Chemistry – Pharmacology Pharmacoeconomics assignment

Ticagrelor (Brilinta®) is an oral, reversible, direct acting platelet inhibitor that has been recently registered in South Africa for use in acute coronary syndrome (ACS). The current standard treatment in preventing cardiovascular events in patients with ACS is clopidogrel.

You are the health economist on your formulary committee and you have been tasked with determining the cost-effectiveness and budget impact of adding ticagrelor to the formulary in 2014. You do a literature search and come up with the following key papers;

a) Wallentin L, Becker RC, Budaj A, et al for the PLATO investigators. Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes.
N Engl J Med 2009;361:1045-57.

b) Nikolic E, Janzon M, Hauch O et al. Cost-effectiveness of treating acute coronary syndrome patients with ticagrelor for 12 months: results from the PLATO study.
Eur H J 2013;34:220-228

You decide to build your health economics model according to the methods and variables used in the European Heart Journal study. You are only required to build a 12 month model – ie for the year of treatment with ticagrelor.

Your budget impact analysis will be determined for 4 years from 2015 to 2018.

Please follow the instructions below to complete the assignment. Please do all your calculations on the excel spreadsheet.

1. Read the PLATO trial

2. Read the Eur Heart J trial – Nikolic E et al

1.
The Clinical Trial – PLATO (18)

a. List the clinical entry criteria (inclusion criteria) for patients eligible to participate in the trial; (4)

b. List the drug, dose, frequency and duration of treatment for each treatment arm (4)

c. Describe the Primary efficacy Endpoint (2)

d. Describe the Secondary efficacy Endpoints (4)

e. Identify which components of the Primary Efficacy Endpoint were statistically significantly different between the treatment arms and list the % events in each treatment arm (4)

2.
Health Economics Model (40)

Build a 1 year Decision Analysis Tree model comparing Ticagrelor to Clopidogrel in ACS. Use the Excel Spreadsheet provided.

a. Draw a decision tree in the Excel Worksheet named “Model” using the 4 health states as determined in the Eur Heart Journal trial (4)

b. Add in the 1-year probabilities of an event occurring in the treatment arms for each health state (hint: these can be found in the supplementary material of the Eur Heart Journal study) – use the “Input Parameters worksheet” (4)

c. Calculate the drug costs for each health state for each arm – use the “Costs” worksheet (4)

d. Calculate the hospital/outcome event costs for each arm – use the “Costs” worksheet. Note – the costs of these events are from 2011 – you will have to adjust them using the CPI figures to bring them to the 2014 costs(8)

e. Add in the total costs to each health state – enter this information into the “Model” spreadsheet(4)

f. Calculate the QALYs for each health state using the utilities given in the spreadsheet (hint – your model is only for 1 year) – enter this information into the “Model” spreadsheet(4)

g. Calculate the ICER (Cost/QALY) for ticagrelor vs clopidogrel at 12 months – enter this information into the “Model” spreadsheet (2)

h. Do a 1-way sensitivity analysis to assess the impact on the ICER of the following changes in variable– enter this information into the “Model” spreadsheet(10)

i. Price of Ticagrelor R350 or R700

ii. Price of Clopidogrel R140 or R450

iii. Cost of MI R50 000 or R100 000

iv. Utility for MI 0.8 or 0.85

v. Utility for Well 0.85 or 0.9

3.
Budget Impact Analysis (40)

Build a 4 year Budget Impact Analysis to assess the financial impact of switching patients from clopidogrel to ticagrelor from 2015 to 2018. Assume the total population you are considering for your formulary is 1 000 000 people and the prevalence of eligible patients for treatment is 0.5%.
Do this part of the exercise in the Excel Worksheet named “Budget Impact”. Use the “Costs” and “Input Parameters” worksheets for information

a. Calculate the number of patients eligible for treatment (1)

b. Calculate the cost of treatment for 2014 assuming every patient is taking clopidogrel, then calculate the cost of treatment assuming 25% of patients switch to ticagrelor (2)

c. Calculate the annual cost of each drug treatment assuming that 50% of patients switch from clopidogrel to ticagrelor in the years from 2015-2017. Assume there will be a 6% SEP increase each year (12)

d. Calculate the incremental budget impact (ie how much more money it is going to cost) for each year based on the uptake (switching) as above (4)

e. Calculate the cost savings accrued from the reduction in MIs in each arm (see the excel spreadsheet for information on this)

i. Calculate the predicted number of MIs if all the patients were taking Clopidogrel for each year (4)

ii. Calculate the reduction in number of MI’s if the patients switched to Ticagrelor at the uptake rates given above for each year (6)

iii. Calculate the cost savings from the reduction in MIs for each year (6)

f. Calculate the Incremental Budget Impact now taking into account the cost offset from savings accrued as a result of reduction in MIs (4)

g. Why would you NOT include savings from stroke in your budget impact analysis? (1)

You are given the required costing and clinical input information as per the excel spreadsheet to assist in your calculations.

4. What recommendation would you give to your Formulary Committee based on the analyses above?
(2)