About the AuthorRichard Meyer is a passionate Internet DTC marketer with over 15 years of progressive experience in consumer marketing who`s worked on top pharmaceutical brands like Cialis, Prozac and Sarafem, as well as two years with Medtronic Diabetes. He is currently consulting for his own company, Online Strategic Solutions, and writes a DTC column for PM 360 magazine and blogs for Eye for Pharma in addition to his own blog, World of DTC Marketing.
The U.S. Food and Drug Administration approved the blood-thinning drug Effient on Friday in a long-awaited victory for its developers, Eli Lilly & Co. and Daiichi Sankyo Co. The drug, however, will carry a strong warning on its prescribing label alerting doctors that Effient (Prasugrel) can cause sometimes-fatal bleeding and it is only approved to reduce the risk of blood clots in patients who undergo angioplasty, a common procedure to unblock a clogged artery. Physicians who want to use Prasugrel off label may find that insurers are not willing to allow use except for label indications. This could lead to a serious confrontation between insurers and HCP’s.
When it comes to off label use of prescription drugs physicians have pretty much had a free rein to prescribe whatever they wanted for conditions that were both on and off the label. Of course drug companies are now allowed to market prescription drugs off label but they are free to disseminate information on off label use of drugs as long as they are from medial journals. That may change now with the very narrow indication with the approval of Prasugrel by the FDA.
Insurers are looking to cut costs and of course one of the best ways to cut costs is to use current medications that are on formularies as well as generic drugs. There have been numerous instances, for example, of insurers recommending OTC Ibuprofen in lieu of Celebrex and OTC antacids in lieu of prescriptions that can cost a lot more.
This new drug is a product that is going to be recommended by physicians. Patients are not going to tell doctors they want Prasugrel. There are risks with its use but who is best to judge those risks? Physicians ? Insurers? The FDA? “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug,” Lilly says. And if a patient dies from bleeding whom will be at risk for legal action from relatives if the risks of the drug were not communicated effectively to the patients caregivers or family?
There are some who believe that Prasugrel could be a big seller but I believe that is not the case here. Insurers are going to have a big say in how and when this drug is used. As for Lilly? My guess is that they will continue clinical trials and try and get a more broad indication for use but until then the cost maybe too high for insurers when there are a lot of other choices.
- Who decides if a risk is acceptable?
- Off label use: The FDA knows better than physicians and drug companies
- If the FDA wants to make prescription drugs safer than change patent protection timing
- Now let’s attack free pharma samples because physicians shouldn’t give them to patients
- I could have been a blockbuster
Tags: clinical-trials, drug, drugs-as-long, drugs-off-label, from-relatives, potential, prasugrel, then-the-cost
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