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Relvar Ellipta: Payers now in sight
GlaxoSmithKline and Theravance’s Relvar Ellipta has found itself making multiple headlines lately– first as the result of a positive CHMP opinion for treatment of asthma and COPD in Europe, and then following Japan’s approval of the drug in the former indication. The product, also approved by the US FDA back in May (as Breo Ellipta in COPD), is the successor to Seretide/Advair, GSK’s combination long-acting beta agonist/inhaled corticosteroid blockbuster. The trajectory of these products will be particularly interesting – for reasons outlined below.
The substitution factor
Although the US patent for Advair expired in 2010, so far no generic has entered the market. Would-be competitors have been stymied by a number of factors, including the complexity of developing an alternative inhalation device (the original is covered by a separate patent) and lack of specific FDA guidance on the requirements for establishing bioequivalence. But that latter obstacle is no longer an issue: earlier this month, the US FDA released draft guidance on the development of substitutable generics for inhaled respiratory products like Advair. Notably, the guidance is less stringent than it could have been, with generic manufacturers only needing to study the drug in asthma but not COPD for example.Still, GSK does not expect to see fully substitutable competitors of the drug for several years to come. In Europe, Greek firm Elpen launched a version of Advair a number of years ago, but again with a different inhalation device – posing problems for straightforward substitution.
The switching factor
While the substitution threat facing Advair may not be immediate, the other question to ask is to what extent there will be switching between this product and its new successor, Relvar/Breo Ellipta. The real differentiator between the two products is dosing, with the latter offering the advantage of once-daily treatment compared to the former’s twice-daily. The idea, of course, is that this will translate into improvements in patient compliance and, consequently, improvements in health outcomes. Whether this is something that payers will deem to be of value is, however, open to debate. In terms of pricing strategy, it has been reported that GSK will price its new entrant on par with Advair, so that the two products have the same wholesale acquisition cost.
Another piece to the puzzle is the role that the results from the innovative “real-world” study that GSK launched for Relvar in 2012 will play in perceptions of value. This study, leveraging e-health infrastructure in the UK, offers the potential to scrutinise healthcare utilisation, and see how the once-daily differentiating factor translates into outcomes and cost savings.
Going forward, it will be particularly interesting to see how the findings from this study shape reimbursement strategy, the extent to which this drives switching, and what kind of differences we see emerging across geographies.
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