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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Specialty Quantity Limit PAH 1771-H P2023

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 tablets
  per 30 days

  40 mg per day

  Alyq (tadalafil)
  20 mg tablets

  60 tablets
  per 30 days

  Adempas (riociguat)
  0.5 mg tablets

  90 tablets
  per 30 days

  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 tablets
  per 30 days

  Adempas (riociguat)
  1.5 mg tablets

  90 tablets
  per 30 days

  Adempas (riociguat)
  2 mg tablets

  90 tablets
  per 30 days

  Adempas (riociguat)
  2.5 mg tablets

  90 tablets
  per 30 days

  Letairis 
  (ambrisentan)
  5 mg tablets

  30 tablets
  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 tablets
  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 tablets
  per 30 days

  10 mg per day

  Revatio (sildenafil)
  10 mg/mL
  oral suspension

  784 mL
  per 30 days

  Patients ≥ 18 years of age:
  20 mg three times a day; may titrate
  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 tablets
  per 30 days

  Tadliq (tadalafil)
  20 mg/5 mL
  oral suspension

  300 mL
  per 30 days

  40 mg (10 mL) per day

  Tracleer (bosentan)
  125 mg tablets

  60 tablets
  per 30 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 tablets
  per 30 days

  Tracleer (bosentan)
  32 mg tablets

  112 tablets
  per 28 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

  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
  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

  Tyvaso (treprostinil)
  DPI 16 mcg
  Inhalation Powder
  Maintenance Kit

  112 cartridges
  per 28 days

  Tyvaso (treprostinil)
  DPI 32 mcg
  Inhalation Powder
  Maintenance Kit

  112 cartridges
  per 28 days

  Tyvaso (treprostinil)
  DPI 48 mcg
  Inhalation Powder
  Maintenance Kit

  112 cartridges
  per 28 days

  Tyvaso (treprostinil)
  DPI 64 mcg
  Inhalation Powder
  Maintenance Kit

  112 cartridges
  per 28 days

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

  224 cartridges
  per 28 days

  Uptravi (selexipag)
  200 mcg tablets

  140 tablets
  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 tablets
  per 30 days

  Uptravi (selexipag)
  600 mcg tablets

  60 tablets
  per 30 days

  Uptravi (selexipag)
  800 mcg tablets

  60 tablets
  per 30 days

  Uptravi (selexipag)
  1000 mcg tablets

  60 tablets
  per 30 days

  Uptravi (selexipag)
  1200 mcg tablets

  60 tablets
  per 30 days

  Uptravi (selexipag)
  1400 mcg tablets

  60 tablets
  per 30 days

  Uptravi (selexipag)
  1600 mcg tablets

  60 tablets
  per 30 days

  Uptravi (selexipag)
  titration pack (200
  mcg/800 mcg
  tablets)

  1 pack (140-200mcg
  tablets, 60- 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

 


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]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; September 2021.
  4. Letairis [package insert]. Foster City, CA: Gilead Sciences, Inc.; August 2019.
  5. Liqrev [ package insert]. Farmville, NC: CMP Pharma, Inc.; April 2023.
  6. Opsumit [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; July 2022.
  7. Revatio [package insert]. Morgantown, WV: Viatris Specialty LLC; January 2023.
  8. Tadliq [package insert]. Farmville, NC: CMP Pharma, Inc.; June 2022.
  9. Tracleer [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; July 2022.
  10. Tyvaso [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; May 2022.
  11. Tyvaso DPI [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; May 2022.
  12. Ventavis [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; March 2022.
  13. Uptravi [package insert]. Titusville, NJ: Actelion Pharmaceuticals US, Inc.; July 2022.
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.

August 09, 2023
Aetna
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