A new report says the FDA will evaluate more than 150 new drugs for approval in 2020, with 11 drugs representing potential blockbuster sales of more than $1 billion each.

The report from OptumRx, the pharmacy benefits manager for UnitedHealth Group, said that 64 of the new drugs already have anticipated approval dates this year. The company monitors the drug development pipeline in the U.S., with an eye for what drugs will likely have the biggest impact in terms of quality, cost, and effectiveness.

Drug trends—oncology drugs dominate new releases

The report predicted that oncology drugs will have the most releases by far—44 new oncology drugs are expected to be approved. The next highest category is neurology drugs, at 29 expected approvals.

"A continuation from past years, oncology is a top therapy class indicating that pharmaceutical manufacturers continue to invest heavily in this space," the report said.

The majority of oncology drugs (70 percent) will be high-cost orphan drugs, the report said. These orphan drugs are focused on relatively small group of patients with rare subsets of cancer, defined by biomarkers or genetic mutations. "Oncology is one of the most-costly drug classes," the report said. "Pharmaceutical companies have been successful in setting high prices for new drugs, which we expect to continue for 2020 and beyond."

Neurology drugs are also expected to produce a high number of new approvals. "The current development pipeline includes new therapies for more common conditions such as migraine, Parkinson's disease, and epilepsy, as well as novel therapies that treat rare or ultra-rare conditions such as spinal muscular atrophy and neuromyelitis optica," the report said, adding that those more specialized drugs also tend to be costly, but that new competition in the area may help bring some prices down.

OptumRx also noted that the number of orphan drugs brought to market in the past ten years has increased dramatically. For 2020, OptumRx found that 40 percent of the expected applications were for orphan drugs. "Similar to the oncology space, orphan drugs are expensive, costing on average $147,000 a year or more, and will require utilization and specialty pharmacy care management to reduce costs for patients and clients," the report said.

High-impact drugs

The report singled out a few drugs that are expected to draw strong interest from patients and payors:

A new class of cholesterol drugs–Bempedoic acid is considered a new approach to fighting high cholesterol, and should be compatible with other types of treatment, the study found. "In clinical trials, bempedoic acid lowered LDL-C by approximately 15 percent to 30 percent compared to placebo," the study said.
The first oral treatment for peanut allergies—AR-101 is a form of oral immunotherapy that has been tried by some immunotherapists but has not yet been formally approved by the FDA as a consumer drug. The drug is predicted to be relatively costly (up to $5,000 annually), and has some limitations, but has had generally good results in reducing peanut allergy symptoms. "Because of the large patient population, and minimal treatment options, there is a $4.5 billion global market for drug manufacturers to treat peanut allergies," the report said.
A treatment for a liver condition—the report also highlighted obeticholic acid, a new treatment for Nonalcoholic steatohepatitis (NASH), a liver condition that can lead to cancer and liver failure. "Obeticholic acid would be the first treatment for NASH and will likely be an attractive option for patients struggling to lose weight," the study said. The drug is expensive (up to $18,000 annually) but with 50 other drugs targeted to treating NASH in the pipeline, competition may drive prices down.

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Oncology drugs lead the way for new approvals in 2020

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