Instituto DARA

Managed Entry Agreements (MEAs) are an evolving mechanism in healthcare systems around the world, including in Australia. MEAs are contractual agreements between pharmaceutical manufacturers and payers to manage the risk and cost of new pharmaceutical products while ensuring patient access to these products. In this article, we will discuss the characteristics of MEAs in Australia.

1. Limited access: MEAs limit access to new pharmaceutical products to specific patient populations. This is done to contain costs while offering access to those patients who will benefit the most. The criteria for eligibility are usually based on clinical and economic criteria.

2. Risk sharing: MEAs are risk-sharing agreements that allow the payer to share the risk of the product’s performance with the manufacturer. This is usually done through a performance-based scheme where the manufacturer will only be reimbursed if the product meets certain predetermined benefits.

3. Cost containment: MEAs aim to contain the costs of new pharmaceutical products while still ensuring patient access. This is done through negotiating lower prices, rebates or discounts with the manufacturer.

4. Transparency: MEAs require open and transparent communication between the manufacturer and the payer. This includes the sharing of data and other relevant information to facilitate the negotiation process.

5. Flexibility: MEAs are flexible in their design and implementation. This is important because each product and payer will have their unique needs, challenges, and goals. This flexibility allows the parties to tailor the agreement to suit their respective requirements.

6. Evaluation: MEAs require ongoing evaluation to ensure that they are meeting their intended goals. This evaluation includes tracking clinical and cost-effectiveness outcomes, as well as any changes in the patient population, market conditions, and technology advancements.

In conclusion, managed entry agreements are a valuable mechanism in healthcare systems around the world, including in Australia. They allow payers to manage the risk and cost of new pharmaceutical products while ensuring patient access to these products. The characteristics of MEAs in Australia include limited access, risk-sharing, cost containment, transparency, flexibility, and evaluation. These characteristics ensure that both the manufacturer and the payer are able to negotiate an agreement that benefits both parties while improving patient outcomes.