Increase sales, mitigate risk and remain compliant.
Successful launch is the second major value point in a drug’s life cycle. While market approval is grounded on quality, safety and efficacy, market access is contingent upon additionally demonstrating cost-effectiveness to payers. Reimbursement authorities assess the impact of the use of a new drug on healthcare budgets, and determine a price, a level of reimbursement, potential limitations in prescribing, as well as consequences of exceeding sales volumes or average daily dose.
Launch timelines are dependent on risk mitigation. This can mean global agency questions and post-approval commitments and pre-launch change control strategy to ensure timely compliance with site manufacturing process.
The third major value point is life cycle development and management. Improving the manufacturing network, cost of goods and method of drug administration, and extending the licence with therapeutic target areas.
Client Goals
Optimize and maintain commercial opportunity
Define targeted medical communication to ensure maximum visibility and knowledge for medical professionals.
Optimize price and reimbursement.
Optimize product value through partnering.
Challenges
- My competitor is about to launch. Should I change my current strategy or wait until after their launch?
- How to identify additional market opportunities?
- How will payers respond to this? Will I have to re-negotiate the pricing? Do I have adequate evidence?
- How to optimize the post-approval regulatory plan?
- How to handle manufacturing changes/issues?
- How to manage life cycle indications, market and competitive changes?
- Should I and how to present the clinical and cost-effectiveness from a patient perspective to the HTAs and payers?
Solutions 
