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The 2006 introduction of Part D under the Medicare Modernization Act will definitely affect medications targeting osteoporosis, the majority of which are prescribed to those 65 or older.
The 2006 introduction of Part D under the Medicare Modernization Act will definitely affect medications targeting osteoporosis, the majority of which are prescribed to those 65 or older. Richard Stefanacci, DO, MBA, founding executive director, Health Policy Institute at the University of Sciences in Philadelphia, says that Part D will put a crimp in accessing appropriate medications for the condition.
"Despite the proven benefits of vitamin D and calcium and recommendations for them as a standard of care, they will be excluded from coverage under Part D," he says. "This illustrates the disconnect between policy and evidence-based medicine. In addition, although formularies need to include at least two bisphosphonates, Prescription Drug Plans can restrict access to different medications that might otherwise encourage better adherence."
Stefanacci is a bit more optimistic about the role of Medicare Advantage plans that are not just responsible for drug costs, but also for Medicare Parts A and B. "They have the ability to provide broader coverage by using non-Part D funds and realize benefits from preventing fractures because of their additional financial responsibility," he says.
The rigid requirements associated with using alendronate-it should be swallowed whole with a full glass of plain water while in an upright position and should be taken at least 30 minutes before the first food, beverage or medication of the day-often affect compliance, according to Terry Maves, director of pharmaceutical services for Touchpoint. "Why bother taking $70 drugs if you aren't taking them on time or correctly?" he asks. "The cost doesn't hit the radar screen until it becomes a compliance cost or when those who need intervention are not getting it and those who don't need it are receiving it.
"You should prevent osteoporosis before disaster kicks in, but not until it's reasonable to do so," he explains. "It makes sense to use more resources where they will make an impact; however, many women fearing bone loss in menopause turn to their ob/gyns to put them on hormone replacement therapy and other medications."
Despite efforts to make it easier to take bisphosphonates, moving from daily doses to weekly-and even monthly-medication compliance still remains a problem. A recent study looked at women aged 50 years or older on either risedronate or alendronate, with 33,767 patients filling at least one prescription daily and 177,552 filling them weekly. Adequate medication persistence was defined as filling and refilling prescriptions at 80% of the expected 12-month supply.
Results indicated that the persistence rate for daily doses was 33.3% compared with 44.8% for weekly prescriptions. These results, along with other studies, indicate that reducing frequency of dosing alone will not improve persistence with bisphosphonates to an acceptable level.
Another recent study indicated that 6,825 postmenopausal women age 45 or older diagnosed with postmenopausal osteoporosis who consistently stayed on their bisphosphonate treatment were significantly less likely to experience a bone fracture over a two-year period than women who did not do so. The results were presented at the Sixth International Symposium on Osteoporosis by Ethel Siris, MD, director, Toni Stabile Osteoporosis Center at New York-Presbyterian Hospital.
Only 21% of the women were persistent and 48% were refill compliant in the study. The relative risk of fracture was 26% lower among compliant vs. non-compliant patients, and 21% lower in persistent vs. non-persistent patients.
One of the main barriers is not the drugs themselves, but the fact that patients cannot directly detect the affect of the drugs because osteoporosis is primarily asymptomatic. It is not until they see the results of a second BMD screening that they realize there has been progress.