CurrentCentenePolicy CP PHAR.564

Antithrombin III (ATryn; Thrombate III) coverage

Defines medical necessity and authorization requirements for recombinant and human antithrombin products (ATryn, Thrombate III) for members under Centene lines of business.

Policy Summary

PayerCentene

PolicyAntithrombin III (ATryn; Thrombate III) coverage

Policy CodePolicy CP PHAR.564

Change TypeNo material changes

Effective DateMar 1, 2022

Next Review Date

Key ActionPrior authorization is required and the provider must document diagnosis, hematologist involvement, and supporting clinical information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Products requiring authorization

80-120%Target activity range

J7196, J7197HCPCS codes referenced

NCState note

Coverage Criteria for Antithrombin Products

Initial Approval Criteria

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Initial criteria: 1. Diagnosis of hereditary antithrombin deficiency.

Initial criteria: 2. Prescribed by or in consultation with a hematologist.

Initial criteria: 3. Age ≥ 18 years.

Request indication (one of): 4. Request is for either: (a) Thrombate III for the treatment or prevention of thromboembolism, OR (b) prevention of peri-operative or peri-partum thromboembolism.

Approval duration note: Approval duration varies by indication: acute thrombosis or peri-operative/peri-partum prevention: 3 months; prevention: Medicaid/HIM 6 months; Commercial 6 months or to member renewal date, whichever is longer.

Approval duration varies by indication and line of business.

Continued Therapy Criteria

Covered for continuation when ANY of the following are met:

Continuation: a. Member is currently receiving medication via the Centene benefit OR has previously met initial approval criteria; AND member is responding positively to therapy.

Continuity of care: b. Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Approval duration for continuation (prevention): Approval duration for prevention: Medicaid/HIM - 6 months; Commercial - 6 months or to the member's renewal date, whichever is longer.

Disseminated intravascular coagulation (DIC) and non–FDA approved indications are explicitly not authorized under this policy unless the request is supported by sufficient documentation of efficacy and safety per the applicable off‑label/use policies or evidence of coverage documents. Providers seeking coverage for non‑FDA indications should follow the referenced off‑label use policies (CP CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP PMN.53 for Medicaid) and submit supporting clinical evidence.

Use of antithrombin for treatment of DIC or for critically ill patients, including sepsis‑associated DIC, is not supported by sufficient evidence. Clinical guidelines and systematic reviews have not demonstrated clear benefit of antithrombin in these populations, and authoritative bodies have concluded that robust evidence is lacking to recommend routine use; therefore such uses are not authorized by this policy.

Coding and Target Activity

HCPCS Codes referencedHCPCS

J7196	Injection,antithrombin recombinant 50 IU
J7197

HCPCS Codes (informational)HCPCS

J7196	Injection,antithrombin recombinant 50 IU.
J7197

Target antithrombin activity

Target antithrombin activityRestore and maintain functional antithrombin activity levels between 80% and 120% of normal human plasma

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

ATryn target rangeRestore and maintain functional antithrombin activity levels between 80% and 120% of normal human plasma

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for ATryn (antithrombin recombinant) and Thrombate III. Providers must obtain prior authorization and document that the member meets all approval criteria in the policy (e.g., diagnosis, prescriber specialty, age, and indication).

Prior authorization required for ATryn and Thrombate III
Provider must document criteria in submitted clinical information

Billing Rule

Prior Authorization and Coding

HCPCS codes J7196 (injection, antithrombin recombinant 50 IU) and J7197 may be referenced in prior authorization requests and claims submissions. Use of these codes is informational and for billing purposes only; providers should confirm coding and billing guidance with current professional resources before claim submission.

HCPCS J7196 — Injection, antithrombin recombinant 50 IU
HCPCS J7197 — (related antithrombin recombinant code)
Inclusion or exclusion of codes in this policy does not guarantee coverage — verify current coding guidance prior to claim submission

Note

Formulary / Off‑Label Routing

For drugs listed on the formulary/PDL, follow the applicable formulary/non‑formulary and prior authorization routing policies for the member's line of business. For off‑label uses not addressed in this policy, refer to the applicable off‑label use policies. Requests for non‑formulary or off‑label uses must meet the referenced policy requirements to be considered.

Follow formulary/non‑formulary routing policies: CP.CPA.190 (Commercial), HIM.PA.33/HIM.PA.103 (Marketplace), CP.PMN.255/CP.PMN.16 (Medicaid) as applicable
Off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace), CP.PMN.53 (Medicaid)

Documentation Required

Required Documentation

Provider must submit supporting documentation with the prior authorization request (e.g., chart notes, labs, genetic testing, prescriber consultation notes) that demonstrates the member meets all approval criteria. Incomplete documentation or failure to show criteria are met may result in denial.

Submit chart notes, lab results, and other clinical information supporting approval criteria
Requests lacking required documentation or not meeting criteria (or requests for excluded indications such as DIC) may be denied

Note

Coverage Governed by Plan Documents

Coverage is governed by the member's plan documents and is subject to the terms, conditions, exclusions, and limitations of the evidence of coverage, certificate of coverage, policy, or contract. State and federal laws and Health Plan administrative policies also apply. This clinical policy does not guarantee payment or coverage.

Coverage subject to plan terms, exclusions, limitations, and applicable law/regulation
Clinical policy is a guidance document and does not guarantee payment

Background

Hereditary antithrombin deficiency is an inherited disorder associated with an increased risk of venous thromboembolism. Antithrombin replacement products include ATryn (recombinant antithrombin) and Thrombate III (antithrombin, human). These products are indicated to prevent peri‑operative and peri‑partum thromboembolism in patients with hereditary antithrombin deficiency; Thrombate III is also indicated for treatment and prevention of thromboembolism in such patients. Known contraindications include hypersensitivity to goat or goat milk proteins for ATryn. Coverage under this policy is limited to the FDA‑approved indications and to situations meeting the documented medical necessity criteria.

Definitions and Contraindications

Disseminated intravascular coagulation (DIC)

DIC exclusionDisseminated intravascular coagulation (DIC) is explicitly listed as a diagnosis/indication for which coverage is NOT authorized

Non‑FDA indicationsNon‑FDA approved indications are not addressed by this policy unless supported per off‑label use policies or evidence of coverage

Evidence statementUse of antithrombin for treatment of DIC or critically ill patients (including sepsis‑associated DIC) is not supported by sufficient evidence and is not authorized

ATryn contraindication and related HCPCS codes

ATryn contraindicationKnown hypersensitivity to goat and goat milk proteins (contraindication specific to ATryn)

HCPCS J7196J7196 — Injection, antithrombin recombinant 50 IU (code referenced for recombinant antithrombin)

HCPCS J7197J7197 — HCPCS code listed in policy (description not provided in source); codes are informational and do not guarantee coverage