Reclassification Of The Medicinal Product For Human Use "adempas (Riociguat) ' Within The Meaning Of Article 8, Paragraph 10, Of The Act December 24, 1993, # 537. (Resolution No. 125/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Adempas (riociguat)»,ai sensi dell'articolo 8, comma 10, della legge 24 dicembre 1993, n.537. (Determina n. 125/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-02-28&atto.codiceRedazionale=15A01350&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

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; 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. the aforementioned 48 as amended by order No. 53 of the Minister of health, in consultation with the Ministers for public administration and simplification and of economy and Finance of the March 29, 2012; Having regard to the Legislative Decree March 30, 2001, n. 165; Having regard to act July 15, 2002, # 145; 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 act December 24, 1993, no. 537 concerning "public finance" corrective action with particular reference to art. 8; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 laying «rationalization measures of public finance ", which identifies the margins of distribution for pharmaceutical companies, wholesalers and pharmacists; Visto l'art. 48, paragraph 33, November 24, 2003, law No. 326, which has negotiating the price for products reimbursed by authorisation holders between agency and S. N.; Having regard to the Legislative Decree of April 24, 2006, n. 219, published in the Gazzetta Ufficiale della Repubblica italiana n. 142 of June 21, 2006 on the introduction of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use and Directive 2003/94/EC; Having regard to the 1 February 2001 CIPE; View the "notes October 29, 2004 determination AIFA 2004 (Revision Notes CUF) ', published in the ordinary supplement to the official journal # 259 of November 4, 2004 as amended; View AIFA'S determination of July 3, 2006 published in the official journal-General series-# 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal-General series-# 227, September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Given the decree by which the company Bayer Pharma AG was authorised the placing on the market of the medicinal product ADEMPAS (riociguat); View 620/2014 June 23, 2014 # the determination, published in the Gazzetta Ufficiale della Repubblica italiana n. 159 of July 11, 2014, on the classification of the medicinal product in accordance with art. 12, paragraph 5, reads November 8, 2012 # 189 of medicinal products for human use centrally approved; Having regard to the application by which the Bayer Pharma AG has applied for reclassification of packs with n. AIC from 043333018/043333158 and (s); Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting on 15/09/2014; Having regard to the opinion of the pricing and Reimbursement in the seat of 05/11/2014; Having regard to resolution No. 43 on November 28, 2014 AIFA's Board of Directors adopted on the proposal of the Director General;
Determines Art. 1 Classification for the purposes of new listings is the medicine ADEMPAS (riociguat) in the packages below and is billed as follows: packaging: 0.5 mg film coated tablet-oral-blister (PP/ALU)-42 tablets-AIC # 043333018/E (10) 19BFDU (based on 32) new listings class ': A price ex factory (VAT): €1395.80 retail price (VAT included): €2303.65 0.5 mg film coated tablet-oral-blister (PP/ALU)-84 tablets-AIC # 043333020/E (10) 19BFDW ( based on 32) class of new listings ': A price ex factory (VAT): €2791.60 retail price (VAT included): €4607.29 0.5 mg film coated tablet-oral-blister (PP/ALU)-90 tablets-AIC # 043333032/E (10) 19BFF8 (based on 32) new listings class ': A price ex factory (VAT): €2991.00 retail price (VAT included): €4936.38 1 mg film-coated tablet-oral-blister (PP/ALU)-42 tablets-AIC # 043333044/E (10) 19BFFN ( based on 32) class of new listings ': A price ex factory (VAT): €1395.80 retail price (VAT included): €2303.65 1 mg film-coated tablet-oral-blister (PP/ALU)-84 tablets-AIC # 043333057/E (10) 19BFG1 (based on 32) new listings class ': A price ex factory (VAT): €2791.60 retail price (VAT included): €4607.29 1 mg film-coated tablet-oral-blister (PP/ALU)-90 tablets-AIC # 043333069/E (10) 19BFGF ( based on 32) class of new listings ': A price ex factory (VAT): €2991.00 retail price (VAT included): €4936.38 1.5 mg film coated tablet-oral-blister (PP/ALU)-42 tablets-AIC # 043333071/E (10) 19BFGH (based on 32) new listings class ': A price ex factory (VAT): €1395.80 retail price (VAT included): €2303.65 1.5 mg film coated tablet-oral-blister (PP/ALU)-84 tablets-AIC # 043333083/E (10) 19BFGV ( based on 32) class of new listings ': A price ex factory (VAT): €2791.60 retail price (VAT included): €4607.29 1.5 mg film coated tablet-oral-blister (PP/ALU)-90 tablets-AIC # 043333095/E (10) 19BFH7 (based on 32) new listings class ': A price ex factory (VAT): €2991.00 retail price (VAT included): €4936.38 2 mg-film-coated tablet-oral-blister (PP/ALU)-42 tablets-AIC # 043333107/E (10) 19BFHM ( based on 32) class of new listings ': A price ex factory (VAT): €1395.80 retail price (VAT included): €2303.65 2 mg-film-coated tablet-oral-blister (PP/ALU)-84 tablets-AIC # 043333119/E (10) 19BFHZ (based on 32) new listings class ': A price ex factory (VAT): €2791.60 retail price (VAT included): €4607.29

2 mg-film-coated tablet-oral-blister (PP/ALU)-90 tablets-AIC # 043333121/E (10) 19BFJ1 (based on 32) new listings class ': A price ex factory (VAT): €2991.00 retail price (VAT included): €4936.38 2.5 mg-film-coated tablet-oral-blister (PP/ALU)-42 tablets-AIC # 043333133/E (10) 19BFJF (based on 32) new listings ' class : Ex factory price (excluding VAT): €1395.80 retail price (VAT included): €2303.65 2.5 mg-film-coated tablet-oral-blister (PP/ALU)-84 tablets-AIC # 043333145/E (10) 19BFJT (based on 32) new listings class ': A price ex factory (VAT): €2791.60 retail price (VAT included): €4607.29 2.5 mg-film-coated tablet-oral-blister (PP/ALU)-90 tablets-AIC # 043333158/E (10) 19BFK6 (based on 32) new listings ' class : Ex factory price (excluding VAT): €2991.00 retail price (VAT included): €4936.38 Discount required to public facilities on the price ex factory as per contractual terms. Admission to the new listings for the only indication: Chronic thromboembolic pulmonary hypertension (chronic thromboembolic pulmonary hypertension, CTEPH). For the purposes of the NHS prescriptions, users specifically identified by the regions, will have to complete the computerized data collection of enrollment indicating eligible patients and follow-up, applying negotiation conditions according to the guidelines that are published on the Agency website, web platform-to the address https://www.agenziafarmaco.gov.it/registri/which form an integral part of this determination. Pending the full implementation of the Register web-based monitoring, in order to ensure the availability of treatment to patients prescriptions must be made according to the criteria of eligibility and appropriateness prescriptive documentation available on the Agency's institutional Portal reported: http://www.agenziafarmaco.gov.it/it/content/registri-farmaci-sott oposti-monitoring. The data relating to the processing operations carried out from the date of entry into force of this determination, through temporary mode above, should then be listed in the web platform, according to modalities which will be listed on the site: http://www.agenziafarmaco.gov.it/it/content/registri-farmaci-sottopos ti-monitoring. Validity of the contract: 24 months.