Parallel Scientific Advice- TLV s perspective. Wing Cheng DIA Euromeeting Vienna 26th March 2014

Transcription

1 Parallel Scientific Advice- TLV s perspective Wing Cheng DIA Euromeeting Vienna 26th March 2014

2 Overview History: Pilot project TLV-MPA National advice process TLVs experience: EMA-HTA and EUnetHTA Comparison National and European Parallel Advice Future

3 Pilot project- TLV/MPA Initially the idea came from industry Objectives: provide joint Scientific Advice create a better understanding between assessors for methodologies used at MPA and TLV create (an even) better interaction between the two agencies Pilot that started September 2009 and was finalized by end of 2010 with 12 joint scientific advices

4 Pilot project- TLV/MPA Company send background information MPA and TLV discussed the questions independently prior to the meeting A (short) joint discussion before the meeting 1,5 hour meeting takes place at the MPA MPA and TLV answered respective questions the different roles of the agencies recognized (important to keep separate) although the process for providing advice is common Feedback from industry(after the meeting and after pilot project) Very positive feedback

5 Current situation national parallel advice The agencies is currently offering joint advices on a regular basis since the beginning of 2011 Currently TLV has participated in 24 national parallel advices. Feedback is still positive Since we decided to offer joint advices on a more regular basis MPA have received fewer request than expected from the experience from the pilot. Why? Not a Swedish Issue?

6 Reflections Most common questions to TLV: Comparator Health economic modeling Timing of advice Before phase III Precise responses on comparators, clinical trials Questions concerning health economic modeling and quality of life measurement Very early with largely non-clinical data Benefit from the multi-stakeholders views on what would be needed to demonstrate value before starting clinical trials

7 TLV experience on EMA/HTA parallel advice Valuable to have both EMA and other HTA at the same meeting Other stakeholders like Clinicians, COMP, Patient Organizations can make the advice very complex. Challenging and very fruitful discussion More of parallel advice rather than joint advice Big Pharma Coordination could be challenging Overall very positive!

8 TLV experience on EUnetHTA Also positive Very collaborative discussion among the HTAs. Only HTA organizations. Discussion focus more on the different HTA requirements. Regulatory input is sometimes missed. Amount of HTAs attending the meeting could be challenging.

9 All advice models are relevant! TLV/MPA Address local need Both academia and big Pharma EUnetHTA(now SEED) Address partly local need. Focus HTA Mostly big Pharma EMA/HTA Global programme Big Pharma All stages Before phase III Before phase III Open discussion, joint advice Parallel advice focusing on HTA issues. Parallel advice Different stakeholders The preference of model should be based indication, development stage, experiences of company.

10 Future for TLV: A developed Price Model Bill: New instruction for TLV Development of value based pricing The price model will contribute to early access to new innovative medicines The price model will enable good control of the cost during the life cycle of a medicine Cost effectiveness is key and needs to be monitored through the life cycle of a medicine Value based utilization based on value based pricing

11 Future National joint advice more important TLV aim for value based utilization based on value based pricing in the future More players involved County councils Clinicians Patients Agencies and organizations supporting innovation Life cycle management: Several advices for the same product depending on the stage of life cycle Adaptive licensing

12 Future European level: More understanding between HTA agencies. Common discussion for methodological issues possible in the future Keep the strength of the regulatory-hta interface Communication concerning the value of the process Evolve from the pilot phase Streamline the different processes

13 Thank You!