Country/Region: New Zealand
PE Guidelines

Prescription for Pharmacoeconomic Analysis: Methods for Cost-utility Analysis Version 2.2 (August 2015)
PDF in English

PE Guidelines Source:

PHARMAC (Pharmaceutical Management Agency)
https://www.pharmac.govt.nz/economic-analysis/

Additional Information:

The guidelines apply to applications for funding within PHARMAC's remit, which includes: Hospital and community funding for medicines, medical devices, vaccines, and some blood products. See also https://www.pharmac.govt.nz/how-medicines-are-funded/ for details on application formats.
https://www.pharmac.govt.nz/how-medicines-are-funded/

Last Webpage Update: Tuesday, March 20, 2018

PE Guidelines Key Features:

Key Features:  
Title and year of the document
Prescription for Pharmacoeconomic Analysis: Methods for Cost-utility Analysis Version 2.2 (August 2015)  
Affiliation of authors
PHARMAC, the Pharmaceutical Management Agency 
Purpose of the document
To guide pharmaceutical suppliers when undertaking their own economic analyses for funding applications. 
Standard reporting format included
Yes 
Disclosure
not stated 
Target audience of funding/ author's interests
PHARMAC staff, pharmaceutical companies and contracted health economists preparing economic analyses for PHARMAC 
Perspective
The health funder and patient, with respect to PHARMAC’s Factors For Consideration. Costs to government budgets other than health, such as social welfare, are excluded because they are outside PHARMAC's remit, but may be discussed qualitatively in full evaluations.   
Indication
Required 
Target population
The New Zealand population most likely to receive treatment. 
Subgroup analysis
Yes 
Choice of comparator
Should be the treatment that most prescribers would replace in New Zealand clinical practice, and the treatment prescribed to the largest number of patients (if this differs from the treatment most prescribers would replace). 
Time horizon
Should be extended far enough into the future to capture all the major clinical and economic outcomes of the alternatives under assessment. 
Assumptions required
Yes 
Preferred analytical technique
The preferred method is cost-utility analysis, which informs the “health benefits” and “costs and savings” dimensions of the Factors for Consideration (https://www.pharmac.govt.nz/factors-for-consideration/), and can generate information helpful for considering Factors in the “need” and “suitability” dimensions.  
Costs to be included
The range of costs included in cost-utility analyses (CUA) depends on the level of analysis undertaken, with a wider range of costs included in more detailed analyses.  
Source of costs
New Zealand data are preferred. The "Cost Resource Manual" (https://www.pharmac.govt.nz/assets/pfpa-v2-2-cost-resource-manual.pdf) documents a range of useful data sources.  
Modeling
Yes. Models should avoid unnecessary complexity and should be transparent, well-described, and reproducible.  
Systematic review of evidences
Yes. All appropriate levels of evidence should be identified; however well-conducted randomized controlled trials (RCTs) and meta-analyses are the preferred data sources when estimating relative treatment effects.  
Preference for effectiveness over efficacy
Yes. RCT in combination with real-life data to capture patients with poor compliance. Actual quality-adjusted life years (QALYs) = potential QALYs x patient continuation/ adherence rate 
Preferred outcome measure
The overall incremental cost per QALY result should be reported as a point estimate as well as the range over which the cost per QALY is likely to vary.  
Preferred method to derive utility
Based on EuroQoL with New Zealand tariffs; type 2 (excluding logically inconsistent responses) in the base case and type 1 (larger sample size but with logical inconsistencies) in sensitivity analysis  
Equity issues stated
Yes. See https://www.pharmac.govt.nz/factors-for-consideration/  
Discounting costs
3.5% , and between 0% and 5% in sensitivity analyses. 
Discounting outcomes
3.5% , and between 0% and 5% in sensitivity analyses. 
Sensitivity analysis-parameters and range
Parameters to consider include those with the greatest level of uncertainty (e.g. those derived from opinion), and those with the greatest influence on model outcomes (e.g. key clinical variables and costs). 
Sensitivity analysis-methods
Sensitivity analysis should include univariate (simple), multivariate and extremes (scenario) analysis. The level of sensitivity analysis undertaken should be determined by the level of analysis 
Presenting results
When presenting the results of the analysis, the incremental QALYs per $1 million invested should be reported.   
Incremental analysis
Yes 
Total costs vs effectiveness (cost/effectiveness ratio)
No 
Portability of results (Generalizability)
Yes, New Zealand context 
Financial impact analysis
A financial impact statement is required (a budget impact analysis with costs discounted at 8% per annum).  
Mandatory or recommended or voluntary
Recommended 

Acknowledgement: Mr. James Harris contributed to the Key-feature form. James Harris, MPhil, Manager, Health Economics, PHARMAC, Wellington, New Zealand.

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