Breo Ellipta inhalerThe estimated 24 million Americans suffering from chronic obstructive pulmonary disease (COPD) have a new pharmacologic treatment option available to them. BREO ELLIPTA, a combination of the inhaled corticosteroid (ICS) fluticasone furoate “FF” and the long-acting beta2-agonist (LABA) vilanterol “VI” (FF/VI 100/25 mcg), is now available to pharmacies throughout the country.

The product is intended for the long-term, once?daily, maintenance treatment of airflow obstruction in patients with COPD, and also to reduce exacerbations in patients with an exacerbation history. The product is manufactured by GlaxoSmithKline (GSK) and Theravance Inc.

“We’re excited about the launch of BREO ELLIPTA because it offers the new once-a-day ICS/LABA combination,” said Jorge Bartolome, senior vice president of GSK Respiratory Business Unit in the United States. “It offers a sustained 24-hour lung function improvement for patients and the ability to manage and control their COPD for a full 24-hour duration, with one inhalation.”

The product received FDA approval in May 2013 and became available in late October, meaning physicians can now prescribe the drug for appropriate patients with COPD.

According to Bartolome, the wholesale acquisition cost for BREO ELLIPTA is $267 per device, which includes 30 once-daily inhalations. Bartolome noted that the cost to the patient will vary depending on factors such as the price set at the pharmacy, or the patient’s healthcare plan. The treatment also will be available for hospital and clinical use; these units will include 14 once-daily inhalations.

As of October 23, 2013, the product has yet to be covered under Medicare Part D, but GSK is working to secure coverage, which he said was important due to the large population of COPD patients who fall under Part D. “Our contracting organization is negotiating with all of the key payors around the country, including commercial and Part D Medicare payors,” Bartolome said. “They are making very good progress, so we should be building payor coverage, including Part D, over the coming weeks.”

The BREO ELLIPTA launch also introduces GSK’s new platform device, the ELLIPTA inhaler. “This is the first time we’re launching an inhaler that has dual strips inside the mechanism — so that’s important because unlike the current dry-powder inhaler delivery devices, for GSK the DISKUS device, which has one inhalation strip, ELLIPTA has two inhalations that mix within the device on actuation,” Bartolome said. “It allows us to better optimize the two medicines that go into the device.”

ELLIPTA also plays a role in GSK’s future pharmaceutical offerings. “It’s the backbone for [our respiratory medication pipeline],” he said. GSK currently has three new products under review at the FDA, including ANORO ELLIPTA, which could be the first dual-bronchodilator LABA/LAMA combination in the United States. GSK also filed in October for a new ICS monotherapy for the treatment of asthma, using the ELLIPTA device.

“What it tells you is that the R&D investment that GSK has been making in the respiratory space is bearing fruit. BREO ELLIPTA will be the first of those, but we have the others under review at the FDA, and we have some future products also under development for future filing,” Bartolome said. RT 


Mike Fratantoro is the managing editor for RT Magazine. Contact him at mikefrat@allied360.com