When we are asked to conduct strategic research on market access, we are typically asked to cover EU5 and USA.  Sometimes Canada.  Sometimes Sweden, to assess how societal impact could weigh on HTA decisions.  

But very rarely are we asked to also consider Central European markets in this ‘core’ group.  Strange.  Together, Poland, Hungary, Czech Republic and Bulgaria represent a population as large as the UK.  

These 4 CEE countries also have an HTA-based drug access process that has many similarities to the UK.

For sure, HTA in Poland, Hungary, Bulgaria and the Czech Republic has become a public priority and a major challenge to the local pharma companies. Therefore, affiliates in these markets have hired a large staff of health-economists or work with external market access experts to satisfy the local HTA requirements.

Some of the national HTA bodies (e.g. the Czech HTA body of the SIDC) may still be understaffed but the delays this causes may be considered as a brake to hold off the stream of expensive new drugs entering these markets.

Even though they benchmark on NICE, their processes are independent and well established and, so are their ICER thresholds. 

The Polish AOTMiT and the Hungarian HTA body demand solid cost-utility studies that need to be tailored and remodelled to the local perspective. Moreover, they utilize ICER thresholds which are “soft” to allow drugs with particularly high unmet need or a low overall budget impact (e.g. orphan drugs).
Clearly, these health care systems are under pressure!  Especially life-changing/saving drugs pose problems and not reimbursing is no longer an option!  Especially when NICE has endorsed such drugs, their HTA is under pressure.  For that reason, they demand perfectly modelled cost-utility analyses to see where the ICER balance becomes acceptable.

Problems often arise here! Sometimes phase 3 comparators are not considered as the local standard of care. Other times, phase 3 study populations are not considered appropriate due to differences in availability of previous lines of therapy.  The attention of HTA bodies can also go to distinct patient subgroups in an attempt restrict reimbursement to special populations.  

In sum, there are many reasons why pharma companies need to properly anticipate the country-specific barriers in these markets.  “Place in therapy” and “place in patient journey” are often the big obstacles in CEE markets.  This may require indirect study comparisons or meta-analyses to adjust the cost-effectiveness models for CEE markets.

Local practices may be different and the time-to-market-access may be longer in these markets.  However, the work of AX'S Consulting in these markets unveils HTA mechanisms that are similar in EU5.  We recommend the global pharma industry to prevent minor HTA issues in EU5 to become major issues in CEE and to timely understand the particular challenges in CEE countries.

Not launching in these markets is no longer an option!

#Papers   #CEE    #HTA   #offthebeatentrack