ModifiedmhnPolicy CP.PHAR.564

Clinical Policy: Antithrombin III (Thrombate III)

Defines medical necessity and prior authorization criteria for Thrombate III (antithrombin III) for members with hereditary antithrombin deficiency and directs handling of other indications and exclusions for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyClinical Policy: Antithrombin III (Thrombate III)

Policy CodePolicy CP.PHAR.564

Change TypeMaterial operational revisions to approval durations and product listing

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation showing hereditary antithrombin deficiency and hematologist prescription or consultation.

SourceLink

POLICY UPDATE CHANGES

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

Atryn was discontinued and removed from criteria; Thrombate III indication updated for pediatric extension and removed requirement for age ≥ 18 years; approval durations for prevention revised to 12 months.

J7197HCPCS code for Antithrombin III (per IU)

80%-120%Target antithrombin level for dosing

500 unitsSingle-dose vial size (approx.)

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Coverage Criteria for Antithrombin III (Thrombate III)

Hereditary Antithrombin Deficiency (Initial)

Covered when ALL of the following are met:

Hereditary Antithrombin Deficiency initial criteria: 1) Diagnosis of hereditary antithrombin deficiency; 2) Prescribed by or in consultation with a hematologist; 3) Request is for one of the following (a or b): a. Treatment or prevention of thromboembolism; b. Prevention of peri-operative or peri-partum thromboembolism.

From section A; all must be met.

Hereditary Antithrombin Deficiency (Continued)

Covered when ALL of the following are met:

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

Continued therapy requirements.

Other Indications / Off-label pathway

For other indications (non-FDA or not listed):

Other indications pathway: 1) If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the formulary/no-coverage or non-formulary cross-reference for the relevant line of business per policy (see options a or b in the policy); OR 2) If the requested use is not listed under '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 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Directs to formulary/non-formulary or off-label Centene policies for handling other/new indications.

Use of antithrombin for indications not addressed in this policy — including requests for non‑FDA approved uses — is not authorized unless supporting documentation demonstrates efficacy and safety per the applicable off‑label use policy for the member's line of business (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member's evidence of coverage documents. Additionally, use of antithrombin for disseminated intravascular coagulation (DIC) is not authorized under this policy.

Coverage determinations made under this clinical policy are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance). Compliance with those plan‑level provisions and applicable administrative policies and procedures may affect whether a requested service is approved.

Antithrombin administration for patients with disseminated intravascular coagulation or other critically ill populations has been evaluated but lacks sufficient evidence of benefit. Clinical guidelines and systematic reviews have not found clear, consistent efficacy; a 2016 Cochrane review concluded insufficient evidence to support its use in critically ill patients, and guideline and expert statements recommend against routine use pending additional prospective trials.

Coding and Dosing References

HCPCS Codes referencedHCPCS

J7197

Antithrombin III (human), per IU

Target antithrombin level

Target antithrombin level80% to 120% of normal human plasma

Dosing goal contextIndividualize dose to achieve antithrombin level of 80% to 120% of normal human plasma (hereditary antithrombin deficiency).

Loading/maintenance guidanceLoading dose and maintenance regimens are adjusted to achieve/maintain target level (see dosing equations in Dosage and Administration).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document diagnosis of hereditary antithrombin deficiency, that therapy is prescribed by or in consultation with a hematologist, and indicate whether the request is for treatment/prevention of thromboembolism or prevention of peri‑operative/peri‑partum thromboembolism. Submit supporting clinical documentation (office notes, lab results, consult notes) that demonstrates the member meets all approval criteria.

Required supporting documentation: office chart notes, laboratory results, hematology consultation notes, treatment plan
Prescriber requirement: prescribed by or in consultation with a hematologist
Indication must be specified: treatment/prevention of thromboembolism OR prevention of peri‑operative/peri‑partum thromboembolism

Note

Coverage Document Compliance

Coverage is subject to the member's plan-level coverage documents and all terms, conditions, exclusions, and limitations therein. This clinical policy is a guide to medical necessity only and does not guarantee payment. Providers should verify benefits and member eligibility and follow applicable Health Plan-level administrative policies and procedures when submitting prior authorization requests.

Background on Thrombate III

Thrombate III is a human antithrombin product used for treatment and prevention of thromboembolism and for peri‑operative or peri‑partum prevention in patients with hereditary antithrombin deficiency. This clinical policy summarizes the medical necessity criteria and administrative requirements applied by the Health Plan to requests for Thrombate III.

Definitions and Terms

disseminated intravascular coagulation

TermDisseminated intravascular coagulation (DIC)

Abbreviation sourceListed in Appendix A as 'DIC: disseminated intravascular coagulation'.

Policy stanceUse of antithrombin for DIC is noted in the discussion but is not supported as routinely medically necessary per policy (see Not Medically Necessary/Exclusions).

Clinical policy definition

DefinitionClinical policy: a guide to medical necessity used to assist in making coverage decisions and administering benefits; it is not a contract or guarantee of payment or results.

RoleProvides evidence- and standards-based guidance to inform coverage determinations and benefit administration by the Health Plan.