Tuesday, 11 October 2016

Adaptive licensing - MAPPs

Regulatory perspective on MAPPs
Francesco Pignati

Sara Garner
MAPPS from HTA perspective
Fix ''menu is not working for everybody
RCTs are ''not working for everybody
Current framework is not giving all the data we need and we have a lot of decision uncertainty

We have not the evidence we need
Slow innovation=slow access
So the adaptive licensing needed

Discussion should start earlier
Not lowering the evidence; we just change the timing
Is the commercial pressure or the scientifical pressure

we will use existing tools: existing design models?
early approval
paying for the volume should be replaced by paying for the health outcome and this requires good data;
-what kind the data we need -and which data will prove what .

Adaptive licensing
Paolo Casali

How EMA   approves
How national rules applied are variate
Joint scientific advise - between the eu regulator and the national authorities
The problem in rare cancers is the companies are not interested to develop the drugs for those disease
The clinical advise is to centralise the care- to refer the patients to centres of excellence and that is a matter of networking (crucial in rare disease-crucial also for melanoma in fact).

Bettina Ryll
using melanoma as a study case
two classes of drugs
in phase I we could already see efficacy which we never were seen
tumours were actually
access to the new drugs was the only way
but these drugs are not a cure/meant we need systematic learning

Seeking early scientifically advice
the value of drug should be assess
early agreements between the payer and companies
sharing the responsibility

Bettina to Francesco
question: why the change is so  slow?
different organisation, different pathways
people that do not understand what is about -people are not confident
how to best design networks that can generate evidence
Timing of the evidence

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