CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Tavalisse (fostamatinib) for Chronic Immune Thrombocytopenia

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This policy governs prior authorization and reauthorization for pharmacy coverage of Tavalisse for adult CareSource Georgia Medicaid members with chronic immune thrombocytopenia, including eligibility, prior treatment requirements, platelet-count thresholds, quantity limits, and renewal criteria.

Policy Summary

PayerCareSource Georgia

PolicyTavalisse (fostamatinib) for Chronic Immune Thrombocytopenia

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of chronic ITP for at least 6 months, required prior therapies including TPO-RA failure, and applicable platelet-count criteria.

SourceLink

POLICY UPDATE CHANGES

The policy changed the required chronic ITP duration from at least 3 months to at least 6 months.

Doptelet was added as a qualifying thrombopoietin receptor agonist alongside Promacta and Nplate.

The platelet-count criteria were changed from less than 35,000 or less than 50,000 to less than 30 x 10^9/L or 30 x 10^9/L to less than 50 x 10^9/L with additional bleeding risk.

Renewal duration was changed from 6 months to 12 months and renewal criteria were clarified.

Exclusions derived from clinical-trial criteria were removed because they were not labeled contraindications.

Adults with chronic ITPCovered population

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CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Tavalisse (fostamatinib) for Chronic Immune Thrombocytopenia

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Policy Summary

PayerCareSource Georgia

PolicyTavalisse (fostamatinib) for Chronic Immune Thrombocytopenia

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of chronic ITP for at least 6 months, required prior therapies including TPO-RA failure, and applicable platelet-count criteria.

SourceLink

POLICY UPDATE CHANGES

The policy changed the required chronic ITP duration from at least 3 months to at least 6 months.

Doptelet was added as a qualifying thrombopoietin receptor agonist alongside Promacta and Nplate.

The platelet-count criteria were changed from less than 35,000 or less than 50,000 to less than 30 x 10^9/L or 30 x 10^9/L to less than 50 x 10^9/L with additional bleeding risk.

Renewal duration was changed from 6 months to 12 months and renewal criteria were clarified.

Exclusions derived from clinical-trial criteria were removed because they were not labeled contraindications.

Adults with chronic ITPCovered population

6 monthsMinimum chronic ITP duration

50 x 10^9/LPlatelet count for continuation

60 tabletsQuantity limit

6 / 12 monthsAuthorization periods

Coverage Criteria

Initial Therapy

Covered for initial authorization when ALL of the following requirements are met. If all requirements are met, Tavalisse will be approved for 6 months.

Member is at least 18 years of age.

Medication is prescribed by or in consultation with a hematologist.

Member has a documented diagnosis of chronic immune thrombocytopenia (ITP) of at least 6 months' duration.

At least ONE of the following prior therapies

Corticosteroids, such as prednisone, prednisolone, methylprednisolone, or dexamethasone.
Immunoglobulins.
Splenectomy.

Member has tried and failed treatment with a thrombopoietin receptor agonist (TPO-RA), such as Promacta, Nplate, or Doptelet.

ONE of the following platelet-count criteria

Current platelet count is < 30 x 10^9/L.
ALL of the following
- Current platelet count is 30 x 10^9/L to < 50 x 10^9/L.
- ONE of the following
  - Active symptomatic bleeding other than minor mucocutaneous bleeding.
  - High risk factor for bleeding, such as use of an anticoagulant, older age (>60 years), or another clearly identified comorbidity.

Dosage is initiated at 100 mg orally twice daily; after 4 weeks, the dose may be increased to 150 mg twice daily, if needed, to achieve platelet counts of at least 50 x 10^9/L as necessary to reduce the risk of bleeding.

Quantity limit: 60 tablets per 30 days. Discontinue Tavalisse after 12 weeks if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.

Reauthorization

Covered for reauthorization when the following requirement is met. If the requirement is met, Tavalisse will be approved for an additional 12 months.

Chart notes include documentation that the member has achieved and maintained a platelet count of at least 50 x 10^9/L.

Conditions or indications that are not listed in this policy are not covered.

CareSource considers Tavalisse (fostamatinib disodium hexahydrate) not medically necessary for the treatment of conditions that are not listed in this policy. For any other indication, refer to the Off-Label policy.

Clinical Thresholds and Response Rules

Low platelet count

Platelet-count thresholdLess than 30 x 10^9/L

Eligibility pathwayCurrent platelet count is below 30 x 10^9/L.

UseQualifies as one pathway for initial Tavalisse authorization when all other criteria are met.

Intermediate platelet count with additional bleeding risk

Platelet-count range30 x 10^9/L to below 50 x 10^9/L

Additional requirementActive symptomatic bleeding other than minor mucocutaneous bleeding, or a high risk factor for bleeding.

Examples of high-risk factors

Authorization and Documentation Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tavalisse (fostamatinib) pharmacy coverage. When approved, initial authorization is issued for 6 months; an approved reauthorization is issued for an additional 12 months.

Benefit type: Pharmacy
Quantity limit: 60 tablets per 30 days

Step Therapy

Required Prior ITP Therapies

Document inadequate response, intolerance, or contraindication to qualifying prior ITP therapy and a failed trial of a thrombopoietin receptor agonist before requesting Tavalisse.

At least one prior therapy: corticosteroids, such as prednisone, prednisolone, methylprednisolone, or dexamethasone; immunoglobulins; or splenectomy
Prior treatment with a TPO-RA must have been tried and failed; examples include Promacta, Nplate, and Doptelet

Therapy Background

Tavalisse (fostamatinib) is an oral spleen tyrosine kinase inhibitor approved for adults with chronic immune thrombocytopenia who have had an insufficient response to previous treatment. Its active metabolite reduces antibody-mediated platelet destruction. The policy applies to adults with chronic immune thrombocytopenia; authorization requires documented chronic ITP for at least 6 months.

Clinical Definitions

Immune thrombocytopenia duration categories

Newly diagnosed ITPITP lasting less than 3 months

Persistent ITPITP lasting 3 to 12 months

Chronic ITPITP lasting more than 12 months

Chronic immune thrombocytopenia

Covered conditionChronic immune thrombocytopenia (ITP)

Covered populationAdult patients with chronic ITP who have had an insufficient response to a previous treatment

Authorization documentationThe diagnosis of chronic ITP must be documented for at least 6 months for initial authorization.

Initial Authorization Criteria

Initial authorization requires all of the following clinical criteria.

Initial authorization

Eligibility and treatment history
- Member is at least 18 years of age.Age >= 18
- Medication is prescribed by or in consultation with a hematologist.
- Member has a documented diagnosis of chronic immune thrombocytopenia (ITP) of at least 6 months' duration.Chronic ITP duration >= 6 months

Reauthorization Criteria

Tavalisse Reauthorization Criteria

Reauthorization is available when the following condition is met.

Tavalisse continuation: Chart notes document achievement and maintenance of a platelet count of at least 50 x 10^9/L.>= 50 x 10^9/L

Approval is for an additional 12 months.

Required Prior Treatment

Step	Prior ITP therapy	TPO-RA requirement
1	Inadequate response, intolerance, or contraindication to at least one documented prior treatment: corticosteroids, immunoglobulins, or splenectomy.	Tried and failed treatment with a thrombopoietin receptor agonist (TPO-RA), such as Promacta, Nplate, or Doptelet.

Quantity Limit

Tavalisse quantity limit

MedicationTavalisse (fostamatinib disodium hexahydrate)

Quantity limit60 tablets

Limit periodPer 30 days

Policy Summary

PayerCareSource Georgia

PolicyTavalisse (fostamatinib) for Chronic Immune Thrombocytopenia

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial revision

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of chronic ITP for at least 6 months, required prior therapies including TPO-RA failure, and applicable platelet-count criteria.

SourceLink

On This Page

Anticoagulant use, older age greater than 60 years, or another clearly identified comorbidity.

Target platelet count

Target platelet countAt least 50 x 10^9/L

Initial treatment goalThe dosage may be increased after 4 weeks, if needed, to achieve platelet counts of at least 50 x 10^9/L and reduce bleeding risk.

Continuation requirementChart notes must document achievement and maintenance of a platelet count of at least 50 x 10^9/L.

Treatment response reassessment

Reassessment pointAfter 12 weeks of treatment

ActionDiscontinue Tavalisse if the platelet count has not increased to a level sufficient to avoid clinically important bleeding.

Clinical purposeAssess whether treatment has produced a platelet response sufficient to reduce clinically important bleeding risk.

Documentation Required

Initial Authorization Documentation

The initial request must include documentation supporting the member-specific coverage criteria, including the member’s chronic ITP diagnosis and duration, prescribing provider, and hematologist involvement or consultation.

Member is at least 18 years of age
Chronic ITP must be documented for at least 6 months
Medication must be prescribed by or in consultation with a hematologist
Document the relevant clinical history and prior treatment response, intolerance, or contraindication

Documentation Required

Reauthorization Documentation

For reauthorization, chart notes must document that the member achieved and continues to maintain a platelet count of at least 50 × 10⁹/L. If the requirement is met, coverage may be approved for an additional 12 months.

Document both achievement and maintenance of the target platelet count: ≥50 × 10⁹/L

Denial Risk

Initial Authorization Criteria Not Met

The initial request may be denied when the member does not meet the age, prescriber or hematology-consultation, chronic-diagnosis, prior-therapy, or clinical platelet-count requirements.

Member is younger than 18 years of age
Prescription is not written by or in consultation with a hematologist
Chronic ITP has not been documented for at least 6 months
Required prior corticosteroid, immunoglobulin, splenectomy, or TPO-RA treatment criteria are not met
Current platelet count is not <30 × 10⁹/L, or 30 × 10⁹/L to <50 × 10⁹/L without active symptomatic bleeding other than minor mucocutaneous bleeding or a high bleeding-risk factor
High bleeding-risk factors may include anticoagulant use, age >60 years, or another clearly identified comorbidity

Denial Risk

Insufficient Response After 12 Weeks

Discontinue Tavalisse after 12 weeks of treatment if the platelet count has not increased to a level sufficient to avoid clinically important bleeding.

Initiate at 100 mg orally twice daily
After 4 weeks, increase to 150 mg twice daily if needed to achieve platelet counts of at least 50 × 10⁹/L and reduce bleeding risk

Denial Risk

Continuation Response Not Documented

Continuation coverage is at risk of denial when chart notes do not document achievement and maintenance of the target platelet count.

Reauthorization requires documented achievement and maintenance of a platelet count of at least 50 × 10⁹/L

Member had an inadequate response, intolerance, or contraindication to documented prior therapy with at least one of the following: corticosteroids, immunoglobulins, or splenectomy.

Examples of corticosteroids include prednisone, prednisolone, methylprednisolone, and dexamethasone.

TPO-RA failure: Member has tried and failed treatment with a thrombopoietin receptor agonist (TPO-RA).

Examples include Promacta, Nplate, and Doptelet.

Platelet-count eligibility

Pathway A: Current platelet count is below 30 x 10^9/L.< 30 x 10^9/L
Pathway B
- Current platelet count is 30 x 10^9/L to below 50 x 10^9/L.30 x 10^9/L to < 50 x 10^9/L
- Additional bleeding risk
  - Member has active symptomatic bleeding other than minor mucocutaneous bleeding.
  - Member has a high risk factor for bleeding.
    Examples include anticoagulant use, older age greater than 60 years, or another clearly identified comorbidity.