ModifiedCentenePolicy CP.PMN.205

Patiromer (Veltassa)

Clinical coverage policy governing prior authorization and medical necessity criteria for patiromer (Veltassa) for members age ≥12 with hyperkalemia across Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyPatiromer (Veltassa) Coverage Criteria

Policy CodePolicy CP.PMN.205

Change TypeMaterial: step therapy addedpediatric indication expandedapproval duration clarified

Effective Date09.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, labs) showing diagnosis, age, Lokelma trial if ≥18, and dose ≤25.2 g/day.

SourceLink

POLICY UPDATE CHANGES

Redirects to Lokelma (sodium zirconium cyclosilicate) as a step prior to Veltassa for adults ≥18 unless contraindicated or intolerant.

Pediatric indication expanded to include patients aged 12 years and older and 1 g packet formulation added to product availability.

Commercial approval duration changed 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.

Added step therapy bypass for IL HIM per IL HB 5395.

≥12 yrsMinimum covered patient age

25.2 g/dayMaximum daily dose

Commercial: up to 12 moTypical approval duration

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No — emergency useNot for emergency use

Lokelma stepLokelma step for adults ≥18

IL HIM bypassState update (IL HIM)

Coverage Criteria

Initial Approval Criteria

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation ® that Veltassa is medically necessary when the following criteria are met:

Initial Therapy — Covered when ALL of the following are met:

Diagnosis of hyperkalemia
Age ≥ 12 years
If age ≥ 18 years, failure of Lokelma ® unless contraindicated or clinically significant adverse effects are experienced; prior authorization may be required for Lokelma; for Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395
Step therapy redirection to Lokelma added per 3Q 2023; IL HIM bypass per IL HB 5395 (effective 1/1/2026)
Dose does not exceed 25.2 g per day
Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria

Continued Therapy

II. Continued Therapy — Continued therapy covered when ALL of the following are met:

ALL of the following

Member meets one of the following
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
If request is for a dose increase, new dose does not exceed 25.2 g per day

Other diagnoses/indications

Other Indications / Off-label pathway — For uses not explicitly covered in policy:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the applicable formulary/non-formulary policy for the line of business: CP.CPA.190 (commercial) or HIM.PA.33 (HIM) or CP.PMN.255 (Medicaid) for formulary/PDL drugs; CP.CPA.190 (commercial) or HIM.PA.103 (HIM) or CP.PMN.16 (Medicaid) for non-formulary drugs
If the requested use (diagnosis, age, dosing) is NOT specifically listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 (commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid)

Coverage criteria (consolidated)

Coverage criteria (not present in this excerpt) — Consolidated coverage rules and exclusions:

ALL of the following

Diagnoses/Indications for which coverage is NOT authorized: Non-FDA approved indications not addressed in this policy, unless sufficient documentation is provided per off-label use policies CP.CPA.09 (commercial), HIM.PA.154 (HIM), CP.PMN.53 (Medicaid)
Emergency treatment for life‑threatening hyperkalemia is NOT authorized due to delayed onset of action
Dose limits and dosing regimens: Initial adult dose 8.4 g PO daily; adjust by 8.4 g at weekly intervals; pediatric (≥12 years) initial dose 4 g PO daily; adjust by 4 g weekly; maximum 25.2 g/day
Prior authorization and documentation requirements apply; providers must submit supporting clinical documentation

Coding and Dosing

No codes present in these chunksmixed

No codes listed

Maximum daily dose

Maximum daily dose25.2 g/day

Approval duration (Commercial)

Approval duration (Commercial)12 months or duration of request, whichever is less

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization is required. Approval durations vary by line of business: Medicaid/HIM = 6 months; Commercial = up to 12 months or duration of request, whichever is less. Provider must request the appropriate approval period and indicate line of business on submission.

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

Documentation Required

Required Documentation for Review

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Lack of supporting documentation may result in denial.

Acceptable documentation: office chart notes, laboratory results, clinical notes, prior treatment records

Background

Patiromer (Veltassa) is a non‑absorbed potassium‑binding polymer indicated for the treatment of hyperkalemia in adults and in patients aged 12 years and older. It is administered orally and can bind other orally administered medications, so dosing should be separated (e.g., give patiromer at least 3 hours before or after other oral drugs) to avoid reduced absorption. Patiromer is intended for non‑emergent management of hyperkalemia and is not appropriate for life‑threatening or immediate potassium lowering.

Definitions and Key Information

Patiromer (Veltassa) - definition

DrugPatiromer (Veltassa)

MechanismNon-absorbed potassium-binding polymer

Indication summaryUsed to treat hyperkalemia in patients age ≥12 years

Drug interaction administration guidance

Administration separationAdminister Veltassa at least 3 hours before or 3 hours after other oral medications to avoid reduced absorption.

ExceptionSome oral medications shown not to have a clinically important interaction may not require separation; follow product guidance.

Policy Summary

PayerCentene

PolicyPatiromer (Veltassa) Coverage Criteria

Policy CodePolicy CP.PMN.205

Change TypeMaterial: step therapy addedpediatric indication expandedapproval duration clarified

Effective Date09.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, labs) showing diagnosis, age, Lokelma trial if ≥18, and dose ≤25.2 g/day.

SourceLink

On This Page

State-specific and line-of-business policies (formulary status, continuity of care, step therapy) apply; IL HIM step therapy bypass per IL HB 5395

Note

Policy Purpose and Coverage Context

Coverage decisions are a guide to medical necessity to assist in coverage decisions and administration of benefits. They are subject to contract terms, state/federal requirements, and applicable Health Plan administrative policies. This policy does not guarantee payment and does not replace provider clinical judgment.

Step Therapy

Lokelma Step Requirement (Adults)

For adults (age ≥ 18 years), a trial and failure of Lokelma is required prior to approval of Veltassa unless Lokelma is contraindicated or clinically significant adverse effects are experienced. For Illinois HIM requests, the Lokelma step requirement does not apply as of 1/1/2026 per IL HB 5395.

Adults ≥18: trial and failure of Lokelma required prior to Veltassa unless contraindicated/intolerant
IL HIM: Lokelma step requirement waived per IL HB 5395 (effective 1/1/2026)

Denial Risk

Common Triggers for Denial

Triggers for denial include requests that lack documentation supporting the diagnosis of hyperkalemia, do not meet age criteria (age ≥ 12 years), fail to document trial of Lokelma for adults ≥18 when required (unless exempt), exceed the maximum dose (25.2 g/day), or request coverage for non‑authorized indications such as emergency treatment for life‑threatening hyperkalemia.

Missing documentation of hyperkalemia diagnosis or supporting labs
Age < 12 years
No documented Lokelma trial/failure for age ≥18 when step required (unless contraindicated/intolerant or IL HIM exemption)
Dose exceeds 25.2 g/day
Requests for non‑FDA approved indications or emergency life‑threatening hyperkalemia treatment

Note

No Other Explicit Denial Triggers Noted

No additional explicit denial triggers are listed beyond those above; however, reviewers should apply the clinical criteria, documentation standards, and exclusion items in the policy when making coverage determinations.

Key trials / references

AMETHYST-DNRandomized clinical trial evaluating patiromer effect on serum potassium in patients with hyperkalemia and diabetic kidney disease (Bakris et al., JAMA 2015).

OPAL-HKTrial of patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors (Weir et al., N Engl J Med. 2015).

Other referencesAdditional supporting sources include Micromedex, Esposito et al. J Clin Med 2020, and Renal Association guidelines.