No abstract

A449drugs in Poland. In the majority of processes RWE confirms conclusions based on EE. RWE is of high quality slightly less often than EE, however it is twice less frequently assessed for reliability. As pharma companies strive to develop high quality RWE it still does not receive the attention it deserves from public funding decision makers.

Background: The aim of the study was to assess the use and impact of RWE in decision-making processes on public funding of drugs in Poland. Methods: The analysis was based on data from the Agency for Health Technology Assessment and Tariff System (AOTMiT) in Poland published between January 2012 and September 2015 in Verification Analyses (VA), Statements of the Transparency Council (STC) and Recommendations of the President of AOTMiT (RPA). Results: RWE related to effectiveness or safety was identified in 53% of VAs, 21% of STCs and 35% of RPAs. Predominantly, RWE was included in reimbursement applications by MAH, however in 4% of VAs AOTMiT analysts found RWE themselves. Most of RWE related to safety (89%) and less to effectiveness (55%). The longitudinal analysis of RWE in AOTMiT evaluations shows steady increase in the number of processes with RWE in 2012–2014 with apparent decline in 2015 to estimated 36 processes p.a. Furthermore, the share of processes with RWE had a peak in 2014 (59% vs. 48% in both 2012 and 2013). Conclusions: RWE on effectiveness or safety is identified in surprising 53% of decision-making processes on public funding of drugs in Poland. Applications with RWE more often had a positive Statement/Recommendation/Decision compared to those without RWE. There is a considerable lack of consistency in identification of RWE on the three distinct levels of assessment and appraisal within the HTA Agency. A growing importance of RWE can be observed in Poland, however, the pace of the growth will mainly depend on building capabilities of the stakeholders in healthcare system.

The experiments presented in this paper show how growing cells on portable substrats can be useful to facilitate and accelerate the passaging (subculture) of anchorage-dependent cells. Experiments have shown that portable substrats are cheap, commercially available, and transparent. They are easily cut into various shapes and sizes, and are easy to sterilize. Portable substrats are also friendly to cells and permit faster than usual cell passaging procedures. Anchorage-dependent cells growing on the bottom of a culture vessel made of glass or polystyrene can be quickly passaged with previously-cut small fragments of glass fiber or nylon meshes or small fragments of polyester foil as well as nylon fishing lines and biodegradable surgeon threads that have been inserted into the vessel. The surfaces of such fragments of portable supports are quickly overgrown with cells and can be easily transferred to a new culture vessel. As with tissue explants, cells migrate and grow over the bottom of the new culture vessels. Using cell viability tests, analyses of proliferation and fluorescence microscopy, we confirmed the utility of the investigated substrats for cell culture. In addition, the passaging cells, together with a portable support (like explants), eliminate the need for an application of proteolytic enzymes which modify numerous cell properties and activities and would keep the cell from detaching from the substratum which would lead to the cell rounding and changes in the cell's cytoskeleton architecture.

A741process timelines, requested reimbursement mode, STC, RPA, MoHD, discrepancy between requested conditions and MoHD, information from BIA and ICER value if applicable, and key findings from available clinical analyses. ConClusions: Health care systems based on public money should treat all applicants equally if the conditions for the decision are similar and should provide equal access to benefits for patients with similar needs. The database gathers information on all precedent decisions of marketing authorization and public payer practices of similar products or similar indications. This approach opens up the possibility for improvement of transparency and decision-making practices not only in Poland, but in each country. PRM62CoMPaRison of iCd-9 to iCd-10 CRosswalks deRived By PhysiCian and CliniCal CodeR vs. autoMated Methods