From Drug Benefit News

Teva Launches Brand Drug, Its Authorized Generic to Compete With Advair in Asthma

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By Angela Maas, Managing Editor
May 5, 2017Volume 18Issue 9

A recent launch by Teva Pharmaceutical Industries Ltd. could put a dent in GlaxoSmithKline plc’s Advair (fluticasone propionate and salmeterol) U.S. market share. While not a substitutable generic, AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation contains the same active ingredients as Advair. Teva launched the drug — which the FDA approved in January — on April 20 simultaneously with AirDuo’s authorized generic, which is priced at a steep discount to Advair, in one of the top classes in terms of payer spend. The new drugs could give payers some cost-saving options ahead of Advair generic competitors potentially receiving FDA approval.

In Express Scripts Holding Co.’s 2016 Drug Trend Report, released in February, the asthma class ranked No. 10 in 2016 per-member per-year spend across the top therapy classes overall, with a $30.42 PMPY spend. Advair Diskus’ cost and utilization both increased, giving it 19.3% of PMPY spend for the class. The PBM anticipated that “overall trend will increase slightly” this year, followed by a decline assuming FDA approval of generic versions of Advair Diskus.

Mylan N.V. had hoped to be the first of those generics to launch in the U.S., but on March 29, the FDA rejected its application. A decision on Vectura Group plc and Hikma Pharmaceuticals PLC’s generic is expected this month, and other manufacturers have generic versions in development.

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AirDuo was approved through a New Drug Application (NDA), meaning it is a brand drug, not a generic, so therefore it is not directly substitutable by a pharmacist for Advair. But the other companies have submitted abbreviated NDAs for FDA approval as generics. If granted, these products would be A/B rated, meaning they are therapeutically equivalent to the brand and thus substitutable for it.

According to Umer Raffat, an analyst at Evercore ISI, a low dose of Advair costs $291, a medium dose $361 and a high dose is $475. All three doses of AirDuo will cost $285, and the authorized generic will cost $90 for all three doses.

Among similar drugs, low and medium doses of Symbicort (budesonide and fomoterol fumarate dihydrate) cost $270 and $309, while the same doses of Dulera (mometasone furoate and formoterol fumarate dihydrate) are both $291, and those doses of Breo Ellipta (fluticasone furoate and vilanterol) are $322.

Raffat said during an April 21 webinar that Teva had made “a very sophisticated and very shrewd move” by using two different price points for its products. By concurrently launching AirDuo RespiClick and its authorized generic, Teva is “using a very unique approach,” he maintained.

“This will clearly be a very important launch for Teva,” Raffat said in an April 20 research note. The inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) class had sales of approximately $4.5 billion in 2016, he said, noting that “Advair is the biggest — about half of total … followed by Symbicort at a third of the total.”

“Advair is still among the top key drivers of cost for payers among their non-specialty (traditional) drug spend,” points out Lynn Nishida, area vice president of pharmacy at Solid Benefit Guidance. The Teva product, she tells AIS Health, “will become another competitive player in the ICS/LABA market.”

At Prime Therapeutics LLC, “Advair is in the top 15 drugs by drug spend for Prime’s book of business,” says April Kunze, Pharm.D., senior director, clinical formulary development & trend management strategy for Prime Therapeutics LLC. “Respiratory is a class with very little generic competition; thus, competition within the class is significant.”

While AirDuo has the same active ingredients as Advair, they are “in different doses with different indications,” explains Kunze. “AirDuo RespiClick is only indicated for asthma patients (ages 12 and older), while Advair is also indicated in chronic obstructive pulmonary disease (COPD) and for a younger population with asthma (ages 4 and older). Prime will be reviewing this product as a new-to-market drug, evaluating the clinical trials for safety and efficacy relative to the other combination products for asthma and COPD. The launch of the authorized generic at a lower price point than branded Advair or AirDuo may be an appealing option for both the health plan and the member. Prime is evaluating the best clinical and financial position for this new entrant.”

Kunze tells AIS Health that the authorized generic “will likely pull some market share from Advair due to its cost; however, Teva’s product is more limited in its patient population and indication. Additionally, Advair has significant brand recognition and a lot of utilization across all books of business. Although A/B rated generics can more easily move market share due to substitution laws, the lower price point of this product may be enough incentive to move some members to the new product. Ultimately, health plan coverage determinations between the two products (Advair and AirDuo) will likely have a greater influence on market share movement.”

“As a fixed dose combination product containing the same active ingredients as Advair,…it is not A/B rated and thus unfortunately not interchangeable with Advair,” says Nishida. That said, “Payers will likely be open to this product. However, for those plans who currently prefer Advair, they are likely receiving rebates as well.” So AirDuo’s price and “competitive contracting that will incentivize payers to consider AirDuo as a preferred product in lieu of Advair will be very important, just like the many other ICS/LABAs on the market.”

“The price difference will result in the evaluation of rebates, implementation of new utilization management programs, tiering considerations and potential drug exclusions,” Kunze says. “Payers will need to consider the pricing between the two products and their ability to move market share from Advair to AirDuo with these strategies.”

According to Nishida, “Payers will often look for deep discounts that make it worth their while to transition members off of Advair. AirDuo will likely be one of these cases.”

And what about the companies working on generic versions of Advair? “The A/B rated manufacturers still want to come to market,” says Kunze. “However, they may need to lower their pricing more than they anticipated.”


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