Working Minutes of the Ephmra Classification Committee

EphMRA Classification Committee August 2018

Provisional 2019 EphMRA ATC Developments

The following new class structures were voted on by EphMRA/PBIRG in May/June 2018 and agreed in principle. These structures will now be used in the next part of the development process which is the detailed refinement of the rules.

Please note that these new class structures are provisional at this time. The 2019 codes, descriptions and Guideline text will be finalised and published by the Committee at the end of 2018. The new structures then come into effect from the beginning of 2019.

Monoclonal antibody antineoplastics

L1G MONOCLONAL ANTIBODY ANTINEOPLASTICS

L1G1 Monoclonal antibody antineoplastics, CD20 (new) Includes products containing obinutuzumab, ofatumumab, rituximab, rituximab with hyaluronidase, etc

L1G2 Monoclonal antibody antineoplastics, VEGF/VEGFR (new) Includes products containing bevacizumab, ramucirumab, etc.

L1G3 Monoclonal antibody antineoplastics, HER-2 (new) Includes products containing margetuximab, pertuzumab, trastuzumab, trastuzumab emtansine, etc

L1G4 Monoclonal antibody antineoplastics, EGFR (new) Includes products containing cetuximab, necitumumab, nimotuzumab, panitumumab, etc.

L1G5 Monoclonal antibody antineoplastics, PD-1/PD-L1 (new) Includes products containing atezolizumab, avelumab, durvalumab, nivolumab, pembrolizumab, etc.

L1G9 Monoclonal antibody antineoplastics, other (new) Includes antibodies with other targets including other CD targets, CTLA-4 (ipilimumab), etc. Includes antibody drug conjugates (ADCs) if not classified with the target class (brentuximab vedotin, gemtuzumab ozogamicin, inotuzumab ozogamicin). Includes radio-labelled antibodies (ibritumomab tiuxetan, tositumomab iodine-131).

Includes alemtuzumab, blinatumomab, brentuximab vedotin, catumaxomab, daratumumab, dinutuximab, elotuzumab, gemtuzumab ozogamicin, ibritumomab

©EphMRA 2018 Page 1

EphMRA Classification Committee August 2018

tiuxetan, inotuzumab ozogamicin, ipilimumab, mogamulizumab, olaratumab, racotumomab, rovalpituzumab tesirine, siltuximab, tositumomab, tositumomab iodine- 131, etc.

Protein kinase inhibitor antineoplastics

L1H PROTEIN KINASE INHIBITOR ANTINEOPLASTICS

L1H1 Protein kinase inhibitor antineoplastics, BCR-ABL (new) Includes products containing bosutinib, dasatinib, imatinib, nilotinib, ponatinib, radotinib, etc.

L1H2 Protein kinase inhibitor antineoplastics, EGFR (new) Includes products containing afatinib, erlotinib, gefitinib, icotinib, olmutinib, osimertinib, etc.

L1H3 Protein kinase inhibitor antineoplastics, ALK (new) Includes products containing alectinib, brigatinib, ceritinib, crizotinib, etc.

L1H4 Protein kinase inhibitor antineoplastics, BRAF/MEK (new) Includes products containing cobimetinib, dabrafenib, trametinib, vemurafenib, etc.

L1H5 Protein kinase inhibitor antineoplastics, CDK 4/6 (new) Includes products containing abemaciclib, palbociclib, ribociclib, etc.

L1H9 Protein kinase inhibitor antineoplastics, other (new) Includes all other protein kinase inhibitor antineoplastics, for example those inhibiting HER-2, JAK 1-2, BTK, Pi3K, etc.

Includes acalabrutinib, apatinib, axitinib, cabozantinib, everolimus, ibrutinib, idelalisib, lapatinib, lenvatinib, midostaurin, neratinib, nintedanib, pazopanib, regorafenib, ruxolitinib, sorafenib, sunitinib, temsirolimus, tivozanib, vandetanib, etc.

Lidomide antineoplastics

L1X2 Lidomide antineoplastics (new) Includes products containing lenalidomide, pomalidomide or thalidomide for multiple myeloma and other cancers.

Products containing thalidomide for both cancer and erythema nodosum leprosum (ENL) are classified here. Products containing thalidomide for ENL only are classified in L4X.

PARP inhibitor antineoplastics

L1X4 PARP inhibitor antineoplastics (new) Includes products containing niraparib, olaparib, rucaparib, talazoparib, veliparib, etc.

CAR T-cell therapies

L1X5 CAR T-cell therapies (new) Includes products containing axicabtagene ciloleucel, tisagenlecleucel, etc.

LAMA/LABA/corticosteroid combinations

R3L3 Long-acting anticholinergic combinations with both long-acting B2-agonists and with (new) corticosteroids, inhalant

Includes products containing a triple combination of a long-acting anticholinergic, a long-acting B2-agonist and a corticosteroid. Includes glycopyrronium plus formoterol plus beclomethasone, tiotropium bromide plus formoterol plus ciclesonide, umeclidinium bromide plus vilanterol plus fluticasone, etc.