OBJECTIVES: To determine the factors that need to be considered while conducting analogue analysis

METHODS: A systematic secondary research was conducted by conducting analogues for three distinct launch scenarios.

RESULTS: Scenario 1: Evidence expectations for a product that is filing for RA followed by other immunological condition- The HTA outcome of several products launched in the recent 5 years were tested, which indicated that for any product launching in RA, a H2H trial is expected for RA and even for following indications such as PsA or AxSpa. Scenario 2: Price and access of Novel combination launching in bladder cancer where one compound has lost exclusivity - Analogues in HIV, diabetes, oncology and others were resulted. Analogue analysis of combination treatments where ore and/or both products had/not lost exclusivity indicated that HTA outcomes were dependent on the combination against the relevant comparators, however the willingness to pay was much lower. The outcomes were agnostic to therapies. Scenario 3: HTA outcomes and price for a compound launched in NASH, a rare condition that has received a conditional EMA approval - In this case, we added the filter of rare conditions, products with conditional approval, HTA outcomes of products in liver and kidney diseases and understood that conditional approval or rare condition did not influence HTA outcome or price.

CONCLUSIONS: Dos: 1. Find analogues for every variable within a scenario 2. Apply therapy area filter for understanding Evidence expectations 3.Relative efficacy filter is good for most scenarios.