TIERS TO TEARS

I have written a number of times about the various practices that insurance companies employ that keep people from getting their needs fully met. Specifically, I have focused on the prior authorization process. So what can happen when it initially seems to go well? I can submit a prior authorization request and have the request approved and all seems good, right? I received a distressed phone call from a patient of mine for whom I had gotten approval for the brand name version of Wellbutrin XL (bupropion extended release), a highly effective antidepressant that does not cause sedation, weight gain or sexual side effects. Unfortunately, her insurance company failed to mention that it would be approved but at the highest level of pay. This is known as the copay tier system, one in which there are preferred generics, non-preferred generics, preferred brand names and non-preferred brand names. I have yet to be able to get an explanation from anyone at any insurance company as to how these tiers are determined, which leaves me to speculate, though I believe my guesswork is most likely quite accurate. Medications are chosen for the various tiers based on the cost to the insurer. So the patient’s Wellbutrin XL 300 mg tablets were “covered,” but at roughly $600/month! The generic would have been a “normal” copay, which would be anywhere between $10-$30/month, which is much more palatable. This patient requested a prescription for the generic with the knowledge that it might not be as effective. The trouble with this particular generic, which was made by Teva, began when an independent consumer lab tested it and found that it was releasing about a third of its contents in the first 2 hours, as opposed to the normal 8% of the brand name. About 5 years later the FDA finally decided to pay attention and mandated that generic makers of the 300 mg dose, the dose in question in this case, pull their products and re-evaluate them. Teva’s product was not permitted back on the market and was therefore withdrawn. The same product made by Impax was also withdrawn. Furthermore, the FDA did not test the generics from four other makers – Anchen, Actavis, Watson, and Mylan. That was well after there were also lawsuits (to learn more, http://www.medhelp.org/posts/Depression/Problems-with-Budeprion-XL-generic-Wellbutrin/show/1012337). It seems that when the FDA originally approved the 300 mg generic, it based that decision on the efficacy of the 150 mg dose, never really requiring testing of the 300 mg dose (to learn more, http://www.drugstorenews.com/article/fda-issues-new-guidelines-budeprion-xl-300-mg-strength). A drug rated by the FDA as AA is the exact equivalent, meaning there are no known or suspected bioequivalence problems, or if there were, they were resolved in satisfactory fashion. An AB rating includes products that meet necessary bioequivalence requirements. Please see my previous blog about the 80-125% rule to better understand this category and therefore waht AB truly means. My patient is presently relegated to an AB rated product that has a history of bioequivalence problems, with two previous generics having been removed from the market in the 300 mg form. There are three brand name versions of bupropion XL: Wellbutrin XL (http://www.drugs.com/cdi/wellbutrin-xl-extended-release-tablets.html), Aplenzin (which is actually bupropion hydrobromide, not hydrochloride, though that difference does not have clinical ramfications) (http://www.drugs.com/aplenzin.html), and Forfivo XL (http://www.drugs.com/price-guide/forfivo-xl), a niche product focusing solely on the top dose, 450 mg. To learn more about the FDA’s AA vs AB rating system, please see http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#Therapeutic%

20Equivalence%20Evaluations%20Codes. For now, I can only hope I can manage to procure more brand name samples of either Wellbutrin XL or Aplenzin to supply to my patient. If you are having issues with this particular drug and in a generic version that seems not to be working, talk with your doctor about the brand name. But first, learn your insurance company’s copay tier system, because the prior authorization may mean nothing once you see the sticker price of a month supply.