Parathyroid Hormone (Natpara) Form

Parathyroid hormone (Natpara®) is a parathyroid hormone. FDA Approved Indication(s) Natpara is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Limitation(s) of use:
• 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. • Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations. • Natpara was not studied in patients with acute post-surgical hypoparathyroidism. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Natpara is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Hypocalcemia Secondary to Hypoparathyroidism (must meet all):

1. Diagnosis of hypocalcemia secondary to hypoparathyroidism;
2. Prescribed by or in consultation with an endocrinologist;
3. Age ≥ 18 years;
4. Natpara is prescribed as an adjunct to calcium supplements and active forms of vitamin D, unless contraindicated;
   5. Recent (dated within the last 30 days) serum calcium level is > 7.5 mg/dL;

5. Recent (dated within the last 30 days) lab result shows sufficient 25-hydroxyvitamin D stores [≥ 50 nmol/L (≥ 20 ng/mL)];

   7. Failure of a 12-week trial of calcium supplements and active forms of vitamin D (e.g., calcitriol) at up to maximally indicated doses, unless contraindicated or clinically significant adverse events are experienced; *Prescriber must indicate that the hypocalcemia is not well controlled with calcium supplements and active forms of vitamin D (see examples in Appendix B below).
   8. Dose does not exceed 100 mcg per day. Page 1 of 6

   CLINICAL POLICY Parathyroid Hormone Approval duration:
   Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Hypocalcemia Secondary to Hypoparathyroidism (must meet all):
   3. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   4. Member is responding positively to therapy as evidenced by one of the following (a or b): a. Recent (dated within the last 90 days) serum calcium level is within 8-9 mg/dL;
      b. Recent serum calcium level is > 9 mg/dL, and Natpara dose is being decreased;
   5. If request is for a dose increase, new dose does not exceed 100 mcg per day.
      Approval duration:
      Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):
   6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: Page 2 of 6

   CLINICAL POLICY Parathyroid Hormone CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents.
      IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
      Drug Name Dosing Regimen calcitriol (Rocaltrol®) 0.25 mcg PO QD initially; dose may be increased at 2- to 4-wk intervals 1-3 g PO QD in divided doses calcium carbonate (Caltrate®, OsCal®, Tums®) calcium citrate (Cal-Citrate®, Cal-C-Caps®) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. 1-3 g PO QD in divided doses 3 g/day 3 g/day Dose Limit/ Maximum Dose 2 mcg/day Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to any component of the product • Boxed warning(s): potential risk of osteosarcoma Appendix D: General Information
      • As stated in the prescribing information, the prescriber should confirm 25- hydroxyvitamin D stores are sufficient and serum calcium is above 7.5 mg/dL before starting Natpara. Page 3 of 6

   CLINICAL POLICY Parathyroid Hormone • The goal of Natpara treatment is to achieve serum calcium within the lower half of the normal range (8 to 9 mg/dL) and to reduce the required doses of calcium and vitamin D supplementation. • Examples of a “failure” of calcium and vitamin D supplementation can include: large swings in calcium levels, calcium phosphate product cannot be maintained within an acceptable range, high risk of renal complications due to hypercalciuria or calcium containing stones, evidence of renal complications such as nephrolithiasis or having a condition causing poor calcium and vitamin D absorption. V. Dosage and Administration
   Indication Hypocalcemia secondary to hypoparathyroidism Dosing Regimen 50 mcg SC QD; increase in increments of 25 mcg every 4 weeks Maximum Dose 100 mcg/day VI. Product Availability
   Multiple-dose, dual-chamber glass cartridges: 25 mcg/dose, 50 mcg/dose, 75 mcg/dose, 100 mcg/dose VII.