PARSABIV (etelcalcetide) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O1034.docx Page 1 of 8
Description: Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist specifically indicated for the treatment of secondary hyperparathyroidism (HPT) in adults with chronic kidney disease (CKD) on hemodialysis. Parsabiv acts on your parathyroid gland and causes them to release less parathyroid hormone (PTH). When PTH goes down, your bones release less phosphorus and calcium. A maintenance dose of Parsabiv is individualized and determined by titration based on PTH and corrected serum calcium response. The maintenance dose is the dose that maintains PTH levels within the recommended target range and corrected serum calcium within the normal range. Parsabiv is the second calcimimetic to be approved by the FDA for this indication, the first being cinacalcet (sensipar ) tablets. Definitions: Adult: Age 18 years and older Target Values: Target goals for PTH, calcium, and phosphorus in adult with CKD on hemodialysis (CKD stage 5), per clinical practice guidelines of the Kidney Disease Outcomes Quality Initiative (K/DOQI 2003): Corrected serum calcium 8.4-9.5 mg/dl (2.1-2.37 mmol/l) Serum phosphorus 3.5-5.5 mg/dl (1.13-1.78 mmol/l) Intact PTH 150-300 pg/ml Serum calcium-phosphorus product < 55 mg 2 /dl 2 Serum calcium correction with low albumin values: The normal serum albumin of 4.0 gm/dl is based on measurements using bromocresol green. If the bromocresol purple method is used, the normal serum albumin should be adjusted accordingly (e.g., 3.5 gm/dl). Local laboratory should be contacted to determine if this correction should be applied to the current result. Calculation for corrected total serum calcium = total calcium + 0.8 (4 - serum albumin) Ex. Calcium 9.9 mg/dl; albumin 2.9 gm/dl Corrected Ca = 9.9 + 0.8 (4 2.9) Corrected Ca = 10.8 (calculations as seen below) [4 2.9] = 1.1 0.8 X 1.1 = 0.88 9.9 + 0.88 = 10.78 (10.8 mg/dl is the corrected serum calcium) O1034.docx Page 2 of 8
Criteria: See Resources section for FDA-approved dosage. Parsabiv (etelcalcetide) for the initial treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis is considered medically necessary with documentation of ALL of the following: 1. Moderate to severe hyperparathyroidism (PTH 300 pg/ml) 2. Receiving hemodialysis 3 times weekly for at least 3 months 3. Evidence that corrected serum calcium is at or above the lower limit of normal prior to initiation of Parsabiv, prior to a dose increase, or prior to re-initiation of Parsabiv therapy after a dosing interruption 4. Evidence that PTH levels are monitored 4 weeks after initiation or dose adjustment and per clinical practice during treatment for maintenance 5. Individual must be taking stable doses of active vitamin D analogs or calcium supplements or phosphate binders. Selection and dosing of each as clinically appropriate 6. Absence of hypersensitivity reaction to Parsabiv, or any of its excipients 7. Individual has failed, or is intolerant to, or has a contraindication such that the individual is unable to use oral Sensipar (cinacalcet) Continuation of Parsabiv is considered medically necessary with documentation of ALL of the following: 1. Evidence that serum calcium levels are monitored within 1 week after initiation or dose adjustment and every 4 weeks during treatment for maintenance Per PI. 2. There has been at least a 30% reduction from baseline in PTH levels 3. Does not have any unacceptable toxicity to Parsabiv (including severe hypocalcemia, ventricular arrhythmia, seizures, heart failure, and upper GI bleeding) O1034.docx Page 3 of 8
Criteria: (cont.) Parsabiv (etelcalcetide) for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 4. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Primary hyperparathyroidism Individuals with chronic kidney disease who are not on hemodialysis Parathyroid carcinoma Treatment with dosing or frequency outside the FDA-approved dosing and frequency O1034.docx Page 4 of 8
Resources: Literature reviewed 11/28/17. We do not include marketing materials, poster boards and nonpublished literature in our review. 1. National Kidney Foundation. The Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. 2003. Parsabiv (etelcalcetide) Package Insert: - FDA-approved indication and dosage: Indication For the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis Recommended Dose Parsabiv is supplied as an injection for intravenous administration. Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of the hemodialysis treatment during rinse back or intravenously after rinse back. Initiating Parsabiv: The recommended starting dose of Parsabiv is 5 mg administered by intravenous (IV) bolus injection three times per week at the end of hemodialysis treatment. If switching from Cinacalcet (Sensipar) to Parsabiv, Cinacalcet must be discontinued at least 7 days prior to initiating Parsabiv Dose Adjustments: The dose may be increased in 2.5 mg or 5 mg increments no more frequently than every 4 weeks A woman should not breast feed while on this drug The safety and efficacy of PARSABIV have not been established in pediatric patients Maintenance Dose: The maintenance dose is individualized and determined by titration based on parathyroid hormone (PTH) and corrected serum calcium response. The maintenance dose range is 2.5 to 15 mg three times per week O1034.docx Page 5 of 8
Resources: (cont.) Parsabiv Package Insert: (cont.) - FDA-approved indication and dosage: (cont.) Indication Recommended Dose Dose Interruption: If a regularly scheduled hemodialysis treatment is missed, do not administer any missed doses. Resume Parsabiv at the end of the next hemodialysis treatment at the prescribed dose. If doses of Parsabiv are missed for more than 2 weeks, re-initiate Parsabiv at the recommended starting dose of 5 mg (or 2.5 mg if that was the patient s last dose). Decrease or temporarily discontinue Parsabiv in individuals with PTH levels below the target range. Consider decreasing or temporarily discontinuing Parsabiv or use concomitant therapies to increase corrected serum calcium in individuals with a corrected serum calcium below the lower limit of normal but at or above 7.5mg/dL without symptoms of hypocalcemia. If the dose is stopped, re-initiate Parsabiv at a lower dose when the PTH is within the target range and hypocalcemia has been corrected. Stop Parsabiv and treat hypocalcemia if the corrected serum calcium falls below 7.5mg/dL or individuals report symptoms of hypocalcemia. Re-initiate Parsabiv at a dose 5mg lower than the last administered dose when the corrected serum calcium is within normal limits, symptoms of hypocalcemia have resolved and predisposing factors for hypocalcemia have been addressed. If the last administered dose was 2.5 mg or 5 mg, re-initiate at a dose of 2.5 mg. O1034.docx Page 6 of 8
Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) 864-4884 for Spanish and (877) 475-4799 for all other languages and other aids and services. If you believe that BCBSAZ 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: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ 85002-3466, (602) 864-2288, TTY/TDD (602) 864-4823, crc@azblue.com. You can file a grievance in person or by mail or email. If you need help filing a grievance BCBSAZ s Civil Rights Coordinator 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 https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, 1 800 368 1019, 800 537 7697 (TDD). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html Multi-Language Interpreter Services: O1034.docx Page 7 of 8
Multi-Language Interpreter Services: (cont.) O1034.docx Page 8 of 8