Traditional tools can be applied to specialty pharmacy management

AMONG THE TOP selling drugs in the United States, a large proportion will fall into the category of injectables or infusibles by next year. In fact, specialty drugs will comprise 11 of the top 16 drugs. And by 2014, specialty pharmaceuticals will account for the majority of total drug spend, according to industry experts.

Specialty drugs, by definition, are large-molecule compounds often derived from living proteins and synthesized using complex bioengineering processes, according to sanofi-aventis. They are generally very expensive to manufacture and can be delivered with infusion, injection, inhalation or ingestion. Recent advances in biotechnology have led to a rapid expansion of the market for specialty drugs. Although few members might need specialty drugs-they're often used for severe or complex chronic disease-their high costs make them a significant factor in overall drug trends.

"We do not want to prevent members from receiving medications, but their high costs make it necessary to use them appropriately," Brian Solow, MD, chief medical officer for Prescription Solutions, a PBM headquartered in Irvine, Calif., says. "The challenge is paying for them."

Although most of study's results were expected, Johnson says he is surprised that 51% of respondents use prior authorization for chemotherapy-a number he anticipated would be lower. Prior authorization also is applied to rheumatoid arthritis by 91% of plans and is commonly used by the majority of plans for intravenous immune globulin (68%), monoclonal antibodies (51%) and multiple sclerosis (51%). Step therapy, another traditional utilization management tool, is used most often for rheumatoid arthritis.

"I didn't expect plans to be so aggressive," he says. "What they really don't want to do is prevent the use of life-sustaining drugs, but instead, ensure that drugs are being used appropriately."

For example, Herceptin (trastuzumab) has been shown to be effective in women with breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+). A widely accepted test can help determine appropriate utilization of the drug.

Medical injectables used to treat cancer account for more than half of medical benefit injectable costs, according to the survey. A quarter of these costs is attributed to injectables used to treat autoimmune disorders, such as rheumatoid arthritis, Crohn's disease and psoriatic arthritis.

The primary concern voiced by payers about injectables is the overall cost, (32%), followed by appropriate utilization (20%). Plans responding to the ICORE survey report that they receive rebates for at least one injectable drug paid under the medical benefit, most often for rheumatoid arthritis drugs.

Intravenous chemotherapy drugs consume 38% of drug spend, followed by 23% for rheumatory medications. Oral chemotherapies, which are paid under the pharmacy benefit, account for about one-tenth of the total cost of drugs used to treat cancer.