ModifiedmhnPolicy CP.PHAR.24

Fostamatinib (Tavalisse) for chronic immune thrombocytopenia

Defines medical necessity and prior authorization criteria for use of fostamatinib (Tavalisse) in adults with chronic immune thrombocytopenia (ITP) across Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyFostamatinib (Tavalisse) for chronic immune thrombocytopenia

Policy CodePolicy CP.PHAR.24

Change TypeMaterial clinical changes (concurrent TPO-RA exclusionapproval duration updated)

Effective DateJun 5, 2018

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating chronic ITP diagnosis, prior therapy failures, prescriber specialty, platelet counts, and that Tavalisse will not be used concurrently with thrombopoietin receptor agonists.

SourceLink

POLICY UPDATE CHANGES

Added requirement that Tavalisse is not prescribed concurrently with thrombopoietin receptor agonists.

Revised initial approval duration from 6 to 12 months.

Added requirement that requests do not exceed health plan-approved quantity limit, if applicable.

≥18Minimum age for coverage

<30k/µLPlatelet threshold for initiation

12 moApproval duration

300 mg/day

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100/150 mgProduct availability

Coverage Criteria for Fostamatinib (Tavalisse)

Initial Therapy

Covered when ALL of the following are met:

Initial approval - chronic ITP: 1. Diagnosis of chronic ITP; 2. Prescribed by or in consultation with a hematologist; 3. Age ≥ 18 years; 4. One of the following: (a) current (within the last 30 days) platelet count < 30,000/µL OR (b) member has an active bleed; 5. Failure of a systemic corticosteroid unless contraindicated or clinically significant adverse effects are experienced; 6. Failure of eltrombopag (Promacta) unless contraindicated or clinically significant adverse effects are experienced; 7. Tavalisse is not prescribed concurrently with thrombopoietin receptor agonists (e.g., Doptelet, Nplate, Promacta, Mulpleta); 8. Request does not exceed health plan-approved quantity limit, if applicable; 9. Dose does not exceed both of the following: (a) 300 mg per day AND (b) 2 tablets per day.

Approval duration: 12 months

Continued Therapy

Covered for continuation when ALL of the following are met:

Continuation therapy - chronic ITP: 1. Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR member is receiving medication with continuity of care protections; 2. Member is responding positively to therapy (e.g., increased platelet count from baseline or reduced bleeding); 3. Tavalisse is not prescribed concurrently with thrombopoietin receptor agonists (e.g., Doptelet, Nplate, Promacta, Mulpleta); 4. Request does not exceed health plan-approved quantity limit, if applicable; 5. If request is for a dose increase, new dose does not exceed both: (a) 300 mg per day AND (b) 2 tablets per day.

Approval duration: 12 months

Other/Off-label

For diagnoses/uses not listed under approved criteria:

Other indications: 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, follow the formulary/no-coverage or non-formulary policy for the relevant line of business as specified (see policy references); 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically 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 (see policy references).

References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety consistent with the referenced off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or the member's evidence of coverage documents.

Coverage determinations and the administration of benefits are governed by the member's coverage documents and applicable legal and regulatory requirements. This clinical policy is guidance to assist in making medical necessity determinations and does not guarantee payment; the Health Plan’s terms, conditions, exclusions, and limitations, as well as state and federal requirements and Health Plan‑level administrative policies and procedures, apply.

Requests for use of fostamatinib for non‑FDA approved indications that lack sufficient supportive evidence per the applicable off‑label use policies are considered not authorized.

Coding and Dose Limits

Policy identifiermixed

CP.PHAR.24

Clinical Policy reference number

Maximum daily dose

Maximum daily dose300 mg/day

Typical dosing regimenStart 100 mg PO twice daily; may increase after 4 weeks to 150 mg PO twice daily

Tablet strengths available (policy appendix)100 mg, 150 mg

Initiation platelet threshold

Initiation platelet thresholdPlatelet count < 30,000/µL (current within last 30 days)

Alternate initiation criterionActive bleeding (as substitute for platelet threshold)

Minimum age for initiation

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tavalisse (fostamatinib). Providers must submit a prior authorization request and supporting clinical documentation showing the member meets the policy's clinical criteria for initial or continued therapy. Approval durations are specified in the policy (typically 12 months for approved indications).

Prior authorization required for Tavalisse (fostamatinib).
Approval duration: 12 months for approved indications.

Note

Prior Authorization Determined by Health Plan

This clinical policy is guidance to assist Health Plan determinations of medical necessity and benefit administration and does not guarantee payment. Coverage decisions are subject to the member's benefit terms, evidence of coverage, policy exclusions/limitations, state and federal law, and applicable Health Plan-level administrative policies and procedures.

Policy is a guide for coverage decisions and benefit administration.

Background

Fostamatinib (Tavalisse) is an oral spleen tyrosine kinase (SYK) inhibitor approved for treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy. The therapeutic goal is to raise platelet counts and reduce bleeding risk. Typical dosing begins at 100 mg orally twice daily with consideration to increase to 150 mg twice daily as needed; the policy limits the maximum daily dose to 300 mg/day.

Definitions and Clinical Thresholds

Chronic ITP — definition

Definition of chronic ITPITP lasting more than 12 months from diagnosis per International Working Group consensus (definitions also supported and used by ASH)

Other ITP durationsNewly diagnosed: 0–3 months; Persistent: 3–12 months

Guideline sourceInternational Working Group consensus panel and American Society of Hematology (ASH)

Durable response — definition

Durable response (per 2019 ASH guidelines)Platelet count ≥ 30,000/µL and >2‑fold increase from baseline at 6 months

Failure definition (for comparison)Platelet count < 30,000/µL or <2‑fold increase from baseline at 6 months

Revision History and Policy Changes

2025-09-23approval_duration_change

Revised initial approval duration from 6 to 12 months for initial therapy.

2023-10-19criteria_addition

Added requirement that Tavalisse is not prescribed concurrently with thrombopoietin receptor agonists.

2026-01-01administrative_added_requirementLatest

Added requirement that requests do not exceed health plan‑approved quantity limit, if applicable (applied during 1Q 2026 annual review).

Policy Summary

Payermhn

PolicyFostamatinib (Tavalisse) for chronic immune thrombocytopenia

Policy CodePolicy CP.PHAR.24

Change TypeMaterial clinical changes (concurrent TPO-RA exclusionapproval duration updated)

Effective DateJun 5, 2018

Next Review Date

SourceLink

On This Page

Coverage subject to terms of coverage documents and applicable state/federal requirements.

Step Therapy

Step Therapy Requirements and State Exception

Step therapy requirements: for initial approval of chronic ITP the member must have failed a systemic corticosteroid (unless contraindicated) and failed eltrombopag (unless contraindicated). State exception: for Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Initial therapy requires failure of a systemic corticosteroid (or contraindication).
Initial therapy requires failure of eltrombopag (Promacta) (or contraindication).
Illinois HIM exception: step therapy requirements waived as of 1/1/2026 (IL HB 5395).

Documentation Required

Required Clinical Documentation

Providers must submit required clinical documentation to support that the member meets all approval criteria. Acceptable supporting documentation includes office chart notes, lab results (including recent platelet counts), documentation of prior therapies and responses/adverse effects, consultation notes (if applicable), and any other clinical information relevant to the request.

Office chart notes documenting diagnosis and clinical status.
Recent laboratory results including platelet counts (evidence of platelet count <30,000/µL when applicable).
Documentation of prior therapies (systemic corticosteroids, eltrombopag) and rationale for contraindication or intolerance if applicable.
Hematology consult notes when required or when prescribed in consultation with a hematologist.

Denial Risk

Documentation and Indication‑related Denial Triggers

Denial risk increases when documentation is insufficient. Common triggers for denial include lack of documentation of chronic ITP diagnosis, absent or non‑recent platelet counts, no evidence of prior required therapies (or documentation of contraindication/intolerance), prescriber not a hematologist or lacking consultation documentation, concurrent use of thrombopoietin receptor agonists, requests exceeding dose or quantity limits, or requests for non‑FDA approved indications without sufficient off‑label justification.

Missing or inadequate diagnosis documentation (chronic ITP).
No recent platelet count or documentation that platelet count meets policy thresholds.
No documentation of failure/intolerance/contraindication to required prior therapies (systemic corticosteroid and eltrombopag).
Prescriber not a hematologist and no consult/justification documented.
Concurrent prescription with thrombopoietin receptor agonists (e.g., Doptelet, Nplate, Promacta, Mulpleta).
Dose or quantity exceeding health plan‑approved limits.

Note

Provider Administrative Requirements

Providers must follow Health Plan-level administrative policies and procedures, the member's specific benefit documents, and any state-specific addendums (for example, continuity of care or step therapy exceptions). This clinical policy does not replace plan terms; providers are responsible for verifying coverage requirements and submitting complete documentation per plan instructions.

Follow applicable Health Plan administrative policies and procedures.
Verify member benefit terms, exclusions, and state-specific addendums (e.g., continuity of care, step therapy exceptions).
Submit complete documentation per plan submission requirements.

Timepoint for assessmentMeasured at 6 months after treatment initiation