Pharmaceutical marketing budgets are more scrutinized than ever before. Companies want to ensure that every promotional investment achieves the desired return. To make every promotional dollar go as far as possible, marketers must not only choose carefully from the available tactical options, but also ensure that all of the pieces of the promotional puzzle work together as part of a well-integrated promotional machine. 
Two pharmaceutical marketing tools used for patient acquisition in the physician’s office are patient starter kits with money-off coupon offers and physical product samples. Both have their advantages, but there are specific situations where the benefits of coupons may outweigh those of samples, particularly if you extend their value by tying them into other patient and physician relationship-marketing programs. 
The launch of Vyvanse
Shire US had grown Adderall XR into the market leading treatment in the ADHD category with nearly 25% market share. In April 2007, the company acquired New River Pharmaceuticals to gain full control of the commercialization of Vyvanse (lisdexamfetamine dimesylate), the first prodrug stimulant approved for the treatment of ADHD. Shire launched Vyvanse in June 2007, with the goal of making this product the US ADHD market leader within three years, and surpassing the success that the company had developed in the category with Adderall XR.
The commercialization of Vyvanse required significant strategic thinking and planning as follow-on molecule product launches in the US pharmaceutical industry had not had a history of success, especially those launched within the past 24 to 36 months prior. 
One area of significant importance was the utilization of free patient trial offers. With my background in pharmaceutical sales and marketing at Wyeth, I was used to utilizing product samples to facilitate new patient starts. As part of this case study, I will highlight the benefits of utilizing patient debit, copay and voucher offers over product samples. This is important to help inform decisions on advertising and promotion (A&P) resource allocation for all marketers to help ensure that we are getting the most out of every dollar that we are provided each year to grow our businesses. 
Vyvanse is a Schedule II product, so there is not an option to leave product samples with physicians. As we moved closer to launch, it was imperative that we closely analyze our options with patient benefit offers because, historically, this investment had yielded a significant ROI, second only to the investment in sales force. 
Because coverage and reimbursement is generally spotty immediately after a product launch in our industry, one brand objective was to provide all patients (cash, Medicaid, Medicare and insured) with access to a free trial (defined as 30 capsules) of Vyvanse. Additionally, we also wanted to track usage across various channels to ensure that the free trial program was delivering the desired ROI. This strategy helped Vyvanse achieve greater than $400 million in gross sales, and around 11% of the ADHD market share in its first full 12 months on the market in the US. This program provides an excellent case study of how free trial offers (we utilized a unique combination of debit, copay, and voucher, from now on simply called “offer”) provide several important advantages for both sales and marketing when compared to traditional product sampling.
How the free trial program worked 
At launch, we wanted to ensure that physicians could initiate a patient’s ADHD treatment on Vyvanse without worrying about how the product would be covered. Positive clinical experience with numerous patients is important to developing a physicians confidence in a medication, especially a new product. 
We knew that a physician’s trial and the use of Vyvanse would be slowed by a physician’s concern over questions regarding coverage and reimbursement. As a result, we offered all patients (cash, Medicaid, Rx insured) an innovative free trial combo card (patent-pending) program. This card was provided to physicians as part of a Vyvanse Patient Starter Kit that provided more than 12 pages of important ADHD disease state and product information to new Vyvanse patients. 
Patients would then call a toll-free number to activate the card and had to provide the card, along with their Vyvanse prescription, to the pharmacist in order to receive their free 30-capsule trial.
Using proprietary processing technology, our copay-assist vendor can determine the proper payment platform based on each patient’s individual payer status (cash, Medicaid, insurance). This unique offer provided several key benefits over the traditional product sampling that the pharmaceutical industry has utilized for decades. The benefits can be divided into three main categories: sales and marketing, managed care and patient compliance. 
Benefits to sales and marketing 
First, utilization of a free trial offer made more A&P dollars available for promotion. Traditional product sampling takes a high percentage of A&P expense, primarily for product & packaging costs. Because the free trial is delivered to the patient at retail, the product cost is recognized by the company as revenue (as opposed to A&P expense) and taken as a sales deduction, impacting gross to net sales. Although there are fixed (set up costs) and variable fees (cost per redeemed free trial voucher) associated with the program, these costs are nominal (<10% of total A&P) when compared to the manufacture and distribution of traditional samples.
Second, this card allowed us to immediately track prescriber utilization (patient starts) as well as card distribution and depletion (inventory). 
One of the shortcomings of using traditional samples is that when representatives leave samples on a sales call, there is no clear tracking process to determine to how many patients the physician has initiated on your product. Moreover, sampling does not provide insight into when the physician starts a new patient on your medication after the sales call. For example, if a physician is “hard to see,” sales and marketing would want to know whether their inventory of samples—or in our case free trial cards—needs to be replenished based on their utilization. It can also be determined, with additional analysis, how offer-sensitive a physician’s behavior is. If a physician is voucher or coupon sensitive, it will be important for sales and marketing to develop a mechanism to replenish the supply as soon as possible in order to avoid a lost new-patient start opportunity. Free trial offer utilization allows all of this to be tracked, with data relayed to the field in real time. 
Vyvanse marketing segmented physicians based on class TRx volume and were able to track card distribution and utilization in each group, and also trended this over time. This level of tracking would be difficult, if not impossible, using traditional samples.
The third sales and marketing benefit is the contribution to market share. Distributing samples, and their subsequent use, does not immediately translate into a prescription. When patients go to redeem their free trial offer, however, a prescription is filled at retail, and thus, immediately adds to market share. During the first nine months of the Vyvanse launch, the free trial program added approximately one market share point to the overall Vyvanse market share. 
Benefits for coverage and reimbursement 
This immediate recognition of Rx volume is important to enhance coverage and reimbursement by payors. It is well recognized that physician and patient demand is critical for early formulary acceptance. Sampling delays the communication of physician trial to insurance programs. 
The Vyvanse free trial program registered physician product trial and utilization immediately to insurance programs and formulary committees because the Rx was filled at retail and the information sent to the payor. During the first 16 weeks of the Vyvanse launch, more than 1,300 new Vyvanse prescriptions registered each day to various payors, large and small, across the US. This proved tremendously helpful in our strategy to gain early formulary acceptance for Vyvanse across the country.
Second, because there is a tremendous amount of data that is available through the program, Vyvanse marketing was able to identify health plans with high co-pays. The corporate account team used this information as part of their efforts to improve coverage and reimbursement. 
Benefits to the ADHD Patient 
ADHD diagnosis and treatment continues to be somewhat controversial. And because of the misinformation on the ADHD disease state, compliance and persistency in the category is quite poor. By using a free trial card, however, Vyvanse marketing was able to provide the patient with a free trial of the medication along with important information on the ADHD psychiatric diagnosis as well as 12 pages of information for the patient on what they can expect with regard to adverse events and symptom improvement with Vyvanse. Additionally, before the patient could receive their 30-capsule trial, they were required to activate their card. As the patient activated, they were provided the opportunity to opt-in to receive more information through “Shine,” the Vyvanse compliance and persistency program. Approximately 80% of activations opted-in to receive more information about ADHD and the importance of continued treatment. 
The success of the Vyvanse launch illustrates a variety of benefits of utilizing free trial offers as part of a new patient starter kit. From a sales and marketing perspective, this approach made available more promotional dollars, provided earlier tracking of physician prescribing behavior for sales force and gave us real time information regarding offer distribution and depletion down to the physician level. Additionally, using the cards immediately added to market share. This helped the company achieve earlier reimbursement with payors, which is especially important for launch brands. And finally, using the combo card instead of samples allowed Vyvanse marketing to provide patients with valuable ADHD disease state and product information, and also opt in for compliance and persistence programs. 
Mike Boken is senior product director and brand team leader for Vyvanse marketing at Shire. He joined Shire in 2004 (after 12 years at Wyeth). Boken is a member of MM&M’s editorial advisory board