HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

Transcription

1 Generic Brand HICL GCN Exception/Other PROLIA, XGEVA If the caller wishes to initiate a request then a MRF must be completed. This drug requires a written request for prior authorization. All requests for high-impact medications require review by a pharmacist prior to final approval. GUIDELINES FOR USE PROLIA 1. Is the request for a postmenopausal woman diagnosed with osteoporosis? If yes, continue to #2. If no, continue to #3. 2. Does the patient meet ONE of the following conditions? A history of fragility fractures Pre-treatment T-score of less than or equal to -2.5 Osteopenia with a high pre-treatment FRAX fracture probability AND ONE of the following criteria: o Indicators of higher fracture risk (e.g., advanced age, frailty, glucocorticoid use, very low T- scores, or increased fall risk) o Failed prior treatment with or is intolerant to previous injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], teriparatide [Forteo]) o Trial with an oral bisphosphonate for a least 1-year duration or there is a clinical reason to avoid treatment with an oral bisphosphonate DENIAL TEXT: Per your health plan's Denosumab guideline, Prolia is only covered for postmenopausal women with a diagnosis of osteoporosis who have one of the following conditions: History of fragility fractures Pre-treatment T-score of less than or equal to -2.5 OR (Denial text continued on next page) Page 1

2 GUIDELINES FOR USE - PROLIA (CONTINUED) Diagnosis of osteopenia with a high pre-treatment FRAX fracture probability and ANY of the following conditions: o Indicators of higher fracture risk (e.g., advanced age, frailty, glucocorticoid use) o Prior treatment failure with injectable osteoporosis therapy (e.g., zoledronic acid [Reclast], teriparatide [Forteo]) o Prior trial with an oral bisphosphonate for a least 1-year duration or there is a clinical reason to avoid treatment with an oral bisphosphonate (e.g., alendronate [Fosamax]) Your physician did not indicate that you [have one of these conditions or select criteria not met] and therefore your request was not approved. 3. Is the request for a male patient diagnosed with osteoporosis? If yes, continue to #4. If no, continue to #5. 4. Does the patient meet ONE of the following conditions? A history of an osteoporotic vertebral or hip fracture A pre-treatment T-score of less than or equal to -2.5 Osteopenia with a high pre-treatment FRAX fracture probability DENIAL TEXT: Per your health plan's Denosumab guideline, Prolia is only covered for males with a diagnosis of osteoporosis who have one of the following conditions: History of an osteoporotic vertebral or hip fracture Pre-treatment T-score of less than or equal to -2.5 Osteopenia with a high pre-treatment FRAX fracture probability Your physician did not indicate that you [have one of these conditions or select criteria not met] and therefore your request was not approved. 5. Is the request for a patient diagnosed with breast cancer who is receiving adjuvant aromatase inhibitor therapy for breast cancer? If no, continue to #6. Page 2

3 GUIDELINES FOR USE - PROLIA (CONTINUED) 6. Is the request for a patient diagnosed with prostate cancer who is receiving androgen deprivation therapy? XGEVA DENIAL TEXT: Per your health plan's Denosumab guideline, Prolia is only covered for one of the following conditions: Postmenopausal women with osteoporosis and high-risk fracture (e.g., T-score of less than or equal to -2.5 OR osteopenia with a high pre-treatment FRAX fracture probability) and one of the following conditions: o Indicators of high fracture risk o Prior treatment failure with injectable osteoporosis therapy o Prior trial with an oral bisphosphonate of at least 1-year duration or there is a clinical reason to avoid treatment with an oral bisphosphonate Men with osteoporosis and a history of an osteoporotic vertebral or hip fracture, pretreatment T-score of less than or equal to -2.5, or osteopenia with a high pretreatment FRAX fracture probability Breast cancer and you are receiving aromatase inhibitor therapy (e.g., anastrozole) Prostate cancer and you are receiving androgen deprivation therapy Your physician did not indicate that you [have any of these diagnoses or select specific criteria not met] and therefore your request was not approved. 1. Is the request for the treatment of ONE of the following conditions? Prevention of skeletal-related events in a patient with bone metastasis from solid tumors other than prostate cancer Prevention of skeletal-related events in a patient with bone metastases from castration recurrent prostate cancer Giant cell tumor of bone (GCTB) APPROVAL TEXT: Your request for Xgeva has been approved for one 120mg vial per 28 days for a 12-month period. If no, continue to #2. Page 3

4 GUIDELINES FOR USE - XGEVA (CONTINUED) 2. Is the request for treatment for a patient with Hypercalcemia of malignancy that is refractory to intravenous (IV) bisphosphonate therapy (e.g., zoledronic acid, pamidronate) If yes, approve for 2 months. [The quantity limit is hard-coded.] Please use status code #056 and the following approval text: APPROVAL TEXT: Your request for Xgeva has been approved for one 120mg vial per 28 days for a 2-month period. DENIAL TEXT: Per your health plan's Denosumab guideline, Xgeva is only covered for one of the following conditions: Prevention of skeletal-related events in a patient with bone metastasis from solid tumors other than prostate cancer Prevention of skeletal-related events in a patient with bone metastases from castration recurrent prostate cancer Treatment of hypercalcemia of malignancy that is refractory to intravenous (IV) bisphosphate therapy (e.g., zoledronic acid, pamidronate) Your physician did not indicate that you have one of these conditions and therefore your request was not approved. RATIONALE Ensure appropriate utilization of Prolia for the treatment of women with a diagnosis of breast cancer, men with non-metastatic prostate cancer or osteoporosis in men or women when such use (including dosage, frequency, site of administration, and duration of therapy) is reasonable, medically necessary, clinically appropriate, and supported by evidence-based literature. Ensure appropriate utilization of Xgeva for prevention of skeletal related events or hypercalcemia of malignancy when such use (including dosage, frequency, site of administration, and duration of therapy) is reasonable, medically necessary, clinically appropriate, and supported by evidence-based literature. FDA APPROVED INDICATIONS Prolia: Treatment of postmenopausal women with osteoporosis at high risk for fracture Treatment to increase bone mass in men with osteoporosis at high risk for fracture 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. Page 4

5 FDA APPROVED INDICATIONS (CONTINUED) Xgeva: 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 that is unresectable or where surgical resection is likely to result in severe morbidity Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy Limitations of use Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma WHO Fracture Risk Assessment Tool High FRAX fracture probability: 10 year major osteoporotic fracture risk 20% or hop fracture risk 3%. 10-year probability; calculation tool available at REFERENCES Prolia [package insert]. Thousand Oaks, CA: Amgen Inc.; August Xgeva [package insert]. Thousand Oaks, CA: Amgen Inc.; March The NCCN Drugs & Biologics Compendium 2016 National Comprehensive Cancer Network, Inc. Accessed October 23, Bisphosphonates. Drug Facts and Comparisons. Facts & Comparisons eanswers [online] Available from Wolters Kluwer Health, Inc. Accessed October 20, Cosman F, de Beur SJ, LeBoff MS, et al. National Osteoporosis Foundation. Clinician s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10): Jeremiah MP, Unwin BK, Greenwald MH, et al. Diagnosis and management of osteoporosis. Am Fam Physician. 2015;92(4): Watts NB, Bilezikian JP, Camacho PM, et al. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract. 2016;22 (Suppl 4):1-42. ACOG Practice Bulletin Number 129: Osteoporosis. Obstet Gynecol. 2012;120(3): no change. National Institute for Health and Care Excellence. Osteoporosis Overview. Last updated September 20, Available at: Accessed October 17, Treatment to prevent osteoporotic fractures: an update. Department of Health and Human Services, Agency for Healthcare Research and Quality. 2012; Publication No. 12-EHC023-EF. Available at Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men : an Endocrine Society clinical practice guideline. J Clin Endocr Metab. 2012;97(6): no change, guidelines coming out in Gralow JR, Biermann S, Farooki A, et al. NCCN Task Force Report: Bone Health in Cancer Care. JNCCN. 2013; 11(Suppl 3):S1-50. Page 5

6 REFERENCES (CONTINUED) FRAX WHO fracture risk assessment tool. World Health Organization Collaborating Centre for Metabolic Bone Diseases: University of Sheffield, UK. Available at: Accessed October 7, NCCN Clinical Practice Guidelines in Oncology: Bone Cancer. Version Accessed October 24, Hu M, Glezerman IG, Leboulleux S, et al. Denosumab for treatment of hypercalcemia of malignancy. J Clin Endocrinol Metab. 2014; 99(9): Created: 05/16 Effective: 07/14/17 Client Approval: 06/30/17 P&T Approval: 09/11/17 Page 6