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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Specialty Quantity Limit PAH 1771-H P2024

Policy:

I.  PROGRAM DESCRIPTION

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. 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

     FDA-recommended dosing

  Adcirca (tadalafil) 20 mg tablets

  60 per 30 days

  40 mg per day

  Adempas (riociguat) 0.5 mg tablets

  90 per 30 days

  The recommended starting dosage is 1 mg taken 3 times a day. For
  patients who may not 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

  Adempas (riociguat) 1.5 mg tablets

  90 per 30 days

  Adempas (riociguat) 2 mg tablets

  90 per 30 days

  Adempas (riociguat) 2.5 mg tablets

  90 per 30 days

  Alyq (tadalafil) 20 mg tablets

  60 per 30 days

  40 mg per day

  Letairis (ambrisentan) 5 mg tablets

  30 per 30 days

  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

  Liqrev (sildenafil) 10 mg/mL oral suspension

732 mL per 30 days

  20 mg three times a day; may titrate to a maximum dose of 80 mg three
  times a day

  Opsumit (macitentan) 10 mg tablets

  30 per 30 days

  10 mg per day

  Opsynvi(macitentan/tadalafil) 10 mg/20 mg tablets

  30 per 30 days

  Treatment-naïve to any PAH specific therapy or transitioning from
  endothelin receptor antagonist (ERA) monotherapy: Initiate treatment at
  one 10 mg/20 mg tablet once daily for one week. If tolerated, up titrate to    one 10 mg/40 mg tablet once daily.

 

  Transitioning from phosphodiesterase type 5 (PDE5) inhibitor
  monotherapy or PDE5 inhibitor and ERA therapy in combination: One 10
  mg/40 mg tablet once daily

  Opsynvi (macitentan/tadalafil) 10 mg/40 mg tablets

  30 per 30 days

  Revatio (sildenafil) 10 mg/mL oral suspension

  784 mL per 30 days

  Patients ≥18 years of age: 20 mg three times a day; may be titrated to a
  maximum dose of 80 mg three times a day

 

  Patients 1 to 17 years of age:
  •  ≤20 kg: 10 mg three times a day
  •  >20 kg to <45 kg: 20 mg three times a day
  •  ≥45 kg: 20 mg three times a day; may be titrated to a maximum dose of
     40 mg three times a day

  Revatio (sildenafil) 20 mg tablets

  360 per 30 days

  Tadliq (tadalafil) 20 mg/5 mL oral suspension

  300 mL per 30 days

  40 mg (10 mL) per day

  Tracleer (bosentan) 32 mg tablets for oral suspension

  112 per 28 days

  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

  Tracleer (bosentan) 125 mg tablets

  60 per 30 days

  Tyvaso (treprostinil) 0.6 mg/mL inhalation solution

  81.2 mL (28 ampules)
  per 28 days

  Up to 72 mcg four times a day

  Tyvaso (treprostinil) DPI 16 mcg and 32 mcg
  Inhalation Powder Titration Kit

  1 kit (196 cartridges)
   per 28 days

  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
  session, 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

  1 kit (252 cartridges)
  per 28 days

  Tyvaso (treprostinil) DPI 16 mcg Inhalation Powder
  Maintenance Kit

  1 kit (112 cartridges)
  per 28 days

  Tyvaso (treprostinil) DPI 32 mcg Inhalation Powder
  Maintenance Kit

  1 kit (112 cartridges)
  per 28 days

  Tyvaso (treprostinil) DPI 48 mcg Inhalation Powder
  Maintenance Kit

  1 kit (112 cartridges)
  per 28 days

  Tyvaso (treprostinil) DPI 64 mcg Inhalation Powder
  Maintenance Kit

  1 kit (112 cartridges)
  per 28 days

  Tyavso (treprostinil) DPI  32 mcg and 48 mcg
  Inhalation Powder Maintenance Kit

  1 kit (224 cartridges)
  per 28 days

  Uptravi (selexipag) 200 mcg tablets

  140 per 28 days

  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

  Uptravi (selexipag) 600 mcg tablets

  60 per 30 days

  Uptravi (selexipag) 800 mcg tablets

  60 per 30 days

  Uptravi (selexipag) 1000 mcg tablets

  60 per 30 days

  Uptravi (selexipag) 1200 mcg tablets

  60 per 30 days

  Uptravi (selexipag) 1400 mcg tablets

  60 per 30 days

  Uptravi (selexipag) 1600 mcg tablets

  60 per 30 days

  Uptravi (selexipag) Titration Pack (200 mcg/800 mcg
  tablets)

  1 pack (140 of 200 mcg
  tablets, 60 of 800 mcg
  tablets) per 28 days

  Ventavis (iloprost) 10 mcg/mL inhalation solution

  270 ampules per 30 days

  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

  Winrevair (sotatercept-csrk) 45 mg kit (one 45 mg
  single-dose vial)

  1 kit (one vial) per 21 days

  Administer once every 3 weeks. Start dosing at 0.3 mg/kg. Increase to the
  target dose of 0.7 mg/kg. Continue treatment at 0.7 mg/kg every 3 weeks
  unless dosage adjustments are required.

  Winrevair (sotatercept-csrk) 60 mg kit (one 60 mg
  single-dose vial)

  1 kit (one vial) per 21 days

  Winrevair (sotatercept-csrk) 90 mg kit (two 45 mg
  single-dose vials)

  1 kit (two vials)
  per 21 days

  Winrevair (sotatercept-csrk) 120 mg kit (two 60 mg
  single-dose vials)

  1 kit (two vials)
  per 21 days

*The initial limits may apply to the generic equivalent medications.

 


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Adcirca [package insert]. Indianapolis, IN: Eli Lilly and Company; September 2020.
  2. Adempas [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; January 2023.
  3. Alyq [package insert]. Parsippany, NJ: Teva Pharmaceuticals; April 2023.
  4. Ambrisentan [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; January 2024.
  5. Bosentan [package insert]. Pennington, NJ: Zydus Pharmaceuticals (USA) Inc. February 2024.
  6. Letairis [package insert]. Foster City, CA: Gilead Sciences, Inc.; August 2019.
  7. Liqrev [package insert]. Farmville, NC: CMP Pharma, Inc.; April 2023.
  8. Opsumit [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; March 2024.
  9. Opsynvi [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; March 2024.
  10. Revatio [package insert]. Morgantown, WV: Viatris Specialty LLC; January 2023.
  11. Sildenafil [package insert]. Piscataway, NJ: Camber Pharmaceuticals, Inc.; February 2024.
  12. Sildenafil for oral suspension [package insert]. East Windsor, NJ: Aurobindo Pharma USA, Inc.; January 2024.
  13. Tadalafil [package insert]. Bridgewater, NJ: Ajanta Pharma USA Inc.; July 2022.
  14. Tadliq [package insert]. Farmville, NC: CMP Pharma, Inc.; October 2023.
  15. Tracleer [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; February 2024.
  16. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; May 2022.
  17. Tyvaso DPI [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; November 2023.
  18. Uptravi [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; July 2022.
  19. Ventavis [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; March 2022.
  20. Winrevair [package insert]. Rahway, NJ: Merck Sharp & Dohme LLC; March 2024.

 

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.

October 30, 2024
Aetna
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