CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mulpleta (lusutrombopag) — coverage criteria for thrombocytopenia in chronic liver disease

Defines accepted indications, dosing limits, exclusions, and coding for use of Mulpleta (lusutrombopag) primarily for thrombocytopenia in chronic liver disease for patients undergoing elective invasive procedures; applies to providers submitting medication requests to Evolent on behalf of Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMulpleta (lusutrombopag) — coverage criteria for thrombocytopenia in chronic liver disease

Policy CodePolicy N/A

Change TypeTemplate conversion and replacement of prior policy

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document chronic liver disease, platelet count < 50 x 10^9/L before an elective invasive procedure.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1343 Mulpleta (lusutrombopag).

<50 x10^9/Lplatelet threshold

3 mgsingle tablet strength limit

7 tabletsmonthly tablet limit

7 daysmax treatment duration

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Mulpleta (lusutrombopag)

Initial therapy for thrombocytopenia in chronic liver disease

Covered when ALL of the following are met

Indication and documentation: Member has chronic liver disease AND is scheduled to undergo an elective invasive procedure AND has platelet count < 50 x 10^9/L prior to the procedureplatelets < 50 x 10^9/L

Use must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature

Use of Mulpleta (lusutrombopag) for chronic immune thrombocytopenia (ITP) is an exclusion and may be denied. Additionally, disease progression for purposes of exclusion is defined as a lack of increase in platelet counts from baseline after 4 weeks at the maximum tolerated dose while the member continued to receive platelet transfusions during treatment with Mulpleta.

Investigational or off‑label uses of Mulpleta that are not supported by sufficient evidence or not generally accepted by the medical community are excluded. Determinations of insufficient evidence include lack of adequate representation of the patient or therapy in published evidence, absence of clinically meaningful outcomes as defined by ASCO standards, inappropriate experimental design for the question, reliance on uncontrolled case reports, or citation of abstracts without full peer‑reviewed articles. Uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature may be considered investigational and denied.

Coding and Thresholds

Covered HCPCS CodesHCPCSCovered

J8499

lusutrombopag

Platelet count threshold

Platelet count thresholdless than 50 x 10^9/L

ContextApplies to members with chronic liver disease scheduled for an elective invasive procedure

Use requirementCount must be measured prior to the procedure

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mulpleta (lusutrombopag) requests. Include supporting documentation demonstrating the indication, relevant labs, and treatment history.

Affected code: J8499 (lusutrombopag)
Supporting sources: FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature

Documentation Required

Documentation Requirements

Documentation must support the diagnosis and clinical scenario for use. For thrombocytopenia in chronic liver disease, provide evidence of chronic liver disease, confirmation the member is scheduled for an elective invasive procedure, and a platelet count < 50 x 10^9/L prior to the procedure. For ITP requests, include documentation that justifies off-label use; note that use in chronic immune thrombocytopenia (ITP) is listed as an exclusion.

Required labs: most recent platelet count prior to procedure

Definitions

Definition — Thrombocytopenia in chronic liver disease

DefinitionThrombocytopenia in chronic liver disease: chronic liver disease in a patient scheduled for an elective invasive procedure with platelet count less than 50 x 10^9/L prior to the procedure.

IndicationUse of Mulpleta (lusutrombopag) is for thrombocytopenia in this context

Documentation neededRecord of chronic liver disease diagnosis and pre-procedure platelet count < 50 x 10^9/L

Definition — Disease progression

DefinitionDisease progression (for exclusion): lack of increase in platelet counts from baseline after 4 weeks at maximum tolerated dose while the member continued to receive platelet transfusions during treatment with Mulpleta.

ImplicationRequests meeting this definition are excluded and may be denied

Background

Mulpleta (lusutrombopag) is a thrombopoietin receptor agonist indicated to increase platelet counts in patients with thrombocytopenia due to chronic liver disease who are scheduled to undergo elective invasive procedures. Use for this indication must align with FDA labeling and be supported by CMS‑recognized compendia, NCCN/ASCO guidance, or adequate peer‑reviewed literature.

Revision History and Policy Changes

2025-04policy_revisionLatest

Converted to new Evolent guideline template and replaced prior UM ONC_1343 Mulpleta (lusutrombopag); updated references.

2024-04administrative_update

Updated NCH verbiage to Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMulpleta (lusutrombopag) — coverage criteria for thrombocytopenia in chronic liver disease

Policy CodePolicy N/A

Change TypeTemplate conversion and replacement of prior policy

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document chronic liver disease, platelet count < 50 x 10^9/L before an elective invasive procedure.

SourceLink

On This Page

Documentation: diagnosis, procedure details, prior therapies, and rationale tied to cited guidelines/compendia

Denial Risk

Quantity, Dose and Duration Limits — Denial Risk

Requests for dosing, quantity, or duration that exceed policy limits will be denied unless strong supporting documentation justifies exception and is consistent with accepted compendia or peer-reviewed evidence. Single-dose requests over 3 mg, monthly quantity over seven 3 mg tablets, or treatment duration beyond 7 days (for chronic liver disease indication) exceed policy limits and are subject to denial.

Single dose limit: 3 mg
Maximum monthly quantity: 7 tablets (3 mg each)
Maximum duration for thrombocytopenia in chronic liver disease: 7 days

Prior Authorization

Continuation / Renewal Rules

Continuation (renewal) requests may be approved without full reauthorization when all the following are met: member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse >30 days of active authorization; and no additional medications are being added to the continuation request. Requests meeting exclusion criteria (for example, disease progression as defined or use for chronic ITP) remain non‑approvable.

Continuation criteria: no disease progression; active use within past year with ≤30-day lapse; no new meds added
Exclusions that preclude continuation: disease progression (no rise in platelets after 4 weeks at max tolerated dose with continued transfusions), chronic ITP

Denial Risk

Specifics for ITP and Disease-Progression Related Denials

Requests for ITP (chronic immune thrombocytopenia) should generally be denied per exclusion criteria. If an exception is sought, provide robust supporting evidence from CMS-recognized compendia or high-quality peer-reviewed literature that addresses the policy’s evidentiary standards.

ITP is listed in exclusion criteria as 'Use in chronic immune thrombocytopenia (ITP)'
Exception requests must include high-quality evidence meeting CMS/ASCO/NCCN standards

Related exclusionUse in chronic immune thrombocytopenia (ITP) is also excluded