Jens Grueger, ISPOR president-elect and former head of global access at F. Hoffmann-La Roche, explains in an interview with 3D Communications’ Kate Dion the importance of fully integrated access strategies and why access will soon be represented on the C-suite of pharma companies.
Access must be an integral part of a pharma company’s business model if drugmakers are to succeed in ensuring patients continue to benefit from groundbreaking scientific advances, says Jens Grueger, affiliate professor at the University of Washington School of Pharmacy.
“Access needs to become a corporate objective and not just a function objective. Full stop,” he says. “It is the key for pharmaceutical companies to be financially successful – and the key to addressing fundamental issues in our society – including affordability and ensuring healthcare systems have the capacity to appropriately use new health technologies.”
There is little doubt that pharmaceutical companies will need to rethink their commercialization strategies as thrifty payers seek to balance their coffers in the face of exploding demand for healthcare services and ever tighter budgets. As a result, the cost implications of a medicine are becoming just as important as the clinical implications.
Until now, efforts to manage payer demands and ensure patient access have largely fallen to global market access teams as well as regional and affiliate teams, but Grueger, who headed the Global Access Department at Roche for more than seven years, believes that companies will soon start to appoint executives responsible for access to their C-suites.
“I am convinced that we will see this in the future because access is increasingly something that investors are looking at and it is definitely something that patients are looking at, that society is looking at,” he says. “In the same way that compliance and regulatory quality have been elements of our license to operate, having a strong mission and overall governance around access will be crucial for pharmaceutical companies.”
But Grueger does not expect these changes to happen overnight.
“Access is still considered to be primarily pricing and therefore part of a company’s commercial responsibilities. The head of pharma and the head of global marketing see access as part of their remit. This will only change gradually as the business model shifts further from the traditional focus on marketing and sales and moves toward a new focus on payer management and access,” he says, adding that in many countries payers now have more impact on prescribing decisions than doctors.
Meanwhile one industry insider told 3D Communications he believes access has not been elevated to the C-suite because it is regarded as a subfunction: “Letting go of these traditions and putting access on an equal footing requires a cultural change that is not always easy to implement,” the source said.
More Is More
Companies need to work with a broader group of stakeholders in an effort to ensure that healthcare systems are ready for the new health technologies coming out of companies’ laboratories, Grueger says. “In the past we focused on the more technical aspects related to access, such as health economics and pricing. But access is a much broader construct now. Roche is now looking at aspects like affordability, outcome certainty, value recognition, and capacity. This means as a drug manufacturer you are not reducing the sale to just producing the drug per se, but you become a full player in the healthcare system,” he adds.
Note that these sentiments were echoed by Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations, at the ICHOM Conference in Rotterdam in May 2019.
Meanwhile, Grueger, who has also held senior positions in access at Novartis and Pfizer, believes those companies as well as Roche are among the front-runners when it comes to adopting more comprehensive access strategies.
“The strategies at Roche are really about integrating commercial, access, and medical strategy for a product,” he says. “Key for a sustainable pricing and market access strategy is that you start to explore development strategies at the earliest possible stage, not just with regulators, but with health technology assessment bodies and payers as well.”
Early engagement will become particularly important as new treatment options, such as gene, cell, and digital therapies, require new reimbursement pathways, he says.
An important aspect of ensuring faster access to medicines will be a more dynamic reimbursement environment – much like the conditional approval approach regulators have adopted. This will allow the benefits and prices of therapeutics to be assessed and reevaluated at different points in time as more evidence is gathered, Grueger says.
“There will be an initial price, but also an agreement with the payers to review the price after a certain period of time when the data become more mature and when you can better assess what the benefits are and whether the price needs to change accordingly,” he says.
A critical component of delivering additional evidence will be the collection and evaluation of real-world data, which Grueger believes will play a revolutionary role in the management of healthcare. “I think the time is coming that the quality of the data and our ability to make sense of the data is going to dramatically increase,” he says. “This will be something that we initially use in our drug-development approaches, but it will also affect value assessments and the kind of pricing and payment models we will be using. For example, we will see a lot more data-driven, outcomes-based solutions. This will lead to health technology management as opposed to health technology assessment.”
As the medicines coming onto the market become increasingly complex, there will be an even greater need for more efficient, competent, and streamlined health technology assessments (HTA), Grueger says.
“We will see more harmonized European clinical scientific assessments and I hope this will be a model for the rest of the world. I think it would be a mistake if, in Latin America, for example, that every country there would start to build its own HTA agencies and review every molecule there. That would not be an efficient use of resources and would not deliver the competent assessment that everybody wants,” he says.
The European Commission issued proposals at the start of 2018 aimed at streamlining the clinical benefit assessments – a crucial part of the HTA process – across Europe in a bid to create broader, faster, and more equitable access to new medicines. At the moment, more than 28 different agencies in Europe are assessing the clinical properties of a new drug in parallel.
“If we can implement a more centralized approach in Europe, this will increase the quality of assessments and will accelerate the assessment timelines so that patients get access to medicines faster,” Grueger says. “The European clinical scientific assessments could become a model for assessments in Latin America and Asia.”
Grueger’s vision for fully integrated access strategies that are supported by strong and visible leadership could be exactly what the doctor ordered. This powerful combination would give creaking business models a much-needed overhaul and would allow companies to embrace a new, more collaborative role within healthcare systems.