A Tale of Two Job Functions

The New Form of Quality as a Core Competency in Pharma

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The word quality refers to a degree of excellence, the standard of something as measured against other things of a similar kind. Quality within the context of the pharmaceutical industry has traditionally referred to quality control and quality assurance in regulatory and manufacturing disciplines. But what is “quality” as it is newly defined in the pharmaceutical industry?

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This new form of quality as a core competency in pharma is health care quality, or quality as an element of value-based care. It is one of the principal focus areas at THCQ Consulting, Inc. and we see this new form of quality becoming an increasingly important core value of biopharmaceutical companies, both small and large.

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The Affordable Care Act (or Obamacare) ushered in a new era of value-based care, incentivizing higher quality of care delivery. The new models of care, payment incentives, and quality measurement initiatives have profound strategic, operational, and financial impacts on external healthcare stakeholder groups who are the most vital customer segments of biopharmaceutical companies. As a result, establishing a consistent presence for this new quality function will help companies align and be responsive to the challenges their customers face.

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We see firsthand at THCQ Consulting, Inc. how advanced levels of competency in this area help our pharma clients better position themselves to understand and serve their customers. These competencies when well-executed lead to elevated trust with customers that help our clients deliver on their business objectives.

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With that said, the goal of the newly defined quality competency is to help pharma companies understand the implications of value-based care changes to external customers (e.g., payers, providers, etc.). This approach results in actionable strategic insights that inform key areas of company strategy (e.g., clinical development, other areas of evidence generation in the commercial business, managed markets/market access, government affairs, business development, etc.).

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Even if you have been in the pharmaceutical industry for a while, it may still be unclear what this new form of quality as a core competency truly means. Let us provide context by outlining a tale of two job functions. When someone within the industry hears, “I work in quality in pharma,” typically what comes to mind are quality control and quality assurance jobs in regulatory and manufacturing. Health care quality, on the other hand, is a part of the value equation. Check out the value equation illustrated below.

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Foundationally, increases in the value of care are associated with increases in quality of care and decreases in cost.

To refresh your memory, we previously wrote on the topic of value and health care quality in the U.S. These articles speak to the what, why, and how this new form of quality as a competency shows up in the pharma industry. Check them out below:

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1. The Big ‘Picture’ of Health Care Quality in the U.S. (February 2020)

2. Basics of Health Care Quality: The Metrics of Quality (June 2020)

3. A New Lens for Pharma (March 2022)

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Where does one comparatively find quality assurance and quality control job functions versus this new form of quality? We’ve developed a schematic to help answer this important question (see below).

The Functional Model above illustrates the major departments of a biopharmaceutical company. Long-standing quality functions are indicated in yellow and represent quality assurance and quality control in manufacturing and regulatory functions. However, segments (highlighted in orange) within Commercial Operations and Government Affairs represent areas within pharma where new quality competencies and job functions may be developed to align with the value-based care paradigm in the evolving healthcare marketplace.

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In addition to these functional areas, other departments within life science companies such as Clinical Development, Scientific Affairs, and State Policy and Advocacy (in red text) also hold varying degrees of strategic importance to the new quality core competency/job function. It is within these areas that pharma companies can keep up-to-date and build on value-based care and health care quality principles when executing their business objectives. Even more importantly, this would allow for the delivery of quality-of-care benefits to health plans in the form of improved member experience, lower total cost of care, etc. and to provider customers manifested as improved patient outcomes, quality of life, etc.

In Conclusion

Value-based care is becoming increasingly important within the healthcare landscape. As a result, competencies should be resourced in many more companies across the biopharmaceutical industry or contracted out to consulting firms possessing these competencies. In a rapidly evolving healthcare marketplace, organizations that bring passion, commitment, and experience to health care quality will help drive better pharmaceutical industry business strategy so they can be well-informed about the challenges that their customers face and take responsive, patient-centered action.

Bonus Content: Click HERE to check out an example Case Study related to this topic

SUMMARY

Value-based care and health care quality are two new competency areas, however, not widespread in the pharma space and is a fundamental focus for us at THCQ Consulting, Inc.  We approach quality strategy in pharma with a unique team that reflects diverse professional experiences and culturally rich backgrounds. Clarifying the confusion between the traditional definition of quality (i.e., quality control and quality assurance) and the new core competency area of health care quality will help inform the challenges that the customers of pharma companies face. By confronting this confusion about the different forms of quality, we can close the gap towards the creation of institutionalizing this new form of quality within the pharmaceutical industry.

Interested in hearing your thoughts,

Norris Turner, PharmD, PhD

President & CEO, THCQ Consulting, Inc.

nturner@thcqconsulting.com

QUESTIONS FOR YOU

1. How do you think value-based care in the external healthcare environment drives the need for health care quality competency in pharmaceutical companies?

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2. Should health care quality be a mainstay functional competency in all biopharmaceutical companies?

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3. Where might you see opportunities for strategic alignment between new value-based roles on hospital C-suite executive teams such as Chief Experience Officer, Chief Value Officer, etc. relative to value-based and health care quality roles in pharmaceutical companies?

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4. Beyond what we do in this article, should the different forms of quality in pharma be redefined for better differentiation and clarification?

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