Metadata Title Olaparib給付規定(高復發風險早期乳癌)-Olaparib Rule2 Version 1.0.0 Status Draft Description 此 Library 為乳癌(高復發風險早期乳癌)患者於申請使用 Olaparib 之給付檢核條件。 Type logic-library from http://terminology.hl7.org/CodeSystem/library-type Parameters Parameter None Library Content CQL Content //高復發風險乳癌_Olaparib給付規定 library BCOlaparibRule2 version '1.0.0' using FHIR version '4.0.1' include FHIRHelpers version '4.0.1' called FHIRHelpers include BCCodeConcept version '1.0.0' called CodeConcept include BCReusable version '1.0.0' called Reusable context Patient //============================================ // 主要規定一：初次使用條件 //============================================ /*規則1*/ //條件1:早期乳癌 define "ICD代碼檢核_布林值": Reusable."ICD-10使用C50" define "醫令類別為1_布林值":Reusable."醫令類別為1" //條件1:轉移性乳癌 //條件1-1 define "規則1-1-1=3個月內影像報告": Reusable."HasRecentImageReport"("本次申請起始日期", 90) //條件1-3 define "規則1-1-3=癌症分期分數或結果為M=0": Reusable."癌症分期分數或結果為M=0" //條件1-4(檢查報告) define "規則1-1-4=3個月內有檢查報告": Reusable."HasRecentMolecularReport"("本次申請起始日期", 90) //條件1-5 define "規則1-1-5=Olaparib申請": Reusable."醫令類別為1" and exists ( [MedicationRequest] MRPlan where MRPlan.intent = 'plan' and exists ( MRPlan.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept.L01XK01 ) ) define "規則1-1=早期乳癌": "ICD代碼檢核_布林值" and "醫令類別為1_布林值" and "規則1-1-5=Olaparib申請" and "規則1-1-3=癌症分期分數或結果為M=0" and ("規則1-1-1=3個月內影像報告" or "規則1-1-4=3個月內有檢查報告") //條件2:成年 define "規則1-2=成年": exists ( [Claim] C where C.created is not null and AgeInDaysAt(C.created) >= 18 ) //條件3:遺傳性 BRCA1/2(germline BRCA1/2)突變 define "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變": exists ( [Observation] OBs where exists ( OBs.category C where exists ( C.coding Cdg where Cdg in CodeConcept.NHIPASSupportingInfoType and Cdg.code = 'tests' ) ) and exists ( OBs.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code in CodeConcept.BRCA1or2 ) and OBs.value is string and Matches(OBs.value as string, '(?i).*(Positive|Pathogenic|Likely Pathogenic).*') ) //條件4:HER2陰性 define "規則1-4=檢驗檢查-HER2陰性": Reusable."HasHER2NegativeTest" define "規則1-4=基因檢測-HER2陰性": Reusable."HasHER2NegativeGene" define "規則1-4=HER2陰性": Reusable."HasHER2Negative" //條件5 //藥物條件 //前導性化療起始日早於此次申請藥物起始日 define "前導性化療早於本品申請起始日": Reusable."醫令類別為1" and exists ( [MedicationRequest] MRApply where MRApply.intent = 'plan' and exists ( MRApply.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept.L01XK01 ) and MRApply.dosageInstruction[0].timing.repeat.bounds is Period and (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and (end of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and exists ( [MedicationRequest] MRChemo where MRChemo.intent = 'order' and exists ( MRChemo.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept."前導性化療" ) and Reusable."HasValidTiming"(MRChemo) and (end of (MRChemo.dosageInstruction[0].timing.repeat.bounds as Period)) < (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) ) ) //影像報告日期早於此次申請藥物起始日 define "影像報告日期早於此次申請藥物起始日": Reusable."醫令類別為1" and exists ( [MedicationRequest] MRApply where MRApply.intent = 'plan' and exists ( MRApply.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept.L01XK01 ) and MRApply.dosageInstruction[0].timing.repeat.bounds is Period and (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and (end of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and exists ( [DiagnosticReport] O where exists ( O.code.coding Cdg where ( Cdg in CodeConcept.ICD10PCS2023Image or Cdg in CodeConcept.ICD10PCS2014Image ) and Cdg.code in CodeConcept.ProcedureCodes ) and O.effective is not null and FHIRHelpers.ToDateTime(O.effective) <= FHIRHelpers.ToDateTime((MRApply.dosageInstruction[0].timing.repeat.bounds as Period).start) ) ) //條件5-2:三陰性乳癌 //條件5-2-1:ER陰性 define "條件5-2-1=檢驗檢查-ER陰性": Reusable."HasTestObservationWithInterpretationAndValuePattern"(CodeConcept.MolecularER, { 'NEG' }, '(?i).*([-−]|0|陰性|negative).*') define "條件5-2-1=基因檢測-ER陰性": Reusable."HasMarkerNegativeGene"(CodeConcept.MolecularER) define "條件5-2-1=ER陰性": Reusable."HasMarkerNegativeWithGeneLoinc"(CodeConcept.MolecularER) //條件5-2-2:PR陰性 define "條件5-2-2=檢驗檢查-PR陰性": Reusable."HasTestObservationWithInterpretationAndValuePattern"(CodeConcept.MolecularPR, { 'NEG' }, '(?i).*([-−]|0|陰性|negative).*') define "條件5-2-2=基因檢測-PR陰性": Reusable."HasMarkerNegativeGene"(CodeConcept.MolecularPR) define "條件5-2-2=PR陰性": Reusable."HasMarkerNegativeWithGeneLoinc"(CodeConcept.MolecularPR) //條件5-2-3:針對曾接受前導性化療的病人，須符合於乳房和/或手術切除的淋巴結中發現有殘餘的侵襲性癌症(non-pCR)(病摘或病理報告結果須至少一項符合) define "條件5-2-3=病摘或病理報告結果其一符合non-pCR": exists ( [DiagnosticReport] O2 where exists ( O2.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code = '66110-8' ) and O2.effective is not null and FHIRHelpers.ToDateTime(O2.effective) >= "本次申請起始日期" - 90 days and FHIRHelpers.ToDateTime(O2.effective) <= "本次申請起始日期" and O2.conclusion is not null and Matches(O2.conclusion, '(?i).*(乳房和/或手術切除的淋巴結中發現有殘餘的侵襲性癌症\(non-pCR\)\+).*') ) or exists ( [Claim] C where exists ( C.diagnosis D where exists ( D.type.text T where Matches(T.value, '(?i).*(乳房和/或手術切除的淋巴結中發現有殘餘的侵襲性癌症\(non-pCR\)\+).*') ) ) ) //條件5-2-4:針對曾接受手術且接續術後輔助性化療的病人，須具有腋窩淋巴結陽性(≧pN1)，或腋窩淋巴結陰性(pN0)且原發性病理腫瘤大小≧2公分(≧pT2)(病摘或病理報告結果須至少一項符合) define "條件5-2-4=病摘或病理報告結果其一符合≧pN1且≧pT2": exists ( [DiagnosticReport] O2 where exists ( O2.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code = '66110-8' ) and O2.effective is not null and FHIRHelpers.ToDateTime(O2.effective) >= "本次申請起始日期" - 90 days and FHIRHelpers.ToDateTime(O2.effective) <= "本次申請起始日期" and O2.conclusion is not null and Matches(O2.conclusion, '(?i).*具有腋窩淋巴結陽性\(≧pN1\)，或腋窩淋巴結陰性\(pN0\)且原發性病理腫瘤大小≧2公分\(≧pT2\).*') ) or exists ( [Claim] C where exists ( C.diagnosis D where exists ( D.type.text T where Matches(T.value, '(?i).*具有腋窩淋巴結陽性\(≧pN1\)，或腋窩淋巴結陰性\(pN0\)且原發性病理腫瘤大小≧2公分\(≧pT2\).*') ) ) ) define "條件5-2-3": "條件5-2-3=病摘或病理報告結果其一符合non-pCR" and "前導性化療早於本品申請起始日" define "條件5-2-4": "條件5-2-4=病摘或病理報告結果其一符合≧pN1且≧pT2" and "前導性化療早於本品申請起始日" and "影像報告日期早於此次申請藥物起始日" define "條件5-2": if ("條件5-2-1=ER陰性" and "條件5-2-2=PR陰性") then ("條件5-2-3" or "條件5-2-4") else false //條件5-3:HR陽性且HER2陰性乳癌 //條件5-3-1:ER陽性 define "條件5-3-1=檢驗檢查-ER陽性": exists ( [Observation] OBs where exists ( OBs.category C where exists ( C.coding Cdg where Cdg in CodeConcept.NHIPASSupportingInfoType and Cdg.code = 'tests' ) ) and exists ( OBs.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code in CodeConcept.MolecularER ) and exists ( OBs.interpretation.coding INT where INT in CodeConcept.InterpretationCodes and INT.code in {'POS'} ) and OBs.value is string and Matches(OBs.value as string, '(?i).*(\\+|陽性|positive).*') ) define "條件5-3-1=基因檢測-ER陽性": exists ( [Observation] OBs where exists ( OBs.category C where exists ( C.coding Cdg where Cdg in CodeConcept.NHIPASSupportingInfoType and Cdg.code = 'geneInfo' ) ) and exists ( OBs.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code = '69548-6' ) and exists ( OBs.component Comp where exists ( Comp.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code in CodeConcept.MolecularER ) and Comp.value is Quantity and (Comp.value as Quantity).value > 30 and (Comp.value as Quantity).comparator = '>' and (Comp.value as Quantity).unit = '%' and exists ( Comp.interpretation I where Matches(I.text, '(?i).*(\\+|陽性|positive).*') ) ) ) define "條件5-3-1=ER陽性": "條件5-3-1=檢驗檢查-ER陽性" or "條件5-3-1=基因檢測-ER陽性" //條件5-3-2:PR陽性 define "條件5-3-2=檢驗檢查-PR陽性": exists ( [Observation] OBs where exists ( OBs.category C where exists ( C.coding Cdg where Cdg in CodeConcept.NHIPASSupportingInfoType and Cdg.code = 'tests' ) ) and exists ( OBs.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code in CodeConcept.MolecularPR ) and exists ( OBs.interpretation.coding INT where INT in CodeConcept.InterpretationCodes and INT.code in {'POS'} ) and OBs.value is string and Matches(OBs.value as string, '(?i).*(\\+|陽性|positive).*') ) define "條件5-3-2=基因檢測-PR陽性": exists ( [Observation] OBs where exists ( OBs.category C where exists ( C.coding Cdg where Cdg in CodeConcept.NHIPASSupportingInfoType and Cdg.code = 'geneInfo' ) ) and exists ( OBs.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code = '69548-6' ) and exists ( OBs.component Comp where exists ( Comp.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code in CodeConcept.MolecularPR ) and exists ( OBs.interpretation.coding INT where INT in CodeConcept.InterpretationCodes and INT.code in {'POS'} ) and OBs.value is string and Matches(OBs.value as string, '(?i).*(\\+|陽性|positive).*') ) ) define "條件5-3-2=PR陽性": "條件5-3-2=檢驗檢查-PR陽性" or "條件5-3-2=基因檢測-PR陽性" //條件5-3-3:曾接受前導性化療的病人，須為 non-pCR(病摘或病理報告結果須至少一項符合) define "條件5-3-3=曾接受前導性化療的病人，須為non-pCR": exists ( [DiagnosticReport] O2 where exists ( O2.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code = '66110-8' ) and O2.effective is not null and FHIRHelpers.ToDateTime(O2.effective) >= "本次申請起始日期" - 90 days and FHIRHelpers.ToDateTime(O2.effective) <= "本次申請起始日期" and O2.conclusion is not null and Matches(O2.conclusion, '(?i).*non-pCR.*') ) or exists ( [Claim] C where exists ( C.diagnosis D where exists ( D.type.text T where Matches(T.value, '(?i).*non-pCR.*') ) ) ) //條件5-3-4:曾接受手術且接續術後輔助性化療的病人，須具有4個以上經病理學證實的陽性淋巴結(病摘或病理報告結果須至少一項符合) define "條件5-3-4=曾接受手術且接續術後輔助性化療的病人，須具有4個以上經病理學證實的陽性淋巴結": exists ( [DiagnosticReport] O2 where exists ( O2.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code = '66110-8' ) and O2.effective is not null and FHIRHelpers.ToDateTime(O2.effective) >= "本次申請起始日期" - 90 days and FHIRHelpers.ToDateTime(O2.effective) <= "本次申請起始日期" and O2.conclusion is not null and Matches(O2.conclusion, '(?i).*須具有4個以上經病理學證實的陽性淋巴結.*') ) or exists ( [Claim] C where exists ( C.diagnosis D where exists ( D.type.text T where Matches(T.value, '(?i).*須具有4個以上經病理學證實的陽性淋巴結.*') ) ) ) define "條件5-3-3": "條件5-3-3=曾接受前導性化療的病人，須為non-pCR" and "前導性化療早於本品申請起始日" define "條件5-3-4": "條件5-3-4=曾接受手術且接續術後輔助性化療的病人，須具有4個以上經病理學證實的陽性淋巴結" and "前導性化療早於本品申請起始日" and "影像報告日期早於此次申請藥物起始日" define "條件5-3": if ("條件5-3-1=ER陽性" and "條件5-3-2=PR陽性") then ("條件5-3-3" or "條件5-3-4") else false define "規則1-5=高復發風險": "條件5-2" or "條件5-3" //條件6:曾接受前導性化療或術後輔助性化療(至少6個週期、須含有anthracyclines 類藥物、taxane 類藥物，或兩者的複方；亦允許含鉑化療) define "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期": Reusable."醫令類別為1" and exists ( [MedicationRequest] MRApply where MRApply.intent = 'plan' and exists ( MRApply.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept.L01XK01 ) and MRApply.dosageInstruction[0].timing.repeat.bounds is Period and (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and (end of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and Count( [MedicationRequest] MRChemo where MRChemo.intent = 'order' and exists ( MRChemo.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept."前導性化療或術後輔助性化療" ) and Reusable."HasValidTiming"(MRChemo) and (end of (MRChemo.dosageInstruction[0].timing.repeat.bounds as Period)) < (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) ) >= 6 ) //條件7:須在最後一次治療(包括手術、化療或放療)完成後的12週內使用olaparib(手術、化療或放療須至少一項符合) define "規則1-7=須在最後一次治療完成後的12週內使用olaparib": Reusable."醫令類別為1" and exists ( [MedicationRequest] MRApply where MRApply.intent = 'plan' and exists ( MRApply.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept.L01XK01 ) and MRApply.dosageInstruction[0].timing.repeat.bounds is Period and (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and (end of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) is not null and exists ( [MedicationRequest] MRChemo where MRChemo.intent = 'order' and exists ( MRChemo.medication.coding Cdg where Cdg in CodeConcept.NHIMedication and Cdg.code in CodeConcept."手術或化療或放療" ) and Reusable."HasValidTiming"(MRChemo) and (end of (MRChemo.dosageInstruction[0].timing.repeat.bounds as Period)) < (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) and (end of (MRChemo.dosageInstruction[0].timing.repeat.bounds as Period)) >= ((start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) - 12 weeks) and not exists ( [MedicationRequest] MRChemoLater where MRChemoLater.intent = 'order' and exists ( MRChemoLater.medication.coding Cdg2 where Cdg2 in CodeConcept.NHIMedication and Cdg2.code in CodeConcept."手術或化療或放療" ) and Reusable."HasValidTiming"(MRChemoLater) and (end of (MRChemoLater.dosageInstruction[0].timing.repeat.bounds as Period)) > (end of (MRChemo.dosageInstruction[0].timing.repeat.bounds as Period)) and (end of (MRChemoLater.dosageInstruction[0].timing.repeat.bounds as Period)) < (start of (MRApply.dosageInstruction[0].timing.repeat.bounds as Period)) ) ) and exists ( [DiagnosticReport] O where exists ( O.code.coding Cdg where ( Cdg in CodeConcept.ICD10PCS2023Image or Cdg in CodeConcept.ICD10PCS2014Image ) and Cdg.code in CodeConcept.ProcedureCodes ) and O.effective is not null and FHIRHelpers.ToDateTime(O.effective) <= FHIRHelpers.ToDateTime((MRApply.dosageInstruction[0].timing.repeat.bounds as Period).start) and FHIRHelpers.ToDateTime(O.effective) >= (FHIRHelpers.ToDateTime((MRApply.dosageInstruction[0].timing.repeat.bounds as Period).start) - 12 weeks) ) ) /*規則1*/ define "規則1": "規則1-1=早期乳癌" and "規則1-2=成年" and "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變" and "規則1-4=HER2陰性" and "規則1-5=高復發風險" and "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期" and "規則1-7=須在最後一次治療完成後的12週內使用olaparib" /*規則2之條件，皆於規則1中已涵蓋*/ //主要規定一 define "主要規定一": "規則1" //============================================ // 主要規定二：續用條件－治療持續給付 //============================================ define "本次申請紀錄": Reusable."LatestMedicationPlan"(CodeConcept.L01XK01) define "本次申請起始日期": Reusable."GetStartTime"("本次申請紀錄") //影像證據顯示病情有無惡化 // 取得前次治療紀錄（最近一次已完成的治療） define "前次治療紀錄": Reusable."LatestCompletedMedicationOrderBefore"(CodeConcept.L01XK01, "本次申請起始日期") // 前次用藥開始日期 define "前次用藥開始日期": Reusable."GetStartTime"("前次治療紀錄") // 條件1:影像證據顯示病情有無惡化 define "規則1=影像證據顯示病情有無惡化": Reusable."HasImageReportBetweenPreviousTreatmentAndCurrentApply"(CodeConcept.L01XK01) // 主要規定二 define "主要規定二": Reusable."續用註記為2" and "規則1=影像證據顯示病情有無惡化" //============================================ // 主要規定三：藥品使用規則 //============================================ /*規則1*/ //每次申請之療程以3個月為限 define "規則1=每次申請之療程以3個月為限": Reusable."HasMedicationPlanDurationWithin"(CodeConcept.L01XK01, 84) /*規則2*/ define "規則2=依藥品仿單記載以1年為上限": Reusable."HasMedicationTotalDurationWithin"(CodeConcept.L01XK01, 365) /*規則3:用於術後輔助治療，olaparib 與 pembrolizumab 僅能擇一給付。(由於此處皆為術後輔助治療，故使用過pembrolizumab者不得使用本品)*/ define "規則3=Olaparib、pembrolizumab僅得擇一使用": not ( Reusable."HasMedicationUse"(CodeConcept.L01XK01) and Reusable."HasMedicationUse"(CodeConcept.L01FF02) ) /*規則4*/ define "規則4=Olaparib每日最多使用4粒": Reusable."HasDailyDoseAtMost"(CodeConcept.L01XK01, 4.0, '{tbl}', 'QD') // 主要規定三 define "主要規定三": "規則1=每次申請之療程以3個月為限" and "規則2=依藥品仿單記載以1年為上限" and "規則3=Olaparib、pembrolizumab僅得擇一使用" and "規則4=Olaparib每日最多使用4粒" //============================================ // 列出「符合」項目判斷式 //============================================ define function "符合項目"(): // 主要規定一：初次使用條件 (if Reusable."初次申請" and ( "規則1-1=早期乳癌" or "規則1-2=成年" or "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變" or "規則1-4=HER2陰性" or "規則1-5=高復發風險" or "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期" or "規則1-7=須在最後一次治療完成後的12週內使用olaparib" ) then '<主要規定一：初次使用條件>\n' + (if "ICD代碼檢核_布林值" then '● 規則1-1-0：ICD代碼為C50\n' else '') + (if "規則1-1-1=3個月內影像報告" then '● 規則1-1-1：3個月內影像報告\n' else '') + (if "規則1-1-3=癌症分期分數或結果為M=0" then '● 規則1-1-3：癌症分期分數或結果為M=0（早期）\n' else '') + (if "規則1-1-4=3個月內有檢查報告" then '● 規則1-1-4：3個月內有檢查報告\n' else '') + (if "規則1-1-5=Olaparib申請" then '● 規則1-1-5：Olaparib申請\n' else '') + (if "規則1-2=成年" then '● 規則1-2：成年（≥18歲）\n' else '') + (if "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變" then '● 規則1-3：遺傳性BRCA1/2（germline BRCA1/2）突變\n' else '') + (if "規則1-4=HER2陰性" then '● 規則1-4：HER2陰性\n' else '') + (if "條件5-2-1=ER陰性" then '● 規則1-5-2-1：ER陰性\n' else '') + (if "條件5-2-2=PR陰性" then '● 規則1-5-2-2：PR陰性\n' else '') + (if "條件5-2-3=病摘或病理報告結果其一符合non-pCR" then '● 規則1-5-2-3：病摘或病理報告結果符合non-pCR\n' else '') + (if "條件5-2-4=病摘或病理報告結果其一符合≧pN1且≧pT2" then '● 規則1-5-2-4：病摘或病理報告結果符合≧pN1且≧pT2\n' else '') + (if "條件5-3-1=ER陽性" then '● 規則1-5-3-1：ER陽性\n' else '') + (if "條件5-3-2=PR陽性" then '● 規則1-5-3-2：PR陽性\n' else '') + (if "條件5-3-3=曾接受前導性化療的病人，須為non-pCR" then '● 規則1-5-3-3：曾接受前導性化療的病人，須為non-pCR\n' else '') + (if "條件5-3-4=曾接受手術且接續術後輔助性化療的病人，須具有4個以上經病理學證實的陽性淋巴結" then '● 規則1-5-3-4：具有4個以上經病理學證實的陽性淋巴結\n' else '') + (if "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期" then '● 規則1-6：曾接受前導性化療或術後輔助性化療，且至少6個週期\n' else '') + (if "規則1-7=須在最後一次治療完成後的12週內使用olaparib" then '● 規則1-7：於最後一次治療完成後的12週內使用olaparib\n' else '') + '\n' else '') + // 主要規定二：續用條件 (if Reusable."續用申請" and "規則1=影像證據顯示病情有無惡化" then '<主要規定二：續用條件－治療持續給付>\n' + '● 續用規則1：已檢附前次治療後影像學報告，確認無惡化\n' + '\n' else '') + // 主要規定三：藥品使用規則 (if "規則1=每次申請之療程以3個月為限" or "規則2=依藥品仿單記載以1年為上限" or "規則3=Olaparib、pembrolizumab僅得擇一使用" or "規則4=Olaparib每日最多使用4粒" then '<主要規定三：藥品使用規則>\n' + (if "規則1=每次申請之療程以3個月為限" then '● 規則3-1：每次申請之療程≤3個月（84天）\n' else '') + (if "規則2=依藥品仿單記載以1年為上限" then '● 規則3-2：使用總療程≤1年（365天）\n' else '') + (if "規則3=Olaparib、pembrolizumab僅得擇一使用" then '● 規則3-3：Olaparib與pembrolizumab僅得擇一使用\n' else '') + (if "規則4=Olaparib每日最多使用4粒" then '● 規則3-4：每日劑量≤4粒\n' else '') else '') //============================================ // 列出「不符合」項目判斷式 - 代碼或條件不符 //============================================ define function "不符合項目_代碼或條件不符"(): // 主要規定一：初次使用條件 - 代碼條件不符 (if Reusable."初次申請" and ( not "ICD代碼檢核_布林值" or not "規則1-1-3=癌症分期分數或結果為M=0" or not "規則1-2=成年" ) then '<主要規定一：初次使用條件>\n' + (if not "ICD代碼檢核_布林值" then '▲ 規則1-1-0：主要疾病之ICD代碼未使用C50\n' else '') + (if not "規則1-1-3=癌症分期分數或結果為M=0" then '▲ 規則1-1-3：癌症分期分數或結果不為M=0（非早期）\n' else '') + (if not "規則1-2=成年" then '▲ 規則1-2：非成年患者（<18歲）\n' else '') + '\n' else '') + // 主要規定三：藥品使用規則 - 代碼條件不符 (if not "規則1=每次申請之療程以3個月為限" or not "規則2=依藥品仿單記載以1年為上限" or not "規則3=Olaparib、pembrolizumab僅得擇一使用" or not "規則4=Olaparib每日最多使用4粒" then '<主要規定三：藥品使用規則>\n' + (if not "規則1=每次申請之療程以3個月為限" then '▲ 規則3-1：每次申請之療程超過3個月（84天）\n' else '') + (if not "規則2=依藥品仿單記載以1年為上限" then '▲ 規則3-2：使用總療程超過1年（365天）\n' else '') + (if not "規則3=Olaparib、pembrolizumab僅得擇一使用" then '▲ 規則3-3：同時使用Olaparib與pembrolizumab\n' else '') + (if not "規則4=Olaparib每日最多使用4粒" then '▲ 規則3-4：每日劑量超過4粒\n' else '') else '') //============================================ // 列出「不符合」項目判斷式 - 必要資料未填寫 //============================================ define function "不符合項目_必要資料未填寫"(): // 主要規定一：初次使用條件 - 必要資料未填寫 (if Reusable."初次申請" and ( not "規則1-1-5=Olaparib申請" or not ("規則1-1-1=3個月內影像報告" or "規則1-1-4=3個月內有檢查報告") or not "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變" or not "規則1-4=HER2陰性" or not "規則1-5=高復發風險" or not "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期" or not "規則1-7=須在最後一次治療完成後的12週內使用olaparib" ) then '<主要規定一：初次使用條件>\n' + (if not "規則1-1-5=Olaparib申請" then '▲ 規則1-1-5：未申請Olaparib\n' else '') + (if not ("規則1-1-1=3個月內影像報告" or "規則1-1-4=3個月內有檢查報告") then '▲ 規則1-1-1/1-1-4：未提供3個月內影像報告或檢查報告\n' else '') + (if not "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變" then '▲ 規則1-3：未提供遺傳性BRCA1/2（germline BRCA1/2）突變檢測資料\n' else '') + (if not "規則1-4=HER2陰性" then '▲ 規則1-4：未提供HER2檢測資料或HER2非陰性\n' else '') + (if not "規則1-5=高復發風險" then '▲ 規則1-5：未符合高復發風險條件（需符合三陰性或HR陽性HER2陰性之相關標準）\n' + (if not "條件5-2" and not "條件5-3" then ' - 未符合三陰性乳癌或HR陽性且HER2陰性乳癌之高復發風險條件\n' else '') else '') + (if not "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期" then '▲ 規則1-6：未提供前導性化療或術後輔助性化療紀錄，或未達至少6個週期\n' else '') + (if not "規則1-7=須在最後一次治療完成後的12週內使用olaparib" then '▲ 規則1-7：未於最後一次治療完成後的12週內使用olaparib\n' else '') + '\n' else '') + // 主要規定二：續用條件 - 必要資料未填寫 (if Reusable."續用申請" and not "規則1=影像證據顯示病情有無惡化" then '<主要規定二：續用條件－治療持續給付>\n' + '▲ 續用規則1：未提供前次治療後影像學報告或顯示疾病惡化\n' + '\n' else '') //============================================ // 審核結果 //============================================ define "乳癌Olaparib申請結果_布林": case when Reusable."初次申請" then ( "規則1-1=早期乳癌" and "規則1-2=成年" and "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變" and "規則1-4=HER2陰性" and "規則1-5=高復發風險" and "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期" and "規則1-7=須在最後一次治療完成後的12週內使用olaparib" and "規則1=每次申請之療程以3個月為限" and "規則2=依藥品仿單記載以1年為上限" and "規則3=Olaparib、pembrolizumab僅得擇一使用" and "規則4=Olaparib每日最多使用4粒" ) when Reusable."續用申請" then ( "規則1=影像證據顯示病情有無惡化" and "規則1=每次申請之療程以3個月為限" and "規則2=依藥品仿單記載以1年為上限" and "規則3=Olaparib、pembrolizumab僅得擇一使用" and "規則4=Olaparib每日最多使用4粒" ) else false end define "乳癌Olaparib申請之CQL檢核結果": if ( Reusable."初次申請" and "規則1-1=早期乳癌" and "規則1-2=成年" and "規則1-3=遺傳性 BRCA1/2(germline BRCA1/2)突變" and "規則1-4=HER2陰性" and "規則1-5=高復發風險" and "規則1-6=曾接受前導性化療或術後輔助性化療，且至少6個週期" and "規則1-7=須在最後一次治療完成後的12週內使用olaparib" and "規則1=每次申請之療程以3個月為限" and "規則2=依藥品仿單記載以1年為上限" and "規則3=Olaparib、pembrolizumab僅得擇一使用" and "規則4=Olaparib每日最多使用4粒" ) then '✓通過：初次使用－高復發風險之早期乳癌 Olaparib 用藥申請' else if ( Reusable."續用申請" and "規則1=影像證據顯示病情有無惡化" and "規則1=每次申請之療程以3個月為限" and "規則2=依藥品仿單記載以1年為上限" and "規則3=Olaparib、pembrolizumab僅得擇一使用" and "規則4=Olaparib每日最多使用4粒" ) then '✓通過：續用－高復發風險之早期乳癌 Olaparib 用藥申請' else if Reusable."初次申請" then '✖不通過：初次使用－高復發風險之早期乳癌 Olaparib 用藥申請' else if Reusable."續用申請" then '✖不通過：續用－高復發風險之早期乳癌 Olaparib 用藥申請' else '✖不通過：無法判定申請類型－高復發風險之早期乳癌 Olaparib 用藥申請' //============================================ // 報告總結 //============================================ define "報告總結": '\n=== 高復發風險之早期乳癌 Olaparib 申請審核報告 ===\n' + '\n【申請類型】' + Reusable."申請類型" + '\n' + '\n【●符合項目】\n' + (if "符合項目"() = '' then '無\n' else "符合項目"()) + '\n【▲不符合項目 - 代碼或條件不符】\n' + (if "不符合項目_代碼或條件不符"() = '' then '無\n' else "不符合項目_代碼或條件不符"()) + '\n【▲不符合項目 - 必要資料未填寫】\n' + (if "不符合項目_必要資料未填寫"() = '' then '無\n' else "不符合項目_必要資料未填寫"()) + '\n【申請結果】\n' + "乳癌Olaparib申請之CQL檢核結果" + '\n===============================================\n' ELM XML Content Encoded data ELM JSON Content Encoded data Generated using version 0.5.3-cibuild of the sample-content-ig Liquid templates
此 Library 為乳癌(高復發風險早期乳癌)患者於申請使用 Olaparib 之給付檢核條件。