The Medical Letter recently (Sept 2, 2013) reviewed Breo Ellipta, a new inhaled corticosteroid/long-acting beta agonist combination that was approved by the FDA for treatment of chronic obstructive pulmonary disease. The odd thing was that it was being marketed by GlaxoSmithKline (GSK), which was already selling Advair Diskus, an older corticosteroid/LABA combination, for the same indication. Why would they compete with themselves? Well, we usually just evaluate the drugs and don’t get into the economic motivations of the manufacturers. But we did wonder a little about this one.
The October 14th issue of “The Pink Sheet”, an excellent Pharma trade publication, offers an explanation. Advair Diskus is not just another drug to GSK. It is their top-selling drug, with sales last year of more than $7 billion. And generic competition is coming. Not right away. Probably not until 2016 and possibly even later. Patent protection for the active ingredients of Advair Diskus (fluticasone propionate and salmeterol) has already expired, but manufacturing a bioequivalent combination of the two in an inhaler apparently will take time. So GSK is covering its successful bet on Advair Diskus with Breo Ellipta.
The new combination, which includes a new long-acting beta agonist (vilanterol), has the major advantage of requiring only one dose per day, compared to 2 doses required for Advair Diskus and other inhaled corticosteroid/LABA combinations. But it is not clear whether Breo Ellipta is as effective as the older combinations, and it has not been approved for use in asthma, which is a large part of the market for Advair Diskus. One reason is that there has been some concern for many years about the safety of long-acting beta agonists in asthma, although giving it with an inhaled corticosteroid seems to be safe. Still, the FDA may be a little skittish about approving a brand new LABA for use in asthma.
“The Pink Sheet” also provides some interesting information on another subject we usually don’t get into: negotiations between the pharmaceutical manufacturer and the health insurance companies on the place of new drugs in their formularies, which many insurers have farmed out to pharmacy benefit managers. And they are giving GSK even more to worry about. CVS Caremark Corp. has said it will not include Breo Ellipta on its formulary starting January 1, 2014, and Express Scripts, which controls the formulary for 30 to 40 million members of health plans, is planning to exclude both Breo Ellipta and Advair Diskus from its 2014 formulary. That may change, though, as negotiations progress. This industry knows how to get things done.