CurrentHealth NetPolicy CP.PHAR.226

ARIXTRA (PDF)

Defines medical necessity criteria, initial and continued approval, contraindications, dosing, product availability, and coding implications for fondaparinux (Arixtra) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyARIXTRA (PDF)

Policy CodePolicy CP.PHAR.226

Change TypeIndication addstep therapy bypasspregnancy duration revisionadministrative updates

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added newly approved indication for treatment of VTE in pediatric patients (aged 1 year or older weighing at least 10 kg) to criteria.

Added step therapy bypass for IL HIM per IL HB 5395.

Revised anticoagulation in pregnancy commercial approval duration to antepartum to estimated delivery date and postpartum up to 6 months.

Multiple annual reviews with reference and appendix D updates; template and wording changes (e.g., 'Member must use' replaced 'Medical justification').

3Approval durations listed (Commercial, Medicaid/HIM, pregnancy)

5Key contraindications listed

4Primary covered indications categories

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Coverage Summary

Policy status: covered_with_criteria. The policy covers fondaparinux (Arixtra) when medical necessity criteria are met and aligned to FDA indications and Centene clinical criteria as detailed in the policy. The policy scope defines initial and continued approval criteria, contraindications, dosing, product availability, and coding implications for fondaparinux across Commercial, HIM, and Medicaid lines of business. Effective date: 05.01.16. Last review date: 02.26.

The policy also includes an off-label anticoagulation-in-pregnancy use path (ante- and postpartum) with specified criteria and approval durations (antepartum to estimated delivery date; postpartum up to 6 months) and reflects 2025–2026 updates (including step therapy bypass for Illinois HIM per IL HB 5395).

Key policy facts

Policy numberCP.PHAR.226

SubjectFondaparinux (Arixtra) coverage / medical necessity policy

StatusCURRENT

Effective date05.01.16

Last review02.26

Lines of business impactedCommercial, HIM, Medicaid

Pediatric VTE indication (threshold)>= 1 year AND weight >= 10 kg

Contraindicated renal functionCrCl < 30 mL/min

Body-weight contraindication (prophylaxis only)Body weight < 50 kg

Initial Therapy Criteria

I. Initial Approval Criteria - Thrombosis/Thromboembolism

Provider must submit documentation supporting that member has met all approval criteria. Fondaparinux (Arixtra) is medically necessary when the following are met:

ALL of the following

Indication (one of)
- Thrombosis or thromboembolism prevention associated with any of: cancer (see Appendix D); unstable angina or myocardial infarction; major surgery - orthopedic or non-orthopedic; critical illness related to ICU admissions or events; restricted mobility associated with acute illnesses or conditions; implanted vascular devices (e.g., central venous access device, umbilical venous catheter, hemodialysis devices/fistulas, ventricular assist devices)
- Thrombosis or thromboembolism treatment
- Short-term prophylaxis for transition to or from oral anticoagulation

Continuation Therapy Criteria

II.A Continued Therapy - Thrombosis/Thromboembolism

Must meet all

ALL of the following

Eligibility for continued therapy (one of)
- Currently receiving medication via Centene benefit or previously met initial approval criteria
- Currently receiving medication and enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Permitted continued indications (one of)

Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Non-coverage

Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Provider Actions & Authorization Rules

Documentation Required

Submit documentation supporting criteria

Submit clinical documentation showing the member meets all approval criteria.

Office chart notes
Laboratory results
Other clinical information

Prior Authorization

Prior authorization and step therapy requirement

A trial and failure of enoxaparin is required prior to approval of fondaparinux unless an exception applies; note Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395 effective 1/1/2026.

Trial and failure of enoxaparin required unless one of the exceptions applies:
a. Enoxaparin is contraindicated

Clinical Evidence & References

Evidence and references cited in the policy include the Arixtra Prescribing Information (Mylan Institutional) December 2024 and guideline sources such as CHEST, NCCN, ACOG, and ASH guidance (2016–2025 updates).

The policy notes the newly approved pediatric VTE indication (treatment of VTE in pediatric patients aged ≥1 year and weighing ≥10 kg) added to the criteria (RT4) and documents guideline references and updates through 2025.

The pregnancy anticoagulation use is described as off-label within the policy and is supported by the listed guideline references and the prescribing information.

Guidelines / Evidence

Prescribing informationArixtra Prescribing Information (Mylan Institutional) December 2024

Guideline referencesCHEST, NCCN, ACOG, ASH guidance cited (2016-2025 updates)

Pediatric threshold (VTE treatment)>= 1 year and >= 10 kg

Renal contraindicationCrCl < 30 mL/min (prophylaxis or treatment)

Background

Background: Fondaparinux is a synthetic factor Xa inhibitor.

FDA indications summarized in the policy include prophylaxis of DVT (which may lead to PE) for specified surgical settings, treatment of acute DVT and acute PE when given with warfarin (with initial in-hospital therapy for PE), and the treatment of VTE in pediatric patients aged 1 year or older weighing at least 10 kg (pediatric VTE approval reflected in the policy).

This policy aligns coverage with FDA indications and Centene clinical criteria, and includes specified off-label anticoagulation-in-pregnancy criteria.

Definitions

Term	Definition
DVT	Deep vein thrombosis
HIT	Heparin-induced thrombocytopenia
LMWH	Low molecular weight heparin
VTE	Venous thromboembolism
PE	Pulmonary embolism

Revision History

RT4 (date recorded in revision log)addition

Added newly approved indication for treatment of VTE in pediatric patients (aged 1 year or older weighing at least 10 kg) to criteria. (RT4: added newly approved indication for treatment of VTE in pediatric patients to criteria.)

2026-01-01policy_revision

Step therapy requirement does not apply for Illinois HIM requests as of 1/1/2026 — added step therapy bypass for IL HIM per IL HB 5395.

1Q 2026 annual review (P&T Approval Date 02.26)policy_revision

Policy Summary

PayerHealth Net

PolicyARIXTRA (PDF)

Policy CodePolicy CP.PHAR.226

Change TypeIndication addstep therapy bypasspregnancy duration revisionadministrative updates

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Exceptions to step therapy (one of)

Enoxaparin is contraindicated
History of clinically significant adverse effects or allergy to LMWH (enoxaparin or dalteparin) or heparin (e.g., history of heparin-induced thrombocytopenia [HIT])
Requested use is FDA labeled for fondaparinux but not for enoxaparin (i.e., hip fracture surgery prophylaxis; PE treatment)

Failure of a trial of enoxaparin

Unless one of the exceptions (a, b, or c) applies

If request is for brand Arixtra, member must use generic fondaparinux unless contraindicated or clinically significant adverse effects are experienced

I.B Anticoagulation in Pregnancy: Ante- and Postpartum (off-label)

Must meet all

ALL of the following

Indication (one of)
- Acute venous thrombosis during current pregnancy
- Prior venous thrombosis
- Receiving long-term therapy with a vitamin K antagonist (e.g., warfarin)
- Prosthetic heart valve
- Inherited thrombophilia
- Antiphospholipid antibody syndrome
- Development of severe ovarian hyperstimulation syndrome post assisted reproduction
- Cesarean section - current pregnancy and request is for the postpartum period
- Any other indication listed in section I.A
Member is pregnant or < 6 months postpartum
History of clinically significant adverse effects or allergy to LMWH or heparin (e.g., HIT)
If request is for Arixtra, member must use generic fondaparinux unless contraindicated or clinically significant adverse effects are experienced

I.C Other diagnoses/indications

Must meet 1 or 2

ANY of the following

If drug has undergone recent label change within last 6 months not reflected in this policy, refer to formulary/no coverage or non-formulary policy as specified (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use is NOT listed under section III and criterion 1 does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Venous thrombosis prophylaxis or treatment in the presence of cancer

Past history of failed anticoagulation therapy (clot development) on warfarin

Any other indication in section I.A where bridging to warfarin is inappropriate or member has a contraindication to warfarin and extended (indefinite) anticoagulation therapy is required

If request is for Arixtra, member must use generic fondaparinux unless contraindicated or clinically significant adverse effects are experienced

II.B Continued Therapy - Anticoagulation in Pregnancy

Must meet all

ALL of the following

Eligibility for continued therapy (one of)
- Currently receiving medication via Centene benefit or previously met initial approval criteria
- Currently receiving medication and enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
See Section II.A for continued anticoagulation therapy beyond 6 months postpartum
If request is for Arixtra, member must use generic fondaparinux unless contraindicated or clinically significant adverse effects are experienced

b. History of clinically significant adverse effects or allergy to LMWH or heparin (e.g., HIT)

c. Requested use is FDA labeled for fondaparinux but not for enoxaparin (e.g., hip fracture surgery prophylaxis; PE treatment)

Illinois HIM step therapy bypass per IL HB 5395 effective 1/1/2026

Billing Rule
Use generic before brand
If the request is for brand Arixtra, the member must use generic fondaparinux unless contraindicated or clinically significant adverse effects are experienced.
Brand/generic guidance: Use generic fondaparinux in place of Arixtra unless contraindicated or adverse effects occur

Denial Risk
Non-FDA or unlisted indications
Requests for non‑FDA approved indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided per the off‑label use policies.
Relevant off‑label policy codes: CP.CPA.09 (Commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid)

HCPCS/J-code for fondaparinuxHCPCS

J1652

Injection, fondaparinux sodium, 0.5 mg

Body-weight contraindicationBody weight < 50 kg (VTE prophylaxis only)

Revised anticoagulation in pregnancy commercial approval duration from 6 months to antepartum to the estimated delivery date and postpartum up to 6 months to accommodate use during and after a full-term pregnancy.

2021-2025 (annual reviews)administrative

Multiple non-substantive annual updates (references and Appendix D updates; template and wording changes such as replacing 'Medical justification' with 'Member must use').