//大腸直腸癌_Bevacizumab給付規定(轉移性大腸或直腸癌患者的第一線治療)
library CRCBevacizumabRule1 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
define "規則1-1=Bevacizumab與FOLFIRI（Folinicacid/5-fluorouracil/irinotecan）併用":
(
  // 存在 Fluorouracil 處方 
  exists (
    [MedicationRequest] MROrder1
    where MROrder1.intent = 'order'
    and exists (
      MROrder1.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01BC02
    )
    and Reusable."HasValidTiming"(MROrder1)
  )
  and
  // 存在 Irinotecan 處方   
  exists (
    [MedicationRequest] MROrder2
    where MROrder2.intent = 'order'
    and exists (
      MROrder2.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01CE02
    )
    and Reusable."HasValidTiming"(MROrder2)
  )
  and
  // Bevacizumab 申請 
  exists (
    [MedicationRequest] MRPlan
    where MRPlan.intent = 'plan'
    and exists (
      MRPlan.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01FG01
    )
  )
)
and Reusable."醫令類別為1"

//條件2
define "規則1-2=Bevacizumab與FOLFOX（Folinicacid/5-fluorouracil/oxaliplatin）併用":
(
  // 存在 Fluorouracil 處方
  exists (
    [MedicationRequest] MROrder1
    where MROrder1.intent = 'order'
    and exists (
      MROrder1.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01BC02
    )
    and Reusable."HasValidTiming"(MROrder1)
  )
  and
  // 存在 Oxaliplatin 處方  
  exists (
    [MedicationRequest] MROrder2
    where MROrder2.intent = 'order'
    and exists (
      MROrder2.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01XA03
    )
    and Reusable."HasValidTiming"(MROrder2)
  )
  and
  // Bevacizumab 申請
  exists (
    [MedicationRequest] MRPlan
    where MRPlan.intent = 'plan'
    and exists (
      MRPlan.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01FG01
    )
  )
)
and Reusable."醫令類別為1"


//條件3
//條件3
define "規則1-3=Bevacizumab與5-fluorouracil/leucovorin的化學療法合併使用":
(
  // 存在 Fluorouracil 處方
  exists (
    [MedicationRequest] MROrder1
    where MROrder1.intent = 'order'
    and exists (
      MROrder1.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01BC02
    )
    and Reusable."HasValidTiming"(MROrder1)
  )
  and
  // 存在 Leucovorin 處方  
  exists (
    [MedicationRequest] MROrder2
    where MROrder2.intent = 'order'
    and exists (
      MROrder2.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.V03AF03
    )
    and Reusable."HasValidTiming"(MROrder2)
  )
  and
  // Bevacizumab 申請
  exists (
    [MedicationRequest] MRPlan
    where MRPlan.intent = 'plan'
    and exists (
      MRPlan.medication.coding Cdg
      where Cdg in CodeConcept.NHIMedication
      and Cdg.code in CodeConcept.L01FG01
    )
  )
)
and Reusable."醫令類別為1"



define "規則1=化學療法合併使用":
  "規則1-1=Bevacizumab與FOLFIRI（Folinicacid/5-fluorouracil/irinotecan）併用"
  or "規則1-2=Bevacizumab與FOLFOX（Folinicacid/5-fluorouracil/oxaliplatin）併用"
  or "規則1-3=Bevacizumab與5-fluorouracil/leucovorin的化學療法合併使用"

/*規則2*/
//條件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2
define "規則2-2=三個月內有影像檢查報告":
  "初次申請" 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.ImageReportCode
    )
    and O.effective is not null
    and FHIRHelpers.ToDateTime(O.effective) >= Today() - 90 days
    and FHIRHelpers.ToDateTime(O.effective) <= Today()
  ) 

//條件3
define "規則2-3=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 in CodeConcept.DiagnosticReport
    )
    and O2.effective is not null
    and FHIRHelpers.ToDateTime(O2.effective) >= Today() - 90 days
    and FHIRHelpers.ToDateTime(O2.effective) <= Today()
  ) 

//條件4
define "規則2-4=癌症分期分數或結果為M>=1":
  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), '.*M[1-9].*')
  ) > 0

//條件5
define "規則2-5=用藥線別為第一線":
  exists (
    [Claim] C
      where exists (
        C.item I
          where exists (
            I.modifier M
              where exists (
                M.coding Cdg
                  where Cdg in CodeConcept.NHILOT
                    and Cdg.code = '1'
              )
          )
      )
  )

define "規則2=轉移性直腸結腸癌病患之第一線治療":
  Reusable."ICD-10使用C18、C19、C20、C21"
  and ( "規則2-2=三個月內有影像檢查報告"
  or "規則2-3=三個月內有檢查報告")
  and "規則2-4=癌症分期分數或結果為M>=1"
  and "規則2-5=用藥線別為第一線"

define "主要規定一":
  "初次申請" and
  "規則1=化學療法合併使用" 
  and "規則2=轉移性直腸結腸癌病患之第一線治療"


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

/*規則1*/
define "規則1=再次申請必須提出客觀證據（如：影像學）證實無惡化，才可繼續使用":
  exists (
    [MedicationRequest] MRPlan
     where MRPlan.intent = 'plan'
     and exists (
        MRPlan.medication.coding Cdg
        where Cdg in CodeConcept.NHIMedication
        and Cdg.code in CodeConcept.L01FG01
      )
  and exists (
    [DiagnosticReport] Report
     where exists (
      Report.code.coding Cdg
        where (
          Cdg in CodeConcept.ICD10PCS2023Image
          or Cdg in CodeConcept.ICD10PCS2014Image
        )
        and 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()
      )
      
    )
  and Reusable."醫令類別為1"

define "主要規定二":
  "續用申請" and
  "規則1=再次申請必須提出客觀證據（如：影像學）證實無惡化，才可繼續使用"


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

/*規則1*/
define "規則1=每次申請事前審查之療程以18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.L01FG01
    )
    and days between
      start of (MRPlan.dosageInstruction[0].timing.repeat.bounds as Period)
      and
      end of (MRPlan.dosageInstruction[0].timing.repeat.bounds as Period)
      <= 126
  )
/*規則2*/
define "規則2=使用總療程以36週為上限":
    Sum(
      [MedicationRequest] MRTotal
      where (MRTotal.intent = 'plan' or MRTotal.intent = 'order')
      and (MRTotal.status is null or MRTotal.status in { 'active', 'completed', 'on-hold' })
      and exists MRTotal.dosageInstruction
      and MRTotal.dosageInstruction[0].timing.repeat.bounds is Period
      and (start of (MRTotal.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
      and (end of (MRTotal.dosageInstruction[0].timing.repeat.bounds as Period)) is not null
      return
        days between
          start of (MRTotal.dosageInstruction[0].timing.repeat.bounds as Period)
          and
          end of (MRTotal.dosageInstruction[0].timing.repeat.bounds as Period)
    ) <= 252


/*規則3*/
//條件1
define "規則3-1=未使用cetuximab、panitumumab藥品":
  not exists (
    [MedicationRequest] M
    where exists (
      M.medication.coding Cdg
      where ( 
      Cdg in CodeConcept.NHIMedication and
        (
          Cdg.code in CodeConcept.L01FE01 or 
          Cdg.code in CodeConcept.L01FE02
        )
      )
    )
    and Reusable."HasValidTiming"(M)
  )

//條件2
define "規則3-2=本藥品未與cetuximab、panitumumab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.L01FG01
    )
    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.L01FE01 or Cdg.code in CodeConcept.L01FE02)
      )
      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
      // 檢查時間重疊
      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))
    )
  )

define "規則3=本藥品不得與cetuximab, panitumumab併用":
  "規則3-1=未使用cetuximab、panitumumab藥品"
  or "規則3-2=本藥品未與cetuximab、panitumumab併用"

define "主要規定三":
  "規則1=每次申請事前審查之療程以18週為限"
  and "規則2=使用總療程以36週為上限"
  and "規則3=本藥品不得與cetuximab, panitumumab併用"


//============================================
// 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Bevacizumab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Bevacizumab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 '初次使用大腸直腸癌之Bevacizumab(一線治療)用藥申請 - 通過'
    when "初次申請" then '初次使用大腸直腸癌之Bevacizumab(一線治療)用藥申請 - 未通過'
    when "續用申請" and "MainRule2_Pass" and "MainRule3_Pass" then '初次使用大腸直腸癌之Bevacizumab(一線治療)用藥申請 - 通過'
    when "續用申請" then '初次使用大腸直腸癌之Bevacizumab(一線治療)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=== 大腸直腸癌之Bevacizumab(一線治療) 申請審核報告 ===\n' +
  '\n【申請類型】' + "申請類型" + '\n' +
  
  // 根據申請類型顯示對應的檢核項目
  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=化學療法合併使用" 
        then '● 符合：Bevacizumab與FOLFIRI或FOLFOX或5-fluorouracil/leucovorin的化學療法合併使用' 
        else '▲ 不符合：Bevacizumab與FOLFIRI或FOLFOX或5-fluorouracil/leucovorin的化學療法合併使用' 
      end + '\n' +
      case when "規則2=轉移性直腸結腸癌病患之第一線治療" 
        then '● 符合：作為轉移性大腸或直腸癌患者的第一線治療' 
        else '▲ 不符合：作為轉移性大腸或直腸癌患者的第一線治療' 
      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 "規則1=再次申請必須提出客觀證據（如：影像學）證實無惡化，才可繼續使用" 
        then '● 符合：須提出客觀證據（如：影像學）證實無惡化' 
        else '▲ 不符合：須提出客觀證據（如：影像學）證實無惡化' 
      end + '\n'
    
    else '\n【錯誤】無法判斷申請類型\n'
  end +
  
  // 藥品使用規則
  '\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=每次申請事前審查之療程以18週為限" 
    then '● 符合：每次申請事前審查之療程以18週為限' 
    else '▲ 不符合：每次申請事前審查之療程超過18週限制' 
  end + '\n' +
  case when "規則2=使用總療程以36週為上限" 
    then '● 符合：使用總療程以36週為上限' 
    else '▲ 不符合：使用總療程超過36週上限' 
  end + '\n' +
  case when "規則3=本藥品不得與cetuximab, panitumumab併用" 
    then '● 符合：本藥品不得與cetuximab, panitumumab併用' 
    else '▲ 不符合：本藥品與cetuximab或panitumumab併用' 
  end + '\n' +
  
  '\n【申請結果】\n' +
  "大腸直腸癌Bevacizumab申請結果" + '\n' +
  '\n====================\n'

Encoded data 

Encoded data