Why the Direct Access Channel Is No Longer Optional for Pharma

For years, legacy intermediaries have controlled pharmaceutical companies' market access, leaving manufacturers disconnected from the consumers they ultimately serve.

Now, PBMs are under pressure from several converging forces. Plan sponsors are asking hard questions about drug spend, rebates and price transparency. Policymakers are scrutinizing why affordability remains such a massive problem amid record profitability. Meanwhile, high-demand therapies like GLP-1s are straining the traditional rebate system.

Together, these dynamics are exposing a deeper issue: the current model is not optimized for manufacturers to compete on factors that should matter most, including science, outcomes, price and patient experience.

The direct access model is opening a new door for drug makers. More than just a workaround, it represents a return to fundamental market dynamics, a chance for manufacturers with the most effective products to compete on benefits and price for the business of patients and payers. It’s the way markets should work.

Why Do Current Models Create Structural Barriers?

Ample media coverage has been devoted to how the mainstream PBM model can harm patients and payers by limiting access to effective, affordable therapies. But it’s not good for drug makers, either.

In a recent Pharmaceutical Commerce survey, gross-to-net economics and affordability ranked among the top concerns for pharmaceutical executives. The reality is, manufacturers ultimately want the same things we all do: Drug accessibility for appropriate patients at a price they can afford and genuine value for the plan sponsors funding care.

But in the current model, that’s not what happens. Instead of competing on efficacy and value, manufacturers are forced into formulary bidding wars that can only be won by the most aggressive discounts. Meanwhile, the intermediary keeps them disconnected from market data, and the ultimate customer, the employer, leaving them mostly blind to real-world costs.

What’s worse: Patients and plan sponsors, the customers that matter most to a manufacturer's long-term goals, aren’t even in the room.

Abandoning the legacy model isn’t an option. With a large portion of revenue tied to this system, manufacturers have no choice but to pay to play.

Instead, what they need is an alternative: A separate channel that better serves their needs and the market’s, particularly for high-demand therapies.

How Does Direct Access Tear Down Barriers?

While many direct-access conversations still focus on service-layer solutions, a new model is connecting manufacturers, employers, pharmacies and patients around shared incentives. This allows drug makers to compete on safety, efficacy and price by putting their products in front of their actual customers with cost clarity built in for plan sponsors, patients and manufacturers.

This shift is already happening. Direct-to-patient programs have normalized patient engagement through manufacturer-supported access platforms. Employer-facing models are also emerging, giving self-insured organizations a clearer way to evaluate therapies based on total value rather than opaque net cost.

And momentum is building. Based on the success of these programs, nearly 40% of pharma executives now say they expect to pursue direct-to-patient access models within the next 24 to 36 months.

The Next Step: A Direct Access Marketplace

The next phase of direct access is even broader: a true marketplace model that delivers value, pharmacy choice, and access as natural outcomes at the point of care.

Think of it like cable TV versus streaming services. Where cable bundles content and controls the consumer experience by restricting access to some products while forcing delivery of others, streaming eliminates those constraints. The need for content, distribution and payment infrastructure remains, but it's reorganized around a direct relationship between content providers and customers.

A direct access employer marketplace does the same, expanding access and choice for payers and in turn, patients. It also provides clearer benefits to pharma manufacturers:

• A level playing field. Instead of bidding for formulary access or having their better-performing therapy blocked from the market by a competitor with deeper pockets, manufacturers can compete on product performance and value.
• Visibility into data. By connecting directly to employers/plan sponsors through a transparent, neutral channel, pharma companies can finally see trends in consumers’ actual out-of-pocket costs, along with data on uptake, refill rate, adherence and the real-world affordability threshold at which patients abandon therapy.
• Better payer alignment. Instead of being shut out of intermediaries’ financially motivated formulary decision process, a direct access marketplace allows employers to evaluate therapies based on total cost-of-care considerations. This transparency benefits manufacturers, who can better understand population needs and how to serve them. It also enables plan sponsors to see exactly what they are paying for an individual drug, which is not possible today.

This doesn’t mean every therapy should move outside traditional benefit structures. But it does offer a way forward in key areas where the current model creates significant friction: high-demand therapies, high-cost specialty categories, competitive classes with meaningful clinical differentiation, and conditions where adherence and long-term outcomes have major economic implications for payers.

The Shift Requires Internal Realignment

A direct access marketplace allows pharma companies to finally compete on factors they control, but making the shift requires a realignment of internal incentives.

Many market access teams are still measured by lives covered, regardless of whether those lives are covered affordably. Their priority is to secure formulary contracts, often with little incentive on whether the plan sponsor realizes actual value.

Brand teams are beholden to quarterly and year-over-year revenue, disincentivizing investment in channel strategies with longer payback. And few organizations have a single leader accountable for the full access continuum, from plan-sponsor economics to pharmacy-counter affordability.

For direct access to work, those divergent incentives need to change.

Pharma doesn’t need to abandon the existing system overnight. But to compete in the new paradigm, it does need the strategic foresight to start building direct access channels alongside it.

The industry is already moving toward greater transparency, clearer pricing and more direct access. Employers are asking for it, patients increasingly expect it and high-demand therapeutic categories are forcing it.

The manufacturers that move first will define the future of access and affordability for the industry. The question is: Who has the courage to lead the way?

Bret Parker is the SVP, pharma solutions, at Prescryptive Health.