Table 1.
Medicines1 included in the analysis: comparison of relevant comparators
| Relevant comparators in the (J)CAs | Reason for the difference | |
|---|---|---|
|
Midostaurin EMA approval: Acute Myeloid Leukaemia FLT3 + ; Newly Diagnosed (Sep 18th 2017) | ||
| EU JCA publication: Nov 8th 2017 (co-) author country: Finland (Norway) | German CA publication: Jan 15th 2018 author: G-BA | |
|
Standard induction and consolidation chemotherapy (cytarabine in combination with daunorubicin 60 mg/m2/day during the induction phase) Induction and consolidation chemotherapy, using daunorubicin 90 mg/m2/day (instead of 60 mg/m2/day) during the induction phase |
Midostaurin with standard induction and consolidation | The German CA for orphan drugs is based on the registration trials only. No definition of additional comparators |
|
Brolucizumab EMA approval: Neovascular (wet) age-related macular degeneration (Feb 13th 2020) | ||
| EU JCA publication: Mar 12th 2020 (co-) author country: Finland (Spain) | German CA publication: Jul 28th 2020 author: IQWiG | |
|
Aflibercept 2 mg/0.05 ml Ranibizumab 0.5 mg/0.05 ml Bevacizumab 1.25 mg/0.05 ml |
Ranibizumab Aflibercept |
EU JCA included off-label comparator bevacizumab due to its relevance in several European healthcare systems |
|
Siponimod EMA approval: Secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity (Jan 13th 2020) | ||
| EU JCA publication: Mar 3rd 2020 (co-) author country: Portugal (Ireland) | German CA publication: May 13th 2020 author: IQWiG | |
|
Interferon-β-1a or -β-1b plus BSC Mitoxantrone plus BSC Ocrelizumab plus BSC Natalizumab plus BSC Fingolimod plus BSC Cladribine plus BSC Rituximab plus BSC |
a. Interferon-beta 1a or interferon-beta 1b or ocrelizumab2 b. BSC3 |
As the patient population was split in the German CA in two subpopulations, two comparators are defined according to these populations. EUnetHTA defined seven active comparators for the whole population |
|
Polatuzumab EMA approval: Relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant (Jan 16th 2020) | ||
|
EU JCA publication: Feb 13th 2020 (co-) author country: Germany (France) |
German CA publication: May 15th 2020 author country: G-BA | |
|
PICO 1a Antineoplastic therapy according to physician’s choice under consideration of the previous therapy and patients characteristics, can include: Platinum- and/or gemcitabine-based regimens (like GemOx) Platinum-based regimens (like ICE or DHAP ± R) without conditioning chemotherapy for transplant (if necessary with reduced dosage) Rituximab bendamustine combination4 PICO 1b After failure of two or more therapies the comparator can include: Axicabtagene ciloleucel Tisagenlecleucel Pixantrone Rituximab–bendamustine combination4 BSC |
Rituximab-bendamustine | The German CA for orphan drugs is based on the registration trials only. No definition of additional comparators |
|
Alectinib EMA approval: First-line treatment of adult patients with ALK + advanced non-small-cell lung cancer (NSCLC) (Dec 18th 2017) | ||
| EU JCA publication: Feb 23rd 2018 (co-) author country: Sweden (Austria/ Croatia) | German CA publication: Mar 28th 2018 author country: IQWiG | |
|
Crizotinib Ceritinib |
Crizotinib | According to the four criteria for comparator derivation, the G-BA prefers the comparator with additional benefit (crizotinib). The German CA of ceritinib did not prove an additional benefit, therefore ceritinib is not included as comparator |
BSC best supportive care, CA clinical assessment, JCA joint clinical assessment, PICO patient, intervention, comparator and outcome
1Data were obtained from the relative clinical effectiveness assessments conducted and published by EUnetHTA (https://eunethta.eu/) and G-BA/IQWiG (https://www.g-ba.de/). Details on indication, posology and administration of each product were derived from the SmPCs available on the European Medicines Agency (EMA) website (https://www.ema.europa.eu/en)
2Patient population: Adult patients with secondary progressive multiple sclerosis (SPMS) with active disease, defined by clinical findings or imaging of the inflammatory activity, with relapses
3Patient population: Adult patients with secondary progressive multiple sclerosis (SPMS) with active disease, defined by clinical findings or imaging of the inflammatory activity, without relapses
4Specifically in elderly patients or patients with comorbidities