Challenge:   New oncologicals are under intense scrutiny in Italy, as elsewhere worldwide, given increasing patient demand, more available but very costly therapies, heightened health technology assessment requirements to demonstrate value for reimbursement and government's need to ration spending to those in greatest need. To allow products to prove their worth to government health authorities, companies entering this market must agree to enter a risk-sharing accord where discounts as much as 50% apply for initial months of therapy. Other stringent requirements exist to enable authorities to monitor prescriptions closely. The company applying the stakeholder management and negotiations strategy decided to go against the grain of risk-share and persuade the government to allow a pay for performance approach from the time its new drug was reimbursed. This pathway had not succeeded before for any oncology product.

Strategy :   Following the customary AIFA (health authority) algorithm to establish degree of innovation, with subsequent impact on price, the company undertook a detailed stakeholder analysis to assess which decision-makers would respond to different types of data and arguments. The company introduced these in an orchestrated manner to build upon small successes with opinion leaders reinforcing arguments with decision-makers. The company built trust with AIFA in developing monitoring software for patient selection and assessment to assure the government only appropriate patients would receive the drug. Once the interests of the regulators, KOLs and reimbursement officials were well established and addressed with precise data pinpointed to the needs of each, the table was set for the negotiation on price and terms of access.

Outcome:   Using the 7 elements approach in Monere's program as developed and taught to the company's Italian management team, the company discussed several options it and AIFA would undertake together. Importantly, it likewise assessed the best alternative to a negotiated agreement (BATNA) for itself and AIFA. Failing a negotiated accord, its BATNA was its fallback position for market entry. For each option, e.g., different price points, risk-share vs. pay for performance, patient and budget caps, clinical investment proposals, and others, the company established points of legitimacy to test if the government accepted those points. Over the course of a several month negotiation, the company succeeded to convince the government to reimburse the product from day 1 with no discount and a pay for performance approach instead of a more restrictive risk-share. The company also succeeded in negotiating a 40% price premium over its closest competitor. A key success factor was the trust the company created with AIFA, illustrated by the government's acceptance of the company's approach to health outcomes modeling and careful patient selection.

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