Mylan Launches Advair Generic Wixela At 70% Discount To GSK's Branded Drug List Price

Two weeks after the product's approval, Mylan finally has launched Wixela and revealed a big price cut for the asthma and COPD medicine over the brand; the actual savings for patients remains dependent on payer negotiations and other factors.

Mylan NV launched Wixela Inhub (fluticasone propionate/salmeterol), its US generic version of GlaxoSmithKline PLC's Advair Diskus, on Feb. 12 at prices it claims are a 70% discount to the brand name product's costs and 67% below a recently launched authorized generic.

It remains to be seen what the actual cost will look like in terms of the net price for Mylan and for payers after rebates or other discounts, and in terms of out-of-pocket costs for asthma and chronic obstructive pulmonary disease (COPD) patients, given the variables involved in drug pricing and reimbursement. In the competitive respiratory space, Advair and other inhalers generally are highly discounted.

However, SVB Leerink analyst Ami Fadia suggested in a same-day note that the net price for Wixela will be 20%-40% below the net price for Advair.

Mylan's launch and pricing announcement came nearly two weeks after the Jan. 30 US FDA approval of Wixela – the final blow to GSK's Advair revenue, since generics of the drug-device combo for asthma and COPD have been available in Europe since 2014.

The generics maker is likely to have at least one year without a competitor in the US aside from branded Advair and an authorized generic launched by GSK's partner Prasco Laboratories on Feb. 8. Novartis AG's generics subsidiary Sandoz Inc. and Hikma Pharmaceuticals PLC both anticipate launching their own Advair generics in 2020, following delays caused by FDA-issued complete response letters. (Also see "Mylan’s Nod For US Advair Rival Puts It A Year Ahead Of The Pack" - Generics Bulletin, 31 Jan, 2019.)

Nevertheless, Mylan is moving forward with what appears to be an aggressive discount for Wixela – the launch of which also was delayed by a complete response letter due to the complexity of duplicating GSK's drug. (Also see "Mylan Sees Generic Advair Marathon Nearing FDA Finish Line" - Scrip, 6 Nov, 2018.)

The wholesale acquisition cost (WAC) of Wixela is $93.71 for the 100 mcg/50 mcg dose, $116.44 for 250 mcg/50 mcg and $153.14 for 500 mcg/50 mcg. These prices are 70% lower than GSK's Advair WACs of $317.05, $393.93 and $518.10, respectively. Mylan claims that Wixela's list price also is 67% below the WACs for Prasco/GSK's authorized generic.

The company may be looking to launch aggressively having learned some lessons from the launch of other complex generics, notably the 40 mg version of Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer), for which it struggled to gain market share. Mylan later ended up taking a steeper 60% price cut on its version of glatiramer to make bigger inroads into the market. (Also see "Mylan To Explore Strategic Options, Claiming Investors Have Failed To Appreciate The Value " - Scrip, 8 Aug, 2018.) Launching high barrier-to-entry complex generics hasn't always proven to be as straightforward as some players have hoped.

Mylan Chief Commercial Officer Tony Mauro noted in the company's statement about Wixela's launch that the discounted list price reflects conversations with customers about the need for an Advair generic with a cost that increases affordability across the US health care system.

The company separately told Scrip that it expects Wixela to be placed on payer formularies on a generic tier, but that out-of-pocket costs for individual patients will depend on their health insurance plans.

External Forces Will Shape Wixela's Final Price

The actual price reduction relative to the branded product is debatable, given the various forces that influence the final price paid by patients at the pharmacy counter, including negotiations with pharmacy benefit managers (PBMs) and other payers, as well as agreements with distributors, wholesalers and retailers.

Mylan was careful to note in its pricing announcement that the WAC for Wixela "does not necessarily reflect the price paid by consumers, pharmacies or third-party payers."

Indeed, SVB Leerink's Fadia wrote in a Feb. 12 note that "while Mylan's list price for generic Advair Diskus (Wixela Inhub) at a 70% discount to brand appears aggressive, we estimate that it is at a 20% discount to the net realized brand price," which could grow to a 40% discount to Advair net price with additional rebates and discounts.

"We believe this would be an appropriately aggressive pricing approach to pick up share, given that GSK launched an [authorized generic] and we do not anticipate additional generics until 2020," the analyst said. "We now see this market evolving like a traditional generic market and continue to believe that Wixela could drive >$200m in sales and ~$0.20 in EPS in 2019."

By year-end 2019, Fadia predicted, Wixela and the Prasco-launched authorized generic are likely to split the Advair market 50-50 with GSK realizing little revenue from its branded drug.

GSK acknowledged the authorized generic's launch in a statement that hints at its appeal to the FDA not to approve Wixela, since the Mylan product label's patient instructions for use differ from the Advair instructions.

"The authorized generic will be manufactured by GSK and distributed by Prasco LLC. The authorized generic contains the same medicines in the same Diskus device familiar to patients with the same instructions for use as Advair Diskus.

"We recognize that generic medicines are an important part of the lifecycle of a medicine. GSK supports the availability of high-quality generic drugs that have met regulatory requirements, and in which the public can have confidence after the branded product loses exclusivity.

"Our goal is to ensure that patients continue to have access to the medicines in Advair, in the Diskus device that is familiar to them either in branded or generic form."

As for what impact Wixela and the authorized generic will have on other asthma and COPD drugs' sales, it's unclear how willing doctors will be to switch from a branded medicine that's working well for patients with severe respiratory diseases to a lower priced generic, especially when actual out-of-pocket costs for patients aren't known.

AstraZeneca PLC told Scrip that "we do not anticipate impact to Symbicort based on the entry of the generic version of Advair Diskus. Of course, treatment decisions should happen between a patient and their physician. Advair Diskus and Symbicort are two different medicines. Each product contains a different combination formulation of an [inhaled corticoid steroid (ICS)] and [long-acting beta agonist (LABA)] medicine in a single inhaler."