Cigna Orenitram quantity limits Policy Update | OpenPayer

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Cigna Orenitram quantity limits Policy Update | OpenPayer

Coverage Criteria for Orenitram (treprostinil ER)

Orenitram 0.125 mg - Covered Criteria

Orenitram 0.125 mg extended-release tablets covered when ANY of the following are met

0.125 mg criteria: (1) Patient's dose is being titrated using the requested product; approve the quantity requested, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery. OR (2) Patient requires a dose of more than 0.375 mg per day; approve the requested quantity, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery.>0.375 mg/day

Approvals are for up to 1 year per policy prior authorization guidance.

Orenitram 0.25 mg - Covered Criteria

Orenitram 0.25 mg extended-release tablets covered when ANY of the following are met

0.25 mg criteria: (1) Patient's dose is being titrated using the requested product; approve the quantity requested, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery. OR (2) Patient requires a dose of more than 0.75 mg per day; approve the requested quantity, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery.>0.75 mg/day

Approvals are for up to 1 year per policy prior authorization guidance.

Orenitram 1 mg - Covered Criteria

Orenitram 1 mg extended-release tablets covered when ANY of the following are met

1 mg criteria: (1) Patient's dose is being titrated using the requested product; approve the quantity requested, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery. OR (2) Patient requires a dose of more than 3 mg per day; approve the requested quantity, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery.>3 mg/day

Approvals are for up to 1 year per policy prior authorization guidance.

Orenitram 2.5 mg - Covered Criteria

Orenitram 2.5 mg extended-release tablets covered when ANY of the following are met

2.5 mg criteria: (1) Patient's dose is being titrated using the requested product; approve the quantity requested, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery. OR (2) Patient requires a dose of more than 7.5 mg per day; approve the requested quantity, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery.>7.5 mg/day

Approvals are for up to 1 year per policy prior authorization guidance.

Orenitram 5 mg - Covered Criteria

Orenitram 5 mg extended-release tablets covered when ANY of the following are met

5 mg criteria: (1) Patient's dose is being titrated using the requested product; approve the quantity requested, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery. OR (2) Patient requires a dose of more than 15 mg per day; approve the requested quantity, not to exceed a 30-day supply per dispensing at retail or a 90-day supply per dispensing at home delivery.>15 mg/day

Approvals are for up to 1 year per policy prior authorization guidance.

Orenitram titration kits

Titration kits coverage stance

Titration kits: Month 1, Month 2, and Month 3 titration kits have specified maximum quantities per dispensing and no clinical overrides are recommended.Month 1 = 168 tablets; Month 2 = 336 tablets; Month 3 = 252 tablets

No overrides recommended.

Any quantity requests for Orenitram that do not meet the criteria listed in this policy are considered not medically necessary. The criteria specify that, for each tablet strength, coverage is granted only when the patient is actively being titrated with the requested product or requires a per-day dose that exceeds the stated threshold; approvals are limited to the allowable supply per dispensing (up to a 30-day retail supply or a 90-day home delivery supply unless otherwise specified).

Exceptions to the Drug Quantity Management program that are not explicitly supported by the coverage criteria in this policy are considered not medically necessary. The policy language states that per‑prescription products are covered only when the specified criteria are met and that "any other exception is considered not medically necessary," so requests relying on exceptions outside these criteria will be denied.

Dose Thresholds and Coding-related Thresholds

Per-day dose thresholds by tablet strength

0.125 mg>0.375 mg/day

0.25 mg>0.75 mg/day

1 mg>3 mg/day

2.5 mg>7.5 mg/day

5 mg>15 mg/day

Provider Actions, Approvals, and Documentation

Note

Approval duration and quantity limits

All approvals for Orenitram under this Drug Quantity Management program will be provided for a 1-year duration when criteria are met. If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the criteria in this section.

Approvals — 1 year duration when criteria are met
If rule not met at point of service, coverage determined by criteria in this section

Billing Rule

Quantity limits per dispensing

For Orenitram 0.125 mg and 5 mg extended‑release tablets: if the patient's dose is being titrated using the requested product, or if the patient requires a dose above the specified daily threshold (0.375 mg/day for 0.125 mg tablets; 15 mg/day for 5 mg tablets), approve the quantity requested provided it does not exceed quantity limits per dispensing (retail: 30‑day supply; home delivery: 90‑day supply).

Background and Indication

Orenitram (treprostinil extended‑release tablets) is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) to delay disease progression and improve exercise capacity. Recommended initiation is 0.125 mg three times daily (TID) with food or 0.25 mg twice daily (BID) with food, with upward titration by 0.125 mg TID or 0.25/0.5 mg BID no more frequently than every 3–4 days; the prescribing information notes a maximum daily dose of 120 mg and advises dosing adjustments for hepatic impairment and when used with strong CYP2C8 inhibitors.

Definitions

Definition — Orenitram

Generic nametreprostinil extended-release tablets

Brand nameOrenitram

IndicationPulmonary arterial hypertension (WHO Group 1) to delay disease progression and improve exercise capacity

Drug classProstacyclin mimetic

Key dosing notesStarting dose 0.125 mg TID or 0.25 mg BID; titrate per prescribing information; maximum recommended daily dose 120 mg

Starting and Titration Guidance

Starting and titration guidance

Recommended starting doses and titration guidance per prescribing information

Starting dose and titration: Start 0.125 mg TID with food (approximately every 8 hours) or 0.25 mg BID with food (approximately every 12 hours); titrate by 0.125 mg TID or 0.25 mg or 0.5 mg BID not more frequently than every 3 to 4 days. Avoid abrupt discontinuation.maximum daily dose 120 mg

Consider slower titration if increments are not tolerated; use special dosing for hepatic impairment and when co-administered with strong CYP2C8 inhibitors.

Per-Prescription Quantity Limits

Orenitram Month 1 titration kit — per Rx maximum

Month 1 titration kit - Retail max per Rx168 tablets (1 kit)

Month 1 titration kit - Home delivery max per Rx168 tablets (1 kit)

Per dispensingLimit applies per dispensing (kit-specific limits override standard 30/90-day dispensing rules)

Orenitram Month 2 titration kit — per Rx maximum

Month 2 titration kit - Retail max per Rx336 tablets (1 kit)

Month 2 titration kit - Home delivery max per Rx336 tablets (1 kit)

Per dispensing