For many patients with rheumatoid arthritis, few therapies can really compare with Enbrel's® effectiveness. A comparison in cost, however, can be even bigger. The average prescription price for Enbrel is $1,417, which helps give new meaning to the phrase "gold standard" when applied to the RA therapy. The overwhelming popularity of this injectable biologic is given the lion's share of the credit for driving up the collective price paid for biotech drugs for inflammatory diseases by a whopping 33.9 percent last year, according to a new report from the pharmacy benefit manager Express Scripts®. And the class of drugs — which also includes Humira®, Kineret® and Remicade® — accounted for about one-fifth of all specialty drug spending. But analysts say this figure is no blip on the radar screen. Biologics have emerged as a key driver of pharmacy costs. And Express Scripts estimates that by 2009 biotech drugs will account for 28 percent of all drug spending in America at a cost of $90 billion. Those figures are helping companies like Express Scripts' subsidiary CuraScript™ pick up new business managing the distribution of high-cost specialty drugs. Trying to reign in costs has emerged as a critical front in the battle against healthcare inflation. "We're going to have to do better and more," says CuraScript's Chief Medical Officer Dr. Steve Miller. That means "working closer with physicians developing true patient care pathways to better manage the appropriateness of care. We have to work with the payer community, and we have to push the FDA to provide a definition of generic biologics. Because one of the tools in traditional pharmaceuticals is the availability of generics, and we need it here, too." Don't expect any apologies from biotechnology companies for these prices, though. "Currently in the U.S., pharmaceuticals' pricing is set at market value," says Biotechnology Industry Organization President Jim Greenwood. And advocates stoutly maintain that these drugs have proven to be solid performers in reducing the cost of hospitalization by providing better care. Another factor in U.S. pricing, says Greenwood, are government price controls in Europe that shift the cost of developing drugs onto the shoulders of American consumers. PhRMA is even more emphatic in its defense of steep drug prices, noting that a drug developer can easily spend hundreds of millions of dollars and years of lab time developing these new therapies. Many of these therapies are designed to be used earlier and longer than traditional therapies, easing symptoms for patients but sending pharmacy bills soaring. And biologics aimed at rheumatoid arthritis fill just one of several fast-growing categories. Express Script's specialty drug report notes that spending on new therapies for multiple sclerosis jumped more than 11 percent last year. Hemophilia treatments, which cost about $100,000 a year, grew by 25 percent as the overall number of doses in the category grew. And anemia drug prices, fueled by inflation, are playing a role here, as well. The price for a prescription of specialty cancer-treating antineoplastics administered outside physician offices jumped 15.6 percent, to an average of nearly $1,600. Not surprisingly, Express Scripts was eager to tout the services of its specialty pharmacy subsidiary CuraScript, one of a number of groups that help insurers manage members who need these higher priced therapies. As the cost per prescription rises, payers are looking to such specialty groups to make sure the money is being spent wisely. "The number one tool is controlling your pharmacy network," says Miller. If a self-insured employer wants to let every worker buy their specialty drugs at every retail pharmacy in their area, he continues, the employer will be hit with high costs. Local pharmacies don't have the negotiating leverage that specialty groups can bring into play, Miller points out. Specialty pharmacies can also provide special monitoring programs for patients who rely on biologics. "Look at hepatitis C," says Dr. Miller, who notes millions of people with the problem often suffer from flu-like symptoms that leave them disoriented and often unable to take their medications without prompting. "If a patient gets his drug retail, his compliance rate is 49 percent. If they get the drug from a specialty pharmacy, with care coordinators to help them get treated for side effects, their compliance rates are over 90 percent. A liver transplant costs $300,000 to $900,000. And it doesn't take preventing too many liver transplants to save an employer a lot of money." Formularies restricting patients to a preferred list of drugs can also help control costs. Pharmacy benefits managers can negotiate prices in many disease categories with competing drugs. And they can also prevent off-label uses of drugs for conditions not approved yet by the FDA. Those kinds of management techniques can add up to fast savings, says CuraScript. For example, preventing higher than recommended doses of Synvisc® saved plan sponsors $750,000 on just 900 prescriptions. The FDA can play a role in managing these costs, as well, says Miller. The agency recently approved a generic competitor to Lovenox®, an anticoagulant. And generic competition is well known for swiftly dropping the price of a therapy to a fraction of its name brand price. But the agency has yet to hammer out an approval process for a new generation of biosimilars that can dramatically reduce the cost of some therapies losing patent protection.