Prior Auth Protocol

FDA Approved Indications:

Treatment of osteoporosis in postmenopausal women

Health Net Approved Indications and Usage Guidelines:

Failure or clinically significant adverse effects to alendronate (Fosamax^R)

AND

Treatment of osteoporosis

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:

The optimal duration of use has not been determined. The safety and effectiveness of Boniva for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Boniva should not be used in a patient with uncorrected hypocalcemia.
According to the National Osteoporosis Foundation, 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.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
alendronate (Fosamax^R)	Post menopausal Osteoporosis (PMO) treatment:10 mg PO QD or 70 mg PO once weekly	10 mg/day 70 mg/week
Fosamax Plus D^R (alendronate/ cholecalciferol)*	PMO 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
Actonel^R (risedronate)*	PMO treatment: 5 mg PO QD or 35 mg PO once weekly or 150 mg PO once monthly	5 mg/day 35 mg/week 150 mg/month
raloxifine (Evista^R)	PMO 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 QOD	Injection: 100 IU/day
Forteo^R (teriparatide)*	PMO treatment: 20 mcg SC QD	20 mcg/day for a maximum of 2 years
Prolia^TM(denosumab)*	PMO treatment: 60 mg SC once every 6 months Prolia should be administered by a healthcare professional.	60 mg per dose once every 6 months
Reclast^R (zoledronic acid)*	PMO treatment: 5 mg IV infusion over at least 15 minutes once yearly	Treatment: 5 mg per dose once yearly

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Boniva	PMO treatment (injection): 3 mg IV every 3 months over 15 to 30 seconds Boniva Injection must be administered by a healthcare professional.	6 months or to member's renewal period, whichever is sooner.

Product Availability:

Boniva injection: 3 mg/3 mL single-use prefilled syringe

References:

1. Boniva Injection [Prescribing information] South San Francisco, CA: Genentech USA; April 2015.

2. National Osteoporosis Foundation-The Clinician`s Guide to Prevention and Treatment of Osteoporosis. Available at: http://nof.org/files/nof/public/content/file/2791/upload/919.pdf. Accessed July 1, 2015.

3. The North American Menopause Society. Management of postmenopausal osteoporosis: 2010 position statement of the North American Menopause Society. Menopause: The Journal of the North American Menopause Society 2010;17(1): 22-54.

4. American Association of Clinical Endocrinologists. AACE medical guidelines for clinical practice for the diagnosis and treatment of menopause. Endocrine Practice. 2011;17(Suppl 6).

5. American College of Rheumatology. 2010 recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Care and Research. 2010:1515-1526.

6. Boniva. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 1, 2015.

7. DRUGDEX System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 1, 2015.

8. Clinical Pharmacology Web site. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. Accessed July 1, 2015.