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AMCP 2016

What Is Coming in Specialty Pharmacy? A Look at the Near-Term Drug Pipeline

Laura Joszt
AMCP Managed Care & Specialty Pharmacy Annual Meeting 2016 kicked off by delving into the near-term specialty pharmaceutical pipeline with Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts.
Dr Tharaldson ran through some of the specialty drugs in the pipeline for a variety of diseases. She highlighted cancer drugs in the pipeline, of which there are so many she didn’t even include a full list of the drugs in the near-term cancer pipeline. She explained that many of these drugs are breakthrough therapies and nearly all of the ones she showed were targeted therapies.
In hepatitis, there are already a number of very effective treatment options available to treat all the different genotypes, but the standard of care is rapidly evolving.
“Looking forward we’re going to see pan-genotypic regimens,” Dr Tharaldson said. These upcoming drugs will be able to treat genotypes 1-6 and will require shorter treatment durations.
Gilead has a drug that is very effective for treating all genotypes, and it will have the market to itself for a while. Velpatasvir with Sovaldi is expected to be approved June 28, 2016, while competitor drugs treating all 6 genotypes probably won’t be approved until late 2017 or early 2018, Dr Tharaldson said.
As of right now, there don’t seem to be any regimens that reduce treatment to 4 or 6 weeks. There is an injection drug being developed that would reduce treatment duration, but she doesn’t expect to see a 4-week regimen be approved until 2018, 2019, or possibly even later.
Another drug area that Dr Tharaldson focused on was nonalcoholic steatohepatitis (NASH), which is fat in the liver, liver inflation, and liver damage. Currently 6 to 10 million patients have severe NASH, which means there could be a very large patient population.
The large population is a mostly a result of the increase in obesity, which is growing to be one of the leading causes of liver transplant. However, while there is a lot of development going on for drugs to treat NASH, these have a slightly longer timeline and are not expected to reach the market until at least 2018.

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