Table 2.
Available CT opinions of drugs indicated in solid tumours (2009-2014)
| INN | Brand name | MA date | Date of price publication/ enforcement | CT initial assessment date | CT extension of indication assessment date | CT re-assessment date | Indication evaluated | SMR score | ASMR score |
|---|---|---|---|---|---|---|---|---|---|
| Abiraterone acetate | Zytiga® | 05/09/2011 | 21/06/2012 | 29/02/2012 | With prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen | Substantial | III | ||
| 12/06/2013 | Treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated | Substantial | IV | ||||||
| Afatinib | Giotrif® | 25/09/2013 | 29/07/2014 | 19/02/2014 | As monotherapy for the treatment of adult patients treatment naive for anti EGFR TKI receptor with a non-small cell lung cancer with locally advanced or metastatic with activator mutation(s) activator for EGFR | Substantial | V | ||
| Aflibercept | Zaltrap® | 01/02/2013 | 14/03/2014 | 24/07/2013 | In combination with irinotecan/5-fluorouracil/folinic acid chemotherapy is indicated in adults with metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen | Substantial | V | ||
| Axitinib | Inlyta® | 03/09/2012 | 01/01/2014 | 09/01/2013 | Treatment of adult patients with advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine | Substantial | IV | ||
| 08/01/2014 (Assessment of two dosages 3 mg and 7 mg) | Substantial | V | |||||||
| Cabazitaxel | Jevtana® | 17/03/2011 | 13/09/2013 | 19/10/2011 | In combination with prednisone or prednisolone is indicated in the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen | Substantial | IV | ||
| 17/10/2012 (Re-assessment of the Improvement in Actual Benefit following submission of new data, on the initiative of the applicant) | Substantial | III | |||||||
| Cabozantinib | Cometriq® | 21/03/2014 | Not available | 12/03/2014 | Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma | Substantial | IV | ||
| Catumaxomab | Removab® | 20/04/2009 | Not available | 19/12/2009 | Intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible | Low | V | ||
| Crizotinib | Xalkori® | 23/10/2012 | 04/09/2013 | 03/04/2013 | Treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer | Substantial | III | ||
| Dabrafenib | Tafinlar® | 26/08/2013 | 26/07/2014 | 07/05/2014 | Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation | Substantial | V | ||
| Degarelix | Firmagon® | 17/02/2009 | 04/02/2010 | 23/09/2009 | Treatment of adult male patients with advanced hormone-dependent prostate cancer | Substantial | V | ||
| Enzalutamide | Xtandi® | 21/06/2013 | 05/02/2014 | 20/11/2013 | Treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel-based chemotherapy | Substantial | III | ||
| Eribulin | Halaven® | 17/03/2011 | 03/07/2012 | 20/07/2011 | Treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease | Substantial | IV | ||
| Everolimus | Afinitor® | 03/08/2009 | 17/03/2010 | 13/01/2010 | Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy | Substantial | IV | ||
| 28/03/2012 | Treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease | Substantial | IV | ||||||
| 03/04/2013 | Treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor | Low | V | ||||||
| 18/12/2013 (Re-assessment of the target population) | - | - | |||||||
| Gefitinib | Iressa® | 24/06/2009 | 22/01/2010 | 04/11/2009 | Indicated for adults in the treatment of locally advanced or metastatic non-small cell lung cancer) with activating mutations of EGFR-TK | Substantial | IV: in first-line treatment V: in 2nd or 3rd line treatment | ||
| Ipilimumab | Yervoy® | 13/07/2011 | 07/03/2013 | 14/12/2011 | Treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy | Substantial | IV | ||
| 06/11/2013 (Re-assessment of the Improvement in Actual Benefit following submission of new data, on the initiative of the applicant and target population) | Treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy | - | IV | ||||||
| Mifamurtide | Mepact® | 06/03/2009 | Not available | 17/11/2010 | In children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically-complete surgicalresection. It is used in combination with post-operative multi-agent chemotherapy | Insufficient | Not applicable | ||
| Pazopanib | Votrient® | 14/06/2010 | 23/11/2013 | 02/02/2011 | First line treatment of advanced renal cell carcinoma and for patients who have received prior cytokine therapy for advanced disease | Insufficient | Not applicable | ||
| 09/01/2013 | Treatment of adult patients with selective subtypes of advanced soft tissue sarcoma who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy | Substantial | IV | ||||||
| 26/06/2013 (Assessment same indication that was rejected in 2011) | First-line treatment of advanced renal cell carcinoma and for patients who have received prior cytokine therapy for advanced disease | Low: first-line treatment Insufficient: second-line | V: first-line treatment Not applicable: second-line treatment | ||||||
| Pertuzumab | Perjeta® | 04/03/2013 | 13/12/2013 | 24/07/2013 | Indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease | Substantial | III | ||
| Radium Ra223 dichloride | Xofigo® | 13/11/2013 | Not available | 02/04/2014 | Indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases | Substantial | IV | ||
| Regorafenib | Stivarga® | 26/08/2013 | 02/01/2015 | 14/05/2014 | Indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidinebased chemotherapy, an antivascular-endothelial-growth-factor therapy and an antiepidermal-growth-factor-receptor therapy | Low for patients with performance scores between 0 and 1 Insufficient for patients with performance scores >1 | V | ||
| Tegafur/ gimeracil/ oteracil | Teysuno® | 14/03/2011 | Not available | 03/10/2012 | Indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin | Insufficient | Not applicable | ||
| Trastuzumab emtansine | Kadcyla® | 15/11/2013 | 31/07/2014 | 19/03/2014 | As a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy | Substantial | II | ||
| Vandetanib | Caprelsa® | 17/02/2012 | 29/06/2013 | 20/06/2012 | Treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease | Substantial | IV | ||
| Vemurafenib | Zelboraf® | 17/02/2012 | 02/02/2013 | 03/10/2012 | In monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma | Substantial | III | ||
| Vinflunine | Javlor® | 21/09/2009 | 13/08/2010 | 16/12/2009 | In monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinumcontaining regimen | Moderate | V | ||
| 01/07/2015 (Re-assessment of the Actual Benefit and Improvement in Actual Benefit following submission of new data, on the initiative of the applicant) | In monotherapy for the treatment of adult patients with advanced or metastatic transitional-cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen | Moderate | V | ||||||
| Vismodegib | Erivedge® | 12/07/2013 | Not available | 18/12/2013 | Treatment of adult patients with symptomatic metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy | Substantial | IV |
Cut-off date: 24 February 2015