HTA & Market Access Agreements in Five

Antonia edit Master subtitle style Click toAndonova Aravind Sivakumar Georgia Tritaki Sebnem Erdol Zeynep Ozdemir

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HTA in Five

Issue of uncertainty: HTA gaining importance

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HTA is least diffused, least organized and not mandatory in Italy. However; UK, France and Germany (NICE, HAS and IQWiG ) have well established HTA process.

HTA is essential and it also triggers Market Access Agreement (MAA) consideration.

MAA in Five:

Commercial Agreement (PVA,PAS,PCS)

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e.g. Sweden, Italy (Bevacizumab), UK (Lenalidomibe), Germany

Outcome based Agreement (individual) Coverage with Evidence Development (population)

e.g. Italy (Tasigna)

e.g. Sweden (Duodopa ), France (Naglazyme, Soliris)

Friend or Foe?

Uncertainty

P4P Outcome based, individual level, administrative costs CA Financial based, not innovative Affordability ??? MAA is not the answer Good-use of HTA ??? Conflict of interest: Industry vs Payer Level of standards ??? When the evidence is sufficient

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CED Evidence based medicine, implementation hurdles

Critiques of MAA

From a societal perspective the process of managing the agreements may involve high administrative costs related to conducting the reviews Lack of transparency Conflict of interest Lowering standards? Decisions made based on public

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Even in examples where the objectives have been achieved, it appears that in many cases the process has not necessarily been worth the cost and time involved.

Conclusion

HTA & MAA

Comparative Effectiveness Research & Coverage Evidence Development as a worthy trend

MAA are in their infancy

Inconsistency of success; the need for further experimentation The cost of administering, negotiating and managing Trend or fad?

MAA schemes difficult to implement

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Common pattern?

Thank you for your attention!!!

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MAA in Five (Contd)

Economic impact Geographical variations

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Italy: Cancer registry launch Different oncology risksharing schemes, 12 & 7 onco drugs in Lombardy and in Molise out of 14.

Why the need for MAA? Trend or Fad?

Manage uncertainty Increasing patient access to medicines in a timely manner Way of entry for pharma companies into the market To control the impact of reference pricing Click to edit Master subtitle style To improve the incentives for innovation Limit the growth in pharmaceutical expenditures
Affordability and public health priority ? Lowered prices on average ?

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MAA (or so-called Risk-sharing Agreements) is a relatively new concept in the healthcare landscape, hence a bit of confusion and misunderstanding, in terms of terminology and also in terms of substance. Different countries adopt and apply different forms of MAAs

MARKET ACCESS AGREEMENTS (MAA)

Specificities of the FIVE

Germany: Sweden: Italy: Cancer registry launch Different oncology risk-sharing schemes, 12 & 7 onco drugs in Lombardy and in Molise out of 14

Economic impact Geographical variations

France:

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