According to a report in the Washington Post, “Medicaid, the joint federal-state health program for the poor, spent $329 million extra in 2009 purchasing 20 brand-name drugs instead of available generic copies, according to an American Enterprise Institute report.”
The spending numbers are iffy. The word “extra” is wrong. And words matter. A lot.
The Post writes, “The study included contraceptives, respiratory medicines and antibiotics. Risperdal, New Brunswick, N.J.-based Johnson & Johnson’s antipsychotic, prescribed in generic form exclusively would have saved $60 million in 2009, the report released Monday found.” It’s important to note (and is mentioned in the Post story) that Teva (the world’s largest generic drugs company) makes a generic version of the drug.
Two things for starters. First, nowhere in the Post story (or, even more surprisingly, in the AEI paper) does it mention that the report’s author receives monetary support from Teva. Whatever happened to the urgency of transparency? That’s a big oops.
Secondly, and more importantly from a therapeutic perspective, generic substitution, while a good way to save payers money in the short term (including our nation’s largest payer – Uncle Sam), often has quite deleterious impact on patient care -- an issue that is well researched and quantified and entirely absent from both the AEI report and the Washington Post reportage.
And this is even more important when it comes to medicines that have a narrow therapeutic index – such as Risperdal.
According to the FDA, narrow therapeutic index means that "small changes in blood concentration have the potential to result in serious therapeutic failures and/or serious adverse drug reactions." The AEI paper not only ignores this issue, but openly shills for more aggressive therapeutic substitution (as a way to save money) without ever once mentioning the very real such a policy would have on patient care.
(Currently, the "sameness" of a brand product and a generic version is evaluated based on two-treatment crossover study to prove bioequivalence, the aim being to show that the 90 percent confidence intervals of the geometric mean test/reference ratios for both maximum plasma concentration and the area under the plasma concentration-time curve fall within a range of 80 percent to 125 percent.)
In fact, this is such an important issue, that at recent meeting of the Generic Pharmaceutical Association, CDER Director Janet Woodcock said that the FDA is discussing tightening the equivalence limits of generic medicines "so there is less variability. And the agency’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee concluded (in an 11-2 vote) that current bioequivalence standards are not sufficient for narrow therapeutic index drugs.
Mention of this in the AEI report? Zero. Mention of “millions of dollars in potential savings? Multiple. Mention of author’s financial relationship with the world’s largest generics manufacturer? None.
The Post reports that, “the top-20 list of drugs Medicaid overspent on in 2009 includes five anticonvulsants.” And that the “estimated waste” cited by the report on the five treatments totals $169 million. The Post finally admits that these medicines “are under Food and Drug Administration scrutiny because of patient and provider concerns that generic versions don’t work as well to treat epilepsy as their brand-name counterparts.”
Thank you. On a personal note, my eldest son has epilepsy – so this issue is both professional and personal for me.
How’s that for transparency?
The report’s author, per the Post, “said he couldn’t comment on whether generics should be substituted for anticonvulsants. “We have to leave it to the FDA to determine what’s interchangeable.”
Alas – that too is lacking from the pages of the report.