Drug vials The majority ofoncology drugs (70 percent) will be high-cost orphan drugs–focusedon relatively small group of patients with rare subsets of cancer.(Photo: Shutterstock)


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


Related: 'Super spenders' accrued $2.1 billion in specialtydrugs costs last year


The report from OptumRx, the pharmacy benefits manager forUnitedHealth Group, said that 64 of the new drugs already haveanticipated approval dates this year. The company monitors the drugdevelopment pipeline in the U.S., with an eye for what drugs willlikely have the biggest impact in terms of quality, cost, andeffectiveness.

Drug trends—oncology drugs dominate new releases

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


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


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


Neurology drugs are also expected to produce a high number ofnew approvals. "The current development pipeline includes newtherapies for more common conditions such as migraine, Parkinson'sdisease, and epilepsy, as well as novel therapies that treat rareor ultra-rare conditions such as spinal muscular atrophy andneuromyelitis optica," the report said, adding that those morespecialized drugs also tend to be costly, but that new competitionin the area may help bring some prices down.


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

High-impact drugs

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

  • A new class of cholesterol drugs–Bempedoic acid is considered anew approach to fighting high cholesterol, and should be compatiblewith other types of treatment, the study found. "In clinicaltrials, bempedoic acid lowered LDL-C by approximately 15 percent to30 percent compared to placebo," the study said.
  • The first oral treatment for peanut allergies—AR-101 is a formof oral immunotherapy that has been tried by some immunotherapistsbut has not yet been formally approved by the FDA as a consumerdrug. The drug is predicted to be relatively costly (up to $5,000annually), and has some limitations, but has had generally goodresults in reducing peanut allergy symptoms. "Because of the largepatient population, and minimal treatment options, there is a $4.5billion global market for drug manufacturers to treat peanutallergies," the report said.
  • A treatment for a liver condition—the report also highlightedobeticholic acid, a new treatment for Nonalcoholic steatohepatitis(NASH), a liver condition that can lead to cancer and liverfailure. "Obeticholic acid would be the first treatment for NASHand will likely be an attractive option for patients struggling tolose weight," the study said. The drug is expensive (up to $18,000annually) but with 50 other drugs targeted to treating NASH in thepipeline, competition may drive prices down.

Read more: 

Complete your profile to continue reading and get FREE access to BenefitsPRO, part of your ALM digital membership.

  • Critical BenefitsPRO information including cutting edge post-reform success strategies, access to educational webcasts and videos, resources from industry leaders, and informative Newsletters.
  • Exclusive discounts on ALM, BenefitsPRO magazine and BenefitsPRO.com events
  • Access to other award-winning ALM websites including ThinkAdvisor.com and Law.com

© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.