Cancer Drug Shortages Continuing and Increasing

Zosia Chustecka

November 15, 2012

Shortages of cancer drugs in the United States are continuing, and in some cases are increasing, according to survey just released by the Community Oncology Alliance (COA).

Virtually all (98.9%) of the 525 physicians from 200 member oncology practices who responded to the survey reported experiencing a shortage of a cancer drug in the previous year. Just over half the respondents (58.2%) say that the problem of drug shortages is worsening.

The cancer drugs reported by respondents as being in short supply are doxorubicin Adriamycin, bleomycin, carboplatin, cisplatin, cytarabine, dacarbazine, Decadron, Doxil, doxorubicin, dexamethasone, etoposide, 5-fluorouracil, irinotecan, leucovorin, levoleucovorin, methotrexate, oxaliplatin, paclitaxel, Taxol, vincristine, vinorelbine, and Zofran. Many also listed intravenous magnesium sulfate and calcium gluconate.

One respondent said there were "too many to list. Most generics have been difficult to obtain during the past year."

The crisis is affecting patient care. Survey respondents indicated that as a result of the shortages, cancer progressed faster in more than 60% of patients, and more than 70% of patients experienced more severe adverse effects.

Respondents were asked to describe specific cases. One described a breast cancer patient who was treated with epirubicin instead of the physician's choice of Adriamycin. Another reported colon cancer patients who had "less than optimal treatments" because there was no leucovorin to provide rescue for 5-fluoruracil," and still another reported a lack of magnesium to replenish levels after cetuximab (Erbitux) infusions. Other respondents indicated that patients with Hodgkin's lymphoma and lung, testicular, and ovarian cancers are being affected by shortages.

The shortages are also having an economic impact: more than 80% of patients and 90% of practices affected by a cancer shortage reported a more severe financial burden. Some practices reported a 20% to 25% increase in costs.

Many practices mentioned the leucovorin shortage in particular because the only substitute for the agent is a branded drug, levoleucovorin (Fusilev), which is much more expensive. One practice using leucovorin at $800 per month had to switch to levoleucovorin at $2400 per month. Another noted a similar price hike, but expressed it differently — $1 for 50 mg of leucovorin increased to $180 for 50 mg of levoleucovorin.

Some said they did not substitute leucovorin; instead, they administered the FOLFOX regimen without it.

Adriamycin was reported by many practices to be in short supply. One practice reported switching to Doxil instead, but found it to be much more expensive than Adriamycin ($514.00 compared with $3.50 per 10 mg).

One practice reported substituting generic etoposide (at $6 per 100 mg) with a branded product that cost $137 per 100 mg. That practice also substituted leucovorin with the more expensive levoleucovorin, and explained that "because reimbursement had been determined using the cheaper formulations, we were under water.... We lost hundreds of dollars on each treatment."

Economics Is the Root Cause

"The root cause of the drug shortage is economic," Ted Okon, executive director of the COA, said in a statement.

"The Medicare system for reimbursing cancer drugs has created pricing instability," he explained. "That has resulted in disincentives for manufacturers to produce these low-cost but vital generic cancer drugs, as well as to invest in manufacturing facilities for these products," he added.

CAO past president Patrick Cobb, MD, an oncologist at the Frontier Cancer Centers and Blood Institute in Billings, Montana, used the example of generic leucovorin to illustrate the problem. "The cost to Medicare is $35 per dose; the patient copayment is $9.... The substitute is a branded drug that is readily available. The cost to Medicare for a dose of the branded drug is $2000, and the cost to the patient is $520." he explained.

"This is an unacceptable consequence of the drug shortage crisis," he said in a statement.