ModifiedmhnPolicy CP.PHAR.564

Antithrombin III (ATryn, Thrombate III)

Prior authorization and medical necessity criteria for antithrombin products ATryn (recombinant) and Thrombate III (human) for members across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyAntithrombin III (ATryn, Thrombate III)

Policy CodePolicy CP.PHAR.564

Change TypeRevised approval duration (Commercial)

Effective Date03.01.22

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets all approval criteria (diagnosis, hematologist involvement, age ≥18, and indication‑specific requirements).

SourceLink

POLICY UPDATE CHANGES

For Commercial line of business, revised initial and continued approval durations for prevention from '6 months' to '6 months or to the member's renewal date, whichever is longer.'

Template changes applied to other diagnoses/indications and continued therapy section.

For Commercial line of business, revised initial and continued approval durations for prevention from '6 months' to '6 months or to the member's renewal date, whichever is longer.'

Template changes applied to other diagnoses/indications and continued therapy section.

Policy created based on medical policy CP.MP.179 (to be retired).

2antithrombin products requiring prior authorization

≥18minimum age for initial approval

3 monthsprevention approval duration (acute/peri‑op)

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NCapplicable state listed

Coverage Criteria

Initial Therapy — Hereditary Antithrombin Deficiency

Covered when ALL of the following are met

Hereditary Antithrombin Deficiency Initial Approval: 1. Diagnosis of hereditary antithrombin deficiency; 2. Prescribed by or in consultation with a hematologist; 3. Age ≥ 18 years; 4. Member meets one of the following (a or b): (a) Request is for Thrombate III for the treatment or prevention of thromboembolism; OR (b) Request is for prevention of peri-operative or peri-partum thromboembolism.

Continuation Therapy — Hereditary Antithrombin Deficiency

Continued therapy covered when ALL of the following are met

Hereditary Antithrombin Deficiency Continued Approval: 1. Member meets one of the following: (a) Currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy.

Refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B for continuity of care details.

Other Diagnoses/Indications

Requests for other indications

Other Indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to one of the following depending on formulary status and line of business: (a) For drugs on the formulary/PDL: no coverage criteria policy — CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid); OR (b) For drugs NOT on the formulary/PDL: non-formulary policy — CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid). 2. If the requested use (diagnosis, age, dosing) is NOT listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid).

See listed policy references for each line of business.

This policy does not authorize antithrombin products for non‑FDA approved indications unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy for the member's line of business (see referenced policies). Specifically, requests for use in DIC (disseminated intravascular coagulation) are listed among indications for which coverage is not authorized based on available evidence. Providers must follow the prior authorization process; initial approvals for hereditary antithrombin deficiency require documentation of diagnosis, hematology involvement, age ≥ 18 years, and indication‑specific criteria.

The evidence base and guideline summaries do not support routine use of antithrombin in DIC or critically ill/septic patients. Systematic reviews and guideline statements conclude that current data are insufficient to demonstrate clear benefit of antithrombin for DIC, and further prospective randomized trials are needed. As a result, coverage for these indications is not authorized under this policy absent compelling off‑label documentation per referenced policies.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any specific coverage rules that supersede this policy.

Disseminated intravascular coagulation (DIC) has been proposed as a potential use for antithrombin, but major guideline reviews and systematic analyses do not support its routine use. The 2009 British DIC guideline did not recommend antithrombin without further prospective randomized evidence, a 2016 Cochrane review found insufficient evidence to support antithrombin in critically ill patients, and recent society statements note antithrombin remains an investigational option pending more robust trial data.

Because of the limited and inconclusive evidence for DIC and other non‑FDA indications, this policy does not authorize coverage for those uses unless the provider supplies sufficient documentation consistent with the plan's off‑label use policies for the member's line of business.

Coding

HCPCS CodesHCPCS

J7196	Injection, antithrombin recombinant, 50 IU
J7197	Antithrombin III (human), per IU

HCPCS Codes referencedHCPCS

J7196	Injection, antithrombin recombinant, 50 IU
J7197	Antithrombin III (human), per IU

Target antithrombin activity level

Target antithrombin activity level80% - 120% (0.8 - 1.2 IU/mL)

Thrombate III target wordingIndividualize dose to achieve antithrombin level of 80% to 120% of normal human plasma

ATryn treatment goalRestore and maintain functional antithrombin activity levels between 80% - 120% (0.8 - 1.2 IU/mL)

Approval duration for prevention (Commercial)

Approval duration (Commercial) for prevention6 months or to the member's renewal date, whichever is longer

1Q 2025 revision noteInitial and continued approval durations for prevention revised to include member renewal date for Commercial line of business

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for ATryn and Thrombate III. Initial approval is granted only when the member meets the specified clinical criteria (see Initial Approval Criteria) and the request is consistent with this policy.

Prior authorization required for antithrombin products: ATryn (antithrombin, recombinant) and Thrombate III (antithrombin III, human).
Initial approval requires documentation that all listed criteria are met.

Billing Rule

HCPCS Codes Referenced

Codes referenced in this policy are informational only. Inclusion does not guarantee coverage; providers must verify prior authorization and billing requirements with the member's plan before claim submission.

Background

Hereditary antithrombin deficiency is an inherited thrombophilia that increases the risk of venous thromboembolism. Antithrombin replacement can be used to prevent peri‑operative and peri‑partum thromboembolism in affected individuals. ATryn is a recombinant antithrombin product (contraindicated in those with goat or goat milk protein hypersensitivity), while Thrombate III is a plasma‑derived human antithrombin product and is indicated for both treatment and prevention of thromboembolism in this population. Prior authorization is required for both products and approval is contingent on meeting the policy's clinical criteria.

Definitions

DIC

DIC (definition)DIC: disseminated intravascular coagulation

ContextUse in disseminated intravascular coagulation (DIC) is not supported by current evidence and is listed among non‑FDA indications not authorized by this policy

Policy scopeDIC appears in exclusions and not medically necessary sections referencing insufficient evidence for antithrombin use in DIC or critically ill/septic patients

Additional definitions / policy context

Clinical policy purposeProvides a guide to medical necessity to assist in coverage decisions and administering benefits

Coverage decisions governanceSubject to terms, conditions, exclusions, and limitations of coverage documents and applicable state and federal requirements

Policy Summary

Payermhn

PolicyAntithrombin III (ATryn, Thrombate III)

Policy CodePolicy CP.PHAR.564

Change TypeRevised approval duration (Commercial)

Effective Date03.01.22

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets all approval criteria (diagnosis, hematologist involvement, age ≥18, and indication‑specific requirements).

SourceLink

On This Page

Prior duration (historical)Previously stated as '6 months' before 1Q 2025 update

HCPCS: J7196 — Injection, antithrombin recombinant, 50 IU

HCPCS: J7197 — Antithrombin III (human), per IU

Inclusion/exclusion of codes does not guarantee coverage; reference current coding guidance prior to claim submission.

Denial Risk

Triggers for Denial

If documentation submitted is incomplete or the requested use is for an excluded indication, the request may be denied. Common triggers for denial include lack of office notes, missing laboratory results, absence of hematologist involvement when required, requests for non-FDA indications without off-label policy support, or diagnosis listed in the "Not authorized" section (e.g., DIC).

Denial triggers: insufficient clinical documentation (office notes, labs), request for excluded indications (see Diagnoses/Indications not authorized).
Denial triggers: lack of required specialist involvement when specified (e.g., hematologist).

Documentation Required

Required Documentation and Coverage Context

Providers must submit supporting clinical documentation (office chart notes, lab results, consultation notes, dosing information) showing the member meets all approval criteria. Coverage decisions remain subject to the member's coverage documents and applicable state and federal rules.

Required documentation: office notes, laboratory results, consultation notes (e.g., hematology), and any other clinical information supporting the requested indication.
Coverage is subject to the member's evidence of coverage, contract terms, and state/federal requirements.

Note

Guidance for Off-label or Newly Labeled Uses

For uses not listed in this policy or for recently changed FDA labeling not yet reflected here, follow the plan's formulary/non-formulary and off-label use policies as applicable. If the drug has a new labeled indication or age expansion within the past 6 months, refer to the appropriate formulary or non-formulary policy; otherwise refer to the off-label use policy for the relevant line of business.

If label changed within last 6 months and policy not updated: follow formulary/no-coverage or non-formulary policies (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable).
For requests not specifically listed and not covered by recent label changes: refer to off-label policies (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Note

Coverage and Administrative Context

This policy is a guide to medical necessity and does not guarantee payment. The health plan may change or withdraw the policy and coverage determinations are governed by the member's contract and applicable laws.

This clinical policy is not a guarantee of coverage or payment.
Policy administration is subject to the member's plan documents and applicable legal/regulatory requirements.

Not medical adviceThis clinical policy does not constitute medical advice, treatment, or care and is not intended to dictate clinical practice