Costco Magazine Article warns of Med Swapping.

Talking Points 1296________________

SB1296 An Act to Protect Patients from Breakthrough Seizures

 Some insurance companies have created a grossly inaccurate picture of the cost.  Costs associated with SB1296 seem to be based on 100% or nearly 100% brand name usage. 

 The goal of SB1296 is NOT increasing the use of brand names drugs.  It is about preventing patients from being switched off a version of a drug they are taking – whether it is a generic or a brand name –that is working for them without their written consent and the written consent of their doctor.

•  Hawaii has had the precise law we are proposing on the books for over 10 years.  Hawaii’s experience shows that the law has no effect on cost.[1]
• According to the latest figures from the U.S. Department of Health and Human Services, a patient is actually more likely to receive a generic medication in Hawaii than in Massachusetts.[2]
•  According to the insurance industry’s own data, the cost of prescription drug coverage in Hawaii is lower than it is in Massachusetts.[3]

 The U.S. Department of Health and Human Services figures also show that the highest utilization of brand name anticonvulsant medications in any state is 20%- 80%less than the 100%claimed by BCBS.[4]

 Insurers suggest that all manufactured versions of any drug act exactly the same in all patients.  They do not.  Bio-equivalency does not equate to therapeutic effect.  Insurers themselves acknowledge this by virtue of the fact that all of them – including BCBS – provide a mechanism for physicians to write a prescription “fill as prescribed.”

 BCBS further suggests that the FDA has looked at every manufactured version of every drug, and developed, based on clinical data – a list of drugs where switching is not advisable.  That is not the case.  In fact, the FDA’s list is not based on clinical data or any systematic review.

 The psychosocial, employment and public safety costs associated with breakthrough seizures can be extensive. 

 Seizure disorders are inherently unpredictable and for many their causes unknown.  Individuals living with epilepsy confront the daily challenges associated with constant flux in their seizures.  Patients must rely on their physician and the prescription medication that work for them.  Upsetting this delicate balance is to say, at the very least, dangerous. 

Letter from Cape Support Group for Study

Gary J. Buehler, R. Ph
Director, Office of Generic Drugs
7500 Standish Place
Rockville, MD 20855

 Subject:  Request for study: Interchanging formulated anti-epileptic drugs with generic for the treatment of epilepsy seizures

 Dear Mr. Buehler:

 The Cape Cod Support Group for Adults with Epilepsy strongly agrees with your statement to the Wall Street Journal that the only way to understand if switching to generic anti-epilepsy drugs (AED) causes epilepsy seizures “is to do a good study.”  (WSJ, 7-13-07. p.1)    

 Most people in our group receive poly-therapy medications for epilepsy.  Members have anecdotally noted the different effects from the interactions of their AEDs with respect to their individual physiological and neurological differences.  Among the repeated reasons given for “break through” epilepsy seizures is switching to generic AEDs.

 “Bob” has nocturnal epilepsy seizures.  He and his wife have one child.  Bob is unemployed due to health consequences from seizures. Bob’s wife began ordering generic AEDs from the inter-net last year to save money.  The couple believes switching from brand to generic drugs explains the recent increases and severity of his seizures. Lately Bob wonders if some morning he will not “wake up.”  

 Therapeutic ranges permitted for generic AEDs by the Federal Drug Agency (FDA) may be too broad for anti-epilepsy medications.  The federal standard for bioequivalence of generics to brand name allows a total range of plus or minus 20% bioequivalence of the mean level of the therapeutic product.

 One of the effective therapeutic measures frequently used by neurologists to control our epilepsy seizures is to make small and gradual dosage adjustments in the amount of daily medication.  The possibility of experiencing an abrupt change of as much as 20%of the bioequivalence from switching between brand and generic could have personal and public health and safety consequences.

 “Sue” has a professional career and is seizure free with the help of her medications.  She legally drives 20 miles to her work place.  No useful public transportation services her job site.  Both brand AEDs she takes lose their patent protection in 2008.  Sue’s neurologist characterizes her therapeutic tolerances as narrow.  She fears the risk of a seizure from being switched to generic AEDs.  If Sue has a seizure she will not be able to drive legally and will lose her good job.  In leaving her work position under these circumstances Sue’s epilepsy disorder would be disclosed.  Sue has previously experienced discrimination when seeking work even when it was known she is seizure free.   

 The consequences of epilepsy breakthrough seizures from switching to generic AEDs could increase costly demands on first responders, ambulances, emergency rooms and physicians.  Breakthrough seizures caused by switching AED medicines create individual and public safety issues, undermine patient self-confidence, severely impact transportation arrangements, stress our families and significantly increase employment difficulties.

 We urge the Office of Generic Drugs to recognize that epilepsy is unique among health disorders given the grave consequences of therapy failure.  If the FDA allows switching from brand to generic medications without a good study then we believe our expectation for generic AED medications to duplicate the patented medication’s performance is only reasonable in order to prevent us from being harmed.

 Without the requested study we anticipate the progress we have made to control our epilepsy seizure disorders, to overcome discrimination and to find a comfortable place in our communities will not only be diminished, but will be in danger of being lost if switching from brand AEDs to generic is permitted.

 We are among the more than two million US citizens with epilepsy who also enjoy numerous benefits from generic medicines for our non-epilepsy medical needs.  We are very appreciative of the FDA for its on going efforts to insure that safe and affordable drugs are available.