Radar on Specialty Pharmacy

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.

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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.

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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.

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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.

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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...
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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...
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Padcev Approval Gives Another Option to Treat Bladder Cancer

The FDA recently expanded the indication of a drug for certain types of urothelial cancer, the most common form of bladder cancer. Payers and oncologists appear to be divided, however, on the drug’s place in a tre...
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New FDA Specialty Approvals

✦ July 30: The FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kin...
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News Briefs

✦ The FDA is requiring revisions to the labels of Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib) following the agency’s r...
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FDA Approval Gives Third Option to Treat Rare, Deadly Disease

The FDA recently approved a third agent to treat paroxysmal nocturnal hemoglobinuria (PNH). With some conditions, that number of treatments may prompt payer preferencing, but that is unlikely to happen with this ult...
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