ModifiedmhnPolicy CP.PHAR.130

Avatrombopag (Doptelet, Doptelet Sprinkle) coverage

Defines medical necessity, prior authorization, and coverage criteria for avatrombopag (Doptelet and Doptelet Sprinkle) for thrombocytopenia related to chronic liver disease and immune thrombocytopenia (ITP) for applicable lines of business.

Policy Summary

Payermhn

PolicyAvatrombopag (Doptelet, Doptelet Sprinkle) coverage

Policy CodePolicy CP.PHAR.130

Change TypeMaterial updates: exclusions addedpediatric extension and new formulation addedITP duration revised

Effective DateDec 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with documentation demonstrating the member meets all initial or continued therapy criteria, including diagnosis, prescriber specialty, platelet counts, prior treatment history, and absence of concurrent excluded agents.

SourceLink

POLICY UPDATE CHANGES

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

Updated pediatric extension for immune thrombocytopenia (ITP) and added Doptelet Sprinkle (oral granules) formulation to the policy.

Approval duration for ITP revised from 6 months to 12 months.

2FDA indications

5CLD dosing days

12 moITP approval duration

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Tablet/Granulesformulations

Coverage Criteria for Avatrombopag (Doptelet, Doptelet Sprinkle)

Initial Therapy - Chronic Liver Disease

Covered when ALL of the following are met:

CLD Initial: Diagnosis of chronic liver disease; request is for Doptelet; prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist; age ≥ 18 years; recent (within the past 14 days) platelet count < 50 x 10^9/L; member is scheduled to undergo a medical or dental procedure within the next 30 days; Doptelet is not prescribed concurrently with another TPO receptor agonist or a spleen tyrosine kinase inhibitor; dose does not exceed specified limitssee children

Dose stratified by platelet count: for platelet count < 40 x 10^9/L -> 60 mg per day for 5 days (3 tablets/day x5 days); for platelet count 40 to < 50 x 10^9/L -> 40 mg per day for 5 days (2 tablets/day x5 days)

Initial Therapy - Immune Thrombocytopenia

Covered when ALL of the following are met:

ITP Initial: Diagnosis of persistent or chronic immune thrombocytopenia (ITP); prescribed by or in consultation with a hematologist; age criteria met (Doptelet tablets: ≥ 6 years; Doptelet Sprinkle capsules: >= 1 year to < 6 years); current (within 30 days) platelet count < 30,000/μL or member has an active bleed; member meets one of the following: failure of a systemic corticosteroid OR intolerance/contraindication to systemic corticosteroids and failure of immune globulin unless contraindicated; Doptelet is not prescribed concurrently with rituximab, another TPO receptor agonist, or a spleen tyrosine kinase inhibitor; dose does not exceed age-based limitsplatelet < 30,000/μL

Dose limits: adults and pediatric patients >= 6 years: 40 mg/day (2 tablets/day); pediatric patients 1 to < 6 years: 20 mg/day (2 capsules/day).

Continued Therapy - Chronic Liver Disease

Re-authorization not permitted; members must meet initial approval criteria.

CLD Continued: Re-authorization is not permitted; ongoing coverage limited to members meeting the initial approval criteria

Continued Therapy - Immune Thrombocytopenia

Covered when ALL of the following are met:

ITP Continued: Member currently receiving medication via the benefit or has previously met initial approval criteria or is enrolled in an applicable continuity-of-care state/product; member is responding positively to therapy (e.g., increase in platelet count from baseline or reduction in bleeding events); Doptelet is not prescribed concurrently with rituximab, another TPO receptor agonist, or a spleen tyrosine kinase inhibitor; if request is for a dose increase, new dose does not exceed age-based maximumsresponse demonstrated

Approval duration: 12 months

Non‑FDA approved indications that are not addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid).

Avatrombopag (Doptelet/Doptelet Sprinkle) requests are not permitted concurrently with other thrombopoietin (TPO) receptor agonists (for example, eltrombopag [Promacta], lusutrombopag [Mulpleta], romiplostim [Nplate]) or with spleen tyrosine kinase (SYK) inhibitors (for example, fostamatinib [Tavalisse]). Providers must document that the requested therapy is not being used in combination with these excluded agents when submitting prior authorization.

The policy applies the concurrent‑agent exclusion across all FDA‑labeled indications for avatrombopag. Concurrent use of a TPO receptor agonist and a SYK inhibitor with avatrombopag is an exclusion that may trigger denial of coverage for any labeled indication.

Use of avatrombopag for indications that are not FDA‑approved and are not specifically addressed in this policy is not authorized unless the request is supported by sufficient off‑label documentation per the plan’s off‑label use policies; absent that documentation, such requests will be considered not medically necessary.

Coding and Clinical Thresholds

Product codes (not specified)NDC

NDCs not listed

NDC codes not provided in this document

Platelet threshold and dosing stratification for CLD peri-procedural use

ThresholdRecent (within 14 days) platelet count < 50 x 10^9/L

Stratification AFor platelet count < 40 x 10^9/L: 60 mg per day for 5 days (3 tablets/day x 5 days)

Stratification BFor platelet count 40 to < 50 x 10^9/L: 40 mg per day for 5 days (2 tablets/day x 5 days)

Platelet threshold and eligibility for ITP treatment

ThresholdCurrent (within 30 days) platelet count < 30,000/µL or presence of an active bleed

Age/formulationDoptelet tablets: ≥ 6 years; Doptelet Sprinkle capsules: ≥ 1 to < 6 years

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document that all initial or continued therapy criteria are met and submit supporting clinical information with the request.

Prior authorization required for new formulation (Doptelet Sprinkle) and pediatric extension for ITP.
Concurrent use of other TPO receptor agonists or spleen tyrosine kinase inhibitors with avatrombopag is excluded for covered indications.

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, laboratory results, procedure scheduling information, or other clinical data) supporting that the member meets all approval criteria for the requested indication.

Include recent platelet counts (timing per indication: e.g., within 14 days for chronic liver disease, within 30 days for ITP).

Background and Drug Information

Avatrombopag is an oral thrombopoietin (TPO) receptor agonist indicated to increase platelet counts for adults with chronic liver disease who are scheduled to undergo a medical or dental procedure and for treatment of immune thrombocytopenia (ITP) in eligible adults and pediatric patients. The product is available as tablets (Doptelet) and as an oral granule formulation (Doptelet Sprinkle); dosing and age eligibility differ by indication and formulation, and the policy includes age‑ and platelet‑count–based dosing thresholds for peri‑procedural and ITP use.

Definitions and Terms

Response (2019 ASH guideline definition)

ASH (2019) response definitionA response is defined as platelet count ≥ 30,000/µL AND a >2‑fold increase from baseline measured on 2 occasions >7 days apart, with absence of bleeding

Measurement frequencyPlatelet counts must be measured on 2 occasions more than 7 days apart to confirm response

Clinical elementAbsence of bleeding is required for response classification per ASH

Failure (2019 ASH guideline definition)

ASH (2019) failure definitionFailure is defined as platelet count < 30,000/µL OR a <2‑fold increase from baseline OR the presence of bleeding; platelet count must be measured on 2 occasions more than a day apart

Measurement frequencyPlatelet counts must be measured on 2 occasions more than a day apart to confirm failure

Policy Summary

Payermhn

PolicyAvatrombopag (Doptelet, Doptelet Sprinkle) coverage

Policy CodePolicy CP.PHAR.130

Change TypeMaterial updates: exclusions addedpediatric extension and new formulation addedITP duration revised

Effective DateDec 1, 2018

Next Review DateN/A

SourceLink

On This Page

Prior therapy requirementMember has failed a systemic corticosteroid or has intolerance/contraindication to corticosteroids and failure of immune globulin (unless contraindicated)

If request is for pre-procedure use, include documentation of scheduled medical or dental procedure and date.

For ITP, include documentation of prior therapies and reason for failure or intolerance (e.g., systemic corticosteroid failure or intolerance and immune globulin failure/intolerance when applicable).

Denial Risk

Denial Triggers

Requests may be denied if documentation does not demonstrate that the member meets all approval criteria for the requested indication, including but not limited to diagnosis, prescriber specialty requirements, age limits, laboratory thresholds, prior therapy/step therapy requirements, dose limits, and concurrent-agent exclusions.

Denial triggers include missing or out-of-window platelet counts, lack of documentation of prior steroid or immune therapy failure/intolerance when required, absence of prescriber specialty or consult notes, and requests for concurrent use with excluded agents (other TPO receptor agonists or SYK inhibitors).
Requests exceeding dose or formulation limits (including pediatric formulation age limits) may be denied.

Note

General Documentation Expectations

This policy is a guide to medical necessity and not a guarantee of payment. Follow the member's coverage documents (e.g., EOC, certificate of coverage, policy) and applicable state/federal requirements and Health Plan-level administrative policies when submitting prior authorization requests.

Provide complete and legible documentation at time of request; incomplete records may delay review or result in denial.
Approval durations and pediatric extensions follow the most recent policy updates — verify effective dates and P&T approvals when applicable.

Clinical elementPresence of bleeding meets the failure definition regardless of count increase

Doptelet Sprinkle (oral granules)

FormulationDoptelet Sprinkle = oral granules (sprinkle capsules) formulation of avatrombopag

Pediatric use noteSprinkle formulation intended for pediatric patients aged 1 to <6 years per dosing guidance

Dose unit exampleEach Sprinkle capsule contains 10 mg (content of 1 capsule) for initiation in 1 to <6 year olds

Allowing ITP to be classified as persistent for coverage

Policy option addedITP diagnosis may be classified as persistent (3–12 months) as an option for meeting initial ITP criteria

Definitions sourcePersistent ITP defined per International Working Group/ASH as 3 to 12 months from diagnosis

Impact on coverageAllows patients with persistent ITP to meet the diagnosis criterion for avatrombopag coverage under ITP indication