Battling patent expiration by building brand loyalty

Kelly Renfro

McKesson Patient Relationship Solutions

Over the next few years, a number of blockbuster drugs face patent expiration, including Zyprexa, Xalatan, Crestor and Symbacort. It is estimated that by 2012, brands with more than $30 billion in sales will face new competition from generics. As more brands face patent expiration, many manufacturers will face the dilemma of how to grow revenue and minimize operational cutbacks as reliance on the new drug pipeline is unrealistic.

One tactic is to develop an extended release formulation of an existing brand. Whether you call it extended release (ER, XR), long-acting (LA), or extra-long (XL), the modified formulation is intended to simplify dosing, improve compliance and extend the life of the patent.

 

“It is estimated that by 2012, brands with more than $30 billion in sales will face new competition from generics.”

 

While it may seem natural for patients to automatically migrate from their existing prescription to the extended release version, that isn’t always the case. Even before the pressures of healthcare reform to reduce costs, many health plans insist on the generic formulation as a first line of therapy. And, if the payer influence isn’t enough, consumers will commonly switch to the generic in order to reduce their out-of-pocket spend. This creates another challenge to the manufacturer – how to keep patients loyal to their brand.

Proactive strategic planning

A major brand used to treat a chronic condition – a leader in its therapeutic class – was preparing to launch a line extension. Prior to the launch, the brand engaged McKesson to implement an intervention solution to address financial and behavioral barriers for the standard formulation. With the goal of building and, ultimately, transferring, patient loyalty to the new formulation, permission was obtained during enrollment to market to program participants.

Measure results and gather learnings

More than 14,000 prescribers and nearly 35,000 patients participated in the program. The brand team conducted a comprehensive ROI analysis to measure the effectiveness of the program. This analysis showed that physicians not participating in the program began to decrease their prescribing for the standard brand. During the study, prescriptions from this group declined by 7 percent, while participants increased prescriptions by an average of 6.5 Rx’s per year. Annualized across all participating prescribers, this resulted in a 27 percent increase in TRx growth for the brand. The analysis also demonstrated that the program had the largest impact on low-tomoderate volume prescribers, which was the largest segment of participants.

 

“And, if the payer influence isn’t enough, consumers will commonly switch to the generic in order to reduce their out-of-pocket spend.”

 

Integrate and apply learnings

This analysis provided valuable insights to the brand team. Once the line extension was approved, McKesson was engaged to implement a new program. Starting with similar components, phase two of the program included a starter kit containing an interactive educational device and unlimited co-pay discounts.

Previously enrolled patients were mailed starter kits to educate them about the new formulation and encourage their conversion to the new extension. In addition, key learnings were employed to appropriately target the distribution of the patient kits to those physicians identified in the analysis as the most influenced by the prior program.

When the new drug launched, patient program enrollment and pharmacy claim activity grew exponentially, and continues to grow today. Pharmacy claims activity for the new brand extension grew to over 60,000 claims each month. The national projected TRx volume for the standard formulation continues to decline since the launch of the product line extension , however the volume for the new brand shows consistent growth.

 

“The loss of patent exclusivity can lead to a drastic decline in both market share and a brand’s profit margin.”

 

Building brand loyalty to battle patent expiration

The loss of patent exclusivity can lead to a drastic decline in both market share and a brand’s profit margin. Planning ahead to build in the right components of a campaign for a new product formulation which includes enrollment, and allows for patient outreach and education, can help mitigate that loss.

While there are many factors which contribute to the growth – or decline – of a brand, building a comprehensive program to engage both the prescriber and the patient has been proven to be an integral component of product adoption and growth.

About the author:

Kelly Renfro is the Marketing Manager for McKesson Patient Realtionship Solutions, an industry leader in providing commercialization and adherence services for pharmaceutical manufacturers. She has over 20 years experience in pharmaceutical marketing and data analytics and is currently responsible for measuring the effectiveness of the company’s alternative sampling program, TrialScript®, and their market-leading patient adherence program, LoyaltyScript®.

Prior to joining McKesson, Kelly was a Product Director at NDCHealth (Wolters Kluwer Health) where she was responsible for developing new prescription informatic products for pharmaceutical manufacturers that optimized their sales and marketing efforts and allowed them to more effectively pursue market opportunities for their products.

Can building brand loyalty help in combating patent expiration losses?