Nine pharmaceutical companies now sell branded drugs directly to patients—Lilly, Novo Nordisk, Pfizer, Amgen, AstraZeneca, BMS, Novartis, Genentech, and Boehringer Ingelheim. Discounts range from 55% to 80% off list price. Home delivery. No PBM. No specialty pharmacy.

Most commercial teams are still filing this under "patient access." That's the wrong drawer.

What changed and why

Two things happened in 2025 that made DTP a commercial necessity rather than a goodwill gesture.

First, IRA drug price negotiation took effect January 1, 2026. Ten Part D drugs are already repriced at 38%-plus below list. Fifteen more are selected for the next round. List price headroom is shrinking annually.

Second, PBMs currently extract 45–55% of list price before a manufacturer sees net revenue. Add IRA pressure on top of that, and for a growing number of specialty brands, the traditional channel is generating poor returns on drugs with strong clinical profiles.

DTP bypasses both. 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.

That's the commercial case. Not charity. Not brand reputation. Net revenue recovery.

Where it works

DTP works when three conditions are all present:

Patients can reach the drug without a specialist initiating treatment. The barrier to access is administrative — prior auth, step therapy, high out-of-pocket cost — not clinical complexity. And the drug is self-administered on a recurring basis.

Obesity, type 2 diabetes, migraine, hyperlipidemia, plaque psoriasis, COPD, and mental health fit this profile. Patients in these categories know what they need, get blocked by payers, and abandon. DTP recovers them.

The data backs this up. 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 it doesn't

Oncology: Treatment is entirely physician-initiated. Most agents carry REMS requirements. DTP removes clinical safeguards that exist for good reason. Not appropriate.

Rare disease: Patient populations are small and specialist-managed. Existing hub programs work. DTP adds cost without solving an access problem that isn't already addressed.

Cell and gene therapy: Single-administration, clinician-delivered. Structurally incompatible with DTP.

Biologics requiring infusion: Same issue. The drug cannot be home-delivered and self-administered.

Products with strong formulary coverage: A DTP discount on a preferred formulary drug signals to payers that your net price can be lower. It risks the formulary position you spent years negotiating. Don't build DTP where insurance already works for the brand.

What commercial and marketing teams need to do differently

Price it before you announce it

A DTP cash price can trigger Most Favored Nation clauses in payer contracts or affect IRA negotiation benchmarks. Legal and Market Access need to clear the pricing before any public announcement. This is not a brand team decision alone.

Own the enrollment experience

The biggest revenue leak in most DTP programs is enrollment drop-off — patients who intend to enroll but don't complete the process. Invest in the UX before launch. Mobile-optimized, frictionless prescriber verification, transparent pricing with no hidden steps. The enrollment portal is not an IT project. It's the front door to your direct channel.

Retrain field teams on what DTP is and isn't

Reps need to be able to explain the program in 60 seconds to an HCP office manager. They need to know which patients qualify and how the referral workflow works. If the field force can't describe DTP clearly, HCPs won't refer patients to it.

Build the data layer before you need it

DTP programs generate real-time patient enrollment, fulfillment, and refill data — first-party, owned by the manufacturer. This is more valuable than the program itself if you build the consent architecture and analytics pipeline correctly from day one. Most teams retrofit the data strategy after launch and lose months of clean data in the process.

Segment DTP patients from commercial patients in your analytics

Adherence rates, refill patterns, and support utilization look different across channels. Blending DTP and commercial data obscures what's actually happening in each. Separate the cohorts from the start.

The bottom line

DTP is not new thinking. The execution is new. Nine major companies have now validated the commercial model across six therapeutic areas. The programs that are working share one thing: they were built as commercial channels, with commercial accountability, not as patient access initiatives managed outside the P&L.

If your brand sits in a high-friction therapeutic area and you haven't modeled the DTP opportunity, you're leaving revenue on the table and giving competitors a head start on the patient relationships you'll want back later.