Many Targeting AbbVie’s Top-selling Drug, the High Profit of Humira Will Not Continue

The best-selling drug in the world: Humira does not look good anymore. The assessment results of ICER, a cost-effectiveness watchdog, are that: Humira isn’t worth its current price. "AbbVie takes issue with the assessment, and it’s unlikely to have much impact on Humira’s hefty sales, at least for now", said Evercore ISI analyst Umer Raffat. However, it might affect the pricing on Humira biosimilars which are to be marketed, and AbbVie’s competitive edges and market shares will also be affected by the lower priced biosimilars.

Immune-modulating RA drugs have, from TNF-alpha inhibitors onward, worked better than older antirheumatic drugs such as methotrexate, however, their pricing earned a lower grade under quality-adjusted life year (QALY) which is a comparative effectiveness analysis method.

Regarding this, market analyst Piper Jaffray said in his weekly industry report, "not surprisingly, Humira’s price has already exceeded the QALY model for traditional drug cost calculation."

QALY is not the drug use price, and can be roughly understood as the money costed by patients to keep healthy and improve life quality.

Of the TNF-alpha drugs, Humira has the highest per-QALY cost at USD 232,644, with Remicade (infliximab injection) from Johnson & Johnson coming in lowest at USD 202,824. The lowest overall is Roche's Actemra (tocilizumab), with a $168,600 per-QALY cost.

In this way, Humira got a "C" rating in the comparative effectiveness analysis while general salable drugs stand at "B+".

To be cost-effective according to the report of the watchdog, Humira’s price would need to be 50% to 69% lower, to contend against its circling rivals.

However, AbbVie had objection to the above, "ICER's methodology had significant flaws; as the ‘behemoth’ in the antirheumatic field, our product has been chosen as a comparator by various institutions, such as a comparator to Pfizer’s Xeljanz (RA drug approved in 2012), Amgen’s Enbrel, UCB’s Cimzia, and Bristol - Myers Squibb’s Orencia; but the market shares of Humira represent the market recognition for our drug."

ICER's evidence was reviewed by the New England Comparative Effectiveness Public Advisory Council, which voted on a variety of head-to-head matchups. Three new regimens got an 11-0 vote, and two therein had "a superior net health benefit, and cost less to obtain same health" compared to Humira.

They were separately Sanofi’s Sarilumab and Eli Lilly’s Barictinib. Roche’s Actemra also got a 11-0 vote despite not having a significant health benefit. Certainly, Baricitinib and Sarilumab have not been approved to be marketed, however, the monotherapy using Baricitinib provided a better statistical edge over adalimumab, the main component of Humira, yielding a "comparable or better" rating in ICER’s rating system.

The analyst Raffat pointed out, "This conclusion covers monotherapy treatment, not combination therapy of Humira’s adalimumab with methotrexate".

 "Baricitinib and Sarilumab have yet to hit the market. The FDA delayed its Baricitinib ruling in January 2017, putting its new decision date at mid-April. Sanofi received a letter on serious problems of Sarilumab based on manufacturing, which have been corrected, and a decision of FDA is now expected this quarter."

From the fierce price competition of biosimilars, Humira will slowly step down the "throne" of top sales in the following years, like other "predecessors". The new best-selling drug will emerge several years later, and AbbVie needs to make the final choice among the profit, pricing and market share.