Want Better Access? Then Take Some More Risk
Biopharma is an industry seeped in an above-average concentration of risk. Scientific, clinical and regulatory uncertainties add to more typical commercial and market-driven risks. Given that, you’d think pharma execs would be a little more willing to stick their necks out and embrace (or at least explore) change.
Some are. They get that payer cost-pressures and pipeline productivity challenges are forcing new, make-or-break approaches to clinical development, payer interactions, and commercial positioning. Yet toward the by-now-rather-less-radical idea of more closely integrating regulatory and HTA requirements, the pharma sector’s attitude is “somewhat capricious,” notes Mel Walker, recently appointed VP Market Access at Otsuka Pharmaceuticals Europe, after six years at GSK. That even a few companies still resist this idea seems odd, since it’s pharma (along with patients) that has most to benefit from a more harmonized regulatory-HTA process.
Some drug industry execs are worried that putting regulators in the same room as HTAs — an idea that has been piloted in Europe, in the context of scientific advice, since 2010 — “may lead to HTA somehow influencing regulators to say ‘no’ to more products”, illustrates Walker, who will chair a discussion on HTA/regulatory convergence at the PharmAccess Leaders’ Forum in Berlin later this month. Alasdair Breckenridge, chairman of the UK regulator MHRA, among the first to engage in discussion with HTA, has a similar impression of pharma’s uneasiness. “Reports from these joint meetings are very mixed,” he told health economistsin London several weeks ago.
Yet smoother, more effective collaboration between regulators and HTA makes sense for all stakeholders. In most markets, new products can’t reach the majority of patients without a green light from both agencies. Pharma’s future depends on making the R&D process (and other activities such as manufacturing and commercialization) more efficient, and that involves “building as much information relevant to both stakeholder groups [regulators and HTA] as possible into pivotal trials” to allow a successful launch at a price that reflects the true value of the product, notes Walker.
So pharma’s risk-aversion is — must be — temporary. EMA has run at least 11 joint regulatory-HTA advisory processes with a number of the big companies (there are five more ongoing). They’re still considered pilots; “we’re not pushing it [joint scientific/HTA advice] on companies,” says an EMA spokeswoman. But “it’s available to them if they want it.”
Those meetings still aren’t perfect: Walker reckons the joint engagements are set up too similarly to the more formal EMA-only advice structure (though the sessions are three times as long); this, he argues, doesn’t lend itself to a more flexible, problem-solving approach required for joint discussions. And pharma may, similarly, send in regulatory folk with a narrow, reg-only perspective. But at the end of the day, regulators and HTA “make decisions on a different basis: for regulators, it’s about clinical efficacy and safety, for HTA, it’s about real-world effectiveness and value-for-money/cost. This won’t change,” opines Walker, even though HTA bodies often rely on regulators’ input, such as EMA’s European Public Assessment Reports (EPARs).
“If we want the industry model to work better and more efficiently, we need that collaboration -between regulators and HTA – to work” warns Walker. No-one’s expecting a European-wide HTA to parallel EMA (although efforts by bodies such as EUnetHTA will start to harmonize information used for HTA). But all stakeholders can learn from, adapt and refine the structure and feel of joint meetings between EMA and various EU HTA bodies during drug development (Walker chairs a sub-group within HTA International that’s looking at what can be learnt from similar pilots across the globe). Pharma can send in different people, ask different questions, work more flexibly. They should do whatever it takes to engage in these processes; not doing so will ultimately result in patients being blocked access to new drugs.
Image courtesy of The Eggplant on flickr.