US approval of Boehringer Ingelheim’s chronic lung disease combination Stiolto Respimat, and positive pivotal data for Novartis’s competing Ultibro Breezhaler, bookended the holiday weekend, signifying that the competitive pressure in this space is not about to ease up anytime soon.
In October Novartis itself is due an FDA decision that will set off a three-way race likely to heighten the struggles of GlaxoSmithKline and its embattled chief executive, Andrew Witty, as Anoro Ellipta has fallen well short of expectations. With the lessons from diabetes and hepatitis C fresh on the sector’s collective mind, the Boehringer medical affairs team will need to tread carefully on price.
In a space long beset by regulatory uncertainty, Boehringer is launching at a time of great commercial uncertainty. Glaxo’s respiratory annus horribilis in 2014 was driven by a loss of payer contracts for its flagship Advair and Anoro, something that the UK group has only begun to reverse by securing its own exclusive pacts (Welcome to respirageddon, February 9, 2015).
To achieve preferred status as a treatment for chronic obstructive pulmonary disease (COPD) the private German group will need to try to match Glaxo’s equivalent product Anoro on price, estimated at about $1,767 per patient this year, according to EvaluatePharma's Sales, Volume and Pricing module.
And it must do so with an eye on additional competition coming from Novartis’s Ultibro, which fell behind the pack when the FDA balked at the once-daily dosage of a component, indacaterol, selected in its pivotal trials. Ultibro is approved in the EU (Novartis' respiratory plans choked by US adcom, March 9, 2011).
The Swiss group last week announced that Ultibro, at the lower US-demanded twice daily dose, had achieved positive results in maintaining lung function compared with its individual components, indacaterol and glycopyrronium. The positive data should serve Novartis well leading up to the expected FDA decision date in October.
The three competitors pair a long-acting beta 2 agonist (LABA) with a long-acting muscarinic antagonist (LAMA), building on the benefits shown by each class as a monotherapy. Stiolto contains the active ingredients of both the FDA-approved products Spiriva and Striverdi, making it the second such combination to get the blessing of the US regulator.
COPD has long been a two-horse race between Boehringer’s LAMA monotherapy Spiriva and Glaxo’s LABA and steroid combination Advair. In 2020, Spiriva is forecast to top the category at $3.2m in sales, but will see its lead chipped away by Anoro and Ultibro, and by generics.
Stiolto is seen as a bit of an afterthought, with a forecast of barely half a billion dollars. However, as Boehringer is a private company the sellside provides few estimates for its products, notwithstanding Spiriva being a competitor product to big pharma entries.
With established products for COPD payers will take some persuading to offer coverage without exacting heavy price cuts, and Glaxo has already set the precedent for exclusive contracts as part of this game.
This is similar to the thrust-and-parry last year in diabetes between the insulin giants Sanofi and Novo Nordisk, which coincided with pharmacy benefit managers and insurance companies ringing alarm bells about their exploding speciality drug benefits – such as new cancer and hepatitis C agents.
When presented with a comparison between Spiriva and Stiolto, pharmacy benefit managers and insurance companies will be making a value calculation and asking asking whether the added patient benefit matches up with the increased cost.
Where there is competition that value may only be demonstrated if the price comes down. Boehringer probably knows this already.