Radar on Specialty Pharmacy
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Study Reveals Home Infusion Pharmacists’ Vital Role With Specialty Drugs
In 2019, home infusion pharmacies served more than 315,000 specialty patients, with about 10% of total home infusion patients receiving specialty drugs. With these specialty products administered less often than nonspecialty drugs, there is limited data on how much time pharmacists spend on care planning and clinical involvement. But a recent study published in Infusion Journal — which is published by the National Home Infusion Association’s (NHIA) National Home Infusion Foundation (NHIF) — has revealed some details about that.
NHIF conducted a multicenter study of pharmacists from participating home infusion providers who reported the time they spent on clinical and administrative duties, tracking their time from when a patient was referred to the completion of two dispensing cycles.
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In Its Third and Final Biosimilar Deal of 2024, Coherus Divests Udenyca
Coherus BioSciences, Inc. is selling its third and last biosimilar per an agreement to divest its Udenyca (pegfilgrastim-cbqv) franchise to Intas Pharmaceuticals Ltd. for up to $558.4 million, Coherus revealed on Dec. 3. The granulocyte colony-stimulating factor is one of six biosimilars of Amgen Inc.’s Neulasta (pegfilgrastim). The FDA approved Udenyca on Nov. 2, 2018, making it the second of those agents to gain approval.
Included in the deal, which will give Coherus an upfront cash payment of $483.4 million, are the Udenyca prefilled syringe and autoinjector, as well as the Udenyca Onbody, an on-body injector that Coherus launched earlier this year. Udenyca is the only Neulasta biosimilar with that presentation, which competes with Neulasta Onpro, which has pulled market share from the original subcutaneous formulation.
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New FDA Approvals: FDA Approves Soliris Biosimilars for gMG
Oct. 23: The FDA granted an additional approval to Amgen Inc.’s Bkemv (eculizumab-aeeb) for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AchR) antibody positive. The agency initially approved the complement 5 inhibitor on May 28, 2024, as biosimilar to and interchangeable with Alexion, AstraZeneca Rare Disease’s Soliris (eculizumab). Dosing for the newest use is 900 mg weekly via intravenous infusion for the first four weeks, then 1,200 mg for the fifth dose one week later and then 1,200 mg every two weeks. The company has settled patent litigation that allows Bkemv to launch March 1, 2025, or an earlier date in certain circumstances. During Amgen’s Oct. 30 call to discuss third-quarter earnings, Murdo Gordon, executive vice president of global commercial operations, revealed that the company was preparing to launch the drug in second-quarter 2025. Drugs.com lists the price of a single-dose 10 mg/mL intravenous solution of Soliris as more than $6,878.
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News Briefs: CMS Gets Agreements With Sickle Cell Gene Therapy Companies
CMS has come to an agreement with the manufacturers of two gene therapies for sickle cell disease to participate in the Cell and Gene Therapy Access Model, it said on Dec. 4. The voluntary model will first test outcomes-based agreements for bluebird bio, Inc’s Lyfgenia (lovotibeglogene autotemcel) and Vertex Pharmaceuticals Inc. and CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel) for people with Medicaid in an attempt to improve patient outcomes, expand access to cell and gene therapies and lower health care costs. The FDA approved both agents on Dec. 8, 2023. Lyfgenia’s wholesale acquisition cost is $3.1 million for a one-time treatment, while Casgevy’s WAC is $2.2 million. The state application portal is live, and states and U.S. territories that participate in the Medicaid Drug Rebate Program can sign up through Feb. 28, 2025. They can choose to start participating at any time between January 2025 and January 2026. States may also apply for optional model funding by Feb. 28.
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Even at 10% Discount, Eylea Biosimilar Pavblu Offers Lower-Cost Option
Although the FDA has approved five biosimilars of Regeneron Pharmaceuticals, Inc.’s best-selling Eylea (aflibercept), patent infringement lawsuits by the drugmaker have successfully kept those competitors off the U.S. market — until now. Following a successful defense of its Pavblu (aflibercept-ayyh), Amgen Inc. recently launched the drug at risk. The agent is entering an increasingly crowded therapeutic class, but it’s one that’s also costly for payers, which may be seeking some savings, say industry experts. But is its price good enough to pull market share?
Pavblu has approval for all of Eylea’s indications — neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) — except for retinopathy of prematurity. Among the vascular endothelial growth factor (VEGF) inhibitors approved for ocular use, Eylea is the only one with that indication on its label.
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