{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T20:29:33Z","timestamp":1792441773141,"version":"4.5.0"},"reference-count":97,"publisher":"Becaris Publishing Limited","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Comp. Eff. Res."],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:p>Failure to adjust for effect modifiers (EMs) in indirect treatment comparisons (ITCs) can produce biased and uncertain effect estimates. This is particularly important for health technology assessments (HTAs), where the availability of new treatments is based on comparative effectiveness results. Much emphasis has been placed on advancing ITC methods to adjust for EMs, yet whether EMs are appropriately identified for the conduct of ITCs in the first place is unclear. To understand the extent of guidance and requirements for the selection of EMs for ITCs currently available and if and how this guidance is applied in practice, a series of pragmatic reviews of guidance documents from HTA and non-payer organizations, primary published ITC analyses, and prior HTA submissions in two indications (non-small cell lung cancer and psoriasis) was conducted. The reviews showed that current ITC guidance mainly focused on developing analytical methods to adjust for EMs. Some organizations, such as HTA bodies in the UK, France and Germany, recommended the use of literature reviews, expert opinion and statistical methods to identify EMs. No detailed guidance on the selection process or the appropriate literature review approach was found. Similar trends were identified through the database search and review of prior HTA submissions; only few published ITCs and submissions included information on the EM selection process which was either based on findings from the literature, trial subgroup analyses, or clinical input. No reference to a systematic selection approach was found.<\/jats:p>\n          <jats:p>There is an urgent need to fill the guidance gap identified across the reviews by including a step in ITC guidelines on how EMs should be identified through systematic reviews, formal expert elicitation, and a quantitative assessment of the EM distribution. Researchers and manufacturers are also encouraged to improve transparent reporting and justification of their selection of EMs to allow for an independent review of the set of factors being considered for adjustment. Both will contribute toward reducing bias in the ITC results and ultimately increase confidence in decision-making.<\/jats:p>","DOI":"10.57264\/cer-2023-0046","type":"journal-article","created":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T13:40:43Z","timestamp":1692625243000},"source":"Crossref","is-referenced-by-count":11,"title":["Increasing transparency in indirect treatment comparisons: is selecting effect modifiers the missing part of the puzzle? 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Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer (TA643) (2020). https:\/\/www.nice.org.uk\/guidance\/ta643"},{"key":"e_1_3_6_56_2","unstructured":"National Institute for Health and Care Excellence. Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer (TA653) (2020). https:\/\/www.nice.org.uk\/guidance\/ta653"},{"key":"e_1_3_6_57_2","unstructured":"National Institute for Health and Care Excellence. Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer (TA654) (2020). https:\/\/www.nice.org.uk\/guidance\/ta654"},{"key":"e_1_3_6_58_2","unstructured":"National Institute for Health and Care Excellence. Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor (TA670) (2021). https:\/\/www.nice.org.uk\/guidance\/ta670"},{"key":"e_1_3_6_59_2","unstructured":"National Institute for Health and Care Excellence. Pembrolizumab with pemetrexed and platinum chemotherapy for untreated metastatic non-squamous non-small-cell lung cancer (TA683) (2021). https:\/\/www.nice.org.uk\/guidance\/ta683"},{"key":"e_1_3_6_60_2","unstructured":"National Institute for Health and Care Excellence. Atezolizumab monotherapy for untreated advanced non-small-cell lung cancer (TA705) (2021). https:\/\/www.nice.org.uk\/guidance\/ta705"},{"key":"e_1_3_6_61_2","unstructured":"National Institute for Health and Care Excellence. Nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small-cell lung cancer (TA724) (2021). https:\/\/www.nice.org.uk\/guidance\/ta724"},{"key":"e_1_3_6_62_2","unstructured":"National Institute for Health and Care Excellence. Selpercatinib for previously treated RET fusion-positive advanced non-small-cell lung cancer (TA760) (2022). https:\/\/www.nice.org.uk\/guidance\/ta760"},{"key":"e_1_3_6_63_2","unstructured":"National Institute for Health and Care Excellence. Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer (TA770) (2022). https:\/\/www.nice.org.uk\/guidance\/ta770"},{"key":"e_1_3_6_64_2","unstructured":"National Institute for Health and Care Excellence. Sotorasib for previously treated KRAS G12C mutation-positive advanced non-small-cell lung cancer (TA781) (2022). https:\/\/www.nice.org.uk\/guidance\/ta781"},{"key":"e_1_3_6_65_2","unstructured":"National Institute for Health and Care Excellence. Tepotinib for treating advanced non-small-cell lung cancer with MET gene alterations (TA789) (2022). https:\/\/www.nice.org.uk\/guidance\/ta789"},{"key":"e_1_3_6_66_2","unstructured":"National Institute for Health and Care Excellence. Pralsetinib for treating RET fusion-positive advanced non-small-cell lung cancer (TA812) (2022). https:\/\/www.nice.org.uk\/guidance\/ta812"},{"key":"e_1_3_6_67_2","unstructured":"National Institute for Health and Care Excellence. Mobocertinib for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy (TA855) (2023). https:\/\/www.nice.org.uk\/guidance\/ta855"},{"key":"e_1_3_6_68_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Tafinlar & Mekinist in combo for non-small cell lung cancer (PC0106-000) (2017). https:\/\/www.cadth.ca\/tafinlar-mekinist-combo-non-small-cell-lung-cancer-details"},{"key":"e_1_3_6_69_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Alecensaro for locally advanced or metastatic non-small cell lung cancer (second line) (PC0114-000) (2018). https:\/\/www.cadth.ca\/alecensaro-locally-advanced-or-metastatic-non-small-cell-lung-cancer-second-line-details"},{"key":"e_1_3_6_70_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Tecentriq for non-small cell lung cancer (PC0115-000) (2018). https:\/\/www.cadth.ca\/tecentriq-non-small-cell-lung-cancer-details"},{"key":"e_1_3_6_71_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Vizimpro for non-small cell lung cancer (PC0129-000) (2019). https:\/\/www.cadth.ca\/vizimpro-non-small-cell-lung-cancer-details"},{"key":"e_1_3_6_72_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Tagrisso for non-small cell lung cancer (first line) (PC0137-000) (2019). https:\/\/www.cadth.ca\/tagrisso-non-small-cell-lung-cancer-first-line-details"},{"key":"e_1_3_6_73_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Keytruda for non-squamous NSCLC (PC0153-000) (2019). https:\/\/www.cadth.ca\/keytruda-non-squamous-nsclc-details"},{"key":"e_1_3_6_74_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Tecentriq & avastin non-squamous non-small cell lung cancer \u2013 details (PC0155-000) (2020). https:\/\/www.cadth.ca\/tecentriq-avastin-non-squamous-non-small-cell-lung-cancer-details"},{"key":"e_1_3_6_75_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Brigatinib (Alunbrig) for non-small cell lung cancer (NSCLC) (PC0167-000) (2019). https:\/\/www.cadth.ca\/brigatinib-alunbrig-non-small-cell-lung-cancer-nsclc-details"},{"key":"e_1_3_6_76_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Keytruda for squamous NSCLC (PC0176-000) (2020). https:\/\/www.cadth.ca\/keytruda-squamous-nsclc-details"},{"key":"e_1_3_6_77_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Lorlatinib (Lorbrena) for non-small cell lung cancer (PC0183-000) (2020). https:\/\/www.cadth.ca\/lorlatinib-lorbrena-non-small-cell-lung-cancer-details"},{"key":"e_1_3_6_78_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Entrectinib (Rozlytrek) for ROS1-positive non-small cell lung cancer (PC0206-000) (2021). https:\/\/www.cadth.ca\/entrectinib-rozlytrek-ros1-positive-non-small-cell-lung-cancer"},{"key":"e_1_3_6_79_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Nivolumab-ipilimumab for non-small cell lung cancer (PC0218-000) (2021). https:\/\/www.cadth.ca\/nivolumab-ipilimumab-non-small-cell-lung-cancer-details"},{"key":"e_1_3_6_80_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Dabrafenib and trametinib for non-small cell lung cancer BRAF V600 mutation (PC0226-000) (2021). https:\/\/www.cadth.ca\/dabrafenib-and-trametinib-non-small-cell-lung-cancer-braf-v600-mutation"},{"key":"e_1_3_6_81_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Brigatinib (Alunbrig) for anaplastic lymphoma kinase positive non-small cell lung cancer (PC0230-000) (2021). https:\/\/www.cadth.ca\/brigatinib-alunbrig-anaplastic-lymphoma-kinase-positive-non-small-cell-lung-cancer-details"},{"key":"e_1_3_6_82_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Lorlatinib (PC0249-000) (2022). https:\/\/www.cadth.ca\/lorlatinib"},{"key":"e_1_3_6_83_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Tepotinib (PC0255-000) (2022). https:\/\/www.cadth.ca\/tepotinib"},{"key":"e_1_3_6_84_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Selpercatinib (PC0261-000) (2022). https:\/\/www.cadth.ca\/selpercatinib"},{"key":"e_1_3_6_85_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Pralsetinib (PC0283-000) (2022). https:\/\/www.cadth.ca\/pralsetinib"},{"key":"e_1_3_6_86_2","unstructured":"National Institute for Health and Care Excellence. Ixekizumab for treating moderate to severe plaque psoriasis (TA442) (2017). https:\/\/www.nice.org.uk\/guidance\/ta442"},{"key":"e_1_3_6_87_2","unstructured":"National Institute for Health and Care Excellence. Adalimumab etanercept and ustekinumab for treating plaque psoriasis in children and young people (TA455) (2017). https:\/\/www.nice.org.uk\/guidance\/ta455"},{"key":"e_1_3_6_88_2","unstructured":"National Institute for Health and Care Excellence. Dimethyl fumarate for treating moderate to severe plaque psoriasis (TA475) (2017). https:\/\/www.nice.org.uk\/guidance\/ta475"},{"key":"e_1_3_6_89_2","unstructured":"National Institute for Health and Care Excellence. Brodalumab for treating moderate to severe plaque psoriasis (TA511) (2018). https:\/\/www.nice.org.uk\/guidance\/ta511"},{"key":"e_1_3_6_90_2","unstructured":"National Institute for Health and Care Excellence. Guselkumab for treating moderate to severe plaque psoriasis (TA521) (2018). https:\/\/www.nice.org.uk\/guidance\/ta521"},{"key":"e_1_3_6_91_2","unstructured":"National Institute for Health and Care Excellence. Certolizumab pegol for treating moderate to severe plaque psoriasis (TA574) (2019). https:\/\/www.nice.org.uk\/guidance\/ta574"},{"key":"e_1_3_6_92_2","unstructured":"National Institute for Health and Care Excellence. Tildrakizumab for treating moderate to severe plaque psoriasis (TA575) (2019). https:\/\/www.nice.org.uk\/guidance\/ta575"},{"key":"e_1_3_6_93_2","unstructured":"National Institute for Health and Care Excellence. Risankizumab for treating moderate to severe plaque psoriasis (TA596) (2019). https:\/\/www.nice.org.uk\/guidance\/ta596"},{"key":"e_1_3_6_94_2","unstructured":"National Institute for Health and Care Excellence. Secukinumab for treating moderate to severe plaque psoriasis in children and young people (TA734) (2021). https:\/\/www.nice.org.uk\/guidance\/ta734"},{"key":"e_1_3_6_95_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Guselkumab (SR0530-000) (2018). https:\/\/www.cadth.ca\/guselkumab"},{"key":"e_1_3_6_96_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Risankizumab (SR0583-000) (2019). https:\/\/www.cadth.ca\/risankizumab"},{"key":"e_1_3_6_97_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Tildrakizumab (SR0624-000) (2021). https:\/\/www.cadth.ca\/tildrakizumab"},{"key":"e_1_3_6_98_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Halobetasol propionate and tazarotene (SR0638-000) (2020). https:\/\/www.cadth.ca\/halobetasol-propionate-and-tazarotene-0"},{"key":"e_1_3_6_99_2","unstructured":"Canadian Agency for Drugs and Technologies in Health. Bimekizumab (SR0698-000) (2022). https:\/\/www.cadth.ca\/bimekizumab"}],"container-title":["Journal of Comparative Effectiveness Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/becarispublishing.com\/doi\/pdf\/10.57264\/cer-2023-0046","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,26]],"date-time":"2023-09-26T15:27:51Z","timestamp":1695742071000},"score":1,"resource":{"primary":{"URL":"https:\/\/becarispublishing.com\/doi\/10.57264\/cer-2023-0046"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10]]},"references-count":97,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["10.57264\/cer-2023-0046"],"URL":"https:\/\/doi.org\/10.57264\/cer-2023-0046","relation":{},"ISSN":["2042-6305","2042-6313"],"issn-type":[{"value":"2042-6305","type":"print"},{"value":"2042-6313","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10]]},"article-number":"e230046"}}