ACOs and other risk-bearing entities face financial pressures to deliver care in a timely, cost-effective manner. Similarly, integrated delivery systems and hospitalled ACOs can incur penalties for Medicare patient readmissions stemming from ineffective acute-care hospital stays7
At the same time, drug shortages have increased administrative costs, such as those associated with managing inventories, planning therapeutic regimens that deliver optimal outcomes, and making decisions about appropriate drug substitutes. In one study, the annual cost of labor associated with managing drug shortages was calculated at $216 million nationally.9
Increased administrative expenses, as well as higher acquisition costs for some substitute products, may force risk-bearing provider organizations to look elsewhere for cost efficiencies (e.g., purchasing multiple-use vials of methohexital). P&T committees in these organizations, then, must re-emphasize safety when making shortage-driven choices. This responsibility comes down from an organization’s medical executive committee and the Joint Commission as a charge to oversee drug-related patient safety matters within their organizations.
Oncology presents common examples of difficult situations facing care-delivery organizations. Chemotherapy agents, particularly cytarabine (DepoCyt, Sigma-Tau/Enzon) and leucovorin, have been subject to shortages. Chemotherapy drug shortages are generally more critical than many others because of the lack of equivalent alternatives for most agents.10
Cytarabine is the primary chemotherapeutic agent used to manage leukemia. Many treatment centers had to ration the drug, giving priority to patients considered to need it most urgently. The cytarabine shortage has received a good deal of attention because this drug can be highly effective for treating several forms of leukemia and lymphoma, but it must be administered as quickly as possible after diagnosis. The lack of supply has also been particularly worrisome, because there is no substitute for treating acute myeloid leukemia, according to oncologists.11
Other shortages have direct cost implications. The difficulty of finding paclitaxel (Taxol, Bristol-Myers Squibb) has forced the substitution of docetaxel (Taxotere, Sanofi), which in turn has driven up the cost of treating women with newly diagnosed ovarian cancer. In a study quantifying this effect, paclitaxel therapy was compared with a docetaxel-based drug shortage substitute regimen. The mean cost of six cycles of paclitaxel 175 mg/m2
was $4,939. In the drug-shortage group, the mean cost of six cycles of docetaxel at a dose of 75 mg/m2
was $16,107—more than a three-fold increase. The authors concluded that a drug shortage affecting approximately 50% of women initiating chemotherapy (about 779 women per month) would cost third-party payers an additional $8.7 million each month.12
Another study described negative clinical outcomes associated with substituting cyclophosphamide (Cytoxan, Bristol-Myers Squibb) for mechlorethamine (Mustargen, Lundbeck). Mechlorethamine is routinely used to treat lymphoma, but supplies became limited in 2009. In a retrospective comparison, cyclophosphamide was significantly less effective, with a 2-year, event-free survival rate of 75% compared with 88% for the mechlorethamine regimen.13
The costs and clinical outcomes described in these cases illustrate the P&T committee’s core responsibility: to construct a formulary that includes safe, effective, and cost-effective drugs. Failure to focus on all three of these in the context of a medication shortage can have negative financial or legal effects on risk-bearing providers.