They are intended to reflect Highmark’s reimbursement and coverage guidelines. They don’t guarantee results or outcomes. Once you accept the terms and conditions below, you’ll be connected to the Medical Policy Portal. The use of the target agent is for an indication that is supported by compendia. This medical policy relates only to the services or supplies described herein. They address common medical situations. Policy: Requests must be supported by submission of chart notes and patient specific documentation. Please keep in mind that: The policies aren’t medical advice. Soliris works by blocking a part of the immune system called complement. Soliris® (eculizumab) FDA approval: 03/16/2007 HCPCS: J1300 . This policy may be updated and therefore subject to change. This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Please refer to the Member's Benefit Booklet for availability of benefits. Revised 11/19/19 Soliris is medically necessary when all of the following criteria are met: Initial Therapy: o Submission of medical records (e.g., chart notes, laboratory values, etc.) Soliris is proven for the treatment of generalized Myasthenia Gravis.1,9,11. You can review our medical policies online any time. In … Life- 500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM Soliris (eculizumab) will also be approved when the following are met: 1. By blocking complement, Soliris reduces the destruction of red blood cells and improves the symptoms of PNH. MBP 54.0 Soliris (eculizumab) Soliris (eculizumab) is approved by the FDA for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). information. Effective Date: 12/03/2020 . Internal Medical Policy Committee 11-19-2020 Adopt new policy to replace I-130-011 Eculizumab (Soliris) and Ravulizumab (Ultomiris) effective 1/1/2021, new policy requires trial of ravulizumab-cwvz (Ultomiris) before eculizumab (Soliris) for a diagnosis of PNH or aHUS. Note that market specific restrictions or transition-of-care benefit limitations may apply. Our medical policies include evidence-based treatment guidelines. Treating providers are solely responsible for medical advice and related treatment of members. to support the diagnosis of generalized Users also may search for a particular policy using the search box. Medical Policy: I-130-005: Topic: Eculizumab (Soliris) Section: Injections: Effective Date: May 28, 2018: Issue Date: May 28, 2018: Last Reviewed: February 2018 CRX-ALL-0488-20 Note: Soliris (eculizumab) has a black box warning for serious meningococcal infections. Benefit: Medical . CPT is protected by copyright and trademark owned by the American Medical Association ("AMA"). Information about medical and pharmacy coverage policies can be found at Humana for Healthcare Providers by selecting “Medical and pharmacy coverage policies” under “Resources.” Policies can be reviewed by name or revision date. Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. Our Medical Policies contain Physician Current Procedural Terminology ("CPT"), a coding work of nomenclature and five-digit codes for reporting of physician services. What Are Medical Policies? Site of care management requires a number of targeted medications (e.g., immune globulins, Remicade, Soliris) to be administered in a non-hospital facility based location (i.e., home, provider’s office or ambulatory infusion site) unless certain medical necessity criteria are met. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy. The Medical Policy Portal offers streamlined navigation to the various types of policies available.