This blog is part of an ongoing series, A Brave New World: Finding life sciences success in modern markets.

The U.S. pharmaceutical landscape is undergoing a seismic shift. With the Inflation Reduction Act (IRA) now in effect and the Trump administration’s 2025 Executive Order on Most Favored Nation (MFN) pricing gaining traction, drugmakers are facing unprecedented pricing pressure. These policy changes are transpiring against the backdrop of continuously evolving patient preferences and needs. Patients increasingly expect a “consumer-like” healthcare experience and are more willing to pay directly for medicines they want and require. Thus, early pharma movers are testing out new models across multiple diseases and are demonstrating that patients are indeed willing to pay cash in lieu of access.

Policy reforms aimed at reducing costs for Medicare and patients, combined with patient demand, may serve as an unexpected catalyst for drug manufacturers to usher in a new era of direct-to-consumer (DTC) or direct-to-patient strategies. DTC programs are emerging business models, where manufacturers bypass traditional intermediaries such as pharmacy benefit managers (PBMs), traditional insurance, and pharmacy distributors to engage patients directly.

The Policy Backdrop: IRA, MFN, and 340B

The IRA grants Medicare the authority to negotiate prices for high-cost, single-source drugs under Parts B and D. The first negotiated prices are set to take effect in 2026, targeting drugs that have been on the market for at least 7 years (small molecules) or 11 years (biologics), and lack generic or biosimilar competition. With discounts as steep as 80% off list price, the negotiated price for Medicare creates new price floors that can convert to affordable cash prices.

Layered on top of this is the MFN Executive Order, which aims to align U.S. drug prices with those in other developed countries. This global benchmarking could further compress margins for blockbuster therapies, especially those with high U.S. list prices. When combined with price pressures from 340B dynamics, an often difficult-to-see but very real price discount, the realized net price for many older brands can be well below 20% of the list price. For many products, that means that offering a DTC price begins to make strategic and economic sense.

Why This Matters for DTC

Pharma’s traditional model of selling through wholesalers, PBMs, and pharmacies relies heavily on negotiated rebates, which leads to opaque pricing. But as the IRA, MFN provisions, and other discounts squeeze net prices amidst calls for increased transparency, manufacturers are exploring alternative channels to preserve revenue and control the patient experience.

Enter DTC. DTC initiatives offer a new model: manufacturers create a platform that pulls together different solutions in a pharma-branded digital ecosystem. This allows patients to access prescription medications directly, often bundled with disease education resources, telehealth consultations, pharmacy fulfillment, and patient support services, among others. These platforms, such as LillyDirect^®, PfizerForAll^™, and NovoCare^® function as an end-to-end digital ecosystem, offering branded medications at discounted cash prices that bypass insurance.

Learnings from Early Pharma DTC Movers

• LillyDirect^®: Vanguard of the “store-front” branded website concept to engage out of pocket diabetes, mental health, and obesity patients, among other disease areas.
• Unique differentiators: Creating an Amazon-like “consumer” end-to-end experience, pulling patients through the process, reducing friction, and increasing patient activation and adherence.
• Initial results: Increase in new-to-treatment Zepbound^® vials and capturing increasing percentage of GLP-1 market share (initial results from IQVIA 2025 Rx data).
• Pfizer4All^™: Leveraging a dedicated telehealth provider, UpScript, to support broader access to both Pfizer and other pharma products.
• Unique differentiators: Delivering comprehensive patient support services across multiple parts of the Pfizer portfolio.
• Initial results: Anecdotal reports of improved patient experiences and satisfaction, while streamlining migraine and respiratory care.
• NovoCare^®: Providing cash-pay diabetes and rare disease patients’ holistic pharmacy services via their Novo-branded website.
• Unique differentiators: Supporting patients with innovative digital solutions, such as virtual diabetes life coaches and personalized adherence support tools
• Initial results: To be determined, given recency of the launch.

Strategic Drivers Linking Policy to DTC

• Margin Preservation
  By selling directly, manufacturers can sidestep PBM rebates and retail markups, offering competitive prices, while retaining more of the transaction value.
• Pricing Control and Transparency
  DTC platforms allow pharma to set and communicate prices clearly, a strategic advantage as MFN rules push for international price parity.
• Patient Access and Loyalty
  With IRA provisions targeting only Medicare-covered drugs, DTC offers a way to reach uninsured or underinsured populations. Chronic therapeutic areas like obesity, migraine, and diabetes, stand out.
• Deeper Patient Insights
  DTC channels provide rich patient-level data and opportunities for personalized engagement that provide a more meaningful exchange of value. This not only supports adherence and outcomes, but also builds brand loyalty and opens avenues to capture important patient reported outcomes.
• Portfolio Strategy
  Manufacturers with large portfolios, portfolios concentrated in a therapeutic area, or with large mature asset portfolios should consider how economies of scale work for DTC offerings. Just because the economics does not work at a brand level does not mean it will not work at a portfolio level.

Strategic Drivers Linking Patient Preferences to DTC

• Speed of Access to Healthcare Professionals
  Reduces patient wait times to see a qualified provider by connecting them to independent telehealth platform providers (reduction by weeks to months for appointments).
• Convenience
  Patients in rural areas or underserved populations now have improved access to telemedicine services with the ability for medications to be delivered directly to their home.
• Desire for Holistic Care
  Almost all DTC programs provide wrap-around patient support services to address challenges with adherence and improve outcomes.
• Expectation of a “Frictionless” Experience
  DTC channels allow patients to have a consumer-like healthcare experience similar to other products and services they interact with, often with the merging and integration of tech-enabled tools (i.e., Uber and Amazon for medication delivery).
• Patient Agency
  Patients who are more involved in their care through shared decision-making often demonstrate greater levels of adherence which can translate into improved outcomes. Incremental value to the patient can also be delivered through opting in to additional services and access to disease awareness educational materials.

Potential Risks of the DTC Shift

While DTC programs offer strategic advantages, they also introduce new risks that pharma leaders must now navigate carefully:

• Regulatory and Compliance Scrutiny
  Lawmakers have raised concerns about pharma-branded platforms influencing prescribing behavior. Companies must ensure HIPAA compliance, avoid inducements, and maintain clear boundaries between marketing and medical decision-making. A recent bipartisan Senate report published in July 2025 underscores this point.
• Channel and Stakeholder Conflict
  DTC channels can bypass traditional players such as PBMs, pharmacies, and a patient’s normal care provider. The impacts can be used in formulary negotiations, reduced foot traffic, and strained relationships with important stakeholders across business segments.
• Operational and Financial Complexity
  Running a DTC platform requires managing telehealth partnerships, pharmacy logistics, customer support, and fulfillment. Many of these are outside pharma’s traditional core. Upfront investments are high, ROI remains uncertain, and there is the possibility that the new channel cannibalizes other volume.
• Data Overload
  It is essential to integrate the appropriate solution and partner for each portfolio and product, while also establishing processes, governance, and feedback loops to make use of the insights gained from collected data.
• Data Privacy and Patient Trust
  Handling sensitive health data directly introduces cybersecurity risks and demands robust infrastructure. Missteps could erode patient trust and invite regulatory action.

Understanding Patient Behavior and Cost Sensitivity

Not all brands have patient cost sensitivity thresholds that work for DTC programs. Brands with high patient abandonment at lower copays will struggle to find a price point that makes sense in the marketplace. The DTC programs worked for obesity medications because patients were willing to come out of pocket at prices that made sense for the manufacturers to sell directly.

For brands that are considering DTC programs in response to MFN pressures, the pricing calculus must overlay patient cost sensitivity to the commercial evaluation. Depending on a brand’s lifecycle stage, net prices, and required promotional efforts, DTC price points may not operate at a positive margin. It is when the patient price sensitivity exceeds the net value of a prescription that DTC programs make financial sense.

What’s Next?

If the IRA’s price negotiation model proves durable and the current administration follows through on drug price reform, we can expect more manufacturers to offer patient-centered programs into the market. DTC may evolve from a niche experiment into a core commercial strategy, particularly for drugs selected for price negotiation, nearing loss of exclusivity, or that have market access hurdles and high rebates. For patients, this could also mean:

• Easier access to care
• More predictable and transparent costs
• Fewer barriers to starting and staying on treatment
• Consumer-like treatment experiences

Final Thoughts

For pharma strategists, the convergence of policy reform and digital health infrastructure presents both a challenge and an opportunity. DTC isn’t just a workaround, it’s a strategic hedge against a future where pricing power is no longer guaranteed while also tapping into rising consumerism. With the IRA, MFN, and 340B changing the drug pricing calculus and patients seeking convenience, DTC could become essential for success in today’s market.

Manufacturers exploring these strategies must work through the complexity of the patient journey, understand the impact of formulary access, balance net prices, and work through the logistics of program design. DTC programs are complex. IQVIA is well positioned to help throughout the evaluation, design, implementation, and measurement of putting these programs into the marketplace.