Managed Care - March 2008 - (Page 25) seizures (epilepsy) without prior notification of Association (GPhA) and the Pharmacy Care Manand the signed informed consent of such interagement Association (PCMA), the pharmacy benchange from the prescribing physician and patient, efit management trade organization, call these ator patient’s parent, legal guardian or spouse of such tempts “carve-outs” because they separate specific person.” therapeutic classes of drugs for an additional subThe laws governing generic substitution vary by stitution requirement at the dispensing level. state, regardless of whether payment is through a “Carve-outs keep affordable medicines from public insurer like Medicaid or through a private inconsumers,” says Kathleen Jaeger, GPhA president surer. All states have laws requiring that brand and CEO. “These anti-generic-substitution polidrugs be dispensed if so ordered by a prescribing cies run contrary to the FDA’s stating that the generphysician, but most states allow pharmacists to ics are the same medicines as the brands with the make a generic substitution if a prescription is not same benefits and results. They also increase state specifically marked “dispense as written” (DAW). In Medicaid program costs by millions of dollars withmore than a dozen states, generic substitution is out any credible, independent evidence-based studmandated unless a physician specifically marks a ies that indicate that using a brand drug will result script DAW. in a different outcome than using a generic.” At the urging of the Epilepsy Foundation and Four major brand-name drugs used for epilepsy other advocacy organizations, legislators in 18 states are expected to lose patent protection and face are considering laws that would ban generic substitution for epilepsy drugs. Top AEDs are blockbusters; In 40 states, legislatures are considering several will soon be off patent laws that would require pharmacists to contact a physician to substitute a According to IMS Health, the five leading antiepilepsy drugs are: generic epilepsy drug, regardless of whether it was marked DAW or not. In Topamax (topiramate), Ortho-McNeil Neurologics Generic substitution approved by FDA in 2006 Tennessee such a law was recently passed Sales: $1,825,400,000 in 2006; $656,600,000, January–April 2007. and signed by the governor, although it Also used to treat migraine headaches. made exceptions for nursing homes, hospitals, and some assisted living facilLamictal (lamotrigine), GlaxoSmithKline ities. (More information about state Comes off patient in 2008 laws governing AEDs is available at Sales: $1,684,300,000 in 2006; $638,900,000, January–April 2007 www.epilepsy.com.) Also used to treat bipolar disorder. In Ohio, legislation was recently proposed that would require pharmacists to Lyrica (pregabalin), Pfizer notify physicians and patients when subApproved by FDA in 2005 stituting a drug used to treat epilepsy. The Sales: $727,800,000 in 2007; $306,800,000, January–April 2007 Ohio Pharmacists Association (OPA) opAlso used to treat neuropathic pain. Lyrica is the first drug approved by the FDA for treatment of fibromyalgia. poses the legislation because pharmacists are already required to inform a patient Keppra (levetiracetam), UCB Pharmaceuticals that he or she may refuse an available Comes off patent in 2009 generic and prescribers always have the Sales: $710,500,000 in 2006; $299,700,000, January–April 2007 option of marking a prescription DAW. Also used to treat neuropathic pain. The OPA is concerned that the proposed law would “greatly reduce the efficiency of Depakote (valproate semisodium), Abbott Laboratories the pharmacist,” according to a statement Comes off patient in 2008 issued by the OPA. Sales: $770,400,000 in 2006; $257,100,000, January–April 2007 Also used to treat migraine headaches and bipolar disorder. The role of carve outs Source: IMS Health Generic proponents such as the Generics Pharmaceutical Manufacturers MARCH 2008 / MANAGED CARE 25 http://www.epilepsy.com
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