CurrentCignaPolicy N/A

DRUG QUANTITY MANAGEMENT POLICY -PER DAYS (Otezla — apremilast)

Defines pharmacy drug quantity limits and one-time induction overrides for Otezla (apremilast) for Cigna-administered health benefit plans; applies to pharmacy point-of-sale and home delivery dispensing. Affects providers and pharmacists submitting claims for Otezla.

Policy Summary

PayerCigna

PolicyDRUG QUANTITY MANAGEMENT POLICY -PER DAYS (Otezla — apremilast)

Policy CodePolicy N/A

Change TypeQuantity limits and starter pack overrides added

Effective DateN/A

Next Review DateN/A

Key ActionEnforce quantity limits at point of service and allow one-time starter pack overrides when there are no Otezla claims in the past 130 days.

SourceLink

POLICY UPDATE CHANGES

New quantity limits were added of 60 tablets per 30 days at retail and 180 tablets per 90 days at home delivery for Otezla 20 mg tablets.

New quantity limit of 55 tablets (one 28-day Starter Pack) per 365 days at retail and home delivery was added for the 28-day Starter Pack (20 mg BID dose).

A one-time override for a 14-day Starter Pack (27 tablets) is allowed if no claims for Otezla in the past 130 days.

60retail max per 30 days (20 mg & 30 mg)

180home delivery max per 90 days (20 mg & 30 mg)

55max per 365 days for 28-day Starter Pack

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one-time override (14-day Starter Pack)

Coverage Criteria

Standard Dispensing Limits

Inflammatory Conditions - Otezla product(s) are covered as medically necessary when the drug quantity management criteria below are met. Any other exception is considered not medically necessary.

Quantity limits for standard dispensing: For Otezla 20 mg and 30 mg tablets: retail maximum = 60 tablets per 30 days; home delivery maximum = 180 tablets per 90 days.see thresholds

No overrides recommended for standard 20 mg or 30 mg tablet strengths.

14-day Starter Pack (discontinued)

14-day Starter Pack (discontinued) — one-time induction override

14-day Starter Pack override: If the patient requires additional induction dosing, and there are no Otezla claims in the past 130 days, approve a one-time override for 27 tablets (one 14-day Starter Pack) at retail or home delivery.absence of Otezla claims in past 130 days

Pack is discontinued but a single one-time override is allowed.

28-day Starter Pack (20 mg & 30 mg BID)

28-day Starter Pack (20 mg and 30 mg BID dose) — one-time induction override

28-day Starter Pack override: If the patient requires additional induction dosing, and there are no Otezla claims in the past 130 days, approve a one-time override for 55 tablets (one 28-day Starter Pack) at retail or home delivery.absence of Otezla claims in past 130 days

Applies to both 20 mg BID and 30 mg BID starter pack formulations.

Any exception outside the specified quantity limits and one-time overrides is considered not medically necessary.

Dispensing quantities that exceed the listed maximums (retail and home delivery) without an approved one-time override are considered not medically necessary.

Coding and Dispensing Limits

Drug codesNDC

NDC not listed

No NDCs provided in document

inv-07: Retail maximum quantity per 30 days — 60 tablets

Retail maximum (30 days)60 tablets

Applies toOtezla 20 mg tablets (retail)

EnforcementQuantity limits enforced at point of sale; overrides only per starter-pack rules

inv-08: Home delivery maximum quantity per 90 days — 180 tablets

Home delivery maximum (90 days)180 tablets

Applies toOtezla 20 mg tablets (home delivery)

Enforcement

Provider Actions and Documentation

Denial Risk

Quantity limit enforcement and induction overrides

Quantity limit enforcement at point of sale: if the Drug Quantity Management rule is not met, coverage will be determined by the criteria; failures may result in denial. One-time induction overrides for starter packs are available at point-of-service when documentation requirements below are met.

If quantity rule not met at point of service, coverage determined by policy criteria; lack of required criteria may result in denial
One-time overrides limited to starter packs as specified below; applied at retail or home delivery

Documentation Required

Proof of prior claim absence for induction override

One-time induction override is permitted only when the provider documents that there have been no paid claims for Otezla for the patient in the prior 130 days. The documentation must be submitted with the request (e.g., pharmacy claims history or other verifiable records) to demonstrate absence of Otezla claims in the past 130 days.

Background

Otezla (apremilast) is an oral phosphodiesterase 4 (PDE4) inhibitor indicated for inflammatory conditions including Behcet's disease with oral ulcers, plaque psoriasis (adult and pediatric ≥6 years and ≥20 kg) who are candidates for phototherapy or systemic therapy, and psoriatic arthritis in adults. Dosing requires a titration period to reduce gastrointestinal adverse events, with typical adult maintenance dosing of 30 mg twice daily and specific renal and pediatric adjustments described in dosing guidance.

This policy implements drug quantity management for Otezla, establishing specific retail and home delivery maximums and limited one-time starter pack overrides to ensure appropriate induction dosing and to prevent premature dose escalation.

Definitions & Initial Therapy

inv-15: Titration — 5-day dosing schedule and pediatric weight-based notes

Titration schedule5-day recommended titration to reach maintenance dosing

PurposeReduce gastrointestinal adverse events during initiation

Pediatric notePediatric initial titration and maintenance doses are weight-based (≥50 kg = 30 mg BID; 20–<50 kg = 20 mg BID)

inv-16: Severe renal impairment — dosing adjustments for CrCl < 30 mL/min

DefinitionSevere renal impairment = CrCl < 30 mL/min (Cockcroft-Gault)

Adult dosing adjustmentReduce to 30 mg once daily; titrate using morning schedule only

Quantity Limits (by formulation & site)

inv-18: Otezla 20 mg tablets — retail maximum (60)

Product and strengthOtezla 20 mg tablets

Retail maximum (30 days)60 tablets

ContextQuantity limits enforced at point of sale per Drug Quantity Management program

inv-19: Otezla 20 mg tablets (home delivery) — home delivery maximum (180)

Product and strengthOtezla 20 mg tablets (home delivery)

Home delivery maximum (90 days)180 tablets

Context

Site of Care Considerations

Note

Apply quantity limits and starter pack overrides to home delivery

Quantity limits and the same one-time starter pack override rules apply to home delivery dispensing; overrides are allowed when the patient has no Otezla claims in the past 130 days.

Home delivery maximums: 180 tablets per 90 days for 20 mg and 30 mg tablets.
One-time override quantities at home delivery mirror retail: 27 tablets (14-day) or 55 tablets (28-day).

Note

Apply quantity limits and starter pack overrides at retail/office dispensing

Quantity limits and one-time starter pack override rules apply to retail dispensing provided in office settings; overrides permitted when claims history shows no Otezla claims in the past 130 days.

Retail maximums: 60 tablets per 30 days for 20 mg and 30 mg tablets.
One-time override quantities at retail mirror home delivery: 27 tablets (14-day) or 55 tablets (28-day).

Policy Summary

PayerCigna

PolicyDRUG QUANTITY MANAGEMENT POLICY -PER DAYS (Otezla — apremilast)

Policy CodePolicy N/A

Change TypeQuantity limits and starter pack overrides added

Effective DateN/A

Next Review DateN/A

Key ActionEnforce quantity limits at point of service and allow one-time starter pack overrides when there are no Otezla claims in the past 130 days.

SourceLink

On This Page

Quantity limits enforced at point of sale; overrides only per starter-pack rules

inv-09: Starter pack maximum per 365 days — 55 tablets

Starter pack maximum (365 days)55 tablets

Applies to28-day Starter Pack (20 mg or 30 mg BID)

Override conditionOne-time override allowed if no Otezla claims in past 130 days

inv-10: 14-day starter pack one-time override quantity — 27 tablets

14-day starter pack one-time override27 tablets

ConditionApprove one-time override if absence of Otezla claims in past 130 days

AvailabilityApplies at retail or home delivery despite pack being discontinued

Required documentation: pharmacy claims history or equivalent record showing no Otezla claims in the prior 130 days
Override is a one-time approval only and applies to the starter pack quantity specified
Applies to retail and home delivery fills

Billing Rule

Quantity management enforcement and allowed starter pack overrides

Specific starter pack one-time override quantities: approve one-time overrides when the prior-claim absence requirement is met — 27 tablets for the 14-day starter pack (discontinued formulation), or 55 tablets for either 28-day starter pack formulation (20 mg BID or 30 mg BID), at retail or home delivery.

14-day Starter Pack (discontinued): one-time override = 27 tablets (retail or home delivery)
28-day Starter Pack (20 mg BID): one-time override = 55 tablets (retail or home delivery)
28-day Starter Pack (30 mg BID): one-time override = 55 tablets (retail or home delivery)

Pediatric adjustmentIf severe renal impairment: ≥50 kg = 30 mg QD; 20–<50 kg = 20 mg QD; use morning-only titration

Titration and Initial Dosing

Titration and weight-based pediatric dosing guidance.

Adult titration and maintenance: Use the recommended 5-day titration schedule, then maintenance dosing of 30 mg twice daily (BID) in adults. For patients with severe renal impairment (CrCl < 30 mL/min), reduce to 30 mg once daily (QD) and perform initial titration using the morning-only schedule (skip evening doses).

Pediatric dosing: Pediatric maintenance dosing by weight: ≥50 kg = 30 mg BID; 20 kg to <50 kg = 20 mg BID. Follow the pediatric titration schedules by weight during initiation; for severe renal impairment, reduce dosing to QD with morning-only titration.

Applies to home delivery dispensing per policy

inv-20: Otezla 30 mg tablets — retail maximum (60)

Product and strengthOtezla 30 mg tablets

Retail maximum (30 days)60 tablets

ContextQuantity limits enforced at point of sale per Drug Quantity Management program

inv-21: Otezla 30 mg tablets (home delivery) — home delivery maximum (180)

Product and strengthOtezla 30 mg tablets (home delivery)

Home delivery maximum (90 days)180 tablets

ContextApplies to home delivery dispensing per policy

inv-22: Otezla 28-day Starter Pack (20 mg or 30 mg BID) — one-time override quantity (55)

Starter packOtezla 28-day Starter Pack (20 mg or 30 mg BID)

One-time override quantity (365 days)55 tablets

ConditionApprove if absence of Otezla claims in past 130 days; applies at retail or home delivery

inv-23: Otezla 14-day Starter Pack (discontinued) — one-time override quantity (27)

Starter pack (discontinued)Otezla 14-day Starter Pack (discontinued)

One-time override quantity (365 days)27 tablets

ConditionApprove one-time override if no Otezla claims in past 130 days; applies at retail or home delivery