Content
1.Product value and stakeholder perspective
2.Trends in medical decision making
3.HTA and public reimbursement of medical products
4.HTA and the “grey zone”
5.Relevance of HTA to marketing and sale
6.Integrated KOL-management and market access strategies

Product value and stakeholder perspective
The key-issue in medical business development is the perceived value of your medical product. Many factors influence the perceived value, and there are many routes of influence concerning product value/product information
The current business development strategy is focussing on “top-down” stakeholders ie the value perspective of payers and clinical/scientific experts.

This centralisation implies an increasing influence from administrative decision makers representing the payers, and implies increased influence from top-scientific advisers focussing on the principles of Evidence Based Medicine (EBM). When using EBM, the clinical documentation is quality assessed according to a strict set of rules, and the trial design and results are exposed to a critical review. Administrative decision makers are focussing not only on efficacy and safety, but also on budget impact and Health economy in order to assure value for money when new technologies or drugs are introduced. This “mixture” of EBM, Health Economy and a society perspective on the “product value” is called HTA (Health Technology Assessment). (In Danish MTV: Medicinsk Teknologi-Vurdering). The “mixture” constitute the information used as decision support for the product value assessment, which decides if reimbursement is granted.
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There is a global trend to use the principles of HTA in national assessments of new medical products. It is therefore wise, to meet the needs of the national agencies by using the HTA-principles, when Reimbursement Applications are prepared, and provide the information expected according to this decision support paradigm. There is also a growing international support among pharmaceutical companies to apply the principles of HTA. One motivation for this is to increase the predictability of the national assessments, which still have variable interpretations of the HTA-paradigm.[ link to EFFPIA grading practice]. A key element of diversity among national medicines agencies is the relative emphasis of clinical value assessment (using EBM) and Health Economic assessment (budget impact and Health Economic modelling).
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The above mentioned national diversity in health political use of the HTA-paradigm, is partly counteracted by an increased cooperation (and cross-influence) between the national medicines agencies and national HTA agencies. Both EBM and Health Economic modelling does however has their limitations and pitfalls, which makes room for national interpretations further shaped by the health political environment.
The methodological limitations to both EBM and the Health Economy sometimes lead to controversies between different national key stakeholder’s e.g clinical-scientific experts versus administrative decision makers. One important example on this is the medical expert focus on Evidence grading for assessment of validity of clinical trial results and the strong administrative focus on “low-graded” outcome trials for Health Economic assessment. This controversy is however more related to different value-perspectives and different research questions – than a true scientific controversy [link to Different perspectives in medical decision making?]
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There is a growing resistance among many health care providers to listen to product specialists and other persons representing the company sales organisation. Many doctors do not allow sales persons to enter their office or restrict the access in different ways. They perceive the information too much biased by company interests. In this way a barrier for communication is created, which hits all types of “news” from pharmaceutical companies no matter the quality.
Health care providers prefer to listen to colleagues or experts from their own professional sphere, where commercial interests are not present. There is however still a high need for unbiased and valid information about new products and technologies. HTA or EBM is considered such unbiased information suitable for presentation by medical experts at professional meetings. Commercial efforts to apply HTA or EBM have been called “evidence based marketing and sale”, which also has the benefit of promoting an informal and indirect spread of new “High Value Information”(HVI) among peers.
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Integrated KOL-management and market access strategies

The tougher climate for new drugs on the market require a more KOL-driven and integrated interaction with a diversity of stakeholders. The days where sales reps did all the customer interaction is over. The new stakeholders require qualified interaction, and the company is dependent on precise understanding and mutual cooperation with such stakeholders to keep up with the competitors and the moving target of cost-effectiveness requirements.
In the old days (a few years ago) global pharma-companies could rely on their phase 3 trials and health economic models and then prepare a comprehensive and global strategy for market access, marketing and sale. Such strategy could be effective for several years, and was everything necessary to get the required sale after product registration.
Today the real fight starts at product registration, to defend and improve the “value position” of the product. New medical and administrative decision paradigms (HTA, EBM, etc.) require a different and more creative interaction with Stakeholders and KOL’s in order provide new projects that supports, investigate and develops the value-position of the drug. Such projects require a totally different organization of the KOL-interaction involving more key specialists (market access, medical, clinical R&D).
A comprehensive approach to KOL-management requires rethinking of the organizational structure of customer interactions and support from expert functions which have earlier not been involved in such direct customer interactions.

I offer workshops and education of your teams to improve integration of KOL-management and market access, medical and sales activities, read more

Medical Business Development -strategies and explanation