Osteonecrosis of the Jaw
➤ Osteonecrosis of the jaw (ONJ) is an uncommon but potentially serious
complication of intravenous bisphosphonates and denosumab. The Expert
Panel agrees with the recommendations described in the revised FDA
label for zoledronic acid and pamidronate, Dear Doctor letters, a white
paper, and various position papers or statements.
• All patients should receive a comprehensive dental examination and appropriate
preventive dentistry before bone modifying therapy.
• Active oral infections should be treated, and sites at high risk for infection should be
eliminated.
• While on therapy, patients should maintain excellent oral hygiene and avoid invasive
dental procedures, if possible.
• Continuation of a bone-targeted agent in the setting of ONJ has to be individualized
and dependent on a risk benefit ratio and severity of bone disease.
Table 1. Estimated Prices for Bone Modifying Agents in the
United States*
Agent, Route Dose Schedule
Price
Per Dose
(USD)
Total Price Per 1-Year
Treatment Cycle (USD)
Bisphosphonates
Pamidronate,
intravenous
90 mg Delivered over ≥2
hours every 3 or 4
weeks
$30.67
a
Every 4 week price:
$398.71 ($30.67 × 13)
Zoledronic
acid,
intravenous
4 mg Delivered over ≥15
minutes every 12
weeks or every 3–4
weeks
$53.64
b
Every 12 week price:
$214.56 ($53.64 × 4)
Every 4 week price:
$697.37 ($53.64 × 13)
Monoclonal antibodies
Denosumab,
subcutaneous
injection
120 mg every 4 weeks
$1995.48
c
Every 4 week price:
$25,941.24
($1995.48 × 13)
* Prices Per Dose were for a single infusion or per single injection. Prices for drugs reimbursed through
Medicare Part B only were identified from the 2nd Quarter 2017 Medicare Payment Allowable Part B
Drugs Average Sales Price (ASP) Data (https://www.cms.gov/apps/ama/license.asp?file=/Medicare/
Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/Downloads/2017-April-ASP-
Pricing.zip). Drug price may vary by plan and by pharmacy where a medication is filled (e.g., preferred
or non-preferred pharmacies). Note: Drug prices are dynamic, and thus the prices listed in the table
may not reflect current prices.
a
$10.223/30 mg × 3
b
$13.411/1 mg × 4
c
$16.629/1 mg × 120
Footnotes:
• Bone modifying treatment continue for a period of ≤2 years. Less frequent dosing has been evaluated
and should be considered in patients with responsive or stable disease. Continuous use is at the
discretion of the treating physician and the risk of ongoing skeletal morbidity. Retreatment should be
initiated at the time of disease relapse.
• While on therapy, patients should maintain excellent oral hygiene and avoid invasive dental procedures.
