Medical Policy Updates

Notification of Policy Revisions Effective January 1, 2021 (Posted October 27, 2020)

Medical Policy Revision
Botulinum Toxin Injection "Notification" Added the following to "When Covered" section for blepharospasm, "if the request is for Botox and the patient is 18 years of age or older, the patient has tried and had an inadequate response to OR has a clinical contraindication or intolerance to Xeomin." Updated criteria for requirement of trial of CGRP product for chronic migraine for clarity with no change to policy intent. Added the following criteria requirement for Dystonia/Spasticity: "If the request is for Botox, the patient has tried and had an inadequate response to OR has a clinical contraindication or intolerance to Xeomin and Dysport." Updated "When Covered" section from "upper limb spasticity" to "spasticity" for consistency with FDA label. Updated indications in "Description" section for Dysport. Reference added. Medical Director review 10/2020. Specialty Matched Consultant Advisory Panel review 10/21/2020. Notification given 10/27/2020 for effective date 1/1/2021.
Eculizumab (Soliris®) "Notification" Added continuation criteria in "When Covered" section for all indications. For NMOSD, added the following criteria to "When Covered" section: "The patient will not receive eculizumab concurrently with other biologics used to treat NMOSD (e.g., inebilizumab, satralizumab)," and "the patient has tried and had an inadequate response to inebilizumab (Uplizna) AND satralizumab (Enspryng), OR the patient has a clinical contraindication or intolerance to both inebilizumab and satralizumab." For aHUS and PNH, added the following criteria: "The patient will not receive eculizumab concurrently with other complement inhibitors (e.g., ravulizumab)." Edits made throughout policy to clarify intent. Added reference to the following related medical and pharmacy policies: "Inebilizumab-cdon (UpliznaTM)" and "EnspryngTM". Medical Director review 10/2020. Policy notification given 10/27/2020 for effective date 1/1/2021.
Interleukin-5 Antagonists "Notification" Under "When Covered" section, added coverage for mepolizumab (Nucala) for treatment of hypereosinophilic syndrome (HES) when specific criteria are met for new indication). Added the following criteria within initial/continuation coverage sections: "The patient will not be receiving the requested agent in combination with another biologic immunomodulator agent used for the same indication (i.e., mepolizumab, benralizumab, reslizumab, omalizumab, dupilumab)." Minor edits made to policy formatting for clarity. References added. Medical Director review 10/2020. Notification given 10/27/2020 for effective date 1/1/2021.
Monoclonal Antibodies for Non-Hodgkin Lymphoma and Acute Myeloid Leukemia In the Non-Hematopoietic Stem Cell Transplant Setting "Notification" Added the following requirements to "When Covered" section: "If the request is for rituximab (Rituxan) or non-preferred rituximab biosimilars, then both of the following criteria are met: patient has a documented serious adverse event that required medical intervention to both preferred rituximab biosimilar products [rituximab-abbs (Truxima), rituximab-pvvr (Ruxience)] that is not anticipated with the requested product AND prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form." Minor typographical and formatting changes made throughout for clarity. Medical Director review 10/2020. Policy notification given 10/27/2020 for effective date 1/1/2021.
Oncologic Uses of Bevacizumab (Avastin®) and Bevacizumab Biosimilars "Notification" Added the following requirements to "When Covered" section: "If the request is for bevacizumab (Avastin) or non-preferred bevacizumab biosimilars, then both of the following criteria are met: patient has a documented serious adverse event that required medical intervention to both preferred bevacizumab biosimilar products [bevacizumab-awwb (Mvasi), bevacizumab-bvzr (Zirabev)] that is not anticipated with the requested product AND prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form." Minor typographical and formatting changes made throughout for clarity. Medical Director review 10/2020. Policy notification given 10/27/2020 for effective date 1/1/2021.
Rituximab for the Treatment of Rheumatoid Arthritis "Notification" Added the following requirements to "When Covered" section: "If the request is for rituximab (Rituxan) or non-preferred rituximab biosimilars, then both of the following criteria are met: patient has a documented serious adverse event that required medical intervention to both preferred rituximab biosimilar products [rituximab-abbs (Truxima), rituximab-pvvr (Ruxience)] that is not anticipated with the requested product AND prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form." Medical Director review 10/2020. Policy remains on notice for effective date 1/1/2021.
Trastuzumab (Herceptin®) and Trastuzumab Biosimilars "Notification" Added the following requirements to "When Covered" section: "Trastuzumab (Hereptin) and trastuzumab biosimilars (trastuzumab-dkst, trastuzumab-pkrb, trastuzumab-dttb, trastuzumab-qyyp, trastuzumab-anns) may be considered medically necessary when the following criteria are met: If the request is for trastuzumab (Herceptin) or non-preferred trastuzumab biosimilars, then both of the following criteria are met: patient has a documented serious adverse event that required medical intervention to both preferred trastuzumab biosimilar products [trastuzumab-anns (Kanjinti), trastuzumab-dkst (Ogivri)] that is not anticipated with the requested product; AND prescriber has completed and submitted an FDA MedWatch Adverse Event Reporting Form." Medical Director review 10/2020. Policy notification given 10/27/2020 for effective date 1/1/2021.
Xolair® (Omalizumab) "Notification" Added the following criteria within initial/continuation coverage sections: "The patient will not be receiving Xolair (omalizumab) in combination with another biologic immunomodulator agent used for the same indication (i.e., mepolizumab, benralizumab, reslizumab, dupilumab)." Minor typographical edits made throughout policy for clarity. Medical Director review 10/2020. Notification given 10/27/2020 for effective date 1/1/2021.