Specialty Medications Becoming More Popular

Atlanta—Although <1% of patients use specialty medications, they account for 15% of drug spending. The trend is expected to continue, as numerous expensive specialty drugs have recently been approved by the US Food and Drug Administration (FDA) and many more are in the pipeline.

Aimee Tharaldson, PharmD, senior clinical consultant for emerging therapeutics at Express Scripts, Inc, spoke about the topic at a Contemporary Issues session at the AMCP meeting titled Specialty Pharmaceuticals Pipeline Update. Dr. Tharaldson used Express Scripts’ definition of specialty medications: injectable or noninjectable drugs intended to treat chronic conditions that have limited distribution, cost >$500 per month, require dosing adjustments or intensive clinical monitoring, intensive patient training or compliance assistance, and specialized handling and administration. Dr. Tharaldson said the top therapeutic classes for specialty medications based on per member per year (PMPY) costs are for inflammatory conditions ($37), multiple sclerosis ($30), cancer ($22), anticoagulation ($7), and growth deficiency ($6).

Cancer is expected to be the top class in the coming years, with half of specialty drugs in the pipeline intended to treat the disease. According to Dr. Tharaldson, $22 billion was spent on cancer drugs in 2010, and 25% of all drugs in the pipeline are intended for cancer. In 2008 and 2009, the FDA approved 16 and 15 traditional drugs, respectively, compared with 8 and 10 specialty drugs, respectively. The trend reversed in 2010 with 14 approvals of specialty drugs and 7 approvals of traditional drugs, and it continues this year.

As of October 20, when Dr. Tharaldson spoke, the FDA had approved 14 specialty drugs in 2011 compared with 11 traditional drugs. They were Makena (to prevent preterm birth), Corifact (for factor XIII deficiency), Benlysta (lupus), Yervoy (malignant melanoma), Caprelsa (thyroid cancer), Zytiga (prostate cancer), Victrelis (hepatitis C), Edurant (HIV), Incivek (hepatitis C), Nulojix (transplant), Zelboraf (malignant melanoma), Adcetris (lymphoma), Firazyr (hereditary angioedema), and Xalkori (lung cancer). With specialty drugs gaining market share, the PMPY costs associated with the drugs are expected to rise significantly, according to Express Scripts data.

Although the PMPY costs for specialty drugs are lower than for traditional drugs, because there are far more people taking traditional drugs, the PMPY costs for specialty medications are projected to increase by >25% in 2011, 2012, and 2013, while the PMPY costs for traditional drugs are expected to increase by <5% in each of those 3 years. Dr. Tharaldson provided an overview of the pipeline drugs based on therapeutic class. She said there are 4 promising oral biologics to treat inflammatory conditions that will compete with injectables. There will also be more oral disease-modifying drugs intended for multiple sclerosis (MS) as well as expanded MS use for drugs already on the market. Dr. Tharaldson said biobetters (new versions of biologics) are likely to impact MS and inflammatory conditions in the next few years, too.

As for cancer drugs in the pipeline, Dr. Tharaldson mentioned there are a few oral drugs as well as targeted therapies that are intended for niche or orphan cancer types. The hepatitis C pipeline includes oral protease inhibitors, direct-acting antivirals, and novel interferons that could be approved in the next 2 to 3 years. In cystic fibrosis, the pipeline drugs are focused on increasing mucus clearance, treating the underlying disease, and fighting lung infections.