Drug Market to See More Competition, Launch of Biosimilars in 2019

If competition is key to finding savings in drug pricing, then the next 2 years should bring plenty of opportunities, according to Aimee Tharaldson, PharmD, senior consultant for emerging therapeutics for Express Scripts, who gave her overview of the specialty pharmacy landscape to kick off Academy of Managed Care Pharmacy Nexus 2018 in Orlando, Florida.

Rising competition across specialty pharmacy classes, the launch of more biosimilars, and approvals of rare disease therapies will create a dynamic landscape, Tharaldson said, although there will still be many new treatments that hit the market at prices of $300,000 a year or higher. She reviewed activity in treatments for HIV, hemophilia, multiple sclerosis, various inflammatory conditions, cancer, and rare diseases. The trend of specialty pharmacy dominating what America spends on drugs will continue, Tharaldson said; Express Scripts’ data show specialty pharmacy accounted for 41% of the drug spend in 2017, and she predicts this share will rise to 50% by 2019 even though only a fraction of those who take prescription drugs use these medications.

Biosimilars

Tharaldson reviewed existing approvals as well as the legal challenges that have kept several promising products from reaching the US market. But she listed target launch dates for some key products, including July 2019 for bevacizumab-awwb (Mvasi), which has indications in several common forms of cancer, and June 2019 for trastuzumab-dkst (Ogivri), a common treatment for breast cancer. She listed 8 more biosimilars with approvals pending before the end of 2018, including additional treatments for neutropenia, more products that reference trastuzumab, and a treatment that references rituximab for non-Hodgkins lymphoma.

Of note, Tharaldson said, FDA is working hard to develop policies to promote the biosimilars market by making it more difficult for branded drug manufacturers to extend patents and stifle competition. “Eventually, this will lead to cost savings,” she said.

Cancer therapies

FDA has already approved 12 cancer therapies so far in 2018, and 4 more are expected. Many forms of cancer have been transformed to chronic conditions, and the 25% reduction in death rates is due to both better treatments and better detectionm as well as less smoking. However, “even though we are seeing new niche products, we are not bringing the prices down very much,” she said, and $150,000 a year for a cancer therapy is fairly common. Drug developers are finding success in treatments for rare cancers, and 30% of the treatments approved for disease that affect 200,000 or fewer patients become blockbusters, she said.

Specialty drug spending

Data from Express Scripts show that spending on inflammatory conditions, such as rheumatoid arthritis (RA) or psoriasis, outranks all other categories and is twice that of cancer. Spending for hepatisis C now trails behind HIV, cancer, and multiple sclerosis. Total specialty pharmacy spending was $444 per member per year. And with 39 new specialty drugs in the pipeline, there’s no sign of that slowing down, Tharaldson said. She highlighted new therapies for HIV-1, metastatic melanoma, cystic fibrosis, rheumatoid arthritis, and acute myeloid leukemia.

In the pipeline

Tharaldson discussed therapies across multiple classes on track for approval over the next 2 years. Four therapies for inflammatory conditions—risankizumab and bimekizumab for psoriasis, and upadacitinib and filgotinib for RA—are anticipated through 2020, while 4 therapies in the pipeline for multiple sclerosis—cladribine, siponimod, monomethyl fumarate, and ozanimod—are all on track for approval in 2019. The latter debilitating condition affects 1 million people in the United States.

As she has in the past, Tharaldson drew attention to nonalcoholic steatohepatitis, or NASH, which is associated with high cholesterol and type 2 diabetes (T2D) and causes liver damage when fat develops in the liver. There are no real treatments, although some may be coming, including a few already approved for other indications. Novo Nordisk’s semaglutide is already approved for T2D and is in trials for NASH, while Gilead’s selonsertib and Intercept Pharmaceutical’s obeticholic acid could be on track for approval in 2019. Eight other therapies are under development for approval beyond 2020.

Alzheimers’ disease, meanwhile, continues to baffle researchers amid growing need, as 5.5 million people already have the disease and more will be diagnosed as the population ages. Tharaldson listed 9 treatments under study, but, “So far, these drugs just haven’t been able to demonstrate that they are effective,” she said. “It’s a very high-risk, high-reward class.”

Drugs to watch

The audience gasped when Tharaldson said she has her eye on an IV drug under development by Novartis, now listed as AVSX-101 for spinal muscular atrophy, which could cost $1 million to $3 million for a single infusion. By contrast, Pfizer’s tafamidis, which could be approved next year to treat transthyretin amyloid cardiomyopathy, will be an important treatment as it promises to greatly reduce hospitalizations, and thus could save health plans money.