Approval Without Access Is Failure.

One Idea Worth Acting On.

A breakthrough oncology drug secures FDA approval.

The R&D team celebrates.

Six months later, the drug is sitting on the shelf.

Not because the science failed. Because the evidence package was built for the wrong audience.

Regulatory approval is no longer the finish line. Reimbursement is.

What's Actually Happening

The industry still runs clinical development as a sequential handoff. R&D designs trials to satisfy regulators. Once approval is secured, the baton passes to Market Access and HEOR to solve the reimbursement problem.

But the reimbursement problem cannot be solved after the data is locked. It has to be designed into the trial from the beginning.

Regulators ask whether the drug is safe and effective. Payers and HTA bodies ask different questions entirely — what is the comparative value against the current standard of care, what is the quality-of-life impact, what does this drug cost the system relative to what it delivers?

Those questions require different data. Data that has to be collected during the trial. Data that is not in the trial if Market Access was not in the room when the protocol was designed.

As Dr. Omar Dabbous, former VP of Global HEOR and RWE at Novartis Gene Therapies and contributor to Voices of Oncology, puts it: when Value and Access teams are not involved early, payers are left with unanswered questions. And unanswered payer questions produce one outcome — patients wait longer.

Why This Matters

In oncology, delayed access is not an operational inconvenience. Months matter. Sometimes they are the difference between a patient receiving a therapy and not receiving one.

When the trial was not designed to answer payer questions, the company faces two bad options after approval: accept restricted reimbursement, or fund post-approval confirmatory studies and real-world evidence campaigns to prove what should have been established years earlier.

Both options cost more — in time, in money, and in patient access — than building the evidence into the original trial.

Ingrid Bryzinski, OVN's Regulatory Affairs contributor, describes the European access gap precisely: after the European Commission grants marketing authorization, reimbursement must still be approved country by country. The median time to reimbursement after regulatory approval varies from days in Germany to nearly two years in Belgium. A drug can be approved across Europe and inaccessible to most European patients simultaneously.

Where It Breaks in the Real World

A Phase 3 trial succeeds using a comparator that satisfies the FDA. By the time the drug reaches market, the standard of care has shifted. The comparator the trial used is no longer what the European HTA body recognizes as the relevant comparison.

At the same time, the trial did not capture patient-reported outcomes or quality-of-life data in a form the payer can use to justify the drug's price.

Market Access was not in the room when the protocol was designed. The evidence gaps are not recoverable. The company cannot defend the value story it never built.

What Needs to Change

Market Access and HEOR belong in the room before Phase 1 — not after approval. The Target Product Profile must reflect payer evidence requirements alongside regulatory ones. Economic endpoints and patient-reported outcomes are not optional additions. They are the data that determines whether an approved drug reaches the patients it was designed for.

You cannot retrofit a value story after the data is locked.

The Bottom Line

Approval without access is not a partial victory. It is an organizational failure. The industry must stop designing trials solely to satisfy regulators and start designing them to secure the access that makes regulatory approval mean something.

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