Subject: cinacalcet-Sensipar 1624-A SGM P2023

Drug

SENSIPAR  (cinacalcet)

cinacalcet

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.

          A.  FDA-Approved Indications
               1.  Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney
                    disease (CKD) on dialysis
               2.  Hypercalcemia in adult patients with parathyroid carcinoma
               3.  Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy
                    would be indicated on the basis of serum calcium levels, but who are unable to
                    undergo parathyroidectomy

          B.  Compendial Use
               Tertiary hyperparathyroidism in post-kidney transplant patients not receiving
               dialysis

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


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Secondary Hyperparathyroidism with CKD on Dialysis
               Authorization of 12 months may be granted for treatment of secondary
               hyperparathyroidism in a member with chronic kidney disease on dialysis who has
               a serum calcium level (corrected for albumin) greater than or equal to 8.4 mg/dL
               (see Appendix).

          B.  Primary Hyperparathyroidism
               Authorization of 12 months may be granted for treatment of primary
               hyperparathyroidism in a member who is not able to undergo parathyroidectomy
               and has a serum calcium level (corrected for albumin) greater than or equal to 8.4
               mg/dL (see Appendix).

          C.  Tertiary Hyperparathyroidism in Post-Kidney Transplant Patients Not
               Receiving Dialysis
               Authorization of 12 months may be granted for treatment of tertiary
               hyperparathyroidism in a member who has had a kidney transplant, is not
               receiving dialysis, and has a serum calcium level (corrected for albumin) greater
               than or equal to 8.4 mg/dL (see Appendix).

          D.  Parathyroid Carcinoma
               Authorization of 12 months may be granted for the treatment of parathyroid
               carcinoma in a member who has a serum calcium level (corrected for albumin)
               greater than or equal to 8.4 mg/dL (see Appendix).


   III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment in members
          requesting reauthorization for an indication listed in Section II when the following
          criteria are met:

          A.  Secondary Hyperparathyroidism with CKD on Dialysis
               Member is experiencing benefit from therapy as evidenced by a decrease in intact
               parathyroid hormone (iPTH) levels from pretreatment baseline.

          B.  All other indications
               Member is experiencing benefit from therapy (e.g., decreased or normalized
               corrected serum calcium levels since starting therapy).


    IV.  APPENDIX

          Corrected calcium = measured total calcium + 0.8(4.0 – serum albumin)

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cinacalcet [package insert]. Cranbury, NJ: Sun Pharmaceuticals Industries, Inc.; December 2021.
2. Sensipar [package insert]. Thousand Oaks, CA: Amgen, Inc.; December 2019.
3. Micromedex Solutions [database online]. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: www.micromedexsolutions.com. Accessed October 5, 2023.
4. AHFS DI (Adult and Pediatric) [database online]. Lexi-Comp, Inc. Hudson, OH. Available at: http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed October 5, 2023.
5. Clinical Pharmacology [Internet]. Elsevier. Tampa (FL). Available at: http://www.clinicalpharmacology.com. Accessed October 5, 2023.
6. Evenepoel P, Cooper K, Holdaas H, et al. A randomized study evaluating cinacalcet to treat hypercalcemia in renal transplant recipients with persistent hyperparathyroidism. Am J Transplant 2014;14:2545-2555.2023.
7. Kruse AE, Ensenberger U, Frey FJ, et al. The calcimimetic cinacalcet normalizes serum calcium in renal transplant patients with persistent hyperparathyroidism. Nephrol Dial Transplant. 2005;20:1311-1314.
8. Srinivas TR, Schold JD, Womer KL, et al. Improvement in hypercalcemia with cinacalcet after kidney transplantation. Clin J Am Soc Nephrol. 2006;1:323–326.
9. Shoback D. Hypoparathyroidism. NEJM. 2008;359: 391-403.

 

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.

April 11, 2024