A Global Risk Mitigation Plan (GRMP) is a critical step in drug development as it helps sponsors identify and address potential Market Access, Pricing & HEOR (health economics outcomes research) barriers that could affect the launch and commercial success of their product.
The GRMP typically consists of two parts: a Risk Assessment Tool and a Risk Mitigation Playbook. The Risk Assessment Tool helps identify potential risks that could arise during the drug development process or at the time of launch. The Risk Mitigation Playbook then outlines specific strategies and tactics for addressing those risks, such as developing contingency plans, evidence generation, or engaging with stakeholders.
Some of the potential risks that might be identified could include regulatory challenges, safety concerns, pricing and reimbursement issues, and competition. By proactively addressing these risks, drug developers can increase their chances of successfully launching and commercializing their product.
The key stakeholders involved in creating the plan include representatives from cross-functional teams to gain a complete view on the issues (e.g., Market access, HEOR, Medical, Public Affairs, Marketing), affiliates, and external payer experts to validate risks.
While similar to the Payer Objection Handler (POH), there are some differences between GRMP and POH.
Both tools are important components of a comprehensive launch strategy and can help to increase the chances of a successful drug launch. However, the GRMP focuses on identifying and mitigating potential risks associated with the launch of a drug, while the POH focuses on addressing objections from payers during the reimbursement process. Therefore, they have different objectives and strategies.
What are the benefits of GRMP?
Developing a GRMP offers several key benefits for pharmaceutical and biotech companies looking to launch a new drug including:
- Proactive Risk Management: helps companies identify potential risks and develop strategies to address them proactively. By identifying risks early and taking steps to mitigate them, companies can avoid costly delays or fails that could compromise the launch of the drug.
- Relevant global market access and HEOR strategy: by gaining insights from markets, Global teams can develop tailored plans and solutions to support markets.
- Commitment by local affiliates: the goal being to prepare a local action plan ahead of launch so affiliates understand the issues better, learn from each other, and create a plan with clear solutions, owners and timelines.
- Enhanced Cross-Functional Collaboration: helps improve communication and collaboration, promoting a more effective team.
- Adaptability: by creating a flexible and adaptable plan, companies can navigate the unique challenges and risks associated with each market and maximize the commercial potential of the drug.
Who is the GRMP for?
You can take part in the GRMP development whether you are a pharmaceutical or biotech company that is planning to launch a new drug in a specific indication. This plan is particularly relevant for companies that expect to face challenges during the drug launch or expanding into another line of treatment. For instance, the GRMP can provide valuable guidance if you are developing a drug in a new indication with a significant competitor, aiming to establish your drug as the standard of care e.g., in the first-line setting, differentiate from the competition, and overcome the high cost of your therapy.
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