Insertion Of The Medicinal Product For Human Use "dabrafenib (Tafinlar)" In The List Of Medicinal Products Granted Sole Responsibility Of National Serviziosanitario Under The Act December 23, 1996, # 648. (Resolution No. 401/2015).

Original Language Title: Inserimento del medicinale per uso umano «Dabrafenib (Tafinlar)»nell'elenco dei medicinali erogabili a totale carico del Serviziosanitario nazionale ai sensi della legge 23 dicembre 1996, n. 648.(Determina n. 401/2015).

Read the untranslated law here:

The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300; Visto l'art. September 30, 2003 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency and, in particular, paragraph 13; Having regard to the Decree of the Minister of health in consultation with the Ministers for public administration and Economics and finance dated September 20, 2004, n. 245 laying down rules on the organisation and the functioning of the Italian Medicines Agency, pursuant to paragraph 13 of article. 48 above, and in particular art. 19; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the register «simple» Visas, sheet # 1282, dated November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as from November 16, 2011; Having regard to the Decree of the Minister of health September 28, 2004 which formed the technical and Scientific Advisory Committee of the Italian Medicines Agency; Having regard to law no December 23, 1996. 648, conversion of Decree Law No 536 October 21, 1996 concerning measures for the containment of pharmaceutical expenditure and determining the expenditure ceiling for the year 1996, published in the Official Gazette No. 300 of December 23, 1996; Having regard to the Commission's decision only (CUF) dated July 20, 2000, published in the Official Journal No. 219 of September 19, 2000 with errata in Official Gazette No. 232 of October 4, 2000, concerning the establishment of the list of innovative medicines whose marketing is authorized in other States but not on the national territory, of medicinal products which have not yet permitted but subjected to clinical trials and medicines to be used for a therapeutic indication other than that authorised, to be the sole responsibility of the national health service where there is no valid alternative therapy in accordance with art. 1, paragraph 4, of Decree Law October 21, 1996 # 536, converted by law December 23, 1996 # 648; Seen yet the measure CUF dated January 31, 2001 clinical medicines placed on the monitoring on the abovementioned list, published in Official Gazette No. 70 of March 24, 2001; Considering the commitment of the free supply of trametinib until the authorization in Italy use in association with dabrafenib; Considered appropriate to enable adults with inoperable or metastatic BRAF mutation-positive melanoma V600 prescription of dabrafenib in combination with trametinib sole responsibility of national health service exclusively for dabrafenib; Considered it necessary to dictate the conditions under which dabrafenib is inserted into the list referred to in decision dated July 20, 2000 on the creation of the list; Taking into account the opinion expressed by the scientific and Technical Advisory Committee (CTS) 10-12 2014 at its meeting in December the AIFA-excerpt from report No. 31; Was therefore considered to include the medicine «dabrafenib (Tafinlar) "in the list of medicinal products granted sole responsibility of national health service established under the Act December 23, 1996 # 648, for the therapeutic indication mentioned in the introduction;
Causes: Art. 1 The medicine «dabrafenib (Tafinlar) ' and ' entered in accordance with art. 1, paragraph 4, of Decree-Law No October 21, 1996. December 23, 1996, 536, converted by law No. 648, on the list established by Commission decision only the drug mentioned in the introduction.