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Prior Authorization Protocol
ADEMPASR (riociguat)

NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (World Health Organization (WHO) Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class
    • Pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening
  2. Health Net Approved Indications and Usage Guidelines:
    • Confirmed diagnosis of PAH (WHO Group 1)
    OR
    • Confirmed diagnosis of CTEPH (WHO Group 4) after surgical treatment or inoperable CTEPH
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and usage guidelines section unless there is sufficient documentation of efficacy and safety in the published literature.
    • Patients on concomitant phosphodiesterase (PDE) inhibitors or nitrates
  4. General Information:
    • WHO classifies patients into 5 groups based on etiologies of pulmonary hypertension
      • Group 1 PAH: sporadic idiopathic pulmonary arterial hypertension (IPAH), heritable IPAH, PAH caused by diseases of the pulmonary arterioles and drug and toxin-induced PAH
      • Group 2 PH: due to cardiac origin
      • Group 3 PH: due to severe lung diseases or hypoxemia
      • Group 4 PH: CTEPH
      • Group 5 PH: miscellaneous, unclear causes
    • Adempas is contraindicated in pregnancy and has a black box warning for embryo-fetal toxicity. All females, regardless of reproductive potential, must be enrolled in a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) program before they can obtain access to the drug. The program requires prescribers to be certified, females of reproductive potential to comply with pregnancy tests and use contraceptive measures, and pharmacies to be certified with the program before dispensing. Males do not need to go through the REMS program.
    • Currently, Adempas has not yet been incorporated into the ACCF/AHA guidelines for pulmonary hypertension.
    • Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated because of hypotension. Clinical experience with co-administration of Adempas and other phosphodiesterase inhibitors (for example milrinone, cilostazole, roflumilast) is limited.
    • Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    LetairisTM (ambrisentan)*

    PAH (WHO Group 1)
    5 to 10 mg PO QD

    10 mg PO QD

    sildenafil citrate (RevatioTM)*
    PAH (WHO Group 1)
    Tablets and Oral Suspension
    5 mg or 20 mg PO TID taken approximately 4 to 6 hours apart
    Injection:
    2.5 mg or 10 mg IV bolus TID
    Tablets:
    20 mg PO TID
    Injection:
    10 mg TID

    TracleerR (bosentan)*

    PAH (WHO Group 1)
    Initiate
    62.5 mg PO BID for 4 weeks
    Maintenance:
    up to 125 mg PO BID

    (if body wt.< 40 kg and age > 12 y/o initial and maintenance is 62.5 mg BID)

    125 mg PO BID

    AdcircaR (tadalafil)*

    PAH (WHO Group 1)
    40 mg PO QD

    40 mg PO QD

    FlolanR, VeletriR (epoprostenol)*

    PAH (WHO Group 1)
    Initiate chronic infusion rate at 2 ng/kg/min continuous IV infusion via central venous catheter and increase in increments of 2 ng/kg/min every 15 min until dose-limiting pharmacological effects are elicited or until a tolerance limit is established or further increases are not clinically warranted.

    Titrate as needed and tolerated, avoid abrupt withdrawal.
    Should dose-limiting effects occur,
    reduce infusion rate by 2 ng/kg/min every 15 minutes.

    VentavisR (iloprost)*
    PAH (WHO Group 1)
    2.5 - 5 mcg inhaled PO 6 to 9 times per day
    (no more than every two hours)

    Do not initiate therapy in patients with systolic blood pressure (SBP) below 85 mmHg

    45 mcg
    (5 mcg nine times per day)

    TyvasoR (treprostinil)*

    PAH (WHO Group 1)
    Initial dosage:
    Inhale 3 breaths PO (18 mcg) per treatment session.
    If 3 breaths are not tolerated, reduce to 1 or 2 breaths.
    Administer in 4 separate treatment sessions each day approximately four hours apart, during waking hours.

    Dosage should be increased by an additional 3 breaths at approximately 1-2 week intervals, if tolerated.
    Titrate to target maintenance dosage of 9 breaths (54 mcg) per treatment session.
    9 breaths (54 mcg) QID

    RemodulinR (treprostinil)*

    PAH (WHO Group 1)
    Initiate at 1.25 ng/kg/min SC continuous infusion (undiluted) or
    IV continuous infusion (diluted).
    The infusion rate should be increased in increments of
    1.25 ng/kg/min per week for the first four weeks
    then 2.5 ng/kg/min per week for the remaining duration of infusion
    depending on clinical response. Avoid abrupt discontinuation.
    Transition from Flolan:
    Initial Remodulin dose is 10% of the current Flolan dose.
    Dose should be increased as Flolan dose is decreased.

    40 ng/kg/min
    Titrate as tolerated. Avoid abrupt withdrawal.

    OrenitramTM (trepostinil)*
    PAH (WHO Group 1)
    Initial dosage:
    0.25 mg PO BID or 0.125 mg PO TID

    Increase by 0.25 or 0.5 mg BID or 0.125 mg TID every 3 to 4 days
    to achieve optimal clinical response.

    21 mg PO BID

    OpsumitR (macitentan)*
    PAH (WHO Group 1)
    10 mg PO QD

    10 mg PO QD

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Adempas

    1 mg PO TID

    If hypotension is a problem, may initiate at 0.5 mg PO TID;
    Increase by 0.5 mg PO every 2 weeks as tolerated up to a max dose of 2.5 mg PO TID.

    Length of benefit

  7. Product Availability:
    Tablets: 0.5 mg, 1 mg, 1.5 mg, 2mg , and 2.5 mg
  8. References:
    1. Adempas [Prescribing Information] Whippany, NJ: Bayer, Inc.; September 2014.
    2. Medscape Web site. The Classification of Pulmonary Arterial Hypertension. Updated 2006. Available at: http://www.medscape.org/viewarticle/544175. Accessed June 14, 2014.
    3. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association. Circulation. 2009;119:2250-2294.
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed May 22,2015.
    5. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/default.aspx. Accessed May 26, 2015.
    6. Adempas. American Hospital Formulary Service Drug Information. Available at https://medicinescomplete.com/mc/ahfs/current/. Accessed May 22, 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.
Draft Prepared: 21-OCT-13 MD
Approved By Health Net National P&T: 19-FEB-14, 19-NOV-14, 18-NOV-15
Revised: 27-NOV-13 SR, 12-MAR-14 MH, 12-JUN-14 MV, 22-MAY-15 JS