Scoping reports

The scoping report defines the research question in concrete terms and develops the methodology for the assessment.

The scoping reports that have been completed are shown below.

Procedure

The FOPH prepares a pre-scope in the form of an initial analysis and a precise definition of the questions asked in relation to the selected theme. On this basis the contractor drafts the actual scoping report. This is submitted to a group of reviewers consisting offour to five independent experts who assess the scientific quality of the report. The report is then submitted to stakeholders and finalised.

Infliximab reference product versus biosimilar for the treatment of rheumatoid arthritis

Infliximab is a monoclonal antibody for the treatment of autoimmune diseases, such as rheumatoid arthritis. In 2016, infliximab was the costliest active substance in Switzerland, generating direct drug costs of over CHF 128 million. For biologics such as infliximab, biosimilars are available, which are sufficiently similar to an approved biological medicinal product (reference product) and are available for a cheaper price. The aim of the HTA is to review the efficacy, safety, cost-effectiveness and budgetary implications of

  1. treating a patient suffering from rheumatoid arthritis with an infliximab biosimilar instead of the infliximab reference product;
  2. switching a patient suffering from rheumatoid arthritis from treatment with the infliximab reference product to treatment with an infliximab biosimilar (or vice versa).

Vitamin D Testing

The Health Technology Assessment (HTA) intends to review the efficacy, safety, cost-effectiveness and budgetary impact of the use of vitamin D testing in risk groups as defined by the Swiss Federal Nutrition Commission (people with bone disease, older adults, obese individuals, pregnant women, people with dark skin and athletes). It will also analyse evidence regarding the clinical effects of vitamin D supplementation in these risk groups.
The feasibility of a full HTA has been determined on the basis of the scoping report. A full HTA is not justified at this stage, as no clinical studies are available that would enable evaluation of vitamin D tests. This issue could be revisited once such studies are available.

Medical cannabis for treating various symptoms in Switzerland

Health Technology Assessment (HTA) is designed to assess the efficacy, safety, cost-effectiveness and budgetary impact of therapy with cannabis as compared with placebo, no therapy or standard of care in patients with various symptoms (pain, spasticity, vomiting and nausea in cancer patients, unintended weight loss).
This scoping report will be used to determine the feasibility of a full HTA.

Palbociclib (Ibrance®) as a treatment for advanced breast cancer

CDK4/6 inhibitors, such as palbociclib, ribociclib and abemaciclib, are a new class of drugs that are used in combination with endocrine therapy to treat advanced hormone receptor-positive, HER2 receptor-negative breast cancer. Results from clinical trials suggest that some of these new compounds may cause severe side effects. There is also evidence that not all CDK4/6 inhibitors contribute equally to prolonging the survival of burst cancer patients and improving their quality of life. The aim of the health technology assessment (HTA) is therefore to evaluate the efficacy, safety, cost-effectiveness and budgetary impact of treatment with CDK4/6 inhibitors in comparison with each other and with standard therapy.

Surgical intervention in shoulder impingement syndrome

The FOPH is re-evaluating subacromial decompression due to recently published evidence that suggests the procedure has limited efficacy. This scoping report aims to identify literature pertaining to the safety, efficacy, effectiveness, cost-effectiveness and budgetary impact of subacromial decompression in patients with subacromial pain, to establish the feasibility of conducting a health technology assessment of subacromial decompression.

The treatment of primary hypercholesterolaemia and mixed/combined hyperlipidaemia with ezetimibe-containing medicines

The aim of the Health Technology Assessment (HTA) is to evaluate the efficacy, safety, cost-effectiveness and budgetary impact of ezetimibe-containing medicines compared to statins or fenofibrate in patients with primary hypercholesterolaemia or mixed/combined hyperlipidaemia.
The feasibility of an HTA is determined by means of a scoping report.

Statins in the primary prevention of cardiovascular events and mortality in Switzerland

The aim of the scoping report is to determine the feasibility of a Health Technology Assessment (HTA) report on statins in the primary prevention of cardiovascular events and mortality in Switzerland. This is in response to the identified quantity and quality of the primary literature.
The HTA report will review the efficacy, safety, cost efficiency and budgetary impact of statin treatment in adults with no proven cardiovascular disease and with a low, moderate or high cardiovascular risk compared with no treatment and/or a change in lifestyle. Its basis for doing so will be the scoping report.

Vertebroplasty or Kyphoplasty in Patients with Symptomatic, Osteoporotic Vertebral Compression Fractures

The objective of this HTA is the evaluation of the efficacy/effectiveness, safety, costs, effectiveness and budget impact of percutaneous vertebroplasty and percutaneous balloon kyphoplasty in patients with symptomatic osteoporotic vertebral compression fractures unresponsive to non-surgical treatment.

Olmesartan Mono- and Combination Therapies in Patients with Essential Hypertension

The aim of the Health Technology Assessment (HTA) is to evaluate the efficacy, effectiveness, safety, cost-effectiveness and budget impact of olmesartan mono- and combination therapies compared to all other sartan mono- and combination therapies available in Switzerland in patients with essential hypertension.

Treatment of non-erosive gastroesophageal reflux disease patients with proton pump inhibitors

The aim of the Health Technology Assessment (HTA) is to evaluate the efficacy, effectiveness, safety, cost-effectiveness and budget impact of long-term continuous proton pump inhibitor (PPI) therapy compared to long-term on-demand PPI therapy in patients with non-erosive reflux disease (NERD) and patients with uninvestigated gastroesophageal reflux disease (GERD).  

Chondroitin Sulfate in Osteoarthritis

The objective of the HTA is to compare the safety, efficacy and effectiveness of chondroitin sulfate with placebo, on-demand analgesics and anti-inflammatory treatments in patients with osteoarthritis of the hands, knees and hips. In addition, the cost-effectiveness and budgetary impact of chondroitin sulfate warrants investigation.

Removal of osteosynthesis devices (e.g. screws, plates, nails and wires) used to treat bone fractures

Research questions: How does the removal of osteosynthesis material in patients without medical indication (elective or routine removal) affect complication rates, clinical outcomes, health-related quality of life and cost-effectiveness outcomes compared to retention of the osteosynthesis material?

Self-measurement of blood glucose in patients with non-insulin treated diabetes mellitus type 2

Research questions:

  • How does a decrease in HbA1c levels affect clinical endpoints?
  • What is the safety profile of self-measurement of blood glucose?
  • What is the cost-effectiveness of the different possible variations in self-measurement of blood glucose?

Knee arthroscopy for the treatment of degenerative changes

Research question: What is the benefit of knee arthroscopy for patients with symptoms resulting from degenerative changes of the knee in general compared with non-invasive forms of therapy?

Iron replacement therapy for iron deficiency without anaemia

Issue:

  1. The connection between iron deficiency without anaemia and non-haematological clinical disorders
  2. Therapeutic need for and efficacy of iron replacement therapy for iron deficiency without anaemia

Last modification 02.10.2020

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Federal Office of Public Health FOPH
Division of Health Care Services
Health Technology Assessment Section
Schwarzenburgstrasse 157
3003 Berne
Switzerland
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