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Prior Authorization Protocol
NATPARAR (parathyroid hormone)

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:
    • As an adjunct to calcium and Vitamin D to control hypocalcemia in patients with hypoparathyroidism.
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of hypocalcemia in patients with hypoparathyroidism
    AND
    • Natpara is being used as an adjunct to calcium and Vitamin D
  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:
    • As stated in the PI, the prescriber should confirm 25-hydroxyvitamin D stores are sufficient and serum calcium is above 7.5 mg/dL before starting Natpara.
    • The goal of Natpara treatment is to achieve serum calcium within the lower half of the normal range (8 to 9 mg/dL).
    • Limitations of use: 1. Because of the potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. 2. Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. 3. Natpara was not studied in patients with acute post-surgical hypoparathyroidism.
    • Because of the potential risk of osteosarcoma, Natpara is available only through a restricted REMS program called the NATPARA REMS Program. Under this program, only certified healthcare providers can prescribe and only certified pharmacies can dispense Natpara.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Natpara

    50 - 100 mcg SC QD

    Length of benefit

  7. Product Availability:
    Natpara injection: 25 mcg/dose, 50 mcg/dose, 75 mcg/dose and 100 mcg/dose in packages containing 2 cartridges
  8. References:
    1. Natpara [Prescribing Information]. Bedminster, NJ: NPS Pharmaceuticals, Inc.; January 2015.
    2. Maanstadt M, Clarke BL, Vokes T, et al. Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomized, phase 3 study. Lancet Diabetes Endocrinol. 2013 Dec;1(4):275-83.
    3. Maanstadt M, Clarke BL, Vokes T, et al. Efficacy and safety of recombinant human parathyroid hormone (1-84) in hypoparathyroidism (REPLACE): a double-blind, placebo-controlled, randomized, phase 3 study. [Supplemental Appendix]. Lancet Diabetes Endocrinol. 2013 Dec;1(4):275-83. doi 10.1016/S2213-8587(13)70106-2. Epub 2013 Oct 7.
    4. MicromedexR Healthcare Series[Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed July 1, 2015.
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.