CurrentCentenePolicy CP.PMN.163

Sodium Zirconium Cyclosilicate (Lokelma)

Defines medical necessity criteria, dosing limits, approval durations, and coverage exclusions for Lokelma for treatment of hyperkalemia in adults for Centene lines of business.

Policy Summary

PayerCentene

PolicySodium Zirconium Cyclosilicate (Lokelma)

Policy CodePolicy CP.PMN.163

Change TypeNo material changes

Effective DateJul 24, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, labs) demonstrating diagnosis of hyperkalemia, age ≥18, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum age

30 g/dayinitial max dose

15 g/daymaintenance max dose

12 moapproval (commercial)

Not for emergencyexplicit exclusion

2018

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Coverage Criteria for Lokelma (Sodium zirconium cyclosilicate)

Initial Therapy (Hyperkalemia)

Covered when ALL of the following are met

Initial Therapy - Hyperkalemia: 1) Diagnosis of hyperkalemia; 2) Age ≥ 18 years; 3) Dose does not exceed both of the following: (a) Initial dose: 30 g per day for up to 48 hours; and (b) Maintenance dose: 15 g per day.Initial: 30 g/day for up to 48 hours; Maintenance: 15 g/day

Provider must submit documentation (e.g., office chart notes, laboratory results) supporting that the member meets all approval criteria.

Continuation Therapy (Hyperkalemia)

Covered when ALL of the following are met

Continued Therapy - Hyperkalemia: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed 15 g per day.Maximum dose for maintenance: 15 g per day

Provider must submit documentation (e.g., chart notes, labs) demonstrating ongoing benefit or reason for continuation.

Coverage for indications that are not FDA‑approved and are not specifically addressed in this policy is not authorized unless the provider supplies sufficient documentation of safety and efficacy as required by the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or evidence of coverage documents.

When provisions in a state Medicaid program conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any specific coverage provisions related to this policy.

Use of sodium zirconium cyclosilicate (Lokelma) for the emergency treatment of life‑threatening hyperkalemia is not medically necessary because of the medication’s delayed onset of action and therefore is not an authorized indication for acute, life‑threatening hyperkalemia management.

Coding and Dosing Limits

Neutral/placeholdermixed

NDC	Not specified in this document

Maximum daily doses — Lokelma

Initial maximum daily dose30 g per day for up to 48 hours (initial regimen)

Maintenance maximum daily dose15 g per day

Initial dosing schedule (source dosing regimen)10 g PO three times daily for up to 48 hours (per dosing regimen section)

Maintenance dosing schedule (source dosing regimen)10 g PO once daily; adjust by 5 g as needed at weekly intervals

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required per plan policy. Requests will be evaluated according to the Health Plan's medical necessity guidelines and administrative procedures. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Documentation should confirm diagnosis of hyperkalemia, member age ≥ 18 years, and dosing within initial (≤ 30 g/day for up to 48 hours) and maintenance (≤ 15 g/day) limits.
Approval durations: Medicaid/HIM – 6 months; Commercial – 12 months or duration of request, whichever is less.

Documentation Required

Required Documentation

Provider must submit documentation supporting that the member has met all approval criteria. Acceptable documentation includes office chart notes, laboratory results, and other relevant clinical information.

Include evidence of diagnosis, labs demonstrating hyperkalemia, prior treatments, and dosing rationale.

Background

Sodium zirconium cyclosilicate (Lokelma) is a non‑absorbed potassium‑binding polymer indicated for the treatment of hyperkalemia in adults. The dosing regimen described in the prescribing information includes an initial regimen (commonly 10 g orally three times daily, up to a maximum initial exposure of 30 g per day for up to 48 hours) followed by a maintenance dose (commonly 10 g once daily; maintenance dosing adjustments not to exceed 15 g per day as specified in this policy). Lokelma is not recommended for emergency management of life‑threatening hyperkalemia due to its delayed onset of action.

Definitions

Sodium zirconium cyclosilicate (Lokelma) — definition and usage notes

Drug descriptionSodium zirconium cyclosilicate (Lokelma) is a non-absorbed potassium-binding polymer indicated for treatment of hyperkalemia in adults.

FDA limitation of useShould not be used as emergency treatment for life‑threatening hyperkalemia due to delayed onset of action.

Typical dosing approachIncludes an initial correction regimen (e.g., 10 g PO TID up to 48 hours) followed by a lower maintenance dose (e.g., 10 g PO QD; maximum 15 g/day).

Health Plan — definition for this policy

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates, as applicable.

Policy role

Policy Summary

PayerCentene

PolicySodium Zirconium Cyclosilicate (Lokelma)

Policy CodePolicy CP.PMN.163

Change TypeNo material changes

Effective DateJul 24, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, labs) demonstrating diagnosis of hyperkalemia, age ≥18, and dosing within specified limits.

SourceLink

On This Page

Denial Risk

Triggers for Denial

Requests lacking documentation that the member meets all stated approval criteria, or requests for non-covered uses (including non‑FDA approved indications without sufficient supporting documentation per off‑label use policies), may be denied.

Non‑FDA approved indications require sufficient documentation of efficacy and safety per CP.CPA.09 (commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid) as applicable.
Emergency treatment for life‑threatening hyperkalemia is not authorized under this policy due to delayed onset of action.

Step Therapy

Step Therapy Note

No step therapy requiring use of sodium polystyrene sulfonate (SPS) is enforced. Redirection to SPS was removed due to SPS toxicity and current standard of practice.

Step therapy preference for SPS was removed (3Q 2021 update).

Note

Follow Coverage Document Terms

Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies and procedures.

Follow the Health Plan's evidence of coverage, certificate of coverage, policy, contract of insurance, and applicable state and federal requirements when submitting requests.

This clinical policy is a guide to medical necessity used to assist in making coverage decisions and administering benefits; it is not a contract or guarantee of payment.

Coverage conditionalityCoverage decisions are subject to terms, conditions, exclusions, limitations of the coverage documents and applicable state/federal requirements and Health Plan-level administrative policies.