The Official Medtipster Blog

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).

We have been hearing a lot in the news about MRSA (methicillin-resistant Staph. Aureus).    Everyone of us can be affected by antibiotic resistance, even if we do not take antibiotics.  Antibiotic resistance occurs when antibiotics will no longer work against disease causing bacteria.  These types of resistant infections can result in longer lasting illnesses, more doctors visits or longer hospital stays.  Taking an antibiotic when you have a viral infection will not make you feel better – but it can contribute to antibiotic resistance.

Citrus fruits especially grapefruit should be avoided when taking many medications, including those purchased over-the-counter.  Do not take these interactions lightly, some can cause potentially dangerous health problems.  Certain chemicals that grapefruit and other citrus fruits contain can interfere with the enzymes that metabolize various medications in our digestive tracts.  If you are uncertain to how you should take your medication(s) consult with your local pharmacist.