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 |
Abbreviations: ASMR Amélioration du Service Médical Rendu, CDF Cancer Drug Fund, DCP Docetaxel, or Pemetrexed, or Ceritinib, ERG Evidence Review Group, FVC Forced Vital Capacity, ICER Incremental Cost Effectiveness Ratio, QALY Quality Adjusted Life Year, SMR Service Médical Rendu
* 2nd opinion was conducted as Budget Impact by Pirfenidon sales was considered significant