Why Big‑Pharma’s Direct‑to‑Consumer Pivot Belongs on Your 2026 Checklist

Drug makers such as Roche, Lilly, and Novo Nordisk are starting to sell medicines straight to U.S. patients. If pharmacy benefit managers (PBMs) lose their middle‑man role, every forecast that still assumes a big rebate line could be wrong overnight, and your 2026 strategy could already be outdated.

What’s really going on?

Pharmacy Benefit Managers sit between drug makers, insurers, and pharmacies. They negotiate formulary placement and rebates, process claims, and often own mail‑order pharmacies. Their margin is the spread between the list price they bill and the net price they remit after rebates. In 2024, the spread booked $28 billion in gross profit across the “Big Three.”

On 24 July 2025, Roche’s CEO told Reuters the company is “looking hard” at a direct‑to‑consumer (DTC) storefront that would ship eligible drugs directly to U.S. patients [1]. It isn’t first: Lilly, Novo Nordisk, and the Bristol Myers Squibb/Pfizer alliance already run live DTC offers, proving the model at scale.

A working DTC channel refashions the U.S. drug supply chain much like Netflix reshaped video rentals, with fewer toll‑booth owners, faster delivery, and a totally new data stream. If the PBM rebate column shrinks toward zero, valuation models, patient‑journey maps, and R&D go‑to‑market plans all need rewrites, now.

Why is DTC taking off right now?

Politics (the tailwind you can’t ignore)

• Most‑Favoured‑Nation (MFN) pricing pilots: The White House wants American prices to stay aligned to the G7 reference basket [2]. DTC gives drug makers a compliance lever without begging PBMs for a smaller spread.
• PBM transparency bill (84‑14 Senate vote): Forces every negotiated rebate into the public domain and caps “spread” earnings at 3%. That cap alone threatens roughly $6 billion in PBM EBITDA.
• FTC Legal Action: Delivered to CVS Caremark, Express Scripts, and OptumRx in September 2024, signalling real enforcement rather than political theatre [3].

Money (follow the margin)

• Gross‑to‑net gap ≈ 46%: On each U.S. dollar of list price, the average manufacturer sees just 54 cents at the bank. Halving the list price for cash‑pay patients can raise net revenue and still delight consumers.
• Digital infrastructure costs are collapsing: Same‑day fulfilment networks (Deliverr, ShipBob), off‑the‑shelf telehealth APIs (Wheel, Amwell), and Stripe‑like payment rails mean a DTC tech stack can launch for low seven figures.
• Private‑equity dry powder: Funds hold $1.1  trillion globally and are shopping for carve‑out plays such as manufacturer‑owned specialty pharmacies.

Patients (demand meets distrust)

67 % of people with chronic illnesses say they’ll switch to a manufacturer program if the price is transparent [4]. 41% of all respondents said they “distrust” PBMs but can’t define what a PBM does - a narrative vacuum manufacturers are keen to fill.

Who is already doing it, and how bold are they?

Transparent pricing plus click‑to‑ship logistics is no longer disruptive; it’s table stakes. The next battleground is user experience and data feedback loops.

Case study: How LillyDirect turned GLP‑1 hype into predictable direct-to-consumer cash flow 

Launch timeline recapped/expanded [11]

• Dec 2024: Beta launch with insulin vials, A1C coaching, and refill reminders.
• Feb 2025: First two Zepbound doses at $499 (flat) go live; telehealth scripts delivered via FORM Health within 24 h.
• Apr 2025: Added social‑commerce referral program - patients earn one free coaching month per sign‑up.
• Jun 2025: Full dose range available; ring‑fenced factory lots protect DTC supply even when wholesaler channels face shortages.

Four practice‑building levers

1. Digital front door: An unbranded quiz qualifies candidates and funnels them directly into video consults, with an average drop-off of only 12% vs. 25% industry norm.
2. Dynamic inventory allocation: Internal API links batch release to live demand data; stock receives a green light only when fill rate > 85% to avoid drug‑shortage headlines.
3. Behavioural refill cadence: 45‑day refill windows smooth factory planning and reduce panic buying. Shipping cost shaved 7% quarter‑over‑quarter.
4. Closed‑loop analytics: Weight, SMBG readings, and adherence scores feed back into marketing segmentation. Upsell of strength-training coaching hit 18% uptake in Q2 2025.

Bottom‑line metrics worth stealing

Eight research questions worth asking right now

1. Rebate thresholds: At what rebate level do formularies lose their cost advantage?
2. Policy guardrails: Under what conditions does a flat‑price offer trigger anti‑kickback scrutiny?
3. State pharmacy law: Which of the 17 “strict‑licence” states could block national roll‑outs?
4. Digital cart choke‑points: Where do most abandonments occur, drug price reveal, shipping cost, or physician intake form?
5. Retail chain trade‑offs: Does click‑and‑collect improve adherence vs. home delivery, and by how much?
6. Cold‑chain exposure: What real‑world temp excursions rise when you bypass wholesaler cold rooms?
7. Data sovereignty: Who owns out‑of‑app adherence data when the drug maker controls fulfilment and the device?
8. 340B backlash: How will hospital networks respond if DTC siphons high‑margin specialty fills?

Techspert can surface ex-policy makers, PBM insiders, digital-pharmacy founders, and cold-chain logisticians within hours, so your diligence timeline stays intact.

What to consider before launching a DTC operation

Launching a cash‑pay channel touches regulation, tech build, and long‑tail patient support. For each stage, bring in specialists who’ve solved the problem before—their lived experience shortcuts months of trial‑and‑error. Techspert can introduce you to each of these niches, fast.

Regulatory and supply‑chain foundations

Talk to ex‑FDA or OIG lawyers who have cleared anti‑kickback questions, plus DSCSA serialization leads and pharmacy‑licence directors from national mail‑order chains. They surface hidden pitfalls, like state-level opioid caps or shipping-time limits,  before you lock distribution contracts.

Digital front door and data guardrails

Book time with HIPAA/CCPA privacy officers from digital‑first pharmacies, HITRUST‑certified cybersecurity chiefs, and product managers who’ve launched one‑click tele‑prescribe flows at scale. They reveal where carts abandon, how to build consent flows that stand up to audit, and which KPIs matter once RWE data starts flowing.

Engagement and feedback loops

Lean on behavioural‑science PhDs who’ve cut chronic‑care churn, medical‑affairs heads who’ve won label expansions with RWE, and support‑operations leaders who run 24/7 dosage hotlines. Their playbooks turn a sale into long‑term adherence while keeping pharmacovigilance boxes ticked.

Techspert sources these profiles on demand, so you can assemble a working group in days, not weeks.

Ready to pressure‑test your 2026 plan?

Tell us the challenges you’re tackling, and our team will map the expert profiles that have the answers. We’ll then outline scope, timeline, and pricing so you can decide when to take your full project forward.

Sources