 hours; some products (e.g., Obizur for acquired Hemophilia A) specify higher loading and maintenance regimens

Routine prophylaxis: Prophylactic regimens are product- and age-specific: adult/adolescent regimens commonly range from 20-50 IU/kg at intervals (twice weekly, three times weekly, every 4 days, or once weekly depending on product); pediatric regimens often use higher IU/kg and differing frequency. Adjust dosing based on clinical response and product guidance.product-specific

See product entries for Altuviiio, Eloctate, Esperoct, Hemofil M, Jivi, Kovaltry, Novoeight, NUWIQ

Perioperative management: Preoperative and postoperative target FVIII activity depend on surgery severity: Minor procedures target approximately 30-60% (some products 30-80%) with dosing every 24 hours; Major surgeries target 80-100% (some products up to 120%) with repeat dosing every 6-24 hours and continuation until wound healing plus at least 7 days of lower-level coverage.product-specific

See product-specific perioperative dosing guidance

Acquired Hemophilia A (Obizur): Obizur dosing specifies loading dose 200 IU/kg; maintenance titrated to maintain FVIII trough levels 50-100 IU/dL for minor/moderate and 100-200 IU/dL during treatment of an acute major bleed, administered every 4-12 hourssee text

chunk 36

Moderate bleed targetTarget FVIII ~30-60%

Major/life-threatening bleed targetTarget FVIII ~60-100% (some product guidance up to 100-200 IU/dL for acute acquired bleed)

Repeat dosing guidanceRepeat intervals vary by product (commonly every 8–48 hours) until bleed resolution

Hemophilia Management Program requirements apply to rendering providers and to clinical review. For routine prophylaxis requests that exceed dosing limits or for members with BMI ≥ 30, a half-life (pharmacokinetic) study should be performed to determine appropriate dose and interval. For requests for specific extended half-life (EHL) products (Eloctate, Adynovate, Jivi, Esperoct, Altuviiio), documentation must show the patient is not a suitable candidate for a standard non‑EHL FVIII product and a half-life study must be scheduled when initiating an EHL product. If switching from a non‑EHL to certain EHL products, a half-life study on the current product is recommended to confirm expected clinical benefit. When requested doses exceed listed EHL dosing limits, documentation must explain why Hemlibra or alternative EHL products are not suitable.

Half-life study recommended when routine prophylaxis exceeds dosing limits or BMI ≥ 30
EHL product requests (Eloctate, Adynovate, Jivi, Esperoct, Altuviiio): must document patient not suitable for standard non-EHL product and schedule half-life study
When doses exceed EHL limits, provide documentation why Hemlibra and alternative EHL FVIII products are not appropriate

Billing Rule

Rendering Provider Dispensing Requirements

Rendering providers must follow dispensing requirements as part of the Hemophilia Management Program. Prescriptions may not be auto-filled and monthly authorization of dispensing quantity must be submitted prior to delivery. Submitted information must include original prescription details, requested dispense amount, available vial sizes, patient clinical history, product inventory, and bleed history. Dispensed dose should not exceed +1% of the prescribed dose; a maximum of three vials may be dispensed per dose. Providers must account for on-hand inventory so patients do not exceed 5 extra doses for acute bleeding.

No auto-filling of prescriptions allowed
Monthly prior authorization required for dispensing quantity with clinical and inventory documentation
Dispensed dose tolerance: ≤ +1% of prescribed dose; max three vials per dose
Limit additional on-hand doses to ≤5 for acute bleeding

Note

Provider Actions and Dosing Documentation

Provider actions specific to step therapy or required sequencing of prior agents are not specified in the provided sections. There is no step therapy sequencing or mandatory trial of alternative agents described in these excerpts. For dosing, providers must use the documented dose calculation formulas and include dosing rationale and calculations in the clinical submission; missing hemophilia program studies or doses exceeding limits may prompt denial or request for additional documentation.

No step therapy sequences or required prior agents described in these sections
Dose calculation formula examples are provided in product dosing (e.g., Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase × recovery/adjustment factor or ×0.5 for many products)
Document indication, dosing rationale, and calculations to support authorization requests
Requests exceeding dosing limits or missing required hemophilia program studies may be denied or require additional documentation

Denial Risk

Billing, Coding, and Administrative Actions

Administrative and coding considerations: prior authorization may be required for specific J‑coded factor VIII products. Ensure correct HCPCS/J‑code and NDC mapping on claims to avoid billing denials. When requesting monthly dispensing authorization packets, include all required documentation (prescription, vial sizes, requested amount, patient inventory, bleed history, and dosing calculations).

PA required for specific J‑coded FVIII products as listed in HCPCS/NDC sections
Verify correct HCPCS/J‑code and NDC mapping to prevent claim denials
Monthly dispensing authorization packet must include original prescription, requested amount, vial sizes, patient product inventory, bleed history, and dosing calculations

Use restrictionIndication is on‑demand treatment; not to be used for congenital Hemophilia A or von Willebrand disease; Obizur requires baseline anti‑porcine FVIII inhibitor titer ≤20 BU

IU of Factor VIII activity — definition and recovery example

IU definitionOne IU of Factor VIII activity corresponds to the quantity of Factor VIII in 1 mL of normal human plasma

Empirical recoveryEmpirically, 1 IU/kg raises plasma Factor VIII activity by approximately 2 IU/dL

Dose calculation basisRequired dose calculations reference IU per kg and desired IU/dL rise

Recovery adjustment — reciprocal used in dose calculation

Recovery adjustment conceptUse the reciprocal of expected/observed recovery when calculating dose (e.g., 0.5 for a recovery of 2 IU/dL per IU/kg)

ApplicationInclude recovery factor in product-specific dose formulas when recovery differs from empirical value

Example sourceKovaltry dosing references reciprocal of expected/observed recovery in required dose formula

Dose calculation — standard formula

Dose formula (per kg)Dose (IU/kg) = Desired factor VIII rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL)

Alternative expressionDosage (IU) = Body weight (kg) × Desired Factor VIII increase × 0.5 (or apply reciprocal recovery adjustment if product‑specific)

UseApply for perioperative and on‑demand dosing calculations unless product specifies fixed dosing or different recovery

Target FVIII trough levels (acquired Hemophilia A) — Obizur guidance

Obizur trough targetsMaintain FVIII trough levels 50–100 IU/dL for minor/moderate bleeding; for treatment of an acute major bleed titrate maintenance to 100–200 IU/dL, then 50–100 IU/dL after control

Dosing scheduleObizur: loading dose 200 IU/kg; maintenance titrated every 4–12 hours to achieve trough targets

Clinical contextObizur guidance applies to acquired Hemophilia A (on‑demand treatment) and includes high loading/maintenance dosing for major bleeds