STRENSIQ (asfotase alfa)

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1 STRENSIQ (asfotase alfa) 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. O976.4.docx Page 1 of 11

2 Description: Strensiq is a tissue nonspecific alkaline phosphatase indicated for the treatment of individuals with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). Definitions: Hypophosphatasia: Hypophosphatasia is an inherited disorder that affects the development of bones and teeth. This condition disrupts a process called mineralization, in which minerals such as calcium and phosphorus are deposited in developing bones and teeth. Mineralization is critical for the formation of bones that are strong and rigid and teeth that can withstand chewing and grinding. The signs and symptoms of hypophosphatasia vary widely and can appear anywhere from before birth to adulthood. The most severe forms of the disorder tend to occur before birth and in early infancy. Hypophosphatasia weakens and softens the bones, causing skeletal abnormalities similar to another childhood bone disorder called rickets. Mutations in the ALPL gene cause hypophosphatasia. The ALPL gene provides instructions for making an enzyme called alkaline phosphatase. Mutations in the ALPL gene lead to the production of an abnormal version of alkaline phosphatase that cannot participate effectively in the mineralization process. A shortage of alkaline phosphatase allows several other substances, which are normally processed by the enzyme, to build up abnormally in the body. Researchers believe that a buildup of one of these compounds, inorganic pyrophosphate (PPi), underlies the defective mineralization of bones and teeth in people with hypophosphatasia. Individuals may present with varying signs and symptoms, history, and inheritance patterns. Adult-Onset HPP: Adult-onset HPP occurs after the age of 18 years. Juvenile-Onset HPP: Juvenile-onset HPP occurs before the age of 18 years. Perinatal/Infantile-Onset HPP: Perinatal/infantile-onset HPP occurs during pregnancy and up to 2 years of age. O976.4.docx Page 2 of 11

3 Criteria: Strensiq will be reviewed by the medical director(s) and/or clinical advisor(s). See Resources section for FDA-approved dosage. Strensiq for the treatment of individuals with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP) is considered medically necessary with documentation of ALL of the following: 1. Documented diagnosis of HPP and ONE or more of the following: One or more of the following clinical features: - Abnormally shaped chest - Craniosynostosis - Defects in dentin (e.g., dental abscesses; early tooth decay) - Enthesopathy (e.g., calcification of tendons, ligaments and joint capsules) - Hypercalcemia - Hyperphosphatemia - Hypertension - Hypophosphatemia - Leg deformities (e.g., bowing, knock knees) - Muscle weakness and myopathy - Nephrocalcinosis - Osteomalacia - Rickets due to hereditary hypophosphatasia - Severe bone pain - Short limbs - Short stature - Slow growth - Unexplained fractures - Vitamin B6-responsive seizures O976.4.docx Page 3 of 11

4 Criteria: (cont.) Strensiq for the treatment of individuals with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP) is considered medically necessary with documentation of ALL of the following: (cont.) 1. Documented diagnosis of HPP and ONE or more of the following: (cont.) Genetic testing and/or counseling to determine a gene mutation in ONE or more of the following genes: - Alkaline phosphatase, liver/bone/kidney (ALPL) gene - Phosphate regulating endopeptidase homolog, X-linked (PHEX) gene - Tissue-nonspecific alkaline phosphatase (TNSALP) gene Serum alkaline phosphatase (ALP) level below the age-adjusted normal range AND plasma pyriodoxal-5 -phosphate (PLP) above the upper limit of normal 2. Ophthalmologic examination is completed prior to initiation of therapy 3. Renal ultrasound is completed prior to initiation of therapy 4. Strensiq is prescribed by a physician experienced in the care of individuals with HPP (e.g., pediatric endocrinologist, metabolic bone disease specialist) Strensiq for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Adult-onset hypophosphatasia Treatment with dosing or frequency outside the FDA-approved dosing and frequency O976.4.docx Page 4 of 11

5 Resources: Literature reviewed 03/07/18. We do not include marketing materials, poster boards and nonpublished literature in our review. 1. Medscape, Plotkin HB. Hypophosphatasia. 12/11/ U.S. National Library of Medicine - Genetics Home Reference. Hypophosphatasia. 12/28/ UpToDate.com. Hereditary hypophosphatemic rickets and tumor-induced osteomalacia. 12/01/ Whyte MP, Greenberg CR, Salman NJ, et al. Enzyme-replacement therapy in life-threatening hypophosphatasia. N Engl J Med. Mar ;366(10): O976.4.docx Page 5 of 11

6 Resources: (cont.) Strensiq Package Insert: - FDA-approved indication and dosage: Indication Perinatal/Infantile-Onset HPP Recommended Dose For subcutaneous use only. Rotate injection sites. Do not administer to areas that are reddened, inflamed or swollen. The recommended dosage of Strensiq is 6mg/kg per week as either: 2 mg/kg three times per week, or 1mg/kg six times per week. The dose of Strensiq may be increase for lack of efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings) up to 9 mg/kg per week administered subcutaneously as 3 mg/kg three times per week. Do not use the 80 mg/0.8 ml vial of Strensiq in pediatric patients weighing less than 40 kg because the systemic exposure of asfotase alfa achieved with the 80 mg/0.8 ml vial (higher concentration). A lower exposure may not be adequate for this subgroup of patients [Refer to Dosage tables listed below] Juvenile-Onset HPP For subcutaneous use only. Rotate injection sites. Do not administer to areas that are reddened, inflamed or swollen. The recommended dosage of Strensiq is 6mg/kg per week as either: 2 mg/kg three times per week, or 1mg/kg six times per week Do not use the 80 mg/0.8 ml vial of Strensiq in pediatric patients weighing less than 40 kg because the systemic exposure of asfotase alfa achieved with the 80 mg/0.8 ml vial (higher concentration). A lower exposure may not be adequate for this subgroup of patients [Refer to Dosage tables listed below] Approval Duration: 12 months O976.4.docx Page 6 of 11

7 Resources: (cont.) Strensiq Package Insert: (cont.) - FDA-approved indication and dosage: (cont.) Table 1 WEIGHT-BASED DOSING FOR ADMINISTRATION OF 2 MG/KG THREE TIMES PER WEEK Body Weight (kg) 1 Dose to Inject Volume to Inject Vial Configuration 3 6 mg 0.15 ml 18 mg/0.45 ml 4 8 mg 0.2 ml 18 mg/0.45 ml 5 10 mg 0.25 ml 18 mg/0.45 ml 6 12 mg 0.3 ml 18 mg/0.45 ml 7 14 mg 0.35 ml 18 mg/0.45 ml 8 16 mg 0.4 ml 18 mg/0.45 ml 9 18 mg 0.45 ml 18 mg/0.45 ml mg 0.5 ml 28 mg/0.7 ml mg 0.75 ml 40 mg/ml mg 1 ml 40 mg/ml mg 1.25 ml Two 28 mg/0.7 ml vials mg 1.5 ml Two 40 mg/ml vials mg 1.75 ml Two 40 mg/ml vials mg 0.8 ml 80 mg/0.8 ml mg 1 ml Two 80 mg/0.8 ml vials mg 1.2 ml 2 Two 80 mg/0.8 ml vials mg 1.4 ml 2 Two 80 mg/0.8 ml vials mg 1.6 ml 2 Two 80 mg/0.8 ml vials O976.4.docx Page 7 of 11

8 Resources: (cont.) Strensiq Package Insert: (cont.) - FDA-approved indication and dosage: (cont.) Table 2 WEIGHT-BASED DOSING FOR ADMINISTRATION OF 1 MG/KG SIX TIMES PER WEEK Body Weight (kg) 1 Dose to Inject Volume to Inject Vial Configuration 3 3 mg 0.08 ml 18 mg/0.45 ml 4 4 mg 0.1 ml 18 mg/0.45 ml 5 5 mg 0.13 ml 18 mg/0.45 ml 6 6 mg 0.15 ml 18 mg/0.45 ml 7 7 mg 0.18 ml 18 mg/0.45 ml 8 8 mg 0.2 ml 18 mg/0.45 ml 9 9 mg 0.23 ml 18 mg/0.45 ml mg 0.25 ml 18 mg/0.45 ml mg 0.38 ml 18 mg/0.45 ml mg 0.5 ml 28 mg/0.7 ml mg 0.63 ml 28 mg/0.7 ml mg 0.75 ml 40 mg/ml mg 0.88 ml 40 mg/ml mg 1 ml 40 mg/ml mg 0.5 ml 80 mg/0.8 ml mg 0.6 ml 80 mg/0.8 ml mg 0.7 ml 80 mg/0.8 ml mg 0.8 ml 80 mg/0.8 ml mg 0.9 ml Two 80 mg/0.8 ml vials mg 1 ml Two 80 mg/0.8 ml vials O976.4.docx Page 8 of 11

9 Resources: (cont.) Strensiq Package Insert: (cont.) - FDA-approved indication and dosage: (cont.) Table 3 WEIGHT-BASED DOSING FOR ADMINISTRATION OF 3MG/KG THREE TIMES PER WEEK ONLY FOR PERINATAL/INFANTILE-ONSET HPP Body Weight (kg) 1 Dose to Inject Volume to Inject Vial Configuration 3 9 mg 0.23 ml 18 mg/0.45 ml 4 12 mg 0.3 ml 18 mg/0.45 ml 5 15 mg 0.3 ml 8 18 mg/0.45 ml 6 18 mg 0.45 ml 18 mg/0.45 ml 7 21 mg 0.53 ml 28 mg/0.7 ml 8 24 mg 0.6 ml 28 mg/0.7 ml 9 27 mg 0.6 ml 8 28 mg/0.7 ml mg 0.75 ml 40 mg/ml mg 1.13 ml 2 Two 28 mg/0.7 ml vials mg 1.5 ml 2 Two 40 mg/ml vials mg 1.88 ml 2 Two mg/ml vials 1 Do not use the 80 mg/0.8 ml vial of Strensiq in pediatric patients weighing less than 40 kg. 2 When preparing a volume for injection greater than 1 ml, split the volume equally between two syringes, and administer two injections. When administering the two injections, use two separate injection sites. O976.4.docx Page 9 of 11

10 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) for Spanish and (877) 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 , (602) , TTY/TDD (602) , crc@azblue.com. You can file a grievance in person or by mail or . 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 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, , (TDD). Complaint forms are available at Multi-Language Interpreter Services: O976.4.docx Page 10 of 11

11 Multi-Language Interpreter Services: (cont.) O976.4.docx Page 11 of 11

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