//早期乳癌_Trastuzumab給付規定
library BCTrastuzumabRule2 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*/
define "手術日期(opdate)":
Max(
flatten(
[Claim] C
return (
C.procedure Proc
where Proc.date is not null
return FHIRHelpers.ToDateTime(Proc.date)
)
)
)
define "手術(或其他處置)項目":
exists (
[Claim] C
where exists (
C.procedure Proc
where exists (
((Proc.procedure as FHIR.CodeableConcept).coding) Cdg
where Cdg is not null
and (Cdg.code in CodeConcept."ICD10PCS2023Image"
or Cdg.code in CodeConcept."ICD10PCS2014Image")
and Cdg.code in CodeConcept."ProcedureCodes"
)
)
)
//條件1:外科手術前後、化學療法(術前輔助治療或輔助治療)治療後
//條件1-1-1
define "條件1-1-1=病摘描述本藥品使用在外科手術前":
exists (
[Claim] C
where exists (
C.diagnosis D
where exists (
D.type.text T
where Matches(T.value, '(?i).*本藥品使用在外科手術前.*')
)
)
)
//條件1-1-2
define "條件1-1-2=外科手術後":
exists (
[MedicationRequest] MR
where MR.intent = 'plan'
and Reusable."HasValidTiming"(MR)
and Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
and Reusable."醫令類別為1"
and MR.dosageInstruction[0].timing.repeat.bounds is Period
and (start of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
and (start of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) > "手術日期(opdate)"
and "手術(或其他處置)項目"
)
//條件1-2
define "條件1-2=化學療法(術前輔助治療或輔助治療)治療後":
Reusable."HasPriorMedicationUse"(CodeConcept.L01FD01, CodeConcept."併用化學治療法")
and Reusable."醫令類別為1"
define "條件1-1=外科手術前後":
(not ("條件1-1-1=病摘描述本藥品使用在外科手術前"
or "條件1-1-2=外科手術後"))
or "條件1-2=化學療法(術前輔助治療或輔助治療)治療後"
//條件2-1
define "條件2-1=檢驗檢查-HER2過度表現(IHC3+或FISH+)":
exists (
[Observation] OBs
where Reusable."IsTestObservation"(OBs)
and exists (
OBs.code.coding Cdg
where Cdg in CodeConcept.LOINC
and Cdg.code in CodeConcept.HER2
)
and OBs.value is string
and Matches(OBs.value as string, '(?i).*IHC3\+.*FISH\+.*')
)
define "條件2-1=基因檢測-HER2過度表現(IHC3+或FISH+)":
exists (
[Observation] OBs
where Reusable."IsGeneInfoObservation"(OBs)
and Reusable."IsGenePanelObservation"(OBs)
and exists (
OBs.component Comp
where exists (Comp.code.coding Cdg where Cdg in CodeConcept.LOINC and Cdg.code in CodeConcept.HER2)
and Comp.value is FHIR.string
and Matches((Comp.value as FHIR.string).value, '(?i).*IHC3\+.*FISH\+.*')
)
)
define "條件2-1=HER2過度表現(IHC3+或FISH+)":
"條件2-1=檢驗檢查-HER2過度表現(IHC3+或FISH+)"
or "條件2-1=基因檢測-HER2過度表現(IHC3+或FISH+)"
//條件2-2
define "條件2-2=檢驗檢查-雌激素受體(ER)為陰性":
Reusable."HasTestObservationResult"(CodeConcept.MolecularER, { 'NEG' }, '(?i).*([-−]|0|陰性|negative).*')
define "條件2-2=基因檢測-雌激素受體(ER)為陰性":
Reusable."HasGeneInfoComponentResult"(CodeConcept.MolecularER, { 'NEG' }, '(?i).*([-−]|0|陰性|negative).*')
define "條件2-2=雌激素受體(ER)為陰性":
"條件2-2=檢驗檢查-雌激素受體(ER)為陰性" or "條件2-2=基因檢測-雌激素受體(ER)為陰性"
//條件2-3
define "條件2-3=腫瘤大於2公分。須經乳房超音波或乳房X光攝影或核磁共振診斷":
exists (
[DiagnosticReport] O
where exists (
O.code.coding Cdg
where (
Cdg in CodeConcept.ICD10PCS2023Image
or Cdg in CodeConcept.ICD10PCS2014Image
)
and Cdg.code in CodeConcept.ProcedureCodes2
)
and O.effective is not null
and FHIRHelpers.ToDateTime(O.effective) >= "本次申請起始日期" - 90 days
and FHIRHelpers.ToDateTime(O.effective) <= "本次申請起始日期"
)
//條件2-4
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2-4-1
define "條件2-4-1=3個月內影像報告":
Reusable."HasRecentImageReport"("本次申請起始日期", 90)
//條件2-4-2
define "條件2-4-2=癌症分期分數或結果為N=0":
Count(
[Observation] O
where exists (
O.code.coding Cdg
where Cdg.code = '399390009'
and Cdg in CodeConcept.SNOMED
)
and O.value is not null
and O.value is FHIR.string
and Matches((O.value as FHIR.string).value, '.*N[0].*')
) > 0
//條件2-4-3(檢查報告)
define "條件2-4-3=3個月內有檢查報告":
Reusable."HasRecentMolecularReport"("本次申請起始日期", 90)
define "條件2-4=且未發生腋下淋巴結轉移之早期乳癌患者，作為輔助性治療用藥":
"ICD代碼檢核_布林值"
and "醫令類別為1_布林值"
and "條件2-4-2=癌症分期分數或結果為N=0"
and ("條件2-4-1=3個月內影像報告" or "條件2-4-3=3個月內有檢查報告")
//條件2-5:依下列條件之一使用
//條件2-5-1
define "條件2-5-1=經外科手術後達病理上完全緩解者(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) > "手術日期(opdate)"
and O2.conclusion is not null
and Matches(O2.conclusion, '(?i).*(外科手術後達病理上完全緩解\（pCR\）\)\+).*')
) and "手術(或其他處置)項目"
//條件2-5-2
define "條件2-5-2=若外科手術後無法達病理上緩解(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) > "手術日期(opdate)"
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\+).*')
)
define "條件2-5=依下列條件之一使用":
"條件2-5-1=經外科手術後達病理上完全緩解者(pCR)" or "條件2-5-2=若外科手術後無法達病理上緩解(non-pCR)"
define "1條件2=符合下列所有條件之早期乳癌患者(限使用Ogivri、Herzuma、Eirgasun、Herceptin、Kanjinti)":
"條件2-1=HER2過度表現(IHC3+或FISH+)"
and "條件2-2=雌激素受體(ER)為陰性"
and "條件2-3=腫瘤大於2公分。須經乳房超音波或乳房X光攝影或核磁共振診斷"
and "條件2-4=且未發生腋下淋巴結轉移之早期乳癌患者，作為輔助性治療用藥"
and "條件2-5=依下列條件之一使用"
//主要規定一＝1規則1
define "主要規定一":
"條件1-1=外科手術前後" and "1條件2=符合下列所有條件之早期乳癌患者(限使用Ogivri、Herzuma、Eirgasun、Herceptin、Kanjinti)"
//============================================
// 主要規定二：續用條件－治療持續給付
//============================================
//條件1:核准後每24週須檢附療效評估資料再次申請，若疾病有惡化情形即不應再行申請
// 本次申請紀錄（以最新一筆申請作為本次申請）
define "本次申請紀錄":
Reusable."LatestMedicationPlan"(CodeConcept.L01FD01)
define "本次申請起始日期":
Reusable."GetStartTime"("本次申請紀錄")
// 前次申請紀錄（本次申請之前最近一次的申請）
define "前次申請紀錄":
Reusable."LatestMedicationPlanBefore"(CodeConcept.L01FD01, "本次申請起始日期")
// 檢查本次申請療程長度是否在24週內
define "規則1-1=每24週須再次申請並檢附療效評估資料":
Reusable."醫令類別為1"
and Reusable."續用註記為2"
and "本次申請紀錄" is not null
and Reusable."HasMedicationPlanPeriodWithinDays"(CodeConcept.L01FD01, 168)
//條件2:疾病有惡化情形須停止使用
// 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.L01FD01, "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")
// 規則1-2: 疾病有惡化情形須停止使用(續用須檢附前次治療後影像學報告)
define "規則1-2=疾病有惡化情形須停止使用":
Reusable."HasImageReportBetweenPreviousTreatmentAndCurrentApply"(CodeConcept.L01FD01)
// 主要規定二
define "主要規定二":
Reusable."續用註記為2"
and Reusable."醫令類別為1"
and "本次申請紀錄" is not null
and "規則1-1=每24週須再次申請並檢附療效評估資料"
and "規則1-2=疾病有惡化情形須停止使用"
//============================================
// 主要規定三：藥品使用規則
//============================================
//條件1:外科手術後達病理上緩解(pCR) 同 "條件2-5-1=經外科手術後達病理上完全緩解者(pCR)"
//條件2:本藥品使用於外科手術前後以9個療程為上限
//三種用藥選擇合併療程計算，上限為9個療程
// 每周療程: count(MR where count=1) ≤ 9 且 sum(useEdate-useSdate) ≤ 63天
define "1條件2-1=三種用藥合併每周療程上限9個療程":
Count(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FY01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01andL01FD02exceptKC011362B5))
and MR.dosageInstruction[0].timing.repeat.count = 1
and Reusable."醫令類別為1"
) <= 9
and Sum(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FY01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01andL01FD02exceptKC011362B5))
and MR.dosageInstruction[0].timing.repeat.count = 1
and MR.dosageInstruction[0].timing.repeat.bounds is Period
and (start of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
and (end of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
return all
difference in days between
FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
)
) <= 63
// 每三周療程: 同一起始日視為同一療程，僅保留結束日最晚的代表醫令後，count ≤ 9 且 sum(useEdate-useSdate) ≤ 189天
define "1條件2-2=三種用藥合併每三周療程上限9個療程":
// 計算三種用藥合併後的代表療程數
Count(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FY01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01andL01FD02exceptKC011362B5))
and MR.dosageInstruction[0].timing.repeat.period = 3
and MR.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MR)
// 若同一起始日有多筆藥物，只保留結束日最晚者作為該療程代表
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
) =
Max(
[MedicationRequest] MRSameCourse
where MRSameCourse.intent = 'plan'
and (Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FY01)
or Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD01andL01FD02exceptKC011362B5))
and MRSameCourse.dosageInstruction[0].timing.repeat.period = 3
and MRSameCourse.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MRSameCourse)
and FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).start
) = FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
return FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).end
)
)
) <= 9
// 僅累加代表療程的天數，避免同一療程重複加總
and Sum(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FY01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01andL01FD02exceptKC011362B5))
and MR.dosageInstruction[0].timing.repeat.period = 3
and MR.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and MR.dosageInstruction[0].timing.repeat.bounds is Period
and (start of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
and (end of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
// 若同一起始日有多筆藥物，只保留結束日最晚者作為該療程代表
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
) =
Max(
[MedicationRequest] MRSameCourse
where MRSameCourse.intent = 'plan'
and (Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FY01)
or Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD01andL01FD02exceptKC011362B5))
and MRSameCourse.dosageInstruction[0].timing.repeat.period = 3
and MRSameCourse.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MRSameCourse)
and FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).start
) = FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
return FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).end
)
)
return all
difference in days between
FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
)
) <= 189
define "1條件2=使用於外科手術前後之總療程合併計算，依藥品仿單記載以9個療程為上限":
"1條件2-1=三種用藥合併每周療程上限9個療程"
or "1條件2-2=三種用藥合併每三周療程上限9個療程"
define "3規則1":
"條件2-5-1=經外科手術後達病理上完全緩解者(pCR)" and "1條件2=使用於外科手術前後之總療程合併計算，依藥品仿單記載以9個療程為上限"
/*規則2*/
//本藥品與trastuzumab emtansine使用於外科手術前後的總療程合併計算，依藥品仿單記載以全部18個療程為上限，其中trastuzumab emtansine以14個療程為上限
// 每周療程: count(MR where count=1) ≤ 18 且 sum(useEdate-useSdate) ≤ 126天
define "2條件2-1=兩種用藥合併每周療程上限18個療程":
Count(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD03))
and MR.dosageInstruction[0].timing.repeat.count = 1
and Reusable."醫令類別為1"
) <= 18
and Sum(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD03))
and MR.dosageInstruction[0].timing.repeat.count = 1
and MR.dosageInstruction[0].timing.repeat.bounds is Period
and (start of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
and (end of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
return all
difference in days between
FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
)
) <= 126
// 每三周療程: 同一起始日視為同一療程，僅保留結束日最晚的代表醫令後，count ≤ 18 且 sum(useEdate-useSdate) ≤ 378天
define "2條件2-2=兩種用藥合併每三周療程上限18個療程":
// 計算兩種用藥合併後的代表療程數
Count(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD03))
and MR.dosageInstruction[0].timing.repeat.period = 3
and MR.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MR)
// 若同一起始日有多筆藥物，只保留結束日最晚者作為該療程代表
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
) =
Max(
[MedicationRequest] MRSameCourse
where MRSameCourse.intent = 'plan'
and (Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD03))
and MRSameCourse.dosageInstruction[0].timing.repeat.period = 3
and MRSameCourse.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MRSameCourse)
and FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).start
) = FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
return FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).end
)
)
) <= 18
// 僅累加代表療程的天數，避免同一療程重複加總
and Sum(
[MedicationRequest] MR
where MR.intent = 'plan'
and (Reusable."HasMedicationCode"(MR, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MR, CodeConcept.L01FD03))
and MR.dosageInstruction[0].timing.repeat.period = 3
and MR.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and MR.dosageInstruction[0].timing.repeat.bounds is Period
and (start of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
and (end of (MR.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
// 若同一起始日有多筆藥物，只保留結束日最晚者作為該療程代表
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
) =
Max(
[MedicationRequest] MRSameCourse
where MRSameCourse.intent = 'plan'
and (Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD01)
or Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD03))
and MRSameCourse.dosageInstruction[0].timing.repeat.period = 3
and MRSameCourse.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MRSameCourse)
and FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).start
) = FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
return FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).end
)
)
return all
difference in days between
FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
)
) <= 378
// trastuzumab emtansine (L01FD03) 每周療程上限14個療程
define "2條件2-3=trastuzumab emtansine每周療程上限14個療程":
Count(
[MedicationRequest] MR
where MR.intent = 'plan'
and Reusable."HasMedicationCode"(MR, CodeConcept.L01FD03)
and MR.dosageInstruction[0].timing.repeat.count = 1
and Reusable."醫令類別為1"
) <= 14
// trastuzumab emtansine (L01FD03) 每三周療程上限14個療程
// 同一起始日視為同一療程，僅保留結束日最晚的代表醫令
define "2條件2-4=trastuzumab emtansine每三周療程上限14個療程":
// 計算 trastuzumab emtansine 的代表療程數
Count(
[MedicationRequest] MR
where MR.intent = 'plan'
and Reusable."HasMedicationCode"(MR, CodeConcept.L01FD03)
and MR.dosageInstruction[0].timing.repeat.period = 3
and MR.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MR)
// 若同一起始日有多筆醫令，只保留結束日最晚者作為該療程代表
and FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).end
) =
Max(
[MedicationRequest] MRSameCourse
where MRSameCourse.intent = 'plan'
and Reusable."HasMedicationCode"(MRSameCourse, CodeConcept.L01FD03)
and MRSameCourse.dosageInstruction[0].timing.repeat.period = 3
and MRSameCourse.dosageInstruction[0].timing.repeat.periodUnit.value = 'wk'
and Reusable."醫令類別為1"
and Reusable."HasValidTiming"(MRSameCourse)
and FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).start
) = FHIRHelpers.ToDateTime(
(MR.dosageInstruction[0].timing.repeat.bounds as Period).start
)
return FHIRHelpers.ToDateTime(
(MRSameCourse.dosageInstruction[0].timing.repeat.bounds as Period).end
)
)
) <= 14
define "2條件2=兩種用藥合併療程計算上限18個療程且trastuzumab emtansine上限14個療程":
("2條件2-1=兩種用藥合併每周療程上限18個療程"
and "2條件2-3=trastuzumab emtansine每周療程上限14個療程")
or ("2條件2-2=兩種用藥合併每三周療程上限18個療程"
and "2條件2-4=trastuzumab emtansine每三周療程上限14個療程")
define "3規則2":
"條件2-5-2=若外科手術後無法達病理上緩解(non-pCR)"
and "2條件2=兩種用藥合併療程計算上限18個療程且trastuzumab emtansine上限14個療程"
// 主要規定三
define "主要規定三":
"3規則1" or "3規則2"
//============================================
// 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 (
"條件1-1=外科手術前後" or
"條件2-1=HER2過度表現(IHC3+或FISH+)" or
"條件2-2=雌激素受體(ER)為陰性" or
"條件2-3=腫瘤大於2公分。須經乳房超音波或乳房X光攝影或核磁共振診斷" or
"條件2-4=且未發生腋下淋巴結轉移之早期乳癌患者，作為輔助性治療用藥" or
"條件2-5-1=經外科手術後達病理上完全緩解者(pCR)" or
"條件2-5-2=若外科手術後無法達病理上緩解(non-pCR)"
)
then '<主要規定一：初次使用條件>\n' +
(if "條件1-1-1=病摘描述本藥品使用在外科手術前"
then '● 1條件1-1-1：病摘描述本藥品使用在外科手術前\n' else '') +
(if "條件1-1-2=外科手術後"
then '● 1條件1-1-2：外科手術後使用(用藥起始日晚於手術日)\n' else '') +
(if "條件1-2=化學療法(術前輔助治療或輔助治療)治療後"
then '● 1條件1-2：化學療法(術前輔助治療或輔助治療)治療後\n' else '') +
(if "條件2-1=HER2過度表現(IHC3+或FISH+)"
then '● 1條件2-1：HER2過度表現(IHC3+或FISH+)\n' else '') +
(if "條件2-2=雌激素受體(ER)為陰性"
then '● 1條件2-2：雌激素受體(ER)為陰性\n' else '') +
(if "條件2-3=腫瘤大於2公分。須經乳房超音波或乳房X光攝影或核磁共振診斷"
then '● 1條件2-3：腫瘤大於2公分(已檢附3個月內影像報告)\n' else '') +
(if "條件2-4=且未發生腋下淋巴結轉移之早期乳癌患者，作為輔助性治療用藥"
then '● 1條件2-4：未發生腋下淋巴結轉移(N=0)，作為輔助性治療用藥\n' else '') +
(if "條件2-5-1=經外科手術後達病理上完全緩解者(pCR)"
then '● 1條件2-5-1：經外科手術後達病理上完全緩解(pCR)\n' else '') +
(if "條件2-5-2=若外科手術後無法達病理上緩解(non-pCR)"
then '● 1條件2-5-2：外科手術後無法達病理上緩解(non-pCR)\n' else '') +
'\n'
else '') +
// 主要規定二：續用條件
(if Reusable."續用申請" and (
"規則1-1=每24週須再次申請並檢附療效評估資料" or
"規則1-2=疾病有惡化情形須停止使用"
)
then '<主要規定二：續用條件－治療持續給付>\n' +
(if "規則1-1=每24週須再次申請並檢附療效評估資料"
then '● 2條件1：於24週內再次申請並檢附療效評估資料\n' else '') +
(if "規則1-2=疾病有惡化情形須停止使用"
then '● 2條件2：已檢附前次治療後影像學報告，確認無惡化\n' else '') +
'\n'
else '') +
// 主要規定三：藥品使用規則
(if "3規則1" or "3規則2"
then '<主要規定三：藥品使用規則>\n' +
(if "3規則1"
then '● 3規則1：達病理上完全緩解(pCR)，三種用藥合併療程符合上限(≤9個療程)\n' else '') +
(if "3規則2"
then '● 3規則2：無法達病理上緩解(non-pCR)，兩種用藥合併療程符合上限(≤18個療程，T-DM1≤14個療程)\n' else '')
else '')
//============================================
// 列出「不符合」項目判斷式 - 條件或代碼不符合
//============================================
define function "不符合項目_條件或代碼不符合"():
// 主要規定一：初次使用條件 - 條件或代碼不符合
(if Reusable."初次申請" and (
not Reusable."ICD-10使用C50" or
not "條件2-1=HER2過度表現(IHC3+或FISH+)" or
not "條件2-2=雌激素受體(ER)為陰性"
)
then '<主要規定一：初次使用條件>\n' +
(if not Reusable."ICD-10使用C50"
then '▲ 1條件ICD代碼檢核：主要疾病之ICD代碼未使用C50\n' else '') +
(if not "條件2-1=HER2過度表現(IHC3+或FISH+)"
then '▲ 1條件2-1：HER2非過度表現(非IHC3+或FISH+)\n' else '') +
(if not "條件2-2=雌激素受體(ER)為陰性"
then '▲ 1條件2-2：雌激素受體(ER)非陰性\n' else '') +
'\n'
else '') +
// 主要規定三：藥品使用規則 - 療程超標
(if Reusable."初次申請" and (not "3規則1" and not "3規則2")
then '<主要規定三：藥品使用規則>\n' +
(if not "1條件2=使用於外科手術前後之總療程合併計算，依藥品仿單記載以9個療程為上限"
then '▲ 3規則1：三種用藥(trastuzumab/pertuzumab+trastuzumab/Phesgo)合併療程超過9個療程上限\n' else '') +
(if not "2條件2=兩種用藥合併療程計算上限18個療程且trastuzumab emtansine上限14個療程"
then '▲ 3規則2：兩種用藥合併療程超過18個療程上限，或trastuzumab emtansine超過14個療程上限\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 "條件1-1=外科手術前後" or
not "條件2-3=腫瘤大於2公分。須經乳房超音波或乳房X光攝影或核磁共振診斷" or
not "條件2-4=且未發生腋下淋巴結轉移之早期乳癌患者，作為輔助性治療用藥" or
not "條件2-5=依下列條件之一使用"
)
then '<主要規定一：初次使用條件>\n' +
(if not "條件1-1=外科手術前後"
then '▲ 1條件1-1：未提供外科手術前後使用證明或化學療法治療紀錄\n' else '') +
(if not "條件2-3=腫瘤大於2公分。須經乳房超音波或乳房X光攝影或核磁共振診斷"
then '▲ 1條件2-3：未提供乳房超音波/X光攝影/核磁共振影像報告資料\n' else '') +
(if not "條件2-4=且未發生腋下淋巴結轉移之早期乳癌患者，作為輔助性治療用藥"
then '▲ 1條件2-4：未提供癌症分期分數或結果、影像或檢查報告資料\n' else '') +
(if not "條件2-5=依下列條件之一使用"
then '▲ 1條件2-5：未提供術後病理報告(pCR或non-pCR結果)\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1-1=每24週須再次申請並檢附療效評估資料" or
not "規則1-2=疾病有惡化情形須停止使用"
)
then '<主要規定二：續用條件－治療持續給付>\n' +
(if not "規則1-1=每24週須再次申請並檢附療效評估資料"
then '▲ 2條件1：未於24週內再次申請或未檢附療效評估資料\n' else '') +
(if not "規則1-2=疾病有惡化情形須停止使用"
then '▲ 2條件2：未提供前次治療後影像學報告資料\n' else '') +
'\n'
else '')
//============================================
// 審核結果
//============================================
define "乳癌Trastuzumab2申請結果_布林":
case
when Reusable."初次申請" then (
"主要規定一" and
"主要規定三"
)
when Reusable."續用申請" then
"主要規定二"
else false
end
define "乳癌Trastuzumab2申請之CQL檢核結果":
if (
Reusable."初次申請" and
"主要規定一" and
"主要規定三"
)
then '✓通過：初次使用－早期乳癌Trastuzumab用藥申請'
else if (
Reusable."續用申請" and
"主要規定二"
)
then '✓通過：續用－早期乳癌Trastuzumab用藥申請'
else if Reusable."初次申請"
then '✖不通過：初次使用－早期乳癌Trastuzumab用藥申請'
else if Reusable."續用申請"
then '✖不通過：續用－早期乳癌Trastuzumab用藥申請'
else '✖不通過：無法判定申請類型－早期乳癌Trastuzumab用藥申請'
//============================================
// 報告總結
//============================================
define "報告總結":
'\n=== 早期乳癌之Trastuzumab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 - 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【▲不符合項目 - 條件或代碼不符合】\n' +
(if "不符合項目_條件或代碼不符合"() = '' then '無\n' else "不符合項目_條件或代碼不符合"()) +
'\n【申請結果】\n' +
"乳癌Trastuzumab2申請之CQL檢核結果" +
'\n===============================================\n'
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