Specialty Drug Pipeline Review Focuses on Competition, Cancer Drugs

At the Academy of Managed Care Pharmacy's Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26, in Boston, Massachusetts, an overflow capacity crowd gathered for one of the meeting’s yearly highlights­: Specialty Pharmaceuticals in Development. Aimee Tharaldson, PharmD, a senior clinical consultant in Emerging Therapeutics for Express Scripts, talked about the key trends in the specialty drug market, including cancer drugs, new competition, and orphan drugs.

Six specialty classes are maturing, she said, including HIV, multiple sclerosis (MS), and drugs for psoriasis, and there is a $25 billion market opportunity through 2022 as 64 drugs come off patent protection.

Likewise, there is a similar opportunity in biosimiliars, as 71 patents lose protection through 2021, creating a $54.4 billion market. There are 10 biosimiliars pending approval this year, targeting treatments for anemia, breast cancer, neutropenia, rheumatoid arthritis (RA), non-Hodgkin lyphoma (NHL), chronic lymphocytic leukemia (CLL), and psoriasis. But there are significant legal hurdles in the biosimiliar market, and the FDA is working on policies to open up competition in this market. Eventually, it will lead to significant cost savings, she said.

Market share capture varies by drug, however.

“It just seems to be taking a bit a little bit longer than we would like,” Tharaldson said. In 5 years, there could be numerous biosimiliars to the immunosuppressant drug Humira—a $16 billion market, she noted.

In orphan drugs, which affect fewer than 200,000 patients, 30% of the drugs are for cancer. Most are blockbusters.

Last year, 41% of pharmacy drug spending was for specialty drugs market compared with 59% for traditional drugs. But fewer than 2% of patients take specialty drugs. The leading category of specialty drugs are for inflammatory conditions, followed by oncology, MS, HIV, and hepatitis C.

Tharaldson discussed a number of therapy classes in the specialty drug pipeline, including migraine, inflammatory conditions, MS, cancer, and HIV. With migraine drugs, she reviewed the category known as calcitonin gene-related peptide (CGRP) inhibitors. Express Scripts is leaning toward covering these drugs as traditional migraine drugs and not specialty migraine drugs, she indicated.

The 2 CGRPs closest to winning approval this spring are Amgen’s erenumab and Teva’s fremanezumab, but fremanezumab may be delayed because of facility issues at its manufacturing plant in South Korea, she said.

The other CGRPs are galcanezumab, with approval expected in October; eptinezumab and ubrogepant both expected next year; rimegepant in 2020; atogepant in 2021; and eptinezumab in 2021.

The pipeline for drugs for inflammatory conditions includes:

• rituximab for RA, NHL, and CLL with an expected approval this May
• certolizumab for an expanded indication for psoriasis, with approval this May
• tofacitinib for an expanded indication for ulcerative colitis this June
• baricitinib for RA this June
• adalimumab for RA and psoriasis in September 2018
• risankizumab for psoriasis for in 2019
• upadacitinib for RA 2019

For MS, the pipeline for drugs potentially winning FDA approval in 2019 and beyond includes fingolimoe, cladribine, monomethyl fumarate, ozanimod, and siponimod.

For cancer drugs, the trend to watch will be what's next for chimeric antigen receptor (CAR) T-cell therapy. Tharaldson said to look for autogenic or “off the shelf” therapies that use donor cells, which may drive down cost.

Last year, 15 new cancer drugs were approved, but despite new competition, it has not brought down prices. CAR T, for instance, runs in the mid-6 figures.

New upcoming therapies may include:

• mogamulizumab for lymphoma in June
• binimetinib/encorafenib for melanoma in June
• iobenguane I‐131 for advanced pheochromocytoma and paraganglioma in July
• lorlatinib for lung cancer in August
• Ivosidenib for leukemia in August

In the HIV market, 2 new drugs are expected this year that are combination treatments aimed at increasing adherence: Janssen’s single-tablet combination of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide is aimed at increasing adherence, and Merck's doravirine, lamivudine, and tenofovir disoproxil. There are also 2 drugs coming up next year: cabotegravir/rilpivirine and PRO-140.