CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Doptelet 3081 A Sgm P2023

Defines coverage, prior authorization documentation, exclusion, prescriber specialty, and initial and continuation approval criteria for Doptelet (avatrombopag) for thrombocytopenia in chronic liver disease (CLD) and chronic immune thrombocytopenia (ITP). Non‑FDA or non‑compendial indications are considered experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoptelet 3081 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvide pretreatment platelet count for CLD initial requests and for ITP initial requests; provide current platelet count for ITP continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material changes

2Covered Indications (CLD, ITP)

1Explicit Exclusion (concomitant TPO-RA or SYK inhibitor)

30d / 6mInitial authorization durations (CLD / ITP)

3 or 12mContinuation authorization options (ITP)

Coverage Summary

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Defines coverage, prior authorization documentation, exclusions, prescriber specialty, and initial and continuation approval criteria for Doptelet (avatrombopag) for thrombocytopenia in chronic liver disease (CLD) and chronic immune thrombocytopenia (ITP). FDA‑approved indications covered with criteria include treatment of thrombocytopenia in adults with CLD who are scheduled to undergo a procedure and treatment of thrombocytopenia in adults with chronic ITP with inadequate response to prior therapy. Non‑FDA or non‑compendial indications are considered investigational and not medically necessary.

Key thresholds & quick facts

Untransfused platelet count — CLD initial< 50 x 10^9/L (measured within 14 days of the request)

ITP — platelet count prior to initiation (severe)Untransfused platelet count < 30 x 10^9/L

ITP — platelet count prior to initiation (with bleeding)30 to 50 x 10^9/L with symptomatic bleeding or bleeding risk factors

Continuation (ITP) — short authorizationCurrent platelet count < 50 x 10^9/L and platelet count not sufficient to prevent clinically important bleeding; 3 months (patient must not have received maximal dose ≥4 weeks)

Continuation (ITP) — standard authorizationCurrent platelet count < 50 x 10^9/L with count sufficient to prevent clinically important bleeding; 12 months

Continuation (ITP) — alternative 12-month rangesCurrent platelet count 50 to 200 x 10^9/L (12 months) or >200 to ≤400 x 10^9/L with dose adjustment to avoid bleeding (12 months)

Continuation for CLD proceduresContinuation beyond the initial approval for the same procedure is not approvable; new procedures must meet initial CLD criteria

Initial Therapy Criteria

A. Thrombocytopenia in chronic liver disease

Covered when ALL of the following are met:

ALL of the following

Indication is treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Member has an untransfused platelet count of <50 x 10^9/L taken within 14 days of the request.
Pretreatment platelet count must be submitted.
Prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist.

B. Chronic immune thrombocytopenia (ITP) — Initial approval

Covered when ALL of the following are met:

ALL of the following

Indication is treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response or intolerance to prior therapy (e.g., corticosteroids or immunoglobulins).
Prescribed by or in consultation with a hematologist.
Platelet count criteria
- Untransfused platelet count at any point prior to initiation is <30 x 10^9/L<30 x 10^9/L
- Untransfused platelet count at any point prior to initiation is 30 x 10^9/L to 50 x 10^9/L with symptomatic bleeding or risk factors for bleeding30–50 x 10^9/L
  Symptomatic bleeding examples: significant mucous membrane bleeding, gastrointestinal bleeding, or trauma. Risk factors: see risk factor list in policy.

Documentation requirements for prior authorization

Submission of the following information is necessary to initiate the prior authorization review:

ALL of the following

For thrombocytopenia in chronic liver disease: pretreatment platelet count for initial requests.
For chronic immune thrombocytopenia (ITP): for initial requests, pretreatment platelet count; for continuation requests, current platelet count.
Documentation of prior therapies and response/intolerance (e.g., corticosteroids, immunoglobulins) for ITP initial requests.
Prescriber specialty or documentation of consultation with required specialist (hematologist; hepatologist or gastroenterologist for CLD).

Covered Indications (general)

Covered when ALL of the following are met:

ALL of the following

Indication is an FDA‑approved use: treatment of thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a procedure, OR treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia with inadequate response to prior treatment.
Not for use in combination with other thrombopoietin receptor agonists (e.g., Mulpleta, Promacta, Nplate) or spleen tyrosine kinase inhibitors (e.g., Tavalisse).
Prescriber specialty: for CLD indications, prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist; for ITP indications, prescribed by or in consultation with a hematologist.

Continuation Therapy Criteria

Continuation approval criteria — Chronic ITP

Authorizations vary by current platelet count and clinical circumstances:

ANY of the following

Authorization of 3 months may be granted to members with current platelet count less than 50 x 10^9/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 x 10^9/L
Member must not have received maximal Doptelet dose for at least 4 weeks.
Authorization of 12 months may be granted to members with current platelet count less than 50 x 10^9/L for whom the current platelet count is sufficient to prevent clinically important bleeding.< 50 x 10^9/L
Authorization of 12 months may be granted to members with current platelet count of 50 x 10^9/L to 200 x 10^9/L.50 to 200 x 10^9/L
Authorization of 12 months may be granted to members with current platelet count greater than 200 x 10^9/L to less than or equal to 400 x 10^9/L for whom Doptelet dosing will be adjusted to achieve a platelet count sufficient to avoid clinically important bleeding.> 200 x 10^9/L to <= 400 x 10^9/L
Dosing will be adjusted to achieve platelet count sufficient to avoid clinically important bleeding.

Continuation approval criteria — Thrombocytopenia in CLD

Continuation of therapy beyond initial approval for the same procedure is not approvable.

ALL of the following

Continuation of therapy (use beyond the initial approval for the same procedure) is not approvable.
All members (including new members) requesting authorization due to a newly scheduled procedure must meet all initial authorization criteria.

Unproven / Exclusions

Exclusions

Coverage will not be provided when any of the following apply:

ANY of the following

Concomitant use of Doptelet with other thrombopoietin receptor agonists (e.g., Mulpleta, Promacta, Nplate).
Concomitant use of Doptelet with spleen tyrosine kinase inhibitors (e.g., Tavalisse).

Per policy, Doptelet is indicated and considered for coverage only for the FDA‑approved uses listed; all other indications are considered experimental/investigational and not medically necessary.

Provider Actions & Prior Authorization

Prior Authorization

Submit platelet count documentation

Provide pretreatment platelet count for CLD initial requests and for ITP initial requests; provide current platelet count for ITP continuation requests.

Prior Authorization

Prescriber specialty requirement

For CLD, prescribe by or in consultation with hematologist, hepatologist, or gastroenterologist; for ITP, prescribe by or in consultation with a hematologist.

Documentation Required

Prior therapy for ITP

Document inadequate response or intolerance to prior therapy (e.g., corticosteroids or immunoglobulins) for ITP initial authorization.

Denial Risk

Concomitant TPO agonist or SYK inhibitor use

Claim will not be covered if Doptelet is used concomitantly with other thrombopoietin receptor agonists or spleen tyrosine kinase inhibitors.

Mulpleta
Promacta
Nplate
Tavalisse

Billing Rule

Duration limits on authorizations

Initial authorization durations: 30 days for CLD; 6 months for ITP. Continuation authorizations for ITP: 3 or 12 months depending on current platelet counts and clinical context. Continuation beyond the initial approval for the same CLD procedure is not approvable.

Background & Definitions

Doptelet (avatrombopag) is a thrombopoietin receptor agonist indicated for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure and for chronic immune thrombocytopenia in adults with an insufficient response to prior treatment. Non‑FDA and non‑compendial uses are considered experimental/investigational and not medically necessary under this policy.

Term	Definition
Untransfused platelet count
Platelet count measured in the absence of recent platelet transfusion; required timing specified in criteria (e.g., within 14 days for CLD initial).
Clinically important bleeding
Bleeding sufficient to be of clinical concern; examples include significant mucous membrane bleeding, gastrointestinal bleeding, or bleeding from trauma.

OpenPayer

Doptelet 3081 A Sgm P2023

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History