Specialty medication approvals continue to outpace those of traditional medications each year, and with the approval of the first biosimilar this spring, the specialty market is only gaining momentum.
Administration of these complex drugs often requires special processes, high-touch care, and a thorough understanding of disease states and potential side effects. In response, specialty pharmacists are providing needed services at every level.
Each year more advanced specialty drugs enter the market to treat complex diseases such as hepatitis C, rheumatic diseases, and cancer. And not only are the numbers of specialty drugs increasing; they are also starting to draw more competition from new alternative and biosimilar formulations.
Sofosbuvir (Sovaldi; Gilead Sciences) now has to share the market with other effective therapies for the treatment of patients with hepatitis C. However, when it was first introduced in late 2013, sofosbuvir made waves across the healthcare community for both its high cost and its potential impact on patients with hepatitis C. Clinical trials have shown that more than 95% of patients with hepatitis C were able to achieve a sustained virologic response after taking the drug, but with an average wholesale price of about $1,000 a pill, its use called for a costly investment.
In December 2014, FDA approved ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekira Pak; Abbvie Inc.), giving rise to Sovaldi’s first competition, and pharmacy benefit managers (PBMs) are taking note.
"Express Scripts made a landmark decision to exclusively cover Viekira Pak, which significantly reduced the cost of care and now makes this curative therapy available to all patients, not just the sickest," said Aimee Tharaldson, PharmD, senior clinical consultant for Express Scripts.
Cancer and RA
This year has also marked the approval of the first biosimilar, filgrastim-sndz (Zarxio; Sandoz), formulated to compete with Neupogen (Amgen) to reduce rates of infection in certain cancer patients during chemotherapy. The drug can be used to treat all nonmyeloid cancer types in patients taking myelosuppressive chemotherapy, as well as in acute myeloid leukemia patients.
Infliximab (Inflectra; Hospira), a new biosimilar intended to compete against Janssen’s rheumatology drug Remicade, could also be approved as early as this year. The approval and launch of the drug are currently delayed by pending litigation; if approved, Inflectra would be the first monoclonal antibody in biosimilar form in the United States. Its potential uses include treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and ankylosing spondylitis.
Many of the specialty drugs moving through the pipeline are intended to treat cancer. According to Tharaldson, approximately 35% of all specialty drugs now in development are for cancer. About half of them will be oral formulations.
Some of the most notable trends are occurring in the treatment of lung cancer, said Tharaldson, and particularly for non-small-cell lung cancer (NSCLC). Nivolumab (Opdivo; Bristol-Myers Squibb), a programmed death receptor-1 (PD-1) inhibitor, was granted expanded approval in March to treat NSCLC. Another PD-1 inhibitor, pembrolizumab (Keytruda; Merck Oncology), is expected to receive approval for this indication this fall. Two oral, next-generation epidermal growth factor receptor (EGFR) inhibitors for NSCLC, AZD-9291 (Astra Zeneca) and rociletinib (Clovis Oncology), are also expected to gain approval by mid-2016.
One significant trend in the cancer pipeline, according to 2014 report from The IMS Institute for Healthcare Informatics, is the development of targeted therapies and agents that work with molecular targets and biomarkers. For this reason, a significant number of drugs under investigation for the treatment of colorectal, breast, and ovarian cancer would target different mutations (KRAS, BRAF, and ALK) as well as human epidermal growth factor receptor 2 (HER2).