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Prior Authorization Protocol
AURYXIATM (ferric citrate)


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:
    • The control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of hyperphosphatemia in patients with chronic kidney disease on dialysis
  3. Coverage is Not Authorized For:
    • Patients with iron overload syndromes (e.g. hemochromatosis)
    • 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:
    • Auryxia is contraindicated in patients with iron overload syndromes.
    • Iron absorption from Auryxia may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial in which concomitant use of Auryxia and IV iron was permitted, 55 (19%) of patients treated with Auryxia had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control.
    • A normal serum phosphorus level is 2.5 – 4.5 mg/dL.
    • Iron overload: Monitor ferritin and TSAT prior to initiating Auryxia and monitor iron parameters throughout the duration of therapy. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron. 
    • Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children.
    • Patients with inflammatory bowel disease or active, symptomatic gastrointestinal bleeding were excluded from clinical trials. Safety has not been established in these populations.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    RenvelaR, RenagelR (sevelamer carbonate and hydrochloride)

    Serum Phosphorus Level > 5.5 and < 7.5 ml/dL: 800 mg PO TID with meals
    Serum Phosphorus Level ≥ 7.5 mg/dL: 1600 mg PO TID with meals
    Titrate by 800 mg per meal every 2 weeks

    For CKD patients on dialysis:
    Renvela: 14 g/day
    Renagel: 13 g/day

    calcium acetate (PhosLoR)

    Initial: 2 capsules, gelcaps, or tablets PO with each meal
    Titrate dose every 2-3 weeks up to
    3 – 4 capsules, gelcaps or tablets PO with each meal

    12 capsules, gelcaps or tablets/day

    FosrenolR (lanthanum carbonate)

    Initial: 1500 mg PO per day in divided doses with meals
    Titrate by 750 mg/day every 2-3 weeks

    4500 mg/day

    VelphoroR (sucroferric oxyhydroxide)

    Initial: 500 mg PO TID with meals
    Titrate by 500 mg/day every week

    3000 mg/day
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Auryxia

    Initial: 2 tablets PO TID with meals
    Titrate by 1 to 2 tablets each day at 1-week or longer intervals as needed to maintain serum phosphorus at target levels
    Maximum of 12 tablets daily

    Length of Benefit

  7. Product Availability:
    Tablet: 210 mg ferric iron, equivalent to 1 g ferric citrate
  8. References:
    1. Auryxia [Prescribing Information]. New York, NY: Keryx Biopharmaceuticals, Inc.; July 2015.
    2. Lewis JB, Sika M, Koury MJ, et al. Ferric citrate controls phosphorus and delivers iron in patients on dialysis. J Am Soc Nephrol. 2014;ePublished July 24, 2014.
    3. Dwyer JP, Sika M, Schulman G, et al. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis. 2013;61(5):759-766.
    4. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. January 20, 2016.
    5. Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed January 20, 2016.
    6. Auryxia. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed January 20, 2016.
    7. Renvela. [Prescribing Information]. Cambridge, MA: Genzyme Corporation; January 2015.
    8. Renagel. [Prescribing Information]. Cambridge, MA: Genzyme Corporation; January 2015.
    9. Fosrenal. [Prescribing Information]. Wayne, PA: Shire US Inc.; September 2014.
    10. Velphoro. [Prescribing Information]. Waltham, MA: Fresenius Medical Care North America; September 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.