OBJECTIVES :

Schizophrenia is associated with a high clinical burden, with lifelong treatments that manage symptoms but are not curative. Schizophrenia therapies are utilized for treatment of both positive and negative symptoms, but regulatory approval is often for a broad non-specific indication. Therefore, payers may not accept symptom specific evidence as part of HTA submission, resulting in lack of differentiation and creating patient access hurdles for innovative therapies. This research will aim to analyze drivers behind payer decision making when it comes to schizophrenia therapies, to outline methods that can be used to demonstrate differentiated benefit and improve patient access.

METHODS :

This research will include an analogue assessment for three recently launched branded drugs (lurasidone, cariprazine, and brexpiprazole) broadly indicated for the ‘treatment of schizophrenia’. Available HTA assessments for these drugs from France and Germany will be analyzed to identify decision drivers and barriers.

RESULTS :

Regardless of symptom-specific evidence, improvement vs. placebo does not lead to positive or differentiated HTA outcomes. In HTA decision-making, focus is largely on comparative benefit to currently utilized therapies, rather than on symptom-specific endpoints or absolute outcomes. However, sensitivity to this data varies across markets. For example, Germany, unlike France, is likely to differentiate symptom-specific subgroups for benefit assessment and adopt blended pricing because of beneficial evidence in specific symptom groups.

CONCLUSIONS :

Overall, schizophrenia is a complicated space given the issues in launching in a heavily genericized market with a perceived lack of differentiation across treatments. Findings from the analogue assessment show that an appropriate trial comparator is the key value driver and symptom-specific evidence is not considered critical. However, sensitivity to symptom-specific benefit varies across markets and investing in this evidence could have a part to play in differentiation across therapies, but more as a supplementary tool rather than as an access driver.