Radar on Specialty Pharmacy

Although the FDA has approved five biosimilars of Regeneron Pharmaceuticals, Inc.’s best-selling Eylea (aflibercept), patent infringement lawsuits by the drugmaker have successfully kept those competitors off the U.S. market — until now. Following a successful defense of its Pavblu (aflibercept-ayyh), Amgen Inc. recently launched the drug at risk. The agent is entering an increasingly crowded therapeutic class, but it’s one that’s also costly for payers, which may be seeking some savings, say industry experts. But is its price good enough to pull market share?

Pavblu has approval for all of Eylea’s indications — neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) — except for retinopathy of prematurity. Among the vascular endothelial growth factor (VEGF) inhibitors approved for ocular use, Eylea is the only one with that indication on its label.

The first biosimilar of Regeneron Pharmaceuticals, Inc.’s Eylea (aflibercept) recently hit the U.S. market when Amgen Inc. launched Pavblu (aflibercept-ayyh). The drug is entering a crowded class that includes a compounded drug used off-label, as well as a high-dose formulation of Eylea. But it’s unclear how much both agents may be used going forward.

A compounded formulation of Roche Group unit Genentech USA, Inc.’s Avastin (bevacizumab) is the least expensive option within the class. It has undergone clinical trials supporting its use in eye disorders, but Genentech has not applied for approval of the indications. For ocular use, it costs about $50 per injection compared with around $1,500 to $2,000 for the other treatments.

Almost one year after the FDA put its approval decision on hold, Lilly has finally crossed the finish line with Ebglyss (lebrikizumab-lbkz). The approval means another option for the treatment of atopic dermatitis, a therapeutic class that is seeing more and more entrants. And while the agent’s mechanism of action is not novel, as it is shared by others within the class, that may give payers the ability to be more aggressive in their rebate negotiations, says one industry expert.

On Sept. 13, the FDA approved Ebglyss for the treatment of people at least 12 years old who weigh at least 40 kg with moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription medications or when those medications are not advisable. Dosing for the interleukin-13 (IL-13) antagonist is 500 mg via two 250 mg subcutaneous injections at weeks zero and two and then 250 mg every two weeks until week 16 or later, when an adequate clinical response is achieved. At that point, maintenance dosing is 250 mg every four weeks.

How the FDA fares during President-elect Donald Trump’s second term will depend, in part, on the pharmaceutical industry’s support for the agency and its staff, Commissioner Robert Califf told the Friends of Cancer Research annual meeting on Nov. 12.

Califf’s second term as commissioner will end when Trump takes office in January.

“This not the first time I’ve ridden out of town after an election,” he joked.

Califf said the incoming administration clearly is intent on changing a lot of things, but “how it gets changed depends on who gets appointed to the key positions and how the various policies play out.”

Medical benefit per-member per-month (PMPM) trend continued to increase last year in commercial, Medicare and Medicaid lines of business. That’s one of the findings from Prime Therapeutics LLC’s 14th annual Medical Pharmacy Trend Report, which also unsurprisingly revealed that oncology is the top category of PMPM spend in all three lines of business. And while biosimilars continue to pull share from their oncolytic reference drugs, next year may be the first year to see nononcology medical benefit biosimilars pick up share, pointed out an industry expert at a recent webinar.

Previously known as the Magellan Rx Management Medical Pharmacy Trend Report, the recently released report includes information on 2023 health plan paid claims data on provider-administered medical benefit drugs, which make up more than half of total drug spending in the U.S.