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

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

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

  2. Health Net Approved Indications and Usage Guidelines:
    • Failure or clinically significant adverse effects to alendronate (FosamaxR)
    AND
      • Postmenopausal osteoporosis (PMO) or high risk of PMO
    OR
      • Male osteoporosis
    OR
      • Glucocorticoid-induced Osteoporosis (GIO) or high risk of GIO
    OR
      • 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.
    • Actonel and alendronate products must be taken at least 30 minutes before the first food, beverage or medication of the day with plain water (6 to 8 oz). However, Atelvia should 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, 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.
    • Combination therapy with estrogen therapy/hormone replacement therapy (ET/HRT) and alendronate has shown significantly greater improvements in bone mineral density than for either agent alone. However, there are no data to demonstrate greater fracture risk reduction with this combination.
    • Selection of patients for pharmacological therapy for prevention of osteoporosis should consider an estimation of fracture risk, as determined by a combination of bone mineral density (BMD) and clinical risk factors. Fracture risk can be calculated using the World Health Organization (WHO) Fracture Risk Assessment Tool (FRAX). A reasonable cut-point is a 10-year probability of hip fracture or 10-year probability of major osteoporotic fracture of ≥3.0 or ≥20 percent, respectively. The National Osteoporosis Foundation (NOF) recommends pharmacological therapy in patients with low bone mass (T-score between -1.0 and -2.5 at the femoral neck, total hip, or lumbar spine [LS]) if there is an estimated 10-year probability of hip fracture of ≥3 percent or of major osteoporotic fracture ≥20 percent.
  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
    Osteoporosis
    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
    PO:
    150 mg/month
    IV:
    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
    (calcitonin-salmon)*

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

    Injection
    100 IU/day

    ForteoR
    (teriparatide)*

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

    20 mcg/day for a maximum of 2 years

    ProliaTM
    (denosumab)*

    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 (ReclastR)*

    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
    Pagets:
    5 mg one time every 6 months.
    PMO treatment, Male osteoporosis treatment and GIO prevention and 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

    Actonel

    PMO prevention & 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 have elapsed since the
    completion of previous therapy.

    Atelvia

    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

    Binosto

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

    Length of
    Benefit

  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: 5 mg, 30 mg, 35 mg, 150 mg
    risedronate (Atelvia) delayed-release tablet: 35 mg
  8. References:

    1. Actonel [Prescribing Information] Rockaway, NJ: Warner Chilcott, LLC; April 2015.
    2. Atelvia [Prescribing Information] Rockaway, NJ: Warner Chilcott, LLC; April 2015.
    3. Fosamax Plus D [Prescribing Information] Whitehouse Station, NJ: Merck & Co., Inc; November 2015.
    4. Binosto [Prescribing Information] San Antonio, TX: Mission Pharmacal Company; February 2015.
    5. National Osteoporosis Foundation-The Clinicians Guide to Prevention and Treatment of Osteoporosis. Available at: http://nof.org/files/nof/public/content/file/2791/upload/919.pdf. Accessed June 17, 2015.
    6. The North American Menopause Society. Management of postmenopausal osteoporosis: 2010 position statement of the North American Menopause Society. Menopause 2010;17(1):22-54.
    7. 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 2010;16(Suppl 3):1-37.
    8. Grossman JM, Gordon R, Ranganath VK, et al. American College of Rheumatology 2010 recommendations for the prevention and treatment of glucocorticoid-induced osteoporosis. Arthritis Care Res 2010;62(11):1515-1526.
    9. Risedronate. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs.current/. Accessed February 27, 2016.
    10. Alendronate. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs.current/. Accessed February 27, 2016.
    11. MicromedexR Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed February 27, 2016.
    12. Clinical Pharmacology Web site. Available at http://cpip.gsm.com/. Accessed February 25, 2016.

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.