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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Mark+Access+Health+Policy
2014 ; 2
(ä): ä Nephropedia Template TP
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Drug repurposing in pharmaceutical industry and its impact on market access:
market access implications
#MMPMID27226833
Murteira S
; Millier A
; Toumi M
J Mark Access Health Policy
2014[]; 2
(ä): ä PMID27226833
show ga
BACKGROUND: Drug repurposing is a group of development strategies employed in
order to overcome some of the hurdles innate to drug research and development.
Drug repurposing includes drug repositioning, reformulation and combination.
OBJECTIVE: This study aimed to identify the determinants of successful market
access outcome for drug repurposing in the United States of America (USA) and in
Europe. METHODS: The case studies of repurposing strategies were identified
through a systematic review of the literature. Price information and
reimbursement conditions for all the case studies were collected mainly through
access of public datasources. A list of attributes that could be associated with
market access outcome (price level and reimbursement conditions) was developed,
discussed, and validated by an external expert group. Detailed information for
all attributes was researched and collected for each case study. Bivariate
regression models were conducted to identify factors associated with price change
for all repurposing cases. A similar analysis was performed for reformulation and
repositioning cases, in the USA and in Europe, separately. A significance level
of 5% was used for all analyses. RESULTS: A total of 144 repurposing case studies
were included in the statistical analysis for evaluation of mean price change.
Combination cases (the combination of two or more individual drug components)
were excluded from the statistical analysis due to the low number of cases
retrieved. The main attributes associated with a significant price increase for
overall repurposing cases were 'change in administration setting to hospital'
(374%, p<0.0001), 'addressing unmet needs' (69%, p<0.05), 'reformulations
belonging to Group 3'-that is, change in administration route (117%, p<0.001),
and being a repurposed product with the 'same brand name' as the original product
(65%, p<0.05). CONCLUSION: We found that the ability of the repurposed product to
address unmet needs, a reformulation where the target product had a different
administration route than the source product, and having a similar brand name for
repurposed and original products, were variables that impacted a positive price
change for repurposed drugs overall. Our research results also suggested that
orphan designation could have a positive impact for repositioning in the USA, in
particular. Although a change of administration from ambulatory to hospital
setting seemed to be significantly correlated with a price increase for the
target product, only one case was retrieved for this parameter; as such, it was
not possible to infer a firm correlation between this parameter and a change in
price.
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