CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hemophilia Products - Factor VIII (Coverage Criteria)

Policy governs authorization, dosing limits, dispensing, renewal, and clinical criteria for multiple intravenous factor VIII products for treatment and prophylaxis of Hemophilia A and acquired Hemophilia A for Medicaid, Commercial, and MMP members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products - Factor VIII (Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with specific product, indication, patient weight, target Factor VIII activity and dosing calculation; initial authorizations are generally for 3 months and may be renewed with documentation of continued benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16+listed factor VIII products covered

3 monthsinitial authorization period

Up to 5max on-hand extra doses allowed

J-codes listedHCPCS/J-codes present

Per-product maxper-product HCPCS unit limits

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Coverage Criteria for Factor VIII Products

Congenital Hemophilia A - Initial Coverage

Covered when ALL of the following are met

Congenital Hemophilia A criteria: Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND indication is one of: on‑demand treatment and control of bleeding episodes OR perioperative management (authorizations valid for 1 month) OR routine prophylaxis; AND if request is for Jivi, patient is at least 12 years of age; AND product will not be used for von Willebrand disease; AND prophylaxis use is to reduce frequency of bleeding episodes OR to reduce bleeding frequency and reduce risk of joint damage in children without pre‑existing joint damage (Kogenate‑FS only) OR as primary prophylaxis for severe FVIII deficiency (FVIII <1%) OR as secondary prophylaxis after at least TWO documented spontaneous joint bleeds; OR patient was previously treated with valoctocogene roxaparvovec (Roctavian) and factor VIII activity decreased and/or bleeding was not controlled.

Acquired Hemophilia A - Initial Coverage

Covered when ALL of the following are met

Acquired Hemophilia A criteria: Patient is at least 18 years of age; AND diagnosis of acquired factor VIII deficiency has been confirmed by blood coagulation testing; AND use is for on‑demand treatment and control of bleeding episodes; AND is NOT being used for congenital Hemophilia A or von Willebrand disease; AND patient does not have baseline anti‑porcine factor VIII inhibitor titer greater than 20 Bethesda Units (BU).

Extended half-life (EHL) products - Requirements

Covered when ALL of the following are met

EHL product criteria: If request is for an extended half‑life (EHL) product (Eloctate, Adynovate, Jivi, Esperoct, Altuviiio): patient is not a suitable candidate for a standard non‑EHL factor VIII product; a half‑life study must be scheduled to determine appropriate dose and dosing interval when initiating the EHL product; prior to switching to an EHL product perform a half‑life study on the current non‑EHL product to ensure a clinical benefit will be achieved; if requested dosing exceeds specified EHL dosing limits, submit documentation explaining why the member is not a suitable candidate for Hemlibra and alternative EHL products.If requested dose exceeds product limits (see source for specific IU/kg limits)

See listed dosing limits for Eloctate, Adynovate, Jivi, and Esperoct in source.

Indication-specific dosing guidance

Dosing and product use guidance (applies when treating patients with Hemophilia A):

On-demand treatment: Use product‑specific dosing calculations (eg, Dose (IU/kg) = Desired factor VIII rise (IU/dL or % of normal) × 0.5, or use reciprocal of observed recovery where provided); target circulating Factor VIII and example dose ranges: Minor ~20–40% (~10–20 IU/kg) repeat every 12–48 hours; Moderate ~30–60% (~15–30 IU/kg) repeat every 12–48 hours; Major ~60–100% (~30–50 IU/kg) repeat every 8–24 hours until bleed resolution. Adjust per product labeling and patient age.severity-based Factor VIII targets

Supported by product dosing guidance (Eloctate, Esperoct, Jivi, Novoeight, Xyntha).

Perioperative management: Select pre‑ and post‑operative target Factor VIII activity by procedure severity and dose using the dosing formula; examples include minor procedures targeting ~30–60% and major procedures targeting up to 80–100% (with repeat dosing intervals commonly every 8–24 hours); follow product‑specific perioperative recommendations and authorization timing (perioperative authorizations valid for 1 month).surgery type-based targets

See product perioperative dosing tables (Eloctate, Jivi, Novoeight, Xyntha).

Indications and dosing-based coverage

Coverage aligned with standard indications for factor VIII products when ALL of the following apply:

Indication: Patient has the product‑specific indicated diagnosis (eg, congenital Hemophilia A for most FVIII products; Obizur indicated for acquired Hemophilia A) per product labeling.

Product‑specific indications apply.

Use case: The requested use is one of: on‑demand treatment of bleeding episodes OR perioperative management OR routine prophylaxis as described by the product dosing tables and labeling.

Dosing and frequency vary by age and severity.

Coverage criteria (general)

Covered when consistent with FDA labeling and relevant clinical literature; plan criteria adopted by P&T Committee:

Primary coverage requirement: Use is consistent with FDA‑approved labeling and/or relevant clinical literature; requests will be reviewed in light of submitted prescriber documentation and applicable NCD/LCDs for Medicare members.

Neighborhood adopted these criteria to ensure medically accepted indications and encourage cost‑effective options when appropriate.

Use of factor VIII products for the treatment of von Willebrand disease is explicitly excluded.

No other explicit broad exclusions are listed in this section. Note that Obizur dosing and indication language in the policy apply specifically to acquired Hemophilia A (adult patients) rather than congenital Hemophilia A.

Key exclusions reported in clinical trials informing the evidence base included subjects with known hypersensitivity to trial products and those with a history of Factor VIII inhibitors or current inhibitor levels above trial-specified thresholds (for example, exclusion for current inhibitor levels ≥0.6 Bethesda units in some Esperoct trials).

For Medicare beneficiaries, coverage decisions follow the Medicare Benefit Policy Manual and any applicable NCDs/LCDs. The plan-level criteria presented in this policy are intended for non‑Medicare determinations and do not override existing NCD/LCD requirements.

Perioperative use is addressed in the policy, but coverage for perioperative management may not be renewed under the plan’s renewal rules.

This section summarizes indications, dosing guidance, and supporting clinical evidence for the listed factor VIII products. It does not itself set out an exhaustive list of conditions that are designated as "not medically necessary," but rather aligns coverage with FDA labeling and relevant clinical literature as reviewed by the P&T Committee.

The excerpt does not include explicit statements labeling specific uses as "not medically necessary." Clinical trial reports cited in the evidence summary do note development of inhibitors in previously untreated patients (for example, a Recombinate PUP cohort with 32% developing detectable inhibitors), which may affect clinical appropriateness and authorization decisions.

Uses of products that do not conform to FDA-approved labeling or the clinical literature reviewed by the plan would not meet adopted coverage criteria. Product-specific indications and dosing (including when extended half‑life products require half‑life studies prior to switching) are applied to determine conformity.

Coding, Units, and Dosing Metrics

Per-product HCPCS unit limitsmixed

Advate: 64,400	billable units per 28 day supply
Adynovate: 46,000	billable units per 28 day supply
Afstyla: 69,000	billable units per 28 day supply
Eloctate: 74,750	billable units per 30 day supply
Kogenate: 64,400	billable units per 28 day supply
Kovaltry: 55,200	billable units per 28 day supply
Novoeight: 69,000	billable units per 28 day supply
Nuwiq: 64,4000	billable units per 28 day supply
Hemofil M: 55,200	billable units per 28 day supply
Koate DVI: 55,200	billable units per 28 day supply

1–10 of 16

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HCPCS/J-codes and linked NDCsHCPCS

J7192	Advate and other Factor VIII products (as listed) - multiple vial sizes and NDCs provided
J7205	Eloctate - multiple vial sizes and NDCs provided
J7211	Other Factor VIII product J-code entries listed in table

Selected NDCs from product tableNDC

00944-3051-02	Advate NDC (vial size 250 units) example
71104-0801-01	Eloctate NDC (vial size 250 units) example

Covered HCPCS J-codesHCPCSCovered

J7211	Recombinate (multiple vial sizes) - J-code as listed in document
J7205	Eloctate - J-code as listed in document
J7190	Koate/Koate-DVI/Hemofil M (multiple listings) - J-code as listed
J7182	Novoeight - J-code as listed
J7209	Multiple products listed under J7209 (various vial sizes)
J7188	Obizur - J-code as listed
J7185	Solofuse / Xyntha Solofuse - J-code as listed
J7210	Afstyla - J-code as listed
J7207	Baxalta product J-code listings
J7208	Jivi - J-code as listed

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Relevant ICD-10 codesICD-10Covered

D66	Hereditary factor VIII deficiency
D68.311	Acquired hemophilia

inv-20: Target FVIII trough or dosing regimens

Maintain FVIII troughExamples include maintaining trough ≥1% for every-third-day dosing; adjust per product-specific prophylaxis ranges (e.g., Eloctate 25–65 IU/kg at 3–5 day intervals)

Eloctate regimen exampleStarting regimen: 50 IU/kg every 4 days; adjustable within 25–65 IU/kg at 3–5 day intervals

Altuviiio exampleWeekly dosing: 50 IU/kg (use conversion/recovery formulas to calculate dose)

Adynovate prophylaxis exampleProphylaxis dosing examples reported: 40–50 IU/kg twice weekly (product-specific)

inv-21: Routine prophylaxis dosing ranges

Provider Actions, Prior Authorization, and Billing

Prior Authorization

Authorization periods and renewal requirements

Initial authorizations are generally provided for 3 months unless otherwise specified and may be renewed. Renewals, when approved, will be for a 6-month authorization period. The cumulative amount of medication the patient has on-hand will be taken into account for both initial authorizations and renewals (authorizations will ordinarily allow up to 5 on‑hand doses for treatment of acute bleeding episodes). Note: initial and renewal authorization periods may vary by specific covered indication.

Initial authorization period: 3 months (unless otherwise specified)
Renewal authorization period: 6 months when renewal criteria are met
Up to 5 on‑hand doses permitted for acute bleeding episodes; cumulative on‑hand inventory considered

Documentation Required

Product‑specific dosing and indication documentation

Prior authorization requests and dispensing authorizations must include product-specific clinical details: product name, indication, patient weight, target factor level (if applicable), dosing history and recent dosing regimen (on‑demand, perioperative, routine prophylaxis), vial sizes requested, and clinical rationale for dose or frequency exceeding standard dosing limits. For routine prophylaxis requests where the requested dose exceeds dosing limits or member BMI ≥ 30, a half‑life study should be performed and results submitted. Documentation of prior exposure and inhibitor testing (including for minimally treated patients) must be provided as applicable.

Definitions and Dosing Calculations

inv-41: Hemophilia A

DefinitionHemophilia A: congenital factor VIII deficiency confirmed by blood coagulation testing

IndicationsUsed for on-demand treatment, perioperative management, or routine prophylaxis per product labeling

Age note (product-specific)Some products (e.g., Jivi) have age limitations (Jivi: ≥12 years) noted in congenital Hemophilia A criteria

inv-42: Acquired Hemophilia A

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

Age requirementObizur and acquired Hemophilia A criteria require patient ≥18 years of age

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHemophilia Products - Factor VIII (Coverage Criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateN/A

SourceLink

On This Page

Routine prophylaxis: Follow product‑specific prophylaxis regimens and adjust by clinical response: typical adult/adolescent regimens range ~20–50 IU/kg given 2–3 times weekly or every other day; pediatric regimens may use higher IU/kg and increased frequency (eg, Xyntha starting 30 IU/kg three times weekly for ≥12 yrs; Eloctate starting 50 IU/kg every 4 days with range 25–65 IU/kg at 3–5 day intervals). Individualize dosing and frequency per product labeling and patient factors.age-specific dosing ranges

Examples: Eloctate, Jivi, Esperoct, Novoeight, Xyntha dosing guidance cited.

Adult prophylaxis rangeAdults/adolescents commonly 20–50 IU/kg given 2–3 times weekly (adjust by clinical response)

Pediatric higher per-doseChildren may receive higher per-dose regimens (examples up to 25–65 IU/kg per dose depending on product and age)

Product-specific examplesExamples include Xyntha: adults 30 IU/kg three times weekly; children 25 IU/kg every other day; Afstyla: adults 20–50 IU/kg 2–3x weekly

inv-22: Circulating Factor VIII required

Minor bleed targetTarget circulating Factor VIII ~20–40% of normal (repeat every 12–24 hours)

Moderate bleed targetTarget circulating Factor VIII ~30–60% of normal (repeat every 12–24 hours)

Major bleed / perioperative targetTarget circulating Factor VIII ~60–100% (major) or up to 80–100% pre-/post-op depending on product; repeat dosing every 8–24 hours as indicated

inv-23: Vial unit reporting

Common vial sizes (examples)Vial unit sizes reported across products include 250, 500, 750, 1000, 1500, 2000, 3000, and 4000 IU

Recombinate vialsRecombinate vial sizes listed: 250, 500, 1000, 2000, 3000 IU (J7211) with corresponding NDCs

Eloctate vialsEloctate vial sizes listed: 250, 500, 750 IU (J7205) with corresponding NDCs

Required: product, indication, patient weight, target level, dosing history, requested vial sizes
If dose exceeds published dosing limits or BMI ≥ 30: submit half‑life study results or plan to perform study
Provide inhibitor testing history for minimally treated patients (<50 exposure days)

Billing Rule

Use product‑specific J‑codes on claims

Providers must use the product‑specific HCPCS/J‑codes and, when applicable, include the NDC on claims. Use the J‑code that corresponds to the product and vial size being billed to ensure accurate adjudication.

Use product‑specific J‑codes on claims (see Billing Code/Availability Information for code mapping)
Include NDC when required by payor billing guidance

Prior Authorization

Prior authorization for factor products (by J‑code)

Coverage and prior authorization review are performed at the J‑code/product level using the listed factor products consistent with FDA labeling and available clinical literature. Requests for J‑code billed factor products will be evaluated against the plan criteria and product‑specific dosing/indication requirements.

Prior authorization applies to listed factor products billed by their J‑code
Requests reviewed for consistency with FDA labeling and plan criteria

Denial Risk

Eligibility and contraindications that may trigger denial

Certain eligibility rules and contraindications may lead to denial if not met. Examples include age restrictions for specific products and disallowed indications. The plan will also consider unacceptable toxicities or development of neutralizing antibodies as reasons to deny renewal.

Jivi: patient must be ≥ 12 years for coverage
Product not to be used for von Willebrand disease (e.g., Jivi not indicated)
Acquired Hemophilia A and other non‑labeled uses require documentation supporting clinical rationale
Renewal denial triggers include unacceptable toxicity (anaphylaxis, thromboembolic events, neutralizing antibodies)

Step Therapy

Step therapy and Hemophilia Management Program considerations

The policy text does not specify additional explicit step therapy sequences or mandatory step requirements for selecting one factor product over another. The Hemophilia Management Program exempts MMP members who have received the medication within the past 365 days from step therapy requirements.

No explicit step therapy rules or preferred sequencing specified in this section
MMP members with prior medication within 365 days are not subject to step therapy requirements

Documentation Required

Required documentation for authorization and dispensing

Required documentation for dispensing and monthly rendering‑provider authorizations (Hemophilia Management Program) includes original prescription, requested amount to be dispensed, vial sizes available from manufacturer, patient product inventory and bleed history. Prescriptions cannot be auto‑filled; an expressed need from patient/caregiver/prescriber is required. Dispensed factor dose should not exceed +1% of prescribed dose and a maximum of three vials may be dispensed per dose. Dispensing decisions must account for the patient’s on‑hand inventory (no more than 5 extra doses for acute bleeding).

Monthly dispensing authorization must include: original prescription, requested amount, vial sizes, patient inventory, bleed history
No auto‑filling; expressed need required
Max dispense: +1% of prescribed dose tolerance; up to 3 vials per dose
Do not allow >5 extra doses on‑hand for acute bleeding

Documentation Required

Product‑specific dosing regimens and supporting evidence

Product dosing regimens should be documented according to the product labeling—on‑demand, perioperative, and routine prophylaxis dosing (including age‑specific adjustments and typical IU/kg regimens). When requesting doses that exceed product‑specific limits, provide clinical rationale and supporting documentation (e.g., half‑life study results, weight change, breakthrough bleeding despite adherence).

Document on‑demand dosing, repeat intervals, and expected duration until bleed resolves
Document perioperative dosing and duration for minor vs major procedures
Document routine prophylaxis starting regimens, age adjustments, and any individualized dosing adjustments

Billing Rule

Billing and documentation

Billing and dispensing must follow the Billing Code/Availability Information: submit the correct HCPCS/J‑code for the product and the appropriate NDC for vial size where applicable. The plan maintains a mapping of listed products to J‑codes (e.g., Advate = J7192; Eloctate = J7205).

Include correct HCPCS/J‑code and NDC for the billed vial size
Refer to Billing Code/Availability Information for full product‑to‑code mapping (Advate J7192; Eloctate J7205, etc.)

Note

Prescriber documentation for individual consideration

The plan will give individual consideration to each prior authorization request based on information submitted by the prescriber. Prescriber documentation supporting FDA‑approved indications, clinical rationale for non‑standard dosing, and pertinent clinical data (half‑life study, inhibitor testing, bleed history) will be considered during review.

Plan provides individual consideration to prescriber‑submitted clinical information
Prescriber should submit documentation supporting FDA‑approved indication or clinical rationale for off‑label use

Note

Coverage adherence and NCD/LCD precedence

Coverage criteria are intended to ensure use consistent with FDA labeling and relevant clinical literature, encourage cost‑effective options first when clinically appropriate, and respect Medicare NCD/LCD precedence for INTEGRITY (Medicare‑Medicaid Plan) members — these plan criteria apply only in the absence of applicable NCD/LCD.

Coverage adheres to FDA labeling and clinical literature
For INTEGRITY members, NCD/LCD criteria take precedence over plan criteria when present
Criteria are intended to promote medically accepted indications and cost‑effective sequencing when appropriate

Indicated for on‑demand treatment and control of bleeding; not to be used for congenital Hemophilia A or von Willebrand disease

inv-43: Dosing formula / conversion factor

Dosing formulaDosage (IU) = Body weight (kg) × Desired Factor VIII increase (IU/dL or % of normal) × 0.5

Per-product applicationApply conversion factor when calculating IU/kg dosing for on-demand, perioperative, and prophylaxis regimens (per product inserts)

Example useEloctate and Altuviiio prescribing information reference this formula for dose calculations

inv-44: Expected incremental recovery

Expected incremental recoveryEstimated incremental rise ≈ 2 IU/dL per IU/kg (i.e., Expected increment = Total dose (IU) / body weight (kg) × 2)

Calculation exampleFor Altuviiio 50 IU/kg, expected peak increase = 50 IU/kg × 2 = 100 IU/dL (% of normal)

Use in dosingUse the recovery estimate to convert between administered IU/kg and expected percent-of-normal FVIII activity when planning doses

inv-45: Routine prophylaxis dosing regimens (examples)

Adult/adolescent examplesExamples include adults/adolescents ≥12 yrs: 30 IU/kg three times weekly (product-dependent) or 20–50 IU/kg 2–3x weekly

Pediatric examplesChildren <12 yrs: examples include 25–60 IU/kg three times weekly or every other day depending on product (adjust for higher clearance)

Product variationsProduct-specific regimens cited: Eloctate starting 50 IU/kg every 4 days (adjustable 25–65 IU/kg at 3–5 day intervals); Afstyla adults 20–50 IU/kg 2–3x weekly

inv-46: Perioperative dosing targets

Perioperative target strategySelect target pre- and post-op FVIII activity per procedure severity and dose using dosing formula; repeat intervals commonly every 8–24 hours

Minor procedure targetsMinor procedures: target circulating FVIII typically 30–60% with repeat dosing every 12–24 hours as needed

Major procedure targetsMajor surgeries: target circulating FVIII up to 80–100% (pre-op and early post-op), continue dosing to maintain healing, then taper to 30–60% for at least 7 days

inv-47: Hereditary factor VIII deficiency

ICD-10 codeD66 — Hereditary factor VIII deficiency

UseCode listed as relevant diagnosis for congenital Hemophilia A coverage determinations

inv-48: Acquired hemophilia

ICD-10 codeD68.311 — Acquired hemophilia

Associated criteriaUsed with acquired Hemophilia A coverage rules that require age ≥18 and inhibitor titer constraints for some products (e.g., Obizur)

Hemophilia A is a congenital or acquired deficiency of factor VIII managed primarily with intravenous factor VIII replacement for on‑demand treatment, perioperative management, and routine prophylaxis. Management considerations in the policy include dosing calculations based on desired factor VIII rise and body weight, half‑life and inhibitor testing when indicated, and product‑specific regimens for prophylaxis and surgical settings.