//大腸直腸_CRCTrifluridineTipiracil給付規定
library CRCTrifluridineTipiracilRule1 version '1.0.0'

using FHIR version '4.0.1'

include FHIRHelpers version '4.0.1' called FHIRHelpers

include CRCCodeConcept version '1.0.0' called CodeConcept

include Reusable version '1.0.0' called Reusable

context Patient

//============================================
// 申請類型判斷
//============================================

define "初次申請":
  "申請類型" = '初次使用'

define "續用申請":
  "申請類型" = '續用'

define "申請類型未知":
  "申請類型" = '無法判斷申請類型'

define "申請類型":
  case
    when Reusable."續用註記為1" then '初次使用'
    when Reusable."續用註記為2" then '續用'
    else '無法判斷申請類型'
  end


//============================================
// 主要規定一：初次使用條件
//============================================

/*規則1*/
//條件1-1
//Reusable."ICD-10使用C18、C19、C20、C21"
define "ICD代碼檢核_布林值": Reusable."ICD-10使用C18、C19、C20、C21"

//條件1-2
define "規則1-1-2=三個月內有影像檢查報告":
  exists (
    [DiagnosticReport] O
    where exists (
      O.code.coding Cdg
      where (
        Cdg in CodeConcept.ICD10PCS2023Image
        or Cdg in CodeConcept.ICD10PCS2014Image
      )
      and Cdg.code in CodeConcept.ImageReportTumorCode
    )
    and O.effective is not null
    and FHIRHelpers.ToDateTime(O.effective) >= Today() - 90 days
    and FHIRHelpers.ToDateTime(O.effective) <= Today()
  )

//條件1-3
define "規則1-1-3=癌症分期分數或結果為M≠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, '.*M[1-9].*')
  ) > 0

//條件1-4
define "規則1-1-4=三個月內有檢查報告":
  exists (
    [DiagnosticReport] O2
    where exists (
      O2.code.coding Cdg
      where Cdg in CodeConcept.LOINC
      and Cdg.code = '65755-1'
    )
    and O2.effective is not null
    and FHIRHelpers.ToDateTime(O2.effective) >= Today() - 90 days
    and FHIRHelpers.ToDateTime(O2.effective) <= Today()
  ) 

//條件1
define "規則1-1=轉移性大腸直腸癌":
  Reusable."ICD-10使用C18、C19、C20、C21"
  and "規則1-1-3=癌症分期分數或結果為M≠0"
  and ("規則1-1-2=三個月內有影像檢查報告"
  or  "規則1-1-4=三個月內有檢查報告")

//條件2 
define "規則1-2=成人":
  exists (
    [Claim] C
    where C.created is not null
    and AgeInDaysAt(C.created) > 18
  )

//條件3-1
define "規則1-3-1=曾接受fluoropyrimidine為基礎的化療":
  (
    exists (
     [MedicationRequest] MROrder2
    where MROrder2.intent = 'order'
    and exists (
    MROrder2.medication.coding Cdg
    where Cdg in CodeConcept.NHIMedication
    and (Cdg.code in CodeConcept.L01BC02
    or Cdg.code in CodeConcept.L01BC03
    or Cdg.code in CodeConcept.L01BC06
    or Cdg.code in CodeConcept.L01BC53
    or Cdg.code in CodeConcept.L01BC59)
     )
    and Reusable."HasValidTiming"(MROrder2)
    and Reusable."GetEndTime"(MROrder2) < Today()
     )
  )

//條件3-2
define "規則1-3-2=曾接受oxaliplatin為基礎的化療":
  (
    exists (
     [MedicationRequest] MROrder3
    where MROrder3.intent = 'order'
    and exists (
    MROrder3.medication.coding Cdg
    where Cdg in CodeConcept.NHIMedication
    and Cdg.code in CodeConcept.L01XA03
     )
    and Reusable."HasValidTiming"(MROrder3)
    and Reusable."GetEndTime"(MROrder3) < Today()
     )
  )

//條件3-3
define "規則1-3-3=曾接受irinotecan為基礎的化療":
  (
    exists (
     [MedicationRequest] MROrder4
    where MROrder4.intent = 'order'
    and exists (
    MROrder4.medication.coding Cdg
    where Cdg in CodeConcept.NHIMedication
    and Cdg.code in CodeConcept.L01CE02
     )
    and Reusable."HasValidTiming"(MROrder4)
    and Reusable."GetEndTime"(MROrder4) < Today()
     )
  )

//條件3-4
define "規則1-3-4=曾接受抗血管內皮生長因子(anti-VEGF)":
  (
    exists (
     [MedicationRequest] MROrder1
    where MROrder1.intent = 'order'
    and exists (
    MROrder1.medication.coding Cdg
    where Cdg in CodeConcept.NHIMedication
    and (Cdg.code in CodeConcept.L01EK
    or Cdg.code in CodeConcept.L01FG)
     )
    and Reusable."HasValidTiming"(MROrder1)
    and Reusable."GetEndTime"(MROrder1) < Today()
     )
  )

//條件3
define "規則1-3=曾接受的基礎化學治療":
  "規則1-3-1=曾接受fluoropyrimidine為基礎的化療"
  and "規則1-3-2=曾接受oxaliplatin為基礎的化療"
  and "規則1-3-3=曾接受irinotecan為基礎的化療"
  and "規則1-3-4=曾接受抗血管內皮生長因子(anti-VEGF)"

//條件4-1
define "規則1-4-1=檢核是否為RAS 原生型(wild type)(符合者需有條件4-2不符合者不用)":
  exists (
    [Observation] RasObs
    where RasObs.status = 'final'
    and exists (
      RasObs.code.coding Cdg
      where Cdg.code = '69548-6'
      and Cdg in CodeConcept.LOINC
    )
    and exists (
      RasObs.component C
      where exists (
        C.code.coding Cdg
        where Cdg.code in CodeConcept.GeneTest
      )
    )
    and exists (
      RasObs.interpretation.coding I
      where I.code = 'NEG'
    )
  )

//條件4-2
define "規則1-4-2=接受過抗表皮生長因子受體（anti-EGFR）療法":
  (
    exists (
     [MedicationRequest] MROrder1
    where MROrder1.intent = 'order'
    and exists (
    MROrder1.medication.coding Cdg
    where Cdg in CodeConcept.NHIMedication
    and Cdg.code in CodeConcept.L01EB
    or Cdg.code in CodeConcept.L01FE
     )
    and Reusable."HasValidTiming"(MROrder1)
    and Reusable."GetEndTime"(MROrder1) < Today()
     )
  )

//條件4
define "規則1-4=若K-ras為原生型(wild type)，需再加上接受過抗表皮生長因子受體（anti-EGFR）療法":
  if "規則1-4-1=檢核是否為RAS 原生型(wild type)(符合者需有條件4-2不符合者不用)"
  then "規則1-4-2=接受過抗表皮生長因子受體（anti-EGFR）療法"
  else true

define "規則1":
  "規則1-1=轉移性大腸直腸癌"
  and "規則1-2=成人"
  and "規則1-3=曾接受的基礎化學治療"
  and "規則1-4=若K-ras為原生型(wild type)，需再加上接受過抗表皮生長因子受體（anti-EGFR）療法"

/*規則2*/
define "規則2=需檢附All-RAS 基因突變分析檢測結果報告":
  exists (
    [Observation] RasObservation
    where RasObservation.status = 'final'
    and exists (
      RasObservation.code.coding ObsCodeCoding
      where ObsCodeCoding.code = '69548-6'
      and ObsCodeCoding in CodeConcept.LOINC
    )
    and exists (
      RasObservation.component ComponentRecord
      where exists (
        ComponentRecord.code.coding ComponentCodeCoding
        where ComponentCodeCoding.code in CodeConcept.GeneTest
      )
    )
    and exists (
      RasObservation.derivedFrom DerivedFromRef
      where DerivedFromRef.reference is not null
    )
    and exists (
      [DocumentReference] DocumentRef
      where exists (
        RasObservation.derivedFrom DerivedFromRef
        where EndsWith(DerivedFromRef.reference, DocumentRef.id)
      )
      and DocumentRef.status = 'current'
      and exists (
        DocumentRef.content ContentRecord
        where ContentRecord.attachment.url is not null
      )
    )
  )

/*規則3*/
define "規則3=申請項目":
  exists (
    [MedicationRequest] MRPlan
    where MRPlan.intent = 'plan'
    and exists (
      MRPlan.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01BC59
    )
  )

define "主要規定一":
  "初次申請" and
  "規則1" 
  and "規則2=需檢附All-RAS 基因突變分析檢測結果報告" 
  and "規則3=申請項目"


//============================================
// 主要規定二：續用條件－治療持續給付
//============================================

define "續用規則1=客觀證據（如：影像學）證實無惡化":
  exists (
    [MedicationRequest] MRPlan
    where MRPlan.intent = 'plan'
    and exists (
      MRPlan.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01BC59
    )
    and exists (
      [DiagnosticReport] Report
      where exists (
        Report.code.coding Cdg
        where Cdg.code in CodeConcept.ImageReportCode
      )
      and Report.effective is not null
      and FHIRHelpers.ToDateTime(Report.effective) >= Today() - 90 days
      and FHIRHelpers.ToDateTime(Report.effective) <= Today()
    )
  )

define "主要規定二":
  "續用申請" and
  "續用規則1=客觀證據（如：影像學）證實無惡化"


//============================================
// 主要規定三：藥品使用規則
//============================================

/*規則1*/
define "規則1=不得與regorafenib併用":
  exists (
    [MedicationRequest] MRmed
    where MRmed.intent = 'plan'
    and exists (
      MRmed.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01BC59
    )
    and exists MRmed.dosageInstruction
    and MRmed.dosageInstruction[0].timing.repeat.bounds is Period
    and (start of (MRmed.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
    and (end of (MRmed.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
    and not exists (
      [MedicationRequest] M
      where M.intent = 'plan'
      and exists (
        M.medication.coding Cdg
        where Cdg in CodeConcept.NHIMedication
        and Cdg.code in CodeConcept.L01EX05
      )
      and exists M.dosageInstruction
      and M.dosageInstruction[0].timing.repeat.bounds is Period
      and (start of (M.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
      and (end of (M.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
      and (start of (M.dosageInstruction[0].timing.repeat.bounds as Period)) <= 
            (end of (MRmed.dosageInstruction[0].timing.repeat.bounds as Period))
      and (end of (M.dosageInstruction[0].timing.repeat.bounds as Period)) >= 
            (start of (MRmed.dosageInstruction[0].timing.repeat.bounds as Period))
    )
  )

/*規則2*/
define "規則2=每次申請事前審查之療程以8週為限":
  exists [MedicationRequest] MRPlan
  where MRPlan.intent = 'plan'
  and exists (
    MRPlan.medication.coding Cdg
    where Cdg in CodeConcept.NHIMedication
    and Cdg.code in CodeConcept.L01BC59
  )
  and days between
    start of (MRPlan.dosageInstruction[0].timing.repeat.bounds as Period)
    and
    end of (MRPlan.dosageInstruction[0].timing.repeat.bounds as Period)
    <= 56

define "主要規定三":
  "規則1=不得與regorafenib併用"
  and "規則2=每次申請事前審查之療程以8週為限"


//============================================
// 審核結果
//============================================

define "MainRule1_Pass":
  if "初次申請"
  then "主要規定一"
  else null

define "MainRule2_Pass":
  if "續用申請"
  then "主要規定二"
  else null

define "MainRule3_Pass":
  "主要規定三"

define "大腸直腸癌TrifluridineTipiracil申請結果_布林":
  case
    when "初次申請" then ("MainRule1_Pass" and "MainRule3_Pass")
    when "續用申請" then ("MainRule2_Pass" and "MainRule3_Pass")
    else false
  end

define "大腸直腸癌TrifluridineTipiracil申請結果":
  case
    when "申請類型未知" then '申請未通過：無法判斷申請類型'
    when "初次申請" and "MainRule1_Pass" and "MainRule3_Pass" then '初次使用Trifluridine/Tipiracil用藥申請 - 通過'
    when "初次申請" then '初次使用Trifluridine/Tipiracil用藥申請 - 未通過'
    when "續用申請" and "MainRule2_Pass" and "MainRule3_Pass" then '續用Trifluridine/Tipiracil用藥申請 - 通過'
    when "續用申請" then '續用Trifluridine/Tipiracil用藥申請 - 未通過'
    else '申請未通過'
  end


//============================================
// 申請審核報告（根據申請類型顯示相關檢核）
//============================================

define "申請審核報告":
  '\n' +
  '\n=== Trifluridine/Tipiracil 申請審核報告 ===\n' +
  '\n【申請類型】' + "申請類型" + '\n' +
  
  case
    when "初次申請" then
      '\n【初次使用條件檢核】\n' +
      '主要規定一：' + case when "MainRule1_Pass" then '通過' else '未通過' end + '\n' +
      case when "規則1"
        then '● 符合：轉移性大腸直腸癌成人患者及治療史條件'
        else '▲ 不符合：轉移性大腸直腸癌成人患者及治療史條件'
      end + '\n' +
      case 
        when "規則1-4-1=檢核是否為RAS 原生型(wild type)(符合者需有條件4-2不符合者不用)" 
          and "規則1-4-2=接受過抗表皮生長因子受體（anti-EGFR）療法"
          then '● 符合：RAS為原生型且已接受anti-EGFR療法'
        when "規則1-4-1=檢核是否為RAS 原生型(wild type)(符合者需有條件4-2不符合者不用)" 
          and not "規則1-4-2=接受過抗表皮生長因子受體（anti-EGFR）療法"
          then '▲ 不符合：RAS為原生型但未接受anti-EGFR療法'
        else '○ RAS非原生型，無需接受anti-EGFR療法'
      end + '\n' +
      case when "規則2=需檢附All-RAS 基因突變分析檢測結果報告"
        then '● 符合：檢附All-RAS基因突變分析檢測結果報告'
        else '▲ 不符合：檢附All-RAS基因突變分析檢測結果報告'
      end + '\n' +
      case when "規則3=申請項目"
        then '● 符合：申請項目為Trifluridine/Tipiracil'
        else '▲ 不符合：申請項目為Trifluridine/Tipiracil'
      end + '\n'
    
    when "續用申請" then
      '\n【續用條件檢核】\n' +
      '主要規定二：' + case when "MainRule2_Pass" then '通過' else '未通過' end + '\n' +
      case when "續用規則1=客觀證據（如：影像學）證實無惡化"
        then '● 符合：提出客觀證據（影像學）證實無惡化'
        else '▲ 不符合：提出客觀證據（影像學）證實無惡化'
      end + '\n'
    
    else '\n【錯誤】無法判斷申請類型\n'
  end +
  
  '\n【藥品使用規則檢核】\n' +
  '主要規定三：' + case when "MainRule3_Pass" then '通過' else '未通過' end + '\n' +
  case when "規則1=不得與regorafenib併用"
    then '● 符合：不得與regorafenib併用'
    else '▲ 不符合：與regorafenib併用'
  end + '\n' +
  case when "規則2=每次申請事前審查之療程以8週為限"
    then '● 符合：每次申請事前審查之療程≦8週'
    else '▲ 不符合：每次申請事前審查之療程超過8週'
  end + '\n' +
  
  '\n【申請結果】\n' +
  "大腸直腸癌TrifluridineTipiracil申請結果" + '\n' +
  '\n====================\n'

Encoded data 

Encoded data