In its slogan, BeiGene says that “cancer has no borders.” It’s a different story in Europe, however, where the influence of multiple regulatory agencies and discrete reimbursement processes can turn drug launches into byzantine feats of negotiation.
In turn, many pharmaceutical companies ultimately focus on just a few choice EU markets—the U.K., Germany, France, Spain and Italy—and often take years to hash out access plans with local governments after regulatory approvals.
Not content to stymie itself in endless pricing talks, BeiGene is taking a different tack, the company’s chief commercial officer for North America and Europe, Josh Neiman, said in a recent interview. “We’re not interested in a two-year negotiation process,” he explained on the heels of a recent tour across the continent. “We want to get access to our patients as quickly as we can.”
BeiGene is looking to shake up the status quo for European drug launches as a relative newcomer. The company largely built out its European team during the pandemic.
Its workforce across the bloc now numbers around 400 people after doubling in the past year, Neiman said. After meeting with his European colleagues last May, Neiman visited the continent this spring to reconnect around the approval and launch of the company’s BTK inhibitor, Brukinsa, in chronic lymphocytic leukemia (CLL).
Unlike the U.S., where the reimbursement process is somewhat predictable and often starts before an FDA approval, Europe comprises many countries—each with their own health technology assessments (HTAs) and “separate and distinct reimbursement processes,” Neiman explained.
“There is no one Europe,” Neiman stressed, echoing his overseas colleagues.
Health technology assessments are used to weigh the effects and costs of new drugs. These are largely used to inform policy decisions around pricing and patient eligibility.
Certain countries like Germany and Austria offer free reimbursement immediately, giving companies the potential to launch or commercialize their drugs right on the heels of an EU green light. But even then, that initial price is temporary, Neiman explained. Eventually, companies must go through formal reimbursement processes and make HTA submissions.
Since each European country has its own HTA process, that puts the onus on drug companies to advance parallel negotiations and provide additional data when they’re requested.
For many companies, this “will potentially take years before they go through those processes to get reimbursement to then actually launch and provide access,” Neiman explained.
Need for speed
As for BeiGene, the company wants to move much faster.
“We’re really trying to truncate the time it takes to get access,” he said, adding that BeiGene feels “good about the speed with which we’re actually able to deliver that access.”
To do this, the company isn’t digging its heels in around premium pricing. Instead, BeiGene is taking a parity pricing approach, setting costs in line with in-class comparators, even in cases where the company has run successful head-to-head studies.
“If we believe we have a better set of data supporting the use of our product, the parity-based approach should lead to quicker access and ultimately better outcomes for patients,” he explained. This approach gets BeiGene’s meds to the market faster and helps the company build familiarity with doctors across a slate of indications, according to the executive.
Part of that strategy relies on investing in local talent with focused expertise and understanding of Europe’s diverse access landscape.
Delivering the goods
The company shared evidence to demonstrate how its strategy is working—so far.
In one example, Brukinsa won the quickest access in Denmark among a roster of 22 big-name drugs, according to a study posted by the Danish pharma industry association Lif.
And in Norway, Brukinsa clinched reimbursement in CLL just four months after the European Medicines Agency’s nod in November, according to a company spokesperson. In Belgium, it took the company nine months (or 270 days) to achieve reimbursement in the med’s Waldenstrom macroglobulinemia use. That’s about half the industry average of 500 days, according to Belgian trade association Pharma.be.
In Italy, Brukinsa ranked third on achieving speedy reimbursement in a 10-month stretch, taking the bronze behind Roche’s Evrysdi and Gilead’s Trodelvy, according to statistics from the Italian medicines agency AIFA.
The big picture
BeiGene is out to prove that its pricing approach can pan out in Europe. It’s implementing the strategy against a backdrop of pricing pressures, clawbacks and tax increases that have sent other drugmakers heading for the hills.
Even Germany—often the proving ground for pharmaceutical pricing in the bloc and once a bastion of drug cost leeway in Europe—has implemented tougher regulations in recent years, according to Forbes.
Those policy shifts likely inspired Bristol Myers Squibb to forego the launch of its cancer med Opdualag in Germany, a move the company blamed on pricing pressures. Previously, gene therapy specialist bluebird bio charted a European exodus, too, after it failed to reach a consensus with authorities around a fair price for its one-and-done blood disorder treatment Zynteglo.
The company’s CEO, Andrew Obenshain, previously called the pricing situation overseas “untenable for a small innovative company at this time.”
Elsewhere, AbbVie and Eli Lilly recently exited the U.K.’s Voluntary Scheme for Branded Medicines Pricing and Access, a government-industry accord that traces its roots to the formation of the country’s National Health Service.
The move, which was prompted by a recent spike in government repayment rates, should send a “warning signal” to the U.K. that pharma companies may be unwilling to shoulder “increasingly punitive revenue clawbacks,” local trade group the Association of the British Pharmaceutical Industry said in January.
Meanwhile, the U.K.’s “discouraging” tax rate prompted AstraZeneca to plan an upcoming, $400 million drug ingredients plant in Ireland rather than on its British home turf, CEO Pascal Soriot recently said.
As Neiman sees it, the issue of pharma’s pullback in Europe is complicated but ultimately comes down to costs. Events of the last several years, from COVID-19 and inflation to Russia’s war in Ukraine, have created “unprecedented” costs across the continent’s healthcare systems.
Source : Fierce Pharma