davemcconkey-tokms

Inside a Complex Oncology Project: How David McConkey (Oxford) Led Cross‑Functional Success

Some of the most powerful learning comes from specific projects. Without naming products or markets, I want to share an example from my work as Europe Region VP of Commercialisation in oncology, often associated with the Oxfordecosystem. It illustrates how cross‑functional leadership can navigate the intersection of JCA, HTA changes, local payer issues, MFN, and price management.

The challenge: high promise, high uncertainty

We were preparing to launch an oncology therapy with:

• Strong early clinical data but immature survival endpoints.
• An evolving competitive landscape, with other entrants racing towards launch.
• A policy environment in flux: JCA implementation timelines uncertain, HTA reforms underway in key markets, and increasing political attention on oncology prices.

The commercial stakes were high, but so was the risk of misalignment with payers and HTA bodies.

Step 1: Align on a shared problem statement

Our first move was to bring together:

• Clinical development and medical affairs.
• Health economics and market access.
• Regulatory colleagues.
• Country commercial and payer‑facing leaders.

We agreed on a shared problem statement:

“How do we secure timely, sustainable access across Europe for this therapy, given evidence uncertainty, JCA and HTA changes, and heightened scrutiny on oncology prices?”

This phrasing made it clear that success was not just approval or launch, but sustainable access.

Step 2: Co‑design an evidence and access strategy

Rather than treating evidence, price, and access as separate tracks, we worked in integrated sprints:

• Evidence: Prioritised endpoints and sub‑analyses that we believed would be most relevant for JCA and key HTA bodies. Planned real‑world evidence collection from day one.
• Access: Identified markets likely to move fast under conditional arrangements versus those that would wait for mature data.
• Price: Defined a corridor that reflected the therapy’s value while being mindful of MFN rules, external reference pricing, and parallel trade.

We also created a playbook for managed entry agreements, including outcomes‑based elements where feasible.

Step 3: Empower local teams to adapt within guardrails

Recognising that local payer issues would vary widely, we:

• Shared the evidence and price strategy with affiliates early.
• Defined non‑negotiables (e.g. core value message, certain price guardrails) and areas for local flexibility.
• Created a mechanism for rapid escalation if local payers proposed terms that could trigger MFN or parallel trade risks.

Local teams appreciated being treated as partners, not recipients of a “finished” strategy.

Outcomes: success and humility

The results were mixed — in a good way:

• Many markets achieved timely access via conditional reimbursement or tailored agreements.
• JCA and national HTA outcomes were generally in line with expectations, with some constructive challenges that helped refine our evidence story.
• We had to adjust prices and contracts in a few markets earlier than anticipated, as new data emerged and competitors arrived.

Crucially, we were able to:

• Avoid a major MFN or parallel trade crisis by monitoring cross‑market implications closely.
• Maintain credibility with payers by being transparent when uncertainty remained and proactive in addressing it.

Lessons for peers

This project reinforced several lessons for me as David McConkey Oxford:

• Alignment on the problem is more important than alignment on every detail of the solution.
• Cross‑functional co‑design is messy but indispensable in an era of JCA, HTA change, and payer scrutiny.
• Price corridors and managed entry agreements are tools, not panaceas; they must be underpinned by robust evidence plans.
• Local payer engagement cannot be fully centralised; the role of the regional leader is to set guardrails, not scripts.

For peers leading similar projects, I would encourage treating each complex oncology launch as both a commercial opportunity and a learning laboratory for how our industry can work more constructively with European health systems.