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FDA Extends Xeljanz Safety Warnings to Other JAK Inhibitors

October 14, 2021

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.

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.

The trial compared Xeljanz with TNFs in people with rheumatoid arthritis (RA) and showed an increased risk of blood clots and death with a lower dose of Xeljanz. A prior study whose results Pfizer disclosed on Jan. 27, 2021, showed the same results but at a higher dose.

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

Infographic: Anticipated Management Actions of Eylea/Lucentis Assuming U.S. Launch of Pipeline Biosimilar Therapies by Percentage of Covered Lives

October 14, 2021

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.

On Sept. 20, the FDA approved Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV) (see brief, p. 8). The drug is a biosimilar of Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). Under an agreement with Genentech, Samsung Bioepis and Biogen will be able to market the therapy in the U.S. in June 2022.

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.

On Sept. 20, the FDA approved Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV) (see brief, p. 8). The drug is a biosimilar of Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). Under an agreement with Genentech, Samsung Bioepis and Biogen will be able to market the therapy in the U.S. in June 2022.

According to Magellan Health, Inc. division Magellan Rx Management’s eleventh annual Medical Pharmacy Trend Report, released in May, ophthalmic injections accounted for the second-highest category of spend in Medicare in 2019, behind only oncology. Lucentis ranked No. 5 in the top 10 Medicare medical benefit drugs by spend. Among commercial plans, Lucentis had 20% of the ophthalmic injectable market, behind Genentech’s Avastin (bevacizumab), with 32%, and Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept), with 37%. In Medicare, Lucentis had a 22% share, compared with 43% for Avastin and 27% for Eylea, and in Medicaid, Lucentis had an 18% share of the market, compared with Avastin’s 55% and Eylea’s 27%.

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Groups Warn Against Avastin Biosimilar Off-Label Use in Eyes

October 14, 2021

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.

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.

Roche Group unit Genentech USA, Inc.’s Avastin is commonly used off-label in ophthalmic indications (see story, p. 1). The drug, first approved in 2004, has undergone clinical trials supporting its use in eye disorders, but Genentech has not filed for FDA approval in those indications. This use requires the drug to be compounded and repackaged — and because this is a much lower dose than the drug’s oncology doses, it costs about $50 per injection, compared with thousands of dollars for the vascular endothelial growth factor (VEGF) inhibitors approved for eye diseases.

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Walgreens Makes Majority Investment in Shields Health

October 14, 2021

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.

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.

Company Made Minority Investment in ’19

Walgreens made a minority investment of 23% in Shields in July 2019; the more recent arrangement — an approximately $970 million investment — will give Walgreens 71% ownership of Shields, with an option to purchase the remaining interests. Shields will continue to operate as a distinct brand and entity under its current leadership.

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New FDA Specialty Approvals

October 14, 2021

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.

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.

Sept. 15: The FDA gave accelerated approval to Takeda Pharmaceutical Company Ltd.’s Exkivity (mobocertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test (see brief below) whose disease has progressed on or after platinum-based chemotherapy. Dosing is 160 mg via four 40 mg capsules once daily. The price of 120 40 mg capsules is $25,000.00.

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