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Prior Authorization Protocol
AMTURNIDER (aliskiren/amlodipine/hydrochlorothiazide), AZORTM (amlodipine/olmesartan), BENICARR(olemesartan), BENICAR HCTR(olmesartan/HCTZ), EDARBITM (azilsartan medoxomil), EDARBYCLORTM (azilsartan/chlorthalidone), TEKAMLOR (aliskiren/amlodipine), TEKTURNAR (aliskiren), TEKTURNA HCTR (aliskiren/hydrochlorothiazide), TEVETEN HCTR(eprosartan/HCTZ), TRIBENZORTM(olmesartan/amlodipine/ hydrochlorothiazide)

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
    Amturnide
    X
    Azor
    X
    Benicar
    X^
    O
    Benicar HCT
    X
    Edarbi
    X
    O
    Edarbyclor
    X
    Tekamlo
    X
    Tekturna
    X
    Tekturna HCT
    X
    Teveten HCT
    X
    Tribenzor
    X

    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
    ^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:
      • An angiotensin converting enzyme (ACE) inhibitor followed by a generic angiotensin II receptor blocker (ARB) or ARB combinations (i.e., losartan, candesartan, irbesartan, telmisartan, eprosartan, valsartan)
    OR
      • Two generic ARBs or ARB combinations (i.e., losartan, candesartan, irbesartan, telmisartan, eprosartan, valsartan)
  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 (30-300 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

    Benazepril
    (LotensinR)

    Hypertension
    10 - 40 mg/day PO QD
    (single or two divided doses)

    80 mg/day

    Captopril
    (CapotenR)

    Hypertension
    25 mg PO BID/TID;
    titrate to blood pressure
    Heart Failure
    6.25 - 12.5 mg PO TID,
    titrate to blood pressure
    Left ventricular dysfunction s/p MI
    6.25 mg PO TID,
    titrated to maintenance dose of 50 mg PO TID

    450 mg/day

    Fosinopril
    (MonoprilR)

    Hypertension
    10 - 40 mg PO QD
    (single or two divided doses)

    Heart Failure
    5 - 40 mg PO QD

    Hypertension
    80 mg/day

    Heart Failure
    40 mg/day

    Lisinopril
    (ZestrilR, PrinivilR)

    Hypertension
    10 - 40 mg PO QD

    Heart Failure
    5 - 40 mg PO QD

    Hypertension
    80 mg/day

    Heart Failure
    40 mg/day

    Quinapril
    (AccuprilR)

    Hypertension
    10 - 80 mg PO QD
    (single or two divided doses)

    Heart Failure
    5 - 20 mg PO BID

    Hypertension
    80 mg/day

    Heart Failure
    40 mg/day

    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

    eprosartan
    (Teveten)*

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

    This section intentionally left blank.

    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

    valsartan
    (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

    320 mg PO QD

    valsartan/ HCTZ
    (Diovan HCT)*

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

    320/25 mg PO QD

    amlodipine/ valsartan
    (Exforge)*

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

    10/320 mg PO QD

    amlodipine/ valsartan/ HCTZ
    (Exforge HCT)*

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

    10/320/25 mg PO QD

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

    Benicar

    Adult Hypertension
    20 - 40 mg PO QD
    Pediatric Hypertension
    20 to <35 kg:
    10 - 20 mg PO QD
    >/=35 kg:
    20 - 40 mg PO QD

    Length of benefit

    Benicar HCT

    Hypertension
    20/12.5 - 40/25 mg PO QD

    Length of benefit

    Teveten HCT

    Hypertension
    600/12.5 - 600/25 mg PO QD

    Length of Benefit

    Edarbi

    Hypertension: 80 mg PO QD; consider 40 mg PO QD for patients on high doses of diuretics

    Length of Benefit

    Edarbyclor

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

    Length of Benefit

    Amturnide

    Hypertension: 150/5/12.5 - 300/10/25 mg PO QD

    Length of Benefit

    Azor

    Hypertension: Initiate with 5/20 mg PO QD for 1 to 2 weeks; titrate as needed up to 10/40 mg PO QD

    Length of Benefit

    Tekamlo

    Hypertension: Initiate with 150/5 mg PO QD; titrate as needed up to 300/10 mg PO QD

    Length of Benefit

    Tekturna

    Hypertension: 150 - 300 mg PO QD

    Length of Benefit

    Tekturna HCT

    Hypertension: 150/12.5 - 300/25 mg PO QD

    Length of Benefit

    Tribenzor

    Hypertension: 20/5/12.5 - 40/10/25 mg PO QD

    Length of Benefit

  7. Product Availability:
    Single agent tablets
    Benicar: 5, 20, 40 mg tablets
    Edarbi: 40, 80 mg tablets
    Tekturna: 150, 300 mg tablets
    In combination w/Diuretic
    Amturnide: 150/5/12.5, 300/5/12.5, 300/5/25, 300/10/12.5, 300/10/25 mg
    Benicar HCT: 20/12.5, 40/12.5, 40/25 mg
    Teveten HCT 600/12.5, 600/25 mg
    Edarbyclor: 40/12.5, 40/25 mg
    Tekturna HCT: 150/12.5, 150/25, 300/12.5, 300/25 mg
    In combination w/Calcium Channel Blocker
    Azor: 5/20, 10/20, 5/40, 10/40 mg
    Tekamlo: 150/5, 150/10, 300/5, 300/10 mg
    Tribenzor: 20/5/12.5, 40/5/12.5, 40/5/25, 40/10/12.5, 40/10/25 mg
  8. References:
    1. Amturnide [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2015.
    2. Azor [Prescribing Information]. Parsippany, NJ: Daiichi Sankyo; September 2014.
    3. Teveten HCT [Prescribing Information]. North Chicago, IL: Abbott. September 2012.
    4. Benicar [Prescribing Information]. Parsippany, NJ: Daiichi Sankyo, Inc; September 2014.
    5. Benicar HCT [Prescribing Information]. Parsippany, NJ: Daiichi Sankyo, Inc.; September 2014.
    6. Edarbi [Prescribing Information]. Atlanta, GA: Arbor Pharmaceuticals; July 2014.
    7. Edarbyclor [Prescribing Information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; October 2012.
    8. MicromedexR 2.0, (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed June 2015.
    9. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 2015.
    10. Rodgers JE and Patterson JH. Angiotensin II receptor blockers: Clinical relevance and therapeutic role. Am J Health-Syst Pharm. 2001;58:671-683.
    11. American Diabetes Association Clinical Practice Recommendations - 2015. Diabetes Care. 2015;38:(Suppl 1): S1-94.
    12. 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.
    13. 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.
    14. Tekamlo [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2015.
    15. Tekturna [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2015.
    16. Tekturna HCT [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2015.
    17. Tribenzor [Prescribing Information]. Parsippany, NJ: Daiichi Sankyo, Inc.; September 2014.
    18. 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.