Subject: Natpara 2306-A SGM P2022

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 are 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 are within
                      normal laboratory limits.
                 3.  Lab results confirming 25-hydroxyvitamin D
                      concentration is 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 treatment of
            hypocalcemia associated with hypoparathyroidism when all of
            the following criteria are met:
            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 are within normal laboratory
                 limits.
            E.  Serum 25-hydroxyvitamin D concentration is above the
                 lower limit of normal laboratory range.
            F.  Serum calcium level is greater than 7.5 mg/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.; April 2022.
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 17, 2023