Specialty Drugs

On April 24, Walgreens Boots Alliance Inc.’s Walgreens revealed that it will launch Walgreens Specialty Pharmacy on Aug. 1. The company is touting the new division, which will include AllianceRx Walgreens Pharmacy and four central specialty pharmacies, as being able to swiftly serve patients without being invested in a PBM. And that could mean enhanced opportunities for contracting with payers and manufacturers, according to one expert.

The new unit will also feature nearly 300 community-based specialty pharmacies across the U.S. and a new 18,000-foot Gene & Cell Services Pharmacy and Innovation Center in Pittsburgh. The division will have more than 1,500 specialty-trained pharmacists, 5,000 patient advocacy support staffers and 10 Specialty360 teams. It also has access to more than 240 limited distribution drugs, including 40 narrow networks and 12 exclusive limited distribution agents.

While over 90% of health plans receive specialty medication rebates under the pharmacy benefit, the receipt of medical-benefit rebates has risen in the past one to two years, according to the 2024 Trends in Specialty Drug Benefits Report, published by Pharmaceutical Strategies Group, an EPIC company. The report also covered topics like the management strategies of Humira biosimilars and the financial risk associated with cell and gene therapy.

The report is based on responses from 185 benefits leaders from employers, unions/Taft-Hartley plans and health plans representing plan sponsors of approximately 86.6 million covered lives, conducted from Sept. 18, 2023, through Oct. 13, 2023.

Fresenius Kabi AG launched Tyenne (tocilizumab-aazg), the first biosimilar of Roche Group member Genentech USA, Inc.’s Actemra (tocilizumab) to become available in the U.S., the company revealed April 15. The FDA approved the interleukin-6 inhibitor on March 5 in both intravenous and subcutaneous formulations, making it the only Actemra biosimilar approved so far in both. On Sept. 29, 2023, the FDA approved Bio-Thera and Biogen Inc.’s Tofidence (tocilizumab-bavi) as an intravenous formulation only. Fresenius says Tyenne is available now in an intravenous formulation only. The agents are approved for several autoimmune conditions.

Sandoz reached an agreement with Amgen Inc. resolving all patent litigation related to denosumab, Sandoz revealed April 30. The FDA approved Sandoz’s Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) on March 5 as biosimilar to and interchangeable with Amgen’s Prolia (denosumab) and Xgeva (denosumab) for all of their indications. They are the first FDA-approved denosumab biosimilars. The agreement will allow the agents to launch on May 31, 2025, or earlier “under certain circumstances if customary acceleration provisions are triggered.”

While over 90% of health plans receive specialty medication rebates under the pharmacy benefit, the receipt of medical-benefit rebates has risen in the past one to two years, according to the 2024 Trends in Specialty Drug Benefits Report, published by Pharmaceutical Strategies Group, an EPIC company. The report also covered topics like the management strategies of Humira biosimilars and the financial risk associated with cell and gene therapy.

The report is based on responses from 185 benefits leaders from employers, unions/Taft-Hartley plans and health plans representing plan sponsors of approximately 86.6 million covered lives, conducted from Sept. 18, 2023, through Oct. 13, 2023.

After first gaining approval more than a decade ago, Takeda Pharmaceuticals U.S.A., Inc.’s Iclusig (ponatinib) recently gained approval for the frontline treatment of an aggressive blood cancer. One clinical trial found that people on the agent experienced complete remission more than twice as often as those on a comparator therapy. Industry sources point to the drug’s clinical efficacy as a significant development in the treatment of the disease.

On March 19, the FDA gave accelerated approval to Iclusig in combination with chemotherapy for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The newest application had priority review and orphan drug designation, and its review used the Real-Time Oncology Review and the Assessment Aid.

Amgen Inc. will discontinue the Repatha (evolocumab) Pushtronex system, an on-body infusor, on June 30, the company said April 12. Certain patients, however, may need to remain on that system, and the manufacturer says it will maintain inventory of it to meet their needs.

In addition to the 420 mg/3.5 mL single-dose Pushtronex, Repatha is available as a 140 mg/mL single-dose SureClick autoinjector and a 140 mg/mL single-dose prefilled syringe. The company is urging users to transition to the SureClick because it plans to discontinue the prefilled syringe in mid-2025.

On April 24, Walgreens Boots Alliance Inc.’s Walgreens revealed that it will launch Walgreens Specialty Pharmacy on Aug. 1. The company is touting the new division, which will include AllianceRx Walgreens Pharmacy and four central specialty pharmacies, as being able to swiftly serve patients without being invested in a PBM. And that could mean enhanced opportunities for contracting with payers and manufacturers, according to one expert.

The new unit will also feature nearly 300 community-based specialty pharmacies across the U.S. and a new 18,000-foot Gene & Cell Services Pharmacy and Innovation Center in Pittsburgh. The division will have more than 1,500 specialty-trained pharmacists, 5,000 patient advocacy support staffers and 10 Specialty360 teams. It also has access to more than 240 limited distribution drugs, including 40 narrow networks and 12 exclusive limited distribution agents.

When the FDA approved Rezdiffra (resmetirom) in March, it gave patients with a serious form of liver disease a long-awaited treatment option tailored to their specific condition. But the drug’s accelerated approval and high price tag are already spurring at least one health insurer to consider options like restrictive coverage criteria and value-based contracting.

NASH represents a progression from a more common condition, nonalcoholic fatty liver disease (NAFLD). It occurs when patients start developing liver inflammation that can eventually lead to liver scarring, dysfunction, and even liver failure and cancer.

Rebates continue to be a huge part of the specialty pharmacy space, with 93% of respondents to a recent survey receiving them for drugs in the pharmacy benefit. Meanwhile, 44% of respondents said their firm received rebates for medical benefit drugs, representing an increase from 39% in the prior year’s survey. Those are just some of the findings in the Trends in Specialty Drug Benefits Report from Pharmaceutical Strategies Group (PSG), an EPIC company.

The 11th annual survey, which reflects 2023 information, was fielded from Sept. 18 through Oct. 13, 2023. The primary source of respondents was PSG’s proprietary database of drug benefit decision makers, and they included people from employers, health plans (or third-party administrators or insurance companies) or union/Taft-Hartley plans. There were 185 benefits leaders from plan sponsors with an estimated 86.6 million lives.

The FDA has approved 10 biosimilars of AbbVie Inc.’s Humira (adalimumab), with nine of them launching in the U.S. since last year, but uptake of them has been relatively slow. Recently, though, a formulary change by CVS Health Corp. seems to have spurred uptake of the agents, and an upcoming change by The Cigna Group should increase their use again. However, some industry experts question whether those changes were made with an eye on increasing biosimilar access — or boosting their own profits.

On April 25, Evernorth Health Services, a subsidiary of Cigna, revealed that it will have a high- and low-concentration interchangeable Humira biosimilar for zero out-of-pocket costs for “eligible patients” of its specialty pharmacy, Accredo, starting in June. The product, according to a press release, “will be produced for Evernorth’s affiliate private label pharmaceutical distributor, Quallent Pharmaceuticals, through agreements with multiple manufacturers.”