Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose.

From 2025, Health Technology Developers (HTDs) have to submit EU HTA dossiers. The joint clinical assessment (JCA) aims to streamline HTA processes and access to medicinal products across Europe. Currently, German HTA bodies IQWiG and G-BA actively shape the JCA methodology.

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective.

Objective: The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by systematically comparing EU JCA and German clinical assessments (CA) based on established assessment elements for HTA and assessing the potential impact of differences on Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) ability to derive the therapeutic added value.

Methods: Identification of all pharmaceuticals undergoing both, EU JCA and German CA between January 2016-June 2020. Qualitative review and data extraction from the assessments, assessment of methodological differences using a hierarchical model.

[Subgroups in the early benefit assessment of pharmaceuticals: a methodical review].

Benefit assessments according to Sect. 35a of the Social Code Book V are frequently divided into subsets of populations. This division of therapeutic indications is evident in almost every other of the completed appraisals by the Federal Joint Committee (G-BA).

[Learning curve in laser treatment of benign prostatic syndrome: a systematic review].

The aim of the present systematic review was to evaluate the evidence of a potential learning curve for laser treatment of benign prostatic hyperplasia. A systematic literature search was conducted in November 2011 using The Cochrane Library, EMBASE and MEDLINE. Overall, 18 sources (mostly case series) were included for further assessment.

[GRADE guidelines: 8. Rating the quality of evidence - indirectness].

Direct evidence comes from research that directly compares the interventions in which we are interested when applied to the populations in which we are interested and measures outcomes important to patients. Evidence can be indirect in one of four ways. First, patients may differ from those of interest (the term applicability is often used for this form of indirectness).

Determinants of willingness to pay for a new therapy in a sample of menopausal-aged women.

Menopause is a natural physiological event that usually begins in women between the ages of 48 and 55 years. In many cases, this event is associated with unpleasant somatic-vegetative, urogenital or psychological symptoms. To test the health and social demographic factors (especially household income level) that influence willingness to pay (WTP) for a new hormone-free treatment in women of menopausal age.

Cataract surgery and the development or progression of age-related macular degeneration: a systematic review.

Age-related macular degeneration and cataract are the most frequent eye disorders of elderly people worldwide. The aim of this systematic review was to evaluate the effect of cataract surgery on the development and progression of age-related macular degeneration. Data were collected by means of a systematic literature search in 28 databases and an additional update in Pubmed.

Effectiveness and cost-effectiveness of behavioural strategies in the prevention of cigarette smoking.

Background: The hazardous health effects of smoking and second hand smoke have been confirmed in numerous studies. For Germany, the mortality attributable to smoking is estimated at 110,000 to 140,000 deaths per year, associated with annual smoking-related costs of 17 to 21 billion euro. Because the majority of smokers initiate this habit early in life, behavioural preventive strategies usually tried to prevent the uptake of smoking among children and youths.

What effects has the cataract surgery on the development and progression of Age-Related Macular Degeneration (AMD)?

Background: The cataract (Cataracta senilis) is the most frequent eye disease of elderly people worldwide. In Germany, the cataract operation - with currently 450,000 interventions each year the most frequent operation in ophthalmology - can be seen as routine surgery. The age related macular degeneration (AMD) is a further one of the most common, age-related eye diseases and the most frequent cause of blindness of elderly people in industrial nations.