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Writing the Value Story
When writing the value story for a new medicine, starting earlier in Development will make sure it’s a page-turner
Narratives. We can’t escape them. They shape every aspect of our lives, help us to find meaning in the mundane and to learn from our mistakes.
When weaving these stories, we are duty-bound to think about the impact they will have upon the recipient. How will they respond to the message? Will it be a force for good or for bad?
The stakes for story-telling could not be higher than in healthcare. With pricing obstacles strewn across route to patient access for innovative drugs, pharma companies must construct a narrative that resonates deeply with its target readership. Lives depend on it.
“We must get the story right – and we need to be responsible in our approach to pricing,” says Debbie Drane, SVP, Commercial Development, at CSL Behring.
When writing the value story for a new medicine, starting earlier in Development will make sure it’s a page-turner.
“Over the last five years, the focus has been shifting from drug approval to drug access, and it is an evolution in many companies to get everyone thinking holistically about access issues facing a drug rather than simply getting regulatory approval,” says Drane.
Companies must think about the value that its drug brings if they are to convince payers. “If we don’t do that properly there are two outcomes; a lower price or tighter access. Therefore, if we want to maintain access at a reasonable price we have to build value into our development pipeline very early on.”
Key to this approach is to talk to payers early, says Ed Pezella, former VP at Aetna, now CEO of consultancy firm Enlightenment Bioconsult. “A lot more pharmaceutical firms, especially larger firms, have caught on to the need to talk to payers much further in advance than we used to. It wasn’t that many years ago that they would say, ‘We need a payer strategy because we’re about to launch, so let’s get a bunch of payer guys in a room and see if our marketing materials are okay’. Now we’re talking to payers much earlier,” he says.
Payers are important, but every stakeholder needs a slightly different narrative, says Drane. “Patients want drugs that work, and which improve their quality of life, but they are being asked to pay more in terms of co-pay and, of course, they don’t want to do that, so the message must be tailored.
“But if you’re trying to get your product registered with a physician, it can be time-consuming for them, and they can ill-afford being bogged down in tonnes of paperwork. Thinking about how to streamline this process – reducing their administration time while improving patient outcomes – should happen much earlier on in the pipeline.”
The payer story must be tailored towards pricing, asking, ‘What is the budget impact? How can they make savings?’
PUTTING PEN TO PAPER
To answer these questions – and to create a nuanced value story – CSL Behring devises a value framework in the early stages of development, says Drane. It focuses on identifying the health problem, understanding the clinical benefits of the drug and understand the economic value.
“Throughout development, a cross-functional value team is charged with creating the value story. It reviews and changes the deliverables from a market access perspective. Very early on, even pre-clinical, we have a process we call ‘stage gate 2’, which is a decision to put a product into development.”
At that point, the team must understand the product proposition, at least from an aspirational perspective, and the unmet need. “We build on that throughout development; so, before we go into the clinic we already want to know whether pricing and reimbursement is going to be feasible,” she says.
With limited information at this stage, discussions remain quite high level. “We really want to know that we are going to have a competitive advantage, and that, if everything goes well, we will have access for the drug at the end.”
By the time a decision must be made about whether to enter late-stage development, Drane wants to know whether they have the data to address the access issues already identified. “If we can’t get the data from the clinical trial, we look to glean it from other sources, whether it be through real-world evidence generation or by doing an additional study. The bottom line is we need go to launch with a value evidence dossier.”
Deconstructing the parts
Early in the development process, pharma companies must have a clear conception of the value that they are creating and be able to extrapolate that value into the real-world impact, says Pezalla.
“The whole point of having stages is that one stage impacts the next one, but we must also remember that not only does it impact the next stage, it may lock you in, from which it may be hard to go back,” says Pezalla.
Think long and hard early on about value creation, he advises. Launch may seem a long way off, but probing deeply into the future, and predicting what the standard of care will be, will pay dividends.
“Is it all generics in this category? That’ll make a difference. You’re going to have to show some reason for superiority or it’s going to be a really hard day. How will payers feel about this category? How do they feel now?”
As you proceed, other questions arise. What outcomes are important to payers? Can you align the FDA’s expectations with those of payers? Does it really do something for patients? What are the outcomes and how are you going to measure them?
At this point, Pezalla recommends seeking a second opinion from someone outside the development program. “You need someone who can confirm there is a connection between the measures you are using in the trial and the ultimate outcome for patients.”
A common grievance from payers is that the tools a company uses to get the right patients on the drug in a clinical trial – and to determine if it is working or not working – are often not the same tools commonly used in clinical practice, and so may be impractical for clinical practice, take too long to use, or be overly complicated.
“You need to develop a simple tool so that, when the drug comes into use, you have some way of knowing if it is working for the patient or not. That way, payers aren’t asking doctors to complete a 100-question survey.”
The move from phase II to phase III presents another stumbling block, says Pezalla. “You’re locking in your patient population for your trial. There are many good reasons to choose a patient population – enough severity of disease to measure a change, no other conditions to cloud the issue, etc. – which creates a good patient population for the trial, but is it the population the payers are really concerned about?”
From an investment standpoint, this is a critical juncture, so additional material is needed to prop up the value story. “What other endpoints are payers interested in that are different from the regulatory ones? You can’t include everything, so you’re going to have to prioritize – this is the time to talk to payers.”
While some European bodies have frameworks for including payers in the process, Pezalla is yet to find an equivalent in the US. “There is supposed to be a pathway for diagnostics and devices, where you can request that a payer come and be part of that, but I haven’t heard of anybody who has taken the FDA up on that.”
You can go at it alone, and most pharmaceutical firms do, but, while payers are not equipped to tell you how to run your clinical trial, they can provide specific advice about the metrics they value.
When grappling with particularly complex pricing challenges, such as how pricing is going to be done, talking to knowledgeable individual payers may be more useful than a “bunch of people on an advisory panel looking puzzled,” he says.
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