CurrentmhnPolicy CP.PHAR.407

Clinical Policy: Lusutrombopag (Mulpleta)

Policy governing medical necessity and prior authorization requirements for Mulpleta in adults with chronic liver disease and thrombocytopenia who are scheduled to undergo an invasive procedure; applies to health plans affiliated with Centene (commercial, HIM, Medicaid).

Policy Summary

Payermhn

PolicyClinical Policy: Lusutrombopag (Mulpleta)

Policy CodePolicy CP.PHAR.407

Change TypeMaterial and non-material annual updates

Effective Date09.18.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing chronic liver disease, platelet count <50 x10^9/L within 14 days, scheduled invasive procedure within 30 days, prescriber specialty, single TPO agonist use, and dose ≤3 mg/day.

SourceLink

POLICY UPDATE CHANGES

Added requirement that Mulpleta is not prescribed concurrently with other thrombopoietin receptor agonists.

Clarified that the medical or dental procedure should be invasive.

Added spleen tyrosine kinase inhibitor (e.g., Tavalisse) concurrent use exclusion.

References reviewed and updated across annual reviews (2021-2025); template wording changes applied to other diagnoses/indications and continued therapy sections.

<50required recent platelet count for approval

7total treatment days (maximum)

3 mgtablet strength / maximum daily dose

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approval duration window

8-14dstart dosing before procedure

Coverage Criteria for Mulpleta (lusutrombopag)

Initial therapy for thrombocytopenia

Covered when ALL of the following are met

Thrombocytopenia initial approval criteria: 1) Diagnosis of chronic liver disease; 2) Prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist; 3) Age >= 18 years; 4) Recent (within the past 14 days) platelet count is < 50 x 10^9/L; 5) Member is scheduled to undergo an invasive medical or dental procedure within the next 30 days; 6) Mulpleta is not prescribed concurrently with another thrombopoietin receptor agonist (e.g., Doptelet, Nplate, Promacta) or a spleen tyrosine kinase inhibitor (e.g., Tavalisse); 7) Dose does not exceed 3 mg per day (1 tablet per day).see node text

Approval duration: 14 days (no more than 7 total days of treatment)

Re-authorization

Re-authorization is not permitted; members must meet the initial approval criteria.N/A

Approval duration: Not applicable

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety and meets the applicable off‑label use policy requirements (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or is supported by an evidence of coverage document.

Uses for non‑FDA approved indications without adequate supporting documentation or without compliance with the applicable off‑label use policy are considered not medically necessary and therefore are not authorized under this policy.

Key Clinical and Dosing Parameters

inv-05: Recent platelet count — < 50 x 10^9/L (within the past 14 days)

ThresholdRecent platelet count < 50 x 10^9/L

TimeframeWithin the past 14 days

ContextRequired for initial approval of Mulpleta for thrombocytopenia in chronic liver disease

inv-06: Dosing initiation window — Begin dosing 8-14 days prior to scheduled procedure

Initiation windowBegin dosing 8–14 days prior to the scheduled procedure

PurposeAllows sufficient time for platelet response before invasive procedure

Dose guidance reference

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mulpleta. Requests must include documentation demonstrating the member meets ALL approval criteria for thrombocytopenia due to chronic liver disease (see clinical criteria).

Applicable policy: CP.PHAR.407
Provider specialty: hematologist, hepatologist, or gastroenterologist (prescriber or consult)
Age requirement: ≥ 18 years
Platelet count: recent (within 14 days) < 50 x 10^9/L
Planned procedure within 30 days
No concurrent thrombopoietin receptor agonist or spleen tyrosine kinase inhibitor
Maximum dose: 3 mg PO once daily (1 tablet/day)

Denial Risk

Treatment Duration and Re-authorization

Definitions

inv-13: Chronic liver disease — examples and scope (alcoholic liver disease, chronic viral hepatitis, metabolic dysfunction-associated, etc.)

Included examplesAlcoholic liver disease

Included examplesChronic viral hepatitis (e.g., hepatitis B and C)

Included examplesMetabolic dysfunction-associated steatohepatitis (formerly NASH)

ScopeCovers chronic liver disease diagnoses referenced in policy required for Mulpleta authorization

Background

Lusutrombopag (Mulpleta) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. Examples of chronic liver disease include alcoholic liver disease, chronic viral hepatitis (e.g., hepatitis B and C), and metabolic dysfunction‑associated steatohepatitis. Dosing is started 8–14 days prior to the scheduled procedure to allow the procedure to be planned 2–8 days after the last dose.

Revision History

11.18.20annual review

Added requirement that Mulpleta is not prescribed concurrently with other thrombopoietin receptor agonists and clarified that the medical or dental procedure should be invasive.

11.06.23annual review

Added exclusion for concurrent use of spleen tyrosine kinase inhibitors (e.g., Tavalisse).

11.20.24annual reviewLatest

References reviewed and updated; no significant clinical changes to coverage criteria.

Policy Summary

Payermhn

PolicyClinical Policy: Lusutrombopag (Mulpleta)

Policy CodePolicy CP.PHAR.407

Change TypeMaterial and non-material annual updates

Effective Date09.18.18

Next Review Date

SourceLink

On This Page

See Dosage and Administration: 3 mg PO QD for thrombocytopenia (total of 7 days)

inv-07: Procedure timing after last dose — Procedure should occur 2-8 days after the last dose

Procedure timingProcedure should occur 2–8 days after the last dose

RationaleTiming aligns with expected platelet count increase following final dose

Relation to treatment durationProcedure window falls within the 14-day approval duration and after up to 7 days of dosing

Treatment is limited and re-authorization is not permitted. Approvals are for a short peri-procedural window only.

Approval duration: 14 days
Total treatment limited to no more than 7 days of dosing
Dosing guidance: begin dosing 8–14 days prior to procedure; perform procedure 2–8 days after last dose
Maximum dose during approval: 3 mg/day

Documentation Required

Required Documentation / Denial Risk

Provider must submit supporting documentation with the prior authorization request. Requests lacking required documentation will be denied or returned to the provider for more information.

Required documentation: office chart notes, recent laboratory results (platelet count within 14 days), procedure scheduling documentation, consultation notes if prescriber is not a hematologist/hepatologist/gastroenterologist
If documentation does not clearly demonstrate all approval criteria are met, the request will be denied or returned