scholarly journals Special Considerations and Patient Access Schemes for Oncology by Health Technology Assessment (HTA) Bodies: Systematic Evaluation in 25 Countries

2016 ◽  
Vol 19 (7) ◽  
pp. A761
Author(s):  
M Mwamburi ◽  
M Nanavaty ◽  
S Gala ◽  
A Nyandege ◽  
V Ramesh
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Systematic Evaluation ◽  
Patient Access

scholarly journals Digi-HTA: Health technology assessment framework for digital healthcare services

2019 ◽  
Vol 11 (4) ◽  
Author(s):  
Jari Haverinen ◽  
Niina Keränen ◽  
Petra Falkenbach ◽  
Anna Maijala ◽  
Timo Kolehmainen ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
State Of The Art ◽  
Health Technology ◽  
Healthcare Services ◽  
The State ◽  
Systematic Evaluation ◽  
Health Technologies ◽  
Digital Healthcare ◽  
And Robotics

Health technology assessment (HTA) refers to the systematic evaluation of the properties, effects, and/or impacts of health technology. The main purpose of the assessment is to inform decisionmakers in order to better support the introduction of new health technologies. New digital healthcare solutions like mHealth, artificial intelligence (AI), and robotics have brought with them a great potential to further develop healthcare services, but their introduction should follow the same criteria as that of other healthcare methods. They must provide evidence-based benefits and be safe to use, and their impacts on patients and organizations need to be clarified. The first objective of this study was to describe the state-of-the-art HTA methods for mHealth, AI, and robotics. The second objective of this study was to evaluate the domains needed in the assessment. The final aim was to develop an HTA framework for digital healthcare services to support the introduction of novel technologies into Finnish healthcare. In this study, the state-of-the-art HTA methods were evaluated using a literature review and interviews. It was noted that some good practices already existed, but the overall picture showed that further development is still needed, especially in the AI and robotics fields. With the cooperation of professionals, key aspects and domains that should be taken into account to make fast but comprehensive assessments were identified. Based on this information, we created a new framework which supports the HTA process for digital healthcare services. The framework was named Digi-HTA.

PP452 Impact Of Patient Access Schemes On Health Technology Assessment Agency Guidance For Rare Diseases In England and Scotland

2021 ◽  
Vol 37 (S1) ◽  
pp. 38-38
Author(s):  
Karen Mark ◽  
Prachi Manchanda ◽  
Judith Rubinstein ◽  
Riza Veronica Inumerable
Keyword(s):  
Cost Effectiveness ◽  
Health Technology Assessment ◽  
Incremental Cost ◽  
Rare Diseases ◽  
Technology Assessment ◽  
Health Technology ◽  
Incremental Cost Effectiveness Ratio ◽  
Base Case ◽  
Patient Access ◽  
Cost Effectiveness Ratio

IntroductionPatient access schemes (PAS) are agreements that may enable patients to access drugs or other treatments that may not be cost effective under normal circumstances. The aim of this study was to determine whether the use of PAS by the National Institute for Health and Care Excellence (NICE) and Scottish Medicines Consortium (SMC) for recommended drugs can lead to greater access to medications for rare diseases.MethodsReimbursement data for rare diseases between 2004 and 2021 from health technology assessment (HTA) agencies, namely the SMC (Scotland) and NICE (England), were included. The reviews with positive HTA decisions were considered, while those with negative decisions were excluded. Several observations were made from these data and reported.ResultsAmong the total positive reviews (n = 81), 43 included PAS. The inclusion of PAS in manufacturer submissions was more frequent for NICE than for the SMC (79% and 40% percent, respectively). Most of the drugs with PAS were included in the HTA guidance from both agencies. The positive NICE reviews contingent on PAS consisted of 20 drugs. For the same set of drugs, the SMC recommended 14 with PAS and one without PAS; five drugs were not assessed. Adalimumab was recommended by NICE with a PAS (base-case incremental cost-effectiveness ratio of GBP12,336 [EUR14,256]; GBP13,676 [EUR15,804]) and by the SMC without a PAS (base-case incremental cost-effectiveness ratio of GBP22,519 [EUR26,023]). Hence, without a PAS, the drug was costlier per quality-adjusted life-year for the National Health Service (NHS) Scotland.ConclusionsPAS submissions for rare diseases are more frequent for NICE than for the SMC. With the PAS discounts, the overall cost of the drugs is reduced, resulting in cost effectiveness. The SMC approved some drugs for which NICE required a PAS to improve the economic argument. Hence, the use of PAS for these drugs could lead to potential cost-savings to the NHS Scotland.

OP305 A Systematic Approach To Include Ethical Aspects In Health Technology Assessments – Experiences And Evaluation

2021 ◽  
Vol 37 (S1) ◽  
pp. 11-11
Author(s):  
Karin Willbe Ramsay
Keyword(s):  
Health Technology Assessment ◽  
Social Services ◽  
Technology Assessment ◽  
Systematic Approach ◽  
Health Technology ◽  
Time Frame ◽  
Ethical Framework ◽  
Systematic Evaluation ◽  
Ethical Aspects ◽  
Ethical Content

IntroductionThe Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) is commissioned to assess ethical aspects in their health technology assessment (HTA) reports, in addition to effects and health economic aspects of the examined interventions. For this purpose, a framework for systematic evaluation of ethical aspects of healthcare technologies has been developed and used at SBU since 2014. With seven years of practice, we decided it was time to evaluate experiences from using the ethical framework and consider possible adjustments to improve future use.MethodsSBU reports in the time period 2014–2020 were systematically screened for ethical content. Focus group meetings with users of the framework (mainly HTA project managers) were held where opinions regarding usability and possible obstacles were collected. A revised version of the document was sent for consultation to relevant stakeholders (possible users, reviewers and recipients) in order to collect additional views.ResultsOf fifty-eight HTA reports produced in the time frame, ethical aspects were evaluated in fifty-five reports (ninety-five percent), and in most cases, the framework had been used as support. In twenty-one cases (thirty-six percent), a professional ethicist had been engaged in the work. In twelve cases (twenty-one percent), ethical aspects were presented in the main conclusions of the report. Opinions from users and reviewers revealed that the framework was generally regarded as a helpful tool, but problems regarding interpretation of specific questions were highlighted and subjected to revision.ConclusionsThe ethical framework is a valuable tool for systematic and transparent identification and discussion of ethical aspects in the HTA context, and it has been well implemented at SBU. A systematic approach to assess ethical aspects can facilitate the communication and dissemination of ethical aspects as principal results from the HTA project.

HEALTH TECHNOLOGY ASSESSMENT OF THREE SCREENING METHODS IN SWITZERLAND

2001 ◽  
Vol 17 (3) ◽  
pp. 389-399 ◽  
Author(s):  
Karin Faisst ◽  
Julian Schilling ◽  
Pedro Koch
Keyword(s):  
Health Insurance ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Mammography Screening ◽  
Specific Antigen ◽  
Normal Pregnancy ◽  
Health Technology ◽  
Systematic Evaluation ◽  
Screening Methods ◽  
Swiss Health

Objective: To describe the level of health technology assessments for three screening methods in Switzerland.Methods: Analysis of documents and expert opinions on mammography screening, ultrasound examinations during normal pregnancy, and screening for prostate-specific antigen (PSA) with a focus on services provided, recommendations, formal regulations, national papers, projects, and formal assessments.Results: Preventive services are explicitly recommended by the Swiss federal law on health insurance. Two routine ultrasound examinations during normal pregnancy as well as PSA analysis for men over 40 years of age on medical indication are covered by basic health insurance. Mammography screening every 2 years has been covered since 1997 for women over 50 years. A systematic screening program for mammography exists in the western part of Switzerland, and a nationwide program is planned. However, a national program may not come into being until a quality assurance program for evaluation is established, and a nationwide fee for reimbursement—to include all costs of such a program—is accepted by providers and insurers.Conclusion: According to the Swiss health insurance law, the effectiveness of mammography screening and ultrasound examinations during normal pregnancy have to be proven. Systematic evaluation of these screening methods is in preparation. PSA is not part of current evaluation. It can be concluded that health technology assessment in Switzerland is now required by law for several medical services. However, limited financial and personnel resources as well as the lack of disease registers may hamper progress in the near future.

PP142 Health Technology Assessment – A Major Bottleneck In Patient Access?

2019 ◽  
Vol 35 (S1) ◽  
pp. 65-65
Author(s):  
George Wang ◽  
Richard Macaulay
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Patient Access ◽  
Gemeinsamer Bundesausschuss ◽  
Significant Delay ◽  
Positive Health ◽  
Cooperative Approach ◽  
Median Delay ◽  
Major Bottleneck

IntroductionConditional marketing authorization (CMA) and accelerated assessment (AA) have been introduced to expedite the development of and access to therapies in Europe. However, to reach patients medicines must also be publicly reimbursed. This research evaluated the reimbursement of therapies which have received European CMA or underwent AA.MethodsMedicines that received CMA or underwent AA between January 2012 and December 2017 were identified. Appraisals of these medicines conducted by major European payer bodies were obtained from relevant websites and key data were extracted.ResultsOut of the 38 medicines that received a CMA, 83 percent (19/23) were assessed by the National Institute for Health and Care Excellence (NICE) and received positive decisions, compared with 57 percent (16/26) by the Scottish Medicines Consortium (SMC) (defined as recommended/restricted), 74 percent (14/19) by Gemeinsamer Bundesausschuss (G-BA) (defined as any level of additional benefit), and 29 percent by Haute Autorité de Santé (HAS) (amélioration du service médical rendu I-III). The median delay between CMA approval and positive health technology assessment (HTA) outcome was 13 months for NICE, 11 months for SMC, 7 months for G-BA, and 5 months for HAS. Thirty-two medicines underwent AA. Of these, 68 percent (17/25) were appraised by G-BA and received positive outcomes, compared with 29 percent (7/24) by HAS, 90 percent (19/21) by SMC, and 86 percent (18/21) by NICE. The median delay between AA approval and positive HTA outcome was 7.4 months for G-BA, 7.9 months for HAS, 11.7 months for SMC, and 11.8 months for NICE.ConclusionsCMA has expedited regulatory approval for products that address severe unmet needs. However, many of these products fail to gain public reimbursement, and even when they do there is a significant delay. AA provides market authorizations two months earlier than standard centralized assessment. Although high rates of positive payer outcomes have been achieved, the products typically experience substantial additional delays in securing public reimbursement. A parallel, cooperative approach among regulatory and HTA bodies across Europe is required to truly expedite patient access.

scholarly journals Health Technology Assessment of the Medical Devices: A Case Study from the Czech Republic

2021 ◽  
Vol 14 (2) ◽  
pp. 253-272
Author(s):  
Jana Rozmarinová ◽  
Barbora Říhová
Keyword(s):  
Czech Republic ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Systematic Evaluation ◽  
The Czech Republic ◽  
Slowing Down

Abstract Health technology assessment (HTA) has become the systematic evaluation of health technology’s properties and effects that inform decision-makers. The implementation and expansion of HTA can contribute to slowing down burgeoning healthcare costs. In the Czech Republic, elements of HTA are quite standardly used in pharmacoeconomics, but questions arise on the use of HTA of medical devices. The theoretical framework developed is followed by a case study of the Czech Republic to assess whether the use of HTA of medical devices in the Czech Republic is implemented. This study uses publicly available resources, mainly public health acts and public notices related to HTA. We examined the institutionalisation of HTA for medical devices (HTA applied only at a selected area of medical devices) in the Czech Republic and compared Czech’s HTA principles of medical devices to the HTA Core Model. It was found that the HTA process used for medical devices is very limited in the Czech Republic. Our data show that HTA was officially established, but in reality, the medical devices have not been assessed following HTA principles.

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