Service Impact Model Calcuator

 

For the best experience we recommend viewing this page on a tablet or desktop.

 

Introduction

The Kisqali (ribociclib) service impact model demonstrates the impact of introducing ribociclib within a service on appointment numbers and costs for patients with early breast cancer treatments for patients with the HR+/HER2− subtype.

The model allows the user to view and select the population by cancer stage and region/organisation. The user can make changes to the assumed baseline for each characteristic, and the whole population.

This document’s intended audience is professionals involved in policy and decision-making on budgets. It is not intended for healthcare professionals whose sole role is to prescribe medicines for the treatment of early breast cancer.

Instructions

  • User input cells. The reset button clears these cells and restores default values
  • Fixed values.
  • Drop down list.

Abbreviations

List of abbreviations used throughout the model:

Al Aromatase inhibitor ALT Alanine aminotransferases AST Aspartate aminotransferases BC Breast Cancer BNF British National Formulary ET Endocrine therapy
HCRU Healthcare resource utilisation HER2 Human epidermal growth factor receptor 2 HR Hormone receptor ICB Integrated Care Boards PI Prescribing Information
QT The time between the start of the QRS complex (combination of the Q wave, R wave, and S wave) and the end of the T wave. QTcF corrected QT interval by Fridericia SmPC Summary of Product Characteristics

Model assumptions

  • Annual treatment costs are calculated using the SmPC and BNF documents. The calculations use drug list prices. Further details of the calculations can be seen in the "Treatment costs" section.
  • Throughout the model, certain medicines are listed as their respective drug class and others are listed as individual drugs. The aromatase inhibitor (Al) cost is the average cost of anastrozole and letrozole. The luteinising hormone releasing hormone (LHRH) agonist cost is the average cost of goserelin and leuprorelin. This is done for simplicity and due to a similar cost and clinical use of individual drugs in the same class.
  • The population is taken as the whole of the HR+/HER2- cohort, and whichever of stage II and III is selected by the user. Due to a lack of specific data, patients with T2NO who do not fulfil the criteria G3 or G2 with Ki-67 > 20% have not been excluded from the population figure, but this group should be excluded to align with the NATALEE eligible population.1
  • The treatment distribution data is auto-populated with placeholder data that assumes an equal split of all applicable treatments in baseline and year 1 of the scenario. This means that baseline takes an equal split of all treatments except those containing ribociclib, as it is not yet available and requires user input to investigate the impact of changes in prescribing.
  • Incidence data is available at a sub-ICB level. This is then extrapolated using population data to achieve values for Trust and ICS footprints.
  • Where possible, we assume that all test and monitoring appointments coincide to achieve the optimal total number of appointments.
  • For treatments involving CDK4/6 inhibitors, after a patient has finished the maximum length of treatment, as defined in the SmPC, patients are assumed to continue on their regimen excluding the CDK4/6 inhibitor add-on (i.e. a patient who has completed 3 years of treatment with ribociclib + Al + LHRH agonist continues to be treated with LHRH agonist + Al for the remainder of the time horizon).
  • Monitoring frequencies are taken from information noted in NICE TA 810. It is assumed that the monitoring frequency for ribociclib can be taken to be the same as that of abemaciclib, both being CDK 4/6is.
 

Regions

Organsiations

 

Population Selection

Selected adult (18+) population2
Incidence of breast cancer3
HR+/HER2- patients4
Stage I3
Stage II3
Stage III3
Stage IV3
Unknown3
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NATALEE eligible population*:

 
 
 
Additional population groups:
Patients diagnosed with HR+/HER2− BC in the previous calendar year.2,3
Proportion of patients with stage II/III BC diagnosed in the previous calendar year who have been on ET for less than 12 months.2,3,4
 
 
 
 
 
Number of patients eligible for treatment with ribociclib per year
Please note this is dependent on the marketing authorisation which has not yet been granted and could be subject to change.
 
 
 

*Please note this is an overestimation. Patients with stage IIA disease that is N0 without additional risk factors, including G3, or G2 with Ki67 20% or high genomic risk, were not eligible for the NATALEE study. No specific incidence data for this sub-population exists.

Treatment costs

Annual costs

Treatment* Therapeutic indications in early breast cancer Treatment Days on* Days off Cost per maintenance cycle Annual cost (year 1) Annual cost (year 2+) Total cost (year 1) Total cost (year 2+) Total cost after maximum CDK4/6i treatment duration
Abemaciclib + AI5-8 Stage II and III (high risk), node-positive, HR+/HER2− Abemaciclib 28 0            
AI 28 0      
Abemaciclib + AI +LHRH agonist5-12 Stage II and III (high risk), node-positive, HR+/HER2−, in pre- and perimenopausal patients Abemaciclib 28 0            
AI 28 0      
LHRH 1 55      
Abemaciclib + Tamoxifen5,13-15 Stage II and III (high risk), node-positive, HR+/HER2− Abemaciclib 28 0            
Tamoxifen 30 0      
Ribociclib + AI6,7,14-16 Stage II and III, HR+/HER2− Ribociclib 21 7            
AI 28 0      
Ribociclib + AI + LHRH agonist6,7,9-12,14-16 Stage II and III, HR+/HER2−, in pre- and perimenopausal patients Ribociclib 21 7            
AI 28 0      
LHRH 1 55      
Tamoxifen monotherapy13 Stage I-III Tamoxifen 30 0            
AI monotherapy6,7 Stage I-III, HR+ AI 28 0            
AI + LHRH agonist6,7,9-12 Stage I-III, HR+, pre- and perimenopausal patients AI 28 0            
LHRH 1 55      

*All patients remain on treatment for the full year.

**This model is based on data from the NATALEE clinical study1 whose aim is to establish the safety and efficacy profile of ribociclib in combination with an aromatase inhibitor (AI) in stage II or III HR+/HER2− early breast cancer. Novartis has the intention of making a submission to health authorities, however, a marketing authorisation cannot be guaranteed.

Unit costs

Drug List price per pack Pack size Description Dosing Cost per dose Dosing regimen Pack Price User input
Abemaciclib5 £2,950.00 56 50 mg film-coated tablets 50 mg   The recommended dose of abemaciclib is 150 mg twice daily when used in combination with endocrine therapy. Dose adjustment is recommended based on adverse reactions: first dose adjustment 100 mg twice daily, second dose adjustment 50 mg twice daily.  
100 mg film-coated tablets 100 mg
1150 mg film-coated tablets 150 mg
Ribociclib16 £2,950.00 63 200 mg film-coated tablets 400 mg   The recommended dose is 400 mg of ribociclib once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Dose adjustments may be required based on adverse reactions.  
Leuprorelin9 £225.72 1 11.25 mg powder and solvent for suspension for injection pre-filled disposable 11.25 mg   The recommended dose is 11.25 mg administered as a single subcutaneous injection every 3 months in combination with tamoxifen or an aromatase inhibitor. Treatment with leuproelin must be initiated at least 6-8 weeks before starting aromatase inhibitor treatment.  
Goserelin10 £70.00 1 3.6 mg implant SafeSystem pre-filled syringes 3.6 mg   One 3.6 mg depot of Zoladex injected subcutaneously into the anterior abdominal wall, every 28 days.  
Tamoxifen13 £2.53 30 20 mg film-coated tablets 20 mg   The recommended dose is 20 mg daily for 5 years for those women at moderate or high risk.  
Letrozole6 £1.75 28 2.5 mg film-coated tablets 2.5 mg   The recommended dose of Letrozole tablet is 2.5 mg once daily.  
Anastrozole7 £1.09 28 1 mg film-coated tablets 1 mg   The recommended dose of Anastrozole for adults including the elderly is one 1 mg tablet once a day. For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years.  

HCRU

HCRU requirements

Treatment Initial tests required?* Initial tests Annual monitoring appointments (Year 1) Annual monitoring appointments (Years 2+) Subcutaneous injection appointments per cycle Cycle length (days) Total appointments (Year 1) Total appointments (Years 2+) Total service cost (Year 1) Total service cost (Years 2+)
Tests Test appointments Electrocardiogram Duration of initial tests
Full blood count Liver function test Serum electrolytes
Abemaciclib** + AI4,8 Yes 6 6 0   0 4 Cycles 8.00 4.00 0 28        
Abemaciclib** + AI + LHRH agonist4,8 Yes 6 6 0   0 4 Cycles 8.00 4.00 0.5 28        
Abemaciclib** + Tamoxifen4,8 Yes 6 6 0   0 4 Cycles 8.00 4.00   28        
Ribociclib*** + AI6,7,14-16 Yes 8 8 6   2 6 Cycles 8.00 4.00   28        
Ribociclib*** + AI + LHRH agonist4,14,15 Yes 8 8 6   2 6 Cycles 8.00 4.00 0.5 28        
Tamoxifen4 No             1.00 1.00   30        
AI4 No             1.00 1.00   28        
LHRH agonist + AI4,11,12 No             1.00 1.00 1 56        

* Initial tests here refer to whether there are specified tests or monitoring requirements upon being prescribed each treatment.

Liver function tests (LFTs) include ASTs and their associated total takes both costs into consideration. LFTs include tests for albumin, bilirubin, ALT, AST and alkaline phosphatase.

**Manufacturer advises monitoring of full blood count, and alanine and aspartate aminotransferases before starting treatment, every 2 weeks for the first 2 months, monthly for the following 2 months, and as clinically indicated thereafter.

***Manufacturer advises to perform full blood counts and liver function tests before initiating treatment, every 2 weeks for the first 2 cycles, at the beginning of the subsequent 4 cycles, and then as clinically indicated thereafter. Manufacturer advises to assess ECG before initiating treatment (only initiate treatment in patients with QTcF values >450 milliseconds); ECG should be repeated at approx. day 14 of the first cycle, then as clinically indicated. Manufacturer advises to monitor serum electrolytes (including potassium, calcium, phosphorus and magnesium) before initiating treatment, at the beginning of the first 6 cycles and then as clinically indicated; any abnormality should be corrected before initiating treatment.

HCRU unit costs

Appointment Cost Manual override
Monitoring*17    
Full blood count18    
Electrocardiogram17    
Serum electrolyte monitoring17    
Liver function test18    
Subcutaneous injection (nurse-led appointment)19    

*A monitoring appointment is taken as an outpatient clinical oncology single professional follow-up appointment

Liver function tests comprise of tests for AST, ALT, alkaline phosphatase, bilirubin and albumin.

Scenario Planning

Treatment distribution

The tables below show the number of patients on treatment for early breast cancer based on the eligible patient population section. All proportions are editable and represent the total breakdown of patients in each year of the scenario. The model compares two 5-year periods; the first where the baseline treatment distribution data remain unchanged year-on-year, representing the current treatment paradigm (baseline), and the second where uptake of ribociclib is modelled through an increase in treatment distribution (Years 1–5). Each year a new incident group of patients join the model. The table at the bottom of this page shows a breakdown in the number of patients on each treatment in the baseline and for each year in the scenario of the model.

 
Total eligible population for treatment over 5 years

 

Disease stage selected

 

 
  Baseline Scenario
Year 1 Year 2 Year 3 Year 4 Year 5
Ribociclib + AI 0 0 0 0 0 0
Ribociclib + AI + LHRH agonist 0 0 0 0 0 0
Abemaciclib + AI 0 0 0 0 0 0
Abemaciclib + AI + LHRH agonist 0 0 0 0 0 0
Abemaciclib + tamoxifen 0 0 0 0 0 0
Tamoxifen monotherapy 0 0 0 0 0 0
AI monotherapy 0 0 0 0 0 0
LHRH agonist + AI 0 0 0 0 0 0
             
             

*Disclaimer: The treatment distribution applies to the new patients initiated on treatment each year.

 

Cumulative number of patients on each treatment option in each year*

  Baseline Scenario
Year 1 Year 2 Year 3 Year 4 Year 5
Ribociclib + AI 0 0 0 0 0 0
Ribociclib + AI + LHRH agonist 0 0 0 0 0 0
Abemaciclib + AI 0 0 0 0 0 0
Abemaciclib + AI + LHRH agonist 0 0 0 0 0 0
Abemaciclib + tamoxifen 0 0 0 0 0 0
Tamoxifen monotherapy 0 0 0 0 0 0
AI monotherapy 0 0 0 0 0 0
LHRH agonist + AI 0 0 0 0 0 0
Total patient numbers            

*Disclaimer: This table shows cumulative patient numbers for each year of the model, summarising the total number of patients on each treatment option in each year. Patients who are initiated on ribociclib or abemacaclib, discontinue treatment after 2 or 3 years, respectively and subsequently move to the monotherapy or LHRH against + AI alternative.

Results

Service impact summary

Total eligible population for treatment

 

Year in Scenario

Service Impact - Appointments

Service Impact
Year x in baseline Year x in future scenario
   
Appointments saved:  
%nbsp;

Breakdown of appointment and test numbers with total service cost

    Year x in baseline Year x in future scenario Difference
Tests Liver function tests      
Full blood count      
Serum electrolytes      
Appointments Electrocardiogram (ECG)      
Monitoring      
Subcutaneous injection      
  Total appointments      
  Total service cost      

Budget impact summary

Total eligible population for treatment

 

Year in Scenario

 

  Budget Impact
  Year x in baseline Year x in future scenario
Overall    
Treatment    
Appointments    
  Budget saved:  
%nbsp;

Modelled treatment breakdown in Year x

Baseline Treated Patients Treatment Cost Number of Appointments Appointment Cost Total Cost
Ribociclib + AI          
Ribociclib + AI + LHRH agonist          
Abemaciclib + AI          
Abemaciclib + AI + LHRH agonist          
Abemaciclib + Tamoxifen          
Tamoxifen monotherapy          
AI monotherapy          
LHRH agonist + AI          
Scenario Treated Patients Treatment Cost Number of Appointments Appointment Cost Total Cost
Ribociclib + AI          
Ribociclib + AI + LHRH agonist          
Abemaciclib + AI          
Abemaciclib + AI + LHRH agonist          
Abemaciclib + Tamoxifen          
Tamoxifen monotherapy          
AI monotherapy          
LHRH agonist + AI          

References

  1. Slamon D, et al. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib +endocrine therapy versus endocrine therapy alone in patients with HR+/HER2– early breast cancer. Ther Adv Med Oncol 2023; 15:17588359231178125. [Accessed November 2024]
  1. Office of National Statistics. Clinical commissioning group population estimates: mid-2020. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/clinicalcommissioninggroupmidyearpopulationestimates. [Accessed November 2024]
  2. Public Health Scotland. Health Board (2019) Population Estimates. Available at: https://www.opendata.nhs.scot/dataset/population-estimates/resource/27a72cc8-d6d8-430c-8b4f-3109a9ceadb1. [Accessed November 2024]
  3. Office of National Statistics. Population estimates for the UK, England and Wales, Scotland and Northern Ireland: mid-2020. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/bulletins/annualmidyearpopulationestimates/mid2020. [Accessed November 2024]
  4. NISRA. Population Projections: 2018. Available at: https://www.ninis2.nisra.gov.uk/public/Theme.aspx. [Accessed November 2024]
  5. NHS Digital. Hosptial Outpatient Activity 2021-22. Available at: https://digital.nhs.uk/data-and-information/publications/statistical/hospital-outpatient-activity/2021-22. [Accessed November 2024]
  1. NHS Digital. Case-mix adjusted percentage of cancers diagnosed at stage 1 and 2 in England, 2020. Available at: https://digital.nhs.uk/data-and-information/publications/statistical/case-mix-adjusted-percentage-of-cancers-diagnosed-at-stages-1-and-2-in-england/2020. [Accessed November 2024]
  2. Public Health Scotland. Cancer Statistics: Cancer of the breast: IC-10 C50 annual incidence. Available at: https://www.isdscotland.org/health-topics/cancer/cancer-statistics/breast/#cancer-of-the-breast. [Accessed November 2024]
  3. Public Health Wales. Official Statistics - Incidence of cancers of the breast, bowel, lung, prostate and ovary, 2002-2020. Available at: https://phw.nhs.wales/services-and-teams/welsh-cancer-intelligence-and-surveillance-unit-wcisu/cancer-reporting-tool/cancer-incidence-in-wales-2002-2020-preliminary-release-docx. [Accessed November 2024]
  4. Queen's University Belfast. Northern Ireland Cancer Registry: All cancers excluding non-melanoma skin cancer (NMSC) 1993-2020. Available at: https://www.qub.ac.uk/research-centres/nicr/CancerInformation/official-statistics/BySite/All-Cancers-excl-non-malignant-melanoma-skin/. [Accessed November 2024]
  5. Public Health Wales. Cancer Incidence in Wales, 2002-2019. Available at: https://phw.nhs.wales/services-and-teams/welsh-cancer-intelligence-and-surveillance-unit-wcisu/cancer-survival-in-wales-2002-2019/cancersurvivalinwalestechnicalguide2002-2019pdf/. [Accessed November 2024]
  6. Northen Ireland Cancer Registry. Breast Cancer and Insitu Tumours. Available at: https://www.qub.ac.uk/research-centres/nicr/CancerInformation/ocial-statistics/BySite/Breastcancerandinsitutumours/. [Accessed November 2024]
  7. Public Health Scotland. Cancer Stating Data using 2018-2020 DCE Data - the impact of COVID-19. Available at: https://www.publichealthscotland.scot/media/9973/2021-11-02-cancerstagingusingdcedata-report.pdf [Accessed November 2024].
  1. National Institute for Health and Care Excellence. Abemaciclib with endocrine therapy for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence. Available at: https://www.nice.org.uk/guidance/ta810/resources. [Accessed November 2024]
  2. Joint Formulary Committee. British National Formulary (online) London: BMJ and Pharmaceutical Press. Abemaciclib. Available at: https://bnf.nice.org.uk/drugs/abemaciclib-specialist-drug/.
  3. Joint Formulary Committee. British National Formulary (online) London: BMJ and Pharmaceutical Press. Letrozole. Available at: https://bnf.nice.org.uk/drugs/letrozole/.
  4. Joint Formulary Committee. British National Formulary (online) London: BMJ and Pharmaceutical Press. Anastrozole. Available at: https://bnf.nice.org.uk/drugs/anastrozole/.
  5. Electronic Medicines Compendium. Verzenios 50mg film-coated tablets SmPC. Available at: https://www.medicines.org.uk/emc/product/9532/smpc#gref.
  6. Joint Formulary Committee. British National Formulary (online) London: BMJ and Pharmaceutical Press. Leuprorelin. Available at: https://bnf.nice.org.uk/drugs/leuprorelin-acetate/.
  7. Joint Formulary Committee. British National Formulary (online) London: BMJ and Pharmaceutical Press. Goserelin. Available at: https://bnf.nice.org.uk/drugs/goserelin.
  8. Electronic Medicines Compendium. Zoladex 3.6 mg Implant SmPC. Available at: https://www.medicines.org.uk/emc/product/1543/smpc#gref.
  9. Electronic Medicines Compendium. Prostap® 3 DCS 11.25 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled syringe SmPC. Available at: https://www.medicines.org.uk/emc/product/4651/smpc#gref.
  10. Joint Formulary Committee. British National Formulary (online) London: BMJ and Pharmaceutical Press. Tamoxifen. Available at: https://bnf.nice.org.uk/drugs/tamoxifen/.
  11. KISQALI® (ribociclib) Great Britain Summary of Product Characteristics.
  12. KISQALI® (ribociclib) Northern Ireland Summary of Product Characteristics.
  13. Joint Formulary Committee. British National Formulary (online) London: BMJ and Pharmaceutical Press. Ribociclib. Available at: https://bnf.nice.org.uk/drugs/ribociclib-specialist-drug/.
  14. NHS. 2023-25 NHS Payment Scheme. Available at: https://www.england.nhs.uk/publication/2023-25-nhs-payment-scheme/. [Accessed November 2024]
  15. National Institute for Health and Care Research. Interactive costing tool 2023. Available at: https://www.nihr.ac.uk/documents/interactive-costing-tool-ict-getting-started/12170#icttari. data [Accessed November 2024]
  16. Personal Social Services Research Unit. Units Costs of Health and Social Care 2022. Available at: https://www.pssru.ac.uk/unitcostsreport/. [Accessed November 2024]