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Prior Authorization Protocol
ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs)
DIOVANR(valsartan), DIOVAN HCTR(valsartan/HCTZ), EXFORGER (amlodipine/valsartan), EXFORGE HCTR (amlodipine/valsartan/hydrochlorothiazide), TEVETENR(eprosartan)

HNMC

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:

    Hypertensiona
    Diabetic nephropathyb
    Heart failurec
    Reduce CV mortality post-MId
    Diovan
    X^
    O
    X
    X
    Diovan HCT
    X
    Exforge
    X
    Exforge HCT
    X
    Teveten
    X
    O

    X = FDA Approved Indication
    O = Sufficient data and/or Guidelines exist to support off-label use
    a = Treatment of Hypertension alone or in combination with other antihypertensive agents
    b = Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and hypertension
    c = Diovan - Treatment of heart failure (NYHA class II-IV)
    d = Reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction
    ^For use in pediatric hypertension as well as adult hypertension
  2. Health Net Approved Indications and Usage Guidelines:
    • Failure or clinically significant adverse effects to at least one preferred generic angiotensin II receptor blocker (ARB) or ARB combinations (i.e., losartan, candesartan, irbesartan, telmisartan)
  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.
  4. General Information:
    • Dual blockade of the renin-angiotensin system (RAS) with angiotensin receptor blockers, angiotensin converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
    • According to the American Hospital Formulary Service Drug Information database (AHFS DI), ARBs have been shown to slow the rate of progression of renal disease in patients with diabetes mellitus and persistent albuminuria and use of ARBs is recommended in patients with modestly elevated (30300 mg/24 hours) or higher (exceeding 300 mg/24 hours) levels of urinary albumin excretion.
    • The 2013 ACCF/AHA practice guideline for the management of heart failure recommend ACE inhibitors as the preferred drugs for inhibition of the renin-angiotensin system in patients with heart failure and reduced left ventricular ejection fraction (LVEF); however, angiotensin II receptor antagonists may be used as an alternative in patients who are unable to tolerate ACE inhibitors.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    losartan
    (CozaarR)
    Adult Hypertension
    25 - 100 mg PO QD (single or two divided doses)
    Pediatric Hypertension
    >/= 6 years:
    0.7 mg/kg (up to 50 mg) - 1.4 mg/kg (up to 100 mg) PO QD
    Hypertension with LVH
    50 - 100 mg PO QD
    Nephropathy
    50 - 100 mg PO QD

    100 mg/day

    losartan/HCTZ
    (HyzaarR)

    Hypertension
    50/12.5 - 100/25 mg PO QD
    (single or two divided doses)

    100 mg/25 mg/day

    irbesartan
    (AvaproR)

    Hypertension
    150 - 300 mg PO QD
    Nephropathy
    300 mg PO QD

    300 mg/day

    irbesartan/HCTZ
    (AvalideR)

    Hypertension
    150/12.5 - 300/25 mg PO QD

    300/25 mg/day

    candesartan
    (AtacandR)

    Adult Hypertension
    8 - 32 mg PO QD (single or two divided doses)
    Pediatric Hypertension
    1 to <6 years: 0.05 - 0.4 mg/kg PO QD
    6 to <17 years (<50 kg): 4 - 16 mg PO QD
    6 to <17 years (>50 kg): 4 - 32 mg PO QD
    Heart Failure
    4 - 32 mg PO QD

    32 mg/day

    candesartan/HCTZ
    (AtacandR HCT)

    Hypertension
    16/12.5 - 32/25 mg PO QD (single or two divided doses)

    32/25 mg/day

    telmisartan
    (Micardis)
    Hypertension: 40 - 80 mg PO QD
    Cardiovascular Risk Reduction: 80 mg PO QD

    80 mg PO QD

    telmisartan/amlodipine
    (Twynsta)

    Hypertension: 40/5 - 80/10 mg PO QD

    80/10 mg PO QD

    telmisartan/ HCTZ
    (Micardis HCT)

    Hypertension: 40/12.5 - 80/25 mg PO QD

    80/25 mg PO QD

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

    Exforge

    Hypertension: 5/160 - 10/320 mg PO QD

    Length of Benefit

    Exforge HCT

    Hypertension: 5/160/12.5 - 10/320/25 mg PO QD

    Length of Benefit

    Teveten

    Hypertension: 400 - 800 mg PO QD (single or two divided doses)

    Length of Benefit

    Diovan

    Hypertension: 80 - 320 mg PO QD
    Pediatric Hypertension:
    6 to 16 years: 1.3 mg/kg (up to 40 mg) - 2.7 mg/kg (up to 160 mg) PO QD
    Heart Failure: 40 - 160 mg PO BID
    Post-MI: 20 - 160 mg PO BID

    Length of Benefit

    Diovan HCT

    Hypertension: 160/12.5 - 320/25 mg PO

    Length of Benefit

  7. Product Availability:
    Single agent tablets
    Diovan: 40, 80, 160, 320 mg tablets
    Teveten: 400, 600 mg tablets
    In combination w/Diuretic
    Diovan HCT: 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 mg
    In combination w/Calcium Channel Blocker
    Exforge: 5/160, 10/160, 5/320, 10/320 mg
    Exforge HCT: 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25, 10/320/25 mg
  8. References:
    1.     Teveten [Prescribing Information]. North Chicago, IL: AbbVie Inc.; July 2014.
    2.     Diovan [Prescribing Information]. East Hanover, NJ: Novartis; September 2014.
    3.     Diovan HCT [Prescribing Information]. East Hanover, NJ: Novartis; September 2014.
    4.     MicromedexR 2.0, (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed June 2015.
    5.     American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 2015.
    6.     Rodgers JE and Patterson JH. Angiotensin II receptor blockers: Clinical relevance and therapeutic role. Am J Health-Syst Pharm. 2001;58:671-683.
    7.     American Diabetes Association Clinical Practice Recommendations - 2015. Diabetes Care. 2015;38:(Suppl 1): S1-94.
    8.     2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014; 311 (5): 507-520.
    9.     Dahlof B, Devereux RB, Kjeldsen SE, et al for the LIFE study group. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A Randomized trial against atenolol. The Lancet. 2002;359:995-1003.
    10.   Exforge [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2014.
    11.   Exforge HCT [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2014.
    12.   Yancy CW, Jessup M et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013; 128:e240-327.
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.