From Drug Benefit News

Payers Brace for Asthma Shakeup as FDA Eyes Third Advair Generic

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By Jane Anderson
November 24, 2017Volume 18Issue 22

GlaxoSmithKline’s Advair (fluticasone propionate and salmeterol) continues to dominate the market for asthma and chronic obstructive pulmonary disease (COPD) medications. But payers and patients may see relief on the horizon with a possible generic alternative plus additional approvals for the increasingly crowded drug class, potentially leading PBMs to re-evaluate formulary status for various medications in the class.

Two pharmaceutical manufacturers have struck out so far in their applications to make a generic of Advair — the FDA delayed approval of Mylan’s version and in May decided not to approve Hikma Pharmaceuticals’ entry. The agency accepted the submission from Novartis’ Sandoz unit for a generic Advair in June but has not yet announced a decision. Generic Advair is available in Europe.

Meanwhile, Teva Pharmaceutical Industries Ltd. launched its competing AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation device in April (DBN 5/5/17, p. 1) simultaneously with AirDuo’s authorized generic, which is priced at a steep discount to Advair.

The drug is not a generic substitute for Advair — it uses the same active ingredients, but is considered a brand-name alternative, since the ingredients are in different doses. In addition, AirDuo RespiClick has different indications — it’s approved only for asthma patients ages 12 and up, while Advair also is approved for younger asthma patients (ages four and older), as well as for chronic obstructive pulmonary disease patients.

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

Teva also launched its ArmonAir RespiClick (fluticasone propionate), which uses the same active ingredient as the asthma inhaler Flovent. Again, the Teva product is not a generic: ArmonAir is approved for asthma maintenance treatment in patients 12 years old and up, while Flovent is approved for asthma maintenance treatment in patients four years and up.

ArmonAir RespiClick, meanwhile, sells for around $167 for a low dose and $225 both for medium and high doses, according to Flovent sells for around $175 for a low dose, $235 for medium and $363 for high, according to “Average wholesale price is very similar between ArmonAir and the Flovent products,” says April Kunze, Pharm.D., senior director, clinical formulary development and trend management strategy for Prime Therapeutics LLC.

Meanwhile, GlaxoSmithKline won FDA approval on Sept. 18 for a triple-therapy inhaler, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), to treat COPD. About one-quarter of COPD patients already use the three drugs separately, according to GSK, which says Trelegy Ellipta will be available in the U.S. “shortly.”

Drug Benefit News

Multiple Generics Will Bring Down Price

One generic alternative for Advair may not bring down prices much, since increased rebates for the brand could offset moderate generic savings. But two or more generics could bring prices down significantly. Advair sales and revenues have been declining worldwide, according to GSK, which has been bracing for a U.S. generic.

“Often, with only one generic entry, the net cost of the original brand is less expensive than the generic,” Kunze tells AIS Health. “In general, costs do not drop substantially until there are multiple generics available or a brand entry comes to market at a significantly lower cost and can move market share. However, the launch of new products can open up the class for negotiation, which helps to drive costs down.”

“Advair was available on most formularies and continues to be available,” Kunze says. But “AirDuo RespiClick cannot be directly substituted for Advair and is not approved for all populations that Advair is currently approved for. Prime added the authorized generic formulation of AirDuo RespiClick to most formularies.”

Kunze says the Teva authorized generic “is covered in the lowest brand tier or the generic tier for many of our formularies. The cost of the authorized generic was significantly less than AirDuo RespiClick as well, therefore Prime did not recommend coverage of Teva’s brand product. Advair remains in a preferred brand tier for many of our formularies as well.”

That tracks with what Lynn Nishida, area vice president of pharmacy at Solid Benefit Guidance, is seeing. “No one as far as I can see has been really aggressive in moving Advair onto exclusion lists, although some might be fiddling with putting it on a higher tier,” Nishida tells AIS Health. “They’re kind of tip-toeing around this, so it isn’t creating a disruption in the market just yet.”

For example, she says, UnitedHealth Group’s OptumRx listed Teva’s AirDuo authorized generic as a preferred option on its generic tier and Advair in Tier 3 as non-preferred.

PBMs Cycle Products On and Off

Other companies have made changes in what is a fairly crowded class. For example, Nishida says, CVS Caremark added Symbicort (budesonide-formoterol fumarate dehydrate) back to its formulary beginning in 2018.

Symbicort, from AstraZeneca Pharmaceuticals, is indicated for patients six years or older who have asthma that’s not controlled by inhaled corticosteroids and for patients with COPD. “It’s not unusual to see on-again, off-again,” Nishida says. “As far as PBMs go, they’re not scared anymore to take things on and off” from year to year, “as long as they’re considering how to do good transitions for members.”

Meanwhile, Teva is treating ArmonAir and AirDuo as brand-name products, she says. “They’re both good options, but because Advair has been out there and people just like the device, it shows in the market share,” Nishida says, adding that the AirDuo authorized generic is treated as a generic on formularies. In addition, physicians might prescribe AirDuo off-label for non-approved indications (but ones for which Advair is approved), Nishida says, warning “plans and payers just need to be ready” for that possibility.

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