BlueCross BlueShield of Tennessee Medical Policy Manual

Romosozumab-aqqg

NDC CODE(S)

55513-0880-XX Evenity 105 MG/1.17ML SOSY (AMGEN)

DESCRIPTION

Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin.  Romosozumab-aqqg inhibits the action of sclerostin, a regulatory factor in bone metabolism. Romosozumab-aqqg increases bone formation and, to a lesser extent, decreases bone resorption (or bone loss).

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*Patients with extremely low BMD (T<-3.5) or a T<-2.5 with a history of fragility fractures are not subject to prior trial and failure requirements with bisphosphonates and/or denosumab

 

**Ineffective response defined as one or more of the following:

·         Decrease in T-score in comparison with baseline T-score from DXA scan

·         Patient has a new fracture while on bisphosphonate therapy

***Examples of contraindications to oral bisphosphonate therapy include the following:

·         Documented inability to sit or stand upright for at least 30 minutes

·         Documented pre-existing gastrointestinal disorder such as inability to swallow, Barrett’s esophagus, esophageal stricture, dysmotility, or achalasia 

***Examples of contraindications to injectable bisphosphonate therapy include the following:

·         Documented pre-existing hypocalcemia and disturbances of mineral metabolism

·         Documented pre-existing renal insufficiency defined as creatinine clearance < 35 mL/min

***Examples of contraindications to RANKL-blocking therapy include the following:

·         Documented pre-existing hypocalcemia and disturbances of mineral metabolism

·         Documented hypersensitivity to the active ingredient or its excipients

RENEWAL CRITERIA

INDICATION

DOSAGE & ADMINISTRATION

Osteoporosis

Administer 210 mg subcutaneously (as two separate subcutaneous injections

of 105 mg each) by a health care provider every month for a total of 12* monthly doses.

*Note: The anabolic effect of Evenity wanes after 12 monthly doses of therapy. Therefore, the duration of Evenity use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered.

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 months and may NOT be renewed.

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION  

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Eastell R, Rosen CJ, Black DM, et al. Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline. J Clin Endo Metab, Vol 104, Iss 5, May 2019, pps 1595–1622, https://doi.org/10.1210/jc.2019-00221

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, April). Romosozumab-aqqg  Retrieved June 17, 2019 from MICROMEDEX Healthcare Series. 

U. S. Food and Drug Administration. (2019,April). Center for Drug Evaluation and Research. Evenity™ (romosozumab-aqqg). Retrieved May 06, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761062s000lbl.pdf

ORIGINAL EFFECTIVE DATE:  9/30/2019

MOST RECENT REVIEW DATE:  9/30/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit

DIAGNOSIS

MAXIMUM UNITS

Osteoporosis

Evenity 210 mg every 1 month