From: Health technology assessment of biosimilars worldwide: a scoping review
Charting dimensions | Aspects |
---|---|
General information | |
General information about HTA organisations and their HTA report | Name and abbreviation of HTA organisation Country of origin of HTA organisation Year of publication Type of biosimilars (substance active, brand name, product name) Biologic reference (brand name) Identification of anatomical and therapeutic group of biosimilars ATC Code (therapeutic drug groups) and ATCa 1st level - anatomical main group) |
Methodological characteristics of biosimilar HTA report | |
Criterium 1 | Described the characteristics and current use of the technology (Yes/No) 1. Yes, very detailed (detailed description, including drug use (indications, pharmaceutical form, and dosage), what is biosimilar and their originator), regulatory status and other information 2. Yes, but not detailed (brief description, no information provided about biosimilar or drug use, or another relevant biosimilars’ information) 3. Not described |
Criterium 2 | Evaluated safety and effectiveness issues (Yes/No) 1. Assessment of efficacy/effectiveness and safety 2. Assessment of efficacy/effectiveness only 3. Assessment of safety only 4. Assessment of efficacy/effectiveness and safety but evidence was not found 5. Neither safety nor effectiveness are evaluated |
Criterium 3 | Did they conduct an economic analysis? 1. Yes, a cost-minimisation analysis 2. Yes, a cost-utility analysis 3. Yes, a cost-effectiveness analysis 4. Yes, a cost-benefit analysis 5. Not clear 6. No, they did not |
Criterium 4 | Provided information on costs/financial impact 1. They provided information on costs and a BIA 2. They provided information on costs, but they did not provide a BIA 3. No information provided on costs or BIA |
Criterium 5 | Discussed organisational considerations 1. Yes 2. No |
Criterium 6 | Conducted a comprehensive systematic literature review or a systematic review of high-level evidence 1. Yes, a systematic review of high-level evidence was conducted 2. Yes, a comprehensive systematic literature review was conducted 3. No, there is no evidence that a systematic review was conducted |
Criterium 7 | Critically appraiseed the quality of the evidence base 1. Yes, adequately (they assessed the risk of bias of primary studies and/or the overall quality of evidence with appropriate tools/approach) 2. Yes, partially (they critically appraised the risk of bias of primary studies and/or the overall quality of evidence, but they did not report the use of any tools/approach) 3. Neither appraised the risk of bias of primary studies or the overall quality of evidence 4. No (evidence not found) |
Criterium 8 | Addressed ethical, social and legal considerations 1. Yes 2. No |
Particularities of HTA reports of biosimilars | |
Item 1 | Immunogenicity was considered 1. Yes 2. No |
Item 2 | Risk of switching or interchangeability was considered? 1. Yes 2. No |
Item 3 | Extrapolation was considered? 1. Yes 2. No |
Item 4 | Do they mention any educational approach about biosimilars to patients, clinicians or pharmacists? 1. Yes 2. No |
Item 5 | Statement in favour or against adoption or reimbursement of biosimilar or no statement 1. Statement in favour of adoption/reimbursement of biosimilar 2. Statement against adoption/reimbursement of biosimilar 3. No statement in favour or against biosimilars |