Medication Prior Authorization Form

Transcription

1 Reclast (Zoledronic Acid) Policy Number: 1050 Policy History Approve Date: 12/11/2015 Revise Dates: 8/22/2016 Next Review: 12/11/2016 Review Dates: 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 WEA Trust does NOT reimburse for brand Reclast (zoledronic acid) I. Zoledronic acid 5 mg is FDA indicated for the treatment of: A. Glucocorticoid-induced osteoporosis B. Osteoporosis in men C. Paget disease of bone D. Postmenopausal osteoporosis

2 Page 2 II. Zoledronic acid is medically necessary when one of the following conditions are met: A. Osteoporosis, treatment to increase bone mass in men when at least one or more of the following are met: i. Femoral neck, spine, or total hip bone mineral density T-score minus 2.5 or less ii. Hip or vertebral fragility (i.e., low-trauma) fracture in patient older than 50 years iii. Osteoporosis secondary to hypogonadism and failure of or intolerance to testosterone iv. Ten year probability of hip fracture 3 percent or a ten year probability of any major osteoporosisrelated fracture 20 percent based upon the US adapted WHO algorithm AND v. Individual has failed an adequate course of therapy, defined by adhering to therapy at least 80% (PDC at least 0.80) of a treatment period of at least one year, or is intolerant to other available osteoporosis therapies (e.g. bisphosphonates) CALCULATED BY WEA PHARMACY OR B. Osteoporosis, treatment in postmenopausal women when at least one or more of the following are met: i. Femoral neck, spine, or total hip bone mineral density T-score minus 2.5 or less ii. Hip or vertebral fragility (i.e., low-trauma) fracture in female older than 50 years iii. Ten year probability of hip fracture 3 percent or a ten year probability of any major osteoporosisrelated fracture 20 percent based upon the US-adapted WHO algorithm AND iv. Individual has failed an adequate course of therapy, defined by adhering to therapy at least 80% (PDC at least 0.80) of a treatment period of at least one year, or is intolerant to other available osteoporosis therapies (e.g. bisphosphonates) CALCULATED BY WEA PHARMACY OR C. Glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 10 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months OR I. Paget s disease of bone in men and women- treatment indicated with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease OR J. Prevention of osteoporosis during androgen deprivation therapy in prostate cancer Renewal Criteria I. Osteoporosis: Once annually based on meeting criteria II. Paget s disease: Once annually based on meeting criteria References 1. Lexicomp and FDA approved product labeling Rosen, HN and Drezner, MK UpToDate April 17, 2015 Overview of the Management of Osteoporosis in Postmenopausal Women 3. Mhaskar R, Redzepovic J, Wheatley K, Clark OA, Miladinovic B, Glasmacher A, Kumar A, Djulbegovic B Bisphosphonates in multiple myeloma. Cochrane Database Syst Rev NCCN practice guidelines. Multiple Myeloma 5. NCCN guidelines. Breast Cancer 6. Stopeck AT, Lipton A, Body JJ, Steger GG, Tonkin K, de Boer RH, Lichinitser M, Fujiwara Y, Yardley DA, Viniegra M, Fan M, Jiang Q, Dansey R, Jun S, Braun A Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study. J Clin Oncol. 2010;28(35): NCCN Guidelines Prostate Cancer 8. Fizazi K, Carducci M, Smith M, Damião R, Brown J, Karsh L, Milecki P, Shore N, Rader M, Wang H, Jiang Q, Tadros S, Dansey R, Goessl C Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study. Lancet. 2011;377(9768): El-Amm J, Freeman A, Patel N, Aragon-Ching JB. Bone-targeted therapies in metastatic castration-resistant prostate cancer: evolving paradigms. Prostate Cancer. 2013;2013: Safra T, Bernstein-Molho R, Greenberg J, Pelles-Avraham S, Stephansky I, Sarid D, Inbar MJ, Stemmer SM,

3 Page 3 Geffen DB The protective effect of zoledronic acid on bone loss in postmenopausal women with early breast cancer treated with sequential tamoxifen and letrozole: a prospective, randomized, phase II trial. Oncology. 2011;81(5-6): Epub 2011 Dec Brufsky AM, Bosserman LD, Caradonna RR, Haley BB, Jones CM, Moore HC, Jin L, Warsi GM, Ericson SG, Perez EA Zoledronic acid effectively prevents aromatase inhibitor-associated bone loss in postmenopausal women with early breast cancer receiving adjuvant letrozole: Z-FAST study 36-month follow-up results. Clin Breast Cancer. 2009;9(2): McClung M, Miller P, Recknor C, Mesenbrink P, Bucci-Rechtweg C, Benhamou CL.Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: a randomized controlled trial. Obstet Gynecol Nov;114(5): National Osteoporosis Foundation Clinician s Guide to prevention and treatment of osteoporosis Issue Version 1. Release date: April 1, 2014 http: //nof.org/files/nof/public/content/file/2610/upload/895.pdf

4 Page 4 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 Reclast (zoledronic acid) 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. A RESPONSE IS REQUIRED FOR EACH OF THE FOLLOWING: Patient has glucocorticoid-induced osteoporosis and is either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 10 mg or greater of prednisone and is expected to remain on glucocorticoids for at least 12 months Patient is male with osteoporosis and is using zoledronic acid for treatment to increase bone mass after having failed a trial of an oral bisphosphonate which was adhered to at least 80% over a period of one year OR oral bisphosphonate is contraindicated Patient is a postmenopausal woman with osteoporosis and is using zoledronic acid for treatmentafter having failed a trial of an oral bisphosphonate which was adhered to at least 80% over a period of one year OR bisphosphonate is contraindicated Patient has Paget s disease of bone and is using zoledronic acid for treatment indicated with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age- specific normal reference range, or is symptomatic, or at risk for complications from the disease Patient has history of hip or vertebral fracture T-score -2.5 (DXA) at the femoral neck or spine, after appropriate evaluation to exclude secondary cau

5 Page 5 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 P.O. Box 7338 Madison, WI