National Centre for Pharmacoeconomics

National Centre for
Pharmacoeconomics

NCPE Ireland

Selexipag (Uptravi®)

Selexipag (Uptravi®) is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.

 

NCPE Assessment Process Complete
Rapid review received 01/11/2016
Rapid review completed 05/12/2016
Rapid Review outcome Full pharmacoeconomic assessment recommended
Full pharmacoeconomic assessment commissioned by HSE 14/12/2016
Pre-submission consultation with Applicant 13/02/2017
Submission received from Applicant 13/10/2017
Preliminary review sent to Applicant 23/01/2018
NCPE assessment re-commenced 26/02/2018
Factual accuracy sent to applicant 19/04/2018
NCPE assessment re-commenced 30/04/2018
NCPE assessment completed
21/05/2018
Full pharmacoeconomic assessment outcome The NCPE recommends that selexipag not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments. This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.

 

NCPE summary selexipag

Sensitivity analysis

A means of exploring the robustness of a mathematical model or analysis to determine how and whether changes in uncertain model inputs affect main results and conclusions of analysis.

St Johns Wort (Pacifa®)

Pacifa® is indicated for the short term treatment of mild depressive symptoms.

Rapid Review

Commenced Completed Outcome
14/04/2015 29/05/2015 Full Pharmacoeconomic Evaluation Recommended

Statistical significance

A conclusion that an intervention has a true effect, based upon observed differences in outcomes between the treatment and control groups that are sufficiently large so that these differences are unlikely to have occurred due to chance, as determined by a statistical test. Statistical significance indicates the probability that the observed difference was due to chance if the null hypothesis is true; it does not provide information about the magnitude of a treatment effect.

Systematic review

A form of structure literature review that addresses a question that is formulated to be answered by analysis of evidence, and involves objective means of searching the literature, applying predetermined inclusion and exclusion criteria to this literature, critically appraising the relevant literature, and extraction and synthesis of data from evidence base to formulate findings.