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THE CLINICAL AND FINANCIAL VALUE OF EVERGREENED DRUGS

August 31, 2011 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News

www.Medtipster.com Source: Navitus Clinical Journal, August 2011

Occasionally, when a patent on a brand drug is about to expire, the manufacturer will create what is unofficially known as an “evergreened” version of the drug. An evergreened drug typically is a metabolite (a substance normally resulting from metabolism of another substance in the body) or other very close chemical relative or a reformulation (extended release version) of a highly profitable, brand drug. For the purposes of this article, we will examine metabolites/close chemical relatives to discuss how a transparent PBM evaluates these drugs as they relate to their formularies.

What is an Evergreened Drug Exactly?
Evergreened drugs are slightly different chemically from their parent (original brand) drug. Some examples of parent brand drugs and their evergreened versions include the evergreening of Claritin to Clarinex, Zyrtec to Xyzal, and Prevacid to Kapidex. Because of the chemical difference in evergreen drugs, the Food & Drug Administration (FDA) considers these drugs to be new drugs. Therefore, the manufacturer is required to submit a New Drug Application, proving the new drug is not a placebo and that it is safe and effective.

Although evergreened drugs may be approved by the FDA, they rarely offer a distinct clinical advantage to the parent drug (occasionally, they are relatively more tolerable). In cases where the evergreen drug provides more tolerability, the clinical advantage dictates the value of the drug and it is placed at a preferred formulary tier. More often, however, there is no evidence that any efficacy or tolerability advantages exist with the evergreened drug over the parent drug.

What is the Financial Value of Evergreened Drugs?
Pharmaceutical manufacturers make a strong effort to maintain the market status of a drug in order to maintain a large share in the marketplace. Some steps used to promote the evergreened drug include:

  1. Increasing public awareness of the drug through direct to consumer advertising—This tactic is used to increase the number of claims for the drug, creating a perceived need for the drug in the marketplace.
  2. Setting the price of the new drug below that of the parent drug—The lower cost may appeal to plan sponsors.
  3. Aggressively rebating the drug—A high rebate may appeal to plan sponsors.

These financial incentives may be tempting, until one considers that the patent expiration of the parent drug is usually imminent, meaning that generic versions will soon be on the market. Generic drug versions typically cost about 20% of the total cost of the parent drug. While the incentives above may make the evergreened drug look financially viable compared to the parent, these incentives will typically be short-term. Even with price reductions and/or aggressive rebates, the evergreened drug rarely meets the low cost of the generic version(s).

How does a transparent PBM Evaluate these Drugs?
Since a transparent PBM manages its formulary to the lowest net cost, each drug is scrutinized for its clinical effect and overall cost. Drug cost becomes an important factor when the clinical advantage of the ‘new’ or evergreened drug over other drugs in its category is unclear. In these cases, where the clinical efficacy is the same for multiple drugs in a category, the PBM will maintain the lowest-net-cost product that yields the best drug therapy. This approach achieves the same clinical results with the lowest price for the client and member. As such, the PBM will often not include the evergreened product on its formularies or will include it on a non-preferred tier (with some exceptions).

Lipitor Stinks

October 25, 2010 By: PharmaSueAnn Category: Medtipster

Pfizer has recalled over 150,000 bottles of Lipitor because of a musty smelling odor.  If you have a prescription for Lipitor and they have a strange odor, return them to the pharmacy where they were dispensed.  http://www.fda.gov/Safety/Recalls/ucm228998.htm

Reporting drug side effects and reactions

December 16, 2009 By: Lior Category: Medicine Advice, Medtipster

An important question came in today on what to do if a medication you are taking does not perform as expected. First and foremost evaluate if emergency medical services are need, and call 911.

Then inform your doctor of the indecent. Try to keep careful notes of what happened before,  during and after. Its important to mention any and all medications, both prescription (RX) and over the counter (OTC). Mention  any and all vitamins, supplements or antacids, since they too may have had a role.

Finally inform the FDA, they keep track of this information and will investigate. You are encouraged to notify them so that future incidents can be avoided thereby turning your unfortunate incident into a potential lifesaver for someone else.

If you like you can share your story and get support by posting in our forum.

Stay Healthy!

Two out of three drugs dispensed in 2008 were generic!

September 14, 2009 By: Jason A. Klein Category: Medtipster, Prescription Savings

jklein20091 In a conversation I had recently with a large employer in North Carolina, I heard the following:

-generics save employers money via the $4 programs, but the majority of drugs available are brands.

Nothing could be farther from the truth. Nearly 70% of all drugs on the market have a generic equivalent. Same active ingredient, just 90% less in cost. Not drug strength, cost.
Please click here (PDF) for a generic information brochure and find information straight from the FDA.

Remember, we don’t sell the drugs…we just tell you where to find ‘em at the lowest price.

Thank you for your time and happy browsing at medtipster.com!

JK

Jason A. Klein
President
Medtipster, LLC.
email: jklein@medtipster.com
web address: www.medtipster.com

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