CurrentUnitedHealthcarePolicy 1 = 2024 P 2100-10

Lokelma (sodium zirconium cyclosilicate) and Veltassa (patiromer) prior authorization

Defines UnitedHealthcare Pharmacy prior authorization and medical necessity criteria for Lokelma and Veltassa for treatment of non-life-threatening hyperkalemia for covered members.

Policy Summary

PayerUnitedHealthcare

PolicyLokelma and Veltassa prior authorization — treatment of non-life-threatening hyperkalemia

Policy CodePolicy 1 = 2024 P 2100-10

Change TypeRemoved requirement (medication adjustment)added Lokelma historically

Effective DateOct 1, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation showing non-life-threatening hyperkalemia, failure of loop or thiazide diuretics when appropriate, and adherence to a low potassium diet (≤3 g/day).

SourceLink

POLICY UPDATE CHANGES

Removed requirement to adjust medications

Added Lokelma to the program

2drugs covered

non-emergentindication

12 moauth duration

7/2024clinical approval

Coverage Criteria

Policy Summary

PayerUnitedHealthcare

PolicyLokelma and Veltassa prior authorization — treatment of non-life-threatening hyperkalemia

Policy CodePolicy 1 = 2024 P 2100-10

Change TypeRemoved requirement (medication adjustment)added Lokelma historically

Effective DateOct 1, 2024

Next Review Date

SourceLink

On This Page

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inv-01: Initial Authorization

Lokelma and Veltassa will be approved when ALL of the following are met:

Initial Authorization Criteria: 1) Diagnosis of non-life threatening hyperkalemia; 2) Where clinically appropriate, loop or thiazide diuretic therapy for potassium removal has failed; 3) Patient follows a low potassium diet (less than or equal to 3 grams per day).

inv-02: Reauthorization

Reauthorization requires BOTH of the following:

Reauthorization Criteria: 1) Patient has a positive clinical response to Lokelma or Veltassa therapy and continues to require treatment for hyperkalemia; 2) Patient follows a low potassium diet (less than or equal to 3 grams per day).

Authorization will be issued for 12 months; state mandates and member benefit plans may affect coverage.

Use of Lokelma (sodium zirconium cyclosilicate) and Veltassa (patiromer) for emergency treatment of life‑threatening hyperkalemia is excluded from this prior authorization program because these agents have a delayed onset of action and are not appropriate for emergent correction of hyperkalemia. Non‑emergent management should focus on addressing reversible causes and initiating therapies intended for more rapid potassium removal.

Use of Lokelma or Veltassa for life‑threatening hyperkalemia (emergency treatment) is not appropriate under this policy and therefore is not eligible for authorization through this program. These agents are indicated for treatment of hyperkalemia but should not be used in emergent situations due to their delayed onset of action.

Reauthorization / Continuation

inv-12: Reauthorization/Continuation

Reauthorization/continuation rules

Continuation Therapy: Reauthorization requires positive clinical response and ongoing need for therapy and patient adherence to a low potassium diet (≤ 3 g/day).

Authorizations issued for 12 months; state mandates and member benefit plans may affect coverage. Supply limits may be in place.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required for Lokelma (sodium zirconium cyclosilicate) and Veltassa (patiromer). Approvals are granted only when all listed initial or reauthorization criteria are met.

Drugs: Lokelma (sodium zirconium cyclosilicate), Veltassa (patiromer)

Step Therapy

Therapeutic Trial Expectation

Therapeutic trial expectation — Where clinically appropriate, a trial of loop or thiazide diuretic therapy for potassium removal should have been attempted and failed before approval is granted.

Attempted and failed loop or thiazide diuretic therapy when clinically appropriate.

Documentation Required

Documentation Requirements

Documentation must support the diagnosis and dietary management — Documentation must confirm a diagnosis of non-life‑threatening hyperkalemia and that the patient follows a low‑potassium diet (≤ 3 grams per day). For reauthorization, documentation must also show a positive clinical response to therapy and ongoing need for treatment.

Diagnosis: non-life threatening hyperkalemia
Diet: low potassium diet ≤ 3 grams/day
Reauthorization: positive clinical response and continued need for therapy

Denial Risk

Denial‑Risk for Emergent Use

Denial‑risk for emergent use — Requests for Lokelma or Veltassa to treat life‑threatening (emergent) hyperkalemia are not appropriate for this authorization process and may be denied; emergent management should follow emergency protocols.

Do not use this authorization pathway for emergent, life‑threatening hyperkalemia cases.

Definitions

Non‑life‑threatening hyperkalemia — definition and context

DefinitionHyperkalemia that does not require emergency intervention; managed with non-emergent therapies and addressing reversible causes (e.g., removing or adjusting medications, correcting reversible contributors to impaired renal function).

Exclusion from emergency careThese oral potassium binders (Lokelma and Veltassa) are not for emergency treatment of life‑threatening hyperkalemia due to delayed onset of action.

Typical management approachNon-emergent management includes addressing reversible causes and initiating therapies for potassium removal rather than urgent/emergent interventions.

Dietary considerationPatients should follow a low potassium diet (≤3 grams/day) as part of non-emergent management when applicable.

Step	Requirement	Notes
1	Where clinically appropriate, failure of loop or thiazide diuretic therapy for potassium removal is required prior to approval	Step therapy may be required prior to approval for Lokelma (sodium zirconium cyclosilicate) and Veltassa (patiromer)

Background

Lokelma (sodium zirconium cyclosilicate) and Veltassa (patiromer) are oral potassium binders indicated for the treatment of hyperkalemia. They are intended for non‑emergent management of elevated potassium and should not be used for emergency treatment of life‑threatening hyperkalemia because of their delayed onset of action. Management of non‑emergent hyperkalemia typically includes addressing reversible causes (for example, adjusting offending medications and treating conditions that impair renal function) and initiating therapies that remove potassium.

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