{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T23:00:27Z","timestamp":1780959627907,"version":"3.54.1"},"reference-count":27,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2023,5,18]],"date-time":"2023-05-18T00:00:00Z","timestamp":1684368000000},"content-version":"unspecified","delay-in-days":137,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int J Technol Assess Health Care"],"published-print":{"date-parts":[[2023]]},"abstract":"<jats:title>Abstract<\/jats:title>\n\t  <jats:sec id=\"S0266462323000259_sec1\">\n\t    <jats:title>Objective<\/jats:title>\n\t    <jats:p>This study aimed to assess whether there have been changes in the quality of clinical evidence submitted for government subsidy decisions on cancer medicines over the past 15\u00a0years.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S0266462323000259_sec2\" sec-type=\"methods\">\n\t    <jats:title>Methods<\/jats:title>\n\t    <jats:p>We reviewed public summary documents (PSDs) reporting on subsidy decisions made by the Pharmaceutical Benefits Advisory Committee (PBAC) from July 2005 to July 2020. Information was extracted on the study design, directness of comparison, sample size, and risk of bias (RoB). Changes in the quality of evidence were assessed using regression analysis.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S0266462323000259_sec3\" sec-type=\"results\">\n\t    <jats:title>Results<\/jats:title>\n\t    <jats:p>Overall, 214 PSDs were included in the analysis. Thirty-seven percent lacked direct comparative evidence. Thirteen percent presented observational or single-arm studies as the basis for decisions. Among PSDs presenting indirect comparisons, 78 percent reported transitivity issues. Nearly half (41 percent) of PSDs reporting on medicines supported by head-to-head studies noted there was a moderate\/high\/unclear RoB. PSDs reporting concerns with RoB increased by a third over the past 7\u00a0years, even after adjusting for disease rarity and trial data maturity (OR 1.30, 95% CI: 0.99, 1.70). No time trends were observed regarding the directness of clinical evidence, study design, transitivity issues, or sample size during any of the analyzed periods.<\/jats:p>\n\t  <\/jats:sec>\n\t  <jats:sec id=\"S0266462323000259_sec4\" sec-type=\"conclusions\">\n\t    <jats:title>Conclusion<\/jats:title>\n\t    <jats:p>Our findings indicate that the clinical evidence supplied to inform funding decisions for cancer medicines is often of poor quality and has been deteriorating over time. This is concerning as it introduces greater uncertainty in decision making. This is particularly important as the evidence supplied to the PBAC is often the same as that supplied to other global decision-making bodies.<\/jats:p>\n\t  <\/jats:sec>","DOI":"10.1017\/s0266462323000259","type":"journal-article","created":{"date-parts":[[2023,5,18]],"date-time":"2023-05-18T06:27:50Z","timestamp":1684391270000},"source":"Crossref","is-referenced-by-count":6,"title":["Is the quality of evidence in health technology assessment deteriorating over time? A case study on cancer drugs in Australia"],"prefix":"10.1017","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6647-2156","authenticated-orcid":false,"given":"Yuan","family":"Gao","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mah","family":"Laka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracy","family":"Merlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2023,5,18]]},"reference":[{"key":"S0266462323000259_r7","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6602750"},{"key":"S0266462323000259_r9","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djt269"},{"key":"S0266462323000259_r21","unstructured":"21. Australia Government Department of Health TGA. Orphan drug designation eligibility criteria. Therapeutic Goods Administration; [cited 2021 1 May]. 2021. Available from: https:\/\/www.tga.gov.au\/resources\/resource\/guidance\/orphan-drug-designation-eligibility-criteria."},{"key":"S0266462323000259_r10","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j4530"},{"key":"S0266462323000259_r12","doi-asserted-by":"publisher","DOI":"10.1001\/jama.283.16.2116"},{"key":"S0266462323000259_r14","unstructured":"14. The Pharmaceutical Advisory Group. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee (PBAC). Australian Government Department of Health; [cited 2022 26 Apr]. 2016. Available from: https:\/\/pbac.pbs.gov.au\/."},{"key":"S0266462323000259_r16","doi-asserted-by":"publisher","DOI":"10.1177\/0272989X12452341"},{"key":"S0266462323000259_r15","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-12-1819"},{"key":"S0266462323000259_r19","unstructured":"19. WHO Collaborating Centre for Drug Statistics Methodology. ATC\/DDD Index 2021. World Health Organisation; [cited 2021 8 Mar]. 2020. Available from: https:\/\/www.whocc.no\/atc_ddd_index\/."},{"key":"S0266462323000259_r4","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l5399"},{"key":"S0266462323000259_r2","volume-title":"Medicines in the health system","year":"2020"},{"key":"S0266462323000259_r22","unstructured":"22. Orphanet. The portal for rare diseases and orphan drugs. Orphanet; [cited 2021 8 Mar]. 2021. Available from: https:\/\/www.orpha.net\/consor\/cgi-bin\/Disease_Search.php?lng=EN."},{"key":"S0266462323000259_r24","first-page":"943","article-title":"Network meta-analysis: A technique to gather evidence from direct and indirect comparisons","volume":"15","author":"Tonin","year":"2017","journal-title":"Pharm Pract"},{"key":"S0266462323000259_r23","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14327"},{"key":"S0266462323000259_r25","unstructured":"25. KEGG DRUG Database [database on the Internet]. KEGG: Kyoto Encyclopedia of Genes and Genomes [cited 6 Oct]. 2021. Available from: https:\/\/www.kegg.jp\/kegg\/drug\/."},{"key":"S0266462323000259_r27","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoto.2014.1570"},{"key":"S0266462323000259_r6","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l5221"},{"key":"S0266462323000259_r3","unstructured":"3. The Pharmaceutical Benefits Scheme. Pharmaceutical Benefits Advisory Committee (PBAC) Membership. Australia Government Department of Health [cited 2021 13 Dec]. 2021. Available from: https:\/\/www.pbs.gov.au\/info\/industry\/listing\/participants\/pbac."},{"key":"S0266462323000259_r18","unstructured":"18. The Pharmaceutical Advisory Group. Public Summary Documents. The Pharmaceutical Benefit Scheme; [cited 2021 27 Sep]. 2021. Available from: https:\/\/www.pbs.gov.au\/pbs\/industry\/listing\/elements\/pbac-meetings\/psd."},{"key":"S0266462323000259_r26","doi-asserted-by":"publisher","DOI":"10.3390\/curroncol28040236"},{"key":"S0266462323000259_r20","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.8588"},{"key":"S0266462323000259_r8","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2018.4710"},{"key":"S0266462323000259_r13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2015.02.011"},{"key":"S0266462323000259_r5","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-011666"},{"key":"S0266462323000259_r11","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx110"},{"key":"S0266462323000259_r1","volume-title":"Cancer in Australia 2019","year":"2019"},{"key":"S0266462323000259_r17","unstructured":"17. The Pharmaceutical Benefits Scheme. 6.3 Management of parallel process submissions. Australia Government Department of Health [cited 2020 1 March]. Available from: https:\/\/www.pbs.gov.au\/pbs\/industry\/listing\/procedure-guidance\/6-consideration-submissions\/6-3-management-of-parallel-process-submissions."}],"container-title":["International Journal of Technology Assessment in Health Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S0266462323000259","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,18]],"date-time":"2023-05-18T06:27:56Z","timestamp":1684391276000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S0266462323000259\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023]]},"references-count":27,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023]]}},"alternative-id":["S0266462323000259"],"URL":"https:\/\/doi.org\/10.1017\/s0266462323000259","relation":{},"ISSN":["0266-4623","1471-6348"],"issn-type":[{"value":"0266-4623","type":"print"},{"value":"1471-6348","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023]]},"article-number":"e28"}}