CurrentBlue Cross Blue Shield - IowaPolicy 05.04.46

Avatrombopag (Doptelet) — Coverage Criteria for Thrombocytopenia

Covers medical necessity and prior authorization criteria for avatrombopag (Doptelet) to treat thrombocytopenia in adults with chronic liver disease (CLD) or chronic immune thrombocytopenia (ITP), including requirements for prescribers, documentation, and quantity limits.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAvatrombopag (Doptelet) — Coverage Criteria for Thrombocytopenia

Policy CodePolicy 05.04.46

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review DateOct 1, 2024

Key ActionSubmit prior authorization with required platelet counts and supporting documentation; prior authorization is required for CLD and ITP.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA indications

30 daysCLD auth period

6 monthsITP init auth

3/dayQty limit

excludedConcomitant TRAs

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Coverage Criteria for Avatrombopag (Doptelet)

Initial therapy — CLD

Covered when ALL of the following are met for thrombocytopenia in chronic liver disease (CLD):

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

Authorization of 30 days may be granted when member is scheduled to undergo a procedure.

Procedure scheduling: Member is scheduled to undergo a procedure

Initial therapy — ITP

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

ITP Initial Approval: Inadequate response or intolerance to prior therapy (e.g., corticosteroids or immunoglobulins)

ITP Platelet Criteria: Untransfused platelet count prior to initiation less than 30 x10^9/L, or 30–50 x10^9/L with symptomatic bleeding (for example significant mucous membrane bleeding, gastrointestinal bleeding, or trauma) or risk factors for bleeding<30 x10^9/L or 30–50 x10^9/L with bleeding or bleeding risk factors

Authorization of 6 months may be granted.

Continuation therapy — ITP

Continuation of therapy — ITP (authorization durations depend on current platelet counts):

Continuation criteria: 1) Current platelet count <50 x10^9/L and platelet count is not sufficient to prevent clinically important bleeding and member has not received maximal Doptelet dose for ≥4 weeks; 2) Current platelet count <50 x10^9/L and the current platelet count is sufficient to prevent clinically important bleeding; 3) Current platelet count 50–200 x10^9/L; 4) Current platelet count >200 to ≤400 x10^9/L when dosing will be adjusted to achieve a platelet count sufficient to avoid clinically important bleedingranges as specified (<50; 50–200; >200–≤400 x10^9/L)

Authorization months: criteria 1 = may be granted (duration per reviewer); criteria 2–4 = authorization of 12 months may be granted. Continuation requests for procedure-related use must meet initial criteria.

Coverage will not be provided for the concomitant use of Doptelet (avatrombopag) with other thrombopoietin receptor agonists such as Mulpleta, Promacta, or Nplate. Additionally, concomitant use with spleen tyrosine kinase inhibitors (for example, Tavalisse) is excluded. Requests for therapy that include simultaneous administration of Doptelet with any of these agents should be denied per policy.

Procedures, Codes, and Platelet Thresholds

Procedures and billing codesmixed

No codes listed

Platelet count thresholds — CLD and ITP

CLD initial thresholdUntransfused platelet count <50 x10^9/L taken within 14 days of the request; authorization of 30 days may be granted when member is scheduled to undergo a procedure.

ITP initial thresholdsUntransfused platelet count <30 x10^9/L OR 30–50 x10^9/L with symptomatic bleeding or bleeding risk factors; authorization of 6 months may be granted for initial therapy.

ITP continuation — <50 x10^9/L (insufficient to prevent bleeding)Authorization months may be granted for members with current platelet count <50 x10^9/L who remain at risk and who have not received maximal Doptelet dose for ≥4 weeks.

ITP continuation — <50 x10^9/L (sufficient to prevent bleeding)Authorization of 12 months may be granted when current platelet count <50 x10^9/L is sufficient to prevent clinically important bleeding.

ITP continuation — 50–200 x10^9/L and >200–≤400 x10^9/LAuthorization of 12 months may be granted for current platelet count 50–200 x10^9/L; and for >200 to ≤400 x10^9/L when dosing will be adjusted to achieve a safe platelet count.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the requested product. Submit a complete prior authorization request to initiate review.

Affected indications: Thrombocytopenia in chronic liver disease (CLD); Chronic immune thrombocytopenia (ITP)

Step Therapy

Preferred Drug Step Requirement

Member must meet the plan's preferred drug requirements before the requested product will be approved: either trial and inadequate response or intolerance to the preferred agent Alvaiz (eltrombopag choline), OR a documented clinical reason to avoid Alvaiz, OR the member is currently receiving and benefiting from the requested product under insurance.

Preferred agent: Alvaiz (eltrombopag choline) — trial and inadequate response or intolerance required
Clinical reason to avoid Alvaiz accepted as alternative to step
Continuation allowance if member is currently receiving product through insurance with positive therapeutic outcome (excludes samples or manufacturer patient assistance programs)

Key Definitions

Thrombocytopenia in chronic liver disease (CLD)

DefinitionThrombocytopenia in chronic liver disease (CLD): adult patients with chronic liver disease who have an untransfused platelet count of less than 50 x10^9/L taken within 14 days of the request.

Scheduling contextIndication applies when the member is scheduled to undergo a procedure; authorization of 30 days may be granted for procedure-related use.

PopulationAdults with chronic liver disease as per FDA-approved indication for avatrombopag (Doptelet).

Chronic immune thrombocytopenia (ITP)

DefinitionChronic immune thrombocytopenia (ITP): adult patients with chronic ITP who have had an insufficient response to prior treatment (for example, corticosteroids or immunoglobulins).

Qualifying platelet counts for initiation

Background

Avatrombopag (brand name Doptelet) is a thrombopoietin receptor agonist indicated for treatment of thrombocytopenia in adults with chronic liver disease (CLD) who are scheduled to undergo a procedure and for adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to prior treatment. Authorization decisions are driven by measured platelet counts and bleeding risk: for CLD the policy requires an untransfused platelet count of 50 x 10^9/L taken within 14 days of the request (short, procedure-related authorizations may be granted), while for chronic ITP authorization criteria include inadequate response or intolerance to prior therapy plus qualifying platelet counts (e.g., 30 x 10^9/L or 30–50 x 10^9/L with symptomatic bleeding or bleeding risk factors), with initial authorizations commonly granted for 6 months and continuation durations varying by current platelet count.

Revision History

2025-01-01Current effective dateLatest

Policy current effective date set to January 1, 2025.

2024-10-01Reviewed

Policy reviewed in October 2024.

2024-09-01Revised

Policy revised September 2024 (updates to coverage criteria and authorizations).