Market Access : Clearing the ambiguity
I must admit that during the first few months of my MSc, I was quite confused about the term "Market Access". I did know it was synonymous with translating one's skills as a health economist into practice, particularly in an industry sponsored role, but it was quite difficult to come by a definitive synopsis of what it is one actually does. What are the specific tasks and activities one is involved in? What level of complexity is involved? What skills does one need to possess? So here is my attempt at dissemination, clarification, & education. I hope it is useful to those considering it as a career and for the layperson who has mistaken it (& me) to be some sort of pharma lobbyist !
The concept of market access (in healthcare) is fundamentally similar to that in other sectors - Introduction to, and uptake by the market, of a new product offering improved value or competition to the current alternative(s). However it is the execution of this strategy which varies substantially (and requires some specialist skills). Some key questions which pose challenges - How to obtain information about target population? Which parameters of efficacy, safety, effectiveness do we measure? What competitive edge does the product hold? How to demonstrate overrall value ( to both payer & consumer)? How to negotiate in a highly restrictive regulatory environment?
Because drug development is an incredibly long process, answering these questions requires collecting data and its analysis at various stages of the products life cycle. To this effect, planning the coordination and sequential timing of activities is a core deliverable in a MA role. Pre-approval, during the clinical trial 1-3 phases, the objectives are largely to incorporate MA issues during development to create the "value proposition" and to gather data in support of or informing product-specific decision making by upper management (i.e. invest vs disinvest, study types, trial population, approval/reimbursement strategy etc). During the phase 1/2 stage the HE/MA activities tend to focus on analysis of the disease area and associated pricing research. This includes conducting cost-of-illness studies, mapping studies, literature & systematic reviews (on outcomes/competitors disease management/policies as per discretion), and possibly even observational studies. On the pricing side, research efforts tend to be focused on assessing the payer landscape and price anchoring, providing an initial insight into the likelihood of reimbursability. Additional activities at this stage may include development of an early cost-effectiveness study, conceptual model, and patient reported outcomes (PRO) tools.
The value story of a drug starts taking shape during Phase 3 / pre-launch stage. Adjacent to maintaining up-to-date knowledge, desk research activities can now become a lot more focused on local issues and populations, and the process of dissemination through publications and scientific stakeholder or key opinion leader management begins to be emphasized. Increased use of piggy-back CE studies means that it is not uncommon to find a formal economic analysis and PRO analysis being conducted at this stage in preparation for a health technology assessment (HTA). On the P&R front, price sensitivity studies, sequence & strategy analysis, and risk evaluations are just some of the acitivities.
Input from the MA unit is especially essential during the post approval & launch stage of the products life. The objective now is to demonstrate the products value to payers and secure reimbursement status on formulary lists. This is most commonly done by providing the necessary evidence and data to either government agencies or independent bodies for them to conduct an HTA. A positive HTA recommendation can go a long way towards determining the success of a drug, as evidenced by the recommendations of NICE (England), SMC (Scotland), CADTH (Canada) to name a few. These dossiers need to not only present clinical evidence data, but also evidence on cost-effectiveness, comparative effectiveness and increasingly, PRO data. Since requirements can vary across geographical jurisductions, local adaptation of dossiers can be a labour intensive process. The pricing life cycle is also largely determined at this stage, as risk sharing agreements and payer negotiations occur. Reaching consensus at the optimal price - which is largely an acceptable ROI for both the manufacturer & payer - could be considered the key outcome. With eventual entry and possible acceptance of the drug, the MA professional has the on-going responsibility of collecting relevant real life effectiveness data to increase product value (and bargaining power), and updating dossiers in anticipation of HTA re-evaluation.
This is by no means an exhaustive list of activities pertainining to MA. Job descriptions can indeed vary depending on organizational capacity, and there are many soft deliverables such as scientific lobbying, patient advocacy, competitive intelligence and management of HTA decisions which need to be incorporated at various stages. However, I hope this article better illustrates the complexity and dynamic nature of MA in healthcare. If I am missing something please feel free to comment and add. I am sure input from working professionals would indeed be invaluable to newcomers in the field.
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The concept of market access (in healthcare) is fundamentally similar to that in other sectors - Introduction to, and uptake by the market, of a new product offering improved value or competition to the current alternative(s). However it is the execution of this strategy which varies substantially (and requires some specialist skills). Some key questions which pose challenges - How to obtain information about target population? Which parameters of efficacy, safety, effectiveness do we measure? What competitive edge does the product hold? How to demonstrate overrall value ( to both payer & consumer)? How to negotiate in a highly restrictive regulatory environment?
Because drug development is an incredibly long process, answering these questions requires collecting data and its analysis at various stages of the products life cycle. To this effect, planning the coordination and sequential timing of activities is a core deliverable in a MA role. Pre-approval, during the clinical trial 1-3 phases, the objectives are largely to incorporate MA issues during development to create the "value proposition" and to gather data in support of or informing product-specific decision making by upper management (i.e. invest vs disinvest, study types, trial population, approval/reimbursement strategy etc). During the phase 1/2 stage the HE/MA activities tend to focus on analysis of the disease area and associated pricing research. This includes conducting cost-of-illness studies, mapping studies, literature & systematic reviews (on outcomes/competitors disease management/policies as per discretion), and possibly even observational studies. On the pricing side, research efforts tend to be focused on assessing the payer landscape and price anchoring, providing an initial insight into the likelihood of reimbursability. Additional activities at this stage may include development of an early cost-effectiveness study, conceptual model, and patient reported outcomes (PRO) tools.
The value story of a drug starts taking shape during Phase 3 / pre-launch stage. Adjacent to maintaining up-to-date knowledge, desk research activities can now become a lot more focused on local issues and populations, and the process of dissemination through publications and scientific stakeholder or key opinion leader management begins to be emphasized. Increased use of piggy-back CE studies means that it is not uncommon to find a formal economic analysis and PRO analysis being conducted at this stage in preparation for a health technology assessment (HTA). On the P&R front, price sensitivity studies, sequence & strategy analysis, and risk evaluations are just some of the acitivities.
Input from the MA unit is especially essential during the post approval & launch stage of the products life. The objective now is to demonstrate the products value to payers and secure reimbursement status on formulary lists. This is most commonly done by providing the necessary evidence and data to either government agencies or independent bodies for them to conduct an HTA. A positive HTA recommendation can go a long way towards determining the success of a drug, as evidenced by the recommendations of NICE (England), SMC (Scotland), CADTH (Canada) to name a few. These dossiers need to not only present clinical evidence data, but also evidence on cost-effectiveness, comparative effectiveness and increasingly, PRO data. Since requirements can vary across geographical jurisductions, local adaptation of dossiers can be a labour intensive process. The pricing life cycle is also largely determined at this stage, as risk sharing agreements and payer negotiations occur. Reaching consensus at the optimal price - which is largely an acceptable ROI for both the manufacturer & payer - could be considered the key outcome. With eventual entry and possible acceptance of the drug, the MA professional has the on-going responsibility of collecting relevant real life effectiveness data to increase product value (and bargaining power), and updating dossiers in anticipation of HTA re-evaluation.
This is by no means an exhaustive list of activities pertainining to MA. Job descriptions can indeed vary depending on organizational capacity, and there are many soft deliverables such as scientific lobbying, patient advocacy, competitive intelligence and management of HTA decisions which need to be incorporated at various stages. However, I hope this article better illustrates the complexity and dynamic nature of MA in healthcare. If I am missing something please feel free to comment and add. I am sure input from working professionals would indeed be invaluable to newcomers in the field.
