CurrentCignaPolicy N/A

Bylvay (odevixibat) — Drug Quantity Management Policy (per Rx)

Defines per-prescription quantity limits and approval criteria for Bylvay (odevixibat capsules and oral pellets) for Cigna-administered health benefit plans; affects prescribers, pharmacies, and Cigna utilization reviewers.

Policy Summary

PayerCigna

PolicyBylvay (odevixibat) — Drug Quantity Management Policy (per Rx)

Policy CodePolicy N/A

Change TypeRevised quantity limits (material)

Effective DateN/A

Next Review DateSep 24, 2024

Key ActionApprove per-Rx quantities only when the requested quantity meets the specified per-strength, per-weight-band, and per-dosing criteria; exceptions are not medically necessary.

SourceLink

POLICY UPDATE CHANGES

Criteria for Bylvay 1,200 mcg capsules for patients taking 120 mcg/kg/day and weighing ≥ 17.5 kg were updated to approve up to 180 capsules per dispensing at retail or 540 capsules per dispensing at home delivery.

120max retail Rx — 1,200 mcg (80 mcg/kg/day, ≥19.5 kg)

180max retail Rx — 1,200 mcg (120 mcg/kg/day, ≥17.5 kg)

360home delivery max — 400 mcg

720home delivery max — 200 mcg

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manufacturer supply per bottle

Coverage Criteria

Per-strength quantity approvals

Bylvay product(s) are covered as medically necessary when the quantity requested per Rx meets the specified per-strength, per-weight-band, and per-dosing criteria below. Any other exception is considered not medically necessary.

600 mcg oral pellets (in dispensing capsules): If the patient’s daily dose is 80 mcg/kg/day and the patient weighs < 17.5 kg, approve the requested quantity not to exceed 60 oral pellets per dispensing at retail or 180 oral pellets per dispensing at home delivery.weight and daily dose dependent

This quantity is sufficient for 80 mcg/kg/day dosing in patients who weigh < 17.5 kg and require a 1,200 mcg daily dose. For patients who weigh 6 17.5 kg and require 80 mcg/kg/day, refer to 200 mcg pellets (weight 17.5 kg to <19.5 kg) or 400 mcg / 1,200 mcg capsules (weight 6 19.5 kg).

600 mcg oral pellets (in dispensing capsules) - higher dose: If the patient’s daily dose is 120 mcg/kg/day and the patient weighs < 19.5 kg, approve the requested quantity not to exceed 120 oral pellets per dispensing at retail or 360 oral pellets per dispensing at home delivery.weight and daily dose dependent

This quantity is sufficient for 120 mcg/kg/day dosing in patients who weigh < 19.5 kg and require a 2,400 mcg daily dose. For patients who weigh 6 19.5 kg and require 120 mcg/kg/day, refer to 1,200 mcg capsules.

400 mcg capsules: If the patient’s daily dose is 80 mcg/kg/day and the patient weighs ≥ 19.5 kg, approve the requested quantity not to exceed 300 capsules per dispensing at retail or 900 capsules per dispensing at home delivery.weight ≥ 19.5 kg and dosing mg/day

This quantity is sufficient for 80 mcg/kg/day dosing up to a 4,000 mcg daily dose. For doses ≥ 4,000 mcg/day, refer the patient to 1,200 mcg capsules.

1,200 mcg capsules: If the patient’s daily dose is 80 mcg/kg/day and the patient weighs ≥ 19.5 kg, approve the requested quantity not to exceed 120 capsules per dispensing at retail or 360 capsules per dispensing at home delivery.weight and daily dose dependent

This quantity is sufficient for 80 mcg/kg/day dosing up to a 4,800 mcg daily dose.

1,200 mcg capsules - higher dose: If the patient’s daily dose is 120 mcg/kg/day and the patient weighs ≥ 17.5 kg, approve the requested quantity not to exceed 180 capsules per dispensing at retail or 540 capsules per dispensing at home delivery.weight and daily dose dependent

This quantity is sufficient for 120 mcg/kg/day up to the maximum daily dose of 7,200 mcg. Criteria updated to increase retail/home-delivery quantities for the 120 mcg/kg/day & ≥ 17.5 kg group.

When the quantity requested per prescription exceeds the maximums specified for a given strength and dispensing channel (retail vs home delivery), or when the request does not match the weight‑ and dose‑based conditions described for that strength, the Drug Quantity Management rule is not met and standard coverage criteria apply. Per the policy, approvals that meet the Drug Quantity Management criteria are issued for 1 year; requests that exceed the stated per‑Rx maximums or fail to satisfy the weight/dose conditions may be denied or require review under the criteria below.

Any request that does not meet the stated Drug Quantity Limits — including requests that exceed the specified maximum quantity per Rx by strength and dispensing channel or that do not meet the stated weight/dose conditions — is considered not medically necessary under this policy.

Product Quantity Limits (per prescription)

Bylvay 200 mcg oral pellets — quantity limits

Retail maximum per Rx120 oral pellets (in dispensing capsules)

Home delivery maximum per Rx360 oral pellets (in dispensing capsules)

Unitoral pellets (in dispensing capsules)

Bylvay 400 mcg capsules — quantity limits

Retail maximum per Rx150 capsules

Home delivery maximum per Rx450 capsules

NoteFor 80 mcg/kg/day and weight ≥19.5 kg approve up to 300 capsules retail / 900 home delivery (see strength-specific criteria)

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Approval Duration

Quantity-based prior authorization is required. Approvals for requests that meet the Drug Quantity Management rules are provided for 1 year in duration.

Affected product: Bylvay (odevixibat) — see Drug Quantity Limits for per-Rx maxima by strength/form and channel.
Approvals granted when requested quantity at point of service meets the Drug Quantity Management rule.

Note

If the requested quantity at point of sale does not meet the Drug Quantity Management rule, providers should anticipate that coverage will be determined according to the policy criteria and prior-authorization process.

Documentation Required

Definitions and Background

Bylvay (odevixibat) is an ileal bile acid transporter (IBAT) inhibitor indicated for pruritus in progressive familial intrahepatic cholestasis (PFIC) in patients ≥3 months and for cholestatic pruritus in Alagille syndrome in patients ≥12 months. Dosing is weight‑based with escalation (for example, 40 mcg/kg once daily with escalation up to 120 mcg/kg daily as clinically indicated) and specific product strengths and counts are used to achieve the total daily dose. This Drug Quantity Management policy defines per‑prescription maximums and weight/dose‑dependent approval quantities for Bylvay formulations to promote dose consolidation, prevent stockpiling, and reduce order‑entry errors; if the quantity management rule is not met at point of service, coverage will be determined by the criteria in this policy.

Bylvay (odevixibat) — mechanism and indications

Mechanism of actionIleal bile acid transporter (IBAT) inhibitor

Approved indicationsPruritus in PFIC (patients ≥3 months) and cholestatic pruritus in Alagille syndrome (patients ≥12 months)

FormulationsAvailable as oral capsules and oral pellets (dispensing capsules)

Policy Summary

PayerCigna

PolicyBylvay (odevixibat) — Drug Quantity Management Policy (per Rx)

Policy CodePolicy N/A

Change TypeRevised quantity limits (material)

Effective DateN/A

Next Review DateSep 24, 2024

Key ActionApprove per-Rx quantities only when the requested quantity meets the specified per-strength, per-weight-band, and per-dosing criteria; exceptions are not medically necessary.

SourceLink

On This Page

Bylvay 600 mcg oral pellets — quantity limits

Retail maximum per Rx30 oral pellets (in dispensing capsules)

Home delivery maximum per Rx90 oral pellets (in dispensing capsules)

NoteStrength-specific approval: up to 60 retail / 180 home delivery for 80 mcg/kg/day & <17.5 kg; up to 120 retail / 360 home delivery for 120 mcg/kg/day & <19.5 kg as detailed in criteria.

Bylvay 1,200 mcg capsules — quantity limits

Retail maximum per Rx60 capsules

Home delivery maximum per Rx180 capsules

NoteFor 120 mcg/kg/day and weight ≥17.5 kg approve up to 180 capsules retail / 540 home delivery (strength- and weight-specific criteria).

Bylvay strengths — strength- and weight-specific approval quantities

200 mcg pellets — weight/dose exampleUp to 240 pellets retail / 720 pellets home delivery for 80 mcg/kg/day in patients <19.5 kg; up to 270 retail / 810 home delivery for 120 mcg/kg/day in patients <17.5 kg.

600 mcg pellets — weight/dose exampleUp to 60 pellets retail / 180 home delivery for 80 mcg/kg/day in patients <17.5 kg; up to 120 retail / 360 home delivery for 120 mcg/kg/day in patients <19.5 kg.

400 mcg capsules — weight/dose exampleUp to 300 capsules retail / 900 home delivery for 80 mcg/kg/day in patients ≥19.5 kg (sufficient up to 4,000 mcg/day).

1,200 mcg capsules — weight/dose exampleUp to 120 capsules retail / 360 home delivery for 80 mcg/kg/day and ≥19.5 kg; up to 180 capsules retail / 540 home delivery for 120 mcg/kg/day and ≥17.5 kg.

Required Documentation and Context

Documentation should include the prescription details, dispensed strength/form, and justification if exceeding standard per‑Rx maxima. Review must consider the applicable benefit plan, any controlling laws/regulations, and relevant collateral materials.

Denial Risk

Coverage Denial Risk for Noncompliant Quantities

Noncompliance with the quantity management rules (e.g., requesting quantities above the listed Retail or Home Delivery maxima per Rx) may result in denial of coverage.

Retail maximum quantities per Rx: 200 mcg oral pellets — 120 pellets; 400 mcg capsules — 150 capsules; 600 mcg oral pellets — 30 pellets; 1,200 mcg capsules — 60 capsules.
Home Delivery maximum quantities per Rx: 200 mcg oral pellets — 360 pellets; 400 mcg capsules — 450 capsules; 600 mcg oral pellets — 90 pellets; 1,200 mcg capsules — 180 capsules.

Dosing guidance — weight-based dosing and limits

Weight-based dosingDosing is weight-based with recommended starting and escalation from 40 mcg/kg up to 120 mcg/kg once daily; follow weight-band tables for total daily mcg and product counts.

Escalation stepsIf no improvement after 3 months increase by 40 mcg/kg increments up to 120 mcg/kg QD (PFIC); ALGS recommended dose is 120 mcg/kg QD.

Absolute maximum daily doseDo not exceed a total daily dose of 6 mg (6,000 mcg) when escalating for PFIC; table notes higher absolute totals for ALGS at higher weights as specified.