The Intensive Road to Market: Pre-Launch Essentials for Emerging Pharma Companies

Emerging pharmaceutical companies often underestimate the extensive preparation required before a drug launch. Effective pre-launch activities can start as early as 18-to-24 months prior to the market debut. Delaying this crucial groundwork can lead to missteps, gaps and even financial penalties that can have a significant impact on revenue once the drug is introduced.

Foundational Steps: Policy Development and Strategic Planning for Market Readiness

One of the first crucial steps for a emerging pharmaceutical companies is to develop comprehensive policies for both commercial and government entities. For commercial entities, this involves establishing formal documents that clearly define the company’s policies on chargebacks, returns, rebates, and more. For government entities, written policies must be created for programs like Medicaid, Medicare, 340B, and FSS/Tricare. Both sets of policies require thorough review and approval by the company’s legal team.

Additionally, it is essential for emerging pharmaceutical companies to create a well-thought-out governance model that outlines not only the organizational structure of governance committees, but the process to make governance an active business function. The governance model should clearly specify roles, responsibilities, meeting cadence, process steps and include a set of tools and templates to ensure appropriate content and tracking for any item considered. This is particularly important for smaller companies where roles may not be well defined.

Emerging pharmaceutical companies should also develop various analytical models before launching to anticipate how the drug will perform in the market. Critical models typically include those for Gross-to-Net (GTN) forecasting, pre-deal assessment, and post-deal measurement, among others. Each model provides insights into critical metrics that can optimize net sales, such as the impact of contract changes, wholesale acquisition cost (WAC) increases, and live shifts.

In addition to these analytical capabilities, companies must establish operations to handle commercial and Medicaid rebates, payment services, and government pricing calculations. Doing the analysis to understand the needs of the product after launch will enable a manufacturer to determine their roadmap to establish operational components either in-house or through arrangements with business process outsourcers (BPOs). This requires careful consideration of the strengths of available vendors and often involves an RFP process to find the best BPO partner. Even after selecting a BPO, significant work remains, including aligning the manufacturer’s preferences, strategies, and requirements with the BPO’s tools and processes, designing and implementing approval and certification processes, and providing necessary training.

Small Pharma Teams, Big Market Challenges

Another challenge for emerging pharmaceutical companies is managing a small team tasked with a wide range of responsibilities. Often, a single employee is responsible for ensuring the company is prepared for the drug launch. While these employees may have expertise in specific areas of the pharmaceutical industry, they might lack experience in other critical aspects. Employees who were knowledgeable in established companies with in-market drugs may find themselves unfamiliar with the numerous tasks required for a first-time launch at an emerging pharma company. This underscores the importance of having a well-defined and comprehensive plan outlining all the necessary steps to ensure a successful launch.

These are just a few of the many steps and challenges that emerging pharmaceutical companies must navigate to prepare for a successful drug launch. Argano offers situational analysis and roadmap projects that provide an effective way to stay ahead of the curve during launch preparation. These projects lay out the tasks clearly and concisely, enabling our clients to understand the necessary work and develop actionable plans to achieve their goals.

FAQs on pharma pre-launch and peri-launch planning

When should a company begin pharma pre-launch and peri-launch planning?

Effective pre-launch and peri-launch activities should start 18 to 24 months prior to a drug's market debut to prevent revenue penalties.

What foundational policies are required for commercial and government entities?

Companies must draft formal commercial policies for chargebacks and returns, alongside government policies for Medicaid, Medicare, 340B, and FSS/Tricare.

Why is a structured governance model critical during the peri-launch phase?

A governance model outlines organizational committee structures, specific roles, meeting cadences, and tracking tools, which is vital for small teams.

What analytical models are critical for anticipating market performance?

Critical models include Gross-to-Net forecasting, pre-deal assessments, and post-deal measurements to optimize net sales and track WAC increases.

How can emerging pharma companies handle rebate operations and payment services?

Companies must evaluate whether to build these capabilities in-house or partner with Business Process Outsourcers (BPOs) through an RFP process.