Radar on Specialty Pharmacy

President Donald Trump has issued another executive order focused on the pharmaceutical industry: a so-called “Buy American” order. While the approach presents some benefits, industry experts maintain that several challenges exist to its implementation, not the least of which is that it’s coming in the middle of a pandemic. And multiple specialty therapies may be impacted by it.

The order, signed Aug. 6, comes only a couple of weeks after the president signed a handful of executive orders focused on drug pricing. One of them, a most-favored nation order, was criticized by industry experts as a last-ditch effort before the Nov. 3 election to show the country that the administration is doing something about drug prices (RSP 8/20, p. 1). At the same time, critics argued that it’s taking away from efforts to develop therapeutics and vaccines for the COVID-19 pandemic. The president held off on publicizing that order with the other three on July 24, saying that he was giving pharma one month to come up with alternatives. As of RSP press time on Sept. 9, that order had not been made public.

✦ July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk myelodysplastic syndromes. The agency gave the application priority review and orphan drug designation. Review of the application was done in collaboration with agency counterparts in Canada and Australia through Project Orbis (RSP 10/19, p. 12). Dosing is one tablet once daily on days one through five of each 28-day cycle. Taiho Oncology will commercialize the drug in the U.S. Its launch is pending. Visit www.inqovi.com.

✦ July 9: The FDA approved Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co., Ltd.’s Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. The agency approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) — the sixth one that the agency has approved — in both prefilled syringe and auto-injector presentations. Dosing varies depending on the indication. A patent license agreement with AbbVie will allow the drug to launch in the U.S. in 2023. Visit https://bit.ly/2DnyjOZ.

Chronic kidney disease (CKD) affects almost 40 million people in the United States. The condition can cause a variety of health complications, including anemia. Treatments for anemia of CKD consist of erythropoiesis-stimulating agents (ESAs), the first of which the FDA approved in 1989. But a new kind of drug is poised to shake up the class, with the first expected approval potentially happening later this year.

When people’s kidneys are healthy, they produce erythropoietin, a product that prompts the bone marrow to make red blood cells. When the kidneys are damaged, their erythropoietin production goes down, causing a decline in red blood cells, which in turn causes anemia.

AstraZeneca and Merck & Co., Inc. released positive results of Lynparza’s Phase III PROfound trial last August. Shortly thereafter, from Sept. 3, 2019, to Oct. 7, 2019, Zitter Insights polled 51 commercial payers with 158.4 million covered lives about how they were likely to manage the therapy.

Commercial payers with 60% of covered lives said they were more likely than unlikely and significantly likely to manage Lynparza at parity with other drugs in the second-line treatment of metastatic castration- resistant prostate cancer (see chart below). The same percentage of payers said they were neither likely nor unlikely to cover it over all other therapies.

Although poly ADP-ribose polymerase (PARP) inhibitors are not new to the market, two of them recently gained approval for use in prostate cancer for the first time. The therapies will bring a new option for the treatment of certain subpopulations of patients.

On May 19, the FDA expanded the label of AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) to include the treatment of people with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following treatment with Xtandi (enzalutamide) or Zytiga/Yonsa (abiraterone acetate). Lynparza also has approvals in breast, ovarian and pancreatic cancers.