Medical Policy:

12.01.080-001

Topic:

Sensipar

Section:

Injections

Effective Date:

October 1, 2025

Issued Date:

July 21, 2025

Last Revision Date:

July 2025

Annual Review:

July 2026

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Sensipar®

(cinacalcet)*

Tablets

Treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis

Limitations of Use:
- Not indicated for use in patients with CKD who are not on dialysis because of an increased risk of hypocalcemia.

Treatment of hypercalcemia in adult patients with parathyroid carcinoma

Treatment of 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

*generic available

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:

A. The patient has a diagnosis of hypercalcemia due to parathyroid carcinoma OR

B. The patient has a diagnosis of primary hyperparathyroidism (HPT) and BOTH of the following:

1. The patient has a pretreatment serum calcium level that is above the testing laboratory’s upper limit of normal AND

2. The patient is unable to undergo parathyroidectomy OR

C. The patient has a diagnosis of secondary hyperparathyroidism (HPT) due to chronic kidney disease (CKD) AND ALL of the following:

1. The patient is on dialysis AND

2. The patient has a pretreatment or current intact PTH (iPTH) level that is greater than 300 pg/mL AND

3. ONE of the following:

A. The patient has tried and had an inadequate response to a phosphate binder [e.g., calcium acetate, calcium carbonate, Renvela* (sevelamer carbonate), Fosrenol* (lanthanum carbonate), Renagel* (sevelamer hydrochloride)] OR

B. The patient has an intolerance or hypersensitivity to phosphate binder therapy OR

C. The patient has an FDA labeled contraindication to ALL phosphate binder agents AND

4. ONE of the following:

A. The patient has tried and had an inadequate response to a vitamin D analog [e.g., calcitriol, Hectorol (doxecalciferol), Rayaldee (calcifediol), Zemplar (paricalcitol)] OR

B. The patient has an intolerance or hypersensitivity to vitamin D analog therapy OR

C. The patient has an FDA labeled contraindication to ALL vitamin D analog agents OR

D. The patient has another FDA approved indication for the requested agent OR

E. The patient has another indication that is supported in compendia for the requested agent AND

2. If the patient has an FDA labeled indication, then ONE of the following:

A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR

B. The is support for using the requested agent for the patient’s age for the requested indication AND

3. If the request is for one of the following brand agent(s) with an available generic equivalent (listed below), then ONE of the following:

Brand	Generic Equivalent
Sensipar	cinacalcet

A. The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent OR

B. The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent OR

C. There is support for the use of the requested brand agent over the generic equivalent AND

4. The patient will NOT be using the requested agent in combination with another calcium sensing receptor agonist [e.g., Parsabiv (etelcalcetide)] AND

5. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval: 12 months

*prerequisite agent may be subject to Step Therapy (ST) program

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan's Prior authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND

2. ONE of the following:

A. The patient has a diagnosis of hypercalcemia due to parathyroid carcinoma OR

B. BOTH of the following:

1. The patient has a diagnosis of primary hyperparathyroidism (HPT) AND

2. The patient's serum calcium level has been evaluated to confirm the appropriateness of the current dose OR

C. The patient has a diagnosis of secondary hyperparathyroidism (HPT) due to chronic kidney disease (CKD) AND BOTH of the following:

1. The patient is on dialysis AND

2. The patient's intact PTH (iPTH) level has been evaluated to confirm the appropriateness of the current dose OR

D. The patient has another FDA approved indication for the requested agent OR

E. The patient has another indication that is supported in compendia for the requested agent AND

3. If the request is for one of the following brand agent(s) with an available generic equivalent (listed below), then ONE of the following:

Brand	Generic Equivalent
Sensipar	cinacalcet

A. The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the brand agent OR

B. The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the brand agent OR

C. There is support for the use of the requested brand agent over the generic equivalent AND

4. The patient has had clinical benefit with the requested agent AND

5. The patient will NOT be using the requested agent in combination with another calcium sensing receptor agonist [e.g., Parsabiv (etelcalcetide)] AND

6. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval: 12 months

PRIOR AUTHORIZATION CLINICAL CRITERIA OPERATIONAL LEVEL OF EVIDENCE REQUIREMENTS

Module	Ops Set Up	Validation Options	Other Explanation
PA	Validation: Apply Baseline and go to Validation Options	Age Verification;Contraind., intolerance, or hypersensitivity to prereq.;Diagnosis;Prerequisites

J0604

Reference to Our Policy Information Guidelines

CLINICAL RATIONALE

Secondary Hyperparathyroidism (HPT) in patients with Chronic Kidney Disease (CKD)	Secondary hyperparathyroidism (HPT) is a frequent complication in patients with chronic kidney disease (CKD). Declining kidney function results in decreased renal phosphate excretion, reduced synthesis of calcitriol (the active form of vitamin D), and decreased extracellular ionized calcium concentration. These derangements in mineral homeostasis promote continuous stimulation of the parathyroid glands and eventually parathyroid hyperplasia. The implications of secondary HPT include renal osteodystrophy, progressive vascular calcification, and in turn, cardiovascular disease and death.(3,4) Guidelines recommend that treatment options for HPT in dialysis patients include a combination of phosphate binders, vitamin D analogs, and calcimimetics. Parathyroidectomy is effective in suitable candidates refractory to medical therapy. Management of hyperphosphatemia involves dietary phosphate restriction and use of phosphate binders to block absorption of ingested phosphates. Phosphate binders are categorized as calcium-containing and non-calcium-containing. Calcium-containing binders include calcium carbonate and calcium acetate. Major non-calcium-containing binders include sevelamer and lanthanum. Synthetic vitamin D analogs (paricalcitol, doxercalciferol) and calcitriol increase the absorption of both calcium and phosphorus and reduce the synthesis of parathyroid hormone (PTH). Calcimimetics [Sensipar (cinacalcet), Parsabiv (etelcalcetide)] increase the sensitivity of the parathyroid calcium-sensing receptor (CaSR) to calcium. CaSR regulates the parathyroid gland hyperplasia and PTH secretion. Calcimimetics reduce the plasma PTH concentration and decrease calcium and phosphate levels.(2,3,4)
Parathyroid Carcinoma	Parathyroid carcinoma has been estimated to cause hyperparathyroidism (HPT) in approximately 1-2% of cases of primary HPT. Parathyroid carcinoma is suspected in patients presenting with marked hypercalcemia and serum PTH, as well as a palpable cervical mass. Surgery is the only effective therapy for parathyroid carcinoma. Medical management of patients with unresectable disease includes agents such as bisphosphonates and calcimimetics.(5,6)
Primary Hyperparathyroidism	Primary hyperparathyroidism (HPT) is a common disorder that arises from autonomous overproduction of parathyroid hormone (PTH) by abnormal parathyroid glands. It is characterized by the persistent elevation of total serum calcium levels with corresponding elevated or inappropriately normal PTH levels. Parathyroidectomy is the only definitive treatment of primary HPT. Symptomatic patients are expected to derive clear benefits from curative parathyroidectomy, and patients considered to be asymptomatic frequently report improvement in quality of life indexes.(7) For patients who decline or are not candidates for surgery, medical therapy such as calcimimetics should be considered.(8)
Safety	Cinacalcet treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range.(1)

REFERENCES

Number	Reference
1	Sensipar prescribing information. Amgen Inc. December 2019.
2	Kidney Disease Improving Global Outcomes (KDIGO) 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney International Supplements. 2017;7(1):1-59. doi:10.1016/j.kisu.2017.04.001
3	Cunningham J, Locatelli F, Rodriguez M. Secondary Hyperparathyroidism. Clinical Journal of the American Society of Nephrology. 2011;6(4):913-921. doi:10.2215/cjn.06040710
4	Cozzolino M, Galassi A, Conte F, Mangano M, Di Lullo L, Bellasi A. Treatment of Secondary Hyperparathyroidism: the clinical utility of etelcalcetide. Therapeutics and Clinical Risk Management. 2017;Volume 13:679-689. doi:10.2147/tcrm.s108490
5	Parathyroid Cancer Treatment (PDQ®). Cancer.gov. Published July 5, 2024. https://www.cancer.gov/types/parathyroid/hp/parathyroid-treatment-pdq.
6	Long KL, Sippel RS. Current and future treatments for parathyroid carcinoma. International Journal of Endocrine Oncology. 2018;5(1). doi:10.2217/ije-2017-0011
7	Wilhelm SM, Wang TS, Ruan DT, et al. The American Association of Endocrine Surgeons Guidelines for Definitive Management of Primary Hyperparathyroidism. JAMA Surgery. 2016;151(10):959. doi:10.1001/jamasurg.2016.2310
8	Marcocci C, Bollerslev J, Khan AA, Shoback DM. Medical Management of Primary Hyperparathyroidism: Proceedings of the Fourth International Workshop on the Management of Asymptomatic Primary Hyperparathyroidism. The Journal of Clinical Endocrinology & Metabolism. 2014;99(10):3607-3618. doi:10.1210/jc.2014-1417

Professional Statements and Societal Positions Guidelines

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Final Module	Target Agent GPI	Target Brand Agent(s)	Target Generic Agent(s)	Strength	Targeted MSC	Targeted NDCs When Exclusions Exist	Final Age Limit	Preferred Status	Effective Date

	3090522510	Sensipar	cinacalcet hcl tab	30 MG ; 60 MG ; 90 MG	M ; N ; O ; Y

CLIENT SUMMARY – PRIOR AUTHORIZATION

Target Brand Agent(s)	Target Generic Agent(s)	Strength	Client Formulary

Sensipar	cinacalcet hcl tab	30 MG ; 60 MG ; 90 MG	Commercial ; HIM ; WY NetR-Commercial Custom

Place of Service: Inpatient/Outpatient

The policy position applies to all commercial lines of business

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