Excellence in market access strategy: A research-based definition and diagnostic tool

Introduction

Many authors have commented on the fundamental changes in market environment of the pharmaceutical and medical technology industries and the responses to those changes made by firms in the sector.^1,2 Prominent and arguably dominant amongst these changes and responses are those concerning the acceptance of new but usually more expensive new products by those governmental authorities responsible for funding the larger part of many healthcare systems. Typically, this subject area is given the shorthand label of market access and although arrangements vary in detail in different national markets they share a common fundamental approach. ^{3 – 7} In essence, market access is granted or refused according to the outcome of some health technology assessment, often performed by a government body (e.g. NICE in the UK). Whilst individual methods of health technology assessment vary, the common and fundamental principle is that the health economic outcomes enabled by the new product are weighed against any additional costs implied by that product. In both developed and emergent markets, it is increasingly difficult to gain market access unless the product provides not only clinical advantages over the incumbent product but also significant and demonstrably superior health economic outcomes. To a large degree, market access now determines the success or failure of any new pharmaceutical or medical technology.

In response to this important shift in the way that governments and other payers define the value of new products, the pharmaceutical and medical technology industries have attempted to develop new processes and capabilities. ^{8 – 10} These have the intent of demonstrating health economic value of new products and so gaining market access. However, the published literature in this area is not extensive and what there is suggests that this is an emergent capability within the sector, one that is embryonic, poorly defined and not yet well developed in many companies. Accordingly, the work described in this article attempts to contribute to our knowledge of market access strategy in the pharmaceutical and medical technology sector. It does so by combining existing knowledge of the content and characteristics of competitive strategy in the sector with new, qualitative, empirical work in the form of four in-depth case studies in major companies.

Research objectives and methodology

The objective of this work was to address three, related primary research questions:

What is the definition of market access strategy? In particular, the work sought to develop a valid definition of market access strategy that met the criteria of a strong definition, namely:

A definition that is inclusive of all cases of market access strategy, independent of detailed context.

The research methodology selected was one of action research, as originally defined by Lewin, ¹¹ using the action science guidelines developed by Gummeson. ¹² Action research methodology, sometimes called action science methodology, has been described by Hult and Lennung ¹³ as:

“Action research simultaneously assists in practical problem-solving and expands scientific knowledge, as well as enhances the competencies of the respective actors, being

performed collaboratively in an immediate situation using data feedback in a cyclical process aiming at an increased understanding of a given social situation, primarily applicable for the understanding of change processes in social systems and undertaken within a mutually acceptable ethical framework”

The results flowing from this work were grouped into three major categories, based upon the three primary research questions:

The definition of market access strategy. In this part of the work, responses were grouped to draw out any consensus about the definition of market access strategy.

Results and findings

Finding 2: The characteristics of market access strategy

The combination of open and closed questions in the second part of the interviews and surveys described above led to the emergence of 9 characteristics of market access strategy that are associated with the probability of the strategy achieving its intended outcome. These are summarised in Table 1.

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Table 1.

The nine differentiating characteristics of a market access strategy

1. The extent to which the market access strategy recognises heterogeneity within the market environment

2. The extent to which the market access strategy makes well-defined resource allocation choices between alternatives

3. The extent to which the market access strategy offers payer-perceived economic value to each targeted segment within the market

4. The extent to which the market access strategy anticipates change in the market

5. The extent to which the market access strategy aligns to the strengths and weaknesses of the product and organisation relative to appropriate comparators

6. The extent to which the activities that flow from the market access strategy are complete, consistent with the strategy and are internally coherent

7. The extent to which the activities that flow from the market access strategy match the targets’ decision making processes

8. The extent to which the market access strategy anticipates and supports management of the product life cycle

9. The extent to which the market access strategy is consistent with the organisation’s financial goals

Finding 3: The differences between market access strategies

The responses to the third part of the questions showed, as described above, a continuous gradation in their association with the effectiveness of market access strategy. Respondents described a fine structure for each of the 9 characteristics that enabled detailed differentiation between market access strategies that were likely to be successful and those that were not. For clarity, this fine structure was grouped into three levels descriptive of strong, mediocre and weak market access strategies for each of the nine characteristics. These are described in Table 2. Within the limits of this research, they provide objective and context-independent criteria by which to assess the strength of a market access strategy and so form the basis of a diagnostic tool by which executives might evaluate and improve their strategies. Further, by providing a method by which to compare different or competing market access strategies, they allow a working definition of excellence in this important area as follows:

“An excellent market access strategy is one which meets the nine criteria of market access strategy strength to a degree that is clearly and demonstrably superior to any relevant competing market access strategy”

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Table 2.

Graduated differences between market access strategies

Characteristic of the market access strategy	Strong market access strategies	Mediocre market access strategies	Weak market access strategies
The extent to which the market access strategy recognises heterogeneity within the market environment	Describe their targets in terms of homogeneous and distinct contextual segments, with reference to all payers, health care professionals and patients	Describe their targets in terms of segments that are not homogeneous or distinct and with reference to either payer or healthcare professional, but not both	Describe their targets in terms of a clinically defined patient sub-population without reference to payer or professional
The extent to which the market access strategy makes well defined resource allocation choices between alternatives	Allocate market access resources differentially with consideration to both the attractiveness and accessibility of target segments	Allocate market access resources according to segment attractiveness without consideration of accessibility	Allocate market access resources approximately evenly across most of the market
The extent to which the market access strategy offers payer-perceived economic value to each targeted segment within the market	Offers segment-specific, superior value to a relevant comparator, is strongly supported by evidence and is expressed in terms used by the target segment	Offers generalised value proposition to all segments or one expressed in terms that the targeted segment does not use	Does not offer a superior value proposition that is expressed in terms that the targeted segments uses
The extent to which the market access strategy anticipates change in the market	Is based on both retrospective market information and extensive, rigorous anticipation of how the market will change	Is based on retrospective market information and some limited, anticipation of market change	Is based only on retrospective market information and not on any rigorous anticipation of market change
The extent to which the market access strategy aligns to the strengths and weaknesses of the product relative to an appropriate comparator	Is fully aligned to objectively assessed strengths and weaknesses of product vs. relevant comparator	Is only partly aligned to subjective strengths and weaknesses of product vs. relevant comparator	Neither assesses objectively nor aligns to the product’s strengths and weaknesses
The extent to which the activities that flow from the market access strategy are complete, consistent with the strategy and are internally coherent	Activities are consistent with the strategy, coherent and synergistic with each other and do not omit any significant activity	Activities may be inconsistent, incoherent and have significant omissions but not have all three failings simultaneously	Activities may simultaneously be inconsistent, incoherent and have significant omissions
The extent to which the activities that flow from the market access strategy match the targets’ decision making processes	Activities accurately reflect the target segment’s decision making process and are adapted to individual payers at local level	Activities do not accurately reflect the target segment’s decision making process or are not adapted to individual payers at local level but do not have both failings simultaneously	Activities neither accurately reflect the target segment’s decision making process nor are adapted to individual payers at local level
The extent to which the market access strategy anticipates and supports management of the product life cycle	Anticipates or leads development of the marketing strategy as it develops over the product life cycle	Supports current marketing strategy actively but does not anticipate the development of the marketing strategy as it develops over the product life cycle	Is at variance with the marketing strategy as it develops over the product life cycle
The extent to which the market access strategy is consistent with the organisation’s financial goals	Gains sufficient market access to a sufficiently large part of the market at a price level and structure to achieve commercial objectives	Gains market access to a proportion of the market at a price level and structure that makes it possible but unlikely to achieve commercial objectives	Gains market access to a proportion of the market at a price level and structure that makes it impossible to achieve commercial objectives

Thus the findings addressed all three research questions:

A definition of market access strategy has been developed that meets the four criteria of a good definition, thus allowing differentiation of market access strategy from other, related concepts.

A set of nine characteristics has been identified that are associated with the probability of that strategy achieving profitable market access, thus identifying the criteria against which any market access strategy might be assessed.

The differences between strong and weak market access criteria in terms of those nine characteristics have been identified on a graduated scale, thus enabling a semi-quantitative and objective evaluation a market access strategy prior to implementation and comparison between alternative or competing market access strategies.

Limitations and implications for further research and for practice

This work has two major limitations, each of which suggests the opportunity for further work. Firstly, the research is based on the respondents’ qualitative perceptions of those factors that contribute to the success of a market access strategy. This is necessarily and obviously subjective and thus subject to numerous cognitive biases. The method therefore places limits on the internal validity or reliability of the findings, which might be tested by quantitative work that seeks to correlate the characteristics of market access strategy with its final outcome. However, the consistency of the responses both within and between cases suggests that the findings have a high level of internal validity in the context of these companies. Secondly, the research is based on a small sample of four cases with a bias towards large companies and a European market access context. This sampling bias necessarily limits the external validity or generalisability of the work, which might be tested by replication of the work with a broader, more geographically spread, sample. However, the consistency of the responses across national boundaries suggests that the findings have a reasonable level of external validity in the context of European and European-like healthcare systems. Notwithstanding these limitations, therefore, this first, exploratory work still represents a valuable contribution to knowledge in this field.

Similarly, whilst recognising the limitations of this work, these findings have three interesting and commercially important implications for practice.

By defining market access strategy content as distinct from market access objectives, operational activity or the market access strategy process, these findings help pharmaceutical and medical technology companies to define a target outcome for the extensive and expensive investments they are making in market access activity.

The author hopes that this work makes a valuable contribution to management practice in the pharmaceutical and medical technology sectors and so, given the importance of these sectors, to society as a whole.