Prioritisation List (EPL) – Pharmaceuticals

Prioritisation List (EPL) – Pharmaceuticals

EUnetHTA prioritises topics for Joint Assessments

EUnetHTA has published the second iteration of the EUnetHTA Prioritisation List (EPL). The EPL expresses the identified significant interest of national HTA bodies in relation to individual compounds as presented in the list. By proactively selecting those topics in direct collaboration with national bodies, EUnetHTA strives to increase the implementation of Joint Assessments at the national level. This is one of the key elements of Joint Action 3.

The EPL is published as part of the overarching Topic Identification, Selection and Prioritisation (TISP) task group. The topics identified and prioritised in the first EPL remain relevant and valid.

Topics have been identified through horizon scanning activities and via feedback from EMA and EUnetHTA partners. Selection and prioritisation are based on four criteria:

  • Whether the topic is of national/sub/national interest;
  • Uptake;
  • Whether the partners are interested in being part of the authoring team for a specific compound;
  • Feasibility in relation to timelines.

 

Attaining the EPL listing demonstrates a significant degree of interest on the part of HTA bodies in receiving a Joint Relative Efficacy Assessment (REA) on the specific topic. EUnetHTA will, therefore, engage with all companies on the EPL in order to establish further dialogue to increase the opportunities for collaboration on prioritised topics.

* EUnetHTA JA3 will not be accepting any further Letters of Intent with regard to new pharma Joint Assessments through the end of Joint Action 3 on 31st May, 2021.
For further information please contact:

wp4_pharmaceuticals@zinl.nl

International non-proprietary name (INN)
Product name (if available)
MAH / pMAH
Anticipated indication, including age and sex if applicable
Application type EM
Estimated submisssion date to EMA/JA start
Status and prioritisation source
Follicular lymphoma (FL), relapsed / refractory.
Eol
Q3 2019
Mantle cell lymphoma (MCL), 1L.
Eol
Q3 2020
Marginal zone lymphoma (MZL), relapsed / refractory.
Eol
Q3 2021
Non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL), 1L.
Eol
Unknown
2/3L Triple negative metastatic breast cancer
Eol
Q1 2020
Triple Negative Breast Cancer – Neoadjuvant
Eol
Q1 2020
1L advanced gastric cancer
Eol
Q1 2020
1L Niercelcarcinoom stadium IV (in combinatie met axitinib)
Eol
Q1 2020
Unresectable or metastatic solid tumours with a microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) biomarker.
Eol
Q1 2020
2L advanced esophageal cancer, squamous
Eol
Q1 2020
Acute steroid-refractory graft versus host disease (GvHD) in adults and children – second-line following allogeneic bone marrow transplant (BMT)
IMA
Q2 2020
Treatment relapsed or refractory multiple myeloma
Eol
Unknown
Apabetalone
Resverlogix
Reducing adverse cardiac events in people with cardiovascular disease, type 2 diabetes and low HDL
IMA
Unknown
EPL 2.0 (July 2019)
Arimoclomol citrat
Orphazyme
Niemann-Pick disease, type C (NPC)
OD
Q2 2020
EPL 2.0 (July 2019)
Autologous CD34+ haematopoietic stem cells (HSCs) transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA
Lenti-D
BlueBird Bio
Cerebral adrenoleukodystrophy
IMA
EPL 1.0 (November 2018). In dialogue with company concerning participation
Avacopan
Vifor Pharma UK or ChemoCentryx
Treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis
IMA
Q2 2020
EPL 2.0 (July 2019)
Brolucizumab
Novartis
Neovascular age-related macular degeneration
IMA
2019
EPL 1.0 (November 2018). Letter of Intent received

Acronym List for EPL

IMA – Initial Market Application

EoI – Extension of Indication

AC – Accelerated Access

OD – Orphan Designation

PRIME – Priority Medicine

ATMP – Advanced Therapy Medicinal Product

 

*Originally prioritised compound: ribociclib+fulvestrant for advanced HR-positive, HER2-negative breast cancer in postmenopausal women – first or second line.

**Originally prioritised compound: ribociclib+alpelisib+fulverstrant for HR-positive, HER2-negative postmenopausal breast cancer – second or third line.