Subject: cinacalcet-Sensipar 1624-A SGM P2022

Drug

SENSIPAR  (cinacalcet)

cinacalcet (generic)

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).

Special Notes:

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 12, 2021.
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 12, 2021.
4. Clinical Pharmacology [Internet]. Elsevier. Tampa (FL). Available at: http://www.clinicalpharmacology.com. Accessed October 12, 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.; June 2020.

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 17, 2022