Criteria Document: Reference #: PC/A011 Page 1 of 5 PRODUCT APPLICATION: PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group PURPOSE: The intent of the criteria document is to: Ensure the intended use is medically necessary; and Require a failed trial of oral/self-administered drug(s) before an infused/subcutaneous drug for osteopenia, osteoporosis; and To consider overall cost effectiveness where it is appropriate. Table 1: Infused/Subcutaneous Drugs Drugs Boniva zoledronic acid Route of Administration intravenous injection subcutaneous injection administered by a healthcare professional intravenous infusion Generics available FYI ONLY Generic Name Drug Class N ibandronate bisphosphonate N/A denosumab monoclonal antibody N/A zoledronic acid bisphosphonate GUIDELINES: Medical Necessity Criteria Must satisfy one of the following: I - III I. Initial request for Boniva injection,, or zoledronic acid (Reclast) for prevention and/or treatment of osteopenia and/or osteoporosis must have one of the following: A-D A. The member has not responded to, is intolerant to, responds to but cannot taper off without recurrent symptoms, or is a poor candidate two oral/self-administered /non-infused drugs (see Table 2) with different mechanisms of action, ie, from different drug classes; or B. The request is for, and the member has severe renal impairment/chronic kidney disease (CKD) with a creatinine clearance less than 35mL/min; or C. The member has a pre-existing condition that precludes the use of an oral bisphosphonate, such as but not limited to one of the following: 1-5 1. The member cannot swallow; or 2. The member has abnormalities that delay esophageal emptying (stricture, achalasia); or 3. The member has esophageal lesions or esophageal ulcers; or 4. The member cannot remain in an upright position post oral administration; or 5. The member is status post restrictive bariatric procedure.
Criteria Document: Reference #: PC/A011 Page 2 of 5 D. The member has gastroesophageal reflux disease (GERD) symptoms from a trial of oral bisphosphonates documentation of both of the following: 1 and 2 1. Patient education regarding taking medication with adequate amount of water while in an upright position, taking at an appropriate interval prior to or after the first food or drink of day, remaining in an upright position for a period of time after taking the medication; and 2. Persistent GERD symptoms despite adequate treatment with use of H2-blockers or proton pump inhibitors. Table 2: Oral/Self-Administered/Non-infused Medications* FYI ONLY DRUGS Route of Generics Biosimilars DRUG CLASS Generic Name Administration available available Actonel oral N N/A risedronate tablets bisphosphonate 5mg, 30mg, 35mg risedronate 150mg tablets oral N/A N/A risedronate tablets bisphosphonate Boniva oral Y N/A ibandronate tablets bisphosphonate selective estrogen Evista oral Y N/A raloxifene tablets receptor modulator recombinant human subcutaneous Forteo N N/A teriparatide parathyroid hormone injection (PTH) alendronate tablets Fosamax oral Y N/A bisphosphonate & oral solution * Listing of drugs in table above does not ensure coverage. Please check member s prescription benefit. Revised 11/09/16 II. Initial request for other diagnoses must have one of the following: A-C A. Initial request for pamidronate - must have one of the following: 1-4 1. Bone metastasis from breast cancer; or 2. Hypercalcemia of malignancy; or 3. Paget s disease that has not responded to, is intolerant to, responds to but cannot taper off without recurrent symptoms, or is a poor candidate for one oral and/or self-administered drug(s); or 4. Multiple myeloma. B. Initial request for Xgeva must have one of the following: 1-3 1. Hypercalcemia of malignancy; or 2. Bone metastases from solid tumors, for prevention of skeletal-related events; or 3. Giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, for treatment of adults and skeletally mature adolescents. C. Initial request for zoledronic acid (Zometa) - must have one of the following: 1-5 1. Adjuvant therapy in premenopausal women with estrogen-responsive early stage breast cancer and are receiving endocrine or hormone suppression therapy (eg, tamoxifen); or 2. Bone metastasis from solid tumors; or 3. Hypercalcemia of malignancy; or 4. Paget s disease that has not responded to, is intolerant to, responds to but cannot taper off without recurrent symptoms, or is a poor candidate for one oral and/or self-administered drug(s); or
Criteria Document: Reference #: PC/A011 Page 3 of 5 5. Multiple myeloma. III. Continuation request must meet both of the following: A and B A. The member has been previously approved by PreferredOne for the medication being requested; and B. There has been a positive clinical response to therapy, ie, no deterioration of bone density T-score, or an increase in bone density T-score. DEFINITIONS: T-score: A measurement of bone density compared with what is normally expected in a healthy young adult of the same gender. It is expressed in number of units (standard deviations) that the bone density is above or below the average. T-score What the score means -1 and above Bone density is considered normal. Between -1 and -2.5 A sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. 2.5 and below Likely have osteoporosis BACKGROUND: This criteria document is based on U.S. Food and Drug Administration (FDA) approved indications and dosing, expert consensus opinion and/or available reliable evidence.
Criteria Document: Reference #: PC/A011 Page 4 of 5 FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes - initial authorize for 12 months; continued use, authorize for 24 months Coverage is subject to the member s contract benefits. CODING: HCPCs J0897 injection, denosumab 1mg J1740 injection, ibandronate sodium, 1 mg J2430 injection, pamidronate disodium, per 30mg J3489 injection, zoledronic acid, 1mg Coverage is subject to the terms of a member s benefit plan. To the extent there is any inconsistency between this criteria document or policy and the terms of a member s benefit plan, the member s benefit plan governs. Approval of a drug under this criteria document does not ensure full coverage of the drug. RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria REFERENCES: 1. National Osteoporosis Foundation. Clinician s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2010. 2. National Pharmaceutical Services. Drug Class Review Parenteral Bisphosphonates Agents. 2013. 3. National Pharmaceutical Services. Drug Class Review Metabolic Bone Disease Agents, Others. 2013. 4. Gnant M, Mlineritsch B, Stoeger, H, et al. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABSCG-12 randomised trial. Lancet Oncolo. 2011 Jul;12(7):631-41. 5. Valachis A, Polyzos NP, Coleman RE, Gnant M, et al. Adjuvant therapy with zoledronic acid in patients with breast cancer; a systematic review and meta-analysis. Oncologist 2013;18(4):353-61. 6. HeM, Fan W, Zhang X. Adjuvant zoledronic acid therapy for patients with early stage breast cancer: an updated systematic review and meta-analysis. J Hematol Oncol. 2013 Oct 23;6(1):80. 7. Boniva injection [package insert]. South San Francisco, CA: Genentech USA, Inc; 2015 8. Pamidronate [package insert]. Bedford, OH: Bedford Laboratories; 2014 9. Reclast [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016 10. Zometa [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016 11. Zoledronic acid [package insert]. Schaumberg, IL: Sagent Pharmaceuticals; 2015 DOCUMENT HISTORY: Created Date: 09/30/16 (previously part of PC/B009) Reviewed Date: Revised Date: 02/13/17, 03/20/17
Attachment A INDICATIONS Treatment of osteoporosis in postmenopausal women DRUGS Boniva pamidronate zoledronic acid denosumab X Treatment and prevention of postmenopausal osteoporosis Reclast Tx to increase bone mass in men with osteoporosis Reclast Treatment and prevention of glucocorticoid- induced osteoporosis Reclast Treatment of hypercalcemia of malignancy Treatment of osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy Treatment for patients with multiple myeloma & patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Treatment of Paget s disease of bone in men and women Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. Prevention of skeletal-related events in patients with bone metastases from solid tumors Treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity. X Zometa Xgeva X Zometa X Reclast Xgeva Xgeva Revised 10/03/2016
PreferredOne Community Health Plan Nondiscrimination Notice PreferredOne Community Health Plan ( PCHP ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PCHP: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Community Health Plan PO Box 59052 Minneapolis, MN 55459-0052 Phone: 1.800.940.5049 (TTY: 763.847.4013) Fax: 763.847.4010 customerservice@preferredone.com You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C. 20201 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Language Assistance Services NDR PCHP LV (10/16)
PreferredOne Insurance Company Nondiscrimination Notice PreferredOne Insurance Company ( PIC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PIC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Insurance Company PO Box 59212 Minneapolis, MN 55459-0212 Phone: 1.800.940.5049 (TTY: 763.847.4013) Fax: 763.847.4010 customerservice@preferredone.com You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C. 20201 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Language Assistance Services NDR PIC LV (10/16)