CurrentNeighborhood Health Plan of Rhode IslandPolicy 3081-A

Doptelet (avatrombopag) — coverage criteria for thrombocytopenia

Defines medical necessity criteria, documentation, prescriber requirements, exclusions, and authorization durations for Doptelet (avatrombopag) for chronic liver disease and chronic immune thrombocytopenia for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoptelet (avatrombopag) — coverage criteria for thrombocytopenia

Policy CodePolicy 3081-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization with required pretreatment platelet count and documentation of prior therapy response for chronic ITP.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications covered

30 daysCLD initial auth

6 monthsChronic ITP initial auth

3 | 12ITP continuation options

<50CLD platelet threshold

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Coverage Criteria for Doptelet (avatrombopag)

Initial approval — Thrombocytopenia in chronic liver disease

Authorization of 30 days may be granted when ALL of the following are met

CLD initial criteria: Member has an untransfused platelet count of less than 50 x10^9/L taken within 14 days of the request.< 50 x10^9/L within 14 days

Pretreatment untransfused platelet count required; authorization limited to 30 days.

CLD initial criteria: Member is scheduled to undergo a procedure.

Authorization is for procedural use; continuation beyond the initial approval for the same procedure is not approvable.

Initial approval — Chronic immune thrombocytopenia (ITP)

Authorization of 6 months may be granted when ALL of the following are met

Chronic ITP initial criteria: Inadequate response or intolerance to prior therapy (e.g., corticosteroids or immunoglobulins).

Documentation of prior therapies and lack of response or intolerance is required.

Chronic ITP initial criteria: Untransfused platelet count at any point prior to initiation is less than 30 x10^9/L OR 30–50 x10^9/L with symptomatic bleeding (e.g., significant mucous membrane bleeding, gastrointestinal bleeding or trauma) or risk factors for bleeding.<30 x10^9/L OR 30–50 x10^9/L with symptomatic bleeding or bleeding risk factors

Historical untransfused platelet count required as part of initial documentation.

Continuation approval — Thrombocytopenia in chronic liver disease

Continuation rules

CLD continuation: Continuation of therapy, defined as use beyond the initial approval for the same procedure, is not approvable.N/A

All members (including new members) requesting authorization for a newly scheduled procedure must meet all initial authorization criteria.

Continuation approval — Chronic ITP

Authorization for continuation may be granted as follows based on current platelet count and clinical status

Chronic ITP continuation options: Option 1: Authorization of 3 months for members with current platelet count <50 x10^9/L for whom the platelet count is not sufficient to prevent clinically important bleeding and who have not received a maximal Doptelet dose for at least 4 weeks.<50 x10^9/L

Requires documentation of inadequate platelet response and dosing history (no maximal dose for ≥4 weeks).

Chronic ITP continuation options: Option 2: Authorization of 12 months for members with current platelet count <50 x10^9/L for whom the current platelet count is sufficient to prevent clinically important bleeding.<50 x10^9/L

Clinical judgment that count is sufficient to prevent bleeding required.

Chronic ITP continuation options: Option 3: Authorization of 12 months for members with current platelet count 50–200 x10^9/L.

Concomitant use of Doptelet (avatrombopag) with other thrombopoietin receptor agonists (for example, Mulpleta, Promacta, Nplate) or with spleen tyrosine kinase inhibitors (for example, Tavalisse) is excluded and will not be covered.

Doptelet is authorized only for its FDA-approved indications: treatment of thrombocytopenia in adults with chronic liver disease (CLD) scheduled to undergo a procedure and treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior therapy. All other indications are considered experimental/investigational and are not medically necessary.

Provider Actions, Documentation, and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be granted only when the listed clinical criteria and documentation are met.

Step Therapy

Step therapy / Prior Treatment Requirement

For chronic immune thrombocytopenia (ITP), the member must have inadequate response or intolerance to prior therapy (e.g., corticosteroids or immunoglobulins) documented in the chart prior to approval of Doptelet.

Documentation Required

Required Laboratory Documentation

Required laboratory documentation must be submitted with the request: pretreatment platelet counts for initial requests.

Documentation Required

Supportive Clinical Documentation

Supporting clinical documentation must be provided: for thrombocytopenia in chronic liver disease, an untransfused platelet count taken within 14 days of the request; for chronic ITP, documentation of inadequate response or intolerance to prior therapy and the relevant pretreatment or current platelet counts as specified in policy.

Denial Risk

Concomitant Use Exclusion — Denial Risk

Do not approve if Doptelet is being used concomitantly with other thrombopoietin receptor agonists (e.g., Mulpleta, Promacta, Nplate) or with spleen tyrosine kinase inhibitors (e.g., Tavalisse). Such concomitant use is an exclusion and should result in denial.

Definitions

Thrombocytopenia in chronic liver disease (CLD) — inv-14

DefinitionThrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure

Coverage qualifierUntransfused platelet count < 50 x10^9/L measured within 14 days of the request is required for initial authorization

Authorization durationInitial authorization limited to 30 days; continuation beyond the initial approval for the same procedure is not approvable

Documentation requiredPretreatment untransfused platelet count within 14 days must be provided

Chronic immune thrombocytopenia (ITP) — inv-15

DefinitionChronic immune thrombocytopenia (ITP) in adults with inadequate response or intolerance to prior therapy

Historical platelet criteria for initiationUntransfused platelet count < 30 x10^9/L at any time prior to initiation OR 30–50 x10^9/L with symptomatic bleeding or bleeding risk factors

Initial authorization durationAuthorization of 6 months may be granted when criteria are met

Continuation qualifiersContinuation authorization depends on current platelet count and clinical status (options include 3 months or 12 months as specified by current count and bleeding risk/dosing history)

OpenPayer

Doptelet (avatrombopag) — coverage criteria for thrombocytopenia

Coverage Criteria for Doptelet (avatrombopag)

Provider Actions, Documentation, and Authorization Requirements

Clinical Thresholds and Coding-Adjacent Values

Definitions

Background