Prior Auth Protocol

FDA Approved Indications:

Treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
Treatment to increase bone mass in men with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
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

Health Net Approved Indications and Usage Guidelines:

Postmenopausal osteoporosis (PMO) or high risk of osteoporosis

OR

Male osteoporosis or high risk of osteoporosis

OR

To increase bone mass in men at high risk for fracture receiving or who have received androgen deprivation therapy [i.e. leuprolide (Lupron^R), bicalutamide (Casodex^R) or Nilandron^R] for nonmetastatic prostate cancer

OR

To increase bone mass in women at high risk for fracture receiving or who have received adjuvant aromatase inhibitor therapy [i.e. anastrozole (Arimidex^R), exemestane (Aromasin^R) or letrozole (Femara^R)] for breast cancer

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

Prolia has a Risk Evaluation and Mitigation Strategy (REMS) program that consists of a Medication Guide and a Dear Healthcare Professional Letter. Patient and physician enrollment in the manufacturers REMS program is not required.
According to the National Osteoporosis Foundation, sequential treatment with anabolic therapy followed by an antiresorptive is generally preferred to concomitant combination therapy. However, combination therapy with teriparatide and an antiresorptive can be considered in a few clinical settings in patients with very severe osteoporosis. There are few indications for combining two antiresorptive treatments, but such options could be considered in the short-term in women who are experiencing active bone loss while on low dose hormone therapy for menopausal symptoms or raloxifene for breast cancer prevention.
There are no data to demonstrate risk reduction for fracture with combination therapy using denosumab.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
alendronate (Fosamax^R)	PMO prevention 5 mg PO QD or 35 mg PO once weekly PMO treatment 10 mg PO QD or 70 mg PO once weekly Male osteoporosis treatment 10 mg PO QD or 70 mg PO once weekly	10 mg/day or 70 mg/week
Fosamax Plus D^TM(alendronate/cholecalciferol)*	PMO and male osteoporosis treatment 70 mg alendronate/ 2,800 units cholecalciferol or 70 mg alendronate /5,600 units cholecalciferol PO once weekly	70 mg alendronate/5,600 units cholecalciferol/week
risedronate (Actonel^R)^*	PMO prevention 5 mg PO QD or 35 mg PO once weekly PMO treatment 5 mg PO QD or 35 mg once weekly or 150 mg PO every month Male osteoporosis treatment 35 mg PO once weekly	5 mg/day 35 mg/week 150 mg/month
ibandronate (Boniva^R)*	PMO prevention & treatment (tablets) 150 mg PO once monthly PMO treatment (injection) 3 mg IV every 3 months over 15 to 30 seconds	PO: 150 mg/month IV: 3 mg per dose
raloxifene (Evista^R)	PMO prevention & treatment 60 mg PO QD	60 mg/day
calcitonin-salmon nasal spray (Miacalcin^RNasal Spray, Fortical^R Nasal Spray)	PMO treatment 200 IU spray in one nostril QD	Nasal Spray: 200 IU/day
Miacalcin^R Injection (calcitonin-salmon)*	PMO treatment 100 IU SC/IM every other QOD	Injection: 100 IU/day
Forteo^R (teriparatide)*	PMO treatment; Male osteoporosis treatment: 20 mcg SC QD	20 mcg/day for a maximum of 2 years
zoledronic acid (Reclast^R)^*	PMO and male osteoporosis treatment: 5 mg IV infusion over at least 15 minutes once yearly PMO prevention 5 mg IV infusion over at least 15 minutes once every 2 years	Treatment: 5 mg per dose once yearly Prevention: 5 mg per dose once every 2 years

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Prolia	60 mg SC once every 6 months While receiving Prolia, patients should take calcium 1000 mg/day and at least 400 IU of vitamin D daily. Prolia should be administered by a healthcare professional.	Length of Benefit

Product Availability:

Injection: 60 mg/1 mL, single-use vial and single-use prefilled syringe

References:

1. Prolia [Prescribing information] Thousand Oaks, CA: Amgen Inc; February 2015.
2. National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Available at: http://nof.org/files/nof/public/content/file/2791/upload/919.pdf. Accessed February 26, 2016.
3. The North American Menopause Society. Management of osteoporosis in postmenopausal women: 2010 position statement of the North American Menopause Society. Menopause 2010;17(1):22-54.
4. Watts NB, Bilezikian JP, Camacho PM, et al. American Association of Clinical Endocrinologistsmedical guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract 2010;16(Suppl 3):1-37.
5. Brown JP, Prince RL, Deal C, et al. 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 2009;24:153-161.
6. Vanasse A, Dagenais P, Niyonsenga T, et al. Bone mineral density measurement and osteoporosis treatment after a fragility fracture in older adults: regional variation and determinants of use in Quebec. BMC Musculoskelet Disorder 2005;6:33.
7. Denosumab. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs.current/. Accessed February 25, 2016.
8. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed February 26, 2016.
9. Clinical Pharmacology Web site. Available at http://cpip.gsm.com/. Accessed February 25, 2016.