ModifiedCignaPolicy N/A

Thrombocytopenia - Doptelet Prior Authorization Policy

Prior authorization policy for Doptelet (avatrombopag tablets and Doptelet Sprinkle oral granules) covering FDA-approved indications (chronic/persistent immune thrombocytopenia in adults and pediatrics; thrombocytopenia in adults with chronic liver disease scheduled for a procedure) with specific clinical criteria, durations, prescriber requirements, and non-covered uses.

Policy Summary

PayerCigna

PolicyThrombocytopenia - Doptelet Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria modified; Sprinkle added

Effective Date

Next Review Date

Key ActionObtain prior authorization and document platelet counts, prior therapies or splenectomy, prescriber's bleeding-risk assessment, and evidence of beneficial response per indication.

POLICY UPDATE CHANGES

For initial therapy for chronic immune thrombocytopenia, the requirement that the patient is ≥ 18 years of age was removed.

Alvaiz (eltrombopag choline tablets) was added to the examples of other therapies.

Doptelet Sprinkle was added to the policy with separate criteria.

3Covered Indications (distinct)

2Formulations covered

1Approval durations vary

This prior authorization policy applies to Doptelet (avatrombopag) in both tablet and Sprinkle (oral granules) formulations and covers FDA‑approved indications: chronic/persistent immune thrombocytopenia in adults and pediatric patients, and thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure. Coverage is provided with clinical criteria and documentation requirements (coverage stance: covered_with_criteria).

Dosing and duration vary by indication: for chronic ITP there are specific initial and continuation approval durations and stopping rules; for chronic liver disease the agent is given as a 5‑day course beginning 10 to 13 days before the scheduled procedure. The Sprinkle formulation is intended for pediatric use in certain ages and is not substitutable on a mg‑to‑mg basis with the tablets.

Platelet count severe< 30 x 10^9/L (< 30,000/mcL)

Bleeding risk threshold< 50 x 10^9/L (< 50,000/mcL)

Procedure timing (chronic liver disease)Procedure scheduled within 10 to 13 days after starting therapy

Formulations covered2

Covered Indications (distinct)3

Initial Therapy Criteria — Doptelet (tablets)

Doptelet (avatrombopag tablets) - FDA-Approved Indications

Immune Thrombocytopenia, Chronic or Persistent - Initial Therapy (Approve for 3 months)

Platelet count criteria (ONE of)
- Option: platelet count < 30 x10^9/L: Patient has a platelet count < 30 x 10^9/L (< 30,000/mcL)< 30 x 10^9/L
- Option: platelet count <50 x10^9/L AND increased bleeding risk
  - Platelet count <50 x10^9/L: Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL)< 50 x 10^9/L
  - Increased bleeding risk per prescriber: According to the prescriber, the patient is at an increased risk of bleeding
Prior therapy or splenectomy (ONE of)
- Tried at least ONE other therapy: Patient has tried at least ONE other therapy (examples: systemic corticosteroids, intravenous immunoglobulin, anti-D immunoglobulin, eltrombopag olamine tablets or oral suspension (Promacta, generic), Alvaiz (eltrombopag choline tablets), Nplate (romiplostim), Tavalisse (fostamatinib), rituximab)
- Prior splenectomy: Patient has undergone splenectomy
Prescriber specialty requirement: The medication is prescribed by or in consultation with a hematologist

Continuation Therapy Criteria — Doptelet (tablets)

Immune Thrombocytopenia, Chronic or Persistent - Currently Receiving Doptelet (Approve for 1 year)

Beneficial clinical response per prescriber: According to the prescriber, the patient demonstrates a beneficial clinical response
beneficial response can include increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes
Ongoing bleeding risk: Patient remains at risk for bleeding complications

Thrombocytopenia in Chronic Liver Disease - Adults (Approve for 5 days)

Age requirement: Patient is >= 18 years of age>= 18 years
Current platelet count: Patient has a current platelet count < 50 x 10^9/L (< 50,000/mcL)< 50 x 10^9/L
Procedure timing: Patient is scheduled to undergo a procedure within 10 to 13 days after starting Doptelet therapy10 to 13 days

Pediatric Initial Therapy — Doptelet Sprinkle

Doptelet Sprinkle (avatrombopag oral granules) - FDA-Approved Indication

Immune Thrombocytopenia, Chronic or Persistent - Initial Therapy (Approve for 3 months)

Age requirement: Patient is < 6 years of age< 6 years
Platelet count criteria (ONE of)
- Option: platelet count < 30 x10^9/L: Patient has a platelet count < 30 x 10^9/L (< 30,000/mcL)< 30 x 10^9/L
- Option: platelet count <50 x10^9/L AND increased bleeding risk
  - Platelet count <50 x10^9/L: Patient has a platelet count < 50 x 10^9/L (< 50,000/mcL)< 50 x 10^9/L
  - Increased bleeding risk per prescriber: According to the prescriber, the patient is at an increased risk of bleeding
Prior therapy or splenectomy (ONE of)
- Tried at least ONE other therapy: Patient has tried at least ONE other therapy (examples: systemic corticosteroids, intravenous immunoglobulin, anti-D immunoglobulin, eltrombopag olamine tablets or oral suspension (Promacta, generic), Alvaiz (eltrombopag choline tablets), Nplate (romiplostim subcutaneous injection), Tavalisse (fostamatinib tablets), and rituximab)
- Prior splenectomy: Patient has undergone splenectomy
Prescriber specialty requirement: The medication is prescribed by or in consultation with a hematologist

Pediatric Continuation Therapy — Doptelet / Sprinkle

Immune Thrombocytopenia, Chronic or Persistent - Currently Receiving Doptelet or Doptelet Sprinkle (Approve for 1 year)

Age requirement: Patient is < 6 years of age< 6 years
Beneficial clinical response per prescriber: According to the prescriber, the patient demonstrates a beneficial clinical response
beneficial response can include increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes
Ongoing bleeding risk: Patient remains at risk for bleeding complications

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Doptelet (avatrombopag) tablets and Doptelet Sprinkle (avatrombopag oral granules). Approvals are provided for the durations specified by indication: 3 months for initial therapy for chronic/persistent immune thrombocytopenia, 1 year for patients currently receiving Doptelet for ITP, and a 5-day approval for use in adults with chronic liver disease who are scheduled to undergo a procedure.

Documentation Required

Document platelet counts and prior therapies

Document the patient’s current platelet counts, the history of prior therapies or splenectomy, the prescriber’s assessment of bleeding risk, and evidence that the patient demonstrates a beneficial clinical response when requesting continuation approvals.

Systemic corticosteroids
Intravenous immunoglobulin (IVIG)
Anti-D immunoglobulin
Eltrombopag olamine (Promacta) tablets or oral suspension (and generics)
Alvaiz (eltrombopag choline tablets)
Nplate (romiplostim)
Tavalisse (fostamatinib)
Rituximab
Or prior splenectomy

Documentation Required

Prescriber specialty requirement

For the indicated uses listed in this policy, Doptelet must be prescribed by or in consultation with a hematologist.

Clinical Evidence & Definitions

Evidence:

Prescribing information: Doptelet tablets and Sprinkle prescribing information, AkaRx, July 2025.

Guideline: American Society of Hematology 2019 guidelines for ITP.

Definition:

Beneficial response: Can include increased platelet counts, maintenance of platelet counts, and/or decreased frequency of bleeding episodes.

Sprinkle formulation noteSprinkle formulation for pediatric use; not mg-to-mg substitutable with tablets

Dosing/indication noteDosing and duration differ by indication

Background

Doptelet (avatrombopag) is a thrombopoietin receptor agonist indicated for: chronic immune thrombocytopenia (ITP) in adults and in pediatric patients ≥ 1 year of age with an insufficient response to prior treatment, and for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure. For chronic ITP, Doptelet should be discontinued if the platelet count does not increase to ≥ 50 x 10^9/L within 4 weeks at the maximum dose.

For the chronic liver disease indication, Doptelet is administered as a 5‑day course beginning 10 to 13 days before the scheduled procedure. In clinical studies, patients generally had platelet counts < 50 x 10^9/L.

The Sprinkle formulation (avatrombopag oral granules) has dosing recommended only in pediatric patients 1 year to < 6 years of age for persistent or chronic ITP, and Doptelet tablets and Sprinkle are not substitutable on a mg‑to‑mg basis.

Scope note: both Doptelet tablets and Doptelet Sprinkle oral granules are covered formulations under this policy when FDA‑approved indication criteria are met.

Revision History

revised (material)Latest

For initial therapy for chronic immune thrombocytopenia, the requirement that the patient is ≥ 18 years of age was removed. Detail: This change allows adults and younger patients per indication for Doptelet tablets initial ITP criteria.

revised (non-material)

Alvaiz (eltrombopag choline tablets) was added to the examples of other therapies. Detail: Note also that Promacta (eltrombopag olamine) is available in generic formulations.

added (material)

Doptelet Sprinkle was added to the policy with separate criteria. Detail: Criteria divided into two sections (Doptelet tablets and Doptelet Sprinkle) and new criteria for Sprinkle were added.