GENERICS do not equal BRAND: The 80-125 Rule

GENERICS do not equal BRAND: The 80-125 Rule

Your insurance health plan’s prescription benefits clearly state that when and where a generic is available, you have to try a generic or incur a higher cost, either meaning a higher copayment of no coverage at all (that means you pay out of pocket for the full retail price of the drug). In so many cases, generics are allowed. And why shouldn’t they be? After all, they’re FDA-approved, right? And it’s common knowledge that generics are the same as, as good as, the brand name. And doesn’t everybody knows that brand names cost a lot of money because the evil Big Pharma is out to make a profit? So why not generics?

In many instances, generics do actually perform just as well as the brand name without any increase in side effects or drop off in therapeutic effect. Take Prozac, for instance. It became widely available in the US somewhere around 1990 (it was FDA-approved in 1987). Its patent expired in 2001, and generics were soon available. In my practice, I have had many patients taking the generic without any problems. I had no problem prescribing it because I have always been cost-sensitive and don’t want my patients having to pay more than they have to to be able to afford quality care. But I also remembered being taught in psychiatric residency training that the FDA actually permits a generic drug to be determined “bioequivalent” if its contents are 80-125% of the targeted dose. That means that a 100 mg dose of Brand X could essentially be anywhere from 80-125 mg of generic X and still be considered “bioequivalent.” To learn more: http://www.consumer-health.com/services/5CommonQuestionsAboutGenericDrugs.php

Several years ago, a patient with bipolar disorder called me complaining of all the symptoms of depression except this patient was not depressed. Symptoms included weight gain, sluggishness, fatigue, increased sleep, decreased energy and concentration, poor motivation and loss of drive to do the things normally of interest to this person. I immediately ordered a lithium level and it returned in the toxic range. It was nothing that stopping the drug for 24 hours couldn’t correct, but it concerned me because her dose had not changed and had the level been a few tenths of a point higher, we would have been looking at a hospitalization. I asked my patient about any medication changes, new medications or any other new medical conditions. The answer to each question was “No.” I asked if the color or shape of the pills had changed and the answer was yes. It turned out that the brand name lithium this patient had been taking had been switched over to a generic. That was the only change. The 80-125 rule was in effect.

Not long after that, patients of mine began complaining whenever their Wellbutrin XL 300 mg was changed to the cheaper generic, Budeprion XL 300 mg, manufactured by Impax Laboratories, Inc and marketed by Teva Pharmaceuticals. In 2008, an independent consumer lab was able to demonstrate through testing that the generic version was dumping roughly 34% of its contents into the blood stream within the first two hours of ingestion, whereas the brand name drug released 8% in the same time frame. Patients were complaining of increased side effects and a recurrence of depressive symptoms. It wasn’t until March 2013 that the FDA formally withdrew the drug from the US market as an approved generic, though it had asked Teva to stop distributing it in September 2012. Contrary to the FDA’s study in 2007 that concluded the two were bioequivalent, the 2012 review concluded that “Budeprion XL 300 mg fails to demonstrate therapeutic equivalence to Wellbutrin XL 300 mg.” Watson Pharmaceuticals, which purchased Actavis (a company that was months behind in submitting tests bioequivalency tests to the FDA for its version of generic bupropion XL), agreed to voluntarily pull that product from the market in October 2013. To learn more: http://www.raps.org/focus-online/news/news-article-view/article/4184/second-generic-version-of-popular-antidepressant-to-be-pulled-from-market-for-b.aspx.
Further information can be found at http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformation
forpatientsandproviders/ucm322161.htm

And in July 2014, the FDA announced that over 40,000 bottles of generic venlafaxine ER (generic for the antidepressant Effexor XR) had been voluntarily recalled by Sun Pharmaceutical Industries, an Indian drug company, for failure to meet “drug dissolution specification.” Drug dissolution is a way to understand how a drug behaves in the body. The FDA classified this as a Class II recall, which means that using the product could cause temporary or reversible negative consequences. To learn more:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
action=select&recall_number=D-1415-2014&w=07092014&lang=eng

It is vitally important for patients to be aware that generics are NOT necessarily equal to the brand name medication. A return of symptoms is not necessarily a call for more medication or a change in medication. In my practice, I have been telling patients to inform me of any change in color, shape, pill type or other changes whenever they receive each new prescription. Typically, health plans will purchase the cheapest generic available, so this is especially important with your mail order prescriptions. Doctors who may be reading this should adopt a similar practice of educating patients about eh 80-125 rule if not already doing so and encourage patients to adopt a similar reporting practice each time there is a prescription renewal. Additionally, with a little effort (ok, sometimes a lot), doctors can get the brand name approved AND a cost exception to the copay tier with the submission of the proper documentation to the insurance company. It may mean threatening filing a grievance with the state’s insurance commissioner and/or legal action to get the job done, but as physicians we need to advocate strongly. Also, in cases where there is no insurance, patients may be eligible for patient assistance from the drug manufacturer, which means they can receive free supplies of the brand name. I have a number of patients who are benefiting from these charitable services.