Humira Competitors Don’t Guarantee Lower Patient Drug Costs

The introduction of seven alternatives to AbbVie Inc.‘s blockbuster drug Humira in July will be the most important test to date on whether market competition can bring down what patients pay for expensive biologics, advocates and drug pricing analysts say.

The wave of biosimilars for the anti-inflammatory treatment, which can cost more than $80,000 annually, marks the most competitors to date for a single biologic drug in the US. Drug pricing analysts and researchers predict other brand-name biologic makers could use this model to avoid government price negotiations under the Inflation Reduction Act. The law allows companies to avoid negotiations if their product faces competition from generics or biosimilar products.

But whether there’s enough competition to actually drive down prices is another question, analysts and patient advocates say. The level of savings patients experience for Humira or biologics in other disease areas will depend heavily on the prices these manufacturers set compared to the brand-name version, the level to which patients switch to these alternatives, and whether health insurers adopt policies that promote the use of these treatments.

What happens for Humira, also known as adalimumab is key, industry members and analysts say, because a lack of market entry and competition here could discourage investments in biosimilars, potentially putting patients at risk of losing out on additional life-saving, less expensive treatments.

“Put the IRA on top of the Humira experience, everything is like piling on as to whether or not biosimilars will continue, which would be disastrous for competition in this marketplace overall moving forward,” said Juliana M. Reed, executive director of the Biosimilars Forum, whose members include Boehringer Ingelheim, Coherus BioSciences, and other manufacturers behind some of the Humira alternatives.

‘An Inflection Point’

Biologic products are derived from human, animal, or microorganism sources, and include vaccines, gene therapies, tissues, and recombinant therapeutic proteins. Adalimumab is a monoclonal antibody, or lab-developed protein, designed to target a specific protein associated with several inflammatory conditions, including rheumatoid arthritis, psoriasis, and Crohn’s disease.

Biosimilars are not exact replicas of a brand-name biologic, but are close enough that they lead to the same clinical outcomes. One of the versions that launched July 1—Boehringer‘s Cyltezo—is “interchangeable” with Humira, meaning a pharmacist can swap out the two for a patient without prior approval from a health provider.

Coherus also launched its biosimilar Yusimry earlier this month, and announced a partnership with Mark Cuban’s Cost Plus Drug Company that will allow the company to sell the product directly to patients at at an 85% discount from Humira’s list price.

The launches this month are “more of an inflection point in the market compared to what we saw in January when Amjevita came to market,” said Alex Brill, founder and CEO of economic policy consulting firm Matrix Global Advisors, referring to Amgen Inc.'s product that became the first Humira biosimilar earlier this year.

Some of the top pharmacy benefit managers—the entities that manage prescription drug coverage for health plans and others—have announced plans to cover these Humira rivals.

The Cigna Group’s Express Scripts said July 10 that it would cover Cyltezo, as well as Sandoz ‘s Hyrimoz and the company’s unbranded version, on its national preferred formulary—list of covered drugs—alongside Humira. And OptumRx, owned by UnitedHealth Group, is also covering those same products, in addition to Amjevita, in its standard formulary.

Test for Biosimilars

Even with the large number of Humira biosimilars on the market, a major factor at play is whether patients and prescribers will want to switch from using Humira, which for years has used multiple patents to delay market competition.

“As a patient, if I’m taking a drug like Humira and it’s working well for me, and it doesn’t produce bad side effects, I am not interested so much in switching unless there’s a big financial incentive to try another drug,” said David Mitchell, founder of advocacy group Patients for Affordable Drugs Now.

AbbVie also creates incentives for patients by promising them savings though a Humira Complete Savings Card, which the company says allows users to pay as little as $5 per month for the treatment.

This “fits that bill of making the patient indifferent in some way to using the brand or using that biosimilar,” said Rena Conti, a health economist and associate professor at Boston University’s Questrom School of Business.

The biosimilars must also compete with AbbVie in offering enough rebates to get better placements on a health plan’s formulary. While Express Scripts and OptumRx are covering some biosimilars, they are covered at the same level as Humira, which analysts say won’t do much to encourage uptake over the branded version.

“A preferred positioning on the formulary would help them more than parity that they’re getting,” Brill said.

Which biosimilar is available to patients can also hinge on decisions made by a specialty pharmacy, which often fills adalimumab and other treatments for serious conditions, said Craig Burton, executive director of the Association for Accessible Medicine’s Biosimilars Council. AAM represents members of the generic and biosimilar industry.

“This is going to come down to a decision of what is the specialty pharmacy stocking and dispensing, and in most cases, that specialty pharmacy is closely tied in with a PBM,” Burton said.

Avoiding Negotiations

The IRA, which gave Medicare the authority to negotiate the prices of some of the drugs it spends the most on, is likely to push biologic manufacturers to allow more competition in order to avoid government-mandated price cuts, analysts predict.

“That strong incentive to delay biosimilar competition in perpetuity for as long as you possibly can doesn’t exist now with the IRA,” said Conti, who until recently served as an adviser to the CMS on implementation of the IRA’s drug pricing provisions.

Instead, companies may enter agreements that limit competitors’ market share, or continue offering higher rebates to PBMs or other incentives that continue to push patients toward the brand-name product, Conti said.

Updated guidance from the Centers for Medicare & Medicaid Services clarified that when analyzing whether a drug is eligible for negotiation, the agency will determine “whether a generic drug or biosimilar is marketed on a bona fide basis” based “on a totality of the circumstances,” including prescription drug event data and average manufacturer price data reported by manufacturers.

Meena Seshamani, CMS deputy administrator and director of the Center for Medicare, said at a Protect Our Care event in Washington July 10 that she couldn’t commit to a specific percentage of the market biosimilars must take up in order to be considered competitive.

“The various drugs all have nuances to them, the markets are different, the patient populations are different, the combinations of different drugs that may be utilized are different,” she said.

Reed agreed that it’s difficult to set one threshold for the entire biosimilar industry to follow. But more is needed to ensure market entry is bringing true competition, she said.

“If you take a decade to develop one and you launch it and you have no access to the market, you have to as a company reconsider that decision,” Reed said.