TAKE ACTION FOR LOWER DRUG COSTS! STOP PHARMA’S BACKROOM DEALS!

Working with consumer advocates across the country, Consumer Catalyst has launched a campaign to stop  ‘Pay-for-Delay’ deals that hurt consumer health!

What you can do:

1. Sign the consumer petition on Change.org
2. Join the discussion on twitter and share your story, using the hashtag: Stop the #RxRacket! And ask others to share their stories too. Also follow us at @postscriptrx.
3. Join our community on Facebook to keep up with the campaign and join our email list of impacted consumers by sharing your story.

You can also tell us your story, if you are interested in joining us as a consumer advocate and speaking out on these issues to local media.

Pharmaceutical companies are colluding to keep drug prices high – and taking that money right out of your pocket.

Did you know drug companies have made more than 160 secret, back-room deals that

• Have kept 100 generic drugs or more off the market for years
• Drive up the cost of each drug by an average of $3,000 a year
• Keep all of our prescription costs high, while divvying up the spoils!

Right now, the Supreme Court is currently deliberating over whether these back-room deals are legal – but we know they’re wrong. Since 2005, as many as 142 different generic drugs have been unfairly kept from consumers, according to government reports. Delaying the launch of a generic drug lets the drug companies make bigger and bigger profits, while patients are stuck footing the bill, or going without the medicines they need.

The Supreme Court heard arguments by the drug companies, and fortunately Justices Kagan and Sotomayor raised consumer concerns – but the Court did not hear the perspective of the thousands of Americans unable to afford their medications. That’s because most people don’t even know that these deals are costing consumers thousands, and our health system billions of extra dollars, each year!

Help us raise awareness of this #RxRacket. The public deserves to know how this decision will affect us all – how thousands of Americans are being forced to choose between skipping their medications or going into credit card debt, just so that drug companies can make even more profit. Not to mention, how health care costs for everyone have gone up, because insurers pay most of these higher costs!

Whatever the Supreme Court decides, help spread the word, so we can help make sure that these deals come to an end, once and for all.

Target drugs: 
If you have taken Cipro, Provigil, or Androgel, you have definitely paid more because of a pay-for-delay settlement. And according to legal experts, it is very probable that many drugs including blockbuster drugs like Lipitor, Plavix and Nexium — have been delayed by pay-for-delay deals.*

We need you to tell everyone you know that this is happening, and help gather and share the stories of people you know that have been negatively impacted. Read the stories shared by two women, Tanna and Karen, who were unable to afford their medications due to pay-for-delay deals that kept generic Provigil off the market for six years. Also, read how the companies’ legal arguments make no sense.

You can find all the information you would ever need about this issue on our Pay-for-Delay info page. Please also feel free to add your thoughts on this #RxRacket in the comments, below.

Thank you for helping us protect your right to affordable medicine!

*The Full List – Drugs Likely to Have High Prices from ‘Pay-for-Delay’ Deals:
Adderall XR, Aggrenox, Altace, Arthrotec, Caduet, Carbatrol, Clarinex, Comtan, Duac, Effexor XR, Eloxatin, Ethyol, Femcon Fe, Fentora, Flomax, Lipitor, Lamictal, Levaquin, Lexapro, Loestrin-24 Fe, Loprox, Lotrel, Lybrel, Namenda, Naprelan, Nexium, Niaspan, Niravam, Olux, Opana ER, Ortho Tri Cyclen Lo, Oxytrol, Plavix, Propecia, Razadyne, Razadyne ER, Rythmol SR, Sinemet CR, Skelaxin, Solodyn, Stalevo, Tricor 145mg, Vanos, Vfend, Wellbutrin XL (150 mg), Xopenex, and Zantac!

A surprising decision in the Second Circuit has breathed new life into legal efforts to prevent drug makers from paying to keep generics off the market.

Since 2005, the drug industry has increasingly used multi-million dollar ‘pay-for-delay’ settlements to prevent generic drugs from coming to the market. The PAL coalition has opposed this industry collusion with lawsuits on Provigil, Tamoxifen, and Cipro, and through our support for legislation (introduced by Rep. Rush and Sen. Kohl). The FTC has also been a steadfast opponent of these anti-competitive agreements and their negative impacts on consumers. Unfortunately, the ability of FTC or PAL members to challenge these settlements in the courts has been hampered by a number of unfavorable legal decisions.

The Second Circuit’s Cipro Decision

The Second Circuit’s April 29th ruling did dismiss the challenge to the ‘pay-for-delay’ settlements totaling $398 million that have prevented a generic version of Cipro from coming to the market. But the Court did so begrudgingly, and then invited the folks bringing the lawsuit to ask the Second Circuit to revisit the question of whether these settlements are legal under anti-trust protections. Even more surprising, the Court then spelled out why. 

In their decision, the three judge panel stated that a review of the binding precedent established under Tamoxifen by the full nine-judge panel for the Second Circuit (called an ‘en banc review’) may be appropriate for four reasons: First, the Court said that United States Department of Justice has urged a review of this decision saying that “Tamoxifen adopted an improper standard that fails to subject reverse exclusionary payment settlements to appropriate antitrust scrutiny.” Second, the Court found that “there is evidence that the practice of entering into reverse exclusionary payment settlements has increased since we decided Tamoxifen.” Third, the panel stated that “after Tamoxifenwas decided, a principal drafter of the Hatch-Waxman Act criticized the settlement practice at issue.” Finally, the Court noted that the Tamoxifen decision was based in no small part on the now erroneous understanding that a pay-for-delay settlement with the first generic competitor would not prevent other generic competitors from attempting to followand file suit.

The 2005 Tamoxifen decision by the Second Circuit Court of Appeals (which covers New York, Vermont, Connecticut) dismissed an FTC order challenging a pay-for-delay settlement. The Tamoxifen Court ruled the practice legal under anti-trust law, because the settlement provided drug maker AstraZeneca with no more protection from generic competition than their patent already did.

This Tamoxifen decision, along with the Eleventh Circuit’s Schering-Plough decision in 2005, and Federal Circuit’s 2008 Cipro decision, have been mounting obstacles to consumer and FTC efforts to oppose these settlements. Only the Sixth Circuit, in its 2002 Cardizem decision, has held that such agreements to “eliminate competition” are a “per se illegal restraint on trade.”

When the Appeals Courts from different US Circuits arrive at differing legal standards, the US Supreme Court should resolve this inconsistency, or ‘split’ between the Courts. Indeed, the PAL-member lawsuits concerning Cipro and Tamoxifen asked the Supreme Court to do just that, as has the FTC. So far, all of these requests have been denied. But a possible reversal in the Second Circuit might change things.

Consumers, legal and medical experts, and the Administration all file briefs in opposition to continued legality of pay-for-delay settlements

Amicus briefs in support of the request for a reconsideration of the Tamoxifen standard were filed by PAL and PAL coalition member AFSCME DC37; AARP, AMA, and the Public Patent Foundation; Consumers Union, US Pirg, Consumer Federation of America, and the National Legislative Associaton on Prescription Drug Prices. Also filing briefs were the American Antitrust Institute, the FTC, and the Department of Justice’s Anti-Trust division.

The amicus brief for the Department of Justice argues that ”by shielding most private reverse settlement agreements from antitrust liability, the Tamoxifen standard improperly undermines the balance Congress struck in the Patent Act between the public interest in encouraging innovation and the public interest in competition.”

The amicus brief from the Federal Trade Commission (FTC) added three additional reasons to those stated by the Second Circuit panel. FTC argued that the Tamoxifen standard gives drug companies an improper incentive to pay off generic drug manufacturers and protect even the weakest patents.

Next, FTC noted that the number of pay-for-delay settlements had grown since 2005, to now insulate “at least $20 billion in sales of branded drugs from generic competition.”

The FTC estimates (very conservatively in our opinion) that these settlements will continue to cost $3.5 billion a year by delaying competition from lower-priced generics, but warned that these costs may grow.

 The amicus brief submitted by PAL and PAL member AFSCME District Council 37pointed out that these settlements have cost consumers and health plans $12 billion or more each year in lost savings on generic drugs, and the costs are likely to increase as brand-name drug prices go up (as they did by 9.2 % in the year ending on March 31, 2010) while generic drug prices decline (as they did by 9.7 % during this time period.) Aside from the effect that higher costs have on reducing access to needed medicines, PAL pointed out how these settlements threaten to reduce the quality of care for consumers by limiting the drug options available to them. PAL pointed out that consumers of the drug Provigil, which is protected from generic competition by a pay-for-delay settlement, end up entering the donut hole faster and paying huge sums out of pocket when their health plans refuse to cover the drug due to its high cost.

AARP, the AMA, and the Public Patent Foundation filed a brief arguing that these settlements threaten our health care system because they undermine consumer access to generic drugs, which have, on the whole, “saved consumers over $734 billion in the last 10 years.” AARP noted that “[e]ven for those patients who are insured but who are on fixed or limited incomes, having a generic option is often the difference between having access to health care treatment and not having any treatment option at all.”

AARP’s brief warned that the Tamoxifen precedent will have long-term negative consequences on the well being of consumers because “when a generic pharmaceutical’s entry into the market is delayed, it limits treatment access to vulnerable patient populations and prolongs the difficulty that physicians have in prescribing affordable treatment options.”

An amicus brief filed by Consumers Union, Consumer Federation of America, U.S. PIRG and National Legislative Association of Prescription Drug Prices pointed out that the Tamoxifen decision allows the pay-for-delay settlements that “prevents patent challenges” which is contrary to the purpose of the Hatch-Waxman Act to “encourage[] patent challenges…..”

The American Antitrust Institute filed an amicus brief highlighting the anticompetitive nature of these settlements, and the Attorney Generals from 34 States filed an amicus noting that “the Cipro case is also of exceptional importance because the United States Supreme Court has refused to review the split between the Sixth and Eleventh Circuits.”

Industry use of these pay-for-delay settlements has driven up costs and prevented access to needed medicines for millions of consumers. This industry practice has prevented or delayed generic versions of the drugs Cipro, Provigil, Androgel, and many other drugs that amount to $20 billion of our nation’s current $278 billion in drug spending, according to the FTC.

PAL, Community Catalyst, and dozens of PAL coalition members have opposed these settlements through lawsuits and legislative advocacy. Please contact us if you would like to join in our work to oppose these anti-competitive settlements.

 — by Emily Cutrell and Wells Wilkinson

PAL’s most important lawsuit and settlement to date wins final approval!

Yesterday, the Massachusetts federal District Court approved class action settlements with publishers First Databank and MediSpan that will require the roll back the illegally inflated prices of over 400 drugs!

PAL coalition members AFSCME District Council 37 Health and Security Plan in New York, and New England Carpenters Health Benefit Fund here in Boston brought the lawsuit against these two publishers, and the pharmaceutical wholesaler McKesson, for their role in unilaterally raising the prices of over 400 drugs through their alleged manipulation of the published “average wholesale price” or AWP. Though the system of pharmaceutical pricing and reimbursement is complex, the AWP is a benchmark that is used by insurers and government programs to reimburse pharmacies. It also effects the cost to cash-paying customers. It is alleged that defendants First Databank, Medispan, and McKesson raised the AWP, while keeping the actual cost (called a ‘wholesale acquisition cost’) the same. This done to give  the large chain and other pharmacies, many of which are McKesson’s customers, an increased return on each of these drugs.

It has been estimated that this 5% increase in the cost of hundreds of drugs by the defendants may have cost consumers, insurers, and government programs over $2 billion in additional drug expenses.

It is estimated that the “rollback” of the price of these 400 drugs could yield between $1.5 Billion or more in future savings on drug costs. Perhaps of even greater importance, this lawsuit, along with other litigation (AWP, Remicade, Lupron) by PAL members, has exposed the weaknesses of the pharmaceutical pricing system that have allowed drug makers and wholesalers to manipulate or “game” the benchmark prices that government programs and insurers use for reimbursement.

The Judge in the case did allow a six month delay before the rollback of the drug prices, ” to alleviate the impact on independent and rural pharmacies.” This addressed the concern raised that small ‘mom and pop’ pharmacies may be forced to bear the full cost of the price rollback if they were unable to renegotiate their supply contracts for drugs with manufacturers and wholesalers.

The settlement also provides $2.7 million to be distributed along with the $350 Million in the preliminary McKesson settlement.

Thanks to PAL members New England Carpenters Health Benefit Fund, and AFSCME District Council 37 Health and Security Plan in New York for their work in bringing this important lawsuit.

Follow these links to see a copy of the Judge’s decision, the First Databank settlement, the Medispan settlement, or the pending McKesson settlement.

Members of Prescirption Access Litigation’s coalition are plaintiffs in a national class action lawsuit that alleges the Cephalon (Nasdaq:CEPH) illegally took steps to keep a less expensive generic version of its narcolepsy drug Provigil off the market, including paying off generic drug companies that challenged Cephalon’s patents on Provigil to not try to bring a generic to market. So we follow news about Provigil quite closely.

Back in September, we wondered aloud “Why did Cephalon close its Provigil Patient Assistance Program.” We speculated:

Cephalon jacked up the price of Provigil 14% back in March [2008], according to a Bloomberg News report. US sales of Provigil for the first half of the year were $417 million. Given that Provigil’s total 2007 sales were $744 million, the drug’s sales are growing….

Provigil is clearly a money maker for Cephalon, approaching the magic $1 billion “blockbuster” market. Provigil has on the one hand deprived consumers of a more affordable generic and on the other hand told uninsured patients seeking assistance that they’re out of luck halfway through the year….

One can’t help but wonder if the Patient Assistance Program’s closure has anything to do with the anticipated introduction next year of Nuvigil, a “successor drug” to Provigil. Nuvigil (armodafinil) is the “single isomer” formulation of Provigil (modafinil), which means that Nuvigil is just one half of the molecule that gives Provigil its kick.

The Wall Street Journal reported this week in How a Drug Maker Tries to Outwit Generics:

Twice this year, Cephalon Inc. has sharply raised the price of its narcolepsy drug Provigil. The drug is now 28% more expensive than it was in March and 74% more expensive than four years ago…The Frazer, Pa., company has said in investor presentations that it plans to continue to raise the price.

The Provigil price increases — the drug’s average wholesale price is now $8.71 a tablet — are an extreme example of a common tactic pharmaceutical companies employ in the U.S. to boost profits and steer patients away from cheaper generics.

It works like this: Knowing that Provigil will face generic competition in 2012 as its patent nears expiration, Cephalon is planning to launch a longer-acting version of the drug called Nuvigil next year. To convert patients from Provigil to Nuvigil, Cephalon has suggested in investor presentations it will price Nuvigil lower than the sharply increased price of Provigil.

By the time copycat versions of Provigil hit the market the company is banking that most Provigil users will have switched to the less-expensive Nuvigil, which is patent-protected until 2023. In the meantime, Cephalon will have maximized its Provigil revenue with the repeated price hikes.

“You should expect that we will likely raise Provigil prices to try to create an incentive for the reimbursers to preferentially move to Nuvigil,” Chip Merritt, Cephalon’s vice president of investor relations, told a Sept. 5 health-care conference, according to a transcript of the meeting.

A more cynical statement by a pharmaceutical spokesperson is hard to find, and that’s saying a lot. What this statement means is that Cephalon is apparently willing to force patients to pay more — for no reason other than to boost sales of its new drug, Nuvigil, and get patients and physicians to switch to it – all before a generic version of Provigil hits the market, which likely will cost 70-80% less than Provigil within a year of a generic being available.

Increasing drug prices, of course, are apparently par for the course in the U.S. But, as the WSJ points out, “Provigil’s price increase over the past four years has been almost four times steeper than the 4% compound annual growth rate of the average drug price during that period, according to a DestinationRx analysis of 2,570 brand-name drugs.”

We at PAL hear from patients on a daily basis who cannot afford Provigil. These include people who are uninsured, people who are in the Medicare Part D “donut hole,” people who have qualified for Social Security Disability Income (SSDI) but who are stuck in the ridiculous 2 year waiting period to get on Medicare, and people whose insurance won’t pay for Provigil.

For many of these people, they need Provigil in order to have functioning daily lives — we’re not talking about, as the WSJ describes, people take Provigil for uses not approved by the FDA, “as a ‘lifestyle drug’ to help them stay awake during work or leisure activities.” We’re talking about people like Jessica, who described her inability to afford Provigil in Jessica’s story: No help from Cephalon for cost of Provigil.

Making payoffs to keep generic Provigil off the market, raising its price at a rate four times higher than other drugs, closing its patient assistance program halfway through the year — all we can say is shame on Cephalon.

(Got a Provigil story to tell? Post a comment below.)

Drug Benefit News brings us this fascinating story: Caterpillar/Wal-Mart Rx Drug Pilot Scraps Use of Average Wholesale Price, Uses Drug Cost-Plus Pricing.

Readers of this blog know that we are prone to getting on a soapbox about the flawed “Average Wholesale Price” (AWP) system that health plans and many government programs (like Medicaid) use to decide how much to pay pharmacies for prescription drugs. In fact, a number of members of our coalition have brought class action lawsuits against drug companies, drug pricing publishers and major drug wholesalers for allegedly inflating the Average Wholesale Prices of prescription drugs.

In a nutshell, pharmacies generally are very protective of the details of how much they pay to drug companies and wholesalers for the drugs that they then sell to consumers and health plans. They argue that revealing those prices would put them at a competitive disadvantage. So, health plans and governments are forced to decide how much to pay for drugs without knowing what the pharmacy paid. The Average Wholesale Price was intended to approximate what pharmacies in general were paying for a drug. The health plan would then agree in a contract with a pharmacy that they’d pay them an amount based on the AWP of each drug — say, AWP minus 5%. The idea was that a health plan would pay a pharmacy an amount that would be a modest amount higher than than what the pharmacy paid – the “actual acquisition cost.”

But AWPs no longer have any basis in any reality — the joke is that AWP stands for “Ain’t What’s Paid.” In the lawsuits mentioned above, there are examples cited where the AWP was many times, even tens or hundreds of times, higher than what pharmacies were actually paying. This meant that health plans were overpaying pharmacies — often massively – for prescription drugs.

First Databank and Medispan, two of the defendants in a class action lawsuit on this issue, have voluntarily agreed to stop publishing AWPs within approximately the next two years. Since these two companies are pretty much the only ones who publish AWPs anymore, this information is going to cease to be available pretty soon. That means that health plans, pharmacies and government programs are going to have to figure out an alternative. And that’s a major question still up in the air — what are they going to use instead of AWP?

Well, it looks as though WalMart (NYSE:WMT) and Caterpillar (NYSE:CAT) are already thinking about that, and have come up with an alternative — at least for those two companies. As Drug Benefit News explains:

A new pharmacy benefit pilot program involving Caterpillar Inc. and Wal-Mart Stores, Inc. cuts “significant waste” out of the pharmaceutical supply chain and scraps the long-maligned average wholesale price (AWP) discount methodology in favor of an Rx cost-plus model, say those involved in the program…

When Caterpillar approached Wal-Mart, the first thing the parties did was address the question of AWP, which Bisping describes as a “flawed methodology.” Typically, PBMs negotiate discounts off AWP, which can be wildly inflated and bear little resemblance to the true cost of the drug.

To address this concern, Caterpillar developed a new pricing methodology based on Wal-Mart’s actual invoice prices on drugs, Bisping says, adding that AWP doesn’t appear at all in the contract. “For all of the drugs that we purchase now from Wal-Mart, the core basis is on the real invoice price, of course, plus some money for their overhead and any margin they have to make,” he explains.

The article doesn’t go into very much detail about what this “new pricing methodology” actually means. We’re willing to bet that there are heavy-duty confidentiality provisions in the contract to prohibit Caterpillar from revealing the “real invoice prices” that Wal-Mart pays for drugs.

What’s most intriguing about this new model, as scant as the details are, is that it’s based on actual prices, instead of inherently unreliable and unverifiable “benchmark” prices. Basing drug reimbursements on actual costs is something we’ve supported for a long time, including in an article that ran several years ago in the BNA Pharmaceutical Law & Industry Report.

Another interesting aspect of this agreement is that it basically cuts out the traditional middleman between an employer (or health plan) and a pharmacy: the Pharmacy Benefit Manager (PBM). The PBM industry grew massively in the 90s to save employers and health plans from the hassle of having to engage in such negotiations. Now, Caterpillar is quite a large company, so don’t expect to see small- or even medium-size companies or health plans negotiating directly with pharmacies anytime soon. And Caterpillar’s PBM doesn’t seem that worried:

For their part, RESTAT [Caterpillar's PBM] executives say they are more than happy to assist Caterpillar with the program. The Wal-Mart agreement doesn’t do anything to change RESTAT’s basic relationship with Caterpillar, except for some negotiating relationships on acquisition costs at the pharmacy level, says David Kwasny, vice president of sales and marketing.

“We’re very flexible,” he tells DBN, adding that RESTAT is a highly transparent PBM that doesn’t make any spread on pharmacy utilization. “It’s not a conflict for us.”

Is this a sign of things to come? Can we expect to see other large employers and insurers moving away from AWP? With the coming demise of AWP, it’s inevitable. Let’s hope that other employers and health plans follow suit in the near future, rather than waiting until AWP is on its way out the door.

Drug companies are required by federal law to extend discounts that they give to health plans, hospitals and other private purchasers to Medicaid and other government health care programs. This is based on the idea that government programs should get as good a deal as any private purchaser.

There’s a complicated system to set the maximum price that can be charged to state Medicaid programs, community health centers and other health facilities serving uninsured and underserved patients. This system relies on so-called “best price” information that drug companies are required to provide to the Center for Medicare and Medicaid Services (CMS). CMS is the federal agency that runs both Medicare and Medicaid.

But this system only works as it should when drug companies accurately and honestly report to CMS the prices they’ve given to different purchasers. If a drug companies conceals a discount it offered to a private entity, then states and the federal government end up paying more than they are legally supposed to. There have been numerous lawsuits brought against drug companies for failing to report accurate “best prices,” resulting in hundreds of millions of dollars in settlements. (Taxpayers Against Fraud’s website describes many of these)

But until recently, only states or the federal government itself could go after drug companies for “best price fraud.” Community health centers, certain hospitals, and other providers couldn’t enforce their rights to similar ‘best price’ discounts under a federal law known as “340B,” until recently.

In August 2005, Santa Clara County (California) filed a lawsuit against a group of pharmaceutical companies on behalf of 340B-covered entities. Santa Clara County operates seven hospitals or health clinics which are “covered entities” under 340B, meaning they are entitled to the discounts that are based on “best price” calculations. This lawsuit was in response to reports issued in March 2003 and June of 2004 by the Office of Inspector General (OIG) of the Department of Health and Human Services. These reports documented that 340B entities were being significantly overcharged for a wide range of drugs. A 2006 OIG report, for instance, estimated that 340B entities overpaid $3.9 million in a single month (June 2005).

Santa Clara County’s case was dismissed, in part because the federal Court hearing the case held that 340B entities didn’t have the right to sue to enforce the contracts that drug companies enter into with CMS, called Pharmaceutical Pricing Agreements (“PPA”).

Normally, only the parties that make a contract have the right to enforce its terms in court. But the exception to this rule is called “third party beneficiary.” Parties can create a contract for the benefit of a third person or entity who’s not one of the parties signing the contract. A good example is life insurance – let’s say Jack buys a life insurance policy (which is a contract) from Acme Insurance, and lists Jill as the person who will receive the proceeds in the event of his death. If Acme refused to pay her upon Jack’s death, Jill could sue Acme as the third party beneficiary of the contract.

Similarly, Santa Clara County had argued that their county hospitals and health centers, as 340B entities, were the third party beneficiaries of the PPAs. The District Court disagreed, and dismissed the case. But on August 27, 2008, the Ninth Circuit Court of Appeals ruled that the County and other 340B entities are the ‘intended beneficiaries’ of both the contract and the federal law that sets the prices, so Santa Clara County could sue to enforce the PPA contract. This of course is not the end of the saga – the lawsuit now returns to the District Court, where it will pick up where it left off.

There’s a particular irony about this lawsuit. Members of Prescription Access Litigation have brought a number of class action lawsuits alleging fraud in the Average Wholesale Price (AWP) system (see here and here). Most private insurers and pharmacies purchase drugs from drug companies and wholesalers based on AWPs, which are self-reported by drug companies but not subject to any government oversight.

By contrast, the data that drug prices paid by Medicaid and 340B entities are based on are reported to CMS and are subject to audit and enforcement. Yet, as the OIG’s reports have amply demonstrated, no one’s minding the store — the federal government is not adequately monitoring whether or not drug companies are reporting accurate price information. While there have been hundreds of millions of dollars in settlements with drug companies for reporting false “best prices,” these cases are most likely the tip of the iceberg.

The price information reported to CMS is confidential, presumably on the notion that it’s a “trade secret” or that revealing information on discounts would help companies’ competitors. Since there’s no transparency, it’s essential that the agencies charged by Congress with policing the system actually do so. Otherwise, the only avenue to recover overpayments requires 340B entities, like Santa Clara County, to sue years after the fact. And even if Santa Clara County’s suit is successful, or settles, the drug companies accused in the complaint have held on to many millions of dollars in improper overcharges for years, depriving health systems that care for some of neediest members of society of much needed funds.

We’ve frequently reported here on the Prescription Access Litigation (PAL) blog about the class action lawsuit brought by PAL coalition member SEIU Health & Welfare Fund and others against Abbott Laboratories [NYSE:ABT], challenging Abbott’s December 2003 price increase of 400% on its HIV/AIDS drug, Norvir. That lawsuit alleged that Abbott’s price-hike was intended to increase the sales and market share of another Abbott HIV/AIDS drug, Kaletra.

We’re pleased to announce that SEIU Health & Welfare Fund, the two individual plaintiffs in the class action and Abbott agreed to a proposed settlement of the case on August 13, 2008. Abbott has agreed to pay between $10 Million and $27.5 Million, depending on court rulings to come, to settle the nationwide claims by consumers who were overcharged for the medicine.

There have been a number of important decisions by the Court to date that have set the stage for this settlement. On June 11, 2007, the Court certified the case as a nationwide class action. On May 16, 2008 the Court issued a ruling that was a partial victory for the plaintiffs and a partial victory for Abbott. The Court held that Abbott could not claim a patent that it holds on Norvir as a defense to the plaintiffs’ claims (the partial win for the plaintiffs). However, the Court also dismissed the plaintiffs’ claims for “unjust enrichment.” These claims alleged that Abbott was “unjustly enriched” by its allegedly illegal Norvir price hike.

What’s important about this dismissal is that these common law unjust enrichment claims were the only nationwide claims for monetary damages (as opposed to claims for “injunctive relief,” that is, for changes in company practices) in the case. When the Court dismissed these claims, the only claims for damages that remained in the case were under California state law. Thus, in a nutshell, after the Court’s May 16 order, the case for monetary damages was narrowed to cover just consumers and health plans in California.

Abbott had asked the Court to allow an “interlocutory appeal.” This means, basically, that Abbott asked the District Court to ask the 9th Circuit Court of Appeals to make a decision on a particular question of antitrust law that Abbott felt could determine the outcome of the case. The Court refused, since the trial was at that point only three months away.

The proposed settlement attempts to get the Court of Appeals to resolve this and several other legal issues, and to tie the amount of the settlement to the decisions of the Court of Appeals. Abbott and the plaintiffs will ask the court hearing the case (the federal District Court for the Northern District of California) to allow them to appeal three legal issues to the 9th Circuit immediately. These legal issues are ones that have been essential to the plaintiff’s success so far, and which Abbott would likely appeal if the plaintiffs were to win at trial.

There are several different forms the settlement could take, depending on how this appeal goes:

• If the District court ”certifies” all three questions up to the Ninth Circuit for appeal, and the Ninth Circuit accepts at least two of them, Abbott will pay a non-refundable $10 Million in to a settlement fund. That $10M (and possibly more – see below) would eventually be distributed to 13 different non-profit organizations that benefit people with HIV/AIDS. (See a list of those organizations here).
• How much Abbott would have to pay beyond the initial $10M depends on how the 9th Circuit rules on the appeals questions:
  • If Abbott wins the appeal of any of the three questions before the Ninth Circuit, then it doesn’t pay anything beyond the initial $10M.
  • If the plaintiffs win on all the questions before the 9th Circuit, then Abbott must contribute another $17.5 Million to the settlement fund.
  • If the 9th Circuit “remands” (sends back) the case to the District Court for any reason (such as asking the District Court to make findings of fact), then Abbott must contribute only $4.375 Million more to the settlement fund.

In a nutshell, Abbott will ultimately pay between $10M and $27.5M. After the attorneys’ fees and expenses are paid (approximately 1/3 of the total), here is how the rest of the settlement will be divided:

• If Abbott wins any one of the questions before the Ninth Circuit, then the $10M, reduced to $6-7 M after costs and attorneys’ fees, will be distributed equally to all the cy pres recipients on the list above.
• If, however, the court remands any question, or if the Plantiffs win all the questions, then the settlement amount ($14.3M or $27.5M respectively, before legal costs and fees, or between $9.6 and $18.4M after) will be divided, with
  • 70% of it (between $6.7M and $12.8M approximately) going to the 13 organizations described above, and
  • 30% (between $2.9M and $5.5M approximately) going to consumers and TPPs in California)

Confusing? Yes. But the settlement is a creative resolution of the lawsuit. It takes into account the different possible outcomes to a trial and inevitable appeal, and essentially adjusts the amount of the settlement accordingly.

The Court has scheduled a hearing for August 19 on whether to grant “preliminary approval” to the Settlement. If it does grant that approval, notice will be published to alert members of the class about the proposed settlement. Consumers and TPPs that paid for Norvir will have the option of opting out of the settlement (if they want to pursue their own individual lawsuits against Abbott), objecting to the terms of the settlement, and, if they are located in California, filing claims forms to receive a portion of the settlement proceeds. The Court will schedule a Final Approval hearing for several months from now. After that hearing, the Court will decide whether to grant Final Approval to the settlement. If it does grant that approval, and after any appeals, the money in the settlement will be distributed as described above.

To see a copy of the settlement, go here.

Other resources:

• A summary of the lawsuit challenging Abbott’s price hike of Norvir
• Earlier PAL blog entries on the plaintiff’s successful class certification, Abbott’s attempt to keep damaging documents from public view, or the plaintiff’s anti-trust claims.

Recently, we posted an entry here titled “What is Abbott trying to hide? Maker of Norvir asks Court to deny public the right to see documents.” We’re pleased to report that the Court denied Abbott’s motion to keep some documents under seal. We analyze these documents below.

In 2003, Abbott Laboratories (NYSE:ABT) raised the price of its HIV/AIDS drug Norvir (ritonavir) by 400% overnight. Norvir is used in combination with other “protease inhibitors,” (PIs) and it “boosts” the effectiveness of the PI it’s used with. Abbott also makes a combination pill called Kaletra that includes both Norvir and its own PI – when they raised the price of Norvir, they didn’t raise the price of Kaletra.

Prescription Access Litigation coalition member SEIU Health and Welfare Fund filed a national class action lawsuit against Abbott. The lawsuit claimed that Abbott violated federal anti-trust laws, alleging that Abbott raised Norvir’s price in order to boost sales of Kaletra, at the expense of competing PI drugs that require Norvir as a booster. In a nutshell, the lawsuit argued that Abbott tried to “leverage” its patent-protected monopoly over Norvir into a monopoly over the market for protease inhibitors.

As we’ve discussed before, Abbott has fought throughout the litigation to keep documents regarding the price increase of Norvir sealed. Abbott’s lawyers recently argued that a set of documents that they wanted shielded from public view contain “highly confidential information related to … how Abbott analyzes, views and makes strategic business decisions in the HIV pharmaceutical market.” [Order, p2.

But after a Judge recently ordered some of the documents unsealed (a copy of the Judge’s order is here) it became clear why Abbott wanted to keep what was in these documents hidden from public view.

First, these documents revealed Abbott’s disregard of how a price increase would affect HIV/AIDS patients. An email from Abbott executive Jesus Leal shows three strategies that Abbott considered to drive up sales of Kaletra, despite the potential interference with patients’ existing or future treatment regimens.

One strategy was to sell Norvir in three ways: as an ingredient in Kaletra, as a separate pill priced at five times its former price, or at the original price in a liquid form that Abbott executives admit tasted “like someone else’s vomit.” Given that many protease inhibitors have nausea as a possible side effect, even considering a strategy that would force the many HIV patients who could not afford a five-fold price increase resort to taking the foul-tasting liquid Norvir is reprehensible.

Another strategy considered was to stop selling Norvir altogether, and offer only Kaletra. But switching to Kaletra is not medically appropriate for many HIV/AIDS patients, because they eventually have to change to different PI drugs as the virus mutates and becomes resistant. A premature switch to Kaletra would deprive patients of a treatment option that they would otherwise have held in reserve until absolutely necessary.

Further, one side effect of Kaletra is hyperlipidemia (high cholesterol), which leads to higher risks of heart attack and stroke. Thus Kaletra may be less appropriate for some HIV patients than other treatments which combine Norvir(ritonavir) and other PI drugs as necessary.

Abbott considered – and eventually adopted -- a third strategy – continue selling Kaletra, but increase Norvir’s price to five times its former price. Since this time, Kaletra sales have grown significantly, from $400 million in 2003, to between $682 and $900 million in 2004, and $1.14 billion in 2006.

Exhibit 18 also reveals that Abbott planned to argue that their price increase was necessary because it was “no longer feasible for Abbott to provide a production line of Norvir capsules at the current price.” Abbott executives speculated that a price increase had a notable weakness - the company would face “exposure on price if forced to open books.” They were right. Their own released documents show that it was profit motivations and market factors, not ‘feasibility’ that caused Abbott’s unconscionable 400% price increase of the widely needed drug Norvir.

It is apparent from these documents that patient and consumer concerns were secondary to, if not absent from, Abbott’s financial considerations. One released document [Exhibit 39] has a chart summarizing a proposed slide presentation on the price increase. Not surprisingly, the one slide summary labeled “Public Relations and Activist Slide” has no summary at all, just a question mark “(?).” This shows that Abbott knew that it would be lambasted by activists for its unconscionable price increase, and that there was no good response to this criticism.

The only remorse or reservation shown in these documents was a comment by Abbott’s Vice President of Global Pharmaceutical Development, John M. Leonard, M.D. He responded to Abbott’s proposals to limit access to Norvir “I think we are on the right (but uncomfortable) track.” [Exhibit 28] ‘Uncomfortable’ is a gross understatement given that the price hike Abbott was proposing increased the annual cost of Norvir for an uninsured patient from $1,300 to $6,600 a year.

The true purpose of the price increase demonstrated: Boost Kaletra sales

The documents also showed that Abbott quintupled the price of Norvir in response to the declining market share of Kaletra relative to protease inhibitors made by competitors. Kaletra sold almost $400 million in 2003 but new PI drugs having fewer side-effects made by other drug companies threatened Kaletra’s future sales.

One slide summary in Exhibit 28 shows that Abbott knowingly increased Norvir’s price in order to push the cost of using a competing drug Reyataz to a “significantly higher price.” This, Abbott speculated, would create “formulary pressures” i.e. pressures on insurers to cover Kaletra instead of Reyataz, or to increase the co-payment that consumers would have to pay for Reyataz.

Another slide summary showed that Abbott saw the treatment improvements from Reyataz not as a boon to HIV/AIDS treatment and to patients, but as a form of unfair gain by their competitor Bristol-Meyers-Squibb (BMS) at the expense of Abbott. Ironically, Abbott didn’t consider raising its price by 400% to be unfair gain at the expense of HIV/AIDS patients.

These released documents don’t reveal much about Abbott’s price hike that wasn’t already known (see, for instance, an article that originally ran in the Wall Street Journal here) but they do reinforce how coldly calculating Abbott was in considering how best to put profits before HIV/AIDS patients.

Abbott recently submitted a Motion for Summary Judgment to the Court hearing the Norvir class action. If this motion is denied, a trial in the case is currently scheduled for August 2008.

Readers, what do you think of the released documents? Do they change your opinion of Abbott? Or just reinforce it? Please post your thoughts in the comments.

And by the way, here are links to all the documents the Court agreed to unseal:

• Exhibit 1 (Rebuttal Expert Report of Joel W. Hay, PHD.)
• Exhibit 4 (08-09-2004 Depisition of Abbott executive Jesus Leal)
• Exhibit 5 (08-11-2004 Deposition of John Leonard)
• Exhibit 8 (12-19-2005 Deposition of Jodi Devlin)
• Exhibit 14 (9-3-03 Strategic Plan)
• Exhibit 18 (09-12-2003 Email from Jesus Leal re three pricing options for norvir)
• Exhibit 20 (07-13-2003 Email from Michelle Jones re 07-13-2003 PR article regarding Reyataz efficacy with Norvir)
• Exhibit 27 (09-10-2004 Deposition of Abbott executive Heather Mason)
• Exhibit 28 (09-22-2003 Email from Dr. John Leonard re Kaletra’s decline and Norvir’s growth with introuction of competitor pi’s)
• Exhibit 29 (08-04-2003 Emails from William Dempsey and John Thomas)
• Exhibit 32 (09-10-2003 Email from Joseph Serio Jr re decline in Kaletra market share)
• Exhibit 38 (Notice of Rescheduled meeting dated 09-25-2003)
• Exhibit 39 (09-29-2003 Email from Jesus Leal re Slide list)
• Exhibit 45 (2006 Jan Monthly Market Research Report re HIV drugs)
• Exhibit 47 (03-24-2006 Declaration of Michael P. Hannan, Product Director, Protease Inhibitors, Glaxo-Smith-Kline)
• Exhibit 49 (12-14-2007 Deposition of Douglas F. Greer, PHD re Profitability of PI’s developed for use with Norvir)
• Exhibit 50 (08-08-2007 Deposition of Dale Kempf re Patent issues)
• Exhibit 51 (07-24-2007 Deposition of Dr. John M. Leonard, Abbott VP)

Julie Appleby at USA Today has a story in today’s edition, “Drug costs rise as economy slides”. In it, she says:

People with health insurance are having more trouble paying for prescription drugs as higher out-of-pocket costs for medications and a slowing economy strain family budgets, according to surveys and health care analysts….

“Incomes aren’t going up, but co-payments are,” says Gary Claxton of the Kaiser Family Foundation, which studies health policy.

In some cases, the patient’s share of drug costs is no longer a flat dollar amount, but a proportion that can range from 20% to 70%.

What appears to be happening is that insurers are coming full circle on how they deal with drug costs. Up until the mid-90s, many patients had insurance that had them pay a percentage of the cost of their prescription drugs (often 20%). When “managed care” became the trend (which limited people to seeing only doctors in the insurer’s network, required referrals for specialists and is most famous for health plans denying coverage for various treatments), there was a move to the “fixed copayment.” Back then, most health plans had one fixed copayment for all drugs — brand-name or generic, new or old, expensive or cheap.

Direct-to-Consumer Advertising of prescription drugs took off after the FDA loosened the rules on drug advertising in 1997. Health insurers saw the costs of the drugs taken by their members skyrocket, and sought to discourage the use of expensive newer brand-name drugs, and encourage the use of older, less expensive generic drugs. So health plans moved to the “tiered” copayment, where cheaper generics had one copayment (say $5), the “preferred” brand-name (i.e. often the one that the insurer got the best deal on from the drug company) had another (say $10), and “non-preferred” brand-names had the highest (say $20).

Over time, as drug costs went up, and as promotions to doctors and consumers led many more people to use prescription drugs on a regular basis, copayments crept up too. Gone are the days of the $5 copayment. Many people now have copayments of $10-$15 for generics, $20-$25 for preferred brand-names and $40+ for nonpreferred brand-names. Plus, more people are facing separate and much higher copayments for “specialty” drugs (i.e. drugs to treat serious illnesses like cancers).

There’s also been something of a trend towards “high deductible” health plans, which make consumers responsible for all of their medical costs until a deductible (say $1500) is met. This was supposed to make people more “responsible” about the cost of their health care but can perversely have the opposite effect, by making people delay medical treatment until it’s an emergency, when of course the treatment is far more expensive.

Medicare Part D has resulted in millions of senior citizens now paying for a percentage of the cost of their drugs, rather than fixed copayments. Which means when the cost of their drugs goes up, so do their out of pocket payments.

The end result of this is that it’s no longer just patients without insurance who can’t afford their prescription drugs — more and more people with insurance can’t afford them either. Someone with a chronic illness who takes, say, 8 or 10 drugs everyday can face hundreds of dollars a month just in copayments. And more and more health plans are putting annual maximums on what they’ll pay for prescription drugs. After you hit the maximum, you’re on your own.

Many drug companies have patient assistance programs that can provide free or discounted drugs to people who can’t afford them. But as a recent post on this blog illustrates, many of those drug company programs are closed to people who have insurance — even if they still can’t afford even the copayments on their drugs, or if their health plan doesn’t even cover the drug in question. In Jessica’s story: No help from Cephalon for cost of Provigil, a young patient with Narcolepsy describes how she couldn’t get any help from Cephalon to get the Provigil she needs. She was ineligible for their program because she had insurance.

As long as drug prices continue to rise, and drug companies convince millions of doctors to prescribe and millions of patients to take expensive, newer brand-name drugs instead of equally effective and much less expensive generic drugs, we’re going to see more and more insured patients, not to mention the uninsured, face drug bills they can’t afford.