Drugs: Pre-launch and Life Cycle Management
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, pricing and reimbursement strategies aim to yield a favorable evidence-based assessment by national authorities, whose priorities and outcome measurement vary across markets. The drug’s core value dossier is adapted for local reimbursement applications, as medical communication ensures visibility and knowledge for medical professionals – hence wider and better use.
Managing the life cycle of a drug requires the undertaking of measures during the marketing stage, to maintain the product on the market and to maximize its value. Real-world evidence provides further data to refine the product’s benefit/risk ratio, which is continuously monitored – this is often the purpose of post-marketing commitments made upon registration. Similarly, changes in manufacturing processes are reported as variations to the initially assessed product, which is the subject of quality assessments by regulators. Line extension opportunities are sought and assessed, as well as opportunities to develop or reposition the product in other indications. Quality improvements or cost reductions are sought to face market entry by generics or biosimilars.
Key challenges encompass:
- Is this pivotal Phase 3 study adequate to support both registration and Market Access for the product?
- 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?
- Define targeted medical communication to ensure maximum visibility and knowledge for medical professionals, and hence ensure wider and better use
- Optimize price and reimbursement
- Adapt core value dossier to local requirements and negotiate with payers
- Assess line extension opportunities
- Adapt market access strategy upon competitor launch and patent expiry
- Optimize product value through partnering
- Provide strategic advice on partnering opportunities
- Ensure Quality Improvement / Cost reduction to face competition from generics/biosimilars