Prioritisation List (EPL)

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EUnetHTA prioritises topics for Joint Assessments

EUnetHTA publishes 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 qualitatively and quantitatively at the national level. This is one of the key elements of Joint Action 3.

The Heads of HTA Agencies of the countries represented in the EUnetHTA Executive Board (ExB) have agreed to take a more proactive approach in performing Joint Assessments. There is a strong consensus within EUnetHTA that this approach will strengthen the methods and procedures of the pharmaceutical Joint Assessments to increase the benefits of EU cooperation on HTA and to shape the future model of collaboration. This facilitates national implementation and uptake of the Joint Assessments, and therefore the EUnetHTA ExB has agreed upon the creation of the EPL.

The EPL is based on the Innovation Observatory. The list was cross-checked with the open access Dutch Horizon Scan and the publicly available EMA list of medicines under evaluation to estimate regulatory timelines. In compiling the list, EUnetHTA partners were asked to indicate their interest, including using the assessment at the national level. The final prioritisation was based on this feedback and combined with the anticipated feasibility of the compatibility of timelines of the EUnetHTA assessment and estimated regulatory timelines. Therefore, prioritisation does not discriminate between pharmaceutical companies, compounds or indication. Of note, the EPL is an ad-hoc approach. As such, it will be evaluated and, in the future, may lead to a systematic approach.

The EPL stands complementary to the already well-established mechanism for voluntary submission of new compounds, which will continue in the future to run in parallel to the EPL.

EUnetHTA will interface with all companies on the EPL in order to establish further dialogue and increase cooperation on prioritised topics.

DrugCompanyIndicationType of SubmissionExpected Date of Positive CHMP OpinionStatus as of May 2019
BrolucizumabNovartisNeovascular age-related macular degeneration (nAMD)NCE2019Letter of Intent received
CefiderocolShionogiSevere gram-negative infectionsNCE2019In dialogue with company concerning participation
DarolutamideBayerNon‐metastatic, castration-resistant prostate cancerNCE2019Company refused to participate
DurvalumabAstraZenecaAdvanced or metastatic non-small cell lung cancer (EGFR and ALK wild type) – first lineType II variation2020In dialogue with company concerning participation
ECCS-50 (Cytori Cell Therapy)Cytori TherapeuticsModerate to severe hand dysfunction due to sclerodermaNCE2019Establishing contact
EnasidenibCelgeneRelapsed or refractory acute myeloid leukaemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutationNCE2019Assessment ongoing
Lenti-DBlueBird BioCerebral adrenoleukodystrophyNCE2020In dialogue with company concerning participation
Rexmyelocel TRexgeneroCritical limb ischemia in patients with diabetes mellitusNCE2020Company has expressed willingness to participate in this Joint Assessment at the time of EMA submission
SiponimodNovartisSecondary Progressive Multiple SclerosisNCE2019Letter of Intent received. Compound has replaced originally listed EPL compound.*
SatralizumabChugai PharmaNeuromyelitis optica and neuromyelitis optica spectrum disordersNCE2019In dialogue with company concerning participation
SelonsertibGileadNon-alcoholic steatohepatitis (NASH)NCE2019In dialogue with company concerning participation
SetmelanotideRhythm PharmaceuticalsPro-opiomelanocortin deficiency obesityNCE2019Establishing contact
VoxelotorGlobal Blood TherapeuticsSickle cell diseaseNCE2020In dialogue with company concerning participation
CrizanlizumabNovartisPrevention of vaso-occlusive crises in sickle cell disease patients aged 16 years and overNCE2020Company will submit Letter of Intent. Compound has replaced originally listed EPL compound.**

*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.

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