Specialty Drugs

The FDA recently expanded the indication of AbbVie Inc.’s Rinvoq (upadacitinib), making it the first oral treatment and the first Janus kinase (JAK) inhibitor for Crohn’s disease. Still, the agent is entering a highly competitive class in which manufacturer rebates play a big role. And while respondents to a Zitter Insights survey said the drug will somewhat lessen the unmet need in the treatment of the condition, they said that a moderate level of need still exists with the agent’s approval.

On May 18, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor. The agency initially approved the JAK inhibitor on Aug. 16, 2019. This is the seventh indication the drug has gotten across rheumatology, dermatology and gastroenterology.

On June 30, Blueprint Medicines Corp. revealed that partner Genentech USA, Inc., a member of the Roche Group, will voluntarily withdraw Gavreto’s (pralsetinib) indication for the treatment of people at least 12 years old with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer who require systemic therapy. The FDA gave the indication accelerated approval on Dec. 1, 2020. Genentech said the decision, which was made in consultation with the FDA, was not due to new safety or efficacy data but rather due to the “feasibility” of conducting the Phase III confirmatory trial required for full approval. Confirmatory studies to convert the other indications of the kinase inhibitor, all of which have accelerated approval, to full approval are ongoing.

As plan sponsors continue to grapple with the high costs of specialty drugs, they have undertaken various strategies to deal with them. The use of copayment accumulators, copay maximizers and alternative funding companies has been a fairly recent trend, noted longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, during a recent webinar. But as that use continues to increase, multiple questions exist around the practices and what the future holds for them.

Fein explained that he chose the focus of the June 23 webinar, titled PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding, because the entities are a hot industry topic currently. “And I think this is a topic of great relevance to manufacturers, to PBMs, to plan sponsors, to patients, to pharmacies, to everyone in the channel. And it’s one that I found is not well understood,” he stated.

Alex Oshmyansky, M.D., the CEO of Mark Cuban Cost Plus Drug Co. (MCCPDC), the online cash pharmacy funded by the eponymous billionaire investor, said the company has become a licensed drug wholesaler nationwide and has plans to roll out quasi-PBM business lines including a retail pharmacy network. Oshmyansky discussed these new ventures — and addressed criticism by health care experts that his firm can’t lower specialty pharma costs — during a June 13 keynote at the 2023 AHIP Conference in Portland, Oregon.

“I think it was always our ambition” to work with retail pharmacies, Oshmyansky said. “I think there’s a variety of products where it just doesn’t necessarily make sense for them to be mail-order products,” citing “cold supply chain” and “acute care medications” as examples.

Alex Oshmyansky, M.D., the CEO of Mark Cuban Cost Plus Drug Co. (MCCPDC), the online cash pharmacy funded by the eponymous billionaire investor, said the company has become a licensed drug wholesaler nationwide and has plans to roll out quasi-PBM business lines including a retail pharmacy network. Oshmyansky discussed these new ventures — and addressed criticism by health care experts that his firm can’t lower specialty pharma costs — during a June 13 keynote at the 2023 AHIP Conference in Portland, Oregon.

“I think it was always our ambition” to work with retail pharmacies, Oshmyanksy said. “I think there’s a variety of products where it just doesn’t necessarily make sense for them to be mail-order products,” citing “cold supply chain” and “acute care medications” as examples.

As potentially as many as eight biosimilars of AbbVie Inc.’s Humira (adalimumab) could launch onto the U.S. market in July, the manufacturer of one of those drugs recently revealed that it would launch its product at a huge discount not seen before in the United States for biosimilar agents. While that highly competitive price certainly will appeal to some payers, commercial payers that favor high-list-price/high-rebate therapies are likely to not cover the agent, say industry experts. In addition, it remains to be seen whether the move signals the beginning of more affordable biologics or the destabilization of the market, they maintain.

On June 1, Coherus BioSciences, Inc. revealed that it would launch Yusimry (adalimumab-aqvh) in July with a list price of $995 per carton — an 85% discount off reference drug Humira’s $6,922 price tag. The tumor necrosis factor (TNF) inhibitor, first approved Dec. 17, 2021, is a low-concentration, citrate-free version of Humira, and it has approval for most of the reference drug’s indications: (1) adults with moderately to severely active rheumatoid arthritis, (2) people at least 2 years old with moderately to severely active juvenile idiopathic arthritis, (3) adults with active psoriatic arthritis, (4) adults with active ankylosing spondylitis, (5) people at least 6 years old with moderately to severely active Crohn’s disease, (6) adults with moderately to severely active ulcerative colitis, (7) adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate, and (8) adults with moderate to severe hidradenitis suppurativa.

The FDA recently expanded the indication of AbbVie Inc.’s Rinvoq (upadacitinib), making it the first oral treatment for Crohn’s disease. And while respondents to a Zitter Insights survey said the drug will somewhat lessen the unmet need in the treatment of the condition, they said that a moderate level of need still exists with the agent’s approval.

On May 18, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. This is the seventh indication the drug has gotten across rheumatology, dermatology and gastroenterology.

With an eye on improving medication adherence for people with rare diseases or chronic conditions, AllianceRx Walgreens Pharmacy recently launched RightGuide. The program helps digitally connect pharma manufacturers to patients and their caregivers in order to provide education on a variety of topics, from training people how to self-administer injectable agents to helping with financial issues and addressing the side effects of medications.

The specialty pharmacy is working with manufacturers to create customized, brand-specific resources “to help facilitate patient conversion, adherence and retention — while minimizing treatment barriers for patients and caregivers,” explains Tracey James, R.Ph., chief operating officer at AllianceRx Walgreens Pharmacy.

Amneal Pharmaceuticals, Inc. launched Fylnetra (pegfilgrastim-pbbk), the company said May 16. The granulocyte colony-stimulating factor is the sixth biosimilar of Amgen Inc.’s Neulasta (pegfilgrastim) to launch in the U.S. The FDA approved the drug on May 26, 2022, to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Its J-code is Q5130. It is the third biosimilar that Amneal has launched in the U.S.

Amgen settled a patent infringement lawsuit (No. 22-cv-1549) with Janssen Biotech Inc., a division of Johnson & Johnson, over a proposed biosimilar of Stelara (ustekinumab), Amgen revealed May 23. Stelara, a human interleukin-12 and -23 antagonist, is indicated for adults with moderate-to-severe plaque psoriasis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis, as well as people at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and people at least 6 with active psoriatic arthritis. The FDA first approved it on Sept. 25, 2009. Amgen said the settlement will allow its biosimilar to launch “no later than” Jan. 1, 2025.

Various randomized controlled trials have found that hypofractionated whole breast irradiation (HF-WBI) for certain patients with early-stage breast cancer is not only equivalent to standard radiation therapy for local control of the disease but also is less toxic, has better patient adherence and provides improved patient well-being. Those results led the National Comprehensive Cancer Network (NCCN) to add the approach to its guidelines. But while hypofractionation can benefit patients, providers and health plans, there has been slow uptake of it. A recent study found that putting clinical pathways in place that include mandating HF-WBI’s use improved compliance with the guidelines.

One retrospective study found that health plans spent $6,375 less for HF-WBI than they spent on conventional whole breast irradiation, and patients saved about $140 aside from travel-related costs.