CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Medicaid_Lokelma_20250611

Policy governs Medicaid coverage and prior authorization criteria for Lokelma for adults with non-life threatening hyperkalemia, criteria for continuation, quantity limits, and coverage durations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMedicaid_Lokelma_20250611

Policy CodePolicy N/A

Change TypeClarified (periodic review)

Effective DateMar 1, 2021

Next Review Date

Key ActionAuthorization may be granted for 12 months only when all initial criteria are met (age ≥18, serum K+ >5 mEq/L, prescriber specialty requirement, exclusion of GI motility disorder, failure/contraindication/intolerance to specified alternatives, no concomitant use with Veltassa).

SourceLink

POLICY UPDATE CHANGES

Document shows periodic reviews (12/2020 through 5/2025) with an effective date of 3/1/2021 and cites Lokelma package insert Feb 2024.

12 monthsInitial coverage duration

12 monthsContinuation coverage duration

1/dayQuantity limit

≥18Minimum age (years)

Coverage Summary

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Policy governs Medicaid coverage and prior authorization criteria for Lokelma (sodium zirconium cyclosilicate) for adults with non-life threatening hyperkalemia. Coverage stance: covered_with_criteria. The policy specifies that authorizations (initial and continuation) may be granted for up to 12 months when criteria are met. Effective date: 3/1/2021; last review: 5/2025.

Key thresholds and quick facts

Minimum age≥18 years

Diagnosis thresholdSerum potassium > 5 mEq/L

Offending agent intervention thresholdDose reduction/discontinuation if serum potassium > 6.5 mEq/L

Quantity limit1 packet per day (Lokelma 5 g & 10 g)

Initial coverage duration12 months

Continuation coverage duration12 months

Initial Therapy Criteria

Initial Approval (12 months)

An authorization of 12 months may be granted when all the following criteria are met:

ALL of the following

Patient is 18 years old or older
Patient has documented diagnosis of non-life threatening hyperkalemia (serum potassium greater than 5 mEq/L)> 5 mEq/L
Medication is prescribed by, or in consultation with a nephrologist OR cardiologist
Prescriber specialty requirement
Patient does not have a history of gastrointestinal motility disorders
ONE of
- Discontinuation of NSAIDs
- Dose reduction or discontinuation of offending agents if serum potassium is greater than 6.5 mEq/L (i.e., ACE inhibitors, ARBs or aldosterone antagonists)> 6.5 mEq/L
  Offending agents include ACE inhibitors, ARBs, aldosterone antagonists
ONE of
- Failure of a loop diuretic
- Contraindication to a loop diuretic
- Intolerance to a loop diuretic
- Failure, contraindication, or intolerance to short term therapy with sodium polystyrene sulfonate
Patient will not use Lokelma concomitantly with Veltassa
Concurrent use with patiromer (Veltassa) prohibited

Continuation Therapy Criteria

Continuation of Therapy (12 months)

Authorization of 12 months may be granted for members who meet the following:

ALL of the following

Member is tolerating treatment and has documentation of a positive clinical response
No severe side effects
No severe adverse events
- Member has not experienced severe edema
- Member has not experienced hypokalemia
Member has not developed a gastrointestinal motility disorder since starting therapy

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required for Lokelma

Authorization may be granted for 12 months only when all initial criteria are met: patient is 18 years or older; documented non-life threatening hyperkalemia with serum potassium > 5 mEq/L; medication prescribed by or in consultation with a nephrologist or cardiologist; no history of gastrointestinal motility disorders; failure, contraindication, or intolerance to other interventions (including loop diuretics or short-term sodium polystyrene sulfonate) or need to discontinue/reduce offending agents when serum potassium > 6.5 mEq/L; and patient will not use Lokelma concomitantly with Veltassa. Approval duration: 12 months when criteria satisfied.

Documentation Required

Document laboratory and treatment history

Providers must document laboratory and treatment history to support authorization decisions.

Serum potassium values: initial value > 5 mEq/L; if reducing or discontinuing offending agents (ACE inhibitors, ARBs, aldosterone antagonists), document serum potassium > 6.5 mEq/L
Prior treatments tried/failed or contraindicated/intolerant: loop diuretics and/or short-term sodium polystyrene sulfonate
Prescriber specialty or documented consultation with a nephrologist or cardiologist
Documentation of absence of a history of gastrointestinal motility disorders

Billing Rule

Quantity limit enforcement

Quantity limits: Lokelma 5 g and 10 g packets are limited to 1 packet per day.

Denial Risk

Concurrent use prohibition

Claims may be denied if Lokelma is used concomitantly with Veltassa (patiromer); concurrent use is prohibited by the policy.

Background & Definitions

Background: Lokelma (sodium zirconium cyclosilicate) is indicated for treatment of hyperkalemia. This policy specifies Medicaid prior authorization criteria for adult patients with non-life threatening hyperkalemia and requires prior trials or documented contraindication/intolerance to other interventions (e.g., loop diuretics or short-term sodium polystyrene sulfonate) and consideration of dose reduction/discontinuation of offending agents when serum potassium exceeds 6.5 mEq/L.

Definitions

TermNon-life threatening hyperkalemia

DefinitionHyperkalemia with serum potassium greater than 5 mEq/L (as specified in this policy).