Building on the whitepaper The DTP Portfolio Test: A Decision Framework for Direct-to-Patient Investment by Pharma, A&M Life Sciences experts James Cleffi, Sierra Benbrook, and Megan Shea examine the next critical question facing pharmaceutical companies: How can organizations scale direct-to-patient (DTP) models without compromising patient safety?

Featured in Pharmaceutical Executive, the article expands on A&M's DTP investment framework by shifting the focus from strategic portfolio decisions to operational execution. While the white paper outlines which products and portfolios are best positioned for DTP investment, this latest article explores the clinical infrastructure required to support sustainable growth.

Key Takeaways

• LillyDirect exemplifies DTP as a demand-unlocking commercial channel rather than a compliance tactic, with executives projecting multi-year growth and substantial GLP-1 initiation volume.
• Stigma-driven willingness to pay for privacy is catalyzing DTP expansion in sensitive therapeutic areas, but privacy-first design risks displacing longitudinal clinician oversight.
• Missing bidirectional medication visibility creates an EHR blind spot that increases drug–drug interaction risk, complicates adverse-event management, and degrades cross-specialty care coordination.
• Near-term mitigation includes one-click PCP notifications and downloadable summaries, while medium- to long-term safety requires consented EHR messaging and full FHIR API integration.
• Sustainable advantage will come from pairing convenience with clinical accountability, robust data governance, and interoperable records, especially in chronic, stigmatized, polypharmacy-prone indication clusters.