The Institute for Quality and Efficiency in Health Care (IQWiG) has released its revised General Methods version 8.0, which aims to improve transparency and scientific recognition in its assessment methods. The new version includes a separate chapter on involving people affected by diseases or interventions in the assessment process.
The European benefit assessment has reached an important milestone with the completion of its first joint clinical assessment, in which IQWiG was directly involved as co-assessor. The subject of this assessment was tovorafenib for treating paediatric low-grade glioma.
A comparative study examines the effectiveness of guselkumab versus golimumab in treating moderately to severely active ulcerative colitis. The results indicate that guselkumab may improve morbidity and health-related quality of life, but there is no clinically relevant benefit compared to standard treatment.
Hereditary angioedema patients may see reduced attacks with garadacimab, a monoclonal antibody approved for routine prevention. This study's indirect comparison suggests a potential added benefit over berotralstat, a standard treatment option.
Chronic wounds heal slowly due to healing disorders, affecting 800,000 people in Germany. Current treatment options lack evidence-based recommendations and patient-reported outcomes are underconsidered.
Shorter-duration antibiotic therapy shows comparable success to longer-duration treatment in children with community-acquired pneumonia. However, more studies are needed for other age groups and diseases like acute otitis media.
Cardiac MRI offers comparable diagnostic accuracy to SPECT for coronary heart disease (CHD), but without exposing patients to radiation. This expansion of diagnostic options allows for more differentiated and less invasive testing.
A workshop by the Cancer Medicines Forum identified gaps in knowledge about optimal cancer drug use, including dosage, duration, and treatment sequence. The forum recommends studies to generate evidence for cancer treatment decisions during drug development and after marketing authorization.
Patients with Stage I and II hidradenitis suppurativa experience substantial improvement in skin damage when treated with a combination of topical antibiotic therapy and skin irradiation. Temporary side effects are present but not serious.
The Institute for Quality and Efficiency in Health Care (IQWiG) has developed a method to assess the relationship between healthcare intervention volume and treatment quality in rare diseases. By transferring evidence from similar procedures or populations, IQWiG aims to inform minimum volume regulations for these services.
The German Institute for Quality and Efficiency in Health Care (IQWiG) has begun joint European health technology assessments of oncology drugs, including tovorafenib. These assessments aim to inform healthcare decisions by providing a scientific evaluation of available evidence.
Digital apps based on cognitive behavioural therapy may provide positive short-term effects for people with GAD, including reduced symptoms and improved quality of life. However, the long-term benefits and potential risks of app use are still unknown.
The study found that both cataract surgery methods are safe and effective, with similar outcomes in terms of vision correction and quality of life. No significant advantages were discovered for laser-assisted surgery over traditional methods.
Biomarker-based tests may lead to premenopausal patients foreging chemotherapy that could prevent recurrence. Women under 50 or premenopausal should not decide against adjuvant chemotherapy based on MammaPrint or Oncotype DX tests.
The Institute for Quality and Efficiency in Health Care found that linzagolix has no suitable comparative data with existing standard treatments like dienogest and GnRH analogues. Comparative studies are crucial to assess the added benefit of new drugs, but placebo comparisons are often unsuitable.
The IQWiG event explores assessment criteria and potential applications of registry data in regulatory research. Experts share experiences working with observational data to discuss its trustworthiness and credibility.
Enfortumab vedotin plus pembrolizumab shows significant survival advantage over previous treatment options, particularly for those ineligible for cisplatin-based therapy. This combination is the first to receive a major added benefit label in this therapeutic indication.
The European HTA agencies and EMA have developed joint positions to address methodological challenges in assessing new drugs. Key findings include the need for randomized controlled trials and flexible study designs that can reduce sample size requirements and development timeframes.
The Institute for Quality and Efficiency in Health Care confirms that nicotine and varenicline are effective treatments for severe tobacco addiction. The meta-analysis found positive treatment effects independent of the severity of tobacco addiction.
A German institute examined the benefits of faricimab in treating visual impairment caused by macular oedema. The study found no evidence of an added benefit for faricimab compared to other treatments, as the manufacturer did not provide suitable data on individualized dosing regimens.
Gozetotide offers an added benefit for patients with metastatic, castration-resistant prostate cancer who receive abiraterone or enzalutamide treatment. The study shows improved overall survival and reduced need for radiotherapy. However, side effects such as myelosuppression are also present.
The EUnetHTA 21 project has developed guidelines and templates for joint HTA work at the EU level, tested in pilot assessments, and aims to improve HTA quality and reduce patient access inequalities. The results of the project will inform the implementation of the European HTA Regulation from 2025 onwards.
Time-to-event (TTE) analyses in systematic reviews provide crucial insights but are often inadequately documented. A study of 100 reviews found inconsistencies and inadequate reporting standards. The authors suggest using methodological guidelines to improve the quality of TTE analyses.
Studies show that varenicline and nicotine are more effective in smoking cessation than no therapy, with significant improvements in six-month abstinence rates. In contrast, the benefits of bupropion and cytisine for severe tobacco dependence remain uncertain due to lack of subgroup data.
Familial hypercholesterolaemia can lead to early heart attacks and strokes. Targeted cascade screening is recommended instead of universal screening for all children and adolescents.
The German Institute for Quality and Efficiency in Health Care found that vadadustat did not provide an added benefit for patients with symptomatic anaemia. Informative outcomes on symptoms and quality of life were not recorded, leaving it unknown how lower haemoglobin levels affect patient wellbeing.
A roundtable consensus emphasizes the importance of collecting long-term patient-reported outcome data in oncology trials to assess treatment effects and disease progression. Stakeholders agree that this information is vital for regulators, payers, physicians, and patients making decisions after treatment discontinuation.
A new study published in the BMJ confirms a trend where supplemental indications for new drugs decline in their likelihood of added value. By the third indication, the probability drops by 45% compared to the first approval.
IQWiG developed two new study filters to reduce hits when searching for non-randomized studies (NRS) in PubMed and Medline. The filters improve the sensitivity and specificity of NRS searches, yielding a high rate of relevant results.
A working group of medical organizations analyzed 29 pivotal phase III trials for disease-modifying drugs in MS, finding that patient symptoms and quality of life were often not considered. They suggest improving studies by focusing on patient-reported outcomes and long-term treatment effects.
A study analyzing 216 early benefit assessments in Germany found that half of new drugs lack proven added benefits. The researchers call for mandatory comparisons between new and standard treatments to improve patient care.
A recent study published in BMJ reveals that European Union clinical trial registrations are incomplete, with universities struggling to meet regulatory requirements. Pharmaceutical companies, however, show relatively good compliance with EU regulations.
A group of authors from IQWiG has contradicted the American Society of Clinical Oncology's conclusion that MammaPrint can identify patients who do not require chemotherapy. The IQWiG analysis found a statistically significant disadvantage of the test for disease-free survival in certain patient groups.
The Autumn Symposium 2015 presented diverse perspectives on the use of real-world data in benefit assessments, highlighting its limitations and potential drawbacks. The consensus among speakers was that non-RCT data is not equivalent to 'real world data' and should not be used as a substitute for rigorous clinical trials.
Researchers found that company dossiers and dossier assessments contain significantly more information than conventional documents on clinical studies, especially regarding patient-relevant outcomes. This suggests that early benefit assessment may be a model for increased transparency in other areas.
IQWiG identified various aspects that could be supplemented and specified, including recommendations on blood glucose levels and treatment of macula oedema. The report's findings suggest no compelling need for revision of the current DMP.
A study published in Trials highlights the widespread issue of publication bias, where favourable results are selectively published, leading to delays in implementing effective treatments. This can result in patients being prescribed futile or harmful treatments, as was the case with a drug used to prevent irregular heartbeats.
A study published in Diabetologia suggests that insulin analogue glargine may increase the risk of cancer in diabetes patients. The analysis found a statistically significant association between glargine use and an increased risk of malignancies, with a dose-dependent relationship observed.
Recent studies suggest that specific immunotherapy can be an effective treatment for allergies, reducing symptoms and adverse reactions. The Institute also found that certain measures, such as quitting smoking and taking probiotics during pregnancy, may help prevent allergies in children.