Pharmacy Prior Authorization Criteria

Sensipar (cinacalcet)

Indications for Prior Authorization

Sensipar (cinacalcet)

• For diagnosis of Secondary Hyperparathyroidism
  Indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

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

• For diagnosis of Parathyroid Carcinoma
  Indicated for the treatment of hypercalcemia in adult patients with parathyroid carcinoma.

• For diagnosis of Primary Hyperparathyroidism
  Indicated for the 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.

Criteria

Brand Sensipar, generic cinacalcet

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Secondary hyperparathyroidism [1-3]

• Patient is 18 years of age or older [1, A]
AND
• Diagnosis of secondary hyperparathyroidism with chronic kidney disease on dialysis
AND
• Trial and failure, contraindication or intolerance to both of the following:
• A phosphate binder (e.g., PhosLo, Fosrenol, Renvela, Renagel, etc.)
• A vitamin D analog (e.g., calcitriol, Hectorol, Zemplar, etc.)
AND
• Trial and failure or intolerance to generic cinacalcet (applies to brand Sensipar only)
AND
• Prescribed by or in consultation with an oncologist, endocrinologist, or nephrologist

Brand Sensipar, generic cinacalcet

Prior Authorization (Initial Authorization)

Length of Approval: 12 Months [B]
For diagnosis of Hypercalcemia with parathyroid carcinoma

• Patient is 18 years of age or older [1, A]
AND
• Diagnosis of hypercalcemia with parathyroid carcinoma
AND
• Trial and failure or intolerance to generic cinacalcet (applies to brand Sensipar only)
AND
• Prescribed by or in consultation with an oncologist, endocrinologist, or nephrologist

Brand Sensipar, generic cinacalcet

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Severe hypercalcemia with primary hyperparathyroidism [4-5]

• Patient is 18 years of age or older [1, A]
AND
• Diagnosis of severe hypercalcemia (level greater than 1 mg/dL above the upper limit of normal) with primary hyperparathyroidism [C, D]
AND
• Patient is unable to undergo parathyroidectomy
AND
• Trial and failure or intolerance to generic cinacalcet (applies to brand Sensipar only)
AND
• Prescribed by or in consultation with an oncologist, endocrinologist, or nephrologist

Brand Sensipar, generic cinacalcet

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All diagnoses listed above

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-06-28, 2023-10-04, 2023-06-23, 2022-07-21, 2021-06-15, 2021-05-26, 2021-05-25, 2020-06-08, 2019-10-30, 2019-07-19

References

1. Sensipar prescribing information. Amgen Inc. Thousand Oaks, CA. December 2019.
2. Block GA, Martin KJ, de Francisco AL, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004;350(15):1516-25.
3. Lindberg JS, Culleton B, Wong G, et al. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005;16(3):800-7.
4. Peacock M, Bilezikian JP, Klassen PS, et al. Cinacalcet hydrochloride maintains long-term normocalcemia in patients with primary hyperparathyroidism. J Clin Endocrinol Metab. 2005;90(1):135-41.
5. Per clinical consult with endocrinologist, July 5, 2011.
6. Cinacalcet Prescribing Information. Actavis Pharma, Inc. Parsippany, NJ. August 2018.

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End Notes

1. Sensipar is not indicated for use in pediatric patients. In aggregate, pediatric clinical studies did not establish a safe and effective Sensipar dosing regimen for the pediatric population. Dosing with Sensipar in Pediatric Study 1 was stopped because of a fatality in a Sensipar-treated individual. The individual was noted to be severely hypocalcemic at the time of death. [1]
2. In the pivotal study of Sensipar for parathyroid carcinoma, patients were treated with maintenance therapy for up to 48 weeks. [1]
3. As recommended by an endocrinologist consultant, hypercalcemia is defined as serum calcium level greater than or equal to 12.5 mg/dL. [5]
4. In the pivotal study of Sensipar for primary hyperparathyroidism, severe hypercalcemia was defined as a screening serum calcium level of > 12.5 mg/dL. The median exposure to Sensipar was 270 days (range: 32-1,105 days). [1]

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Revision History

• 2024-06-28: 2024 UM Annual Review. No criteria changes.
• 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
• 2023-06-23: 2023 UM Annual Review. No changes
• 2022-07-21: Annual review - no changes.
• 2021-06-15: Annual review - no changes.
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-06-08: Annual review - no changes to clinical criteria. Updated references.
• 2019-10-30: Added step through generic cinacalcet for brand Sensipar. Updated references.
• 2019-07-19: Annual review. No changes to clinical criteria. Updated references. XC 7/19/19.

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