HN Logo
Prior Authorization Protocol
ACTONELR (risedronate immediate release), ATELVIATM (risedronate delayed-release),
BINOSTOR (alendronate sodium effervescent tablets), FOSAMAX PLUS D TM (alendronate/cholecalciferol)

Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:

    PLUS D
    Prevention of postmenopausal osteoporosis (PMO)
    Treatment of postmenopausal osteoporosis (PMO)
    Prevention of glucocorticoid-induced osteoporosis (GIO)
    Treatment of glucocorticoid-induced osteoporosis (GIO)
    Male osteoporosis treatment to increase bone mass
    Treatment of Paget's disease of bone

  2. Health Net Approved Indications and Usage Guidelines:
    • Failure or clinically significant adverse effects to alendronate (FosamaxR)
      • Postmenopausal osteoporosis (PMO)
      • Male osteoporosis
      • Glucocorticoid-induced Osteoporosis (GIO)
      • Confirmed diagnosis of Paget's disease
  3. 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.
  4. General Information:
    • The optimal duration of use has not been determined. The safety and effectiveness of bisphosphonates 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.
    • Additive effects on bone mass and turnover have been observed with combination therapy with Fosamax and estrogen therapy/hormone replacement therapy (ET/HRT). However, there are no data to demonstrate greater fracture risk reduction with the combined use of Fosamax with ET/HRT compared with monotherapy with either agent alone.
    • Actonel and Fosamax products must be taken at least 30 minutes before the first food or drink of the day with plain water (6 to 8 oz). However, Atelvia can be taken in the morning immediately following breakfast with at least 4 oz. of plain water.
    • In the pivotal trial, the incidence of upper GI tract adverse reactions in the Atelvia 35 mg once-a-week and risedronate sodium immediate-release 5 mg daily groups were: diarrhea (8.8% vs. 4.9%), abdominal pain (5.2% vs. 2.9%), constipation (4.9% vs. 2.9%), vomiting (4.9% vs. 1.6%), dyspepsia (3.9% versus 3.9%), nausea (3.6% vs. 3.9%) and upper abdominal pain (2.9% versus 2.3%). Study discontinuation due to abdominal pain occurred in 1.3% of the Atelvia 35 mg once-a-week group and 0.7% of the risedronate sodium immediate-release 5 mg daily group.
    • 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.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    alendronate (FosamaxR)

    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
    GIO treatment
    5 mg PO QD or 10 mg PO QD
    (in postmenopausal women not receiving estrogen)
    Paget's disease
    40 mg PO QD for 6 months
    10 mg/day or 70 mg/week
    Paget's disease
    40 mg/day for 6 months.
    Re-treatment may be considered following a 6 month post-treatment
    evaluation based on increases in serum alkaline phosphatase

    ibandronate (BonivaR)*

    PMO prevention & treatment (tablets)
    150 mg PO once monthly
    PMO treatment (injection)
    3 mg IV every 3 months over 15 to 30 seconds
    150 mg/month
    3 mg per dose

    raloxifine (EvistaR)*

    PMO prevention & treatment
    60 mg PO QD

    60 mg/day

    calcitonin-salmon nasal spray
    (MiacalcinR Nasal Spray, ForticalR Nasal Spray)

    PMO treatment
    200 IU spray in one nostril QD

    Nasal Spray
    200 IU/day

    MiacalcinR Injection

    PMO treatment
    100 IU SC/IM QOD
    Treatment of Paget's Disease
    100 IU SC/IM QD

    100 IU/day


    PMO treatment, GIO treatment, Male osteoporosis treatment
    20 mcg SC QD

    20 mcg/day for a maximum of 2 years


    PMO treatment, Male osteoporosis treatment
    60 mg SC once every 6 months

    Prolia should be administered
    by a healthcare professional.

    60 mg per dose once every 6 months

    (zoledronic acid)*

    Treatment of Pagets Disease:
    5 mg IV infusion over at least 15 minutes for one dose
    PMO treatment, Male osteoporosis treatment and GIO prevention and treatment:
    5 mg IV infusion over at least 15 minutes once a year
    PMO prevention:
    5 mg IV infusion over at least 15 minutes once every two years
    5 mg one time every 6 months.
    PMO treatment:
    5 mg one time every year.
    PMO prevention:
    5 mg one time every two years
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit


    PMO prevention
    5 mg PO QD or 35 mg PO once weekly
    PMO treatment
    5 mg PO QD or
    35 mg PO once weekly or
    150 mg PO once monthly
    Male osteoporosis treatment
    35 mg PO once weekly
    GIO prevention & treatment
    5 mg PO QD
    Paget's disease
    30 mg PO QD for 2 months
    Length of Benefit

    Paget's disease
    2 months

    Re-authorizations will be issued if relapse occurs or
    treatment fails to normalize serum alkaline phosphatase
    (i.e. normal range defined as 35-110 units/L) and
    2 months (Actonel) have elapsed since the
    completion of previous therapy.


    PMO treatment
    35 mg PO once weekly
    Length of Benefit

    Fosamax Plus D

    PMO treatment and male osteoporosis treatment
    70 mg alendronate / 2800 IU vitamin D3 or
    70 mg alendronate / 5600 IU vitamin D3 PO once weekly

    Length of Benefit


    PMO treatment and male osteoporosis treatment:
    70 mg dissolve one tablet in approximately half a glass of water PO once weekly

    Length of

  7. Product Availability:
    Actonel immediate release tablets: 5 mg, 30 mg, 35 mg, 150 mg
    Atelvia delayed-release tablets: 35 mg
    Binosto effervesent tablets: 70 mg
    Fosamax PLUS D tablets: 70 mg alendronate/ 5600 IU vitamin D3
    risedronate (Actonel) immediate release tablet: 150 mg
  8. References:
    1. Actonel [Prescribing Information] Rockaway, NJ: Warner Chilcott, LLC; April 2013.
    2. Atelvia [Prescribing Information] Rockaway, NJ: Warner Chilcott, LLC; April 2013.
    3. Fosamax Plus D [Prescribing Information] Whitehouse Station, NJ: Merck & Co., Inc; May 2014.
    4. Binosto [Prescribing Information] San Antonio, TX: Mission Pharmacal Company; August 2013.
    5. National Osteoporosis Foundation-The Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at: Accessed July 1, 2014.
    6. 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.
    7. American Association of Clinical Endocrinologists. AACE medical guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocrine Practice 2010;16(3):1-37.
    8. American College of Rheumatology. 2010 recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis and Rheumatism 2010;62(11):1515-1526.
    9. Meunier PJ, Delmas PD, Eastell R et al: Diagnosis and management of osteoporosis in postmenopausal women: clinical guidelines. International Committee for Osteoporosis Clinical Guidelines. Clin Ther 1999;21(6):1025-1044.
    10. Harris ST, Watts NB, Genant HK, et al. The effects of risedronate treatment on vertebral and non-vertebral fractures in women with postmenopausal osteoporosis. JAMA 1999;282(14):1344-52.
    11. Reginster JY, Minne HW, Sorensen OH, et al. Randomized trial of the effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis. Osteoporosis Int 2000;11:83-91.
    12. Reid D, Cohen S, Pack S, et al. Risedronate reduces the incidence of vertebral fractures in patents on chronic corticosteroid therapy. Arthritis and Rheum 1998; 41(suppl): abs #624.
    13. Cohen S, Levy RM, Keller M, et al. Risedronate therapy prevents corticosteroid-induced bone loss. Arthritis and Rheum 1999; 42(11):2309-18.
    14. Miller P, Zroux C, McClung M, et al. Risedronate reduces hip fractures in patients with low femoral neck bone mineral density. American College of Rheumatology 63rd Annual Scientific Meeting, Poster 1299: Boston, MA; November 16, 1999.
    15. Liberman et al. Effect of oral alendronate on bone mineral density and the incidence of fractures in postmenopausal osteoporosis. N Engl J Med 1995;333:1437-43.
    16. McClung M, et al. Alendronate prevents postmenopausal bone loss in women without osteoporosis: a double-blind, randomized, controlled trial. Ann Intern Med 1998;128:253-261.
    17. Black DM, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebra fractures. Lancet 1996;348:1535-1541.
    18. Karpf DB, et al. Prevention of nonvertebral fractures by alendronate: a meta-analysis. JAMA 1997;277:1159-1164.
    19. Saag KG, et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. N Engl J Med 1998;339:292-299.
    20. Lindsay R, et al. Addition of alendronate to ongoing hormone replacement therapy in the treatment of osteoporosis: a randomized, controlled clinical trial. J Clin Endocrinol Metab 1999;84(9):3076-81.
    21. Bone HG, et al. Alendronate and estrogen effects in postmenopausal women with low bone mineral density. J Clin Endocrinol Metab 2000;85(2):720-6.
    22. Greenspan SL, et al. Combination therapy with hormone replacement and alendronate for prevention of bone loss in elderly women. JAMA 2003;289(19):2525-33.
    23. Palomba S, et al. Effect of estrogen replacement plus low-dose alendronate treatment on bone density in surgically postmenopausal women with osteoporosis. J Clin Endocrinol Metab 2002;87(4):1502-8.
    24. Davas I, et al. Effect of daily hormone therapy and alendronate use on bone mineral density in postmenopausal. Fertil Steril 2003;80(3):536-40.
    25. Evio S, et al. Effects of alendronate and hormone replacement therapy, alone and in combination , on bone mass and markers of bone turnover in elderly women with osteoporosis. J Clin Endocrinol Metab 2004;89(2):626-31.
    26. Harris ST, et al. Effect of combined risedronate and hormone replacement therapies on bone mineral density in postmenopausal women. J Clin Endocrinol Metab 2001;86(5):1890-7.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.