CurrentCignaPolicy N/A

Potassium Binders - Veltassa Drug Quantity Management Policy

Defines quantity limits, exceptions, and authorization guidance for Veltassa (patiromer for oral suspension) prescriptions under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyPotassium Binders - Veltassa Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeQuantity limit additions and overrides

Effective Date

Next Review DateSep 27, 2024

Key ActionIf the Drug Quantity Management rule is not met at point of service, submit a prior authorization request per the policy criteria to obtain approval for the requested dispensing quantity.

SourceLink

POLICY UPDATE CHANGES

New quantity limits for Veltassa 1 gram packets of 120 packets per dispensing at retail and 360 packets per dispensing at home delivery were added.

A clinical override was added to allow approval up to 720 packets retail or 2,160 packets home delivery for 1 gram packets when required dosing cannot be achieved with 8.4 g or 16.8 g packets.

Quantity limits for Veltassa 8.4 gram packets changed to 90 packets per dispensing at retail and 270 packets per dispensing at home delivery (retail increased from 30).

120Retail max 1 g

360Home delivery max 1 g

90Retail max 8.4 g

Policy Summary

PayerCigna

PolicyPotassium Binders - Veltassa Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeQuantity limit additions and overrides

Effective Date

Next Review DateSep 27, 2024

Key ActionIf the Drug Quantity Management rule is not met at point of service, submit a prior authorization request per the policy criteria to obtain approval for the requested dispensing quantity.

SourceLink

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Coverage Criteria for Veltassa (patiromer)

Drug quantity limits and clinical overrides

Covered subject to the following Drug Quantity Limits and exceptions.

Default quantity limits: Veltassa packet-specific maximum quantities per prescription are enforced: 1 g: retail 120 / home delivery 360; 8.4 g: retail 90 / home delivery 270; 16.8 g: retail 30 / home delivery 90; 25.2 g: retail 30 / home delivery 90 (25.2 g obsolete 10/01/2024).

Any exception must meet the listed criteria; any other exception is not medically necessary.

Clinical override for 1 g packets: If the patient requires a dose that cannot be achieved using either the 8.4 gram packets or the 16.8 gram packets, approve the requested quantity not to exceed 720 packets per dispensing at retail or 2,160 packets per dispensing at home delivery.Retail ≤ 720 packets per dispensing; Home delivery ≤ 2,160 packets per dispensing

This override supports pediatric titration in 4 g intervals up to a maximum of 24 g once daily to achieve the desired serum potassium target range.

No overrides for larger packets: No overrides are recommended for Veltassa 8.4 gram, 16.8 gram, or 25.2 gram packets; requests exceeding the specified packet limits for these strengths are considered not medically necessary unless meeting separate documented criteria.

25.2 g packet is obsolete effective 10/01/2024.

Any exception to the quantity limits listed in this policy is considered not medically necessary unless it meets the specific criteria described under the Drug Quantity Limits and clinical overrides sections.

Exceptions beyond the specified clinical override conditions for packet quantities—i.e., requests that do not meet the stated override criteria—are considered not medically necessary and will not be approved.

Provider Actions and Prior Authorization

Prior Authorization

Drug Quantity Management — coverage when POS rule not met

If the Drug Quantity Management rule is not met at the point of sale, coverage for the requested Veltassa medication will be determined based on the criteria in this policy and the member’s applicable benefit plan document. All approvals granted through this process are for the duration specified in the policy.

Applies when quantity limits (retail or home delivery) in the Drug Quantity Limits table are exceeded
Approvals provided per criteria in policy

Step Therapy

No specified step-therapy sequence — dose titration/consolidation managed by quantity rules

Step therapy is not required for Veltassa in a specific multi-step sequence under this policy. Instead, the Drug Quantity Management program governs allowable dose titration and consolidation; providers should follow the dosing/quantity rules and request exceptions per the policy when needed.

Definitions

Veltassa (patiromer for oral suspension) is an oral potassium binder indicated for the treatment of hyperkalemia in adults and pediatric patients aged 12 years and older. Adult dosing typically starts at 8.4 g once daily with titration in 8.4 g increments up to a maximum of 25.2 g daily; pediatric dosing may start at 4 g with 4 g titrations as clinically required.

Veltassa (patiromer) — product summary

ProductVeltassa (patiromer for oral suspension)

Drug classPotassium binder

IndicationTreatment of hyperkalemia in adults and pediatric patients ≥ 12 years of age

Age approvalsAdults and pediatric patients 12 years and older

Available packet sizes1 g, 8.4 g, 16.8 g, 25.2 g (25.2 g packet noted as obsolete effective 10/01/2024)

Quantity Limits and Overrides

Veltassa 1 g packet — quantity limits

Strength & formVeltassa (patiromer) 1 gram packet

Retail maximum per Rx120 packets per Rx

Home delivery maximum per Rx360 packets per Rx

Related override allowanceClinical override may permit up to 720 packets per dispensing retail (when dose cannot be achieved with 8.4 g or 16.8 g packets)

Veltassa 8.4 g packet — quantity limits

Strength & formVeltassa (patiromer) 8.4 gram packet

Retail maximum per Rx

Documentation Required

Documentation required for coverage review

Coverage determinations require documentation showing medical necessity and adherence to the exception criteria when quantity limits are exceeded. Review will consider: the terms of the applicable benefit plan document in effect on the date of service; applicable laws/regulations; relevant collateral materials (including this coverage policy); and the specific facts of the individual case. Provide clinical records, prescribing information (dose, strength, quantity requested), prior treatment history (including attempts at dose titration or prior authorizations), and rationale for any requested quantity exception.

Include prescription details: strength, form, quantity, frequency
Attach relevant clinical notes supporting the need for a quantity exception or consolidation
Document prior doses tried, titration steps, and rationale for deviation from standard quantity limits
Reference applicable benefit plan terms when submitting requests