Anthem Blue Cross California Tysabri (natalizumab) Form

Medical Drug Clinical Criteria Subject: Tysabri (natalizumab) Document #: CC-0020 Publish Date: 03/27/2023 Status: Revised Last Review Date: 08/19/2022 Table of contents Overview Clinical criteria Overview Coding Document history References This document addresses the use of Tysabri (natalizumab), approved by the Food and Drug Administration (FDA) as an infused monotherapy for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease or active secondary progressive disease. Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating and continuing treatment, physicians should consider whether the expected benefit is sufficient to offset the risk. Tysabri is also approved to induce and maintain clinical response and remission in adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to conventional Crohn’s disease therapies and TNF-α inhibitors. Multiple sclerosis is an autoimmune inflammatory demyelinating disease of the central nervous system. Common symptoms of the disease include fatigue, numbness, coordination and balance problems, bowel and bladder dysfunction, emotional and cognitive changes, spasticity, vision problems, dizziness, sexual dysfunction and pain. Multiple sclerosis can be subdivided into four phenotypes: clinically isolated syndrome (CIS), relapsing remitting (RRMS), primary progressive (PPMS) and secondary progressive (SPMS). Relapsing multiple sclerosis (RMS) is a general term for all relapsing forms of multiple sclerosis including CIS, RRMS and active SPMS. The treatment goal for multiple sclerosis is to prevent relapses and progressive worsening of the disease. Currently available disease- modifying therapies (DMT) are most effective for the relapsing-remitting form of multiple sclerosis and less effective for secondary progressive decline. DMT include injectable agents, infusion therapies and oral agents. The American Academy of Neurology (AAN) guidelines suggest starting disease-modifying therapy in individuals with relapsing forms of multiple sclerosis with recent clinical relapses or MRI activity. The guidelines also suggest DMT for individuals who have experienced a single clinical demyelinating event and two or more brain lesions consistent with multiple sclerosis if the individual wishes to start therapy after a risks and benefits discussion. The guidelines do not recommend one DMT over another. However, some DMTs were recommended for certain multiple sclerosis subpopulations, including a recommendation for Tysabri for highly active disease. Crohn’s disease is a chronic, relapsing inflammatory bowel disease affecting the gastrointestinal mucosa. Fistula formation, fissuring, discontinuous intestinal and transmural involvement with bowel-wall thickening and extraintestinal manifestations including arthritis, skin and eye manifestations, metabolic deficiencies, hypercoagulation and hepatobiliary disease are frequent complications. Treatment options include 5-ASA products, glucocorticoids, antibiotics, immunosuppressive drugs, methotrexate and targeted immune modulator agents. Tysabri has a black box warning for progressive multifocal leukoencephalopathy (PML). Tysabri increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior use of immunosuppressants and presence of anti-JCV antibodies. Monitor patients and withhold Tysabri immediately at the first sign or symptom suggestive of PML. Because of this safety concern, Tysabri has been generally reserved for individuals who have had an inadequate response or are unable to tolerate alternate therapies for multiple sclerosis or Crohn’s disease. Tysabri is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH Prescribing Program. Clinical Criteria When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose. 1 Tysabri (natalizumab) Requests for Tysabri (natalizumab) may be approved if the following criteria are met: I. II. III. IV. V. AND VI. Individual has a diagnosis of relapsing multiple sclerosis (RMS) (including clinically isolated syndrome, relapsing-remitting disease or active secondary progressive disease); AND Individual is enrolled in and meeting all conditions of the MS Touch Prescribing Program; OR Individual has a diagnosis of moderate to severe Crohn’s disease (CD) with evidence of inflammation and is using Tysabri for induction and maintenance of clinical response and remission; AND Individual has had an inadequate response to or is unable to tolerate conventional Crohn’s disease therapies and TNF-α inhibitors; AND Individual is enrolled in and meeting all conditions of the CD Touch Prescribing Program; Individual has had a John Cunningham virus (JCV) antibody test and the results as well as risks and benefits have been discussed and understood. Tysabri (natalizumab) may not be approved for the following: Individual is using to treat primary progressive multiple sclerosis ; OR Individual is using to treat non-active secondary progressive multiple sclerosis; OR Individual is currently responsive to and tolerating another treatment for multiple sclerosis or Crohn’s disease; OR I. II. III. IV. Individual has a current or prior history of progressive multifocal leukoencephalopathy (PML); OR V. Individual has a medical condition which significantly compromises the immune system including HIV infection or AIDS, leukemia, lymphoma or organ transplantation; OR VI. Use in combination with chronic antineoplastics, immunosuppressants (for example, azathioprine) or TNF-α inhibitors; OR VII. Use in combination with other MS disease modifying agents (including Aubagio, Avonex, Bafiertam, Betaseron, Copaxone/Glatiramer/Glatopa, Extavia, Gilenya, Kesimpta, Lemtrada, Mavenclad, Mayzent, Ocrevus, Plegridy, Ponvory, Rebif, Tecfidera, Vumerity and Zeposia); OR VIII. May not be approved when the above criteria are not met and for all other indications. Step Therapy Note: When Tysabri (natalizumab) is deemed approvable based on the clinical criteria referenced above, the benefit plan may have additional criteria requiring the use of a preferred1 agent or agents. Tysabri Step Therapy A list of the preferred products is available here. Requests for Tysabri (natalizumab) for Multiple Sclerosis may be approved when the following criteria are met: I. Individual has been on Tysabri (natalizumab); OR II. OR III. Documentation has been provided that individual has had a trial and inadequate response (including but not limited to confirmed clinical relapse, new or enlarged lesions on MRI or confirmed disability progression) or intolerance to the following: A. Preferred fumaric acid derivative; May approve for individual with high disease activity despite treatment with fingolimod (Gilenya, Tascenso ODT) defined as the following (AAN 2018, Devonshire 2012): A. At least one relapse in the previous year while on therapy; AND B. At least 9 T 2-hyperintense lesions in cranial MRI; OR C. At least one Gadolinium-enhancing lesion. 2 1Preferred, as used herein, refers to agents that were deemed to be clinically comparable to other agents in the same class or disease category but are preferred based upon clinical evidence and cost effectiveness. Quantity Limits Tysabri (natalizumab) Quantity Limit Tysabri (natalizumab) 300 mg/15 mL single-use vial 1 vial per 28 days Drug Limit Coding The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. HCPCS J2323 Injection, natalizumab, 1 mg [Tysabri] ICD-10 Diagnosis G35 Multiple sclerosis K50.00-K50.919 Crohn’s disease [regional enteritis] Z01.84 Encounter for antibody response examination Document History Revised: 8/19/2022