The ESMO-MCBS:H consists of 6 evaluation forms.
Choosing which form to use depends on the information available in the peer reviewed publication of the clinical trial that led to the licensed indication of the treatment you are interested in. The type of study will dictate which evaluation form to use.
The highest grade of the ESMO-MCBS:H is A in the curative setting and this is restricted to new curative treatments with a grade B also to be considered to trigger rapid reimbursement. For non-curative indications 5 is the highest possible grade with 4 also to be considered to trigger rapid consideration for reimbursement.
Evaluation form 1a: For RCTs evaluating new approaches to new potentially curative therapies
Evaluation form 1b: For single arm therapies with curative intent and de-escalation studies
Evaluation form 2a: For therapies that are not likely to be curative with primary endpoint of OS with separate sheets for:
- IF median OS with the standard treatment is <12 months
- IF median OS with the standard treatment ≥12 - <24 months
- IF median OS with the standard treatment ≥24 - <36 months
- IF median OS with the standard treatment ≥36 months
Evaluation form 2b: For therapies that are not likely to be curative with primary endpoint PFS with separate sheets for:
- IF median PFS with standard treatment <6 months
- IF median PFS with standard treatment ≥6 - <12 months
- IF median PFS with standard treatment ≥12 months
Evaluation form 2c: For therapies that are not likely to be curative with primary endpoint other than OS or PFS or equivalent (non-inferiority) studies.
Evaluation form 3: For single-arm studies in “orphan diseases” and for diseases with “high unmet need” when primary outcome is PFS or ORR.
For more information on how to use the evaluation forms check out the instructions.