Medication Prior Authorization Form

Transcription

1 (Orelizumab) Policy Number: 1073 Policy History Approve Date: 05/19/2017 Effective Date: 05/19/2017 Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for certain service(s) listed in this policy. Decisions for authorization are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations as well as applicable state and/or federal laws. Please review the benefit plan descriptions for details. We utilize a combination of MCG and internally developed evidence-based clinical guidelines to support our prior authorization work. All internally developed prior authorization guidelines follow a rigorous process including, but not limited to, review by clinical pharmacist, clinical nurse manager, Chief Medical Officer, independent 3 rd party physician review agency and WEA Trust s Medical Advisory Committee. Prior authorization guidelines are reviewed at least annually, or when there are significant labeling changes made by FDA or peer-reviewed clinical outcomes (via Cochrane or Hayes). INSTRUCTIONS: Please review section I and complete sections II, III, and IV (type or print clearly). Prescribers are asked to submit this form along with supporting clinical documentation to the WEA Trust for review. Submission of form does not guarantee approval. Submit preauthorization (PA) by fax to the WEA Trust at (608) or by mail to WEA Trust, Pharmacy Services Prior Authorization, P.O. Box 7338, Madison, WI Section I Approval Criteria I. Orelizumab () is medically necessary for: A. Individuals diagnosed with primary progressive multiple sclerosis (MS) with evidence of one year of disease progression (worsening neurological function without remission) PLUS two or more of the following criteria: i. Dissemination in space in the brain based upon one or more T2 lesions in at least one area characteristic for MS (periventricular, juxtacortical, or infratentorial) ii. Two or more lesions of the same type in the spinal cord iii. Positive cerebrospinal fluid findings with isoelectric focusing evidence of oligoclonal bands and/or elevated IgG index II. Orelizumab () is not medically necessary and excluded forall other uses and for individuals with any of the following: A. Types of MS other than primary progressive OR B. Current or prior history of progressive multifocal leukoencephalopathy (PML) OR

2 Page 2 C. Medical condition which significantly compromises the immune system including HIV infection or AIDS, leukemia, lymphoma or organ transplantation OR D. Receiving chronic antineoplastics or immunosuppressants (for example, azathioprine) OR E. Receiving any other immune system modifying drugs such as interferon beta-1 (for example, Avonex) OR F. Positive screening for hepatitis B viral infection G. Positive pregnancy test or breast feeding H. Diagnosis of breast cancer I. Active Infection (upper or lower respiratory tract infection or skin infection) J. Received a live or live attenuated vaccine in the previous six weeks Renewal Criteria I. All renewals will be for six months if there is no evidence of further progression of disease and in the absence of significant adverse effects. References 1. Montalban X, Hauser SL, Kappos L, et al. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017;376(3): Package Insert 3. ICER report: Disease-Modifying Therapies for Relapsing-Remitting and Primary-Progressive Multiple Sclerosis: Effectiveness and Value; March Olek, M. (2017). Treatment of progressive multiple sclerosis for adults. In J.A. melin (Ed.), UpToDate. Retrieved May 2, 2017.

3 Page 3 Section II Member Information Name (Last, First, Middle Initial) Date of Birth WEA Trust Subscriber Number Diagnosis 1. MEDICATION 2. STRENGTH 3. DIRECTIONS 4. QUANTITY PER 30 DAYS (Orelizumab) Specify: 5. DIAGNOSIS: 6. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY NOTE: Any areas not filled out are considered not applicable to your patient and MAY AFFECT THE OUTCOME of this request. Patient has a relapsing form of multiple sclerosis (MS) Tysabri (natalizumab) is being used as monotherapy Patient has had an inadequate response to at least two less toxic agents (glitiramer acetate, dimethyl fumarate or interferon beta-1a/pegylated interferon beta-1a) with established adherence of at least 80% over two subsequent years, or is unable to tolerate alternative treatments for MS Patient is an adult with moderate to severe Crohn s disease (CD) Patient has evidence of inflammation Tysabri (natalizumab) is being used for induction and maintenance of clinical response and remission Patient has had an inadequate response to, which includes adhering to therapy at least by 80% (CALCULATED BY WEA PHARMACY) over the previous year, or is unable to tolerate conventional CD therapies and inhibitors of TNF-a Patient is enrolled in and has met all conditions of the CD Touch Prescribing Program Patient has a type of MS other than relapsing forms Patient is currently responsive to and tolerating another treatment for the prescribed indication Patient has current or prior history of progressive multifocal leukoencephalopathy (PML) Patient has a medical condition which significantly compromises the immune system including HIV infection or AIDS, leukemia, lymphoma or organ transplantation Patient is receiving chronic antineoplastics or immunosuppressants (for example, azathioprine) Patient is receiving any other immune system modifying drug such as interferon beta-1 (for example, Avonex) Patient has positive test results for anti John Cunningham virus (JCV) antibodies

4 Page 4 Section III Physician Information Physician Name National Provider Identification (NPI) Number Clinic Name Address (Street, City, State, Zip Code) Physician Telephone Number Physician Fax Number Physician Signature Date Section IV For WEA Trust Use Only Plan: Copay Tiers: Date of Receipt: Remarks: Approve Deny More information is needed Incomplete form Submission and review of this form does not guarantee approval of this request. Unless approved, payment of the brand-name medication will be limited to the amount the Trust would have paid for the generic equivalent. Insureds and providers will be informed of the decision in writing within approximately 30 days. Fax to: Pharmacy Services (608) Mail to: WEA Trust Pharmacy Services Prior Authorization PO Box Eagan MN

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