Prior Auth Protocol

FDA Approved Indications:

As an adjunct to calcium and Vitamin D to control hypocalcemia in patients with hypoparathyroidism.

Health Net Approved Indications and Usage Guidelines:

AND

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.

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.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Natpara	50 - 100 mcg SC QD	Length of benefit

Product Availability:

Natpara injection: 25 mcg/dose, 50 mcg/dose, 75 mcg/dose and 100 mcg/dose in packages containing 2 cartridges

References:

Natpara [Prescribing Information]. Bedminster, NJ: NPS Pharmaceuticals, Inc.; January 2015.
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.
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.
Micromedex^RHealthcare Series[Internet database]. Greenwood Village, CO: Thomson Healthcare. Updated periodically. Accessed July 1, 2015.