Coalition Opposing the Merger

The coalition includes Families USA, Public Citizen, U.S. PIRG Education Fund, Service Employees International Union, American Federation of State, County, and Municipal Employees, UNITE HERE, Consumer Action, American Federation of Teachers, Alliance for Retired Americans, American Family Voices, Doctors for America, End AIDS Now, Prescription Justice, Social Security Works, the Other 98, Treatment Action Group, and NextGen California.  It is asking the FTC to conduct a thorough investigation and to block the merger if the facts support it and a remedy cannot be devised to restore competition.  The coalition highlights the competitive problems arising from continued consolidation in the pharmaceutical industry and requests that the FTC include in its investigation ongoing anticompetitive conduct by the parties, such as the use of rebate walls, which will have an even more profound anticompetitive effect if this merger is consolidated, as well as past abuse of the patent system.

The letter makes three points.

First, the merger of AbbVie and Allergan will continue a tremendous trend of consolidation and the evidence shows that consumers are paying higher prices and losing out on access and choice because of less innovation by big pharma companies.  Mergers result in fewer choices for consumers, and drug companies are increasingly spending their money on acquisitions instead of research and development.

Second, the merger will reduce competition in a number of markets where the companies directly overlap with each other.  The coalition underlines an overlap between AbbVie’s blockbuster, Humira, which already treats 10 indications including Crohn’s disease and ulcerative colitis, and its new IL-23 blockbuster, Skyrizi, which is currently marketed to treat moderate to severe psoriasis but is being investigated to treat Chron’s disease and ulcerative colitis, with Allergan’s brazikumab, an IL-23 inhibitor that is currently being investigated to treat Crohn’s disease and ulcerative colitis.  The coalition further points out that the FTC’s policy is to accept divestitures of actually manufactured pharmaceutical products over pipeline products.

Third, the merger will exacerbate competitive problems that already exist in the pharmaceutical drug industry relating to rebate walls and patent abuses.  The coalition requests that the FTC not limit its investigation to direct product overlaps because the combination of AbbVie’s and Allergan’s blockbuster drugs will enable AbbVie to engage in a whole range of potentially anticompetitive conduct to hamper the ability of rivals to compete.  Indeed, both manufacturers have previously engaged in anticompetitive behavior to prolong their monopolies, suppress competition and raise prices.  The coalition points out, for example, that the merger would enable AbbVie to increase its bargaining leverage over payors to use exclusionary practices such as rebate walls to limit the ability of rivals to expand and enter.  It underscores that both AbbVie and Allergan have used rebate walls to stifle competition in the past.

Families USA, one of the groups that signed onto the letter, said, “The proposed acquisition of Allergen by AbbVie will combine two companies that independently engage in anticompetitive practices that make prescription drugs unaffordable for families into one mega corporation.  We urge the FTC to carefully consider the impact of this proposed drug company merger on competition and prices and protect access to critical medicines for consumers.”  And Peter Maybarduk, Access to Medicines Director for Public Citizen, said, “Two leading price gouging patent manipulators unite.  AbbVie is notorious for manipulating its patent power over the blockbuster medication Humira and AIDS drugs like ritonavir, keeping affordable generics off the market and even slowing innovation.  Allergan is notorious for hiding its patents behind the sovereign immunity of a Mohawk tribe.  Unless the FTC steps in, we can look forward to new efforts to destroy competitive markets by the pharma giant that emerges from this deal, in an industry increasingly focused on monopolizing yesterday’s inventions instead of creating new ones.”

Rebate Walls

Pharmaceutical manufacturers have implemented a new strategy to block and delay entry of biosimilars and other drugs from the market through a contracting practice that creates what is known as a “rebate wall” or “rebate trap”.   A rebate wall occurs when a manufacturer leverages its market-dominant position to secure preferred formulary access for its products by offering lucrative incentives to pharmacy benefit managers (“PBMs”) and health insurers in the form of volume-based rebates.  These rebates are often offered across multiple products, indications, and therapeutic specialties, the breadth of which cannot be matched by new and innovative therapies.  The Trump Administration earlier this year sought to eliminate rebates from the Medicare prescription drug program because pharmaceutical rebates raise more profound competitive problems than discounts in other industries.  In fact, the coalition notes that there is increasing evidence that rebates actually inflate prices (as opposed to decreasing them) and that these rebates, unlike typical discounts, do not ultimately benefit consumers.

FTC is Currently Investigating Rebate Walls

On July 29, 2019, Johnson & Johnson (“J&J”) disclosed that the FTC issued a civil investigative demand regarding its investigation of whether J&J’s contracting practices related to its rebates for Remicade (infliximab) amount to exclusionary conduct illegal under the antitrust laws.

In 2017, Pfizer Inc. (“Pfizer”) filed a lawsuit against J&J for its contracting practices that protect Remicade’s position in the market and deny patients access to Pfizer’s infliximab biosimilar, Inflectra.  The lawsuit is still in the discovery phase.

Biosimilar developers have been urging the FTC to weigh in on whether exclusionary contracts for brands based on aggressive rebating strategies are legal and the agency has chosen a high-profile example to investigate.

Pfizer applauded the FTC’s investigation in a statement: “We believe the [FTC’s] decision to open an investigation into the competitiveness of the biosimilar is an important step, which we hope will lead to a robust, competitive marketplace for patients and physicians to access biosimilar medicines.”

Rebate Wall Concerns Were Raised in the FTC’s Investigation of Bristol-Myers/Celgene

On January 11, 2019, Rep. Peter Welch (D-VT) and Rep. Francis Rooney (R-FL) wrote a letter to the FTC, urging the agency to investigate Bristol-Myers Squibb Company’s (“Bristol-Myers”) acquisition of Celgene Corporation (“Celgene”).  The letter asked the FTC to examine how the acquisition allows Bristol-Myers to increase its drug portfolio and leverage over PBMs when negotiating preferred drug placement on formularies.  The letter argued that the larger the firm, the more it can use rebate walls to block more affordable and, in some cases, more efficacious products’ access to formularies.

Thoughts

The AbbVie/Allergan merger gives the FTC an opportunity to investigate the questionable contracting practice in the pharmaceutical drug industry known as a “rebate wall”.  Payors such as PBMs and health insurers obtain rebates on prescription drugs from pharmaceutical manufacturers that have actually inflated the price of drugs and stifled the ability of rival drug manufacturers to effectively compete.  This practice is recognized by both the administration and industry players as anticompetitive.  Department of Health and Human Services Secretary Alex Azar has noted that rebate walls can prevent competition and new entrants into the system.  Moreover, major drug manufacturers such as Pfizer, Shire, and Sanofi have filed antitrust suits challenging rebate walls as antitrust violations.  In theory, rebates could have a positive impact on the prescription drug market if they led to lower prices and benefitted consumers.  But, in practice, this is simply not the case.  Rebate walls distort the workings of the free market, result in higher drug prices, and reduce patients’ access to affordable branded drugs.

While rebates and discounts can be procompetitive if they lead to lower prices for consumers, some drug manufacturers are structuring discounts to limit competition from rivals in an effort to protect their monopolies.  The FTC understands that when a rebate wall is successfully erected by a market-dominant manufacturer, a payor faces strong financial disincentives to grant access to new and innovative therapies, as doing so would result in the loss of hundreds of millions in guaranteed rebate dollars for the payor.  This condition creates a “trap” for payers who would otherwise be inclined to grant formulary access to therapies that are newer and more innovative, yet lack established volume and subsequent potential for rebate revenue.  In many cases, these actions prevent patients and physicians from seriously considering new medications at competitive prices.

Given the competitive risks that rebate walls pose, the coalition has asked the FTC to investigate how this transaction may make the situation related to this suspect contracting practice worse.  Competition works when new rival drugs (biosimilars, branded drugs or generics) are allowed open and fair access to the market and consumers have access to cost saving treatments.  And while the FTC has not publicly acknowledged examining mergers between drug manufacturers under this type of theory before, the issue is now in front of the staff.

Background on Pfizer/J&J

In September 2017, Pfizer filed an antitrust lawsuit under Sections 1 and 2 of Sherman Act alleging J&J engaged in exclusionary anticompetitive practices to keep Pfizer out of the market for infliximab products.

In 1999, J&J introduced the first infliximab product under the brand name Remicade, a biologic, which treats a variety of immune-mediated diseases. In 2016, Pfizer launched Inflectra as the first biosimilar to Remicade.

According to Pfizer’s allegations, within a week of Inflectra’s launch, J&J began to deploy its “Biosimilar Readiness Plan,” which allegedly involved a multi-pronged anticompetitive scheme including exclusive contracts and bundle rebates and multi-product bundling.   Pfizer’s allegation was that J&J threatened to withhold rebates (which often grow larger as performance metrics such as market share or volume rise, or which may be bundled together with rebates for other products) from insurers unless they agreed to exclude biosimilars from their formularies.  This is what Pfizer refers to as a “rebate trap”.

Exclusive Contracts: Pfizer alleges J&J sought and secured contractual commitments from commercial insurance companies to exclude Remicade biosimilars, such as Inflectra, from their plans.  These contracts made Remicade the exclusive infliximab product available to patients covered under those plans. At least 70% of commercially insured patients in the U.S. fall under plans that have adopted these express or de facto agreements to exclude Inflectra and other biosimilars.  As of September 2017, J&J maintained market share of over 96% of infliximab unit sales in the United States.

Bundling Rebates: Pfizer alleges J&J enticed insurers into accepting exclusive contracts via a rebate program that would provide discounts off Remicade’s increasing list price—but only so long as new patients are also given Remicade rather than Pfizer’s biosimilar, Inflectra. (bundling of new (contestable) and existing (noncontestable) patients)

Multi-Product Bundling: Pfizer alleges J&J bundled rebates across multiple products such that if an insurer refuses to grant exclusivity to Remicade, the insurer would be forced to pay a higher price on other J&J products in addition to Remicade.

Impact on Prices and Competition:

Pfizer alleges that both J&J’s net price accounting for rebates and other discounts continued to rise despite insurers and providers now having a lower-cost alternative in Pfizer’s Inflectra.  As a result, Pfizer claims that it has been prohibited from competing for at least 70% of all commercially insured patients in the United States.

Biosimilars:

Biosimilars are expected to be a key factor in efforts to contain prescription drug costs.  Biologics are complex, large-molecule medicines derived from living organisms and are used to treat a range of serious conditions, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, lymphoma, leukemia, breast cancer, and diabetes.  Biologics are among the most expensive prescription drugs in the United States and account for an increasing share of U.S. prescription drug costs.

The development of biosimilars is still a nascent industry.  But many industry experts and former Commissioner Gotlieb of the Food & Drug Administration (“FDA”) have expressed their views that increased competition from biosimilars could result in enormous benefits to the tune of $54 billion in savings between 2017 to 2026 for the U.S. healthcare system so making sure that biosimilars are allowed to compete on fair terms with higher priced branded biologic medicines is vitally important.  Some have indicated that the savings could be approximately $150 billion under the right conditions.  Exclusionary tactics through the use of a rebate wall threatens to stifle biosimilar competition and reduce patients access to affordable life saving drugs.

District Court’s Opinion

In J&J’s motion to dismiss, J&J argues that Pfizer failed to plead facts that constitute an antitrust injury.  J&J also identified a number of alternative reasons why Pfizer’s launch failed other than J&J’s conduct.  The district court found that Pfizer’s complaint sufficiently and plausibly alleges that it suffered an antitrust injury because it contained detailed allegations regarding J&J’s exclusionary terms with the nation’s largest insurers; the incentive structure that forces end payers and providers into accepting those terms; Pfizer’s efforts to compete (e.g., guarantee that Inflectra would cost less than Remicade); and showed how market participants on many levels are injured from J&J’s ability to sell Remicade without any competition.  With regards to bundled rebates, the district court noted that bundled rebates pose antitrust concern when a defendant forecloses competition from its product in a competitive market by linking it to a product on which it faces no competition. LePage’s Inc. v. 3M, 324 F.3d 141, 156 (3d Cir. 2003); SmithKline Corp. v. Eli Lilly & Co., 575 F.2d 1056, 1065 (3d Cir. 1978).The district court cited, SmithKline, noting the Third Circuit affirmed as an antitrust violation the defendant’s rebates based on the purchase of multiple products because the bundle, in effect, “insulated its product from true price competition.” 575 F.2d at 1065.  The district court noted the same was true in LePages’s, where the defendant “used its monopoly in transparent tape, backed by its considerable catalog of products, to squeeze” its competitor from the market. 324 F.3d at 157. Similar to exclusive dealing agreements, bundled rebate claims are analyzed under a rule of reason framework.

J&J relying on Eisai argued that Pfizer did not suffer antitrust injury because Pfizer did not allege that it was incapable of offering its own multi-product bundle and that bundling contestable and noncontestable patients cannot be an antitrust violation.  The district court rejected both arguments basically saying that discovery will show if Pfizer will have the facts to prove the theory of harm and Eisai lost on summary judgment because of a lack of factual support.

Takeaways:

Pfizer’s win is big step in the right direction.  Indeed, the ultimate outcome of this case will help define the scope of antitrust protections for biosimilars for years to come and may even determine the viability of the biosimilar industry.  This case demonstrates how some pharma manufacturers engage in contracting practices that create what is known as a rebate wall or trap.  This conduct may be anticompetitive if they block and delay the entry of biosimilars. When a rebate wall is successfully erected, an insurer faces strong financial disincentives to grant access to new and innovative therapies such as biosimilars, as doing so would result in punitive action that would result in the loss of hundreds of millions in guaranteed rebate dollars for the payor. This condition creates a “trap” for insurers which would otherwise be inclined to grant formulary access to biosimlars.

In many cases, these rebate traps prevent patients and physicians from seriously considering new medications at competitive prices.  The conditional rebate penalizes insurers if they use biosimilars because they would lose their rebates not only on the incumbent branded drug, but on all the products in which the rebate is bundled together.  Accordingly, these rebates are not discounts that benefit customers rather they are exclusionary tactics designed to stifle the entry of rivals.

In summary, rebate walls distort the workings of the free market, result in higher prices, and reduce patients’ access to affordable drugs.  Even worse, if J&J’s rebate trap is successful, it will provide other pharma manufacturers a roadmap on how to stifle stifle biosimilar competition and pharma manufacturers will have less incentives to develop biosimilars in the future.

Andre Barlow
(202) 589-1838
abarlow@dbmlawgroup.com