Table 1 Timing and Outcome of HTA appraisals in France, Italy, and Germany since 2011
| Medicine | EMA Appro-val | Indication | France | Italy | Germany |
|---|---|---|---|---|---|
| Vemurafenib | Feb 17th 2012 | Melanoma |
1st Appraisal: Oct 3rd, 2012 2nd Appraisal: Mar 22nd, 2017 Publication Price: Feb 1st, 2013 Both Appraisals: SMR: substantial ASMR: moderate (level III) |
Publication: Jun 4th, 2013; Class H Payment by Result scheme and sales cap |
1st appraisal: Sep 6th, 2012 2nd appraisal: Mar 6th, 2014 Both appraisals: Indication considerable benefit |
|
Pirfenidon (Orphan Designation) | Feb 28th, 2011 | Idiopathic Pulmonary Fibrosis |
1st Appraisal: Mar 14th, 2012 2nd Appraisal: Feb 18th, 2015 Publication Price: Oct 16th, 2012 SMR 1st Appraisal: Low SMR 2nd Appraisal: Moderate ASMR: minor (level IV) |
1st Publication: Jun 14th, 2013 Class H ‘success fee’ agreement and stopping rule 2nd Publication: Jul 3st, 2015 Removal of ‘success fee’ and stopping rule due to new evidence submitted |
Appraisal: Mar 15th, 2012 Additional benefit non-quantifiable |
|
Pertuzumab 1st Indication Metastatic | Mar 4th 2013 | Her2+ metastatic Breast Cancer |
Appraisal: Jul 24th, 2013 Publication Price: Dec 13th, 2013 SMR: substantial ASMR: moderate (level III) |
Publication: June 23rd, 2014 Class H ‘Innovation designation’ |
Appraisal: Oct 1st, 2013 • Visceral Metastases: Hint Considerable benefit • Non-visceral Metastases: no additional benefit • Locally recurrent: no additional benefit |
|
Pertuzumab 2nd Indication Neoadjuvant | Jul 28th 2015 | Neo-adjuvant |
Appraisal: Jul 6th, 2016 SMR: insufficient ASMR: not applicable |
Publication: Jan 5th, 2017 No reimbursement |
Appraisal: Feb 18th, 2016 No additional benefit |
| Vismodegib | Jul 12th 2013 | Locally advanced or metastatic Basal Cell Carcinoma |
Appraisal: Dec 18th, 2013 Publication Price: Sept 2nd, 2015 SMR: substantial ASMR: minor (level IV) |
Publication: April 9th, 2015 Class H Cost sharing agreement |
1st appraisal: Feb 6th, 2014 2nd appraisal: Aug 4th, 2016 Both appraisal: • Metastatic BCC: no additional benefit • Locally Advanced BCC: Hint Minor Benefit |
| Trastuzumab Emtansine | Nov 15th, 2013 | Her2+ Breast Cancer |
Appraisal: Mar 19th, 2014 Publication Price: Nov 14th, 2014 SMR: substantial ASMR: substantial (level II) |
Publication: Sep 26th, 2014 Class H ‘Potential Innovation’ designation Payment by Result scheme |
Appraisal: Jun 19th, 2014 • Locally Advanced: no additional benefit • Previous therapy includes Anthracycline: Indication considerable benefit • Previous therapy without Anthracycline: no additional benefit |
|
Obinutu-zumab 1st indication (Orphan Designation) | Jul 23rd 2014 | Chronic Lymphocytic Leukaemia |
Appraisal: Feb 18th, 2015 Publication Price: Dec 24th, 2015 SMR: substantial ASMR: moderate (level III) |
1st Publication: Jan 3rd, 2015 Class C 2nd Publication: Feb 24, 2017 Class H Reimbursed with cost sharing scheme |
Appraisal: Feb 5th, 2015 Non-quantifiable additional benefit |
|
Obinutu-zumab 2nd indication (Orphan Designation) | Jun 13th, 2016 | Follicular Lymphoma |
Appraisal: Mar 8th, 2017 SMR: substantial ASMR: no (level V) |
Publication: Aug 31st, 2017 Class H Reimbursed with discount (removal of previous cost sharing agreement) |
Appraisal: Dec 16th, 2016 Non-quantifiable additional benefit |
| Cobimetinib | Nov 20th, 2015 | Melanoma |
Appraisal: Mar 16th, 2016 Publication Price: Feb 16th; 2017 SMR: substantial ASMR: moderate (level III) |
Publication: Oct 1st, 2016 Class H Reimbursed with Payment by Result Scheme |
Appraisal: Jun 2nd, 2016 Indication Considerable benefit |
| Alectinib | Feb 16th 2017 | Non-small lung cancer |
Appraisal: Dec 13th, 2017 Publication Price: Pending SMR: substantial ASMR: minor (level IV) | Publication: Final Publication pending |
Appraisal: Oct 19th, 2017 • Patients eligible for DCP: Hint Minor benefit • Patients not eligible for DCP: no additional benefit |