WHAT ARE THE IMPLICATIONS OF AN ATC CODE? MAKING THE RIGHT CHOICE TO OPTIMIZE PRICE AND ACCESS

Author(s)

ABSTRACT WITHDRAWN

OBJECTIVES: The Anatomical Therapeutic Chemical (ATC) code system aims to classify drugs according to their therapeutic area and pharmacological/chemical properties. The ATC code is usually requested when a substance is ready to be submitted for market access. For certain innovative drugs, there is an opportunity for the manufacturer to shape this definition. We assess the relationship between the ATC code definition and price, and pricing risk of suboptimal code, at each stage of the product lifecycle, including potential usage and impact of ATC classification in ongoing cost or budget monitoring. METHODS: Through secondary research into public sources, the impact of ATC codes across various countries is evaluated. A basket of products is defined, and national guidelines are reviewed. We classify per country in which situations the ATC code has a direct or indirect influence on drug price at: initial market authorization; initial P&R assessment; point of procurement; price re-assessment; loss of exclusivity; cost monitoring. RESULTS: We find that the ATC code can impact a subset of specific topics related to pricing, in certain countries. ATC-4 is the most relevant level for the definition of price groups, comparators, tender lot composition, and price cuts per class. Since the classification is international, there are country-specific trade-offs: E.g., “Anti-inflammatory” classification requires guidance in Italy to prevent price-reducing effect of low reference price, but underscores a novel mechanism in France, likely leading to favourable ASMR rating and high willingness-to-pay. CONCLUSIONS: Our analysis identifies countries in which ATC codes have an impact on price negotiations and re-negotiations. Furthermore, we draw conclusions on the key considerations for pharmaceutical companies when there are options for the definition of the ATC code of a new product, to ensure alignment with strategic goals. We assess the trade-offs and guidance to prioritize ATC classification accordingly.

Conference/Value in Health Info

2019-11, ISPOR Europe 2019, Copenhagen, Denmark

Code

PDG60

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy, Systems & Structure

Disease

Drugs

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