New-to-Market Oral Drugs May Not Always Have a Leg Up on Injectables

by Leslie Small

In its latest quarterly Drug Pipeline Insights Report, OptumRx includes a diverse array of medications that the UnitedHealth Group-owned PBM believes are likely to make a market impact when they're approved by the FDA. One interesting trend that applies to three of the five highlighted drugs is the fact that each is the first oral option in its respective category.

While oral medications tend to be thought of as more convenient than injectable or IV-administered therapies, that factor alone may not confer as much of a competitive advantage as one might think, according to one OptumRx executive.

Take roxadustat, which if approved would be the first novel therapy for chronic kidney disease-related anemia since 1989 and would offer an oral alternative to the injectable erythropoiesis-stimulating agents (ESAs) currently being used to treat the condition.

"Dialysis-dependent patients usually get their ESAs administered with dialysis via IV infusion, so the oral alternative in these patients doesn't provide a convenience benefit necessarily," says Bill Dreitlein, senior director of pipeline and drug surveillance at OptumRx. "However, there may be alternative benefits around safety."

Then there's Orladeyo (berotralstat), BioCryst Pharmaceuticals, Inc.'s treatment for hereditary angioedema (HAE) attacks. When the FDA approved Orladeyo on Dec. 3, it became the first oral plasma kallikrein inhibitor for the prevention of HAE attacks, Dreitlein says.

"The convenience benefit for berotralstat would have been more significant," he says, but the 2018 approval of approval of Takhzyro, which is subcutaneously administered every two to four weeks and can be self-administered, "diminishes that because it already reduced the number of injections vs. older C1 concentrate products."

The FDA is expected to decide on Dec. 20 whether to approve relugolix, which would be the first oral GnRH receptor antagonist on the market for advanced prostate cancer.

Relugolix's oral administration gives it an advantage over Firmagon (degarelix), which requires monthly subcutaneous injections by a health care provider "and hasn't garnered much commercial success because of the frequent injections and injection site reactions," Dreitlein says.

The more common GnRH receptor agonists, on the other hand, require intramuscular injections at intervals ranging from one to six months. "Compared to these drugs, relugolix might confer some clinical advantages, but the convenience benefit is reduced because you are replacing an injection given potentially every six months with an oral daily medication," Dreitlein adds.

From RADAR on Drug Benefits