Editor's note: Denise Wong is vice president of the Boston office of The Modellers LLC, a specialist divison of Hall & Partners, a New York research company. She can be reached at 801-260-9134 or at denise.wong@themodellers.com. This article appeared in the February 10, 2014, edition of Quirk's e-newsletter.

Vaccines are the epitome of a preventative health strategy - a single or series of interventions to ward off disease before any signs or symptoms emerge. They have been the most efficient and cost-effective way of reducing mortality and morbidity from infectious diseases in both industrialized and developing countries. Unlike other pharmaceutical products with a preventative value, a set of tangible markers that suggest that risk for a single individual is actually reduced does not exist for vaccines.

As such, this concept of taking a vaccine to prevent disease before any symptoms appear, with no way to track efficacy other than herd immunity at the population level, continues to be a challenge to public acceptance of vaccines. This is one of several ways in which the vaccine marketplace is unique and these factors present a distinct set of business development and marketing and research challenges for biotechnology and pharmaceutical companies when bringing new vaccines to the market.

Three ways vaccines are different

1. The treatment pathway and patient flow for vaccines is unlike that of pharmaceutical products, with many more opportunities for drop-off.

When developing a business and marketing strategy for any pharmaceutical product, it is important to understand the general treatment pathway and patient flow for a particular condition. For most medications, a typical treatment pathway consists of a patient presenting to a physician with symptoms, who then evaluates the patient and makes a diagnosis. The physician then recommends a medication and writes a prescription to fill at a pharmacy. Subsequent follow-up occurs to gauge changes in symptomatology and other relevant measures, as well as the patient's adherence with the medication.


However, the process for vaccines presents different key decision points, as well as barriers to uptake: 1) the absence of an immediate risk or physical symptoms to drive disease identification, physician recommendation/prescribing and patient acceptance; 2) a general lack of priority given to vaccines by both physicians and consumers, especially elective adolescent or adult vaccines; and 3) significant challenges related to patient adherence.


Why aren't all eligible candidates identified for vaccination?


The targeting of relevant vaccine candidates is driven by physicians' perceptions or through consumer self-identification of being at-risk. This motivates the subsequent step to initiate a conversation or request a vaccine. Outside of standard vaccines on the pediatric schedule, which are recommended and generally mandated, the process by which physicians identify eligible patients for other vaccines is much less systematic and is characterized by the absence of protocols for recognizing eligible candidates. Much of this is attributable to a lack of clarity around when to vaccinate against certain diseases. When health care providers fail to identify candidates for vaccination, the burden then shifts to consumers to self-identify. However, a consistently-reported barrier to self-identification from both consumer and physician perspectives is the low perceived risk of contracting a particular disease or the perception that vaccines are more critical to pediatric care as opposed to adult health.


Why is making a vaccine recommendation and motivating consumers to accept so challenging?


The strength of physicians' recommendations is particularly critical in driving consideration and acceptance of a product whose success is defined by a non-occurrence of a disease. The ability of physicians to make a recommendation can be complicated by lack of time, low priority and difficulties in persuading consumers of the value of the vaccine because of the intangible nature of prevention that lacks proof points.


Cultural physician-patient dynamics can also complicate the recommendation process. For example, physicians in Asia (Taiwan, South Korea, Malaysia) and in some Eastern European and Latin American markets (Turkey, Mexico) may be hesitant to make a strong recommendation for a vaccine, especially those not reimbursed by insurance or covered by national health. This apprehension is driven by concern around creating the perception that physicians are aligned with pharmaceutical companies to push expensive vaccines that the patient may or may not need, with subsequent loss of patient-physician trust. Furthermore, the vaccine proposition is even less compelling if the vaccine is not government funded and consumers need to pay out of pocket.


What makes adherence to vaccines different and particularly challenging to achieve compared to other pharmaceutical products?


Unique barriers present themselves in the process of achieving compliance to vaccinations. Perhaps the biggest barrier is the abundance of multi-dose vaccine series. Many vaccines require multiple doses administered over long, irregular intervals. Unintuitive revaccination schedules can complicate an already challenging process with series completion (unlike most pharmaceutical products with routine administration schedules). Because of these irregular vaccination schedules, consumers often do not appreciate the need to receive all doses of a vaccine and may fail to prioritize returning for subsequent vaccine doses. This is compounded by the fact that physicians often focus on simply convincing the patient to receive the first dose and less on ensuring the vaccine series completion. In light of these complexities in vaccine adherence, it is challenging to keep track of each individual patient's vaccine series completion. The absence of a formal and specialized process of record-keeping and reminders, even with increased access to electronic medical records, greatly compromises the ability to encourage and ensure adherence among consumers.


2. Stocking and distribution of vaccines is unique from delivery systems of other pharmaceutical products.


Unlike other pharmaceutical products, stocking and management of vaccines is much more of an intricate exercise in business management. Particularly in the U.S., physician offices essentially act as a store to purchase and sell vaccine doses to patients. As a result, extensive upfront costs and significant staff time are required to purchase vaccine refrigerators; keep vaccines in stock; manage the ordering and tracking of inventory; and submit for reimbursement. In many cases, stocking vaccines fails to be a profitable business and practices actually lose money due to inadequate reimbursement of vaccines they administer. Pediatricians continue in this practice, as vaccines represent a fundamental part of health care for infants and children. Yet, other specialties, who may be less philosophically engaged in immunizations, are increasingly discouraged by the cash flow and administrative burden.


It is also important to recognize that vaccine-stocking models are highly variable across the globe. The U.S. practice of keeping a sizable and consistent stock of vaccines in the physician office is more an anomaly than the norm. For example, in Mexico, physicians typically have small refrigerators in their offices for vaccines but only for storage of doses that are given that day. In Brazil, patients are often referred to vaccine clinics with a prescription to receive a vaccine, whereas patients in Poland may have an option to receive a vaccine at a hospital clinic or pick up a dose of vaccine at the pharmacy and have it administered at their doctor's office. These alternate vaccine stocking models, while financially less burdensome for physicians' practices, actually create gaps in time between the recommendation, acceptance and administration of the vaccine, which complicates the ability to track whether patients follow through with accepting a prescription and receiving an administration of the vaccine.


3. Brand differentiation can be highly nuanced.


One of the fundamental ways in which the vaccine marketplace is different from other pharmaceutical products is that the opportunities for differentiation between vaccines within a particular category can be very narrow and nuanced. Efficacy and safety of vaccines can vary depending on the indication but is generally favorable. As such, the two clinical parameters on which physicians are typically evaluating pharmaceutical products to drive brand choice can often be very similar across key players in a given vaccine category. Consequently, physicians may be looking at differences that can be challenging to define or communicate the clinical value (e.g., strain coverage, dosing schedule, device, etc.). For example, Merck's Gardasil has coverage of a larger number of HPV strains that cause cervical cancer and genital warts whereas GSK's Cervarix protects against fewer strains that cause cervical cancer but offers longer duration of protection.


Additionally, unlike pharmaceutical products, brand recognition of vaccines is low among patients. Patients are not likely to come into the doctor's office requesting Sanofi Pasteur's Fluzone over Novartis' Fluvirin for influenza; or Merck's Pneumovax 23 over Pfizer's Prevnar 13 for pneumococcal disease because they have heard of specific brands. If patients do ask or request a vaccine, it's usually at a broader category level. Thus, the ultimate choice of brand of vaccine in most disease categories is completely driven by physician preference, whichever brand is stocked in the office or whichever brand is reimbursed or covered by insurance or national health. Given this lack of differentiation, the first-to-market vaccine in a given vaccine category, regardless of the lead time, can gain a significant advantage as this player can more clearly dictate the development of new vaccine infrastructure and protocols in the office.


Three tips for research and marketing strategy


1. Understand the broader infrastructure in your market.


It is critical to have an in-depth understanding of the broader infrastructure of how vaccines are delivered to patients, as well as the way in which conversations, recommendation and follow-up unfold between health care providers and consumers. Recognizing the various steps of this process and how they vary by market will allow for the full exploration and identification of potential drop-off points throughout this flow and the factors that drive or could prevent this attrition.   


2. Capture all stakeholder barrier and opportunity perceptions.


The vaccine network is intricate and involves many different players who can provide perspectives on key drivers of immunization success, as well as barriers that lead to lost opportunities. Consequently, it is important to capture the perspectives of the broad set of health care providers beyond physicians in the vaccine process, including nurses, physician's assistants, vaccine managers/coordinators, office managers and pharmacists (retail and hospital-based providers) to obtain a comprehensive understanding of the consideration set and factors that drive decisions to recommend and administer a vaccine.


3. Leverage the nuances of doctor-patient interaction.


The vaccine pathway shifts from being a physician-driven process, up until a recommendation is made, to a patient-driven process to ensure adherence to the initial and subsequent doses of the vaccine. Therefore, it is critical to understand the specifics of the physician-patient interaction and explore what is being said and heard and the way in which this may contribute to initial acceptance and adherence issues. Furthermore, the various gaps in time between recommendation, acceptance and administration of the first and subsequent doses of vaccines due to various vaccine distribution models warrants immediate capture of data at these decision points to fully understand drivers and barriers and how they may vary over time. Mobile technology can be flexibly leveraged for real-time capture of retrospective and prospective behaviors and emotions to gain insight into these drivers and barriers at various points in time.


Three tips for business and marketing strategy


As pharmaceutical and biotechnology manufacturers develop potential vaccine products, three key business issues emerge that should be considered in the development of successful marketing strategy.


1. Ease distribution.


The complex and financially/logistically burdensome vaccine infrastructure and purchasing/distribution process require greater support to keep physicians and other health care providers and institutions incentivized to continue purchasing and stocking specific brands. Consequently, this creates opportunities for manufacturers to provide support to set up appropriate vaccine systems, manage inventory and provide discounts and bundling to create financial incentives for physician practices to continue to stock vaccines and, more importantly, build loyalty to a particular manufacturer's portfolio of brands.


2. Provide support.


With as many potential holes in the pathway leading to patient drop-off, this also creates opportunities for manufacturers to provide support to health care providers to effectively communicate to patients and help them understand the value of immunizations and adherence to vaccine series. Furthermore, with non-adherence being such a significant barrier, manufacturers can differentiate themselves by providing more formal and extensive support to promote adherence in physicians' practices.


3. Focus on the corporate brand.


With several vaccine products targeting the same disease state or pathogen, brand equity may reside more with the manufacturer and less with the vaccine brand itself. The service offerings from a particular manufacturer (including sales rep engagement, other company support and pricing/bundling) may be more of a differentiating factor driving choice than the specific clinical profile of the vaccine product itself. Moreover, any snafus in manufacturing or delivery of vaccine stock (e.g., shortages, shipping issues, etc.) for a specific vaccine can have a lasting impact on perceptions of the corporate brand and impart a halo effect that extends to an entire vaccine portfolio. As such, it may be just as important for manufacturers to offer strong support services to their customers as it is to develop good vaccine products.


A high-engagement space


Ultimately, the vaccine marketplace is a high-engagement space where biotechnology and pharmaceutical developers and manufacturers must invest resources to not only develop new and cutting-edge products but also effective health care provider and consumer support programs. These can create demand for their products but the delivery of thorough, seamless and financially-attractive support offerings in marketing their vaccines products will foster and maintain a competitive edge.