The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.

Biotechs and Medtechs, don’t forget your market access strategy (part 2 of 4): The critical role of market access planning in clinical development

November 21, 2019

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel

In my previous post, I established the importance of market access strategy in the clinical development process and why emerging biotechs cannot afford to overlook it.

Click on the button if you missed Part 1 or want to revisit it.

Read Part 1

It is imperative to start developing your strategy with market access due diligence and value story creation early in the product development (at least by phase II of drug development or the proof-of-concept phase of a device development). Impactful market access planning involves designing your clinical programs so they sufficiently address the evidence needs of market access stakeholders, patients, and regulators. This means demonstrating the value of your therapy to payers and HTA agencies by generating compelling and robust clinical trial data against appropriate comparators, augmented where possible and helpful with real-world evidence, health economic arguments, economic models and/or relevant patient-reported outcomes.

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Biotechs and Medtechs, don’t forget your market access strategy (part 1of 4): Why is market access strategy crucial to succeed?

November 14, 2019

Market access strategy is an integral part of the clinical development process to ensure success in global healthcare markets and vital access to patients

Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel 

In clinical development, it’s easy to underestimate the critical role that market access plays in the commercial success of a product. Understandably, organizations instead focus on the regulators, and the steps needed to secure eventual approval. However, ensuring the development plan is aligned with a well-planned market access strategy is essential to help the therapy actually reach the intended patients and realize its true commercial potential following regulatory approval. This is particularly crucial considering that payers and other key stakeholders demand compelling information on a drug’s/device’s value as well as justification of its pricing.

In this four-part blog series, I will address what can be done to optimize your market access planning, and why all that effort is really worth it.

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