CurrentCignaPolicy IP0154

Tavalisse

Defines Cigna's prior authorization, coverage criteria, and documentation requirements for Tavalisse (fostamatinib) for treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP). Applies to benefits administered by Cigna companies.

Policy Summary

PayerCigna

PolicyTavalisse

Policy CodePolicy IP0154

Change TypeClarified (documentation requirements added)

Effective DateSep 1, 2025

Next Review DateJun 15, 2025

Key ActionObtain prior authorization; document platelet counts, prior therapies or splenectomy status, and prescriber specialty to support approval.

SourceLink

POLICY UPDATE CHANGES

Added documentation requirements throughout the policy.

≥18minimum age for approval

<30,000/mcLplatelet threshold (pathway A)

<50,000/mcLplatelet threshold (pathway B)

3 moinitial approval

1 yrcontinuation approval

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Coverage Criteria for Tavalisse (fostamatinib)

FDA-Approved Indication

Covered for chronic immune thrombocytopenia (FDA-approved indication). Approve when ONE of the following A or B is met:

A) Initial Therapy (approve 3 months)
- i: Patient is ≥ 18 years of age
- ii: Either: a) platelet count < 30 x 10^9/L (< 30,000/mcL) [documentation required]; OR b) BOTH: (1) platelet count < 50 x 10^9/L (< 50,000/mcL) [documentation required] AND (2) prescriber states patient is at increased risk of bleedingPlatelet counts as specified
  Documentation required
- iii: Either: a) tried at least ONE other therapy [documentation required] (examples: systemic corticosteroids, IVIG, anti-D immunoglobulin, eltrombopag, romiplostim, avatrombopag, rituximab); OR b) has undergone splenectomy [documentation required]
  Documentation required
- iv: Medication is prescribed by or in consultation with a hematologist
B) Currently Receiving Tavalisse (approve 1 year)
- i: Prescriber documents the patient demonstrates a beneficial clinical response [documentation required]
  Beneficial response may include increased platelet counts, maintenance of platelet counts, or decreased frequency of bleeding episodes
- ii: Patient remains at risk for bleeding complications

Line of therapy context: Tavalisse has been studied in third-line setting; policy requires prior therapy or splenectomy (i.e., post-initial treatments)

Examples of prior therapies provided; documentation required

Use of Tavalisse for indications other than chronic immune thrombocytopenia (ITP) in adults is considered not medically necessary. The policy explicitly lists B-cell lymphomas (for example, non-Hodgkin’s lymphoma and diffuse large B‑cell lymphoma [DLBCL]) as not covered because Tavalisse has been investigated in these conditions but many other therapies are available.

Tavalisse is considered not medically necessary for any use other than treatment of chronic immune thrombocytopenia in adults as specified in this policy. Examples of such noncovered uses include B‑cell lymphomas (e.g., non‑Hodgkin’s lymphoma, DLBCL) and rheumatoid arthritis, where alternative, better‑established therapies are recommended.

Regimen	Indication	Prescribing/Authorization Details	Approval Duration
Tavalisse (fostamatinib) monotherapy
Chronic immune thrombocytopenia in adults with insufficient response to prior treatment
Per prescriber; patient must meet coverage criteria including age ≥ 18 years, platelet-count criteria, prior therapy or splenectomy, and hematologist involvement; prior authorization required; documentation required for platelet counts, prior therapies/splenectomy, and clinical benefit
Initial approval: 3 months for new starts meeting initial-therapy criteria; Continuation approval: 1 year for patients currently receiving Tavalisse who demonstrate clinical benefit

Regimen	Indication / Use	Coverage Stance
Tavalisse (fostamatinib)
B-cell lymphomas (e.g., non-Hodgkin's lymphoma, diffuse large B-cell lymphoma)
Not medically necessary — investigational/other use

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Tavalisse. All approvals are provided for the duration noted in the policy (e.g., initial approvals for new starts are 3 months; approvals for patients currently receiving therapy are 1 year). Prescriptions must be written by or in consultation with a physician who specializes in the condition being treated (hematologist).

Approvals: Initial therapy — 3 months; Continuation/currently receiving — 1 year
Specialist requirement: Prescribed by or in consultation with a hematologist

Billing Rule

Coding/Claim Submission

Claims submitted for services that are not accompanied by covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service. Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this Coverage Policy.

Claims without covered diagnosis/procedure codes will be denied as not covered
Use most appropriate codes effective on the date of submission

Step Therapy

Prior Therapies or Splenectomy

For initial approval, the patient must have tried at least one other therapy OR have undergone splenectomy. Examples of other therapies include systemic corticosteroids, intravenous immunoglobulin, anti-D immunoglobulin, Promacta (eltrombopag), Nplate (romiplostim), Doptelet (avatrombopag), and rituximab. Documentation of prior therapy trials or prior splenectomy is required.

Prior therapy: At least one prior therapy trial required (examples listed)
Splenectomy: Acceptable alternative to prior therapy — documentation required
Examples: systemic corticosteroids; IVIG; anti-D immunoglobulin; Promacta (eltrombopag); Nplate (romiplostim); Doptelet (avatrombopag); rituximab

Documentation Required

Documentation is required where noted in the criteria. Acceptable documentation may include chart notes, laboratory tests (e.g., platelet counts), claims records, and other relevant clinical information. For initial therapy, platelet count documentation is required (e.g., <30,000/mcL or <50,000/mcL with increased bleeding risk). For continuation therapy, documentation of a beneficial clinical response (such as increased or maintained platelet counts or decreased bleeding frequency) is required.

Acceptable documentation: chart notes, labs, claims records, other clinical information
Initial therapy: platelet count documentation required (<30,000/mcL; or <50,000/mcL plus increased bleeding risk)
Continuation therapy: documentation of beneficial clinical response required

Regimens and Indications

Regimen	Patient Eligibility Requirements	Documentation Required	Approval Duration
Tavalisse (fostamatinib) monotherapy
1) Patient is ≥ 18 years of age; 2) Platelet-count criteria: either platelet count < 30 x10^9/L (<30,000/mcL) OR platelet count < 50 x10^9/L (<50,000/mcL) with prescriber-documented increased bleeding risk; 3) Either tried at least one other therapy (examples: systemic corticosteroids, IVIG, anti-D immunoglobulin, eltrombopag, romiplostim, avatrombopag, rituximab) OR has undergone splenectomy; 4) Medication prescribed by or in consultation with a hematologist
Documentation of platelet counts, prior therapies or splenectomy, and prescriber specialty are required; for continuation, documentation of beneficial clinical response (e.g., increased or maintained platelet counts or decreased bleeding frequency) is required
Initial approval (A: Initial Therapy): 3 months. Continuation approval (B: Currently receiving Tavalisse with documented benefit): 1 year

Regimen / Use	Examples	Coverage Stance
Tavalisse (fostamatinib) for non-ITP indications
Examples include B-cell lymphomas (e.g., non-Hodgkin's lymphoma, diffuse large B-cell lymphoma) and rheumatoid arthritis
Not medically necessary — investigational or other uses; many other therapies available for these conditions

OpenPayer

Tavalisse

Coverage Criteria for Tavalisse (fostamatinib)

Coding and Clinical Thresholds

Provider Actions, Prior Authorization, and Documentation

Regimens and Indications

Background

Definitions

Line of Therapy