CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Doptelet (avatrombopag) — Coverage Criteria

Defines accepted indications, coverage criteria, exclusions, and coding for Doptelet (avatrombopag) for members of the payer lines of business; applies to medication requests processed by Evolent on behalf of the plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoptelet (avatrombopag) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversion / replacement

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent for Doptelet (avatrombopag) requests; continuation requests require prior active authorization within the past year without >30-day lapse and no disease progression.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced UM ONC 1334 Doptelet (avatrombopag).

2FDA/accepted indications

60 mgMax single dose (CLD)

40 mgMax single dose (ITP)

J8499Billing code listed

6Lines of business

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Coverage Criteria for Doptelet (avatrombopag)

Idiopathic Thrombocytopenia Purpura (ITP)

Covered when ALL of the following are met:

ITP indication criteria: Member has a diagnosis of relapsed/refractory chronic ITP AND the member has had an insufficient response to (defined by failure of platelet count to increase and stay above 30 x 10^9/L) or has an intolerance or contraindication to corticosteroids AND platelet count less than 30 x 10^9/L prior to start of therapy.platelets <30 x10^9/L

Thrombocytopenia in Chronic Liver Disease (periprocedural)

Covered when ALL of the following are met:

Thrombocytopenia in chronic liver disease: Member has chronic liver disease AND a mean baseline platelet count of less than 50 x 10^9/L AND the member is scheduled to undergo an invasive procedure.mean platelets <50 x10^9/L

Use as single agent for procedure-related thrombocytopenia.

After a member has tried lusutrombopag (Mulpleta) and therapy is being considered with Doptelet (avatrombopag), requests will be excluded if the request is for use after documented failure with lusutrombopag for thrombocytopenia in chronic liver disease. Operational limits that will also trigger exclusion include exceeding the single‑dose limits of 60 mg for chronic liver disease or 40 mg for chronic ITP, exceeding monthly tablet limits (15 × 20 mg tablets per month for chronic liver disease or 60 × 20 mg tablets per month for chronic ITP), or exceeding the treatment duration limit of 5 days for chronic liver disease. Additionally, requests meeting criteria for disease progression—defined as failure of platelet count to rise from baseline after 4 weeks at the maximum tolerated dose—will be excluded.

Doptelet (avatrombopag) is considered investigational and will be denied for off‑label indications when the evidence is insufficient or the use is not generally accepted by the medical community. Insufficient evidence includes situations where the clinical characteristics of the patient or therapy are not adequately represented in published studies, study outcomes are not clinically meaningful, experimental design is inappropriate for the question, or the available literature consists only of abstracts without full peer‑reviewed articles. Case reports and abstracts without full articles do not provide adequate supportive clinical evidence for coverage.

Billing and Clinical Thresholds

HCPCS billing codeHCPCS

J8499

avatrombopag

Platelet count thresholds for ITP and chronic liver disease indications

ITP platelet thresholdPlatelet count less than 30,000 x 10^9/L prior to start of therapy

Insufficient response definition (ITP)Failure of platelet count to increase and stay above 30 x 10^9/L after treatment

ITP clinical requirementDiagnosis of relapsed/refractory chronic ITP AND insufficient response or intolerance/contraindication to corticosteroids

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Doptelet (avatrombopag) for the indications covered by this policy. Continuation requests are allowed when prior authorization criteria were previously met and the member has not had disease progression on the requested medication, the medication was used within the last year without a gap of more than 30 days since an active authorization, and no additional medications are being added to the continuation request.

Prior authorization required before initiation
Continuation allowed if no disease progression, prior use within 1 year with ≤30-day lapse, and no added medications

Step Therapy

Step Therapy / Prior Treatment Requirement for ITP

For idiopathic thrombocytopenia purpura (ITP), step therapy / prior treatment requirements must be documented. The member must have relapsed or refractory chronic ITP and have had an inadequate response to, or intolerance/contraindication to, corticosteroids (inadequate response defined as failure of platelet count to increase and remain above 30 x 10^9/L). Additionally, the platelet count must be <30,000 x 10^9/L prior to initiation of therapy.

Background

Avatrombopag is a thrombopoietin receptor agonist approved to increase platelet counts in chronic immune thrombocytopenia (ITP) and to raise platelet counts in patients with chronic liver disease who require an invasive procedure. Its mechanism of action is stimulation of the thrombopoietin receptor to promote megakaryocyte proliferation and platelet production. Coverage decisions for avatrombopag must align with FDA‑approved labeling and recognized compendia or peer‑reviewed literature.

Definitions and Clinical Thresholds

Definition — Insufficient response (ITP) threshold

DefinitionFailure of platelet count to increase and stay above 30 x 10^9/L after treatment

ContextUsed to establish inadequate response to corticosteroids for ITP prior to avatrombopag initiation

Related criterionApplies when member has relapsed/refractory chronic ITP and intolerance/contraindication to corticosteroids

Definition — Thrombocytopenia in chronic liver disease (procedure indication) threshold

Procedure indication thresholdMean baseline platelet count of less than 50 x 10^9/L

Clinical contextApplies to members with chronic liver disease who are scheduled to undergo an invasive procedure

Revision History

2025-04conversion_and_replacementLatest

Converted to new Evolent guideline template and replaced prior policy UM ONC 1334 (Doptelet/avatrombopag); references updated.

2024-04verbiage_update

Updated NCH verbiage to Evolent.

Denial Risk

Exclusion Triggers and Dosing / Duration Limits

Requests meeting any exclusion criteria will be denied. Exclusion triggers include disease progression (no rise in platelet counts from baseline after 4 weeks at maximum tolerated dose), prior failure with Mulpleta (lusutrombopag) for thrombocytopenia in chronic liver disease, dosing above single-dose limits (60 mg for chronic liver disease; 40 mg for chronic ITP), exceeding monthly tablet limits (15 tablets [20 mg] per month for chronic liver disease; 60 tablets [20 mg] per month for chronic ITP), exceeding treatment duration limits (more than 5 days for chronic liver disease), or investigational/off-label use lacking sufficient evidence per CMS standards.

Disease progression: no platelet rise after 4 weeks at max tolerated dose
Prior failure with Mulpleta (lusutrombopag) for thrombocytopenia in chronic liver disease
Single-dose limits: >60 mg (chronic liver disease) or >40 mg (chronic ITP)
Monthly tablet limits: >15 (20 mg) tablets/month (chronic liver disease) or >60 (20 mg) tablets/month (chronic ITP)
Treatment duration limit: >5 days (chronic liver disease)
Investigational/off-label indications without sufficient CMS-recognized evidence