Subject: Natpara 2306-A SGM P2021

Drug

NATPARA  (parathyroid hormone)

Policy:

I.   INDICATIONS

     The indications below including FDA-approved indications and compendial uses are considered
     a covered benefit provided that all the approval criteria are met and the member has no
     exclusions to the prescribed therapy.

     FDA-Approved Indication
    
     Natpara is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients
     with hypoparathyroidism.

     Limitations 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.    

      All other indications are considered experimental/investigational and not medically necessary.

II.  DOCUMENTATION

Submission of the following information is necessary to initiate the prior authorization review:
A.   Initial requests:
      1.   Lab results confirming serum parathyroid hormone concentrations below the lower limit of normal
            for the laboratory reference range on 2 separate days (at least 21 days apart) within the last 12 months.
      2.   Lab results confirming magnesium levels within normal laboratory limits.
      3.   Lab results confirming 25-hydroxyvitamin D concentration above the lower limit of normal laboratory range.
      4.   Lab results confirming serum calcium is above 7.5 mg/dL prior to initiating therapy with the requested medication.
B.   Continuation of therapy requests: Lab results confirming maintenance or normalization of calcium levels
      compared to baseline.

III. EXCLUSIONS

     Coverage will not be provided for members with the following exclusion:
     Acute postsurgical hypoparathyroidism (within 6 months of surgery) and expected recovery from
     the hypoparathyroidism

IV.  CRITERIA FOR INITIAL APPROVAL

      Hypocalcemia-Hypoparathyroidism
      Authorization of 12 months may be granted for members who are initiating treatment with
      Natpara for treatment of hypocalcemia associated with hypoparathyroidism who meet all of
      the following:
      A.   Member has hypocalcemia and concomitant serum parathyroid hormone concentrations
            below the lower limit of normal for the laboratory reference range on at least 2 separate
            dates at least 21 days apart within the last 12 months
      B.   Member is receiving vitamin D metabolite/analog therapy with calcitriol greater than or
            equal to 0.25 mcg per day or alphacalcidol greater than or equal to 0.5 mcg/day
            (or equivalent) 
      C.   Member is receiving supplemental calcium treatment greater than or equal to 1000 mg/day
            over and above normal dietary calcium intake
      D.   Serum magnesium levels within normal laboratory limits
      E.   Serum 25-hydroxyvitamin D concentration above the lower limit of normal laboratory range
      F.    Serum calcium is greater than 7.5mg/dL prior to initiating therapy with the requested
            medication
 
V.  CONTINUATION OF THERAPY  

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section IV who are experiencing benefit from therapy as evidenced by maintenance or normalization of calcium levels compared to baseline.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Natpara [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc.; July 2020.
2. Khan MI, Waguespack SG, Hu MI. Medical management of postsurgical hypoparathyroidism. Endocr Pract. 2011;17(Suppl 1): 18-25.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

February 14, 2022