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ObjectivesTo identify consensus on patient prioritisation for rectal hydrogel spacer use during radiation therapy for the treatment of prostate cancer in the UK.DesignDelphi study consisting of two rounds of online questionnaires, two virtual advisory board meetings and a final online questionnaire.SettingRadical radiation therapy for localised and locally advanced prostate cancer in the UK.ParticipantsSix leading clinical oncologists and one urologist from across the UK.InterventionsRectal hydrogel spacer.Primary and secondary outcome measuresNone reported.ResultsThe panel reached consensus on the importance of minimising toxicity for treatments with curative intent and that even low-grade toxicity-related adverse events can significantly impact quality of life. There was agreement that despite meeting rectal dose constraints, too many patients experience rectal toxicity and that rectal hydrogel spacers in eligible patients significantly reduces toxicity-related adverse events. However, as a consequence of funding limitations, patients need to be prioritised for spacer use. A higher benefit of spacers can be expected in patients on anticoagulation and in patients with diabetes or inflammatory bowel disease, but consensus could not be reached regarding patient groups expected to benefit less. While radiation therapy regimen is not a main factor determining prioritisation, higher benefit is expected in ultrahypofractionated regimens.ConclusionThere is a strong and general agreement that all patients with prostate cancer undergoing radical radiation therapy have the potential to benefit from hydrogel spacers. Currently, not all patients who could potentially benefit can access hydrogel spacers, and access is unequal. Implementation of the consensus recommendations would likely help prioritise and equalise access to rectal spacers for patients in the UK.

Next-generation sequencing (NGS) is recognised by a growing audience of medical professionals as a functional diagnostic tool in oncology. However, adoption in clinical routine proceeds haphazardly in Europe.A semi-structured interview survey was administered to 68 cancer care professionals in four EU countries between June-August and November-December 2021. Pre-screening questionnaires assessed sufficient NGS expertise, diverse geographical distribution, and professional roles.Our findings provide a better understanding of current clinical, regulatory, and reimbursement practices for NGS in four EU countries.Despite the impending European In-vitro Diagnostic Medical Devices Regulation (IVDR), tortuous national guidelines implementations and limping reimbursement policies are common traits across surveyed countries and produce disparity in access to advanced healthcare services amid regional distinctions.The evident information gap between involved parties and demand for consistent national guidelines could be filled by health economics analyses tailored to local specifics to provide factual leverage for a structured adoption of NGS testing.

IntroductionNext-generation sequencing (NGS) can be run in-house or outsourced to an independent laboratory. It has enabled wider use of deoxyribonucleic acid/ribonucleic acid (DNA + RNA) sequencing in clinical practice. Within oncology, NGS has paved the way for more effective treatment, including personalized medicine. There are, however, large variations in access and reimbursement across Europe. The aim is to understand the European NGS landscape and barriers to access.MethodsStructured telephone interviews covered topics on NGS perception, guidelines, use-cases, benefits, costs, and future expectations. Twelve experts per country (France, Germany, Italy, Spain): two payers, five oncologists, and five pathologists were interviewed between June and August 2021. Responses were translated into English for qualitative analysis.ResultsNGS was considered most useful when there were approved, targeted treatments. Although often noted that there was a lack of published evidence to support a beneficial link, respondents perceived that NGS has the potential to improve patient quality of life (QoL) and reduce resource use through avoiding suboptimal treatment. All of the payer respondents expected the role of NGS to increase, though it may be held back by lack of reimbursement. Respondents favored in-house NGS over outsourcing in terms of clinical benefit: “Advantages of in-house NGS are turnaround time, results and lean processes” … “you build the expertise in-house. If you have urgent samples, it’s easy to prioritize them”. Reasons for not having in-house NGS included “costs, lack of personnel. Basically, organizational and financial issues.” In-house NGS was perceived to be associated with high setup-costs (acquisition, setup, training), but lower running costs (per-test costs). There was a view that in-house solutions are mainly suitable in larger centers undertaking many tests.ConclusionsNGS can save costs and provide QoL benefit through enabling optimized, personalized therapy, but published evidence establishing the outcomes link is lacking. From the hospital perspective, investing in NGS requires understanding the cost of NGS over its entire lifecycle, likely entailing a health-technology assessment including health-economic analysis.

IntroductionIn 2020, the Swedish regions cemented a national managed-introduction project for medical devices, to ensure equal, cost-effective, and appropriate use. Health technology assessment (HTA) is an important component of the project. Swedish national health registers have world-class coverage and completeness but may lack information enabling adequate evaluation of medical devices. This study reviews the current situation and ongoing initiatives. Additionally, the potential for medical device health economics and outcomes research (HEOR) using Swedish registers is assessed.MethodsA review of Swedish national health registers was undertaken, focusing on available data, and contextualized for the purpose of HEOR for medical devices. Additionally, the review included an evaluation of the Swedish reimbursement authority's (The Dental and Pharmaceutical Benefits Agency, TLV) ongoing initiatives to improve the potential to follow-up the impact of the technologies they assess and develop value-based pricing schemes.ResultsFive registers were deemed the most relevant national health registers for device research. They include high-quality longitudinal data and are linkable on a per-patient basis. For devices, main limitations include limited data on specialized outpatient care, lags in updating certain registers, lack of laboratory data, and challenges in identifying the specific device used. Reports indicate that certain limitations are being addressed, including pilot-studies investigating the opportunity for automated reporting of data from regional systems, and app-collected patient-reported health data.ConclusionsSwedish registers provide comprehensive sources for HEOR studies, but limitations related to the assessment of medical device impact remain. As is common with register data reporting grouped diagnoses and interventions, specific devices are not directly identifiable in the national health registers. For some devices, this might be addressable through linkage with other data-sources. Swedish authorities are undertaking several initiatives that will likely improve the potential for HTA and follow-up of medical devices using national health register data.

IntroductionAlthough randomized controlled trials (RCTs) are recognized as providing the highest level of clinical evidence, few medical device RCTs are available due to underfunding or inherent challenges associated with trial design. This study examines the extent to which real-world evidence (RWE) supports the recommendations made by the National Institute for Health and Care Excellence Medical Technologies Evaluation Programme (MTEP).MethodsAll MTEP guidance documents published online prior to October 2020 were reviewed. The “case for adoption” recommendation, type of clinical data, and clinical critiques for each MTEP submission were extracted and categorized. RWE was defined as studies with neither blinding nor prospective selection or control of patient characteristics.ResultsOf the MTEP submissions reviewed, 34 of 45 (76%) received a positive recommendation. Independent of outcome, all submissions included RWE, but only 19 (42%) utilized RCT evidence (15 were recommended and four were not). Meta-analyses of RWE were used whenever possible. The most common clinical critiques in unsuccessful submissions were the following: (i) not generalizable to the United Kingdom National Health Service (NHS); (ii) low quality; (iii) likelihood of bias; (iv) trial design faults; (v) uncertain benefit; and (vi) evidence unrelated to scope.ConclusionsThis study suggests that while the use of RCTs has not always led to a positive recommendation, RWE can be valuable in decision-making. Evidence that is generalizable to the NHS, is related to the scope, and shows clear indication of benefit is more likely to positively influence MTEP decision-making.

IntroductionThe United Kingdom spends approximately GBP4.2 billion (USD5.6 billion; EUR4.7 billion) each year on medical devices, but healthcare providers receive little health technology assessment (HTA) guidance on cost-effective device procurement. Our objective was to assess the availability of HTA guidance for medical technologies and to identify key challenges related to the economic assessment of these technologies.MethodsNational Institute for Health and Care Excellence technology appraisal (TA) and Medical Technologies Evaluation Programme (MTEP) appraisals published online between November 2009 and October 2020 were identified. The “case for adoption” recommendation, type of devices, and critiques of economic analyses for each MTEP appraisal were extracted and categorized.ResultsIn comparison to 415 publicly available TAs for pharmaceuticals, only 45 medical technologies have been appraised through the MTEP. MTEP-submitted technologies can be categorized into diagnostic (7), monitoring (3), prophylaxis (5), therapeutic (28), and other (2). Furthermore, 11 were implants, seven were used by patients, and 27 had provider interaction. Major points of MTEP criticism were a failure to model cost consequences, training costs, and organizational impact. There was also the barrier of transferring costs across budgeting divisions.ConclusionsIn comparison to HTA guidance for pharmaceuticals, there is a dearth of medical device guidance. Therapeutic and implantable devices appear to be disproportionately overrepresented in the MTEP process. This may be because their appraisal is most akin to pharmaceuticals, for which HTA processes are well established. To encourage more HTAs of medical devices, HTA guidance should elaborate on issues specifically related to medical devices.