Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Bisphosphonates are a class of medications used to increase the strength of bones. These medications are:

a)    Oral medications covered under the pharmacy program:

i)       Fosamax (alendronate)

ii)     Boniva (ibandronate) – subject to step therapy

iii)    Actonel (risedronate)

b)    IV medications covered under the medical program pay for certain diagnoses while others require preauthorization:

i)       Aredia

ii)     Zoledronic acid (Zometa, Reclast)

2)    These medications are used for the following:

a)    To prevent or treat osteoporosis

b)    To treat osteitis deformans (Paget’s disease)

c)     To treat osteogenesis imperfecta (OI)

d)    Hypercalcemia of malignancy

e)    For the treatment of patients with multiple myeloma and patients with bone metastases from solid tumors

1)    Oral bisphosphonates are covered under the pharmacy plan. Alendronate and Actonel (risedronate) are considered first-line agents.  Ibandronate is considered a second-line agent and will require documentation of a trial of BOTH alendronate and Actonel (risedronate).

2)    Pamidronate (Aredia) is covered for members with:

a)    Hypercalcemia secondary to malignancy (E83.52) OR

b)    Treatment of moderate to severe Paget’s disease (M88.0 – M88.9) OR

c)     Treatment of osteolytic bone metastases in patients with multiple myeloma or breast cancer (C79.51, C90.00 – C90.02, C50.011 – C50.929)

3)    Zoledronic Acid (Reclast, Zometa) is covered for members with:

a)    Demonstrated lytic bony metastases from solid tumors who are receiving chemotherapy (C79.51)

b)    Multiple myeloma (C90.00 – C90.02)

c)     Hypercalcemia secondary to malignancy (E83.52)

4)    Zoledronic Acid requires preauthorization for members with:

a)    Moderate to severe Paget’s disease (osteitis deformans) (M88.0 – M88.9)

i)       The patient must have tried and failed at least two oral bisphosphonates and at least two different dosing regimens OR a course of Aredia; AND

ii)     The treatment is a single injection only

b)    Osteoporosis treatment –  M80.00XA – M80.00XS, M80.011 – M80.079, M80.08XA – M80.08XS, M80.811 – M80.879, M80.88XA – M80.88XS, M81.0 – M81.8

i)       The diagnosis is established as osteoporosis by World Health Organization (WHO) criteria (T score less than or equal to -2.5) AND

ii)     The patient will have tried and failed at least two oral bisphosphonates and at least two different dosing regimens (these medications are available for daily, weekly or monthly dosing); AND

iii)    The treatment is one injection annually.

c)     Osteoporosis prophylaxis

i)       In postmenopausal women (dose is 5mg IV once every other year)

ii)     For prevention of glucocorticoid-induced osteoporosis in men and women taking systemic glucocorticoids (dose is 5mg IV once yearly)

d)    Osteogenesis Imperfecta – Q78.0

i)       The patient will have tried and failed at least two oral bisphosphonates and at least two different dosing regimens (these medications are available for daily, weekly or monthly dosing);

ii)     The treatment is one injection annually.

Codes Used In This BI:

J2430           Aredia (Pamidronate)

J3487           Zometa (Zoledronic Acid) (CODE DELETED 1-1-14)

J3488           Reclast (Zoledronic Acid) (CODE DELETED 1-1-14)

J3489           Zoledronic Acid

Q2051          Zoledronic Acid (CODE DELETED 1-1-14)

Intravenous bisphosphonates are considered investigational for use in members with blastic bony metastases as there is insufficient evidence of its effectiveness.

1. 2003 Update on the Role of Bisphosphonates and Bone Health Issues in Women With Breast Cancer, American Society of Clinical Oncology at: http://www.asco.org/portal/site/ASCO/menuitem.7c5d3ce76288ddab1ee5ad106e37a01d/?vgnextoid=a6dd6c54249b1110VgnVCM100000ed730ad1RCRD&aid=21_21_4042
2. The Role of Bisphosphonates in Breast Cancer, American Society of Clinical Oncology at: http://www.asco.org/ac/1,1003,_12-002032-00_18-0010896-00_19-0010897-00_20-001,00.asp
3. The Role Of Bisphosphonates In Multiple Myeloma, American Society of Clinical Oncology at: http://www.asco.org/portal/site/ASCO/menuitem.5d1b4bae73a9104ce277e89a320041a0/?vgnextoid=add51f886024a010VgnVCM100000ed730ad1RCRD  
4. New advances in the biology and treatment of Myeloma bone disease, American Society of Clinical Oncology at: http://www.asco.org/portal/site/ASCO/menuitem.c608d82cf53347fd506fe310ee37a01d/?vgnextoid=c759201eb61a7010VgnVCM100000ed730ad1RCRD&vmview=edbk_detail_view&confID=16&index=y&abstractID=487
5. Wilkinson GS et al. Intravenous bisphosphonate therapy and inflammatory conditions or surgery of the jaw: A population-based analysis. J Nat’l Cancer Inst; 2007 Jul 4; 99:1016-24.
6. Black, DM et al. Once Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. N Engl J Med 2007 May 3; 356:1809-22.
7. Zometa approval letter, US Food and Drug Administration at: http://www.fda.gov/cder/foi/nda/2002/21-386_Zometa_Approv.pdf

Addendum:

1.     Effective 07/01/2017: Added indication for Osteogenesis Imperfecta.