ON-GOING MARKET ACCESS ADVICE A POSSIBLE SOLUTION TO HELP ENSURE LONG-TERM SUCCESS IN POST-MARKETING CLINICAL STUDIES- CROSS FUNCTIONAL TEAMS OR EXTERNAL CONSULTATION?

Author(s)

Kirpekar S, Mallinson MDouble Helix Consulting, London, United Kingdom

OBJECTIVES: Manufacturers are under increasing pressure to conduct shorter clinical trials in order to bring products to market as soon as possible and ensure revenue maximisation before loss of exclusivity. At the same time, authorities from markets across the globe have demonstrated increased interest in post-marketing real-life clinical data in order to help make decisions with regards to reimbursement of drugs as well as their positioning in the treatment pathway. METHODS: Manufacturers are spending increasing proportion of their budgets to produce this post-marketing clinical data. It is important to ensure if the data that is being produced is close to the needs of the payers. In majority of instances, it is seen that the data being created is quite far from the expectations of authorities to whose benefit it is being created. The data is typically considered for use in payer discussions only at the end of the clinical study when little flexibility is possible in the end-points and outcomes that will be demonstrated. Also, benefits such as considering early data cuts to present on-going benefit of this long term data is not usually seen. RESULTS: ; Market access, outcomes research and medical affairs teams tend to function independently with very little collaboration as a result of differing targets and budgets. This has made it difficult to have early payer-focussed input into clinical studies. This is particularly so if they are post-marketing studies involving teams with lower focus on payer needs compared to peri-launch market access teams. There is an increased need for greater cross-functional effort on producing clinical data to ensure efficient use. CONCLUSIONS: Involving an external market access agency that is able to advise on the production, analysis and use of post-marketing clinical data is seen to be the solution to this issue.

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PHP166

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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