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Prior Authorization Protocol

RENAGELR (sevelamer hydrochloride), RENVELAR (sevelamer carbonate)

HNAZ

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:
    • Renagel: To control serum phosphorus in patients with Chronic Kidney Disease (CKD) on dialysis
    • Renvela: To control serum phosphorous in patients with Chronic Kidney Disease (CKD) on dialysis
  2. Health Net Approved Indications and Usage Guidelines:

    • Patient is on dialysis
    AND
    • Serum phosphorus is > 5.5 mg/dL - for initial requests only
    AND
    • Any ONE of the following criteria:
      • Failure or clinically significant adverse effect to calcium-based phosphate binding agents (i.e. calcium carbonate or calcium acetate)
      • Hypercalcemia as evidenced by serum calcium level > 10.2 mg/dL
      • Serum levels of calcium x phosphate product > 55 mg2/dL2
      • History of severe vascular and/or soft-tissue calcifications

  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:
    • The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) Bone Metabolism and Disease guidelines recommend successful treatment of Stage 5 Chronic Kidney Disease with the following parameters:
    Parameter
    Target Concentration
    Serum calcium (corrected)
    8.4 - 9.5 mg/dL
    Serum phosphorus
    3.5 - 5.5 mg/dL
    Calcium-phosphorus product (Ca x P)
    < 55 mg2/dL2
    • Aluminum-based phosphate binders are typically used as short-term therapy (4 weeks) and for one course only, when potent phosphate binding is required (> 7.0 mg/dL). It is not considered first line therapy due to the risk of aluminum toxicity (adynamic bone diseases, osteomalacia, anemia, constipation, and encephalopathy).
    • Renagel and Renvela are contraindicated in patients with bowel obstruction.
    • There are published data about the use of Renagel in patients with CKD not on dialysis, but it is not FDA approved for use in this population.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Calcium-based phosphate binder

    calcium carbonate (OTC)**


    **(Coverage of OTC agents will vary with plan formulary and benefit design)

    1 tablet PO BID to TID with meals;
    titrate to response

    Total elemental calcium should not exceed 1,500 mg/day

    calcium acetate (PhosLoR)

    Initial
    2 gelcaps PO TID with meals;
    titrate to phosphorus < 6 mg/dL and calcium < 9.5 mg/dL

    Total elemental calcium should not exceed 1,500 mg/day

    FosrenolR (lanthanum carbonate)

    Initial
    250 to 500 mg PO TID with meals;
    titrate every 2 - 3 wks to target serum phosphate level.
    Dosing range
    1500 to 3000 mg/day

    Maximum dose studied was 4500 mg

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

    Renagel

    Starting dose based on serum phosphorus level
    If serum phosphorus is:
    Renagel 800 mg tablet
    Renagel 400 mg tablet
    > 5.5 and < 7.5 mg/dL
    1 tab PO TID w/meals
    2 tabs PO TID w/meals
    > 7.5 and < 9 mg/dL
    2 tabs PO TID w/meals
    3 tabs PO TID w/meals
    > 9 mg/dL
    2 tabs PO TID w/meals
    4 tabs PO TID w/meals
    Starting dose for patients switching from calcium
    acetate to Renagel
    Calcium Acetate
    667 mg
    (gelcaps per meal)
    Renagel 800 mg
    (Tablets per meal)
    Renagel 400 mg
    (Tablets per meal)
    1 gelcap
    1 tablet PO
    2 tablets PO
    2 gelcaps
    2 tablets PO
    3 tablets PO
    3 gelcaps
    3 tablets PO
    5 tablets PO
    Titrate dosage to serum phosphorus level < 5.5 mg/dL
    Maximum average daily Renagel dose studied was 13 gms.

    Length of benefit

    Renvela

    Starting dose based on serum phosphorus level
    If serum phosphorus is:
    Renvela 800 mg Tablet
    Renvela
    Powder
    > 5.5 and < 7.5 mg/dL
    1 tab PO TID w/meals
    0.8g PO TID w/meals
    > 7.5 mg/dL
    2 tabs PO TID w/meals
    1.6g PO TID w/meals
    Starting dose for patients switching from calcium
    acetate to Renvela
    Calcium Acetate 667 mg
    (gelcaps per meal)
    Renvela 800 mg (Tablets per meal)
    Renvela
    Powder
    (dose per meal)
    1 gelcap
    1 tablet PO
    0.8g PO
    2 gelcaps
    2 tablets PO
    1.6g PO
    3 gelcaps
    3 tablets PO
    2.4g PO
    The highest daily dose of Renvela studied was
    14 grams in CKD patients on dialysis.

    Length of Benefit

  7. Product Availability:
    Renagel Tablet: 400 mg, 800 mg
    Renvela Tablet: 800 mg, Powder for Oral Suspension: 0.8 g and 2.4 g packet
  8. References:
    1. Renagel [Prescribing Information] Cambridge, MA: Genzyme Corporation; May 2011.
    2. Renvela [Prescribing Information] Cambridge, MA: Genzyme Corporation; May 2011.
    3. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J of Kidney Dis. 42:S1-S201, 2003 (suppl 3).
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 3, 2015.
    5. MedicinesComplete [online]. London: Pharmaceutical Press. Available at: http://www.medicinescomplete.com. Accessed June 30, 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.