CurrentHealth NetPolicy CP PHAR.407

Lusutrombopag (Mulpleta) Clinical Policy

Coverage criteria for use of lusutrombopag (Mulpleta) for adult members with chronic liver disease and thrombocytopenia who are scheduled to undergo an invasive procedure; applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyLusutrombopag (Mulpleta) Clinical Policy

Policy CodePolicy CP PHAR.407

Change TypeNo material changes

Effective Date09.18.18

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 mgtablet strength available

7total treatment days (max)

14 daysapproval duration window

>=50platelet count threshold

Adultage group

Coverage Criteria for Lusutrombopag (Mulpleta)

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Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: 1) Diagnosis of chronic liver disease

See Appendix D examples of chronic liver disease

Thrombocytopenia criteria: 2) Prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist; 3) Recent (within the past 14 days) platelet count is >= 50 x 10^9/L; 4) Patient is >= 18 years of age; 5) Member is scheduled to undergo an invasive medical or dental procedure within the next 30 days; 6) Dose does not exceed 3 mg per day (1 tablet per day) and total treatment does not exceed 7 days; 7) Mulpleta is not prescribed concurrently with another thrombopoietin receptor agonist (e.g., eltrombopag, romiplostim) or with a spleen tyrosine kinase inhibitor (e.g., fostamatinib/Tavalisse).platelet >=50 x10^9/L; dose <=3 mg/day; treatment <=7 days

Approval duration: 14 days; prior authorization requires documentation that all criteria are met

Non‑FDA approved indications for lusutrombopag (Mulpleta) are not authorized under this policy unless there is supporting documentation consistent with the applicable off‑label use policies or evidence of coverage documents. Specifically, requests for uses outside the FDA‑approved indication must be supported by the referenced off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or by applicable evidence of coverage.

Re‑authorization for lusutrombopag is not permitted for the treatment of thrombocytopenia. Each authorization request must demonstrate that the member meets the initial approval criteria; continued or maintenance therapy does not qualify for renewal under this policy (Approval duration: Not applicable).

Coding and Clinical Thresholds

Platelet count — recent threshold

Required platelet countRecent (within the past 14 days) platelet count is 50 x 10^9/L

Timing of platelet labMust be performed within 14 days prior to request

Threshold contextUsed to determine eligibility for Mulpleta prior to scheduled invasive procedure

Dosing window before procedure

Dosing start windowBegin dosing 8-14 days prior to scheduled procedure

RationaleAllows time for platelet count to rise before invasive procedure

Relation to procedure timingProcedure must be scheduled within 30 days of treatment course per approval criteria

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mulpleta. Documentation must show all approval criteria are met, including diagnosis of chronic liver disease with thrombocytopenia, a recent platelet count, planned invasive procedure, appropriate prescriber consultation, and dosing within limits.

Recent platelet count within 14 days (must be ≥ 50 x 10^9/L)
Member scheduled for an invasive medical or dental procedure within 30 days
Prescribed by or in consultation with a hematologist, hepatologist, or gastroenterologist
Dose does not exceed one 3 mg tablet per day
Not prescribed concurrently with another thrombopoietin receptor agonist or a spleen tyrosine kinase inhibitor
Approval duration: 14 days (no more than 7 total days of treatment)

Documentation Required

Provider must submit supporting documentation (office chart notes, lab results, or other clinical information) that the member has met all approval criteria. Requests lacking required documentation may be delayed or denied.

Include recent platelet count lab results (within 14 days)
Provide documentation of planned invasive procedure date
Include specialist consultation notes when applicable

Note

If Requested Use Is Not Listed / Formulary Status Differs

If the requested use is not listed in this policy, is for a non‑formulary indication, or the formulary status differs, follow the referenced formulary/non‑formulary or off‑label policies for the relevant line of business.

For formulary drugs: refer to no coverage criteria policies (commercial: CP.CPA.190; marketplace: HIM.PA.33; Medicaid: CP.PMN.255).
For non‑formulary drugs: refer to non‑formulary policies (commercial: CP.CPA.190; marketplace: HIM.PA.103; Medicaid: CP.PMN.16).
For off‑label uses: refer to off‑label use policies (commercial: CP.CPA.09; marketplace: HIM.PA.154; Medicaid: CP.PMN.53).
If the drug’s FDA label changed within the last 6 months and the policy is not yet updated, follow the appropriate referenced policy above.

Denial Risk

Denial Risk for Insufficient Documentation / Non‑FDA Uses

Requests for non‑FDA approved indications that do not include sufficient documentation of efficacy and safety per the off‑label use policies may be denied. Ensure submission includes evidence consistent with CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid) when applicable.

Non‑FDA indications require supporting clinical evidence per off‑label policies
Lack of required evidence or documentation is a denial risk

Step Therapy and Related Policy References

Step	Action
1	For requested uses that are not specifically listed in this policy or for non‑formulary requests, follow the referenced formulary/no‑coverage or non‑formulary policies for the member's line of business (e.g., CP.CPA.190, HIM.PA.33, CP PMN.255 for formulary/no‑coverage; HIM.PA.103, CP PMN.16 for non‑formulary).
2	If the drug has had a label change within the past 6 months that is not yet reflected in this policy, refer to the applicable corporation guidance or the referenced policies for handling recent label updates.
3	If the requested use (diagnosis, age, dosing) is not listed in section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53).

Policy Summary

PayerHealth Net

PolicyLusutrombopag (Mulpleta) Clinical Policy

Policy CodePolicy CP PHAR.407

Change TypeNo material changes

Effective Date09.18.18

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) showing the member meets all approval criteria.

SourceLink

On This Page

OpenPayer

Lusutrombopag (Mulpleta) Clinical Policy

Coverage Criteria for Lusutrombopag (Mulpleta)

Coding and Clinical Thresholds

Provider Actions and Documentation Requirements

Initial Therapy Dosing and Timing

Continuation Therapy

Step Therapy and Related Policy References

Quantity Limits

Site of Care

Definitions

Background