European public health experts estimate that pharmaceutical companies cashed-in over the last decade by pushing 'evergreen' medications on Swiss consumers. The researchers calculated that evergreening - where pharmas slightly modify a drug formula so they can extend its patent - cost the healthcare system in Geneva an extra 30 million euros between 2000 and 2008.

The last few decades have witnessed the implementation of stricter regulatory procedures for drug approval. These laws work to keep consumers safe, but limit the time that a pharma has to capitalize on a drug patent.

Drug patents last for 20 years, but much of this time is spent in the expensive research and development (R&D) phase. It takes 12 years and $350 million on average to progress a new drug from the laboratory to a pharmacy shelf.

Combined with new price control policies and competition from generic drugs, it is easy to see why evergreening practices have become so pervasive in the pharmaceutical industry. Using a little chemical wizardry, companies can make small modifications to their brand names and market the product as a 'new' drug.

"Pharmaceutical companies have responded by developing a number of tactics to extend market monopoly," wrote the authors, who were led by Nathalie Vernaz from the Geneva University Hospitals. "These are known as ''evergreening'' strategies, or more euphemistically as ''life cycle management'', with sometimes questionable benefit to society."

In some cases, these companies can file for an extension with the new drug and push back the patent's expiration date by up to five years. A more common scenario involves companies relying on the reputation of the former brand along with new marketing campaigns to convince consumers.

This trend has led pharmaceutical companies to spend nearly twice as much on marketing than on research and development

Swiss Missed Savings

To measure the pervasiveness of evergreening tactics and what they cost Swiss consumers, Vernaz and colleagues collected data on all of the prescriptions issued in the public hospital system of the canton of Geneva, representing about five percent of Switzerland's total population, from 2000 to 2008.This included information from Geneva's single public hospital and community pharmacies.

Like many district hospital systems, Geneva features a restricitive drug formulary, a list of medications approved for use in the hospitals. This list allows the hospital to save money by buying drugs in bulk and simplifies daily operations.

Coupons and rebates on brand names and evergreen drugs are a common tool used to sway the opinions and future recommendations of health care professionals at hospitals. In 2006, the Swiss government tried to counter this marketing scheme and promote the wider use of generics by raising copayments for brand name prescriptions.

The authors found this new policy had limited impact on stemming the prescribing of brand name and second-generation medications.

They focused on eight evergreen drugs and their predecessor brands:

Evergreen

Medical Condition

Original Brand

Levocetirizine (Vozet)

Allergies

Cetirizine (Zyrtec)

Escitalopram (Lexapro)

Depression

Citalopram (Celexa)

Esomeprazole (Nexium)

Acid reflux

Omeprazole (Prilosec)

Desloratadine (Clarinex)

Allergies

Loratadine (Claritan)

Alendronic acid (Fosamax)

+

Colecalciferol (vitamin D3)

Osteoporosis

Alendronic acid-alone

Simvastatin (Zocor)

+

Ezetimibe (Zetia)

Cardiovascular

Simvastatin-alone

Zolpidem Extended Release (Ambien CR)

Insomnia

Zolpidem (Ambien)

Pregabalin (Lyrica)

Seizures

Gabapentin (Neurotonin)

Consumers and the Geneva healthcare system spent 144 million euros on these brand name and evergreen drugs during this eight-year timespan, while only 27 million euros was spent on generics. The number of patients on brand names and evergreens more than doubled from 56,000 to 131,000, and the most common drugs used were lexapro and nexium.

Failing to use generics added an extra cost of 30 million euros to this local health system.

The authors also discovered that when hospitals switched to generics, community pharmacies tended to follow suit, which saved money for everyone. This finding suggests aggressive marketing and discounts that target hospitals can have a broader systemic effect on the economics of a region.

"Research that assesses the implications of life-cycle management in the pharmaceutical market is rare," wrote Dr. Aaron Kesselheim, M.D., an assistant professor of medicine at Brigham and Women's Hospital and Harvard Medical School.

In 2006, Kesselheim and others conducted a similar study on three brand drugs (Prilosec, amoxicillin/clavulanate, and Glucophage). The patents of these drugs were extended with evergreen tactic, such as lawsuits against generic competitors. The team concluded that Medicaid and low-income patients could have saved $1.5 billion if the development of generic alternatives had not been stymied.

Kesselheim concluded: "While their manuscript did not directly address patient outcomes, their results suggest that addressing life-cycle management [evergreening] through rational regulatory oversight or alterations in patent or market exclusivity laws will be an important way that policymakers can achieve cost savings without adversely affecting public health."

Sources: Vernaz N, Haller G, Girardin F, et al. Patented Drug Extension Strategies on Healthcare Spending: A Cost-Evaluation Analysis. PLoS Med. 2013.

Kesselheim AS. Rising Health Care Costs and Life-Cycle Management in the Pharmaceutical Market. PLoS Med. 2013.