Projected Future Trends in Specialty Pharmacy

San Antonio—Specialty drugs may be used by a small percentage of the population, but they represent about 60% of drug approvals and continue to gain momentum in the pharmaceutical industry.

An AMCP meeting session, led by Aimee Tharaldson, PharmD, a senior clinical consultant in the emerging therapeutics department at Express Scripts, titled Specialty Pharmaceuticals in Development, explored projected trends in specialty pharmacy.

"Drug trend for specialty medications has been rising by 15% to 20% annually, while trend for traditional medications fell last year. By 2015, our research shows that 3 of the 4 most expensive classes will be specialty medications for cancer, multiple sclerosis (MS), and inflammatory conditions like rheumatoid arthritis (RA)," Dr. Tharaldson said. "We forecast that the country will spend roughly $114.7 billion on specialty medications—mostly biologics—in 2014."

Dr. Tharaldson mentioned several key trends that are currently occurring within the specialty market, including increased competition, more drug development for rare or orphan conditions, and an increased number of oral drug options.

The specialty market is seeing an increase in drug development for orphan diseases, which affect approximately 25 million people in the United States. Orphan drugs represent 6% of the total drug spend, but their growth rate is higher than the rate for nonorphan drugs (>25% vs 20%, respectively). According to data provided by Dr. Tharaldson, orphan drugs represent 42% of the specialty drugs within the pipeline and carry a high cost. See Figure 2 (below). The average annual cost of noncancer orphan drugs approved since 2012 is approximately $220,000.

In addition to an increase in orphan drug development, Dr. Tharaldson says there are also more oral options for specialty medications. By 2012, the number of approvals for oral medications had surpassed approvals for injectables. Trends in the MS pipeline include improvement to immunomodulators, the move to some generic immunomodulators, development of monoclonal antibody drugs, and competition from oral drugs.

Cancer drugs will also see more competition from oral drugs, as Dr. Tharaldson noted several drugs in this pipeline have been granted breakthrough therapy designations, such as obinutuzumab for chronic lymphocytic leukemia or daratumumab for multiple myeloma, which may hit the market soon. The cancer pipeline also includes targeted therapy and immunotherapy drugs. Dr. Tharaldson also highlighted medications in the specialty pipeline and the trends she observed within therapy classes. She said the pipeline trends for inflammatory conditions will be medications with expanded indications and routes, new injectable biologics, and competition from oral drugs, such as baricitinib, a once-daily oral RA drug expected in 2014.

The future of HIV drugs is expected to include more injectable therapies and single tablet regimens, along with a new booster, integrase inhibitor and nucleoside reverse transcriptase.

When it comes to hepatitis C medications, Dr. Tharaldson said the pipeline includes several oral direct antivirus agents, all-oral regimens, or secondary warehousing drugs.

The cystic fibrosis pipeline shows new drugs that will fight lung infections, treat the underlying disease, and increase mucus clearance, while the pulmonary arterial hypertension pipeline includes the first drug for chronic thromboembolic pulmonary hypertension and a generic version of bosentan.

Finally, Dr. Tharaldson said the trend for bleeding disorder drugs is next-generation and recombinant factors, new options for Von Willebrand disease and Factor XIII deficiency, and long-acting formulations.