Specialty Drugs

As President Joe Biden’s administration nears its end, two promised rules on copayment accumulators and maximizers have yet to be released. They stand to have a huge impact on whether pharma manufacturer-provided patient assistance — much of which is provided for specialty drugs — must be counted toward patients’ out-of-pocket responsibility.

The first concerns a lawsuit over the 2021 Notice of Benefit and Payment Parameters (NBPP) and its stance toward copay accumulators.

Health plans and PBMs several years ago began implementing accumulators to counter manufacturer copay assistance programs. Traditionally, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

Optum Rx recently revealed that Optum Health Solution’s new biosimilars-focused, private-label subsidiary will join the other two big PBMs’ similar offerings. On Jan. 1, 2025, two Nuvaila-labeled biosimilars will be added to three of its commercial formularies — and for a $0 copay.

Amgen Inc.’s Wezlana (ustekinumab-auub), an interchangeable biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine, will be added to Optum Rx’s commercial formulary on Jan. 1, 2025, the PBM revealed. The agent will be provided as a private-label product from Nuvaila — known as Wezlana for Nuvaila — and will be available in both high-wholesale acquisition cost and low-WAC versions.

The human interleukin-12 and -23 antagonist has approval for all of Stelara’s indications and is available in both subcutaneous and intravenous formulations. It also is latex-free, while Stelara contains a derivative of latex.

A newly approved immune globulin for primary immunodeficiency will bring another option to a class of products that often is plagued by shortages. It is also a crowded space, and payers have several considerations when deciding on the coverage of these agents, say industry experts.

On June 13, the FDA approved Grifols Group company Biotest AG’s Yimmugo (immune globulin intravenous, human-dira) for the treatment of primary humoral immunodeficiency in people at least 2 years old. Dosing via intravenous infusion is every three to four weeks, with the first infusion started at 0.5 mg/kg per minute and increasing up to 3.0 mg/kg per minute; afterwards, the maintenance infusion rate is 13 mg/kg per minute. The dosage can be adjusted over time to achieve the desired trough levels and clinical response.

Commercial and government payers can play a key role in generating real-world evidence (RWE) and helping the health care system reduce costs and improve outcomes, according to a special communication published last month in JAMA. Meanwhile, speakers at a July 25 virtual meeting sponsored by Duke University’s Margolis Institute for Health Policy emphasized that payers should work together with pharmaceutical companies, medical device manufacturers and policymakers to institute better ways to incorporate RWE into practice.

Mark McClellan, M.D., Ph.D., director of the Margolis Institute and a former FDA commissioner and HHS administrator, defined real world data as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” such as registries, wearable devices and electronic health records. He added that RWE is “clinical evidence about the use, potential benefits or risks of a medical product or practice or care delivery model that’s derived from the analysis of real-world data.”

Some findings from the new report by Pharmaceutical Strategies Group (PSG), an EPIC company, may have seemed like old news: AbbVie Inc.’s Humira (adalimumab) was the top specialty drug in terms of spend. Inflammatory treatments dominated the top 10 of those agents. But the 2024 Artemetrx State of Specialty Spend and Trend Report, released July 25, also revealed some new findings, including that rebates had a smaller impact in 2023 than they did the previous year and that cost per claim played a bigger role in the 2023 specialty drug trend than it did in the prior time frame.

PSG based the report — which is sponsored by Walmart Specialty Pharmacy — on integrated pharmacy and medical claims data from the book of business for its proprietary SaaS platform Artemetrx. In its eighth year, the newest report is based on 138 million medical claims and 136 million pharmacy claims. The findings are based mainly on commercial health plans.

GoodRx will offer Boehringer Ingelheim’s adalimumab-adbm, a biosimilar of AbbVie Inc.’s Humira (adalimumab), at a cash price of $550 per two-pack, revealed the companies on July 18. The price for the citrate-free biosimilar is 92% off that of its reference drug. It is available in both high-concentration and low-concentration formulations. The FDA has approved the 50 mg/mL version as interchangeable with Humira. Consumers may purchase the lower-cost tumor necrosis factor (TNF) inhibitor — which also is available as brand drug Cyltezo — at more than 70,000 retail pharmacies across the U.S.

Walmart is opening 25 new autoimmune-focused Specialty Pharmacies of the Community (SPOC) across five states, said Kevin Host, Pharm.D., senior vice president of pharmacy at Walmart Health and Wellness Pharmacy, on July 25. In October 2023, the company launched six SPOC, which are now available in nine states: Alabama, Idaho, Louisiana, New York, Oregon, Pennsylvania, Rhode Island, Texas and Wisconsin.

Some findings from the new report by Pharmaceutical Strategies Group (PSG), an EPIC company, may have seemed like old news: AbbVie Inc.’s Humira (adalimumab) was the top specialty drug in terms of spend. Inflammatory treatments dominated the top 10 of those agents. But the 2024 Artemetrx State of Specialty Spend and Trend Report, released July 25, also revealed some new findings, including that rebates had a smaller impact in 2023 than they did the previous year and that cost per claim played a bigger role in the 2023 specialty drug trend than it did in the prior time frame.

PSG based the report — which is sponsored by Walmart Specialty Pharmacy — on integrated pharmacy and medical claims data from the book of business for its proprietary SaaS platform Artemetrx. In its eighth year, the newest report is based on 138 million medical claims and 136 million pharmacy claims. The findings are based mainly on commercial health plans.

When benefits managers from a range of employers gathered at the Midwest Business Group on Health’s (MBGH) recent forum in Chicago, the final session of the day revealed that specialty drugs were some of their top concerns. And it appears employers are getting savvier about managing them.

A big focus of the conference was benefits managers’ fiduciary duty to their employees — and how shirking that duty could land them in hot water.

“If you haven't done a market check, do a market check,” recommended Dan Dentzer, manager of health and wellness design for United Airlines, at the June 26 MBGH Employer Forum on Pharmacy Benefits, Specialty and Biopharma Therapies. “I do market checks like I change my socks because you have to know what's going on out there. You have to know what others are doing. You have to know you're getting the best deal possible. If you haven't done that, please do.”

The FDA recently approved a new agent for the treatment of primary immunodeficiency. Payers expect it will have a moderate impact on their coverage of other agents in the class, while immunologists also anticipate its availability will affect their prescribing of competing drugs, according to a survey conducted late last year.

On June 13, the FDA approved Grifols Group company Biotest AG’s Yimmugo (immune globulin intravenous, human-dira) for the treatment of primary humoral immunodeficiency in people at least 2 years old. Dosing via intravenous infusion is every three to four weeks, with the first infusion started at 0.5 mg/kg per minute and increasing up to 3.0 mg/kg per minute; afterwards, the maintenance infusion rate is 13 mg/kg per minute. The dosage can be adjusted over time to achieve the desired trough levels and clinical response.

Cancer has become the top condition driving costs for employers, and a recent report found that most of them expect their annual spend on the condition will increase by up to 9% each year over the next three years. Last fall, the Midwest Business Group on Health and the Florida Alliance for Healthcare Value, in collaboration with MBGH employer members, shared information around the management of oncology benefits with an eye on making sure that the right care is given to the right person at the right place, right time and right price, for both the employer and the member.

Among the topics of discussion for the Oncology Learning Collaborative were prevention, including screening and early identification; navigation, including psychosocial support and return to work; and diagnosis, including a second opinion, biomarkers and treatment.