Growth in the Specialty Drug Pipeline Continues

San Francisco—The specialty market continues to see a significant rate of growth due to broader use of specialty medications to treat common and rare diseases. Aimee Tharaldson, PharmD, senior clinical consultant, emerging therapeutics, at Express Scripts, discussed specialty market trends and top drugs in the pipeline at AMCP during a Contemporary Issues session titled Specialty Pharmaceuticals Pipeline Update.

Key specialty market trends identified by Dr. Tharaldson were competition in research and development, biosimilars, and biobetters; cancer drug development, which represents 25% of all pipeline medications; targeted drug therapies including orphan drugs and pharmacogenomics; and oral specialty drugs for rheumatoid arthritis (RA), multiple sclerosis (MS), hepatitis C, and cancer.

She noted the trend in the current specialty markets shows that a proportion of spending and utilization of specialty medications remains significantly lower than traditional drugs. In 2011, 71% of medical and drug spending was in the traditional market, with 14% in the specialty medical market and 15% in the specialty drug market; in 2014 the projections are for 60% of total spending to be in the traditional market, with 19% of expenditures in the specialty medical market and 21% in the specialty drug market. Dr. Tharaldson said the top 5 specialty therapy classes in 2011 were inflammatory conditions ($41 per member per year [PMPY]), MS ($33 PMPY), cancer ($25 PMPY), HIV ($18 PMPY), and growth deficiency ($7 PMPY).

The shift in the specialty market is also evident in the number of new FDA drug approvals from 2008 to 2011. In 2008, there were 16 traditional drugs and 8 specialty drugs approved, compared with 12 traditional drugs and 18 specialty drugs approved in 2011.

Dr. Tharaldson also reviewed recent specialty drug approvals, including Eylea^® (aflibercept injection; indication: wet age related macular degeneration; approval: 11/18/2011), Erivedge^™ (vismodegib; indication: basal cell carcinoma; approval: 1/30/2012), Kalydeco^™ (ivacaftor; indication: cystic fibrosis; approval: 1/31/2012), Korlym^™ (mifepristone; indication: Cushing’s syndrome; approval: 2/17/2012), and Omontys^® (peginesatide injection; indication: anemia; approval: 3/27/2012).

The final part of her presentation was an overview of the near-term specialty pipeline. Therapy classes with specialty drugs in development include inflammatory conditions, MS, cancer, HIV, hepatitis C, and cystic fibrosis. Trends for drugs in the pipeline for inflammatory conditions show that oral drugs will compete with injectables with new therapies for the treatment of gout and biosimilars on the horizon. The pipeline shows 14 drugs for the treatment of gout, RA, lupus psoriasis, ulcerative colitis, and Crohn’s disease with FDA approval expected beginning July 2012 through 2014.

MS pipeline trends project greater emphasis on disease modifying drugs, expanded MS use for currently-marketed drugs, and new therapies for secondary-progressive MS. Eleven drugs are in the pipeline with FDA approval expected beginning in June 2012 through 2015.

Cancer pipeline trends indicate significant development of oral cancer drugs and targeted therapies and vaccines. Drugs are being developed to treat niche or orphan cancer types and common cancer types. The pipeline shows 12 drugs are expected to receive FDA approval between now and 2014.

The growing HIV population with patients wanting convenience with their drug regimen and fewer side effects are influencing the HIV pipeline trends. The pipeline shows 13 drugs are expected to receive FDA approval between now and 2014.

Hepatitis C pipeline trends indicate that oral protease inhibitors continue to grow. Several direct-acting antivirals are in development and, within 1 to 2 years, novel interferons will be available. Currently 23 drugs in the pipeline are expected to receive FDA approval beginning in 2013 through 2015.

Trends in the cystic fibrosis pipeline include drugs to increase mucus clearance, treat underlying disease, and fight infections. Six drugs are in the pipeline with FDA approval expected beginning October 2012 through 2015.