12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
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`M E D I C A T I O N M A N A G E M E N T
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`MS Drug Going Generic Without
`Making Waves
`Generics for other diseases have upended formularies, but the effect
`of generic Copaxone may be limited.
`Thomas Reinke
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`The multiple sclerosis medications, a specialty class of therapy that
`costs $5,000 to $6,000 a month, is about to get its first generic. In April
`the FDA approved a knockoff of the class-leading, disease-modifying
`agent Copaxone, which has annual sales of more than $3 billion.
`
`When generic versions of such class leaders as Lipitor and Nexium came
`out, they turned formulary design on its head and put a real dent in drug
`expenditures. But that won’t happen in MS. The factors that allowed
`generics to completely dominate branded drugs in other classes simply
`don’t exist in MS.
`
`Moreover, experts say that while health plans and PBMs will need to
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
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`1/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 1
`
`
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`LOG IN REGISTER
`
`MANAGED CARE June 2015. © MediMedia USA
`
`M E D I C A T I O N M A N A G E M E N T
`
`MS Drug Going Generic Without
`Making Waves
`Generics for other diseases have upended formularies, but the effect
`of generic Copaxone may be limited.
`Thomas Reinke
`
`
`Share
`
`Tweet
`
`
`
`Share
`
`236
`
`
`
`0
`
`The multiple sclerosis medications, a specialty class of therapy that
`costs $5,000 to $6,000 a month, is about to get its first generic. In April
`the FDA approved a knockoff of the class-leading, disease-modifying
`agent Copaxone, which has annual sales of more than $3 billion.
`
`When generic versions of such class leaders as Lipitor and Nexium came
`out, they turned formulary design on its head and put a real dent in drug
`expenditures. But that won’t happen in MS. The factors that allowed
`generics to completely dominate branded drugs in other classes simply
`don’t exist in MS.
`
`Moreover, experts say that while health plans and PBMs will need to
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`1/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 1
`
`
`
`12/31/2015
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`figure out how generic Copaxone fits in, they should also focus on
`broader issues in MS therapy.
`
`Limited impact
`MS is an autoimmune disease that attacks the myelin sheaths of the
`nerves of the central nervous system. Between 250,000 and 400,000
`Americans have the disease, which is the leading cause of permanent
`disability among young adults.
`
`The generic name for Copaxone is glatiramer acetate. It is a synthetic
`protein that is antigenically similar to myelin basic protein, a
`component of the myelin sheath that protects nerves. Copaxone works
`by blocking T cells that damage myelin. How it does so is uncertain.
`
`One reason generic Copaxone will have a limited impact is the lack of
`branded me-too agents for MS, all with the same mechanism of action.
`When a generic comes along for a disease with lots of branded copycat
`drugs, it has ample opportunity to knock out some of those copycats.
`Copaxone doesn’t have copycats, so the pickings won’t be so easy for
`generic Copaxone.
`
`Another factor is the lack of strong treatment guidelines for MS that
`would give a particular drug—or drugs sharing the same mechanism of
`action—a dominant position in the armamentarium. As a result,
`clinicians take many different approaches to treating MS, and some of
`those approaches don’t include Copaxone—or, presumably, the newly
`available generic, explains Atheer Kaddis, PharmD, a senior vice
`president at Diplomat Pharmacy, a specialty pharmacy in Flint, Mich.
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
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`2/17
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
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`New formulary designs may be developed because
`of generic Copaxone, says Atheer Kaddis, PharmD,
`of Diplomat Pharmacy.
`
`The new generic kid on the block, from Sandoz, also faces some stiff
`competition. Teva saw the patent expiration coming, so it rolled out a
`patented 40-mg version that reduces the frequency of injections from
`daily to three times per week. The FDA approved Teva’s formulation in
`March 2014. Since then, the company has shifted more than 60% of its
`volume to the three-days-a-week version, according to Kaddis.
`
`A market for generic Copaxone
`The formularies for MS agents often include Copaxone as a preferred
`agent, so now it is a question of whether the generic version will get
`listed instead.
`
`Annual sales and total prescriptions for leading MS drugs
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
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`3/17
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`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 3
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
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`Source: IMS National Sales Perspectives
`
`Currently, in highly managed formularies there is usually a preferred
`interferon, Copaxone, one or more of newer oral agents, and
`natalizumab (Tysabri), a monoclonal antibody with a unique
`mechanism of action, according to Kaddis. For less-managed
`formularies, there may be two interferons, perhaps two orals, Copaxone,
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`4/17
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
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`and natalizumab.
`
`Rebates are offered by pharmaceutical manufacturers for the brand-
`name MS therapies, Kaddis explains. The rebates are typically market-
`share based so additional rebates are offered if greater market share is
`driven toward formulary preferred therapies.
`
`Kaddis expects there to be a solid market for generic Copaxone. An
`increasing number of physicians are taking on risk by participating in
`ACOs and other value-based care. In some of those arrangements
`pharmacy costs are measured, and physicians are rewarded for
`reducing them. Even if 60% of Copaxone sales have moved to the new
`three-days-a-week formulation, 40% of the volume is still open to the
`generic. That can result in a considerable cost savings, notes Kaddis.
`
`Moreover, new formulary designs may be developed because of generic
`Copaxone, says Kaddis: “There’s the potential for health plans to
`implement step therapy or to provide incentives such as a fixed copay in
`place of a percentage coinsurance.”
`
`High hopes for monoclonal antibodies
`Generic Copaxone is entering the market as treatment of MS is changing
`and is more likely to involve fairly aggressive treatment with the goal of
`preventing relapse and slowing long-term disease progression. Kaddis
`says part-and-parcel of a more aggressive approach to treatment is
`greater attention to the diagnosis of the disease and recognition of
`clinically isolated syndrome (CIS), the appearance of single or multiple
`neurologic symptoms such as an attack of optic neuritis or weakness on
`one side. If CIS is confirmed through MRI or other means, doctors
`nowadays may prescribe MS drugs to head off a full-blown exacerbation
`of the disease.
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`5/17
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`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 5
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
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`The treatment of MS is also characterized by a willingness—even
`eagerness—on the part of physicians and patients to try new agents,
`partly because there’s no surefire treatment strategy for MS. Open-
`mindedness is also part of the MS treatment mindset because how
`patients respond to MS drugs varies so much.
`
`Doctors and patients, to say nothing of biotech companies, have high
`hopes for monoclonal antibodies improving the treatment of MS in a
`meaningful way. Tysabri is gaining acceptance. Alemtuzumab
`(Lemtrada) was approved in November 2014, and, in April, Biogen and
`AbbVie announced the FDA’s acceptance of their application for
`daclizumab (Zinbryta).
`
`Cost of FDA-approved drugs for relapsing multiple sclerosis
`Drug
`Manufacturer
`
`Annual cost
`
`Parenteral
`
`alemtuzumab (Lemtrada)
`
`glatiramer acetate (Copaxone)
`
`20 mg once daily
`
`40 mg 3x/week
`
`interferon beta-1a
`
`Avonex
`
`Rebif
`
`interferon beta-1a pegylated (Plegridy)
`
`interferon beta-1b
`
`Betaseron
`
`Extavia
`
`mitoxantrone (generic)
`
`natalizumab (Tysabri)
`
`Genzyme
`
`Teva
`
`
`
`
`
`
`
`Biogen
`
`EMD Serono
`
`Biogen
`
`
`
`Bayer
`
`Novartis
`
`
`
`Biogen
`
`$59,250
`
`
`
`$73,326
`
`$65,104
`
`
`
`$65,442
`
`$70,638
`
`$65,442
`
`
`
`$69,397
`
`$57,694
`
`$3,167
`
`$64,480
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
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`6/17
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`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 6
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`
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`Oral
`
`fingolimod (Gilenya)
`
`teriflunomide (Aubagio)
`
`dimethyl fumarate (Tecfidera)
`
`Novartis
`
`Genzyme
`
`Biogen
`
`$70,752
`
`$66,017
`
`$65,520
`
`*Approximate WAC for one year of treatment at the usual dosage. WAC=wholesaler
`acquisition cost or manufacturer’s published price to wholesalers.
`Source: Adapted with permission from The Medical Letter on Drugs and Therapeutics, May
`11, 2015; Vol. 57 (1468):68.
`
`While they are more effective than other medications at slowing
`relapses, the monoclonal antibodies can have alarming side effects,
`albeit in a very small number of patients. Tysabri has been linked to
`progressive multifocal leukoencephalopathy, and Lemtrada to serious
`autoimmune conditions. The monoclonal antibodies are also extremely
`expensive. Lemtrada’s price has been reported at $158,000 for two
`courses of therapy, although they are taken a year apart.
`
`The National Multiple Sclerosis Society says that in many cases, health
`plans and PBMs focus too much on controlling costs instead of
`accommodating current treatment philosophies. The counterargument
`is that payers serve the important function of holding down costs that,
`ultimately, makes treatment more accessible.
`
`There are 12 disease-modifying therapies. Often formulary designs with
`a limited number of drugs in preferred tiers do not allow switching
`among medications without incurring high copayment or coinsurance
`costs, says Tim Coetzee, MD, chief officer for advocacy, services and
`research for the MS Society.
`
`“Relapsing patients or those with new lesions may need to switch
`medicines and the hurdles are significant,” he continues. “People are
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
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`7/17
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`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 7
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`
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`not switching their medications out of convenience; they are trying to
`control their disease activity.
`
`“High cost share can really wreak havoc on people with MS,” Coetzee
`continues. “It’s not like they are shopping for a blood pressure medicine.
`They are trying to get their immune system under control and minimize
`brain damage.”
`
`People covered by health plans sold through ACA exchanges may face
`the most restrictive tiering. Avalere Health analyzed 20 drug classes and
`found that MS agents were placed exclusively on the specialty tier more
`often than any other drug class but oncology. This year, 51% of the silver
`plans put all of the medications for MS on the specialty tier, an increase
`from last year when 42% did so, according to Avalere. However, patient
`assistance programs are very common in MS, so many MS patients pay
`only a fraction of the published copays or coinsurance amounts—or
`avoid those costs entirely.
`
`Keeping tabs on patients
`Criticizing insurers and PBMs for having a blinkered perspective—no
`matter what the problem—is a well-worn path. But the integrated
`approach that Geisinger is taking to MS treatment does seem to argue
`for rethinking MS treatment so it is not so narrowly focused. The
`Pennsylvania health care system has implemented the concept of
`integrated practice units for several diseases, including MS.
`
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`8/17
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`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 8
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`
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`“We’ve been able to… get patients into a routine of
`comprehensive care,” says Bret Yarczower, MD,
`head of Geisinger’s P&T committee.
`
`“It is very important that MS is identified and treated early in the onset
`of the disease because that is when the inflammatory component is
`most manageable,” says Bret Yarczower, MD, MBA, head of Geisinger’s
`P&T committee. To help make that happen, Geisinger has set up
`multidisciplinary teams. The teams coordinate patient care and keep
`tabs on MS patients with the goal of improving adherence and medical
`care of the disease.
`
`“When we started this, we found that there were patients who hadn’t
`seen their neurologist in two years,” says Yarczower. “We’ve been able
`to change that and get patients into a routine of comprehensive care.”
`
`Coetzee of the MS Society points out, though, that many patients may
`not have easy access to a neurologist.
`
`Clearly there may be many opportunities to improve the care of MS
`patients. Generic Copaxone will probably be only a very small piece of a
`very complicated puzzle.
`
`1
`Big meets even bigger: More
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
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`9/17
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`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 9
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`
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`consolidation in the offing
`
`Susan Ladika
`The implementation of the ACA seems to have put
`this trend on steroids. While regulators weigh the
`pros and cons of the proposed Aetna-Humana and
`Anthem-Cigna deals, provider systems are joining
`forces and snapping up private practices while Walgreens is currently
`poised to acquire Rite Aid.
`Continue reading…
`2
`On or off track? 2016 could be the year
`that value-based payment arrives–or
`maybe not
`
`Timothy Kelley
`American health care has been waiting a long time
`for this new payment system to pull into the
`station. It won’t fully arrive in 2016, even though
`ACOs continue to shift more risk onto providers. It
`takes time to figure out how to make these models
`work.
`Continue reading…
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`10/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 10
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`
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`12/31/2015
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`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`3
`Sagging sign-ups: Slowing enrollment
`may mean big trouble for the ACA
`
`Robert Calandra
`UnitedHealthcare’s recent announcement that it
`may exit the ACA exchanges in 2016 sowed more
`doubt about what many see as a law that’s
`fundamentally flawed and beyond fixing.
`Defenders of the ACA say that the exchanges are robust enough to
`withstand the absence of a large insurer.
`Continue reading…
`4
`Sticker shock waves: Players to
`respond to drug priciness
`
`Peter Wehrwein
`There will be pushback, but the reaction to high
`drug prices will vary with the player and the turf
`being protected. Public and private players will
`talk and take some action toward basing drug
`choices on the value delivered. But how will that
`value be measured?
`Continue reading…
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`11/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 11
`
`
`
`12/31/2015
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`5A
`Slimming too fast: New rules coming
`for narrowing networks
`
`Jan Greene
`Because it’s hard for consumers to choose a network without knowing
`what providers are in it, rules are tightening up on health plans’
`obligations to maintain accurate provider lists. CMS recently laid out
`new rules on this for Medicare Advantage plans on the federal
`marketplace.
`Continue reading…
`5B
`Picking up the tab: Out-of-network bills
`will be a hot issue
`
`Jan Greene
`The problem stems from the inability of health plans and out-of-
`network hospital specialty providers to agree on a proper fee, so
`consumers end up being billed the balance. The issue has gotten
`national attention and legislators vow to come up with a solution.
`Continue reading…
`6
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`12/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 12
`
`
`
`12/31/2015
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`The 2016 election season: Democrats
`to play D while GOP devises a game
`plan
`
`Robert Calandra
`Democratic frontrunner Hillary Clinton is likely to paint the ACA as a
`symbol of success that just needs a bit of fine-tuning. GOP candidates
`want to repeal and replace it, but the eventual nominee with be asked:
`Replace it with what, exactly?
`Continue reading…
`7
`The hunger gains: Appetite for quality
`to grow
`
`Joseph Burns
`Quality tools are not some panacea. The fact is
`that few patients use the proprietary quality and
`price transparency apps that health plans provide.
`Are they not useful? Do people not care? Are health
`plans not to be trusted? Answer: all of the above.
`Continue reading…
`
`Lynn Quincy,
`Consumers Union
`
`8
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`13/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 13
`
`
`
`12/31/2015
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`Cyberthievery: Will health care
`companies respond in 2016?
`
`Susan Ladika
`Health insurers are a prime target because of the
`richness of the information they hold. Payers need
`to increase their investment in people and
`processes to try to fend off data breaches. The
`greatest risk might come from interaction with
`vulnerable third-party vendors.
`Continue reading…
`9
`Too much of a good thing:
`Overdiagnosis to get its due
`
`Joseph Burns
`Everyone in health care recognizes that early
`detection comes at a cost: It can lead to
`unnecessary treatment and spending and, in some
`cases, real harm to patients because of the risks
`and side effects of treatment. This is a particularly
`vexing problem when it comes to cancer
`screening.
`Continue reading…
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`14/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 14
`
`
`
`12/31/2015
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`10
`Doing the MACRA-ena: Will the
`celebrations continue in 2016?
`
`Robert Calandra
`The foundation for the Medicare Access and CHIP Reauthorization Act
`(MACRA)—scheduled to go into effect in 2019—will start to be laid in
`2016. The law affects physicians receiving Medicare payments, but not
`all of them will be happy with the changes.
`Continue reading…
`11
`Growing testiness: Disagreements
`between insurers, labs about new
`molecular tests
`
`Joseph Burns
`Health plans can’t keep up with orders from physicians for new complex
`molecular diagnostic tests that clinical labs develop and promote as the
`next best technology to improve patient care. The issue is proper
`vetting, and the debate promises to become more heated.
`Continue reading…
`
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`15/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 15
`
`
`
`12/31/2015
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`New download
`Disease State Report: PAIN
`The Societal and Economic Burden
`of Chronic Pain and Opioid Abuse
`The Role of Abuse-Deterrence Technology
`
`PTCommunity News Headlines
`
`New Jersey Wants Tax-Exempt Hospitals to Pay Host Towns
`Legislators take aim at ‘nonprofit’ institutions with for-profit businesses on site
`
`Multiple Sclerosis Society Recaps 2015 Research Progress
`Scientists find new leads in stopping the disease
`
`Company Recalls Infection Test
`Erroneous results may lead to treatment failure and death
`
`New Breast Cancer Drug May Be Effective Against Other Types of Cancer
`Treatment targets tumor cell division
`
`Study: Type-2 Diabetes Increases Dementia Risk
`Women are more vulnerable than men
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`16/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 16
`
`
`
`12/31/2015
`
`MS Drug Going Generic Without Making Waves | Managed Care Magazine Online
`
`Contact Us
`Editorial: Peter Wehrwein, Editor
`Advertising: Maureen Dwyer Liberti,
` Vice President, Group Publisher
`Production: Kevin Riley,
` Production Services
`Circulation: Jackie Ott, Circulation Manager
`Webmaster: Webmaster
`
`Latest Biosimilars News
`
`http://www.managedcaremag.com/archives/2015/6/ms-drug-going-generic-without-making-waves
`
`17/17
`
`MYLAN PHARMS. INC. EXHIBIT 1104 PAGE 17
`
`
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