RADAR on Specialty Pharmacy

FDA Extends Xeljanz Safety Warnings to Other JAK Inhibitors

The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack, stroke, cancer, blood clots and death to the labels of the Janus kinase (JAK) inhibitors indicated for inflammatory conditions: Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib). The move follows the agency’s review of a large, randomized safety clinical trial of Xeljanz. The FDA also is limiting the approved uses for all the drugs to certain people who have not responded to or cannot tolerate at least one tumor necrosis factor (TNF) inhibitor. While some payers may already have had TNF inhibitors as a first step, they need to make sure that they have utilization management strategies in place to help ensure these drugs are used in the second-line setting, recommend industry experts.

FDA Approves Byooviz, First Ophthalmology Biosimilar in U.S.

The FDA approval of the first biosimilar for ocular use is poised to bring savings to a costly class, particularly in Medicare. However, ophthalmologists’ and retinologists’ lack of experience with biosimilars is a potential roadblock to these drugs’ uptake. Payers should focus on provider education and outreach ahead of these drugs’ launches in order to ease concerns about their use, say industry experts.

Groups Warn Against Avastin Biosimilar Off-Label Use in Eyes

Biosimilars are finally starting to bring down the prices of their innovator products across a range of indications, research shows. The FDA often approves biosimilars across some or all of the innovator drug’s indications even if applicant companies have not conducted studies in those uses. But two professional societies have been pushing back against payers’ allowance of two Avastin (bevacizumab) biosimilars in untested ocular indications.

Walgreens Makes Majority Investment in Shields Health

Walgreens Boots Alliance recently revealed that it is making a majority investment in Shields Health Solutions through its subsidiary Walgreen Co. The deal will expand Walgreens’ position within the growing hospital-based specialty pharmacy space.

Shields is a specialty pharmacy integrator that partners with health systems to help them create and grow a hospital-owned specialty pharmacy program. The hospitals own the pharmacies while Shields manages them.

New FDA Specialty Approvals

✦ Sept. 15: The FDA granted another indication to BeiGene, Ltd.’s Brukinsa (zanubrutinib), giving it accelerated approval for the treatment of people with relapsed or refractory marginal zone lymphoma following treatment with at least one anti-CD20-based regimen. The agency first approved the drug on Nov. 14, 2019. The recommended dose of the capsule is 160 mg twice daily or 320 mg once daily. Website Drugs.com lists the price of 120 80 mg capsules as more than $14,094.00.

News Briefs

✦ Over the past five years, biosimilars created competition that resulted in savings of $9.8 billion. That’s according to Amgen Inc.’s 2021 Biosimilar Trends Report, its eighth edition. The therapies also have the potential to save people out-of-pocket costs of $238 million in the nine classes in which the agents have been approved. The drugs are launching with wholesale acquisition costs that are generally between 15% and 37% less than those of their reference products.

Anthem Launches Voluntary Oncology Dose Reduction Program

As payers continue to search for ways to reduce their drug spend, one health plan recently rolled out a dose reduction program for some oncology therapies. Anthem Blue Cross and Blue Shield is asking providers in ce...

Legislation Seeks to Change Medicare Home Infusion Policies

Bipartisan groups in both the Senate and the House have introduced bills aimed at changing the way the professional services benefit for Medicare Part B home infusion therapies is implemented. The current situation,...

Specialty Trend Increase Slows; Biosimilars Are Having Impact

In 2020, specialty trend — which consists of utilization and cost trend components — continued to increase, but it did so at a slower pace than that of the past five years. That’s one of the findings of Pharma...

Another Immunotherapy Indication Will Be Withdrawn

The seventh indication since late December for an immunotherapy is being withdrawn from the U.S. market. All of the indications were granted through accelerated approval. All of the affected therapies have other FDA...