CurrentCentenePolicy CP.PHAR.407

Lusutrombopag (Mulpleta) for thrombocytopenia in chronic liver disease

Defines medical necessity criteria and authorization requirements for Mulpleta in adults with chronic liver disease and thrombocytopenia who are scheduled to undergo a procedure; applies to Centene-affiliated health plans and relevant lines of business.

Policy Summary

PayerCentene

PolicyLusutrombopag (Mulpleta) for thrombocytopenia in chronic liver disease

Policy CodePolicy CP.PHAR.407

Change TypeNo material change

Effective DateSep 18, 2018

Next Review DateFeb 26, 2025

Key ActionPrior authorization required; submit documentation (office notes, labs) showing diagnosis, recent platelet <50 x10^9/L, planned procedure timing, and that dose does not exceed 3 mg/day.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

<50eligibility threshold

≥18minimum age

3 mgtablet strength

8–14ddosing lead time

2–8dprocedure timing

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Coverage Criteria for Lusutrombopag (Mulpleta)

Initial Therapy for Thrombocytopenia in Chronic Liver Disease

Covered when ALL of the following are met:

Eligibility criteria for Mulpleta: 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 TPO receptor agonist (e.g., Doptelet, Nplate, Promacta) or a spleen tyrosine kinase inhibitor (e.g., Tavalisse); 7) Request does not exceed health plan-approved quantity limit, if applicable; 8) Dose does not exceed 3 mg per day (1 tablet per day).see individual nodes

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

Re-authorization / Continuation

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

Approval duration: Not applicable

Other indications / Off-label handling

Other uses: If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the referenced formulary or non-formulary policy for the applicable line of business; if the requested use is not listed and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business.N/A

See references: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable. Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation is provided per off‑label use policies.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (for example, CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Coverage is limited by dose, concurrent agents, platelet thresholds, and related exclusions. Specifically, requests will not meet medical necessity if the dose exceeds 3 mg per day (maximum of one 3 mg tablet daily), if Mulpleta is prescribed concurrently with another thrombopoietin receptor agonist (e.g., Doptelet, Nplate, Promacta) or a spleen tyrosine kinase (SYK) inhibitor (e.g., Tavalisse), or if the member’s platelet count is ≥ 50 x 10^9/L within 14 days prior to the procedure. Approval is limited to the plan‑approved quantity and duration: approval duration 14 days with no more than 7 total days of treatment.

Key Clinical Thresholds and Timing

inv-06: Platelet count — threshold for eligibility

Eligibility platelet thresholdRecent (within the past 14 days) platelet count is < 50 x 10^9/L

Timing window for platelet measurementPlatelet count must be documented within 14 days prior to request

Related exclusionPlatelet count ≥ 50 x 10^9/L within 14 days does not meet medical necessity

inv-07: Timing to begin dosing — 8-14 days before procedure

Recommended start of dosingBegin dosing 8–14 days prior to the scheduled procedure

Dosing regimen3 mg PO once daily when initiating per schedule

Purpose of timing

Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization and demonstrate that all approval criteria are met, including diagnosis, provider specialty, age, recent platelet count, scheduled invasive procedure timing, dosing limits, and that Mulpleta is not prescribed with other TPO receptor agonists or spleen tyrosine kinase inhibitors.

Diagnosis of chronic liver disease required
Prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist
Age ≥ 18 years
Recent platelet count < 50 x 10^9/L within 14 days
Member scheduled for an invasive medical or dental procedure within 30 days
Not prescribed concurrently with another TPO receptor agonist or spleen tyrosine kinase inhibitor
Dose ≤ 3 mg per day; request does not exceed plan quantity limits
Approval duration: 14 days (no more than 7 total days of treatment)

Drug Background

Lusutrombopag (Mulpleta) is a thrombopoietin (TPO) receptor agonist indicated to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo an invasive procedure. The agent is used to raise platelet counts and reduce the need for platelet transfusion in the periprocedural period.

Definitions and Examples of Chronic Liver Disease

inv-14: Chronic liver disease examples — includes alcoholic liver disease, chronic viral hepatitis (B, C), metabolic dysfunction-associated steatohepatitis

Included examplesAlcoholic liver disease

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

Included examplesMetabolic dysfunction-associated steatohepatitis (formerly NASH)