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`Three key antipsychotics lose patent
`protection
`
`November 16, 2011 by Brian Albright
`
`@ | Reprints
`
`State Medicaid programs,patients to save as major atypical
`meds “go generic”
`
`
`
`Pharmaceuticals are one of the fast growing
`cost centers in most state Medicaid programs,
`and antipsychotic medications are among the
`most expensive drugs prescribed to Medicaid
`recipients. There may be somerelief on the
`wayfor straining state Medicaid budgets, as
`several major atypical antipsychotics become
`
`https:// www. behavioral netarticle’three-key-antipsychotics-lose-patent-protection[9/20/2018 9:22:00 PM]
`
`1
`
`Exhibit 2077
`Slayback v. Sumitomo
`IPR2020-01053
`
`
`
`Three key antipsychotics lose patent protection | Behavioral Healthcare Executive
`
`Sen fae)ia(a)mtLeKet at ie
`
`
`
`
`available in generic form.
`
`
`
` www.furnitureconcepts.com 800.969.4100
`
`Already, Zyprexa (olanzapine), has lost its patent protection and in March
`2012, both Seroquel IR (quetiapine), and Geodon(ziprasidone)will go off-
`patent. As generic versions of these drugs enter the market (see sidebar),
`prices could fall anywhere from 20 to 50 percent or more over the next
`several years. That could mean big savings not only for Medicaid agencies,
`but also for patients whose out-of pocket costs for purchases and co-pays
`could fall substantially.
`
`"You could see significant savings," says Joe Parks, MD, chair of the
`NASMHPD Medical Directors Council and chiefclinical officer for the
`
`Missouri Department of Mental Health. "Psychotropic medications are about
`a third of most Medicaid pharmacy budgets, so we're talking about big
`dollars.”
`
`Insurers participating in Medicaid Part D plans could also potentially receive
`a windfall. Reimbursementrates are adjusted retrospectively, meaning they
`would trail the drop in drug prices, allowing insurers to keep the difference
`during the first year the prices drop.
`
`Perhaps the only organizations that are not looking forward to 2012 are the
`pharmaceutical companies that developed these soon-to-be-generic
`medications. Research firm Decision Resources (Waltham, Mass.) predicts
`a significant decline in the size of the market for atypical antipsychotics as
`more generics enter and fewer potential blockbuster medications are
`introduced,
`
`In the markets covered by their research (the U.S., France, Germany, Italy,
`Spain, Japan, and the UK), the bipolar disorder drug market is expected to
`drop from $6.5 billion in 2010 to just $4 billion in 2020 (See Figure: Global
`Market Share). In the United States, the market will drop from $5.8billion to
`$3.1 billion during that period. Atypical antipsychotics accounted for $5.3
`billion of the total bipolar drug sales in 2010, with Seroquel, Abilify, and
`Zyprexa leading the market.
`
`More formulary options
`
`Althoughit could be a while before prices drop (specific generic
`manufacturers typically get six months of exclusive distribution rights), the
`introduction of new generics will likely impact managed care formularies and
`preferred druglists. In the past, there were only two generic atypicals
`
`available (risperidone and clozapine).
`
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`
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`
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`CURRENT ISSUE
`
`"Generics really do present a cost-effective opportunity to treat psychotic
`patients,” says Karen Rhea, MD, Chief Medical Officer at Centerstonein
`Nashville. "I'm also very interested in seeing the uninsured population have
`accessto atypicals. In Tennessee, many of our state hospital patients are
`being discharged onolder antipsychotics, and this will present an
`opportunity for that particular population."
`
`Summer 2018
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`Atypical antipsychotics have a range ofefficacy for schizophrenia, mania,
`and bipolar depression, as well as differing levels of common side effects
`(like weight gain, sedation, and links to cardiac disease and diabetes).
`
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`Three key antipsychotics lose patent protection | Behavioral Healthcare Executive
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`Having a mix of generics available will make it easierto tailor individual
`treatment at a lowercost.
`
`"We will have a good balance of choices," says George Oestreich, Pharm.D,
`MPA,principal at Missouri-based consultancy G.L.O. and Associates.
`Oestreich was formerly the Deputy Division Directorfor clinical Services at
`MO HealthNet, the Missouri Medicaid agency. "The idealsituation is you
`have onethat is a low sedative, one that has a relatively low weight-gain
`profile, and one that would have a general low metabolic disease process
`initiating propensity. We're getting pretty close to that with these generics."
`
`the
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`Generics moveto the frontoftheline ea ie
`One potential downside is that with less expensive options available,
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`"There is a concern that we would haveless accessto a wider rangeof
`atypicals when there are more generic versions available,” Rhea says.“In
`Tennessee we havea significant numberof branded atypicals in our
`preferredlist. For other drugs, there are step therapies, so you have to have
`a failure, intolerance, or contraindication of two preferred agents before you
`get to the non-preferred drug.”
`
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`Once these new generics are widely available, their use will likely balloon
`fairly quickly. One majoratypical antipsychotic, Risperdal(risperidone), went
`generic in 2008, andit provides a good case study of what could occur in the
`marketoverthe next two years.
`
`OnceRisperdal lost its patent protection, generic penetration in the atypicals
`market wentfrom three percent in 2008 to more than 25 percentby the end
`of 2009, according to research published in the journal Psychiatry last year.
`"Whenyoulookat state formularies and the managed care approach, they
`went crazy to include generic risperidone,” says William Glazer, MD,
`president of Glazer Medical Solutions in Key West,Fla. "It went right to the
`front of the line in formularies.”
`
`Becauseofthe risks inherent in treating patients with these agents, most
`programs provide a significant amount of leeway for prescribers, since
`several studies have shownthat denying access to expensive antipsychotics
`can increase other medical treatments (including emergency mental health
`treatment and hospitalization) down the road.
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