The therapeutic area of hepatitis C calmed down after the 2013 approval of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) in 2014, but in June 2016, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), the first single tablet regimen approved for treatment of all genotypes of the virus, was approved.
Lyle says, however, that it should cost less than the initial prices of its predecessors, about $890 per pill versus $1,000 and $1,125 for Sovaldi and Harvoni, respectively. In addition, in January 2016, Zepatier (elbasvir and grazoprevir) to treat genotypes 1 and 4 in competition with Harvoni came on board costing $54,600 compared to Harvoni’s initial price of $94,500 for a course of treatment.
CareMark will cover Harvoni, Sovaldi and Epclusa and has removed Viekira Pak from its formulary, while Express Scripts remains loyal to Viekira Pak.
Aimee Tharaldson, senior clinical consultant, emerging therapeutics for Express Scripts, says that although there has been a lot of attention paid to cancer drugs, there has been even more directed at orphan drugs. Cancer drugs (non-orphan status) account for 22% of the specialty drug pipeline, while orphan drugs account for 40%, she says. In addition, 30% of these drugs are expected to be blockbusters. Tharaldson shared this information as a keynote speaker at the Academy of Managed Care Pharmacy 2016 Nexus conference.
Medications for some orphan diseases are moving through the pipeline, such as the first treatment for Duchenne muscular dystrophy (DMD) called Exondys 51 (eteplirsen) that received accelerated approval in September 2016, and corticosteroid deflazacort, also for DMD, awaits further study.
Two new drugs for tardive dyskinesia, involuntary movements of the face and jaw, could be on the market in 2017—valbenazine and deutetrabenazine. Neurocrine Biosciences submitted a New Drug Application for the first in August 2016, while Teva received breakthrough therapy designation status in 2015.
Other new drugs are targeting more common chronic diseases. The FDA approved Bevespi Aerosphere, a combination of glycopyrrolate and formoterol fumarate, to treat chronic obstructive pulmonary disease, in April 2016. The product with its new co-suspension technology, which helps maintain consistent dosing for a combination of drugs in a single inhaler, competes with two other dual bronchodilators already on the market.