Approval of a drug under this criteria document does not ensure full coverage of the drug.

Transcription

1 Criteria Document: Reference #: PC/A011 Page 1 of 8 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 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. PURPOSE: The intent of the criteria document is to: Ensure the intended use is medically necessary; and Allow for both on-label use and National Comprehensive Cancer Network s (NCCN) Drug and Biologics Compendium recommended use; and Require a failed trial of self-administered drugs (unless contraindicated) before a provider administered drug, for prevention and/or treatment of osteoporosis/osteopenia and for continuation /non-emergent use of bisphosphonates for Paget s disease of bone; and To consider overall cost-effectiveness. Table 1: Provider Administered Medications FYI ONLY Drugs Route of Administration Generics Drug Class Generic Name available Boniva intravenous injection N ibandronate bisphosphonate pamidronate intravenous injection N/A pamidronate bisphosphonate subcutaneous injection given by a Prolia healthcare professional N denosumab RANKL inhibitor Reclast intravenous infusion Y zoledronic acid bisphosphonate geva subcutaneous injection given by a healthcare professional N denosumab RANKL inhibitor Zometa intravenous infusion Y zoledronic acid bisphosphonate

2 Criteria Document: Reference #: PC/A011 Page 2 of 8 GUIDELINES: Medical Necessity Criteria Must satisfy one of the following: I-III I. Initial request for denosumab (Prolia), ibandronate injection (Boniva), or zoledronic acid (Reclast or Zometa) for prevention or treatment of osteoporosis - must meet: A and either B or C A. The request is for one of the following medications must have one of: Denosumab (Prolia) - must have one of the following diagnoses: a or b a. On-label use one of the following: i-iii i. Treatment of postmenopausal women with osteoporosis at high-risk for fracture; or ii. Treatment to increase bone mass in men with osteoporosis at high-risk for fracture; or iii. Treatment of glucocorticoid induced osteoporosis (GIOP) in men and women at high-risk for fracture. b. NCCN recommended use in prostate cancer - prevention or treatment of osteoporosis during androgen-deprivation therapy for members with high fracture risk. 2. Ibandronate injectable (Boniva) - On-label use for treatment of osteoporosis in postmenopausal women. 3. Zoledronic acid (Reclast) On-label use - one of the following diagnoses: a-c a. Treatment and prevention of postmenopausal osteoporosis; or b. Treatment to increase bone mass in men with osteoporosis; or c. Treatment and prevention of glucocorticoid-induced osteoporosis. 4. Zoledronic acid (Zometa) - NCCN recommended use in prostate cancer for prevention or treatment of osteoporosis during androgen deprivation therapy for members with high fracture risk. B. The member has tried and failed one self-administered medication(s) (see Table 2) as evidenced by one of the following: 1 or 2 1. A decline in bone mineral density (BMD) of equal to or greater than 5%; or 2. Experienced a fragility (low-trauma) fracture. C. The member has severe renal impairment/chronic kidney disease (CKD) with a creatine clearance less than 35 ml/min.

3 Criteria Document: Reference #: PC/A011 Page 3 of 8 Table 2: Self-Administered Medications* Drugs Route of Administration Generics available FYI ONLY Generic Name Drug Class Actonel oral Y risedronate bisphosphonate Boniva oral Y ibandronate bisphosphonate Fortical, Miacalcin nasal, subcutaneous injection, intramuscular injection Y calcitonin polypeptide hormone selective estrogen Evista oral Y raloxifene receptor modulator recombinant human Forteo subcutaneous injection N teriparatide parathyroid hormone Fosamax oral Y alendronate bisphosphonate recombinant human Tymlos subcutaneous injection N abaloparatide parathyroid hormone * Listing of drugs in table above does not ensure coverage. Please check member s prescription benefit. Revised 11/30/17 II. Initial request for denosumab (Prolia or geva), ibandronate injection (Boniva), pamidronate, or zoledronic acid (Reclast or Zometa) for indications other than prevention or treatment of osteoporosis - must meet one of the following: A-E A. Denosumab (Prolia) - must meet: 1 or 2 1. On-label use - one of the following diagnoses: a or b a. Treatment to increase bone mass in men at high-risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; or b. Treatment to increase bone mass in women at high-risk for fracture receiving adjuvant aromatase inhibitor therapy for invasive breast cancer. 2. NCCN recommended use in breast cancer, invasive - post-menopausal (natural or induced) members receiving adjuvant endocrine therapy along with calcium and vitamin D supplementation to maintain or improve bone mineral density and reduce risk of fractures. B. Denosumab (geva) must meet: 1 or 2 1. On-label use - must satisfy both of the following: a and b a. Treatment of hypercalcemia of malignancy; and b. Refractory to IV bisphosphonate therapy with pamidronate or Zometa (Table 1). 2. One of the following: a or b a. On-label use one of the following diagnoses: i or ii i. Prevention of skeletal-related events in members with bone metastases from solid tumor or multiple myeloma; or ii. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

4 Criteria Document: Reference #: PC/A011 Page 4 of 8 b. NCCN recommended use one of the following diagnoses: i-ix i. Bone cancer, giant cell tumor of the bone - as a single agent or combined with interferon alfa or radiation therapy for localized disease for giant cell tumor of the bone; or ii. Bone cancer, giant cell tumor of the bone - as a single agent for metastatic disease; or iii. Breast cancer, invasive - post-menopausal (natural or induced) members receiving adjuvant endocrine therapy along with calcium and vitamin D supplementation to maintain or improve bone mineral density and reduce risk of fractures; or iv. Breast cancer, invasive - with calcium and vitamin D supplementation in addition to chemotherapy or endocrine therapy, for bone metastases in members with expected survival of equal or greater than 3 months and adequate renal function; or v. Kidney cancer, clear cell and non-clear cell - as a component of best supportive care for bone metastases; or vi. Non-small cell lung cancer (NSCLC) - as a component of best supportive care for bone metastases; or vii. Prostate cancer - prevention of skeletal-related events in men with castration-recurrent prostate cancer who have documented bone metastases and creatinine clearance greater than 30mL/min; or viii. Thyroid carcinoma as palliative care for bone metastases (anaplastic); or ix. Thyroid carcinoma for bone metastases (follicular, Hurthle cell, medullary or papillary). C. Pamidronate - one of the following diagnoses: On-label use for moderate to severe Paget s disease of bone must meet: a or b a. Initial request allow 30mg daily on 3 consecutive days; or b. Continued use request contraindication to oral bisphosphonates - allow continued use for of the following: i or ii i. The member has a pre-existing condition that precludes the use of an oral bisphosphonate (Table 2); or ii. The member has gastroesophageal reflux disease (GERD) symptoms from a trial of an oral bisphosphonate (Table 2). [Note: Allow continued use of pamidronate only when there is a contraindication to oral bisphosphonates] 2. On-label use - one of the following diagnoses: a-c a. Moderate or severe hypercalcemia associated with malignancy, with or without bony metastases; or b. Osteolytic bone metastasis of breast cancer in conjunction with standard antineoplastic therapy; or c. Osteolytic lesions of multiple myeloma in conjunction with standard antineoplastic therapy. 3. NCCN recommended use - one of the following diagnoses: a g a. Breast cancer, invasive postmenopausal (natural or induced) members receiving adjuvant endocrine therapy along with calcium and vitamin D supplementation to maintain or improve bone mineral density and reduce risk of fractures; or b. Breast cancer, invasive with calcium and vitamin D supplementation in addition to chemotherapy or endocrine therapy for members with invasive breast cancer with bone metastases with expected survival of equal or greater than 3 months and adequate renal function; or

5 Criteria Document: Reference #: PC/A011 Page 5 of 8 c. Kidney cancer, clear cell and non-clear cell - as a component of best supportive care for bony metastases; or d. Multiple myeloma - in combination with primary therapy; or e. Non-small cell lung cancer (NSCLC) - supportive therapy in members with bone metastases; or f. Thyroid carcinoma, anaplastic - palliative care for bone metastases; or g. Thyroid carcinoma, follicular, Hurthle cell, medullary or papillary - for bone metastases. D. Zoledronic acid (Reclast) - on-label use - treatment of Paget s disease of bone in men and women: 1 or 2 1. Initial request allow a single 5mg infusion 2. Continued use request contraindication to oral bisphosphonates - allow continued use for of the following: a or b a. The member has a pre-existing condition that precludes the use of an oral bisphosphonate (Table 2); or b. The member has gastroesophageal reflux disease (GERD) symptoms from a trial of an oral bisphosphonate (Table 2). [Note: Allow continued use of zoledronic acid (Reclast) only when there is a contraindication to oral bisphosphonates] E. Zoledronic acid (Zometa) - must meet one of the following: 1 or 2 1. On-label use - must have one of the following diagnoses: a or b a. Hypercalcemia of malignancy; or b. Members with multiple myeloma and members 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. 2. NCCN recommended use - must have one of the following diagnoses: a-h a. Breast Cancer, invasive postmenopausal (natural or induced) members receiving adjuvant endocrine therapy along with calcium and vitamin D supplementation to maintain or improve bone mineral density and reduce risk of fractures; or b. Breast Cancer, invasive with calcium and vitamin D supplementation in addition to chemotherapy or endocrine therapy for bone metastasis in members with expected survival of equal or greater than 3 months and adequate renal function; or c. Kidney Cancer, clear cell and non-clear cell - as a component of best supportive care for bony metastases; or d. Multiple myeloma in combination with primary therapy; or e. Non-small cell lung cancer (NSCLC) supportive therapy in members with bone metastases; or

6 Criteria Document: Reference #: PC/A011 Page 6 of 8 f. Prostate cancer - prevention of skeletal-related events in men with castration-recurrent prostate cancer with documented bone metastases and creatinine clearance greater than 30mL/min; or g. Thyroid carcinoma, anaplastic as palliative care for bone metastases; or h. Thyroid carcinoma, follicular, Hurthle cell, medullary or papillary for bone metastases. III. Continuation request for denosumab (Prolia or geva), ibandronate injection (Boniva), pamidronate or zoledronic acid (Reclast or Zometa) - Allow an additional 24 months [Note: Continuation request for pamidronate and zoledronic acid (Reclast) for Paget s disease - see above for continued use criteria requirements.] DEFINITIONS: Contraindication/pre-existing condition that precludes the use of an oral bisphosphonate: The member cannot swallow; or The member has abnormalities that delay esophageal emptying (stricture, achalasia); or The member has esophageal lesions or esophageal ulcers; or The member cannot remain in an upright position post oral administration; or The member is status post restrictive bariatric procedure. High-risk for fracture: Low bone mineral density (BMD), advancing age, previous vertebral fracture/fragility fracture/low trauma fracture, glucocorticoid therapy, parental history of hip fracture, low body weight, current cigarette smoking, excessive alcohol consumption, rheumatoid arthritis, secondary osteoporosis (eg, hypogonadism or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease) Gastroesophageal reflux disease (GERD) symptoms from a trial of oral bisphosphonates: Documentation of 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 30-minutes after taking the medication; and Persistent GERD symptoms despite adequate treatment with use of H2-blockers or proton pump inhibitors. 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 A sign of osteopenia, a condition in which bone density is below normal and may lead to Between -1 and -2.5 osteoporosis -2.5 and below Likely have osteoporosis

7 Criteria Document: Reference #: PC/A011 Page 7 of 8 FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes - initial authorize for 24 months (except where otherwise stated); 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 RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria REFERENCES: 1. Boniva injection [package insert]. South San Francisco, CA: Genentech USA, Inc; Pamidronate [package insert]. Bedford, OH: Bedford Laboratories; Prolia [package insert]. Thousand Oaks, CA: Amgen Inc; Reclast [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; geva [package insert]. Thousand Oaks, CA: Amgen Inc; Zometa [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; Zoledronic acid [package insert]. Schaumberg, IL: Sagent Pharmaceuticals; National Osteoporosis Foundation. Clinician s Guide to Prevention and Treatment of Osteoporosis. Washington, DC: National Osteoporosis Foundation Retrieved from 9. 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 Jul;12(7): 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): He M, Fan W, Zhang. Adjuvant zoledronic acid therapy for patients with early stage breast cancer: an updated systematic review and meta-analysis. J Hematol Oncol Oct 23;6(1): NCCN Drugs & Biologics Compendium. Accessed 07/27/ Rosen, HN, Drezner MK. Overview of the management of osteoporosis in postmenopausal women. In UpToDate, Mulder, JE (Ed), UpToDate, Waltham, MA, Lewiecki EM. Osteoporotic fracture risk assessment. In UpToDate, Mulder, JE (Ed), UpToDate, Waltham, MA, DOCUMENT HISTORY: Created Date: 09/30/16 (previously part of PC/B009) Reviewed Date: 07/19/17, 01/18/18 Revised Date: 02/13/17, 03/20/17, 08/16/17, 10/10/17, 11/30/17, 01/18/18,, 06/06/18

8 Attachment A FDA APPROVED INDICATIONS DRUG Tx (*& prevent) PMO in women (^& are at high-risk for fracture) ( reduction in risk of invasive breast cancer in PMO w/osteoporosis; or at high-risk for invasive breast cancer) Tx to increase bone mass in men with (+primary or hypogonadal) osteoporosis (^& are at high risk for fracture) Tx (*& prevent) (# sustained systemic) glucocorticoid -induced osteoporosis (^& are at high risk for fracture) Hypercalcemia of malignancy Patients w/ multiple myeloma & patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy Tx of Paget s disease of bone in men and women Tx to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer Tx to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer Tx to prevent skeletalrelated events in patients with bone metastases from solid tumors or multiple myeloma Tx of osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma Actonel (risedronate tablets) Boniva tablets (ibandronate) calcitonin * * * Evista (raloxifene tablets) Forteo (teriparatide subq injection) Fosamax (alendronate tablets & oral solution) Tymlos (abaloparatide subq injection) Boniva injection (ibandronate) pamidronate injection * ^ * ^ * +^ *#^ Prolia (denosumab injection) ^ ^ ^ Reclast (zoledronic acid injection) * * geva (denosumab injection) Zometa (zoledronic acid injection) Page 8 of 8 of PC/A011

9 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 Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . 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 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 , (TDD) Complaint forms are available at Language Assistance Services NDR PCHP LV (10/16)

10 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 Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . 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 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 , (TDD) Complaint forms are available at Language Assistance Services NDR PIC LV (10/16)