Timely, consistent, transparent assessment of market access evidence: implementing tools based on the HTA Core Model® in a pharmaceutical company.

Objectives: Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model® provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement ("access evidence").

IS THE EUNETHTA HTA CORE MODEL® FIT FOR PURPOSE? EVALUATION FROM AN INDUSTRY PERSPECTIVE.

Objectives: The HTA Core Model® was developed to improve the transferability of health technology assessment (HTA) between settings. The model has been used by HTA agencies but is also of interest to manufacturers, for improving internal evidence generation and communicating with other HTA stakeholders. To establish if the model is fit for purpose from an industry perspective, the pharmaceutical company Roche, collaborating with the European Network for HTA (EUnetHTA), conducted an assessment of the model.

Leveraging EUnetHTA's conceptual framework to compare HTA decision drivers in France, Italy, and Germany from a manufacturer's point of view.

Background: Health Technology Assessments (HTA) procedures differ substantially across the various European countries. We reviewed recent appraisals of a pharmaceutical manufacturer in three major European markets (France; Italy; Germany) and identified and categorized related decision drivers.

Methods: New marketing authorisation between January 2011 and August 2017, and Roche being the Marketing Authorization Holder, were included.

Cost effectiveness of oseltamivir treatment for patients with influenza-like illness who are at increased risk for serious complications of influenza: illustration for the Netherlands.

Background: Oseltamivir is effective in the treatment of influenza. Utilisation in The Netherlands is limited, but increasing.

Objective: To estimate the cost effectiveness of oseltamivir treatment (vs symptom relief only) for patients with influenza-like illness (ILI) who are at increased risk for serious complications of influenza.

Effect of influenza treatment with oseltamivir on health outcome and costs in otherwise healthy children.

Objective: To evaluate the effect of treating children with influenza with oseltamivir on health outcomes and costs to healthcare payers.

Patients And Design: Health outcome data from the oseltamivir paediatric clinical development programme plus data from the literature were used in an economic model developed to predict morbidity and mortality due to influenza and its specified complications. Published data on the cost of care in the UK were used to compare oseltamivir with usual care in children aged 1-12 and 1-5 years by estimating cost-effectiveness and cost-utility ratios.

Impact of influenza treatment with oseltamivir on health, sleep and daily activities of otherwise healthy adults and adolescents.

Objective: To determine the effect of oseltamivir (75mg twice daily) on time to return to baseline health, sleep and activity in patients with laboratory-confirmed influenza infection.

Patients And Methods: Data from 1642 otherwise healthy adults (aged 13-64 years), who had experienced a febrile influenza-like illness (>38 degrees C) of up to 36 hours' duration together with at least one respiratory and one systemic/constitutional symptom, were pooled from four randomised, double-blind, placebo-controlled clinical trials. Patients in these trials had been randomised to receive either oseltamivir or placebo for 5 days and had been allowed unlimited use of symptom-relief medications.

Post-exposure influenza prophylaxis with oseltamivir: cost effectiveness and cost utility in families in the UK.

Objectives: To assess the cost effectiveness and cost utility of preventing post-exposure influenza infection using the neuraminidase inhibitor oseltamivir from a healthcare payer's perspective in the UK.

Methods: A simulation model was developed, based on clinical trial results and published data, to predict morbidity and mortality due to influenza and to compare oseltamivir post-exposure prophylaxis (PEP) with no prophylaxis within families with members aged >or=13 years. Two scenarios were tested:1.

Influenza treatment with neuraminidase inhibitors: cost-effectiveness and cost-utility in healthy adults in the United Kingdom.

We assessed the cost-effectiveness and cost-utility of treating influenza with neuraminidase inhibitors (oseltamivir and zanamivir) from a health care payer's and societal perspective in the United Kingdom. A simulation model was developed to predict morbidity and mortality due to influenza and its specified complications, comparing neuraminidase inhibitors with usual care in an otherwise healthy adult population. Robustness of the results was tested by one-way and multiway as well as probabilistic sensitivity analyses.

Pharmacoeconomic assessment of oseltamivir in treating influenza--the case of otherwise healthy Danish adolescents and adults.

Objective: To assess the pharmacoeconomics of treating influenza with oseltamivir in healthy Danish adolescents and adults.

Method: Cost-effectiveness and cost-utility analyses were used to compare oseltamivir to usual care (symptomatic treatment with over the counter (OTC) medicine), considering both the societal and health care payer's perspectives. The population group studied was otherwise healthy adolescents and adults, aged 13 to 64.