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`Three key antipsychotics lose patent
`protection
`
`\ovcnaer ‘6 20‘1 bv B'icn f-Jcrght
`
`a | Reprints
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`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 some relief on the
`way for straining state Medicaid budgets. as
`several major atypical antipsychotics become
`
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`IPR2020—01053
`
`
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`Three key antipsychotics lose patent protection | Behavioral Healtlicare Executive
`
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`
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`available in generic form.
`
`Already, Zyprexa (olanzapine), has lost its patent protection and in March
`2012, both Seroquel IR (quetiapine), and Geodon (a'prasidone) will go off-
`patent. As generic versions 01 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,
`
`butalso 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 chief clinical 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. Reimbursement rates 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 $5.8 billion to
`$3.1 billion during that period. Atypical antipsychotics accounted for $5.3
`billion of the total bipolar drug sales in 2010, with Seroquel, Ability, and
`Zyprexa leading the market.
`
`More formulary options
`
`Although it 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 drug lists. In the past, there were only two generic atypicals
`available (risperidone and clozapine).
`
`CURRENT ISSUE
`
`
`
`"Generics really do present a cost~effective opportunity to treat psychotic
`patients." says Karen Rhea. MD, Chief Medical Officer at Centerstone in
`
`Nashville. "I'm also very interested in seeing the uninsured population have
`access to atypicals. In Tennessee, many of our state hospital patients are
`being discharged on older antipsychotics, and this will present an
`opportunity for that particular population."
`
`Summer 2018
`View issues archive
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`Subscribe today!
`
`Atypical antipsychotics have a range of efficacy 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 antipsyc hotics lose patent protection | Behavioral Healthcsre Executive
`
`Having a mix of generics available will make it easier to tailor individual
`treatment at a lower cost.
`
`"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 Director for clinical Services at
`MO HealthNet. the Missouri Medicaid agency. ”The ideal situation is you
`have one that 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."
`
`Generics move to the front of the line
`
`One potential downside is that with less expensive options available.
`patients may have to jump through more hoops to receive the best
`medication for their treatment.
`
`"There is a concern that we would have less access to a wider range of
`atypicals when there are more generic versions available," Rhea says. "In
`Tennessee we have a significant number of branded atypicals in our
`preferred list. 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."
`
`Once these new generics are widely available, their use will likely balloon
`fairly quickly. One major atypical antipsychotic. Risperdal (risperidone), went
`generic in 2008, and it provides a good case study of what could occur in the
`market over the next two years.
`
`Once Risperdal lost its patent protection. generic penetration in the atypicals
`market went from three percent in 2008 to more than 25 percent by the end
`of 2009, according to research published in the journal Psychiatry last year.
`"When you look at state formularies and the managed care approach. they
`went crazy to include generic risperidone." says lMlliam Glazer, MD,
`president of Glazer Medical Solutions in Key West. Fla. '1t went right to the
`front ofthe line in formularies."
`
`Because of the risks inherent in treating patients with these agents. most
`programs provide a significant amount of leeway for prescribers, since
`several studies have shown that denying access to expensive antipsychotim
`can increase other mediml treatments ancluding emergency mental health
`treatment and hospitalization) down the road.
`
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