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Table 1 Summary of the identified sources of uncertainty in the economic analysis

From: A critical assessment framework to identify, quantify and interpret the sources of uncertainty in cost-effectiveness analyses

 

Quantifiable?

Scenario available in the model?

Incremental costs

(HUF)a

Incremental effectiveness

(QALY)a

ICER

(HUF/QALY)a

Impact on

cost-effectiveness conclusionb

Base case (darolutamide is cost-effective to ADT)

-

-

ref

ref

ref

-

Time horizon of the analysis

(BC: time horizon ins 27 years; ScA: time horizon is 10 years)

[Type of economic analysis]

Yes

Yes

-2%

-32%

45%

Significant

Restriction of the efficacy analysis population to mITT

(BC: censor patients who develop metastasis before starting treatment;

ScA: patients who develop metastasis before starting treatment count as events)

[Evaluation of the economic model—transition probabilities]

Yes

Yes

13%

8%

4%

Significant

Long-term effectiveness of darolutamide on overall survival

(BC: assume benefit in mortality over the entire analysis time horizon;

ScA: do not assume benefit in mortality after 10 years)

[Evaluation of the economic model—transition probabilities]

Yes

Yes

 < 1%

-5%

6%

Significant

Resource use patterns (comparator and subsequent therapies)

(BC: assume equal distribution of degarelix, goserelin, leuprorelin,

triptorelin and buserelin as part of ADT;

ScA: differentiate the distribution of compunds used as part of ADT:

higher share for degarelix, goserelin and leuprorelin,

lower for triptorelin and buserelin)

[Evaluation of the economic model – cost inputs]

Yes

Yes

 < 1%

-

 < 1%

Not significant

Price discount on subsequent treatments

(BC: use the public list prices of abiraterone-acetate, enzalutamide, degarelix;

ScA: assume 30% discount on abiraterone-acetate, enzalutamide, degarelix

list prices)

[Evaluation of the economic model – cost inputs]

Yes

No

7%

-

7%

Significant

EQ-5D value set used to estimate utilities

(BC: use the UK value set when estimating utilities;

ScA: use the Hungarian value set for estimating utilities)

[Evaluation of the economic model – utility inputs]

No

No

-

?↕

?↕

Not quantifiable

  1. For non-quantifiable sources of uncertainty, „?↕” marks the uncertain direction of impact. For each source of uncertainty, parentheses hold the parameter input for base case (BC) and the scenario analysis (ScA), respectively; brackets hold the name of the relevant section of the assessment report
  2. aThe quantifiable or expected impact on base case results of each source of uncertainty
  3. bIf considering the impact of the source of uncertainty changes the base case cost-effectiveness conclusion, it is deemed significant