SENSIPAR 1 (CINACALCET) UTILIZATION MANAGEMENT CRITERIA

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1 SENSIPAR 1 (CINACALCET) UTILIZATION MANAGEMENT CRITERIA DRUG CLASS: Calcium-Sensing Receptor Agonist BRAND (generic) NAMES: Sensipar (cinacalcet) 30 mg, 60 mg, 90 mg strength tablets FDA-APPROVED INDICATIONS Sensipar (cinacalcet) is a calcium-sensing receptor agonist indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis, Hypercalcemia in adult patients with Parathyroid Carcinoma (PC), 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. COVERAGE AUTHORIZATION CRITERIA Sensipar (cinacalcet) may be eligible for coverage when the following criteria are met: 1. The patient has a diagnosis of hypercalcemia due to parathyroid carcinoma; OR 2. The patient has a diagnosis of primary hyperparathyroidism (HPT) and BOTH of the following: a. The patient currently has or had pretreatment severe hypercalcemia, defined as serum calcium >12.5 mg/dl; AND b. The patient is unable to undergo parathyroidectomy; OR 3. The patient has a diagnosis of secondary hyperparathyroidism (HPT) due to chronic kidney disease (CKD) and ALL of the following: a. The patient is on dialysis; AND b. The patient has a pretreatment or current intact PTH (ipth) level >300 pg/ml; AND c. The patient has tried and failed or had an inadequate response to a prerequisite agent [Fosrenol 1 (lanthanum carbonate), Renvela 1 (sevelamer carbonate), Renagel 1 (sevelamer hydrochloride), calcium acetate or calcium carbonate]; OR d. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to a prerequisite agent [Fosrenol (lanthanum carbonate), Renvela (sevelamer carbonate), Renagel (sevelamer hydrochloride), calcium acetate or calcium carbonate]; AND 4. The patient does NOT have any of the following FDA labeled contraindication(s): a. Hypocalcemia: Sensipar treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range. Originated: January 2016 Page 1

2 Length of Approval: 12 months CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS Contraindications: Sensipar treatment initiation is contraindicated if serum calcium is less than the lower limit of the normal range. Warnings and Precautions: Hypocalcemia: Life threatening events and fatal outcomes were reported. Hypocalcemia can prolong QT interval, lower the threshold for seizures, and cause hypotension, worsening heart failure, and/or arrhythmia. Monitor serum calcium carefully for the occurrence of hypocalcemia during treatment. Adynamic Bone Disease: May develop if ipth levels are suppressed below 100 pg/ml. Hepatic Impairment: Cinacalcet exposure (i.e. area under the plasma concentration time curve) is increased in patients with moderate and severe hepatic impairment. Patients should be closely monitored for serum calcium, serum phosphorus, and ipth levels throughout treatment. **See full prescribing information for Contraindications, Warnings, and Precautions** DOSAGE AND ADMINISTRATION Secondary HPT in patients with CKD on dialysis: Starting dose is 30 mg once daily. Titrate dose no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily as necessary to achieve targeted intact parathyroid hormone (ipth) levels. ipth levels should be measured no earlier than 12 hours after most recent dose. Hypercalcemia in patients with PC or hypercalcemia in patients with primary HPT: Starting dose is 30 mg twice daily. Titrate dose every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalize serum calcium levels. **See full prescribing information for Dosage and Administration** REFERENCES Sensipar prescribing information. Amgen. March POLICY IMPLEMENTATION/UPDATE INFORMATION January 2016: Original utilization management criteria issued. Originated: January 2016 Page 2

3 Non-Discrimination and Accessibility Notice Discrimination is Against the Law Blue Cross and Blue Shield of North Carolina ( BCBSNC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. BCBSNC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. BCBSNC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: - Qualified interpreters - Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: - Qualified interpreters - Information written in other languages If you need these services, contact Customer Service , TTY and TDD, call If you believe that BCBSNC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: BCBSNC, PO Box 2291, Durham, NC 27702, Attention: Civil Rights Coordinator- Privacy, Ethics & Corporate Policy Office, Telephone , Fax , TTY You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, Civil Rights Coordinator - Privacy, Ethics & Corporate Policy Office is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD). Complaint forms are available at Originated: January 2016 Page 3

4 This Notice and/or attachments may have important information about your application or coverage through BCBSNC. Look for key dates. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call Customer Service ATTENTION: If you speak another language, language assistance services, free of charge, are available to you. Call ATENCIÓN: Si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística. Llame al 注意 : 如果您講廣東話或普通話, 您可以免費獲得語言援助服務 請致電 (TTY: ) CHÚ Ý: Nếu bạn nói Tiếng Việt, có các dịch vụ hỗ trợ ngôn ngữ miễn phí dành cho bạn. Gọi số 주의 : 한국어를사용하시는경우, 언어지원서비스를무료로이용하실수있습니다 (TTY: ) 번으로전화해주십시오. ATTENTION : Si vous parlez français, des services d'aide linguistique vous sont proposés gratuitement. Appelez le (ATS : ). ملحوظة: إذا كنت تتحدث اللغة العربیة فا ن خدمات المساعدة اللغویة تتوافر لك بالمجان. اتصل برقم المبرقة الكاتبة: LUS CEEV: Yog tias koj hais lus Hmoob, cov kev pab txog lus, muaj kev pab dawb rau koj. Hu rau ВНИМАНИЕ: Если вы говорите на русском языке, то вам доступны бесплатные услуги перевода. Звоните (телетайп: ). PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulong sa wika nang walang bayad. Tumawag sa ચન : જ તમ જર ત બ લત હ, ત ન: લ ભ ષ સહ ય સ વ ઓ તમ ર મ ટ ઉપલબ ધ છ. ફ ન કર ច ណ របស ន ប ល កអ កន យយជភ ស ខ រ សវកម ជ ន យ ផ កភ ស ម នផ ល ជ នស រម ប ល កអ ក ដយម នគ ត ថ ស មទ នក ទ នងត មរយ លខ (TTY: ) ACHTUNG: Wenn Sie Deutsch sprechen, stehen Ihnen kostenlos sprachliche Hilfsdienstleistungen zur Verfügung. Rufnummer: Originated: January 2016 Page 4

5 ध य न द : य द आप हन द ब लत ह त आपक लए म फ त म भ ष सह यत स व ए उपलब ध ह (TTY: ) पर क ल कर ໂປດຊາບ: ຖ າວ າ ທ ານເວ າພາສາ ລາວ, ການບ ລການຊ ວຍເຫ ອດ ານພາສາ, ໂດຍບ ເສ ຽຄ າ, ແມ ນມ ພ ອມໃຫ ທ ານ. ໂທຣ 注意事項 : 日本語を話される場合 無料の言語支援をご利用いただけます (TTY: ) まで お電話にてご連絡ください Originated: January 2016 Page 5

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