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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).

Try Local Drugstore For Faster Refund On Recalled Kids’ Medicines

May 13, 2010 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: NPR Health Blog – Scott Hensley, 5.6.2010

If you’ve rooted around your medicine chest and found some of the kids’ Tylenol, Motrin, Benadryl or Zyrtec recalled by Johnson & Johnson, what should you do?

The company’s McNeil unit says it will give you a refund, but you have to fill out a form online. Oh, and you also have to be available for a chat, in case a company rep wants to call and verify the info.

The New York Times’ Ron Lieber ripped J&J for not being better prepared and for not telling people sooner that refunds would be an option. The early advice was just to toss the stuff out.

On a listserv for families in our D.C. suburb, one helpful mom said she’d had good luck with the local CVS drugstore, which would even take back the affected medicines without a receipt.

We called CVS HQ in Rhode Island, where spokesman Mike DeAngelis told us the chain would, as is its usual policy, give cash refunds if a customer has a receipt. Without one, you get store credit in the form of a CVS gift card.

What if some of the medicine has been used? Doesn’t matter, he said. Bring in what you’ve got. So far, he said, the returns haven’t been all that heavy. CVS has already cleared its shelves of the affected medicines, and the computerized cash registers won’t let you buy any either.

We emailed rival chain Walgreens, but haven’t heard back yet. The company did post a letter it got from McNeil on what to do with the recalled remedies, though.

Update: OK, we just talked to Robert Elfinger, a spokesman for Walgreens, and you can take your recalled meds back to them for a refund, too.

“Bring the bottle back to the store, whether it’s full, or halfway full,” he just told us. “We’ll take it back and give the customer store credit.” If you’ve got the receipt, Walgreens will give you cash.

Locate a CVS Pharmacy or Walgreens closest to your home on Medtipster.com

Pediatric Versions of Tylenol, Motrin, Zyrtec and Benadryl Recalled

May 03, 2010 By: Nadia Category: Medicine Advice, Medtipster, Prescription News

www.Medtipster.com Source: Wall Street Journal, May 3, 2010

Consumer complaints about certain over-the-counter children’s medications spurred an investigation that led to a recall of more than 40 different products because of manufacturing problems, according to officials at a unit of Johnson & Johnson.

The recall, announced over the weekend by the company and the U.S. Food and Drug Administration, prompted drug stores and other merchants to pull the medicines off their shelves and caused concern among parents who took steps to avoid giving the products — largely pain and allergy remedies — to their children.

A spokesman for J&J’s McNeil Consumer Healthcare unit wasn’t more specific about what issues consumers raised that led to the internal probe.

“We always receive some consumer inquiries about our products and those inquiries led to the investigation that ultimately led to this recall,” the spokesman, Marc Boston, said.

The company said there haven’t been any serious side effects reported, and the company and the FDA said the potential for harm is remote. Still, the company and the agency said the products shouldn’t be given to children for precautionary reasons.

The recall involved at least 1,000 lots of products, including pediatric versions of Tylenol, Motrin, Zyrtec and Benadryl.

Some of the liquid formulations may contain a higher concentration of their active ingredient than they should while others may contain inactive ingredients at inappropriate levels, or tiny metallic particles that are a residue of the manufacturing process, the company said.

The medicines were sold in the U.S. and Canada as well as in countries as far away as Fiji and Kuwait. All were made at a factory in Fort Washington, Pa., the FDA and the company said. Neither the company nor the FDA could say how many bottles of medicine were involved.

At English Drug, an independent pharmacy in Bethel, Conn., staffers removed several products from the store’s shelves Sunday morning after learning about the recall on the Internet. “These are very popular products, but we pulled them” out of safety concerns for consumers, said Denise McMahon, a pharmacist at the store.

In New York City, Natalia Carin said she recently gave her 2-year-old son Cole children’s Zyrtec and Motrin. He appears to be fine, she said, but added, “I’d like some information about what kind of substance this was and how dangerous it might be and what we can expect.”

Kenneth Polin, a pediatrician at Town and Country Pediatrics, with offices in Chicago and its suburbs, had heard from few worried parents Sunday, but says his advice is to turn to generic versions of the medicines. He recommended that before consumers buy a generic, they make sure to ask a pharmacist whether J&J manufactured it.

The recall is another dent in J&J’s reputation as a model of corporate responsiveness. That harks back to the deadly Tylenol poisonings in the early 1980s, when the company reacted swiftly to recall the product and inform the public.

More recently U.S. regulators have criticized J&J’s handling of product-quality issues, because of a widening series of recalls of over-the-counter medicines that accelerated late last year.

In November, the company recalled a limited number of certain bottles of Tylenol arthritis-pain caplets after identifying an uncharacteristic smell or taste associated with the products.

In December, J&J had to expand the recall to include all lots of the product. A month later, J&J widened the recall again to include other brands such as Motrin and Benadryl.

That resulted in the FDA sending J&J a warning letter saying the company had violated good-manufacturing rules at its Las Piedras, Puerto Rico, plant.

Therapeutic Alternatives

June 02, 2009 By: PharmaSueAnn Category: Medtipster, Prescription Savings

What is a Therapeutic Alternative and How do they work with the $4 Type Discount Programs?

Let’s start from the beginning, therapeutic alternatives are drugs that provide the same effect but are chemically different from one another. If you are considering a therapeutic alternative to your current medication you will need to discuss the change with your doctor and get a new prescription.

Many brand name drugs have therapeutic alternatives available. In reviewing the Top 50 prescribed drugs many were identified as having possible therapeutic alternatives.

Example of brand name drugs with generic therapeutic alternatives – some of the alternatives are available on the $4 Discount Programs:

Lexapro
Lipitor
Nexium
Prevacid
Crestor
Valtrex
Fosamax
Zyrtec
Aciphex
Coreg
Imitrex Oral
Ambien
Nasonex
Actonel

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