Demonstrating “healthcare value” is key to avoiding another Exubera

25-Nov-2008 - Last updated on 02-Apr-2014 at 10:32 GMT

Related tags Pharmacology Clinical trial

Pfizer’s Exubera failure need not be the final nail in the coffin for inhaled biopharmaceuticals as long as developers focus on proving “healthcare value” and addressing payer needs, according to Bruckner Group’s David Balekdjian.

At a symposium at this year’s American Association of Pharmaceutical Scientists (AAPS) meeting in Atlanta, US, Balekdjian argued that even before studies linked it to lung cancer, Exubera was destined to fail because Pfizer focused on patient convenience rather than proving the drug’s clinical efficacy to medical insurance providers.

Balekdjian explained that despite the difficulties in dosing, its cumbersome administration device and high cost, many “physicians wanted to get patients on to Exubera but had run into insurance walls,” erected by payers to whom the drug’s benefits over existing therapies had not been sufficiently demonstrated.

He suggested that Pfizer’s failure to show compliance benefits to insurers had been the major shortcoming of the Exubera campaign in the US.

In more general terms, Balekdjian indicated that the failure to show “healthcare value” is widespread in the drug industry because big pharma’s approach is “to introduce health economic value at the end of the development process as a kind of accounting exercise.”

Fuzeon too?

Balekdjian also offered the opinion that the HIV drug Fuzeon, sales of which fell some 38 per cent in the third quarter alone, were suffering because its developer Roche had failed to make a strong enough argument for the drug’s benefits to both patients and insurers.

He suggested that Roche and co-developer Trimeris had not emphasized Fuzeon’s clear clinical benefits and that this, coupled with the general reluctance to adopt new injectable drugs, had damaged its healthcare value. Roche’s recent announcement that it would pull out of the HIV market altogether would seem to add weight to this idea.

Instead of the current late stage focus on demonstrating healthcare value, Baledjian suggested that developers should use iterative methods of driving up value, and that they need to concentrate on proving the clinical and value benefits of a product from initial candidate selection through to Phase III testing and beyond.