AbbVie's Humira needs a discount, ICER says, warning Lilly, Sanofi to price with care

AbbVie's megablockbuster Humira, which brought in more than $16 billion in 2016, would need to win coverage at 50% or more off list price to be cost-effective, a new report stated.

The best-selling drug in the world isn’t worth its current price—and isn’t as good at its job as two of its potential competitors. That’s the conclusion of the Institute for Clinical and Economic Review, a cost-effectiveness watchdog, which evaluated rheumatoid arthritis drugs and found AbbVie’s Humira wanting.

AbbVie takes issue with the assessment, and it’s unlikely to have much impact on Humira’s hefty sales, at least for now, Evercore ISI analyst Umer Raffat concluded over the weekend. It might, however, affect pricing decisions on forthcoming novel meds—and the case for those novel meds with payers. It might also affect pricing on Humira biosimilars when they make their debut, and AbbVie’s competitive stance when that happens.

Overall, ICER found that immune-modulating RA drugs, from TNF-alpha inhibitors onward, work better than older therapies such as methotrexate. Pricing, however, earned a lower grade under quality-adjusted life year (QALY) analysis; “not surprisingly [ICER concluded] that most exceed traditional cost/QALY thresholds,” Piper Jaffray analysts said in their weekly industry report.

Of the TNF-alpha drugs, Humira (adalimumab) had the highest per-QALY cost at $232,644, with Remicade (inflixumab) from Johnson & Johnson coming in lowest at $202,824. The lowest overall was Roche’s Actemra (tocilizumab), an IL-6 inhibitor, with a $168,600 per-QALY cost.

Perhaps more surprising were ICER’s comparative effectiveness analyses. Humira got a “C” rating, Raffat noted, where ICER’s thumbs up for “moderate certainty of incremental or better benefit” generally stands at a B+.

To be cost-effective, Humira’s net price would need to be at a 50% to 69% discount to list price, the report said. None of its competitors, TNF-alpha or otherwise, hit ICER’s benchmark for value.

However, as Raffat pointed out in his note, ICER assumed a particular net price for Humira—$40,415 per year—that may or may not be accurate. Contacted by the analyst, AbbVie itself said ICER's methodology had "significant flaws"; it considered a limited number of trials and endpoints, for instance. And according to at least one payer cited in the note, "legacy products with large existing patient base(s) may not be as directly impacted near-term," he wrote.

As the behemoth in the field, Humira has been chosen as a comparator in many clinical trials of meds newer to the RA field. Pfizer’s Xeljanz (tofacitinib), approved in 2012 for RA, matched Humira in effectiveness, ICER noted, based on head-to-head data. Amgen’s not-as-new Enbrel (etanercept) held up, comparatively, in lowering disease activity; UCB’s Cimzia (certolizumab) and Bristol-Myers Squibb’s Orencia (abatacept) matched up on a variety of measures.

Actemra did better, beating Humira at cutting disease activity and on one common assessment scale. And the newest meds did better still. They topped the AbbVie stalwart by three standards, lowering disease activity and two assessment tools. Eli Lilly’s baricitinib hit those marks, and Sanofi and Regeneron’s sarilumab, an IL-6 inhibitor, did the same.

ICER's evidence was reviewed by the New England Comparative Effectiveness Public Advisory Council, which voted on a variety of head-to-head matchups. As Raffat wrote in an investor note, “At least two new regimens got an 11-0 vote vs Humira on having a superior ‘net health benefit.’” Those would be sarilumab on the one hand and barictinib in combination with an older disease-modifying therapy on the other. Actemra also got a 11-0 vote.

Of course, the two yet-to-be approved meds, baricitinib and sarilumab, have no long-term history to their credit. But ICER said that, as monotherapy, “there is moderate certainty of an incremental or better benefit for sarilumab … compared with adalimumab.”

The margin was thinner for baricitinib, at least at this point, and in combination with methotrexate, ICER said. “[C]ombination therapy with baricitinib provided statistically significant but modest benefits over adalimumab, yielding a ‘comparable or better’ rating,” the report states, based on a single clinical trial.

Raffat pointed out that these two conclusions cover monotherapy treatment, not combination therapy with methotrexate, “which happens to be a major chunk of how Humira is used in this setting.”

Both of those drugs have yet to hit the market. The FDA delayed its baricitinib ruling in January, putting its new decision date at mid-April. Sanofi and Regeneron’s sarilumab received a dreaded complete response letter, based on manufacturing problems, last October; those issues have since been corrected and a decision is now expected this quarter.

It’s important to note that those QALY figures aren’t prices, but a calculation of the cost-effectiveness and improvements in patient quality of life. ICER assumed net prices of those drugs at $40,415 annually for Humira, $28,906 for Remicade and $21,861 for Actemra.

Editor's note: This story was updated to show sarilumab is an IL-6 inhibitor, rather than an IL-4/IL-13 inhibitor. Pfizer's Xeljanz was first approved for RA in 2012, with a new formulation approved last year.