ModifiedCentenePolicy CP PHAR.130

Avatrombopag (Doptelet) coverage

Defines medical necessity criteria, dosing, and prior authorization requirements for avatrombopag (Doptelet) for thrombocytopenia related to chronic liver disease and chronic immune thrombocytopenia (ITP) for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyAvatrombopag (Doptelet) coverage

Policy CodePolicy CP PHAR.130

Change TypeMaterial: added exclusions for concurrent TPO receptor agonists and SYK inhibitors (4Q 2024)

Effective DateDec 1, 2018

Next Review Date

Key ActionSubmit prior authorization with clinical documentation including platelet counts and specialty prescriber or consultation as specified in the criteria.

SourceLink

POLICY UPDATE CHANGES

Added concurrent TPO receptor agonists and spleen tyrosine kinase inhibitor exclusions to all FDA-labeled indications.

Template changes to other diagnoses/indications and continued therapy section updated.

2FDA-approved indications covered

12 mocontinued therapy approval

20 mgtablet strength

4Q 2024most recent annual review

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Initial — Thrombocytopenia with chronic liver disease

Covered when ALL of the following are met for thrombocytopenia with chronic liver disease:

Chronic liver disease peri-procedural criteria: 1) Diagnosis of chronic liver disease; 2) Prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist; 3) Age ≥ 18 years; 4) Member scheduled to undergo a medical or dental procedure within the next 30 days; 5) Recent (within 14 days) platelet count is provided; 6) Not prescribed concurrently with another TPO receptor agonist or a spleen tyrosine kinase inhibitor; 7) Dosing based on platelet count: for platelet count ≤ 40 x 10^9/L: 60 mg PO once daily for 5 days; for platelet count 40 to < 50 x 10^9/L: 40 mg PO once daily for 5 days; Approval duration: 14 days (no more than 5 total days of treatment).

Initial and continued — Chronic immune thrombocytopenia (ITP)

Covered when ALL of the following are met for chronic immune thrombocytopenia (ITP):

Chronic ITP initial criteria: 1) Diagnosis of chronic ITP; 2) Prescribed by or in consultation with a hematologist; 3) Age > 18 years; 4) Current (within 30 days) platelet count ≤ 30,000/µL or active bleeding; 5) Failure of a systemic corticosteroid OR intolerance/contraindication to systemic corticosteroids plus failure of an immune globulin unless contraindicated; 6) Not prescribed concurrently with rituximab, another TPO receptor agonist, or a spleen tyrosine kinase inhibitor; 7) Initiate at 20 mg PO once daily and titrate to maintain platelet count ≥ 50 x 10^9/L; dose must not exceed 40 mg/day (maximum 2 tablets/day).

Chronic ITP continued therapy: For continuation: member is currently receiving the medication via the Centene benefit or previously met initial criteria; member is responding to therapy (increase in platelet count from baseline or reduction in bleeding); dose increases must not exceed 40 mg/day and 2 tablets/day; Approval duration: 12 months.

Other indications / Off-label pathway

Other diagnoses/indications:

Other uses / off-label pathway: Requests for uses not listed should follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.103/HIM.PA.33, CP PMN.16/CP PMN.255 as applicable) OR, if the use is not specifically listed and criterion 1 does not apply, follow the off-label use policy for the relevant line of business (e.g., CP.CPA.09 or HIM.PA.154).

Exclusions added 4Q 2024

Policy-level exclusions and template updates affecting FDA-labeled indications

Concurrent therapy exclusion: Concurrent use of other thrombopoietin receptor agonists and spleen tyrosine kinase inhibitors is excluded for all FDA-labeled indications per 4Q 2024 update.

Applied per competitor criteria; recorded in 4Q 2024 annual review.

Requests for uses of avatrombopag that are non‑FDA approved indications and are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy (commercial: CPCPA.09; marketplace: HIM.PA.154; Medicaid: CP PMN.53) or other binding evidence of coverage documents.

Concurrent administration of avatrombopag with other thrombopoietin (TPO) receptor agonists or with spleen tyrosine kinase (SYK) inhibitors is excluded for all FDA‑labeled indications per the 4Q 2024 policy update and therefore will not meet coverage criteria when requested in combination.

Use of avatrombopag for indications that are not FDA‑approved and are not listed in this policy will be unauthorized unless the request includes the required off‑label documentation demonstrating sufficient evidence of efficacy and safety as specified by the referenced off‑label policies.

This policy excerpt does not include an explicit wording of 'not medically necessary' for any specific use; the recent updates emphasize administrative/template changes and the addition of concurrent therapy exclusions (4Q 2022 template updates and 4Q 2024 exclusions). Coverage determinations will continue to follow the criteria and referenced off‑label policies cited in the document.

Coding and Key Clinical Thresholds

Neutral/administrativemixed

NDC	Not specified in this document

Referenced documents (no explicit billing codes in this excerpt)mixed

No codes listed

Platelet count thresholds for dosing (chronic liver disease)

Threshold — ≤40 x10^9/LDosing for thrombocytopenia with chronic liver disease when platelet count is ≤40 x10^9/L: 60 mg PO once daily for 5 days.

Threshold — 40 to <50 x10^9/LDosing for thrombocytopenia with chronic liver disease when platelet count is 40 to <50 x10^9/L: 40 mg PO once daily for 5 days.

Measurement timingRecent platelet count required (per criteria: within 14 days for peri-procedural use).

ITP response threshold

ITP response thresholdCurrent (within 30 days) platelet count ≤30,000/µL required for initial chronic ITP criteria; response definition uses 30,000/µL as the threshold.

Context — initial criteriaFor initiation in chronic ITP, member must have current platelet count 30,000/µL or active bleeding.

Reference guidanceThreshold aligns with ASH/International Working Group definitions for response and failure in ITP.

Tablet strength — formulation

Tablet strengthAvatrombopag tablet formulation available as 20 mg tablets.

Dosing implicationChronic ITP initiation typically starts at 20 mg PO once daily (one tablet), titratable up to 40 mg/day (2 tablets).

Product availability noteListed in product availability as Tablet: 20 mg.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (office chart notes, consultation notes, procedure schedule, and recent laboratory results such as platelet counts) that supports the diagnosis and meets all approval criteria. Requests for Doptelet (avatrombopag) will be reviewed against the applicable criteria for the requested indication; incomplete documentation may result in denial or delay.

Acceptable documentation: office notes, lab reports (recent platelet count), hospital records, consultation notes, procedure scheduling documentation.

Prior Authorization

Prior Authorization for Avatrombopag (Doptelet)

Prior authorization is required for avatrombopag (Doptelet). For FDA‑labeled indications, requests must demonstrate the specific indication, platelet counts within the required timeframes, treating or consulting specialist (e.g., hematologist, hepatologist, or gastroenterologist where applicable), and dosing consistent with label criteria. Approval duration and dosing limits will follow the clinical criteria (for example, periprocedural dosing courses are limited to 5 days with approval duration typically 14 days).

Concurrent therapy exclusion: avatrombopag must not be prescribed concurrently with another thrombopoietin (TPO) receptor agonist (e.g., eltrombopag [Promacta], romiplostim [Nplate], lusutrombopag [Mulpleta]) or a spleen tyrosine kinase (SYK) inhibitor (e.g., fostamatinib [Tavalisse]) for FDA‑labeled indications.
Per 4Q 2024 update: explicit exclusion of concurrent TPO receptor agonists or SYK inhibitors applies across all FDA‑labeled indications.

Denial Risk

Non‑FDA Indications

Requests for non‑FDA (off‑label) indications are not covered under this policy unless the request includes sufficient documentation demonstrating efficacy and safety consistent with the plan’s off‑label use policies and referenced evidence. Such requests will be evaluated against the commercial and state‑specific off‑label policies (e.g., CPCPA.09, HIM.PA.154, CP PMN.53) and the evidence base; absent adequate support, requests for non‑FDA uses will be denied.

If submitting for a non‑FDA indication, include literature or guideline support, rationale for use, prior therapies tried, and member‑specific factors.
Referenced off‑label policies: CPCPA.09 (Commercial), HIM.PA.154 (Marketplace), CP PMN.53 (Medicaid).

Documentation Required

Therapeutic Failure Requirement (Chronic ITP)

For chronic immune thrombocytopenia (ITP), prior authorization requires documentation of therapeutic failure or intolerance to prior therapies: failure of a systemic corticosteroid and failure of an immune globulin (unless contraindicated or not tolerated). For members with contraindication or intolerance to corticosteroids, documentation of intolerance plus failure of immune globulin (unless also contraindicated) is required. Prescriptions must be by or in consultation with a hematologist. Current platelet count (within 30 days) and evidence of active bleeding when applicable must be provided.

Required: documentation of prior corticosteroid trial and response, prior IVIG trial and response (or documented contraindication/intolerance).
Specialist expectation: prescribed by or in consultation with a hematologist for chronic ITP.
Lab requirement: current platelet count within 30 days (thresholds per criteria, e.g., ≤30,000/µL or active bleed).

Definitions and Clinical Response Criteria

Response (ITP) definition

Response (ITP) — numeric definitionPlatelet count ≥ 30,000/µL and a greater than 2‑fold increase from baseline measured on two occasions >7 days apart.

Additional requirementAbsence of bleeding is included in the response definition per ASH/international working group guidance.

Measurement frequencyPlatelet increases must be documented on two separate occasions (specified timeframe >7 days apart for response).

Failure (ITP) definition

Failure (ITP) — numeric definitionPlatelet count < 30,000/µL or less than a 2‑fold increase from baseline, or presence of bleeding; measured on two occasions more than 1 day apart.

Measurement frequencyFailure must be documented on two occasions >1 day apart per policy and ASH guidance.

Clinical correlatePresence of bleeding qualifies as treatment failure in addition to platelet thresholds or inadequate doubling response.

20 mg tablet formulation of avatrombopag — formulation note

FormulationAvatrombopag is supplied as a 20 mg tablet formulation.

Dose units20 mg tablets are used to achieve initiation and titration doses (e.g., 20 mg = 1 tablet; 40 mg = 2 tablets).

ReferenceProduct availability section lists Tablet: 20 mg.

OpenPayer

Avatrombopag (Doptelet) coverage

Coverage Criteria for Avatrombopag (Doptelet)

Coding and Key Clinical Thresholds

Provider Actions, Prior Authorization, and Documentation

Background

Definitions and Clinical Response Criteria