Overview

This document addresses the use of zoledronic acid (Reclast) which is a bisphosphonate agent specifically used to inhibit bone resorption. Zoledronic acid is approved for the treatment of osteoporosis, glucocorticoid-induced osteoporosis, Paget’s disease, multiple myeloma, bone metastases, hypercalcemia of malignancy, and other indications as applicable.

Clinical criteria

The American College of Endocrinology (AACE/ACE) (2020) osteoporosis treatment guidelines stratify initial treatment based on risk status. For those at high risk/no prior fractures, initial therapy options include bisphosphonates (alendronate, risedronate, or zoledronic acid) or denosumab. For those at very high risk/prior fractures, initial therapy options are denosumab, abaloparatide, teriparatide, romosozumab, or zoledronic acid. The Endocrine Society osteoporosis guideline update (2020) recommends initial therapy with bisphosphonates (alendronate, risedronate, zoledronic acid, or ibandronate) or alternatively denosumab for those at high risk. Osteoporosis may be diagnosed by bone mineral density (BMD) testing indicating a T-score in the spine, femoral neck, total hip or distal 1/3 of the radius of less than or equal to -2.5 as compared to a young-adult reference population. It also may be clinically diagnosed based on a history of a fragility fracture (low trauma fracture).

Higher risk for fracture may be defined as:

1. History of osteoporotic fracture; or
2. Multiple risk factors for fractures, including but not limited to: Prior low-trauma fracture as an adult, advanced age, gender, ethnicity, low bone mineral density (T-score -1.0 to-2.5), low body weight (<57.6kg), family history of osteoporosis, use of glucocorticoids (daily dosage equivalent to 5 mg or greater prednisone for at least 3 months), current cigarette smoking, excessive alcohol consumption (3 or more drinks per day), secondary osteoporosis (such as rheumatoid arthritis), early menopause, height loss of kyphosis, fall risk and low calcium intake; or
3. Failure or intolerance to other osteoporosis therapies. A failure of other osteoporosis therapies, otherwise known as refractory disease, may be defined as a decline in BMD while on therapy (≥5%) or a fragility fracture while on therapy.

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Reclast (zoledronic acid)

Requests for Reclast (zoledronic acid) may be approved for any of the following conditions:

1. Glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months; OR
2. Osteoporosis, treatment to increase bone mass in men; OR
3. Osteoporosis, treatment and prevention – in postmenopausal women; OR
4. Paget’s disease of bone in men and women – treatment indicated with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease.

Zoledronic acid 4 mg

Requests for Zoledronic acid 4 mg may be approved for any of the following conditions:

1. I.
2. II.
3. III.
4. IV.
5. V.
6. VI.

Bone metastases documented on imaging or bone pain associated with imaging-documented metastases from breast, prostate, lung, kidney, thyroid, or other solid tumors; OR

Hypercalcemia of malignancy, treatment; OR

Multiple myeloma; OR

Breast cancer, prevention of bone loss secondary to adjuvant hormone therapy (such as aromatase inhibitors) (NCCN 2A); OR

Prevention of osteoporosis during androgen deprivation therapy in prostate cancer (NCCN 2A); OR

Bone disease associated with Langerhans Cell Histiocytosis (NCCN 2A).

Requests for zoledronic acid agents (Reclast, Zolendronic acid 4 mg) may not be approved when the above criteria are not met and for all other indications.

Quantity Limits

Bisphosphonate Agent Quantity Limit

• Reclast (zoledronic acid) 5 mg/100 mL
• 100 mL (5 mg) once per year

Drug Limit Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• J3489
  Injection, zoledronic acid, 1 mg [Reclast, zoledronic acid 4mg]

ICD-10 Diagnosis

• C00.0-C80.2
  Malignant neoplasms
• C81.00-C81.99
  Hodgkin lymphoma
• C82.00-C86.6
  Non-Hodgkin lymphoma
• C88.4
  Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma]
• C90.00-C90.32
  Multiple myeloma and malignant plasma cell neoplasms
• C96.0 - C96.5 - C96.6
  Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis
  Multifocal and unisystemic Langerhans-cell histiocytosis
  Unifocal Langerhans-cell histiocytosis
• D00.00-D09.9
  In situ neoplasms
• E83.52
  Hypercalcemia
• M80.00XA-M80.88XS
  Osteoporosis with current pathological fracture
• M81.0-M81.8
  Osteoporosis without current pathological fracture
• M85.80-M85.9
  Other specified disorders of bone density and structure [osteopenia]
• M88.0-M88.9
  Osteitis deformans [Paget’s disease of bone]
• Z79.52
  Z79.811
  Z79.83
  Long term (current) use of systemic steroids
  Long term (current) use of aromatase inhibitors
  Long term (current) use of bisphosphonates
• Z85.00-Z85.9
  Personal history of malignant neoplasm
• Z92.241
  Personal history of systemic steroid therapy

Document History

Revised: 08/18/2023