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Prior Authorization Protocol
ADCIRCAR (tadalafil), REVATIOR (sildenafil citrate)



NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Revatio is indicated for the treatment of pulmonary arterial hypertension (World Health Organization (WHO) Group 1) in adults to improve exercise ability and delay clinical worsening.
    • Adcirca is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise ability.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of pulmonary arterial hypertension (PAH) (WHO Group 1)
    AND
    • Revatio requests: For patients less than 18 years of age, failure or clinically significant adverse effects to two other PAH therapies
  3. Coverage is Not Authorized For:
    • Patients taking nitrates (e.g., NitrodurR, NitrobidR, NitrostatR, IsordilR, IsmoR)
    • 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.
  4. General Information:
    • Revatio is not recommended to be used in pediatric patients. An increase in mortality was observed with increasing Revatio doses. The hazard ratio for high dose compared to low dose was 3.5 (p=0.015). Causes of death were typical of patients with PAH. Use of Revatio, particularly chronic use, is not recommended in children. The FDA advised against the off-label use of Revatio in children aged 1 through 17 years, but clarified that there may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring.
    • Safety and efficacy of Adcirca have not established in pediatric patients younger than 18 years.
    • Adding Revatio to bosentan therapy does not result in any beneficial effect on exercise capacity.
    • Studies establishing effectiveness of Revatio were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%).
    • Studies establishing effectiveness of Adcirca included predominately patients with NYHA Functional Class II - III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).
    • Use of Adcirca should be avoided in patients with severe renal impairment (Creatinine clearance <30 mL/min and on hemodialysis) or severe hepatic impairment (Child Pugh Class C). Use of Adcirca should be avoided in patients taking potent inhibitors of CYP3A (ketoconazole or itraconazole) or potent inducers of CYP3A (rifampin).
    • 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 Pulmonary Hypertension (PH): due to cardiac origin
      • Group 3 PH: due to severe lung diseases or hypoxemia
      • Group 4 PH: Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
      • Group 5 PH: miscellaneous, unclear causes
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    FlolanR, VeletriR (epoprostenol)*

    Initiate chronic infusion rate at 2 ng/kg/min continuous IV infusion via central 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.

    LetairisTM (ambrisentan)

    5 to 10 mg PO QD

    10 mg PO QD

    RemodulinR (treprostinil)*

    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.

    TracleerR (bosentan)

    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

    VentavisR (iloprost)*

    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)*

    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

    OpsumitR (macitentan)*

    10 mg PO QD

    10 mg PO QD

    OrenitramTM (treprostinil)*
    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

    AdempasR (riociquat)*

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

    2.5 mg PO TID

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

    Length of benefit

    Adcirca

    40 mg PO QD

    Length of Benefit

  7. Product Availability:
    Revatio: 20 mg tablets; 10 mg (12.5 mL) single use vial; 10 mg/mL oral suspension
    Adcirca: 20 mg tablets
  8. References:
    1. Revatio [Prescribing Information] New York, NY: Pfizer; April 2015.
    2. Adcirca [Prescribing Information] Indianapolis, IN: Eli Lilly; April 2015.
    3. Sildenafil. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 26,2015.
    4. Tadalafil. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 26,2015.
    5. MicromedexR Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed May 26,2015.
    6. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com/default.aspx. Accessed .[JS1] May 26,2015.
    7. Medscape Web site. The Classification of Pulmonary Arterial Hypertension. Updated 2006. Available at: http://www.medscape.org/viewarticle/544175. Accessed June 14, 2014.
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.