Merging market access with launch planning
Leela Barham looks at how bringing together launch and market access plans can increase the success of bothBy Sep 25, 2011 on
Regardless of whether you’re talking about the launch plan or market access plan, reimbursement at a price justified by the product’s value is the “ultimate goal,” according to Ansgar Hebborn, Roche’s head of payer & HTA program policy.
That means companies increasingly have to look at the full pathway from getting regulatory approval to meeting payer needs.
And payer needs are starting to receive attention much earlier, typically at Phase I, although some companies may still only do this at Phase III.
“Launch planning and market access are obviously subjects that go hand in hand,” says Steven Flostrand, pricing and market access director at Creativ-Ceutical.
“There is no question of separating them. The real question is getting the research and development (R&D) and commercial teams to acknowledge the importance of the payer stakeholders and getting top management to put resources ‘at risk’ to develop the evidence needed for market access pre-launch.”
For Alicia Granados, senior director global HTA strategy-GMA at Genzyme, “True market access planning” stretches across functions such as medical, regulatory, health economics/health outcomes, policy, and marketing, emulating the HTA process in itself.
(For more on HTAs, see ‘Market access and HTAs: the role of ISPOR ’ and ‘Market access: How to meet both marketing authorisation and HTA needs’.)
Granados sees a clear role for including this expertise much earlier in the development process, so that companies can make more informed go/no go R&D decisions.
The best strategy includes patient, payer, and regulator needs at the outset
Roche brings together a variety of viewpoints—clinical, regulator, health economic, and patient—to develop a comprehensive strategy during development and finalization of clinical trials.
“The endpoints the trials will focus upon can be used to show value to all these parties, as each plays a role in influencing market access,” says Hebborn.
“Getting these functions together early largely determines successful market access in the future.”
Creativ-Ceutical has even done projects with preclinical teams, looking at decisions to take products into clinical trials, according to Flostrand.
“It is never too early to plan for market access,” he says.
Of course, the further out the projection, the greater the uncertainty.
But market access is another layer added to existing epidemiology, market, and marketing analyses to value portfolio projects.
And all of this is consistent with a trend toward increasing alignment between regulators and HTAs.
“This is really around the scientific and clinical parts of HTA,” Granados points out, rather than the economic evaluation.
Supporting the value proposition
Supporting the value proposition is a core part of the strategy.
“There are differences in the specific ways that payers want value to be demonstrated: by formal cost effectiveness in the UK, Canada, and Australia or by demonstrating added therapeutic value through the QALY approach as in Germany and France,” Hebborn says.
“The aim is to set out what data is needed in a payer evidence plan and then operationalize that.”
(For more on QALY, see ‘HTAs go global: What it means for market access’.)
Such a plan goes beyond the evidence generated to support reimbursement negotiations to include evidence required post-launch to persuade payers of the value of a new product.
In order to achieve market access, the plan must also potentially include wider outcomes, such as patient reported outcomes (PROs) and evidence of unmet need. (For more on patient-reported outcomes, see ‘The importance of patient reported outcomes in compliance’.)
The latter is often drawn from retrospective review of other data and literature reviews to back up the case for reimbursement.
Health economic modeling is part of that support; often a global function will develop the model, while country affiliates work to validate the assumptions.
The development of health economic models in an early development stage “gives a more conclusive understanding of where the value proposition will eventually take you,” according to Hebborn. (For more on health economics, see ‘Health economics data and market access’.)
Hebborn also notes that companies can supplement their plans through early engagement with agencies such as the National Institute for Health and Clinical Excellence (NICE) in the UK and the Swedish TLV.
But given the differences among payer requirements, he warns that companies must ultimately “decide whether to meet all the needs of payers or focus just on some.”
For Hebborn, success is measured in terms of “achieving regulatory approval, achieving the envisaged reimbursement status at the targeted value-based price, and the willingness of payers and providers to allocate healthcare budgets.”
Utilization and sales won’t follow if approval and reimbursement are not achieved or a place in the treatment pathway, often formally influenced by clinical guidelines, is not secured.
Achieving a given price point may be all the more challenging if the trend toward reviewing prices over time continues.
“With coverage decisions increasingly of the ‘Yes, but’ and ‘Yes, for now’ variety,” Flostrand says, “companies should consider the HTA decision to be just the mid-point of a dialogue that started early in development, and which will continue for some years after launch, through evidence development and the provision of real world data.”
For more on marketing and market access, join the sector’s key players at Sales & Marketing Excellence Latin America on October 20-21 in Miami, Sales & Marketing Excellence Russia CIS on October 24-25 in Moscow, 3rd Annual Market Access Canada on November 1-3 and eMarketing Canada on November 8-9 in Toronto, and Marketing Europe on November 22-23 in Berlin.
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