Specialty Pharmacy Pipeline Trends: Inflammatory Conditions

In a session at the 2013 Academy of Managed Care Pharmacy Nexus meeting, Aimee Tharaldson, PharmD, identified the top specialty drugs in the pipeline and highlighted the most recent therapeutic trends within the inflammatory conditions class.

Specialty Pharmacy Times contributor Aimee Tharaldson, PharmD, senior clinical consultant, Emerging Therapeutics, Express Scripts, recently conducted a session at the 2013 Academy of Managed Care Pharmacy Nexus meeting on the specialty pharmacy pipeline. In her session, she identified the top specialty drugs on the horizon and discussed the role of these therapies in the treatment of specialty disease states. She also summarized the ways in which new therapies will impact the market.

Just like last year, we were particularly interested in the inflammatory conditions pipeline. This class is associated with the highest per member per year (PMPY) costs, and the double-digit trend in this therapy class is expected to continue, according to data from Express Scripts’ Drug Trend Report.

Inflammatory Conditions

Drugs to watch: vedolizumab, sarilumab, apremilast, baricitinib

In this class, tumor necrosis factor inhibitors (TNFis) dominate the market, Tharaldson noted, and most are administered subcutaneously. In terms of pipeline trends in this class, watch for expanded indications and routes of administration, similar to what occurred with Cimzia (certolizumab) and Stelara (ustekinumab) when they were approved for new indications. There are new injectable biologics on the horizon for conditions like rheumatoid arthritis (RA), psoriatic arthritis, and irritable bowel syndrome, and more oral drugs will compete in this market.

Many of the injectable biologics in the immunotherapy space are monoclonal antibodies that inhibit inflammatory cytokines, noted Tharaldson. Of particular note are vedolizumab (which works much like Tysabri [natalizumab] but is more selective to the gut) for the treatment of ulcerative colitis (UC) and Crohn’s disease. It was found to be more effective in inducing response to UC and, as a result, was granted Priority Review by the FDA for this indication. This drug will probably be ideal to treat patients who no longer respond to TNFis, a population which accounts for approximately 10% to 50% of patients every year, asserted Tharaldson. In addition, there are not as many concerns with vedolizumab about progressive multifocal leukoencephalopathy as there have been with Tysabri.

Another standout is sarilumab for the treatment of RA. This is an IL-6 inhibitor specifically for patients who have previously failed on Humira (adalimumab). Sarilumab is currently being studied in a head-to-head trial with Enbrel (etanercept). Rather than having RA patients switch between TNFi therapies when one TNFi stops working, sarilumab could present another option for these patients.

In terms of oral competitors in this class, Celgene expects to release apremilast, a phosphodiesterase inhibitor for the treatment of psoriatic arthritis that is expected to be approved in March 2014. The company is also filing the drug for a psoriasis indication, and is expected to gain approval for this indication during the third quarter of next year (2014). According to Tharaldson, apremilast is not as effective as a TNFi but is a safer option, especially for patients presenting with mild symptoms or for patients using the therapy as a bridge between methotrexate and the TNFis. Celgene projects apremilast to be a $2- to $3-billion drug, noted Tharaldson.

Baricitinib is an oral Janus kinase (JAK) inhibitor for RA that is expected to directly compete with Xeljanz (tofacitinib). Unlike Xeljanz, which is taken twice daily, baricitinib is taken once daily, and Xeljanz inhibits JAK 3 receptors, whereas baricitinib inhibits JAK 1 and 2 receptors.

The therapies highlighted in dark blue in the chart below represent examples of drugs that are already on the market but have new formulations or new indications that are expected to be released. For a more detailed look at other specialty drugs in the pipeline in other classes, read Tharaldson's "Near-Term Specialty Pipeline Highlights."

Slide by Aimee Tharaldson, PharmD, Senior Clinical Consultant, Emerging Therapeutics, Express ScriptsReprinted with permission from Express Scripts Holding Company