How drugs make it on to formularies has always puzzled me. After listening to a talk on the process, I’m even more mystified.
I’m attending the Pharmacy Benefit Management Institute annual meeting in Arizona (demonstrating once again how diligent I can be in the search for valuable insights to pass on to loyal readers). One of the presentations was a (fairly simplistic) overview of evidence-based medicine and its use in assessing new drugs.
The real meat of the session was the analysis of clinical studies, journal articles, and research papers performed by the presenter’s company, RegenceRx, when they consider adding a drug to their formulary. The point made? There is little to no use of real evidence-based studies in evaluating new medicines.
As an example, take Lyrica. This drug has been prescribed for nerve pain across the country, despite a lack of solid clinical evidence supporting that use. RegenceRx’s review of the reports, articles, and studies that purported to validate Lyrica’s usefulness in treating nerve pain revealed that the studies often failed basic scientific rigor (studies weren’t random or blind), and/or Lyrica was not compared to other drugs commonly used for nerve pain, and/or the study methods themselves were flawed. Oh, and there was no study of Lyrica’s long term safety.
In fact, of the twelve studies on Lyrica’s effect on nerve pain, not one satisfied RegenceRx’s (appropriate and fair) standards for evidence-based research.
Yet LyrIca is on many a formulary and is commonly covered when used to treat nerve pain.
I’d suggest that paying for a rather expensive drug that has not been adequately proven to be effective or safe is not good business. This type of business behavior may actually increase costs, as payers end up spending dollars on Lyrica and other drugs in an effort to do the job that Lyrica was supposed to.
What does this mean for you?
Time to check the rigor of your P&T committee.
Kudos to RegenceRx for doing the heavy lifting.
I wonder how much it would cost and how long it would take to do a proper study comparing the efficacy and side effects of a particular drug vs other similar drugs and then apply cost-benefit analysis to the results. Who should pay that cost? Each PBM, Medicare, NIH?
I guess I’m naive. I thought the FDA was, at the very least, supposed to resolve the basic safety and efficacy question before the drug even got to market, otherwise why else does the approval process exist? I thought the P&T committees were mainly there for the fine tuning — the comparitive analysis of efficacies of competing drugs, weighed against price, and the plan’s case mix. Now you say they’re also having to do the coarse adjustments as well, trying to figure out whether a drug is safe, and even does what it’s supposed to do? We really are in worse trouble than I thought.
I cannot understand why Lyrica, a drug that has not been tested is on ANY formulary. On top of the fact that it has never been properly tested, it is a controlled substance, with side effexts such as ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema. Neurontin, which is available as a generic, in my opinion is a much safer and cheaper alternative, and it has been around for years.
Oxycontin was on a major Medicaid health plan’s formulary until just recently. Go figure……
“Neurontin, which is available as a generic, in my opinion is a much safer and cheaper alternative, and it has been around for years.”
Cheaper, safer . . . blah.
Effective?
Approved for nerve pain?
Howzabout as an adjunct therapy for narrow types of epilepsy?
I have some snakeoil and sugar pills that have been proven just as effective . . . damned cheap and very safe.
Yes, I also heard that Lyrica is not much effective for nerve pain.
– Prakash Arige
I have had peripheral neuropathy for 6 years. I tried neurontin and it did little to help the neuropathic pain and when the MD increased the dose I had a terrible reaction 2 days after the MD increased the dose. The adverse reaction read like a PDR of neurontin side side effects. I have also taken ultram for years for the neuropathy which helps a little but I hate taking them as they give me headaches, decreased appetite and make me feel generally “lousy”. I started lyrica about one month ago.The lyrica is a wonder drug for my peripheral neuropathy from diabetes.Lyrica has almost stopped the neuropathic pain while on the lowest dose of 50mg 3x/day. The side effects are minimal for me. I am concerned about long term use and any permanent damage or side effects that could occure but I realize that even after proper scientific testing using all the double blind placebo testing etc; that only a small population of patients are used relative to the number of people who will use lyrica.Even if the testing lasts ten years before FDA approval, when the drug hits the market and is used by many more prople than the drug company testing used, there may be effects not seen in testing as every person reacts in a different way as far as side effects are concerned.The long term use / safety may be called safe by the FDA or Drug company that synthesized the drug but after the amt. of time the drug was tested before release to the public we then become somewhat of a “guinea pig” if we use the drug longer than the testing time.Then there is the individual reactions that may occure due to the fact that we are all different and there will always be exceptions when it comes to side effects or unforseen problems.The bottom line is all drugs carry risks even the ones that have been around forever.There is always that one in a million reaction or damage that someone gets. I do though strongly advocate strict testing following stringent scientific method to make drugs as safe as possible.I hope lyrica (pregamblin) becomes one of those drugs that prove to be relatively safe for long term use. As far as I am concerned lyrica is a miracle drug for my diabetic peripheral neuropathy.
RE:(Oxycontin was on a major Medicaid health plan’s formulary until just recently go figure). What do you mean by that? Has it now been taken off? I am neww to all this as only recently gotten cancer and have tried all the above medications mentioned.
So tell me again, or just give me some basic information Why is Lyrica a controlled substance? I don’t see an addictive property, I don’t see a high re-sale potential. Why controlled?
My daughter was just prescribed Lyrica for Fibromyalgia. She has suffered with joint pain for years and this is the first drug, including Neurontin that has helped her. She was so excited until she went to fill her RX and was told that insurance would not cover it and it would cost $132 a month! I find it ridiculous that insurance will cover Viagra etc but not something that would decrease a 23 year olds pain so she can function.