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Analyzing the Near-Term Pipeline for Specialty Drugs

Laura Joszt
The Academy of Managed Care Pharmacy Annual Meeting kicked off on March 28, 2017, in Denver, Colorado, with a look at the specialty pharmaceutical pipeline with Aimee Tharaldson, PharmD, senior clinical consultant for emerging therapeutics at Express Scripts.
Multiple Sclerosis
The current treatments for multiple sclerosis (MS) include immunomodulators, monoclonal antibodies, and oral therapies. However, these has been significant development for patients with progressive MS, for which there are currently no FDA-approved treatment options.
There are 6 drugs in development for progressive MS. About 15% of patients are diagnosed with primary progressive MS, for which there are no acute relapses or remission.
Ocrelizumab was is expected to be approved on March 28, although it hadn’t been approved yet when Tharaldson spoke. The drug treats primary progressive MS and can treat relapsing forms; however, she noted some safety concerns that need to be monitored, such as the fact that 2.3% of patients developed tumors.
There are a large number of cancer drugs even in the near-term pipeline. Current treatments for cancer include chemotherapy, targeted therapies, and immunotherapies. Tharaldson expects to see more breakthrough therapies approved, which will bring more treatments to the market more quickly, as well as more targeted therapies.
She noted a list of 22 drugs in the near-term pipeline, which didn’t even cover all the drugs in the near-term pipeline. Already, 11 are pending approval. Among the drugs being watched is midostaurin, which would treat acute myeloid leukemia (AML) and systemic mastocytosis. This is a breakthrough therapy for AML as these specific patients do not have a treatment, Tharaldson said.
In addition, the first CAR-T treatment, tisagenlecleucel-T for acute lymphocytic leukemia, is expected to be approved in October 2017.
“These CAR-Ts are interesting, you have to keep an eye on these medications,” Tharaldson said. “They’re very effective in clinical trials.”
CAR-T treatments are immunotherapies that are sent to a manufacturer to develop the antibodies to be infused in patients. It is a 3-week process and given as 1 infusion. However, they can cause cytokine release syndrome and neurotoxicity has also been seen in clinical trials.
“But, again, they’re very effective for patients who have no other treatment options,” she said.
While there aren’t any drugs in the near-term pipeline for nonalcoholic steatohepatitis (NASH), Tharaldson spent the time to go through some drugs in development because this is poised to be a very expensive drug class.
NASH is when there is fat in the liver, plus liver inflammation, plus liver damage, diagnosed by liver biopsy. As many as 16 million Americans have NASH, and another 6 to 10 million are at high risk of developing it. NASH is associated with comorbidities such as high cholesterol, type 2 diabetes, insulin resistance, and obesity.
“There really are limited treatment options other than losing weight eating a healthy diet, exercise and then obviously treating the comorbidities as well,” she said.
The soonest a drug may be available to treat NASH is 2019, and many of the drugs in development are oral therapies. However, Tharaldson noted that semaglutide, which is expected to be approved in September for diabetes, is also being looked at for NASH.
“It is expected that the NASH market could be as much as $35 billion per year,” she said. “So there’s a lot of focus on NASH.”

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