Co-pay card adjustment programs: How do they affect patients, payers, and pharma?

“Co-pay cards” (or “co-pay coupons”) are financial assistance programs from drug manufacturers (pharma) that drastically reduce the out-of-pocket (OOP) costs for someone who needs an expensive medication. These programs are controversial: Pharma and patients believe that these programs allow sick people to afford the medications they need. Healthcare payers (ie, insurance companies or their pharmacy…

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Common Protocol Template—Streamlining Protocol Implementation

Study protocols are required for every clinical trial. Approximately 20,000 are submitted and posted to www.clinicaltrials.gov every year1—each one different. The format and core content can vary from sponsor to sponsor, costing the US Food and Drug Administration (FDA) time and resources to interpret, review, and ultimately, approve each uniquely complex protocol. This process, as…