Has Medical Affairs Become A Victim Of Its Own Success?
As medical affairs mushrooms, new skills and capabilities are urgently needed.
Such has been the growing remit of medical affairs departments of late that some schools of thought suggest they could even lead payer negotiations.
When put to Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs at Bayer Canada, he affirms that his owns team’s work is closely aligned with market access functions. Together, he says, they have forged an entrenched partnership in presenting real-world data to payers.
But Choudhri ultimately demurs over the possibility of medical affairs unilaterally going into meetings with payers. “Medical plays an important role, of course, in making information available for payers when it comes to reimbursement,” he says. “And we work very closely with our market access colleagues, but I don’t think medical will ever take over completely.”
This will undoubtedly feature as a strand of debate at eyeforpharma’s Medical Affairs Europe conference, to be held in Barcelona in March. Whether you concur with Choudri or not, the outsized role of medical affairs is indisputable.
As Heather Moses, Head of Medical Affairs at Roche, puts it: “The payer environment is constantly changing, as the goal posts of healthcare value make dramatic adjustments in order to meet the needs of truly personalised patient care. The skills and mindset of our teams will have to change too in order to stay in the game.”
Moses isn’t wrong. Today’s medical affairs departments have their work cut out, working beyond what Moses describes as “the traditional application of competitive intelligence”. At the same time, field-based medical continues its ascent to the fore, through which departments involve themselves in the big discussions and questions that face clinicians as part of their day-to-day practice.
Medical affair’s role within medical governance also continues to mushroom, particularly in North America, as Choudhri explains:
“Earlier this year, we conducted a workshop on the difference between medical governance and compliance,” he says. “Historically, the focus was on compliance, but now medical affairs is starting to take ownership of a number of processes, where the goal is not just to catch people when things go wrong, but really to have the right processes already in place. It’s a much more proactive approach.”
Putting this all together means medical affairs teams are being asked to develop new skills on the job. In which areas in particular is there a pressing need to hone these capabilities?
Communicate to accelerate
Many of today’s pharma companies have integrated development and commercialization structures to better identify product potential – as well as communicating the needs of what a future market might represent.
In light of this, says Moses, “the strategic link between commercial potential, payer needs and medically prioritized and interpreted insights should be joined together as early as possible”.
This harmony, however, is not easy to achieve, especially given the wide distribution of resources across country affiliate teams, and where tough investment trade-off decisions need to be hammered out over products that need to deliver now versus “providing enough investment into dedicated early pipeline medical staff to understand, quantify, and communicate a future looking portfolio strategy”.
“Investing in the unknown future is the gamble that all pharma companies need to make,” states Moses. “However, there is a delicate balance of allocating enough resource and skill within any one country’s payer market to be able to effectively influence a global development programme, in order to meet the local needs of the future.”
The digital takeover
In line with the remote monitoring technologies becoming more widely available and cheaper, it’s possible that clinical trials, as well as patient support programmes, will be encompassed under the umbrella of digital health.
While some companies may be more au fait than others with the idea of collecting patient data from the likes of wearables, some will need help in progressing from analogue cultures of case report forms.
“The move to digital health doesn’t just require expertise in collecting these huge amounts of data, but also an infrastructure that most companies don’t currently have,” says Choudhri. “With these monitoring devices you’re collecting millions of data points a day, which goes way beyond what humans can interpret and analyse. This requires some form of AI interface to simplify the data and turn it into something more meaningful.
“Companies need to pick up on this, because the technology is already available and becoming integrated into what we do. However, we don’t necessarily have the platforms and systems right now to make optimal use of it.”
According to Choudhri, medical affairs have traditionally suffered from a shortage of internal expertise when it comes to epidemiology.
“We definitely need to develop more skills in this area, particularly as real-world evidence become more important,” he says. “So that expertise is essential in dealing with and interrogating these large data sets in a scientifically sound way. That will become and more important, I feel.”
Articulating the unknown
Traditionally, medical affairs teams were reliant on robust phase III trial data, and known disease area demographics, as the best means of conveying value stories around health technology assessments.
However, “those days are gone”, asserts Moses, with more complex combination therapy approaches becoming increasingly difficult to validate by standard endpoints as to their cost effectiveness.
“For example, in cancer immunotherapy, mechanisms of accurately measuring progression-free survival may be clouded by the mechanism of action of the therapy itself, and benefit may be observed through a different pattern of response as compared to other cancer treatment approaches, leaving more reliance on long term survival outcomes” she says.
“This leaves both medical, health economists and payer bodies seeking alternative methods to communicate what represents value to patients.”
Another string to the bow
Today’s clinical development strategies require the application of faster, more agile processes, with labels granted on the basis of phase II data – and sometimes even phase I data.
As a result, it falls on medical teams to fill in data gaps for payers – placing an increasing onus on close collaboration with health economists to do so.
“This places a larger burden on the data generation strategic skillsets needed in modern medical affairs,” says Moses. “It also places a burden on local clinical trial management and operations capability, and the need to think about data generation with an innovative eye.
“It requires pragmatic designs, and real-world data approaches being used to fill these gaps in a faster, efficient, and economical way.”
The upshot? Medical is about to get even more technical.
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