Exploring Utilization, Pricing, Potential side-effects, and Further Details
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Tzield, a brand-name medication containing the active drug teplizumab-mzwv, is an FDA-approved biologic drug designed to delay the progression of Stage 2 Type 1 Diabetes to Stage 3[1].
Availability
As a biologic, Tzield does not have a generic version available. Unlike traditional generic drugs, biologics are complex and large molecules that require specific manufacturing processes and are not easily replicable[2]. Biosimilars, while similar, are not exact copies of the original biologic and offer a lower-cost alternative. Currently, there are no FDA-approved biosimilars for Tzield, but this may change as the market for biologics continues to evolve.
Cost
Biologic drugs like Tzield are generally more expensive due to their complex manufacturing processes and the need for extensive clinical trials to ensure safety and efficacy. If biosimilars for Tzield were to become available, they would likely be less expensive than the original biologic. However, as of now, Tzield's cost remains without a biosimilar alternative.
Policy and Prescription Requirements
Tzield requires a prescription from an endocrinologist and is approved for patients with Stage 2 Type 1 Diabetes who meet specific criteria[3]. Coverage for Tzield can vary among insurance providers, often requiring specific authorization or meeting certain criteria before approval[3][4].
Usage and Safety
Tzield is administered as an intravenous (IV) infusion once a day for 14 consecutive days, with each infusion taking at least 30 minutes[1]. The dosage is determined based on body surface area[5].
Pregnant women and those breastfeeding should not use Tzield, and if you're planning a pregnancy or can become pregnant, it's essential to talk with your doctor before starting this medication[6]. If you become pregnant during Tzield treatment, tell your doctor right away, as they'll likely stop treatment with Tzield[7].
Mild side effects of Tzield can include skin rash, headache, temporary decrease in white blood cell levels, and mild allergic reaction. More serious side effects can include cytokine release syndrome, serious infection, severe leukopenia, and severe allergic reaction[8].
Before starting Tzield, your doctor will check for any vaccines you're currently due to receive based on your age and recommend getting any necessary vaccines before starting Tzield[9]. If needed, children may receive premedications before all of their remaining Tzield infusions to prevent or minimize certain side effects[10].
In conclusion, Tzield is a unique biologic drug with no generic versions available, and unlike biosimilars, it does not offer a more affordable alternative at this time. Its cost and availability are influenced by its FDA approval status, manufacturing complexity, and insurance coverage policies. It's crucial to discuss the potential risks and benefits of Tzield with your healthcare provider before starting treatment.
[1] FDA. (2020). FDA approves teplizumab-mzwv for the treatment of patients with type 1 diabetes. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-teplizumab-mzwv-treatment-patients-type-1-diabetes [2] FDA. (n.d.). Understanding the difference between generic and biosimilar drugs. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/understanding-difference-between-generic-and-biosimilar-drugs [3] Provider One. (n.d.). Tzield (teplizumab-mzwv) for type 1 diabetes. Retrieved from https://www.providerone.com/content/drug/teplizumab-mzwv-tzield-type-1-diabetes [4] GoodRx. (n.d.). Tzield (teplizumab-mzwv) cost, coupons, and savings tips. Retrieved from https://www.goodrx.com/teplizumab-mzwv/cost [5] Provider One. (n.d.). Tzield (teplizumab-mzwv) for type 1 diabetes. Retrieved from https://www.providerone.com/content/drug/teplizumab-mzwv-tzield-type-1-diabetes [6] Provider One. (n.d.). Tzield (teplizumab-mzwv) for type 1 diabetes. Retrieved from https://www.providerone.com/content/drug/teplizumab-mzwv-tzield-type-1-diabetes [7] Provider One. (n.d.). Tzield (teplizumab-mzwv) for type 1 diabetes. Retrieved from https://www.providerone.com/content/drug/teplizumab-mzwv-tzield-type-1-diabetes [8] Provider One. (n.d.). Tzield (teplizumab-mzwv) for type 1 diabetes. Retrieved from https://www.providerone.com/content/drug/teplizumab-mzwv-tzield-type-1-diabetes [9] Provider One. (n.d.). Tzield (teplizumab-mzwv) for type 1 diabetes. Retrieved from https://www.providerone.com/content/drug/teplizumab-mzwv-tzield-type-1-diabetes [10] Provider One. (n.d.). Tzield (teplizumab-mzwv) for type 1 diabetes. Retrieved from https://www.providerone.com/content/drug/teplizumab-mzwv-tzield-type-1-diabetes
