Are generics okay for HRT?

That's a good question. Our insurance companies think so, but then they are the ones who think we should get our medical care from JimBob's House of Automotive Painting and Gynecology because he'd cut them a reduced-price deal, too.

So long as the active ingredient(s) is the same, the FDA considers HRT generics to be fully equivalent to brand name products. And in that regard they are indeed: 17-B estradiol is going to be the same hormone no matter what it's delivered by; conjugated equine estrogens aren't the same as conjugated plant estrogens, so they aren't considered interchangeable generics for each other even when delivered exactly the same way.

But if you've hung in here reading with us for some time, you may be getting the idea that even within the same route of delivery, the peculiarities of which we've already discussed elsewhere, the individual HRT dose dynamics can make a difference. And this is where the real keen eye of fine tuning can come into play.

In patches, for example, all of the major brands contain human-identical 17-B estradiol. All of them are different (so that they can be patented) in the adhesive composition and characteristics, however, and those different adhesives affect the delivery of the hormone in ways that make one patch brand perform quite differently from another brand. The same is true for the generic patch, since it cannot infringe upon any of the brand names' patents. And because it's different (and I use the singular, but generic brands come and go, so on any given day there may be more than one), it can indeed be enough different from a brand name version that it will deliver differently when applied to your body.

And in the case of some generic patches, part of the different construction includes a much larger, thicker, stiffer form. We have read numerous reports from women complaining of the great difficulty, if not impossibility, they encountered getting generic patches to stick because of these characteristics. And, alas, because they don't necessarily understand that a patch must be adhered to deliver and that these patches do not predict the performance of all patches, many women (or their doctors) give up on patches just because of these mechanical problems. For these women, then, a generic isn't good enough. Does this apply to all women and all generic patches? We doubt it: there must be someone out there who buys the generic more than once or the company wouldn't find it profitable enough to keep in production. Will this be your experience? There's really no way to tell without a trial. Our point, however, is that if you experience unsatisfactory performance from a generic patch, it may be mechanical difficulties with that particular patch, and neither the hormone nor patches as a class of HRTs need to be ruled out solely based upon that one trial.

With oral HRTs, the same thing can happen. Take the example of Estrace, a tablet of human-identical micronized estradiol that can also be taken transbuccally. It's a fairly inexpensive HRT, being simple and rather old, but a prescription for the brand name may cost $70-$90 whereas the generic may be available for $10-15. Even without insurance restrictions, many women wonder whether this is a case where brand makes a difference.

The answer lies, as it does with all tablets, in the inert ingredients that make up the rest of the tablet. Leaving aside things like allergies to some coloring agents (which are always listed, along with all of the other inert ingredients, on the brand data sheet and, when we can find them, on our website HRTs pages), which will be distinct and special contraindications for some brands, there are many factors that can individualize our reactions to "equivalent" formulations. Some generics—and in the case of Estrace there are a number of generic manufacturers—are rather hard; some cut cleanly if the pill must be divided; others crumble and dissolve almost before you can swallow them. In turn, these different mechanical behaviors affect how rapidly the hormone may enter our system and, further, how the dose uptake curve affects us and how quickly the hormone may be eliminated from our systems. A slower uptake from a less soluble tablet may preserve more of the dose in the system (sneaking it past the first pass effect) and prevent things like headaches that may be caused by more rapidly-rising hormone levels. On the other hand, a more rapid uptake may prevent a woman who is taking it transbuccally from swallowing (and losing) as much of the dose. There are lots of variations on this, the exact details of which aren't necessarily important. What's important is knowing that variations can occur. We've been told by one woman who has surveyed the generic market for Estrace that she sees actual in-body dose equivalency variations of up to 0.5mg. That is, she has found that she can take 1.5mg of one generic brand and get the same effect as 2.0mg of another generic brand. But those numbers don't matter—what matters, again, is understanding that there can be this variation and if one generic performs slightly off, adjustments or changing brand may solve the problem without moving to a different HRT entirely.

So will a generic be okay for you? Maybe; maybe not. But it's worth trying out first, because if the delivery dynamic of the generic works, the hormone equivalancy means that it can be just as good an HRT as the brand name. And if it doesn't, then it's worth considering whether you want to push for the brand name or a different generic (your pharmacist is your best resource for finding out what generic brand you're using and whether other generic options exist for you) to stick with the overall type of HRT you've chosen. It's a little outside our scope to get into how you manipulate your insurance company's coverage for these things—sometimes a responsive company will permit a brand name if a doctor attests in a letter or in the prescription that the brand name is the only one that provides the desired effect; sometimes a higher copay is required; sometimes one has to simply bite the bullet and buy out of pocket. These things are determined by individual plan and the attitudes and policies of the company you're working with, and you'll have to do the research on that.

One thing that we've found helpful, when considering a switch from a brand to a generic, is talking about it beforehand with the pharmacist. If your doctor writes the prescription specifying that the choice of generic or brand be left up to patient preference, your pharmacist may be willing to sell you a very small test refill—say a week or so's worth—to try out the new variation before purchasing a whole three months' or whatever your refill quantity normally is. This lets you audition the new version without spending much money and without ending up with three months' worth of something that is suboptimal but you're stuck with it. We can often audition new options in brand names, especially the newer, more heavily-promoted ones, using samples our doctor's office receives from drug reps, but this mechanism doesn't exist for generics. But a mini-refill can let us test the waters without jumping in all the way, something that can be reassuring when dealing with something as personal and individual as HRT.

And, finally, do be sure, when reporting back to your doctor on an HRT, that you distinguish clearly between generic and brand in your discussions. A doctor who hears "well, this one didn't work," is going to hear "I want a different HRT," not "I like this type of HRT but I don't think this is the best brand for me and I want to experiment around and by the way do you have any samples of Brand X or Brand Y in my dose?"