What is the meaning of the pharmaceutical market access? Market access is the process to ensure that all appropriate patients who would benefit, get rapid and maintained access to the brand, at the right price.

Today, Global Market Access (MA), within various pharma organization, is responsible for leading cross-functional access project teams to design and execute the work streams associated with the development of global market access strategies and implementation plans for prioritized products. The cross-functional team usually includes team members from Global Pricing, Center for Observational and Real-World Evidence and Product Marketing, with additional input from Regional or Country Representatives, Medical, and others. Leading the access work includes overseeing the design and conduct of Payer Landscape research, analyzing and synthesizing global pricing and reimbursement systems and needs of payers, to develop payer strategies, communication, and implementation plans to improve targeted product access. Market Access leads various cross functional work streams to provide global access related input into the clinical development plans for assigned pipeline products, as well as provides cross-functional access input into Business Development, Licensing opportunities or deals. The MA Lead role is a player and coach role, with specific team leader responsibilities for select products and franchises.

The market access processes must link the requirements at a global level, which guide the clinical development process, to the needs at the regional and country level. The global value proposition and global value dossier must be adapted to specific market access customers at a national/local level, as each healthcare system is unique. The key challenge is linking all these processes together – for payers, for R&D, for commercial and for market access, to deliver commercial success.

Market access is a complex and business critical area that has been evolving very dynamically over the last decade. As a result, to date, there seem to be no clear industry standards and nomenclatures for MA function. Pharma struggles with defining a unified set of MA roles, responsibilities, and qualifications in parallel to a shortage of the talent on the job market. It is a vicious cycle that has to be broken by specifying explicitly of what is needed from MA Leads, who can do the job and what are the development prospects for MA talent pool. As announced in November 2016 edition of the Pharmaceutical Executive, Boston Consulting Group brought together senior MA leaders to work on progressing the relevant decisions and discussions on market access.

Few immediate needs were identified at the current stage:

1. To increase the visibility of MA Leads role and their cross-functional involvement in drug development process
2. To split the role of pricing into two separate domains: pricing (to deal with development and execution of strategic and operational plans for pricing) and evidence (covering the development of value propositions for Health Technology Assessments, etc.)
3. To transfer the previous scope of the Health Economics and Outcome Research to evidence synthesis (e.g. working with HTA) and evidence generation (e.g. epidemiology models, health outcomes).

Below is a high-level proposal of roles and responsibly (R&R) for various MA positions the BCG proposed in the referenced paper. The various competencies could be combined into one job. Who and how many is accountable within the MA function is depended on the size of the pharma company and/or operational structure of the MA department.

Access Lead; leads the access strategy and execution by:

– shaping and developing strategy and anticipating landscape changes

– cross-functional collaboration with commercial, medical, clinical, regulatory teams

– building access capabilities through training and communication

Policy; creates the access environment by:

– generating insights in healthcare trends and identifying policy priorities

– developing strategies to access pricing barriers, support patient choices and uptake of products, creates disease impact policies

– advocating with relevant networks & advocacy groups, develops communications to and relationship with public media

Pricing Lead; develops the pricing strategic and operational plans by:

– generating insights on Pricing and Reimbursement (P&R) systems, trends, and competitors, tracking P&R decisions

– strategic pricing: conducting relevant research, shaping Target Product Profiles, developing pricing strategies and guidance

– operational pricing: managing negotiation with payers, developing market access solutions and their implementation

Evidence Synthesis; develops product value proposal for the successful HTA evaluation by:

– shaping requirements by monitoring HTA shaping plans, providing early HTA advice, helping the clinical teams to close the evidence gaps

– demonstrating value proposition by building models, HTA studies

– submitting HTA evidence and engagement of HTA authorities

Evidence Generation; supports the identification and generation of evidence for access by:

– shaping environment by monitoring HTA evidentiary requirements such as epidemiological data

– developing cross-functional evidence strategies that support reimbursement

– collaboration with clinical on clinically and patient reported outcomes and ensuring their submission to HTA

I look forward to seeing some of the new outputs from the BCG working group. Off note, similar initiatives could be helpful for other evolving functions such as project management. I see there is a need to standardize the PM job function R&R and consistent nomenclature across the industry.

 References:

• Building Market Access Competences for the Future, Pharmaceutical Executive, November 2016 edition
• Real World Evidence: A New Era for Health Care Innovation
• The true meaning of market access?