Reuters Events | Pharma

Thought leadership and innovation for the Pharmaceutical Industry

Pharma seeks swift market access for innovative treatments amid evolving regulations, emphasizing collaboration and proactive planning for timely delivery of life-changing therapies.

By Nick Taylor on Jan 10, 2024

Expediting market access is now one of the key challenges for the pharma industry. Breakthroughs in our understanding of the biological basis of disease and the validation of novel modalities are unlocking ways to address major unmet medical needs. Yet, those drugs will only change patients' lives if companies can navigate new legislation, pricing reforms, and shifts in payer expectations while building frameworks that facilitate and accelerate access. 

Pharma commercial teams face challenges in major markets around the world. In the US, drugmakers are grappling with the impact of the Inflation Reduction Act on drug pricing, while in Europe healthcare budgets, the gap between the evidence needs of payers and regulators, and the lag between approval and reimbursement are areas of focus.

In that landscape, pharma companies need compelling evidence of value to turn effective therapies into successful products, making market access an increasingly important function. Talking on a Reuters webinar, Sandro Cesaro, Head of Europe, Market Access & Pricing, Oncology at AstraZeneca, discussed how market access has become “front and center” for the pharma and diagnostic industries.

“Market access has really expanded from a primarily technical function ... which was outside of the core areas of development, regulatory, and commercial ... to one with a broader remit with dedicated access strategy leaders that are typically part of an integrated strategy, cross-functional team. Market access today provides stewardship and leadership to bring innovation to patients,” Cesaro said.

Co-create systems to avoid logjams

Cesaro and other panelists on the webinar discussed how to work through the challenges and expedite market access. Tay Salimullah, Vice President, Head of Global Value & Access at Novartis, identified the co-creation of a system that works for stakeholders with different incentives as a way to prevent logjams that stop new medicines from reaching patients.

“It's easy to say, ‘oh, we can't find a solution, we're not launching or we didn't get a price, and it's all your fault.’ I think it's harder to co-create a system together,” Salimullah said. “We have a fundamental shared incentive around patients, but the ability to converge and cooperate with external healthcare systems and payers I think is going to be really a test of our leadership going forward.”

Salimullah added that “we now have to really up our game on what it looks like to develop progressive solutions with payers in real time.” That will require market access teams to work with their colleagues in finance, legal, and ethics, risk, and compliance, the Novartis VP said, and with medical and commercial partners.

Magdalena Siemon, Global Market Access Operations Lead at Sanofi, shared additional insights into the co-creation of health solutions, addressing the need to bring together different functions at the company and focus on the needs of patients.

“We need to solve ... the patient’s needs together. It does not make sense to be a group of departments each pursuing its own goals because at the end it will not come together. We obviously need to work with medical R&D for development of the clinical trials. If the patient's perspective is not evaluated there and we do not provide the evidence they need, it will not be successful at the end,” Siemon said.

Salimullah cited the gene therapy Zolgensma as an example of how Novartis co-creates and cooperates with governments to bring products to patients. With a list price of $2.1 million in the US, the one-time treatment for spinal muscular atrophy posed market access challenges. Yet, Novartis had reimbursement in half of Europe the year after winning approval and now has access in markets from Ecuador to Egypt.¹

“It's up to us to bring the best version of our toolkit, our playbook, and reconfigure the market access launch sequence and make sure we can find a way by collaborating, co-creating, and cooperating with some of those governments and payers in those markets. It challenges some of our own biases as an industry that we must follow a traditional launch sequence,” Salimullah said.

Act early, scan the horizon

Novartis’ ability to quickly secure reimbursement for Zolgensma was, in part, a result of its decision to engage governments before receiving approval. Cesaro also picked up on the value of early engagement, with both payers and patient organizations, and cited it as an explanation for why AstraZeneca was able to receive reimbursement for cancer drug Enhertu “within 12 months in the majority of markets.”

Cesaro listed early engagement and horizon scanning as two critical success factors in market access. To the AstraZeneca leader, horizon scanning is part of an attempt to build “a deep understanding of the evolving payor needs” and keep partners abreast of upcoming developments at the company. Siemon outlined how early engagement and horizon scanning fit into Sanofi’s approach to market access.

“There are opportunities to engage early with payers to understand what challenges they may have using different traditional or digital tools,” Siemon said. “The primary insights that often happen locally are also important to take into [the] equation to get ready and to be aware early about changes that are coming.”

Those externally focused activities complement work on internal critical success factors. Cesaro named creating a robust evidence plan and considering market access early as internal success factors. Pharma companies should consider market access early enough for the talks to “influence clinical development plans for statistical analysis,” Cesaro said.

Conclusion

Co-creation, early engagement, and horizon scanning can help companies expedite market access and maximize the impact of their products. While individual companies work to adopt such practices, there are opportunities for the industry as a whole to ensure “innovation is seen as an investment rather than a cost,” Cesaro said, and push to improve legislation and regulations that affect all drugmakers.

Through such individual and collective actions, pharma can provide a stable ground for pre and post drug launch and effectively communicate the value of products, expediting market access to enable patients to receive life-changing therapies.

References

1.     Sagonowsky, E. Novartis has negotiated Zolgensma access for half of the European SMA population, exec says. How’d it get there? FiercePharma https://www.fiercepharma.com/pharma/novartis-europe-zolgensma-access-gene-therapy (2021).