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Biosimilars & Exclusive Dealing Antitrust Law: The Case of Pfizer Inc v Johnson & Johnson et al.

Lawrence W. Abrams No Comments

Summary

Following the generally accepted theories of the legal scholar Robert Bork and his Chicago School colleagues, vertical restraints such as exclusive dealing contracts are presumptively procompetitive and welfare-enhancing because it would be irrational for a buyer to exclude the lowest cost supplier.  

On September 20, 2017, the drug manufacturer Pfizer filed a lawsuit Pfizer Inc, v Johnson & Johnson et al (link to the full court filing)  claiming that Johnson & Johnson (J&J) violated Section 2 of the Sherman Antitrust Act by monopolizing the market for its incumbent biologic drug Remicade®.  This was achieved via rebate contracts with the largest insurance companies in the USA that had the effect of excluding from coverage Pfizer’s biosimilar drug Inflectra®.

We will present the case that Pfizer’s antitrust case is weak because it was unlikely that Pfizer was the low cost supplier based on a view of lump sum rebate offers as  efficiency-enhancing “signals” of expected consumer demand for a product.  

Introduction

Johnson & Johnson’s (J&J) biologic drug infliximab — trade name Remicade® —  was approved by the FDA for use in August 1998.  It was the first autoimmune drug to be approved in three different therapeutic classes and is used to treat patients with autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.

In 2016, Remicade was the 5th highest selling drug in the United States with estimated sales of $5.3 Billion.  Remicade was J&J’s top selling drug, representing 20% of its total global drug sales.     

Remicade consists of monoclonal antibodies bioengineered from mouse tumors. It is prescribed to patients with autoimmune diseases. Because it is infused at physician’s offices or outpatient clinics, it is almost always covered by a medical benefit plan rather than a drug benefit plan.  Remicade is a live, large molecule protein.  It is impossible for other companies to manufacture perfect substitutes, only “biosimilars”.  

Remicade now faces competition from biosimilars due to the expiration of FDA exclusivity coupled with court judgements invalidating some of J&J’s patents protecting it bio-engineering processes.

In November 2016, the FDA approved Pfizer’s biosimilar drug Inflectra® followed by a June 2017 approval of Merck and Samsung’s biosimilar drug Renflexis®.

Pfizer’s Antitrust Lawsuit 

On September 20, 2017, Pfizer filed a lawsuit Pfizer Inc, v Johnson & Johnson et al (link to the full court filing)  in the U.S. District Court, Pennsylvania Eastern District Court, Philadelphia Office, No 17-04180.

Pfizer claimed that J&J violated Section 2 of the Sherman Act by monopolizing the infliximab market using a

“…web of exclusionary contracts on both health insurers and healthcare providers (e.g., hospitals and clinics) to maintain its stranglehold in respect of an important biologic, brand named Remicade, also known by its generic name, infliximab.”

It is significant to note that the Pfizer chose Section 2 (monopolization) of the Sherman Act rather than Section 1 (restraint of trade) of the Sherman Act or Section 3 (exclusive dealing) of the Clayton Act.

Former FTC Commissioner J. Thomas Rosch had noted in a 2007 article that the one exception to the trend of courts ruling against plaintiffs in vertical restraint cases focused on Section 2 of the Sherman Act.  He found that the 1978 case of Eli Lilly v SmithKline was often cited by plaintiffs who won their cases.

It is interesting to note that the SmithKline case involved bundled drug discounts. It was tried by the Third Circuit Court of Appeals which encompasses the District Court in which the Pfizer case is to be tried.

J&J’s exclusionary contracts were

“… designed to block both insurers from reimbursing, and hospitals and clinics from purchasing, Inflectra or other biosimilars of Remicade despite their lower pricing.”

The suit also claimed that J&J engaged in below cost predatory pricing:

“..when the total amount of discounts and rebates that J&J offers to insurers and providers under the contracts described herein, including multi-product bundle contracts, is attributed to the portion of Remicade sales that is contestable by a biosimilar like Inflectra, J&J is pricing Remicade below its own average variable cost.”

 

Expectation for Price Competition Between Biologics and Biosimilars

The pattern of price competition in 2017 between Remicade and Inflectra represents the first “clean” case study of price competition in the United States between a newly introduced biosimilar and its original biologic.

A year and a half earlier in March 2015, Sandoz introduced a self-administered, injectable drug called Zarxio that was a biosimilar to Amgen’s biologic Neupogen used to stimulate white blood cell production after chemotherapy.

Zarxio’s ease at gaining exclusivity on drug benefit formularies turned out to be an anomaly. That is because Amgen decided not to compete with Sandoz on price. Instead, Amgen focused its marketing efforts on converting existing Neupogen users to Amgen’s newly introduced, long-lasting version of Neupogen called called Neulasta.   

Before we turn to the lawsuit itself, we want to discuss the expectations that experts had for biosimilar competition in general.  We also want point to signs indicating what Pfizer’s own expectations were.  

The reason for this is to show that no one was expecting aggressive price competition from the incumbent.  When Pfizer realized its strategy was a failure, it decided to sue, claiming it was J&J fault.  

Instead, it should have renewed its efforts by devising a “winnable” strategy involving deeper discounts and rebate percentages on contracts that offered exclusive coverage for a subset of infliximab users.

At the time of its launch, Pfizer list priced Inflectra at $946 a vial, only 15% below $1,113 for a comparable vial of Remicade.  The normal regimen for both drugs consists is an IV infusion every 8 weeks or 6.5 times a year.  This translates to a yearly list price of $6,149 for the biosimilar versus $7,235 for Remicade.

Pfizer stated in its antitrust lawsuit that it

“… introduced Inflectra with a list price 15 percent lower than Remicade, and, in negotiations with insurers and providers, offered substantial additional pricing concessions in the form of discounts and/or rebates that in some instances were more than 40 percent below Inflectra’s list price. The goal and effect was to offer Inflectra for less than J&J was offering Remicade; indeed, for many customers, Pfizer committed to ensure that Inflectra would have a lower net per-unit price than Remicade”

Pfizer failed to mention in its lawsuit that, when Merck launched a second biosimilar called Renflexis in June 2017, Pfizer reduced its list price from 15% to 35% to match Merck.   We view this downward revision as an acknowledgement by Pfizer that its pricing between November 2016 and July 2017 had not been competitive.

In September 2017, J&J’s CFO Dominic Caruso told Wall Street analysts  that Remicade sales had dropped only 5% year-over-year since the introduction of Pfizer’s biosimilar.   He attributed J&J’s success to doing a  “pretty good job of contracting for Remicade well in advance of the biosimilar entry from Pfizer.” He also attributed J&J’s success to natural barriers to biosimilar adoption in general.

The costs above do not include infusion costs, running $3,000+ per visit or $19,500 a year, for administering the infusion at physicians offices or outpatient clinics.   Insurance coverage for the combination of drug and infusion fall under a medical benefit plan rather than a drug benefit plan, which limits coverage to self-administered drugs.  In the case of Medicare, both drugs are covered under Medicare Part B as opposed the drug benefit plan Medicare Part D.   

Pfizer’s choices for discounts off list have been in line with general expectations for new biosimilars.   Experts had thought that biosimilar competition would mirror the modest price competition that had been observed among branded, but therapeutically equivalent, small molecule drugs.  

No one believed that the competition would mirror the vigorous price competition initiated by generic manufacturers once a brand drug lost its patent protection. In these cases, a number of generic manufacturers with offshore operations would enter the market within a year and offer perfect substitutes that pharmacists could switch to automatically.  The vigorous competition caused generic prices to fall  80+% lower than the original brand.

These expectations for modest price competition seemed to be based only on the economics of the biosimilar manufacturer.  The idea was that the willingness of a biosimilar manufacturer to compete on price was a lot less than a generic manufacturer.  This stems from a need to cover amortized R&D expenses estimated at $100 Million to $250 Million for a biosimilar versus $1 Million to $4 million for a generic.

Biologic and Biosimilar manufacturing

It was also felt that biosimilar manufacturers would hold back from aggressive pricing because substantial gross profits would be needed to cover large sales expenses for consumer advertising and “physician detailing.”  This non-price competition followed from the expectation that physicians would be reluctant to switch existing patients to another drug that was not a perfect substitute.

No one in general, and not Pfizer specifically, expected that the manufacturer of the biologic would become the driver of vigorous price competition upon entry of a biosimilar.  After enjoying 16 years of monopoly profits with fully amortized R&D, the incumbent could afford to undercut any biosimilar “burdened” by the yearly amortization of $100 – $250 Million in R&D expenditures.

Also, no one considered  the possibility that payers — insurance companies and plan sponsors  — would be the drivers of biosimilar price competition.  This is surprising because there there has been considerable evidence since 2010  that payers and contracted specialists called pharmacy benefit managers (PBMs),  have been driving price competition among small molecule brand drugs via exclusive formulary rebate contracts.  

 

The Chicago School on Exclusive Dealing

Following the now generally accepted theories  of the legal scholar Robert Bork and his University of Chicago colleagues,  vertical restraints such as exclusive dealing contracts are presumptive welfare-enhancing and procompetitive because it would not be rational for a buyer to exclude the lowest cost supplier.    

Beginning in the 1980s, Federal courts have ruled that most cases involving various vertical restraints — exclusive dealing, tying arrangements, slotting arrangements, rebate bundling, etc —  are procompetitive and do not violate antitrust laws.

The Chicago School argued persuasively that antitrust cases involving vertical restraints  should be decided on the basis of prices and costs.  The Chicago School has rendered the industrial organization paradigm of structure-performance-conduct and related data, which Pfizer offered as evidence in its lawsuit,  as irrelevant to vertical restraint antitrust cases.

We believe that Pfizer’s antitrust lawsuit is weak.  Following the Chicago School, we believe that the exclusive dealing contracts between J&J and insurance companies are procompetitive as it is highly unlikely that Pfizer’s biosimilar had a lower price after rebates than Remicade.

Pfizer Inc v Johnson & Johnson et al is no different that the 2014 case of Eisai Inc. v. Sanofi-Aventis U.S., LLC, No. 08-4168 (MLC) (D.N.J. Mar. 28, 2014)  tried in The United States District Court for the District of New Jersey. The court ruled that contracts between a drug company and hospital groups offering “loyalty discounts” if buyers met market share targets were procompetitive as long as the net prices exceeded costs.

 

Predatory Pricing

Pfizer alleged in its lawsuit that “J&J is pricing Remicade below its own average variable cost.”

Predatory pricing is a form of vertical restraint initiated from the sell-side.  The Chicago School argued that predatory pricing is unlikely to occur as it would be irrational for a seller operating under a normal profit-maximizing business model to so.

Pfizer’s claim of predatory pricing is weak. The bioengineering costs to manufacture infliximab have to be about the same for the two companies.  Where the two firms’ cost structures differ is in the area of amortized R&D expenditures.   

J&J has been amortizing Remicade’s R&D costs for the past 18 years. By now J&J’s R&D expenditures on its balance sheet have been fully amortized. No longer is J&J required by GAAP to “burden” its cost of goods sold.  

On the other hand, Pfizer introduced Inflectra a year ago and has to “burden” its cost of goods sold with a yearly amortization of the total R&D for its biosimilar in range of $100 Million to $250 Million.

Unburdened by amortization,  J&J could easily underprice Pfizer without going below its costs of goods sold.  In other words, J&J would not have to engage in predatory pricing to outbid Pfizer for exclusive dealing contracts.  It would be irrational for them to do so.

 

Business Model Misalignment

One factor that might have bolstered Pfizer’s case would have been a misalignment of the business model of the buyers.  But, we rule that out here.

The buyers in this case are the largest national health insurance companies in the United States and a slew of regional Blue Cross Blue Shield companies. Below is the list of these companies and how they chose to cover Pfizer’s biosimilar.

  • UnitedHealthcare  – only after Remicade failed first
  • Anthem — outright exclusion
  • Aetna — complex indication list before approval
  • Cigna — only after Remicade failed first

In its lawsuit Pfizer estimated that “70% of medical drug benefits of commercially insured patients in US”  are managed by the companies named in its lawsuit.  

EVERY SINGLE ONE of the national health insurance companies either excluded Inflectra outright or required Remicade to “fail first” before covering Inflectra. It is presumed that EVERY SINGLE ONE of these big insurance companies signed these exclusive coverage contracts only after a thorough investigation of competing bids leading to the conclusion that J&J was the low cost supplier.

In the lawsuit, Pfizer did make the persuasive argument that “fail first” coverage for Inflectra amounted to de facto exclusion.  They argued that if one infliximab drug — Remicade — did not work, a physician would then turn to a non-infliximab drug, not to another biosimilar infliximab drug like Inflectra. This is because years of clinical trials submitted to the FDA  proved that there was no meaningful difference in outcome between Remicade and Inflectra.

The question is are there other circumstances under which a large insurance company would intentionally exclude coverage for a biosimilar with lower costs?

We have been the first to raise the possibility that a buyer with a misaligned business model could be an exception to the Chicago School dictum about vertical restraints. This is because their conclusion depends on the assumption that the buyer has a rational business model in the economic sense of maximizing revenue minus costs.

But, we rule the possibility of irrational business model out as the insurance companies in this case operate under normal economic business models.  

One is an insurance model based on revenue from fixed premiums offset by provider reimbursement costs.  The other is a self-insured model where the insurance company operates as a fee-for-service contractor offering medical benefits management with 100% pass through of provider reimbursements to plan sponsors.

While mistakes can occur without affecting profits in the short run,  it is in the best interest of an insurance company to produce a cost-effective medical benefit as plans will compare results at contract renewal time.

Unlike cases involving insurance companies as buyers, we have pointed out that the Chicago School’s assumption of a rational buyer business model is problematic in instances involving exclusionary formulary contracts between drug companies and PBMs as buyers.  

PBMs have a reseller business model where their gross profits on brand Rx are derived only from opaque retained rebate percentages.  The PBM business model setups up a possible misalignment of interests between plan sponsor preferences for the lowest net cost drug in a therapeutic class and PBM preferences for the drug with the highest rebate retention DOLLARS.

 

Lump Sum Rebates

The question is how do you determine the low cost supplier in cases where the defendant uses market share or lump sum rebates in return for exclusive deals?

Pfizer alleged that its rebates offers would have make Inflectra the lower cost drug on a “unit-for-unit” basis.  While Pfizer’s specific descriptions of the form of J&J rebates is somewhat vague in the lawsuit, it appeared that J&J’s payments to insurance companies were in the form of a contractual commitments of multimillion dollar lump sums contingent upon meeting near 100% market share targets for Remicade.  

Below, we  present a “stylized facts” comparison of rebates offers where our estimate for the total annual lump payment paid by J&J reasonably could have been as much as $2 BILLION, or 28% off Remicade’s list price.  

We show that on “unit for unit” basis, Pfizer is the low cost supplier.  However, on a “dollar for dollar” basis, J&J is the low cost supplier given our estimated 25:1 volume advantage for Remicade coupled with our estimated $2 Billion lump sum rebate.

Who is the low cost supplier here?

J&J is the low cost supplier based on a view of lump sum rebate offers as  efficiency-enhancing “signals” of expected consumer demand for a product.   

Lump sum rebates can be viewed as the product of a unit rebate times a manufacturer’s expected demand for their product.   They provide a “signal” to buyers of which product among a group of therapeutic equivalents might offer buyers the single best opportunity for satisfying downstream consumer demand.

The intermediate market buyer is looking to maximize expected profits.  This can be cast at the product of unit margin (unit resale price – unit cost) times expected downstream demand.  It would be irrational for an intermediate market buyer to enter into exclusive dealing contracts only on the basis of unit costs after rebates without considering expected demand as well.

What buyers are doing by comparing rebates on a lump sum basis and not on a unit basis is similar to the AdWord algorithm Google came up with for “slotting”  search ads based on keyword bids on a unit basis.  

Slotting ads based only on cost per click (CPC) bids most likely would have resulted in the top slots going to bidders advertising products that few viewers were interested in,  resulting in few clickthroughs.  Slotting ads only on the basis of CPC bids would be far from revenue-maximizing as measured by the product of CPC times clickthroughs.

Instead, Google looked at past data on bidders, their ad relevancy to viewers,  and calculated something called an expected clickthrough rate (eCTR), a measure of expected demand.  Google then sold the top slots to bidders with the highest “AdRank”, a rating index that is function of CPC and eCTR.

Consider insurance company in a situation similar Google selling a single slot for insurance coverage of supplying infliximab vials to patents. The insurance companies received two rebate bids — $333 per vial from J&J vs $400 per vial from Pfizer.  Who should they choose for the slot?

Unfortunately, insurance companies did not have a genius like Larry Page to come up with a “AdRank” for the two bids — a measure combining unit bid with expected consumer demand.  But, insurance companies were provided with a “signal”  of expected demand in the form of a J&J’s market share or lump sum rebate offer.

Pfizer could have chosen to outbid J&J’s on a market share or lump sum basis.  But, this would have required Pfizer to have the confidence that it could deliver a 25x increase in patient demand for its biosimilar if given exclusive coverage. But Pfizer did not have such confidence.  

 

 Bundling or Tying Arrangements

Pfizer’s anticipated the “signaling”  defense of lump sum rebates by arguing that J&J’s rebates covering the entire market for infliximab were exclusionary bundling or tying arrangements.  In its lawsuit, Pfizer viewed the “contestable” market for its biosimilar as consisting only of new patients.  It viewed as “uncontestable” current users of Remicade.

Pfizer argued that J&J’s offer should be viewed as tying a lump sum payment for supplying existing patients with a lump sum payment for supplying new patients.  

Pfizer argued that its rebate offer should be compared with J&J’s lump sum, but only after it had been prorated over the “contestable” market.  In effect, pro-rating amounts to an “unbundling” of J&J lump sum rebate offer turning it into a “unit-for-unit” offer.  As we have shown above, Pfizer would be the low cost supplier on a “unit-for-unit” basis.

Again, the Chicago School argued that it is presumptive to expect that rational buyers would accept bundling or tying arrangements if they involved excluding the low cost supplier.

We recommend that in the future Pfizer asks insurance companies to create two types of contracts: (1) one contract offering exclusive coverage of patients already using Remicade; and (2) another contract offering exclusive coverage for new infliximab patients.  Give this division, Pfizer has a chance to outcompete J&J on price by bidding only on (2).

 

Conclusion

We believe that Pfizer’s case is weak.  Pfizer did compete, but only moderately so. Pfizer never expected existing users of Remicade to switch to its biosimilar.  Being excluded from that market was not a shock.  

Pfizer really thought it had a chance to win over physicians looking to prescribe an infliximab for new patients.  But, Pfizer was not smart enough to devise a “winnable” contract specifying rebates in return for coverage only in its “contestable” market.

AbbVie’s Mavyret Drug Pricing: Disruptive to the Pharmacy Benefit Manager Business Model

Lawrence W. Abrams No Comments

Summary:

AbbVie’s pricing for its new Hepatitis C Virus (HVC) drug Mavyret is disruptive to the current PBM business model because it forces the Big 3 PBMs to consider a drug for inclusion in their national formularies that is aligned with their clients interests — more cost-effective than Harvoni — but not aligned with their own interest of squeezing out all the rebates they can from specialty drug manufacturers.

Will PBMs open up the HCV therapeutic class and include Mavyret?

Or, will they expose themselves to claims of misalignment by excluding AbbVie’s Mavyret?

Stay tuned.

The PBM Business Model Today

The management of the prescription (Rx) drug benefit portion of health care plans has become the domain of contracted specialists called pharmacy benefit managers (PBMs).

The three largest, independent PBMs — Express Scripts, CVS Health,  and Optum Rx, (known as “The Big 3”) control 73% of the total Rx claims processed the United States in 2015.

Since the early 2000s, PBMs have continually come under attack for not acting in the best interest of their clients.  We have written a number of papers since 2004 pinpointing an opaque reseller business model as the source of this misalignment.

In a 2017 paper, we presented the case that there have been 3 distinct phases of the PBM business model over the past 15 years demarcated by radical shifts in the primary source of gross profits: (graph below)

  1. up to 2005 — reliance on retained rebates from small molecule brand drugs;  
  2. 2005 – 2010 — reliance on mail order generics Rx margins;
  3. 2010 – today — reliance on retained rebates from specialty drugs.

To compensate for declining mail order generics Rx margins after 2010, PBMs saw the rising trend of specialty and biotech drugs as a promising basis for a renewed reliance on retained rebates.

But there are several constraints today on this phase of the PBM business model.

The first constraint in that the specialty drug Rx volume “basis” for collecting rebates today is a lot less than it was ten years ago when small molecule drugs were the basis for rebates.

The second constraint is a newfound awareness by clients that retained rebate dollars can be substantial yet an opaque source of PBM gross profits.   As a defensive move, CVS Health finally declared publicly on their website that,

“CVS Caremark was able to reduce trend for clients through… negotiations of rebates, of which more than 90 percent are passed back to clients.”

The problem facing PBMs today is how to derive a majority of gross profits from specialty Rx while maintaining a transparent rebate retention rate of 10% on average.

Using data supplied by the drug company Merck, we reconstructed a step-by-step sequence of how PBMs and drug companies might negotiate the parameters of a rebate deal under the triple constraints of (1) Pharma’s net prices must grow; (2)  PBMs retained rebate gross profit DOLLARS must grow; and (3) PBM rebate retention rate must be fixed at 10%.  

We found that to do this required PBMs to “coax” drug companies into increasing list prices for brand drugs at double-digit rates yearly while demanding that nearly all of it be rebated back to the PBMs. The result of this scheme is an occurrence now known as the “gross-to-net price bubble.”  Below is a graph of the phenomenon using data supplied by Merck:

PBMs and Formulary Choice

As we said in the prior section, the PBM business model relies heavily today on rebates received from drug companies in return for placement on a list of drugs covered by a Rx benefit plan.  That list of covered drugs is called a formulary.  

The formulary is a lookup table that PBMs add to their claims processing systems that checks a Rx request against a list of therapeutic equivalents preferred by PBMs and rubber-stamped by plans.  The formulary is designed to limit Rx to the most cost-effective drug(s) in each of 50-80 different therapeutic classes.  

In 2005, we were the first to conceptualize formularies and their 50-80 therapeutic classes as a group of markets.  On the sell-side are brand drug companies with close, but not perfect substitutes, called therapeutic equivalents.  On the buy-side are the Big 3 PBMs representing plan sponsors and their members.

Economists call such markets bilateral oligopolies.  We have written a number of papers about the Pharma – PBM bilateral oligopoly available for download free on our website.

Rebates are essentially tariffs paid by drug companies to gatekeepers (PBMs) for access to markets with limited competition. We have presented that case that the most “rebatable” brand drugs fall in oligopolistic therapeutic classes featuring a small number of patented drugs that are therapeutic equivalents.  

Over time, “me too” drugs enter and older drugs lose patent protection opening the door to generics or biosimilars.  The therapeutic class becomes competitive and no manufacturer has any wiggle room left to negotiate price reductions with PBMs.

We have observed a change in PBMs’ approach to formulary design over the past 15 years.  Basically, “rebatable” therapeutic classes have gone from being open — a few approved drugs — to being closed — a single approved drug.  We are just beginning to figure out the causes of this change.  

But our basic view of what drives PBMs to choose  open versus closed therapeutic classes is this:

The more a PBMs limits competition in a therapeutic class, the more potential entrants will pay for access.  Small molecule therapeutic classes tend to be open, hence less valuable to entrants.  Specialty and biotech therapeutic classes tend to be closed, hence more valuable to the single favored entrant.  

Today, PBMs need to squeeze everything they can from granting access to specialty therapeutic classes.  This is the reason for the trend toward closed formularies and correspondingly more drugs on excluded lists.   

The Hepatitis C Virus Drug Therapeutic Class

In 2013,  the biotech company Gilead Sciences got FDA approval for its “innovative” Hepatitis C Virus (HCV) drug combo called Sovaldi.  Eight month later, an improved version of Sovaldi,  called Harvoni, came on the market.  These drugs produced fewer side effects than first generation combo drugs requiring interferon.  Also, Sovaldi / Harvoni only required regimens lasting 12 weeks, instead of 24 to 28 weeks with prior combo drugs.  

In 2016, Gilead’s Harvoni stood at #2 on the list of top selling Rx drugs at $10.0 Billion a year, after AbbVie’s top selling biotech drug Humira at $12.9 Billion used to treat a variety of autoimmune diseases.

In the three years since Harvoni came on there market, there have been 5 additional HCV drugs approved by the FDA, but only AbbVie’s Viekira Pak has garnered any significant sales.  

The reason has been that the Big 3 PBMs have decided the make the HCV therapeutic class a “winner-take-all” proposition, coaxing competing companies to choose a high list price to be in a position to offer PBMs  a “deep discount” rebate reaching 70% to 80% of list price to gain exclusivity in the HCV therapeutic class.  Below is a summary of the formulary choices of Big 3 PBMs and Prime Therapeutics for the HCV therapeutic class for 2017.   

Gilead has secured exclusive preferred status for Harvoni with CVS Health, OptumRx and Prime Therapeutics. AbbVie has secured exclusive status for Viekira Pak with Express Scripts.   

All of these choices are aligned with plan interests of having the most cost-effective drug included in the formulary.  All choices are also aligned with PBMs’ interest of securing the most rebate DOLLARS.

Harvoni and Viekira Pak are both about equally effective so rebates become the determining factor for cost-effectiveness.  For CVS Health, OptumRx and Prime Therapeutics, Gilead’s Harvoni is more cost-effective choice because Gilead’s rebate offer was greater than AbbVie’s.

For Express Scripts, Viekira Pak is the most cost-effect choice because AbbVie’s rebate offer was greater than Gilead’s whose bid might have been constrained due to a depleted budget after all the other wins.   

AbbVie’s Mavyret Drug Pricing Is Disruptive to the PBM Business Model

On August 3, 2017, the FDA approved a new HCV drug call Mavyret from AbbVie. According the Speciality Pharmacy Times, this new drug has the potential to challenge the dominant position of Gilead’s Harvoni on two fronts: (1) a regimen requiring only 8 weeks versus 12 weeks for Harvoni; and (2) a disruptive ultra-low regimen list price that leaves little to no room for PBM rebates.  

Below is our spreadsheet comparison of the NET REGIMEN for Mavyret versus Harvoni:

AbbVie’s pricing for Mavyret is disruptive to the current PBM business model because it forces the Big 3 PBMs to consider a drug for inclusion in their national formularies that is aligned with their clients interests — more cost-effective than Harvoni — but not aligned with their own interest of squeezing out all the rebates they can from specialty drugs.

On July 31, 2017,Express Scripts released its 2018 National Formulary, but noted:

“Please note that product placement for Hepatitis C and treatment for Inflammatory Conditions are under consideration and changes may occur based upon changes in market dynamics and new product launches. The full list of excluded products will be available on or before September 15, 2017.”

In August 2017, CVS Health released a white paper outlining the criteria it uses for formulary choices and exclusion lists. It stated that in January 1, 2018,  it expects to remove 17 products from their Standard Control Formulary in 10 drug classes, but noted that  

“We are in the process of finalizing changes for autoimmune and hepatitis C categories, which will be communicated mid-September.”

Will the PBMs open up the HCV therapeutic class and add Mavyret?  

Or, will they expose themselves to claims of misalignment by excluding AbbVie’s Mavyret?

Stay tuned.

Postscript added October 17, 2017

Was CVS’s Formulary Exclusion of Mavyret a Violation of Antitrust Laws?

Merck Data Discredits PBM-Sponsored Study of Brand Drug Price Inflation

Lawrence W. Abrams No Comments

Summary

We present data supplied by the drug company Merck that discredits a study sponsored by the pharmacy benefit manager (PBM) trade association showing no correlation between PBM rebate rates and brand drug price inflation.

Introduction

The management of the prescription (Rx) drug benefit portion of health care plans has become the domain of contracted specialists called pharmacy benefit managers (PBMs).

The three largest, independent PBMs — Express Scripts, CVS Health,  and Optum Rx, (known as “The Big 3”) control 73% of the total Rx claims processed the United States in 2015.

Since the early 2000s, PBMs have continually come under attack for not acting in the best interest of their clients.  We have written a number of papers since 2004 pinpointing an opaque reseller business model as the source of this misalignment.

In a 2017 paper, we have presented the case that there have been 3 distinct phases of the PBM business model over the past 15 years demarcated by radical shifts in the primary source of gross profits:

  1. up to 2005 — reliance on retained rebates from small molecule brand drugs;  
  2. 2005 – 2010 — reliance on mail order generics Rx margins;
  3. 2010 – today — reliance on retained rebates from specialty drugs.

To compensate for declining mail order generics Rx margins after 2010, PBMs saw the rising trend of specialty and biotech drugs as a promising basis for a renewed reliance on retained rebates.

But there are several constraints today on this phase of the PBM business model.

The first constraint in that the specialty drug Rx volume “basis” for collecting rebates today is a lot less than it was ten years ago when small molecule drugs were the basis for rebates.

The second constraint is a newfound awareness by clients of PBMs that retained rebate dollars can be substantial yet an opaque source of PBM gross profits.   As a defensive move, CVS Health finally declared publicly on their website that,

“CVS Caremark was able to reduce trend for clients through… negotiations of rebates, of which more than 90 percent are passed back to clients.”

The problem facing PBMs today is how to derive a majority of gross profits from specialty Rx while maintaining a transparent rebate retention rate at 10% on average.

In order to show how PBMs can overcome these constraints,  we have deconstructed data supplied by the drug company Merck (see below) that depicts a growing a divergence between their list prices for brand drugs (gross) and the prices they receive after deductions of rebates paid to PBMs (net).

This growing divergence has come to be known as   “gross-to-net rebate bubble”   Other drug companies are publishing similar data as a way of defending themselves against charges of double-digit price-gouging tactics.

This is a graphic depiction of Merck’s gross-to-net price bubble:

Our deconstruction of the Merck data lays out a step-by-step sequence of how PBMs and drug companies might negotiate the parameters of a rebate deal today under the constraint that PBMs have to grow gross profit DOLLARS over time while fixing the rebate retention rate at 10%.

We can use the same Merck-supplied data to plot annual % increases in list prices (line 1 above) against the annual negotiated rebates and discounts as a % of the list prices (line 3 above).  The result shows a significant positive correlation coefficient ratio of .653

PBMs Under Attack for Causing Drug Price Inflation

In January, 2017 newly elected President Donald Trump attacked drug companies in press conference for “getting away with murder” by raising drug prices at double-digit rates in recent years.

Since the Trump rant,  there have been articles in the New York Time, the Los Angeles Times and other publication where both retail pharmacists and drug companies are quoted as saying it is PBMs that drive drug price inflation.  Here is a quote from the New York Time article,

“Want to reduce prescription drug costs?” the pharmacists argued during their visits. “Pay attention to the middlemen.”

The PBM-Sponsored Study

The PBM trade group association Pharmaceutical Care Management Association (PCMA) commissioned a study by the health care consulting company Visante to provide data relevant to the issue of the causes of recent drug price inflation.  

In April 2017, the PCMA announced in a press release that results of the Visante study were available on-line.  The key result:

“There is no correlation between the prices drug companies set and the rebates they negotiate with PBMs”

The press release also provided a quote by PCMA President and CEO Mark Merritt:

“This study debunks the notion that the prices drugmakers set are contingent on the rebates they negotiate with PBMs…”

Below is a screenshot of the graph depicting the finding of “no correlation”

Reconciling Differences in Results: A Question of Sample Chosen

The Merck data shows a significant positive correlation between annual brand drug list price inflation and annual rebates rates that Merck has negotiated with PBMs.  The PBM-sponsored study shows no correlation.

Obviously, a key reconciling difference revolves around the sample chosen.  

The Merck results are heavily weighted by three brand drugs.  Merck has reported In its 2017 annual 10-K report that about one-third of its drug sales comes from three brand drugs: (1) the diabetes drug Januvia; (2) the cholesterol drug combinations Zetia/Vytorin; and (3) the cervical cancer prevention vaccine Gardasil.  

In terms of rank among the top 200 selling brand drugs, Januvia ranked #19, Zetia #38, and Gardasil #56 according to a 2015 listing.

Each of these drugs are what we call highly “rebatable” — in therapeutic classes where there are a number of other brand that are therapeutically equivalent.  

Merck competes vigorously with other drug companies for preferred status on formularies which list drugs approved by PBMs for coverage.  Competition insures that winning bids are high for placement in these therapeutic classes.  Merck has to “pay to play” and covers higher and higher rebate percentages paid to PBMs with list price inflation.

To achieve such high rankings,  it means that Merck must be winning placement for its top selling drugs with each of the Big 3 PBMs who control collectively 73% of the market.

While Merck’s sample size is small compared to the PBM-sponsored study, Merck’s data represents the essence of what has been going on between Pharma and Big 3 PBMs since 2010.

The sample size of the PBM-sponsored study is much larger. It contained a

“sample of the top 200 self-administered, patent protected, brand-name drugs, 24 drugs were excluded because of incomplete data for the study time period, leaving a remaining sample of 176 drugs for analysis”.

First, the initial sample size of 176 was aggregated in 23 therapeutic classes with the averages used in plots.  No mention is made as to whether the 23 data points represent simple or averages weighted by revenue.  In any case, samples of averages smooth out differences in the raw data.

Second, the larger sample size could contain significant number of drugs that just are not “rebatable” — in “aging” therapeutic classes with a 4+ brand drugs that are therapeutically equivalent (“me-too drugs”) plus a number of off-patent, low cost generic drugs.

In short, we believe that the sample used in the PBM-sponsored study is a smoothed-out representation of the outcomes of negotiations between drug companies with “rebatable” brand drugs and the Big 3 PBMs.

 

Blame Pharmacy Benefit Managers For Driving Drug Price Inflation

Lawrence W. Abrams No Comments

Summary:

We start with a review of the history of the opaque pharmacy benefit manager (PBM) reseller business model. We present our prior estimates of the distribution of PBM gross profits over the past decade showing that they have become dependent today on retained rebates from specialty drugs.

Next, we present numbers showing how PBMs today have painted themselves into a corner with a relatively small basis for drug rebates coupled with promises to hold their overall average rebate retention rate, a term we coined in 2003, to a “reasonable” 10%.

We conclude the paper with a deconstruction of the growing divergence between brand drug list prices (gross) and the prices Pharma actually receive after PBM rebates (net) — the so-called “gross-to-net price bubble”.  We use data supplied by the drug company Merck to go through a step-by-step sequence of how PBMs and drug companies might negotiate the parameters of a rebate deal today under the constraint that PBMs have to grow gross profit DOLLARS over time while fixing the rebate retention rate at 10%.  

We show that the outcome of such constrained negotiations produces a gross-to-net price bubble.

The “Gross-To-Net Price Bubble”

Before 2017, there had been two well-publicized exposes of massive increases in the list price of off-patented brand drugs that were rubber-stamped by pharmacy benefit managers (PBMs).  This included Mylan’s EpiPen and Martin Shkreli and his Turning Pharmaceutical’s HIV drug Daraprim.

There are now numerous reports providing quantitative evidence of outrageous increases in specialty brand drugs list prices over the past 5 year.  For example, consider this table of list price inflation between 2012-7 of Multiple Sclerosis drugs taken from Congressman Michael Vounatsos’ request to manufacturers for more information:

In April 2017, Adam Fein first reported on his blog Drug Channels that the health information company QuintilesIMS had just published  aggregate trend data for brand name drug prices before (gross) and AFTER rebates (net) had been paid to pharmacy benefit managers (PBMs).

The data showed  two trends beginning in 2011: (1) gross prices were growing faster than net prices; (2) the divergence itself was growing.

Dr. Fein coined the term “gross-to-net rebate bubble” to describe (2) above, which has become the standard lexicon for the phenomena. Below is graph summarizing QuintilesIMS latest findings taken from an April 2017 blog post by Dr. Fein:

The PBM Business Model:  2005 – 2010

In an earlier 2017 paper, we presented the case that there has been three distinct phases of the pharmacy benefit manager (PBM) business model over the past 15 years. Each has been demarcated by radical shifts in their primary source of gross profits:

  1. up to 2005 — reliance on retained rebates from small molecule brand drugs;  
  2. 2005 – 2010 — reliance on mail order generic Rx margins;
  3. 2010 – today — reliance on retained rebates from specialty drugs.

Below is graph of our estimates of the distribution of PBM gross profits over the past 15 years.

The majority of PBMs gross profits between 2005 – 2010 came a mail order generic Rx.   The Big 3 PBMs devised a strategy of tacitly colluding with their counterpart Big 3 retail pharmacies — Walgreen, CVS, and Rite-Aid — to hold up margins on generic Rx fills.  

Essentially the Big 3 PBMs have the power to set their competitors’ prices, an anti-competitive weapon if there ever was one.   PBMs gave retailers fat margins for 30-day generics in return for promises not to compete on 90-day Rx.  Then, PBMs set the prices of generic Rx filled by captive mail order operations slightly less than retail to give the appearance of alignment with client interests.  But, the supply chain hold up still allowed for fat mail order generic Rx margins.

The first blow to this scheme came in late 2006 when Walmart saw the fat retail margins and began a disruptive  $4 / generic Rx campaign. They could do this as an “outsider” retailer because their business model wasn’t dependent on fat pharmacy margins subsidizing the rest of the store.

The final blow to this “hold-up” scheme came around 2008 several years after the vertical merger of the pharmacy retailer CVS and the PBM Caremark.   Consistent with the business model of the merged company, CVS-Caremark began offering preferred provider pharmacy networks featuring lower  unit prices at retail in return for Rx volume.  

While this managed care technique is used successfully in reducing hospital and physician costs, it has never really been instituted by PBMs prior to the CVS-Caremark merger.  This absence had been an obvious sign to us at the time of tacit collusion between the Big 3 retail pharmacies and the Big 3 PBMs.

The PBM Business Model: 2010 – today

To compensate for declining mail order generic margins after 2010, PBMs saw the rising trend of specialty and biotech drugs as a promising basis for a renewed reliance on retained rebates.

But there were several problems with the goal of deriving a majority of gross profits from specialty drug rebates.    Reconstructing how PBMs solved these problems is the key to understand why PBMs, not Pharma, drive the gross-to-net drug price bubble today.

First, assume that since 2010, the Big 3 PBMs needed additional gross profits each year from specialty drug retained rebates to replace incremental losses in margins from mail order generics Rx.

This creates a problem in that the specialty drug Rx volume “basis” for collecting rebates today is a lot less than it was ten years ago when small molecule drugs were the basis for rebates.  How much less?  The Pew Charitable Trust Foundation sponsored a study which found that in 2015 special Rx comprised only 1% of total Rx.  

A decade ago, we estimated that about 20% of total Rx filled were “rebatable” brand drugs, i.e. in therapeutic classes with a few other brand drugs that were therapeutic equivalents.  So instead of 1:100 specialty Rx to total Rx basis differential, we arrive at a 1:20 “rebatable” specialty drug Rx to “rebatable” small molecule brand drug Rx basis differential.

In other words,  ten years ago PBMs has 20 times the volume of Rx available to them to use as a basis for generating retained rebates as they do today.

The second constraint that PBMs have today is an awareness by their clients that retained rebate dollars can be a substantial yet opaque source of PBM gross profits.    

Today,  there seems to be an order of magnitude more articles critical of PBMs in general, and retained rebates specifically,  As a defensive move, CVS Health finally declared publicly on its website that,

“CVS Caremark was able to reduce trend for clients through… negotiation of rebates, of which more than 90 percent are passed back to clients.”

The problem facing PBMs today is how to derive a majority of gross profits from specialty Rx while maintaining a transparent rebate retention rate at 10% on average.

The business model of the drug companies is simple and stable by comparison.  Sure, drug companies want to maximize profits just like the PBMs.  But drug companies are not constrained as much as the Big 3 PBMs and don’t need a convoluted gross-to-net price scheme to achieve their targets.

It is important to remember that it takes two parties to negotiate drug rebate deals. Drug companies have some power in determining how these deals are structured, especially if there are only one or two other brands drugs that are therapeutic equivalents.

The Big 3 PBMs today have a lot of power in rebate negotiations.  Drug companies have a lot to lose if negotiations fall through.  Exclusion of a single drug from one of Big 3 PBMs’ national lists of drugs covered by an insurance plan  — called formularies — can cost a widely-used or expensive drug $3+ Billion dollars in lost revenue.

It is the Big 3 PBMs who drive schemes involving high-list-price / high-rebate specialty drug deals.  For now, drug companies are accomplices along for the ride. They are culpable, but much less so than PBMs.  

A Deconstruction of Merck’s Gross-to-Net Drug Price Bubble

We conclude the paper with a deconstruction of the growing divergence between brand drug list prices (gross) and the prices Pharma actually receive after PBM rebates (net) — the so-called “gross-to-net price bubble”.  We use data supplied by the drug company Merck to go through a step-by-step sequence of how PBMs and drug companies might negotiate the parameters of a rebate deal today under the constraint that PBMs have to grow gross profit DOLLARS over time while fixing the rebate retention rate at 10%.

We show that the outcome of such constrained negotiations reproduces produces a gross-to-net price bubble.

Below is a screenshot from a Merck memo laying out for all to see their “gross-to-net drug price bubble”.  Other drug companies are publishing similar data as a way of defending themselves against charges of “double-digit” price-gouging tactics.

This is a graphic depiction of Merck’s gross-to-net price bubble:

Below we build a spreadsheet which “deconstructs” Merck’s bubble for a hypothetical specialty drug.  It  shows how PBMs can grow retained rebates dollars via a combination of growing rebate percentages while maintaining a retention rate fixed at 10%.

A larger view of the spreadsheet above:

 

Note that despite being constrained to a 10% rebate retention rate, this deal scheme give PBMs yearly retained rebate DOLLARS that are 176% greater that what they received 6 years earlier.

Some have predicted that the divergence between gross and net prices will level off after 2017.

We tend to agree with that prediction as the current bubble was fueled by PBMs’ need to REPLACE a declining trend in gross profits from mail order generic Rx.  With that loss fully offset, PBMs could grow gross profits in the future by maintain a steady divergence between list prices and net prices.

PBM Drug Rebates

Lawrence W. Abrams No Comments

All papers downloadable .pdf

 Pharmacy Benefit Managers as Conflicted Countervailing Powers (01/07)

Who is Best at Negotiating Pharmaceutical Rebates? (12/05)

The Role of Pharmacy Benefit Managers in Formulary Design: Service Providers or Fiduciaries?
Journal of Managed Care Pharmacy Vol. 10 No. 4 July/August 2004 pp 359-60

PBMs as Bargaining Agents
Paper presented at the 80th Annual Western Economic Association Meeting, July 6, 2005, San Francisco

PBMs as Bargaining Agents
PowerPoint presented at the 80th Annual Western Economic Association, Meeting, July 6, 2005, San Francisco

The Effect of Corporate Structure on Formulary Design: The Case of Large Insurance Companies
Poster Presentation, ISPOR 10th Annual Meeting, Washington DC, May 2005

 

The Pharmacy Benefit Manager Business Model

Lawrence W. Abrams No Comments

CURRENT PAPERS:

Three Phases of the Pharmacy Benefit Manager Business Model (09/17)

It is Pharmacy Benefit Managers that Drive the Gross-to-Net Drug Price Bubble (09/17)

Merck Data Discredits PBM-Sponsored Study of Brand Drug Price Inflation (09/17) 

Pharmacy Benefit Managers: The Sopranos of The Specialty Drug Market (09/17)

Hepatitis C Virus Formulary Choices for 2018: Will CVS Caremark Risk Looking Bad? (09/17)

AbbVie’s Mavyret Hep C Drug Pricing is Disruptive to the PBM Business Model (09/17)

PAST PAPERS:

Pharmacy Benefit Manager Valuation and Profitability: Business Models Matter (07/09)

Medco As a Business Model Imperialist (07/08)

Quantifying Medco’s Business Model: An Update (11/08)

A Tale of Two PBMs: Express Scripts vs. Medco (11/05)

Searching for Windfall Profits from a Change in the AWP Markup Ratio (09/09)

Exclusionary Practices in the Mail Order Pharmacy Market (09/05)

Quantifying Medco’s Business Model (04/05)

Estimating the Rebate-Retention Rate of Pharmacy Benefit Managers (04/03)

Walgreen’s Transparency Issue (11/03)

 

An Amazon Read: The Future of Consumer-Directed Pharmacy Benefits – PBMs

Lawrence W. Abrams No Comments

All papers downloadable .pdfs

The Future of Consumer-Directed Pharmacy Benefits

Show Me the Display: A Review of an ESI Study of Consumer-Directed Pharmacy Benefits