For pharma companies, the commercial landscape has transformed radically over the past five years. Drug prices are skyrocketing. Market access is of primary concern. Establishing a drug’s value story is paramount.
Responding to a sea change in the industry, Syneos Health assembled top industry market access experts across their Consulting, Deployment Solutions, Communications and Real World Evidence teams to help customers confidently navigate the shifting market landscape, create and communicate value and optimize access. Their individual expertise, coupled with the synergy between their disciplines and teams, arm pharma clients with a formidable arsenal.
- Andrew Rosner, MBA, VP, real world evidence
- David Byram, director, commercial advisory group, consulting
- Katherine Seay, EVP, managing director, managed markets communications
- Michelle Leeds, senior strategist, reputation and risk management
- Pat Leary, EVP, clinical field teams and market access, deployment solutions
MM&M caught up with the cross-discipline Syneos Health Value & Access team at the company’s New York office for a discussion on the issues impacting product pricing and commercialization. The most pressing question the group addressed was, when it comes to pricing, how long can pharma companies hold out?
“In the past, (the approach) would be all about, ‘How are you going to commercialize the product? How big should your sales force be? Where should it be deployed?’” Pat Leary said. “Now it starts with, ‘What’s your pricing strategy? What’s your trade and distribution strategy? What’s your product’s value? And how are you going to craft that story to be able to get access?’”
“If you’re not communicating with payers as early as possible, then you’re really missing the boat,” Katherine Seay added. “Now, we communicate with them across the product’s life cycle — whether that product is on the market, is not yet approved or is receiving a follow-on indication. Pharma organizations should be maximizing, understanding and fully utilizing opportunities to tell their economic story early and often.”
David Byram said in his experience, when drug companies delay disclosing prices, they run the risk that payers have not accounted for their drug’s cost in premiums for the following year, leaving them with no way to recoup that medical loss ratio.
“Payers need this information to determine how they’re going to pay for this medication and how it’s going to be covered. They also need to understand how many patients are going to be eligible,” he said.
In addition to providing payers with these answers, companies also have to be willing to take on the risk associated with the pricing, added Leary.
“Five years ago you didn’t have to worry about being on the front page of The Wall Street Journal because of a price increase — it was just routine. Now, if you don’t have value stated in your product profile, payers are just not going to cover it.”
In thinking about the cost and value of a drug, payers need to look at the bigger picture by tapping patient advocates and including them in the conversation, said Michelle Leeds.
“Patient advocates may be able to point out that while the cost of a drug may be high, the drug treatment may actually be less expensive than hospital costs in the long run,” she said. “They are becoming much more involved in the whole process of drug development and commercialization.”
With an election year approaching, Leeds acknowledged it is more important than ever for stakeholders to raise their voices on the topic of how to bring down drug costs for constituents.
“There’s a lot of focus on drug pricing in the policy world right now,” she explained. “And I think some of that’s going to have the effect of increasing a little bit of the health literacy in this country, for better or for worse. Sometimes transparency actually makes things a lot more confusing for people.”
“With some of the proposals,” she continued, “like the Medicare Part B international pricing index proposal, which ties the cost of drugs in Part B to drugs in other industrialized nations, I think that will increase the conversation in the public around what we pay for drugs as opposed to other countries, which I don’t think a lot of people have a line of sight to right now.”
Byram agreed, noting that outside of the U.S. drug prices are dictated to consumers, which impacts the approach manufacturers must take when doing business overseas.
“You need to talk about the value of the product and price it accordingly, and the market will bear what it will bear,” said Byram. “It could have an effect on the rest of the world where some countries don’t get the innovative therapies any longer because manufacturers decide not to sell their products there.”
“A challenge for most manufacturers today,” he continued, “is that they haven’t built the economic evidence. They haven’t built the reimbursement platform in order to really meet the needs of payers, whether it be public or private.”
Leary said payers’ hesitation to cover certain drugs, especially those treating less common illnesses, stems from the fact that patient loyalty to health plans is low.
“Some payers will say, ‘It’s $180,000 a year, to only have this patient for two years, and then have them go somewhere else,’” he said. “That’s when pharma companies need to step in and tell them the story. You may have some flow out, but others are going to flow in, so if everybody behaves the right way, it saves the system.”
Seay added that if left to their own devices, payers will often choose a low-cost generic as the comparator, and that can really skew the value story significantly. “Manufacturers need to be willing and able to use the 21st Century Cures Act, as well as the recent FDA guidance on communications with payers to communicate the economic story and value of the product relative to an appropriate comparator.”
Establishing that value story as early as possible during clinical trial development can make the difference between the success or failure of a drug launch, Leary said. “Historically, whoever was heading up the trials had two concerns: ‘Is it safe and is it efficacious? I don’t care about anything else. I just have to get the product approved by the FDA, right?’ That is no longer applicable. Your clinical development predetermines your launch trajectory and your commercial value, period.”
Leeds’ team is well-versed in helping companies define the value of their product before the Institute for Clinical and Economic Review (ICER) does, she pointed out. One of the many benefits of the structure of Syneos is that the communications agencies have access to “the brilliant folks on the clinical side,” she noted.
“If you think your product might be up for an ICER review, you need to start building your arguments and be ready to defend them,” Leeds said. “Get a seat at the table. Don’t just it let it happen to you and then try to go into defensive mode. Be proactive and be part of the conversation.”
While all agreed that approval is and probably always would be the No. 1 priority for pharma companies, Seay said that accumulating the strongest evidence to demonstrate value was “a close second.” The 21st Century Cures Act has put “focus on the use of real world data and its potential to support regulatory submissions and product label extensions” added Andrew Rosner.
As payers continue to look for help in accessing that “real world evidence,” Byram said Syneos Health’s “breadth of services from clinical trials all the way through commercialization” has put the company in a unique position to “influence those types of discussions and decisions.”
Rosner was also quick to shine a spotlight on the team’s strengths, noting, “our competitors don’t have all the pieces we do to drive things forward. Syneos Health is able to tap into the strengths of over 24,000 individuals, the experiences they offer and how we are able to connect the dots at the right time across the clinical and commercial continuum. This unique mix is what leads to our success.