Management with specialty pharmaceuticals imminent for various conditions

Key Points

Specialty pharmaceuticals are expected to eventually replace non-specialty agents for the management of various conditions, including gout, lupus, diabetes, and hypercholesterolemia. This is according to research presented during the Academy of Managed Care Pharmacy's 2010 Educational Conference in St. Louis.

Pharmaceutical manufacturers are focusing research efforts on biosimilars or bio-betters. Bio-betters are new dosage forms or more targeted approaches for biologics, like "product-line extensions" for these agents. It is anticipated that in 10 years, 25% of specialty products will be biogenerics-a significant change.

Additionally, there will be more orphan drugs and oncology agents that garner FDA approval. Most recently two-thirds of approvals for specialty pharmaceuticals were for orphan drugs to treat rare cancer types. In the future, biogenetic testing may be combined with these approvals to greater enhance efficacy and safety.

Current leading specialty categories include inflammatory conditions, MS, cancer, HCV, lysosomal storage disorders, cystic fibrosis, and HIV-related lipodystrophy. There likely will be new biologics with novel mechanisms of action to treat lupus, gout, cystic fibrosis, rheumatoid arthritis (RA), psoriasis, and psoriatic arthritis (PsA). Some of these potential new agents will be oral, such as tasocitinib (RA, psoriasis) and apremilast (psoriasis, PsA). The MS pipeline is robust with laquinimod, Tovaxin, dimethyl fumarate, and teriflunomide. Dimethyl fumarate and teriflunomide are oral.

The more than 4 million patients with HCV are soon to get some good news-a pipeline rich with novel agents, including 2 oral protease inhibitors, telaprevir and boceprevir, which provide a greater sustained virological response than currently available agents.

According to Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapeutics at Express Scripts, "These new oral agents fill a significant unmet need for HCV patients since they dramatically improve viral 'cure' rates. Several years from now, it is possible that there will be an all 'oral drug' cocktail to treat HCV, similar to how HIV is now treated."

For treating HIV-associated lipodystrophy, tesamorelin was approved on November 10, 2010, and is the first drug approved for this condition.