Direct-to-Patient Models Reshape Pharma's Commercial Strategy as Nine Major Companies Launch Branded Drug Channels
核心洞察
Nine pharmaceutical companies, including Lilly, Pfizer, and Novo Nordisk, now sell branded drugs directly to patients with discounts ranging from 55% to 80% off list price, bypassing PBMs and specialty pharmacies.
The IRA's drug price negotiation taking effect in 2026 and PBM extraction of 45–55% of list price have made DTP a commercial necessity rather than a goodwill gesture for specialty brands.
Well-run DTP programs capture 15–25% of a brand's total script volume by recovering patients lost to prior authorization denials, step therapy, and high out-of-pocket costs.
The pharmaceutical industry is undergoing a structural shift in how medicines reach patients, as nine major drugmakers now operate direct-to-patient (DTP) commercial channels that bypass traditional intermediaries. Lilly, Novo Nordisk, Pfizer, Amgen, AstraZeneca, Bristol Myers Squibb (搜索), Novartis, Genentech, and Boehringer Ingelheim have all launched branded DTP programs offering discounts of 55% to 80% off list price, complete with home delivery and no involvement from pharmacy benefit managers (PBMs) or specialty pharmacies.
The transformation has been years in the making. Mail-order pharmacy services trace their roots to 1946, when the Veterans Administration began mailing prescriptions to eligible veterans. By 1992, according to Frost & Sullivan, mail-order companies were handling $6.8 billion worth of prescriptions — approximately 12% of the United States' $56 billion pharmaceutical market. The internet accelerated the trend, and by 2004, direct-to-consumer advertising had fully matured. Yet the pharmacy counter remained the final stop: the message could travel directly, but the medicine still could not.
The COVID-19 pandemic changed that calculus. The Centers for Medicare and Medicaid Services expanded reimbursement for virtual visits, while the FDA loosened restrictions around remote monitoring and electronic consent. Within hours, a patient could see a DTC ad and talk to a clinician through the same device — a seamless hand-off that had previously taken days or weeks. Telemedicine became both a distribution channel and a data stream, enabling manufacturers to understand patient behavior in real time.
The commercial case for DTP
Two developments in 2025 transformed DTP from a patient-access initiative into a commercial necessity. First, the Inflation Reduction Act's drug price negotiation provisions took effect January 1, 2026, with ten Part D drugs already repriced at 38%-plus below list and fifteen more selected for the next round. Second, PBMs currently extract 45–55% of list price before a manufacturer sees net revenue.
"DTP bypasses both," industry analysts note. "The manufacturer sets the price, collects directly, and keeps the margin that would otherwise flow to intermediaries. For patients who were abandoning therapy due to prior auth denials or unaffordable cost-sharing, a DTP transaction generates revenue that the traditional channel was failing to capture at all."
The data supports this assessment. A well-run DTP program captures 15–25% of a brand's total script volume — patients who were being lost, not patients being moved from commercial insurance to cash pay.
Where DTP delivers — and where it doesn't
DTP works when three conditions align: patients can reach the drug without a specialist initiating treatment; the barrier to access is administrative rather than clinically complex; and the drug is self-administered on a recurring basis. Obesity (搜索), type 2 diabetes (搜索), migraine (搜索), hyperlipidemia, plaque psoriasis, COPD, and mental health all fit this profile.
Conversely, DTP is structurally incompatible with oncology, where treatment is entirely physician-initiated and most agents carry REMS requirements; rare disease, where small patient populations are specialist-managed; cell and gene therapy, which involves single-administration, clinician-delivered treatments; and biologics requiring infusion.
Products with strong formulary coverage also warrant caution. A DTP discount on a preferred formulary drug signals to payers that the net price can be lower, potentially jeopardizing formulary positions negotiated over years.
The DTP landscape takes shape
Lilly moved first, launching LillyDirect in January 2024 to link patients with telehealth providers and home delivery for its diabetes and weight-management portfolio. Pfizer followed in August with PfizerForAll. Novo Nordisk launched NovoCare Pharmacy in March 2025, offering fixed-price delivery and adherence tracking for its GLP-1 therapies Wegovy and Ozempic. By June, Lilly expanded its Zepbound dose range and ring-fenced factory lots to protect direct-channel supply even during wholesaler shortages.
The shortages that plagued traditional pharmacies gave these direct platforms new legitimacy. Patients who once waited months for refills now had predictable, trackable deliveries.
Political momentum also accelerated. In May 2025, President Trump issued an executive order introducing "Most-Favoured-Nation" pricing and instructing the FDA to build a regulatory framework for direct sales. When TrumpRx was formally announced in September 2025, Pfizer signed on as the first major partner, with AstraZeneca and Merck KGaA following a month later. PhRMA responded by launching AmericasMedicines.com, a portal connecting patients with verified manufacturer programs.
Operational imperatives for commercial teams
Industry experts emphasize that DTP programs must be managed as commercial channels with commercial accountability, not as patient-access initiatives outside the profit-and-loss statement. Key operational priorities include clearing DTP cash pricing with legal and market access teams before any public announcement, as pricing can trigger Most Favored Nation clauses in payer contracts or affect IRA negotiation benchmarks.
The enrollment experience represents the biggest revenue leak in most DTP programs. Investment in mobile-optimized, frictionless prescriber verification and transparent pricing is essential before launch. Field teams must be retrained to explain DTP programs clearly to HCP office managers, and first-party data infrastructure — covering patient enrollment, fulfillment, and refill data — should be built from day one rather than retrofitted after launch.
DTP patient cohorts should be segmented from commercial patients in analytics from the start, as adherence rates, refill patterns, and support utilization differ across channels. Blending the data obscures what is actually happening in each.
As the IRA's price-negotiation era unfolds and PBM pressure intensifies, DTP offers pharmaceutical companies a path to control their own margins while promising affordability. For brands in high-friction therapeutic areas, the message is clear: the direct channel is no longer an experiment — it is a commercial battleground.