Medication Policy Manual. Topic: Prolia, Xgeva, denosumab Date of Origin: August 11, 2010

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1 Medication Policy Manual Policy No: dru223 Topic: Prolia, Xgeva, denosumab Date of Origin: August 11, 2010 Committee Approval Date: June 20, 2014 Next Review Date: June 2015 Effective Date: July 1, 2014 IMPTANT REMINDER This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Denosumab (Prolia ) is a medication used to treat osteoporosis (bone loss). It is a monoclonal antibody that targets the receptor activator of nuclear factor kappa B ligand (RANKL). Binding of denosumab (Prolia) to RANKL interferes with osteoclast activity, which is responsible for bone resorption. Reducing bone resorption leads to a favorable increase in bone mass and reduction in fracture risk. Denosumab is also marketed as Xgeva and is used to prevent skeletal complications of bone metastases from solid tumor cancers, and for the treatment of giant cell tumor of the bone. dru223.9 Page 1 of 11

2 Policy/Criteria I. Most contracts require prior authorization approval of denosumab prior to coverage. Denosumab may be considered medically necessary in patients when criterion A, B or C is met. For denosumab (Prolia): A. Patients at high risk for fracture when criteria 1 and 2 are met: 1. Patients at high risk for fracture defined by meeting either criterion a or b or c or d or e or f: a. Have a bone mineral density that is 2.5 or more standard deviations below that of a "young normal" adult (T-score at or below 2.5). b. Have osteopenia (T-score between -1 and -2.5) and glucocorticoid use for at least 3 months at a dose of 5 mg per day or greater, of prednisone (or equivalent). c. History of osteoporotic (fragility) fracture. d. Men receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer e. Women receiving adjuvant aromatase inhibitor therapy for breast cancer. f. The probability is 20% for an occurrence of a major osteoporotic fracture or 3% for hip fracture, based on the US-adapted WHO algorithm Fracture Risk Assessment Tool (FRAX tool). AND 2. Bisphosphonate therapy has been ineffective, not tolerated or contraindicated as defined by at least one of the following: a. At least one bisphosphonate is not effective after at least a 24- month treatment period based on objective documentation. b. Both oral and IV bisphosphonates are not tolerated due to documented clinical side effects. dru223.9 Page 2 of 11

3 c. Bisphosphonates are contraindicated based on current medical literature and objective documentation describing the contraindication is provided (including, but not limited to, creatinine clearance of less than 35 ml/min or esophageal abnormalities such as stricture or achalasia). For denosumab (Xgeva): B. Prevention of skeletal related events (such as fractures) in patients with: 1. Bone metastases from breast cancer or any other solid tumor. AND 2. Prior treatment with an IV bisphosphonate [e.g. pamidronate or zoledronic acid (Zometa)] has been ineffective, contraindicated, or not tolerated. C. Treatment of giant cell tumor of the bone when: 1. The tumor is unresectable. 2. The tumor is resectable, but surgical resection is contraindicated. II. Administration, Quantity Limitations, and Authorization Period A. OmedaRx does not consider denosumab to be a self-administered medication. B. When prior authorization is approved 1. Denosumab (Prolia) may be authorized in quantities of two 60 mg injections per year for the treatment of osteoporosis. 2. Denosumab (Xgeva) may be authorized: i. In quantities up to 13 of the 120 mg injections per year for the prevention of complications of bone metastases from solid tumor cancers. ii. In quantities up to 15 of the 120 mg injections per year for the treatment of giant cell tumor of the bone. C. Authorization may be reviewed at least annually to confirm that current medical necessity criteria are met and that the medication is effective. III. Denosumab is considered investigational when used in combination with a biologic response modifier, including but not limited to: tocilizumab (Actemra ), certolizumab (Cimzia ), etanercept (Enbrel ), adalimumab (Humira ), anakinra (Kineret ), abatacept (Orencia ), infliximab (Remicade ), rituximab (Rituxan ), golimumab (Simponi ), ustekinumab (Stelara ), or natalizumab (Tysabri ). dru223.9 Page 3 of 11

4 IV. Denosumab is considered investigational when used for all other conditions, including but not limited to: A. Prevention of postmenopausal osteoporosis. B. Prevention of skeletal-related events in patients with multiple myeloma. Position Statement - Bisphosphonates, such as alendronate, are currently the most predominantly prescribed treatments for osteoporosis. Alendronate has reliable evidence for reducing fracture risk, has a well-established adverse event profile, and is generically available. - Denosumab (marketed as Prolia) is used to treat osteoporosis. Denosumab (marketed as Xgeva) is used to prevent skeletal complications of bone metastases from solid tumor cancers or to treat giant cell tumor of the bone. - There is consistent evidence that denosumab (Prolia, Xgeva) is a potent antiresorptive therapy. The effect is consistent across the placebo-controlled trials and comparative, non-inferiority trials. However, there is low confidence in the evidence with regard to whether denosumab is better than other available treatment options. * Denosumab (Prolia) has the potential to decrease the risk of fractures in patients with osteoporosis similar to other established treatment options such as bisphosphonates. It is unknown if it is more effective. * As a monoclonal antibody, denosumab (Prolia) has potential safety risks that need to be weighed against its convenience and increased cost relative to the other products currently available to prevent or treat bone loss (osteoporosis). * Denosumab (Xgeva) and zoledronic acid (Zometa) appear to be at least similar in delaying the time to first skeletal related event (SRE) in patients with metastases from solid tumor cancers. * Generic pamidronate and generic zoledronic acid provide the best value for prevention of skeletal complications in patients with breast cancer or other solid tumors. - Denosumab (Xgeva) demonstrated overall objective response (decrease in tumor size) in 25% of patients with giant cell tumor of the bone in an open-label, uncontrolled trial. Clinical Efficacy- Osteoporosis Denosumab (Prolia) has not been proven in reliable clinical studies to be more effective than generic options. - There is a large number of randomized controlled trials (RCTs) assessing the efficacy of denosumab. However, only one trial studied the clinically meaningful endpoint of fracture prevention. All other efficacy trials used percent change in bone mineral density (BMD) as the primary endpoint. Bone mineral density (BMD) is a surrogate marker and change in BMD is poorly correlated to fracture prevention. dru223.9 Page 4 of 11

5 * There is one placebo controlled trial that established the efficacy of denosumab (Prolia) with regard to decreased fracture risk. Denosumab (Prolia) reduces the risk of vertebral, hip and non-vertebral fractures in post-menopausal women with osteoporosis over 36 months when compared to placebo. * Data from the first three years of the extension portion of this trial is now available. Reduction in bone turnover and increases in BMD were maintained over time with denosumab (Prolia); however, due to the cross-over design of the trial the benefit for reducing fracture risk beyond 36 months of treatment cannot be determined. [30] - There are trials comparing denosumab (Prolia) to weekly alendronate for the treatment of osteoporosis in post-menopausal women. The primary endpoint of these trials is bone mineral density (BMD) changes at 12 months, which is not as clinically relevant as fracture data. - The FRAX tool ( was developed by the World Health Organization (WHO) to evaluate fracture risk of patients. It integrates clinical risk factors with bone mineral density (BMD) at the femoral neck. The FRAX tool provides the 10-year probability of fracture. The output is a 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture (forearm, shoulder or clinical vertebral fracture). - Treatment should be considered if the 10-year risk is 3% or more for hip fracture or 20% or more for major osteoporosis-related fracture based on the US-adapted WHO algorithm (FRAX tool). [10] Prevention of Osteoporosis Due to Hormone Suppression: - In breast and prostate cancer patients on hormone suppression therapy, hormone suppression increases bone turnover and decreases bone mineral density (BMD). - Oral bisphosphonates are the best value for the prevention of osteoporosis in patients on hormone suppression therapy. - There is a limited body of evidence for fracture prevention during hormone suppression therapy. Trials were designed to demonstrate an increase in BMD without evidence of fracture prevention. BMD is a surrogate for fracture risk, the more clinically meaningful measure of efficacy. - There are two denosumab trials in the prevention of bone loss due to hormone ablation therapy in prostate and breast cancer. There is low confidence in the results of both of the trials because they used change in BMD as the primary endpoint, and were not comparative trials. Despite the shortcoming of the trials there was a decrease in new vertebral fractures compared to placebo. There are many other treatment options available including generics for the prevention of bone loss. - For prevention of osteoporosis in patients with prostate cancer during androgen deprivation therapy (ADT): [25] dru223.9 Page 5 of 11

6 * There is evidence that denosumab, pamidronate, zoledronic acid and alendronate increase BMD during ADT. * NCCN Prostate Cancer guideline recommends denosumab every 6 months, zoledronic acid once annually, or alendronate 70 mg weekly when risk of fracture warrants treatment. [23] * Zoledronic acid increases BMD when administered every three months annually. There is no comparative evidence that demonstrates that more frequent dosing is more effective. - There is no comparative evidence among bisphosphonates or denosumab for prevention of osteoporosis in patients with breast cancer during hormone suppression therapy. - Bisphosphonate treatment for prevention of bone loss, regardless of cause, is the standard of care due to the body of evidence supporting efficacy and track record of safety. Clinical Efficacy in Cancer-Related Bone Metastases: Breast Cancer: - Generic pamidronate provides the best value for prevention of skeletal complications in patients with metastatic breast cancer. - Zoledronic acid (Zometa) is as effective as intravenous pamidronate for reducing bone pain, decreasing the incidence and rate of skeletal events, and delaying skeletal events in women with breast cancer with bone metastases. [28] - The effectiveness of denosumab relative to zoledronic acid was evaluated in a low confidence, randomized, double-blind, non-inferiority trial that included 2,046 women with bone metastases from breast cancer. [9] * The primary endpoint was the non-inferiority of denosumab relative to zoledronic acid for time to first SRE (defined as bone pain, pathologic fractures, spinal cord compression, and bone complications that required radiation or surgery). * Denosumab was shown to be at least similar to zoledronic acid for delaying the time to first SRE. The study authors concluded that denosumab was superior to zoledronic acid for delaying time to first SRE; however, the evidence is of insufficient quality to validate that conclusion. There was no difference between treatment groups for overall survival or disease progression. * There is low confidence in the evidence that denosumab is superior to zoledronic acid because the clinical relevance of delaying the time to first SRE is uncertain, particularly in the absence of improved overall survival or disease progression. Additional concerns with the study include high attrition and the potential for suboptimal dosing of zoledronic acid. Prostate Cancer: - Generic zoledronic acid (Zometa) provides the best value for prevention of skeletal complications in patients with metastatic castration-resistant prostate cancer (mcrpc). dru223.9 Page 6 of 11

7 - The effectiveness of denosumab relative to zoledronic acid was evaluated in a low confidence, randomized, double-blind, non-inferiority trial in 1,904 men with bone metastases from mcrpc. [25] * The primary endpoint was the non-inferiority of denosumab relative to zoledronic acid for time to first SRE. * Denosumab was shown to be at least similar to zoledronic acid for delaying the time to first SRE. The study authors concluded that denosumab was superior to zoledronic acid for delaying time to first SRE; however, the evidence is of insufficient quality to validate that conclusion. There was no difference between treatment groups for overall survival or disease progression. * There is low confidence in the evidence that denosumab is superior to zoledronic acid because the clinical relevance of delaying the time to first SRE is uncertain, particularly in the absence of improved overall survival or disease progression. Additional concerns with the study include high attrition coupled with a small observed differential treatment effect, and the potential for suboptimal dosing of zoledronic acid. Other Solid Tumor Cancers and Multiple Myeloma: - The effectiveness of denosumab vs zoledronic acid was evaluated in a low confidence, randomized, double-blind, non-inferiority trial that included 1,779 patients with bone metastases from various advanced solid tumor cancers (excluding breast or prostate cancer) or patients with multiple myeloma. [26] * The primary endpoint was the non-inferiority of denosumab relative to zoledronic acid for time to first SRE. * Denosumab was shown to be non-inferior to zoledronic acid for time to first SRE. There was no difference between treatment groups for overall survival or disease progression. * The trial is considered low confidence because the clinical relevance of delaying the time to first SRE is uncertain, particularly in the absence of improved overall survival or disease progression. Additional concerns with the study include high attrition and the potential for suboptimal dosing of zoledronic acid. * In a subgroup analysis of patients with multiple myeloma (n = 180), an increase in mortality was observed with denosumab relative to zoledronic acid. Denosumab is not indicated for patients with multiple myeloma. [12] Clinical Efficacy in Giant Cell Tumor of the Bone: - The safety and efficacy of denosumab (Xgeva) was evaluated in 282 adult of skeletally mature adolescent patients with giant cell tumor of the bone. * Two open-label, uncontrolled trials studied denosumab in patients with giant cell tumor of the bone that was recurrent, unresectable, or for which surgery would likely result in morbidity. [1] dru223.9 Page 7 of 11

8 * Objective response rate (decrease in tumor size) was evaluated as the primary efficacy endpoint. The overall objective response rate was 25%, and all responses were partial response. [1] - The studied and approved dosing for denosumab (Xgeva) in giant cell bone tumors is 120 mg SC ever 4 weeks, with additional doses on Days 8 and 15 of the first cycle. [1] National Guidelines - The 2014 National Comprehensive Cancer Network (NCCN) breast cancer guidelines recognize denosumab (Xgeva), pamidronate, and zoledronic acid (Zometa) as category 1 recommendations for the prevention of skeletal-related events in patients with invasive breast cancer in addition to chemotherapy or endocrine therapy when there are bone metastases. [24] - The 2014 NCCN prostate cancer guidelines recognize zoledronic acid (Zometa) and denosumab (Xgeva) as category 1 recommendations for the prevention of skeletal-related events in patients with metastatic prostate cancer with bone metastases. [23] - The American Society of Clinical Oncology (ASCO) guideline recognizes denosumab (Xgeva), pamidronate and zoledronic acid (Zometa) as treatment options for patients with breast cancer with evidence of bone metastases. Per the ASCO guideline, there is insufficient evidence to demonstrate greater efficacy of one product over another for the prevention and treatment of skeletal-related events. [27] - The 2014 NCCN bone cancer guidelines recognized denosumab as a category 2A recommendation for giant cell bone tumors that are unresectable or are resectable with unacceptable morbidity. Interferon, peg-interferon, radiation therapy, and observation are also listed as category 2A recommendations in these treatment settings. [29] Safety - The most common side effects reported with denosumab (Prolia) include urinary tract infection, upper respiratory tract infection, cataract, constipation, rash, sciatica and pain in the extremities. - The following serious safety issues associated with denosumab (Prolia) have been identified in clinical trials: [1] * Occurrence of serious infection * Development of new malignancies * Potential for tumor progression in patients with cancer * Complications such as delayed fracture healing, osteonecrosis of the jaw (ONJ), or atypical fracture with long-term use, and * Dermatologic adverse events. - Because of potential safety concerns with long-term use of denosumab, it appears to have a less favorable risk versus benefit profile than bisphosphonates for the prevention of osteoporosis. dru223.9 Page 8 of 11

9 - Denosumab (Xgeva) can cause severe symptomatic hypocalcemia, and fatal events have occurred. All patients should be adequately supplemented with calcium and vitamin D. - Denosumab (Prolia) has a risk evaluation and mitigation strategy (REMS) in place to help ensure that potential for these risks is considered prior to use. - In a subgroup analysis of patients with multiple myeloma, mortality was higher in the denosumab (Xgeva) arm than in the zoledronic acid (Zometa) arm. Denosumab (Xgeva) is considered investigational for the prevention of skeletal-related events in patients with multiple myeloma or any other blood cancer. - The safety and efficacy of denosumab has not been established in patients with concomitant use of biologic response modifiers such as Actemra, Cimzia, Enbrel, Humira, Kineret, Orencia, Remicade, Rituxan, Simponi, Stelara, or Tysabri. Cross References Actonel, risedronate, OmedaRx Medication Policy Manual, Policy No. dru155 Prolia, denosumab, BlueCross BlueShield Association Specialty Pharmacy Combined Capacity (SPCC) Report # 8. July Xgeva, denosumab, BlueCross BlueShield Association Specialty Pharmacy Combined Capacity (SPCC) Report # December Forteo, teriparatide, OmedaRx Medication Policy Manual, Policy No. dru085 Codes Number Description HCPCS J0897 Injection, denosumab 1 mg HCPCS J2430 Injection, pamidronate disodium, per 30 mg HCPCS J3487 Injection, zoledronic acid (Zometa), 1 mg HCPCS J3488 Injection, zoledronic acid (Reclast), 1 mg (Reclast 5 MG/100ML SOLN) References 1. Background Document for Meeting of Advisory Committee for Reproductive Health Drugs (August 13, 2009) FDA briefing document for denosumab. /ReproductiveHealthDrugsAdvisoryCommittee/UCM pdf. Accessed May 19, Committee for Medicinal Products for Human Use Summary of Positive Opinion* for Prolia. European Medicines Agency, 2009 available at: Accessed May 19, Smith MR, Egerdie B, Hernández Toriz N, Feldman R, Tammela TL, Saad F, Heracek J, Szwedowski M, Ke C, Kupic A, Leder BZ, Goessl C; Denosumab HALT Prostate Cancer Study Group. Denosumab in men receiving androgen-deprivation therapy for prostate cancer. N Engl J Med Aug 20;361(8): Cummings SR, San Martin J, McClung MR, Siris ES, Eastell R, Reid IR, Delmas P, Zoog HB, Austin M, Wang A, Kutilek S, Adami S, Zanchetta J, Libanati C, Siddhanti S, dru223.9 Page 9 of 11

10 Christiansen C; FREEDOM Trial. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med Aug 20;361(8): Lipton A, Steger GG, Figueroa J, Alvarado C, Solal-Celigny P, Body JJ, de Boer R, Berardi R, Gascon P, Tonkin KS, Coleman RE, Paterson AH, Gao GM, Kinsey AC, Peterson MC, Jun S. Extended efficacy and safety of denosumab in breast cancer patients with bone metastases not receiving prior bisphosphonate therapy. Clin Cancer Res Oct 15;14(20): Brown JP, Prince RL, Deal C, Recker RR, Kiel DP, de Gregorio LH, Hadji P, Hofbauer LC, Alvaro-Gracia JM, Wang H, Austin M, Wagman RB, Newmark R, Libanati C, San Martin J, Bone HG. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res Jan;24(1): Ellis GK, Bone HG, Chlebowski R, Paul D, Spadafora S, Smith J, Fan M, Jun S. Randomized trial of denosumab in patients receiving adjuvant aromatase inhibitors for nonmetastatic breast cancer. J Clin Oncol Oct 20;26(30): Beck TJ, Lewiecki EM, Miller PD, Felsenberg D, Liu Y, Ding B, Libanati C. J Clin Densitom. Effects of denosumab on the geometry of the proximal femur in postmenopausal women in comparison with alendronate Jul-Sep;11(3): Stopeck AT, Lipton A, Body JJ, et al. 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 Nov National Osteoporosis Foundation: Clinician's Guide to Prevention and Treatment of Osteoporosis. April update. Available at: Accessed June 6, Prolia [package insert]. Thousand Oaks, CA: Amgen; July Xgeva [package insert]. Thousand Oaks, CA: Amgen; June Prolia (denosumab injection) Formulary Dossier. Amgen. Thousand Oaks, CA. June Actonel [package insert]. Rockaway, NJ: Warner Chilcott (US); April Fosamax [package insert]. Whitehouse Station, NJ: Merck & Co, Inc.; December Boniva [package insert]. Nutley, NJ: Roche Laboratories Inc.; April Forteo [package insert]. Indianapolis, IN: Eli Lilly and Company; April Evista [package insert]. Indianapolis, IN: Eli Lilly and Company; September Reclast [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May Zometa [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April Aredia [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September NCCN Clinical Practice Guidelines in Oncology. Multiple Myeloma. v Available at: Accessed 6/5/ NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. v Available from Accessed 6/5/ NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. v Available from Accessed 6/5/ 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 Mar 5;377(9768): dru223.9 Page 10 of 11

11 26. Henry DH, Costa L, Goldwasser F, Hirsh V, Hungria V, Prausova J, Scagliotti GV, Sleeboom H, Spencer A, Vadhan-Raj S, von Moos R, Willenbacher W, Woll PJ, Wang J, Jiang Q, Jun S, Dansey R, Yeh H. Randomized, double-blind study of denosumab versus zoledronic acid in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. J Clin Oncol Mar 20;29(9): Van Poznak CH, Temin S, Yee GC, et al. American Society of Clinical Oncology executive summary of the clinical practice guideline update on the role of bonemodifying agents in metastatic breast cancer. J Clin Oncol Mar 20;29(9): Epub 2011 Feb Pavlakis N, Schmidt RL, Stockler MR. Bisphosphonates for breast cancer. Cochrane Database of Systematic Reviews 2005, Issue 3. Art. No.: CD DOI: / CD pub NCCN Clinical Practice Guidelines in Oncology. Bone Cancer. v Available from: Accessed 6/5/ Bone HG, Chapurlat R, Brandi M-L, et. al. The effect of three or six years of denosumab exposure in women with postmenopausal osteoporosis: results from the FREEDOM extension. J Clin Endocrinol Metab Nov;98(11): PMID: dru223.9 Page 11 of 11

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