Specialty Quantity Limit PAH 1771-H P2021b - Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan

Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan

Subject: Specialty Quantity Limit PAH 1771-H P2021b

Drug

Pulmonary Arterial Hypertension

Policy:

I. PROGRAM DESCRIPTION

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization. The recommended dosing parameters for the treatment of pulmonary arterial hypertension fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

II. COVERED QUANTITIES

Medication**	Standard Limit	Exception Limit*	FDA-recommended dosing
Adcirca (tadalafil) 20 mg tablets	60 per 30 days	Not applicable	40 mg per day
Alyq (tadalafil) 20 mg tablets	60 per 30 days	Not applicable	40 mg per day
Adempas (riociguat) 0.5 mg tablets	90 per 30 days	Not applicable	The recommended starting dosage is 1 mg taken 3 times a day. For patients who cannot tolerate the hypotensive effect of Adempas, consider a starting dose of 0.5 mg taken three times a day. If systolic blood pressure remains greater than 95 mmHg and the patient has no signs or symptoms of hypotension, up-titrate by 0.5 mg taken three times a day. Dose increases should be no sooner than 2 weeks apart. The dose can be increased to the highest tolerated dosage, up to a maximum of 2.5 mg taken 3 times per day. If at any time, the patient has symptoms of hypotension, decrease the dosage by 0.5 mg taken three times per day.
Adempas (riociguat) 1 mg tablets	90 per 30 days	Not applicable
Adempas (riociguat) 1.5 mg tablets	90 per 30 days	Not applicable
Adempas (riociguat) 2 mg tablets	90 per 30 days	Not applicable
Adempas (riociguat) 2.5 mg tablets	90 per 30 days	Not applicable
Letairis (ambrisentan) 5 mg tablets	30 per 30 days	Not applicable	Initiate treatment at 5 mg once daily with or without tadalafil 20 mg once daily. At 4-week intervals, either the dose of Letairis or tadalafil can be increased, as needed and tolerated, to Letairis 10 mg or tadalafil 40 mg.
Letairis (ambrisentan) 10 mg tablets	30 per 30 days	Not applicable
Opsumit (macitentan) 10 mg tablets	30 per 30 days	Not applicable	10mg per day
Revatio (sildenafil) 10 mg/mL suspension	224 mL per 30 days	Not applicable	Up to 20 mg three times a day
Revatio (sildenafil) 20 mg tablets	90 per 30 days	360 per 30 days	Up to 20 mg three times a day
Tadliq (tadalafil) 20 mg/5 mL oral suspension	300 mL per 30 days	Not applicable	40 mg (10 mL) per day
Tracleer (bosentan) 125 mg tablets	60 per 30 days	Not applicable	Patients >12 years of age and >40 kg: Initiate treatment at 62.5 mg twice daily for 4 weeks and then increase to maintenance dose of 125 mg twice daily. Patients >12 years of age and <40 kg - Initial and maintenance dosing: 62.5 mg twice daily Patients <12 years of age – Initial and maintenance dosing: · >4-8 kg: 16 mg twice daily · >8-16 kg: 32 mg twice daily · >16-24 kg: 48 mg twice daily · >24-40 kg: 64 mg twice daily
Tracleer (bosentan) 62.5 mg tablets	60 per 30 days	Not applicable
Tracleer (bosentan) 32 mg tablets	112 per 28 days	Not applicable
Tyvaso (treprostinil) 0.6 mg/mL inhalation solution	81.2 mL (28 ampules) per 28 days	Not applicable	Up to 72 mcg four times a day
Tyvaso (treprostinil) DPI 16 mcg and 32 mcg Inhalation Powder Titration Kit	196 cartridges per 28 days	Not applicable	Initial dosage: One 16 mcg cartridge per treatment session, four times daily. Dosage should be increased by an additional 16 mcg per treatment session at approximately 1- to 2- week intervals, if tolerated Titrate to target maintenance doses of 48 mcg to 64 mcg per treatment sessions, four times daily If the prescribed dose is higher than 64 mcg per treatment session, more than 1 cartridge will be needed per session.
Tyvaso (treprostinil) DPI 16 mcg, 32 mcg, and 48 mcg Inhalation Powder Titration Kit	252 cartridges per 28 days	Not applicable
Tyvaso (treprostinil) DPI 16 mcg Inhalation Powder Maintenance Kit	112 cartridges per 28 days	Not applicable
Tyvaso (treprostinil) DPI 32 mcg Inhalation Powder Maintenance Kit	112 cartridges per 28 days	Not applicable
Tyvaso (treprostinil) DPI 48 mcg Inhalation Powder Maintenance Kit	112 cartridges per 28 days	Not applicable
Tyvaso (treprostinil) DPI 64 mcg Inhalation Powder Maintenance Kit	112 cartridges per 28 days	Not applicable
Tyavso (treprostinil) DPI 32 mcg and 48 mcg Inhalation Powder Maintenance Kit	224 cartridges per 28 days	Not applicatble
Uptravi (selexipag) 200 mcg tablets	140 per 28 days	Not applicable	Starting dose: 200 mcg twice daily. Increase the dose by 200 mcg twice daily at weekly intervals to the highest tolerated dose up to 1600 mcg twice daily.
Uptravi (selexipag) 400 mcg tablets	60 per 30 days	Not applicable
Uptravi (selexipag) 600 mcg tablets	60 per 30 days	Not applicable
Uptravi (selexipag) 800 mcg tablets	60 per 30 days	Not applicable
Uptravi (selexipag) 1000 mcg tablets	60 per 30 days	Not applicable
Uptravi (selexipag) 1200 mcg tablets	60 per 30 days	Not applicable
Uptravi (selexipag) 1400 mcg tablets	60 per 30 days	Not applicable
Uptravi (selexipag) 1600 mcg tablets	60 per 30 days	Not applicable
Uptravi (selexipag) titration pack (200 mcg/800 mcg tablets)	1 pack (140- 200mcg tablets, 60- 800 mcg tablets) per 28 days	Not applicable
Ventavis (iloprost) 10 mcg/mL inhalation solution	270 ampules per 30 days	Not applicable	5 mcg up to nine times per day. The 20 mcg/mL concentration is intended for patients who are maintained at the 5 mcg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing.
Ventavis (iloprost) 20 mcg/mL inhalation solution	270 ampules per 30 days	Not applicable

*Coverage up to the exception limits may be provided with prior authorization. See Specialty Post Limit Quantity
Exception Criteria for the criteria for approval.
** The limit may apply to the generic equivalent medications.

Place of Service:

Outpatient

The above policy is based on the following references:

Adcirca [package insert]. Indianapolis, IN: Eli Lilly and Company; September 2020.
Adempas [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; September 2021.
Alyq [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; January 2019.
Letairis [package insert]. Foster City, CA: Gilead Sciences, Inc.; August 2019.
Opsumit [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; October 2021.
Revatio [package insert]. New York, NY: Pfizer Labs; February 2020.
Tadliq [package insert]. Farmville, NC: CMP Pharma, Inc.; June 2022.
Tracleer [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; July 2021.
Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; March 2021.
Tyvaso DPI [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; May 2022.
Ventavis [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; January 2021.
Uptravi [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.; October 2021.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

September 26, 2022

Additional Information

Clinical Policy Bulletin Notes

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