Asembia 2021: Start Early, Be Clear, And Be Ready For the FDA: Some Ingredients in the Market Access Recipe

Collaboration and communication are imperative for pharmaceutical companies to improve market access of their products, according to panelists speaking today at Asembia’s 2021 Specialty Pharmacy Summit.

Experts Dave MacLeod, Erin Mistry, M.S., and Robert Rouse, M.S. — each of whom have worked in both the pharmaceutical and service industries — offered their perspectives on best practices for market access. MacLeod is head of global patient services and commercial distribution at Amylyx Pharmaceuticals in Plainville, Massachusetts; Mistry is senior vice president of payer strategy, government affairs and trade relations at CorMedix in Berkeley Heights, New Jersey; and Rouse is head of U.S. market access for CSL Behring, whose parent company, CSL Limited, is headquartered in Melbourne, Australia,

Tony Lanzone, MBA, managing director, value, and HEOR at Syneos Health in Morrisville, North Carolina, moderated the afternoon discussion at the meeting, which is being held the Wynn Las Vegas hotel in Las Vegas.

As part of effective communication, the panelists stressed the importance of consistent, clear messaging throughout all levels of the organization and of maintaining a consistent definition of value when working with different stakeholders. They said the definition of value should be consistent, but when it comes to engaging patient advocacy groups, providers, or government payers, approaches may need to be tailored.

Value is also not confined to one time point in the product’s lifecycle and can be complex, MacLeod, Mistry and Rouse noted. Defining value at clinical, precommercial, and commercial stages is essential and relies upon effective collaboration and communication.

Market access isn’t restricted to contracts, MacLeod noted.

“If you're preparing to bring a drug to market and your regulatory team is putting together an NDA (new drug application) and a label, you want your market access team in there to provide insights,” he told the meeting attendees. “Not to tell them how to do it, but to let them know what is going to read back out from the payers, what are they going to understand, and what are they going to see to give you the broadest label you can get.”

Keeping regulatory changes in mind is also crucial, advised Mistry. Understanding the regulatory changes that the FDA might make and keeps tabs on the issues that CMS is prioritizing — such as health equity and patient outcomes — can be hugely beneficial to market access efforts, she added.

Characterizing market access as a policy function, Mistry said that “if you don't have the folks that are knowledgeable about policy sitting at the table with you when you're in discussions, then I think that that's a missed opportunity.”

Companies seeking FDA approvals teams need to be prepared to make a strong case for their products, said Mistry: “Your regulatory team needs to know what to argue to the FDA to make it the most commercially viable product on the market.”

Rouse discussed how the perceptions and calculations of a product’s value may vary with the customer. He also said the work needed to anticipate how a product might be valued by various stakeholders can start even when a product is still in phase 1 or 2 trials.

The direction (and amounts) of revenue and payment in American healthcare system can be baffling, particularly with respect to the payment for pharmaceuticals, the panelists noted.“I think that's what a market access function brings internally. Marketing, sales, medical affairs — you can educate your teams on how the flow of money works,” said Mistry.

Granular and specific data that is concise and digestible plays a role in effective communication the panelists noted. Physician to physician communication about the value of a product is key, in Mistry’s view.

Sometimes providers will distrust the payer or manufacturer perspective on a product’s value, Rouse added. Peer exchanges among providers or input from patient advocates can help fill this communication gap.

“You can't be rigid in how you approach market access, or a product launch, or even a product that's further down in its lifecycle, because there’s always going to be challenges” summarized MacLeod. Alignment in messaging and multipartnered communication can help clear these hurdles, he said.