ModifiedCentenePolicy CP PMN.205

Clinical Policy: Patiromer (Veltassa)

Clinical policy governing medical necessity criteria, coverage, and utilization controls for patiromer (Veltassa) for treatment of hyperkalemia for Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyClinical Policy: Patiromer (Veltassa)

Policy CodePolicy CP PMN.205

Change TypeMaterial operational and clinical updates (redirect to Lokelmapediatric indication/formulation updatesapproval duration clarified)

Effective DateSep 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation of hyperkalemia and age criteria; for adults, document trial or failure of Lokelma unless contraindicated.

SourceLink

POLICY UPDATE CHANGES

Redirected to Lokelma (sodium zirconium cyclosilicate) as preferred alternative in 3Q2023.

Pediatric FDA approval expanded to age 12 and a 1 g powder formulation was added (then removed and later re-added).

Commercial approval duration clarified to 12 months or duration of request, whichever is less.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

Removed redirection to preferred sodium polystyrene sulfonate (SPS) due to SPS toxicity and current standard of practice.

Added redirection to Lokelma per SDC.

Reflected newly FDA approved pediatric indication extending use down to 12 years of age and added new 1 gm powder pack formulation (later removed and re-added in subsequent reviews).

Removed 1 g strength as discontinued per FDA and Medispan (3Q 2024), then later added 1 g strength back as supported by clinical pharmacology and active in Medispan (3Q 2025).

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lines of business covered

25.2 g/daymax daily dose

Commercial: 12 motypical approval duration

Nonot for emergency use

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - Hyperkalemia: Diagnosis of hyperkalemia.

Age requirement: Member is >= 12 years of age.

Step therapy for adults: If member is >= 18 years of age, failure of Lokelma (sodium zirconium cyclosilicate) unless Lokelma is contraindicated or the member experienced clinically significant adverse effects.

Dose limit: Requested dose does not exceed 25.2 g per day.<= 25.2 g/day

Documentation: Provider has submitted supporting documentation (e.g., office chart notes, laboratory results, or other clinical information) that member meets all approval criteria.

Approval duration note: Approval duration: Medicaid/HIM 6 months; Commercial 12 months or duration of request, whichever is less.

Apply duration per line of business.

Continuation Therapy

Covered when ANY of the following are met:

Continued Therapy - Current use: Member is currently receiving patiromer via the Centene benefit.

Continued Therapy - Prior approval met: Member has previously met the policy's initial approval criteria.

Continuity of care: Member is currently receiving the medication and is enrolled in a state/product with continuity of care regulations (refer to state-specific addendums).

Clinical response: Member is responding positively to therapy.

Dose increase threshold:

Emergency treatment of life‑threatening hyperkalemia with patiromer (Veltassa) is excluded because the product has a delayed onset of action and is not appropriate for immediate, emergent potassium lowering.

For members enrolled in Medicaid, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers should consult the applicable state Medicaid manual for specific coverage rules and requirements.

Use of patiromer (Veltassa) for indications that are not FDA‑approved and are not specifically addressed in this policy is not authorized unless there is sufficient supporting documentation per the applicable off‑label use policies (see referenced policies for Commercial, HIM, and Medicaid).

Product Coding and Dosing

Product strengthsmixed

1 g	Packet, powder for oral suspension
8.4 g	Packet, powder for oral suspension
16.8 g	Packet, powder for oral suspension
25.2 g	Packet, powder for oral suspension

Product Coding and Dosing

NotesIf age ≥ 18 years, require failure of Lokelma unless contraindicated or clinically significant adverse effects are experienced. Prior authorization may be required.

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document diagnosis of hyperkalemia and meet age criteria. For patients age ≥18 years, prior authorization requires prior trial and failure of Lokelma unless Lokelma is contraindicated or the patient has clinically significant adverse effects.

Applicable to Veltassa (patiromer) requests
Age criteria: ≥12 years for pediatric authorization; additional Lokelma step applies for ≥18 years

Prior Authorization

Prior Authorization Duration Limits

Approval for Commercial line of business is limited to 12 months or the duration of the request, whichever is less. Medicaid/HIM approval duration is 6 months per policy.

Commercial: up to 12 months or duration of request, whichever is less
Medicaid/HIM: 6 months

Background

Patiromer (Veltassa) is a non‑absorbed potassium‑binding polymer indicated for the treatment of hyperkalemia in adults and in pediatric patients aged 12 years and older. It is formulated as an oral powder for suspension available in packet strengths including 1 g, 8.4 g, 16.8 g, and 25.2 g, and due to its mechanism has a delayed onset of action; separate dosing considerations apply when co‑administered with other oral medications.

Definitions

inv-17: Definition — Veltassa

DefinitionVeltassa is a non-absorbed potassium-binding polymer used to lower serum potassium.

IndicationIndicated for treatment of hyperkalemia in adults and pediatric patients 12 years and older.

Clinical considerationNot for emergency treatment of life-threatening hyperkalemia due to delayed onset of action.

inv-18: Definition — Patiromer formulation notes

Formulation typeOral powder for suspension (packet formulations).

Available packet strengths1 g, 8.4 g, 16.8 g, and 25.2 g noted in product availability; strengths changed across reviews.

Policy Summary

PayerCentene

PolicyClinical Policy: Patiromer (Veltassa)

Policy CodePolicy CP PMN.205

Change TypeMaterial operational and clinical updates (redirect to Lokelmapediatric indication/formulation updatesapproval duration clarified)

Effective DateSep 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation of hyperkalemia and age criteria; for adults, document trial or failure of Lokelma unless contraindicated.

SourceLink

On This Page

If request is for a dose increase, the new total daily dose does not exceed 25.2 g per day.

Approval duration note: Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Apply duration per line of business.

Denial Risk

Triggers for Denial

Requests will be denied for emergency treatment of life‑threatening hyperkalemia and for non‑FDA indications that lack sufficient documentation per off‑label policies and evidence of coverage.

Emergency/acute life‑threatening hyperkalemia: excluded due to delayed onset of action
Non‑FDA approved indications: require sufficient documentation per off‑label policies (e.g., CP.CPA.09, HIM.PA.154, CP PMN.53) or will be denied

Denial Risk

Approval Duration - Denial Risk

Requests that exceed the Commercial approval duration (beyond 12 months or the duration of the request, whichever is less) may be denied.

Authorization beyond the allowed Commercial maximum risks denial

Documentation Required

Required Documentation

Provider must submit supporting documentation with the prior authorization request. Acceptable documentation includes office chart notes, relevant laboratory results, and any clinical information demonstrating that the member meets all approval criteria.

Include documentation of hyperkalemia diagnosis and relevant potassium lab values
If claiming Lokelma failure or contraindication, provide documentation of trial, intolerance, or contraindication

Documentation Required

Documentation and Coverage Governance

Providers should follow Health Plan clinical policy procedures and retain clinical records consistent with standards of medical practice. Documentation must be available upon request for coverage review and audit.

Maintain records in member's medical file per Health Plan standards
Records must be available on request to support medical necessity determinations

Step Therapy

Step Therapy to Lokelma

Step therapy requires failure of Lokelma (sodium zirconium cyclosilicate) for patients aged ≥18 years prior to approval of Veltassa, unless Lokelma is contraindicated or there is clinical justification for bypassing the step.

Document trial of Lokelma and reason for failure or intolerance if applicable
Step therapy requirement applies only to patients ≥18 years

Note

Preferred Agent Redirection

Policy redirects to Lokelma as the preferred agent per subject matter committee (SDC) guidance; prior redirection to sodium polystyrene sulfonate (SPS) has been removed due to SPS toxicity and current standard of practice.

Do not redirect to SPS; Lokelma is the preferred alternative prior to Veltassa where step therapy applies

1 g pack was added (3Q2023), removed as discontinued (3Q2024), then re-added (3Q2025) per Medispan updates.

inv-19: Definition — Lokelma referenced as an alternative potassium binder

Alternate agentLokelma (sodium zirconium cyclosilicate) is the preferred alternative potassium binder to which the policy redirects per SDC.

Policy changeRedirection to Lokelma added in 3Q2023 annual review; redirection from SPS removed due to toxicity and standard practice.

Step therapy implicationFor adults (≥18 years), failure of Lokelma is required prior to approval of Veltassa unless contraindicated or intolerant.