Greek health min­is­ter takes is­sue with Roche's with­draw­al of can­cer med­i­cine due to manda­to­ry, retroac­tive dis­count

Drug prices are not just a US prob­lem. Greece’s min­is­ter of health on Tues­day ex­pressed dis­may over Roche’s de­ci­sion to with­draw a can­cer med­i­cine be­cause of a new manda­to­ry dis­count im­posed by the coun­try.

Greek health min­is­ter An­dreas Xan­thos called the move by Switzer­land-based Roche “un­ac­cept­able” and said cit­i­zens’ ac­cess to in­no­v­a­tive med­i­cines should not be a busi­ness de­ci­sion, ac­cord­ing to a trans­la­tion of a state­ment re­leased Tues­day.

The can­cer treat­ment that was pulled from Greece’s mar­ket by Roche is Cotel­lic (co­bime­tinib), which is used to treat melanoma in com­bi­na­tion with Zelb­o­raf (ve­mu­rafenib). Cotel­lic was ap­proved in the US in 2015, and the com­bo is re­port­ed­ly priced at $17,600 per month, or about $211,000 per year.

Roche spokesper­son An­ja von Treskow told Fo­cus: “With the im­po­si­tion of the manda­to­ry 25% dis­count on new in­no­v­a­tive prod­ucts, which is added to a se­ries of manda­to­ry dis­counts, mak­ing Cotel­lic avail­able in Greece at the re­im­bursed price has be­come un­sus­tain­able.

“We want to en­sure that Greek pa­tients con­tin­ue to have ac­cess to in­no­v­a­tive med­i­cines and treat­ments now and in the fu­ture. At the same time, we need to pro­tect our com­pa­ny from the ex­treme­ly un­fa­vor­able en­vi­ron­ment cre­at­ed by the re­bate and dis­count based pric­ing pol­i­cy for phar­ma­ceu­ti­cal com­pa­nies in Greece,” the drug­mak­er said.

Ac­cord­ing to news re­ports, the manda­to­ry 25% dis­count has been ap­plied retroac­tive­ly to Jan­u­ary 2017 in Greece and could cause oth­er com­pa­nies to with­draw prod­ucts from the mar­ket.

James Love, di­rec­tor of Knowl­edge Ecol­o­gy In­ter­na­tion­al, told Fo­cus he thinks Greece should is­sue com­pul­so­ry li­cens­es on ex­pen­sive can­cer med­i­cines and “this is a good can­di­date.”


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

Author

Zachary Brennan

managing editor, RAPS

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