Subject: cinacalcet-Sensipar 1624-A SGM P2022a

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. Sensipar [package insert]. Thousand Oaks, CA: Amgen, Inc.; December 2019.
2. Micromedex Solutions [database online]. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: www.micromedexsolutions.com. Accessed October 5, 2022.
3. 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, 2021.
4. Clinical Pharmacology [Internet]. Elsevier. Tampa (FL). Available at: http://www.clinicalpharmacology.com. Accessed October 5, 2021.
5. 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.
6. 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.
7. 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.
8. Shoback D. Hypoparathyroidism. NEJM. 2008;359: 391-403.
9. Cinacalcet [package insert]. Cranbury, NJ: Sun Pharmaceuticals Industries, Inc.; December 2021.

 

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, 2023