Public Planning Research Articles

5G implementation and multi‐level governance: The case of Quebec municipalities

AbstractMunicipalities are often considered to be places of innovation. However, certain issues, such as 5G, suggest that the municipal level of government is hampered by challenges. In this article, we present the results of a survey of 220 respondents from 54 different municipalities of various sizes, alongside a media press review. We show that 5G is indicative of the challenges pertaining to multi‐level governance, the presence of a significant information deficit as well as the clout of the private sector in public planning. These findings call on us to examine municipal governance and the relevance of creating intermunicipal cooperation.

Empowering Urban Public Transport Planning Process for Medium-Sized Cities in Developing Countries: Innovative Decision Support Framework for Sustainability

The challenges resulting from rapid economic growth, urbanization, and increased motorization in developing nations necessitate a comprehensive and sustainable approach to urban public transport planning. While sustainable urban public transport (SUPT) planning offers a solution, the complexity of choosing suitable policy measure options remains a challenge. This study first introduces a decision support framework (DSF) that integrates the sustainable urban public transport manual (SUPTM) adopted for generating the potential SUPT policy measure options, the KonSULT knowledge base applied for providing the performance scores of each measure option for all determined criteria, and the HMADM (including FAHP, FSM, and TOPSIS) technique to create, rank, and select SUPT policy measure options tailored to medium-sized urban areas in developing nations. A case study of Khon Kaen City, Thailand, illustrates the practical application of the framework, resulting in a set of 31 (91.2%) out of the total of 34 ranked policy measure options. Comparing these prioritizations with the city’s existing plan reveals a substantial agreement, which suggests the potential applicability of the DSF. Overall, the DSF marks a significant advancement in SUPT planning, which is crucial for shaping efficient, equitable, and environmentally conscious urban mobility in developing countries, which are undergoing transformative change.

Agent-based decision-support model for bus route redesign in networks of small cities and towns: case study of Agder, Norway

Small cities and towns often struggle to provide high-quality public transport services to daily commuters. This is reflected in the modal split, where the share of car users dominates. Such a problem requires a modern solution, where transport planners can verify the impact of potential transport network improvements on the travel behavior of the residents before the changes are actually deployed. This study aims to demonstrate the usefulness of employing an agent-based simulation tool in the decision process for redesigning an express service regional bus route connecting a network of small cities and towns. The model was initially developed as a Mobility as a Service simulation solution for suburban areas of European metropolises. The model is adapted and applied to a case study for the region of Agder, Norway, simulating the impact of nine different scenarios on the patronage of a specific bus route. The simulation model proposes to upgrade the classic agent structure to a persona profile designed specifically for the case study. The main objective of this research is to identify the scenario that maximizes patronage while minimizing total route travel time and additional costs. The results suggest that the proposed model can be successfully adapted from suburban metropolitan areas to the realities of the considered case study, and potentially other similar regions. Specifically, out of the nine proposed scenarios, the model identified four promising ones. One of the four scenarios also fits the cost constraints imposed by the transport provider. The model provides a solid approach for analyzing complex transport systems that are practically impossible to consider in detail if the analysis is done without computer support. Thus, the results can be used as a decision support system for public transport planning and operations in networks of small cities and towns.

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Strengthening legal preparedness and response within the global health emergency framework: the role of the GHSA Legal Preparedness Action Package*

The COVID-19 pandemic exposed failings in preparedness and response across the world and a shortfall in global health security. The crisis also highlighted shortcomings in global and regional legal frameworks, including the International Health Regulations (2005) and relevant European Union law, as well as in national public health legislation and emergency plans. Lessons learned from the pandemic converge around strengthening preparedness and response capacities at all levels, with special attention to be paid to legal preparedness, a critical component of public health emergency preparedness. Improving legal capacities at country level is one of the strategic priorities set by the Global Health Security Agenda (GHSA), which established a new Legal Preparedness Action Package (LP AP) in order to elevate attention to and the importance of legal preparedness worldwide. Since 2021 the LP AP has been front and centre in international efforts to bridge the legal preparedness gap at national level. In bringing together technical experts in global health law and government health policy officials from a broad range of countries and partners, the LP AP seeks to set a foundation for legal preparedness by developing technical and capacity-building tools, legal guidelines, policy briefs, information and training. This article aims to illustrate and contextualize the work of the GHSA LP AP and raise awareness about the importance of its contribution to enhanced global health security. It also intends to highlight how its work promotes and develops synergies with parallel initiatives, processes and tools, facilitates regime interaction and harmonization of technical assistance and ultimately ensures consistency of action, methodology and approaches.

Alemtuzumab, Cladribine, Fingolimod, Natalizumab, and Rituximab as First-Line Treatments in Adults With Highly Active Relapsing-Remitting Multiple Sclerosis

What Is the Problem? Relapsing-remitting multiple sclerosis (RRMS), the most common disease course of multiple sclerosis (MS), is a chronic immune-mediated disease with clearly defined episodes of new or increasing neurologic symptoms followed by periods of relative stability. In contrast, the highly active, aggressive disease course leads to rapid disability, and these patients face an unmet need. The principal goal of MS treatment is to delay and prevent the accumulation of disability by reducing the frequency of relapses. Currently reimbursed first-line drugs fail to prevent the consequences of irreversible damage to the nervous system. There has been a paradigm shift in clinical practice toward the use of a high-efficacy treatment strategy as early as possible during the inflammatory process to provide optimal clinical benefits in preserving neurologic function in patients with highly active RRMS. What Did We Do? A systematic review of the clinical effectiveness and safety of alemtuzumab, natalizumab, cladribine, fingolimod, and rituximab relative to current first-line drugs in adults with highly active RRMS was conducted; it identified post hoc subgroup analyses from 5 randomized controlled trials (RCTs) and 1 prospective comparative cohort study. What Did We Find? Evidence was uncertain and conclusions were limited by risk of bias and small sample sizes; conclusions for some outcome comparisons were also limited by imprecision and incomplete reporting. Compared to placebo, cladribine and natalizumab may result in a clinically important reduction in relapses, disability, and key MRI lesions. Alemtuzumab may result in a clinically important reduction in relapses compared to interferon, while fingolimod may result in a clinically important reduction in relapses compared to placebo. The clinical evidence was insufficient to determine the effect of fingolimod on relapses when compared with interferon. Harms outcomes, when reported, appeared consistent with the known harms profile of the drugs. Assessment of the effectiveness and safety of rituximab could not be performed due to the lack of evidence. Evidence was also lacking for many important outcomes such as health-related quality of life (HRQoL), instrumental activities of daily living, symptoms, and cognitive outcomes. No evidence could be identified to inform on treatment sequencing. Two pragmatic RCTs (the TREAT-MS and DELIVER-MS trials) are currently ongoing, aiming to compare an early, high-efficacy treatment strategy versus a traditional escalation treatment strategy, which may inform treatment sequencing. Further research is needed to compensate for clinical data gaps to inform an appropriate and relevant economic evaluation. What Does This Mean? Jurisdictions may reconsider the current reimbursement criteria for drugs used in the first-line setting specifically for adults demonstrating highly active RRMS; however, caution should be taken given the gaps and uncertainty in evidence. Upon request from public drug plans, this review may inform a future implementation advice panel or expert committee recommendation.

Metreleptin (Myalepta)

We recommend that Myalepta should be reimbursed by public drug plans as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in patients with lipodystrophy (LD) if certain conditions are met. Myalepta should be covered to treat patients with confirmed congenital generalized LD (GL) (Berardinelli-Seip syndrome) or acquired GL (Lawrence syndrome) in both adults and children who are at least 2 years old and have at least 1 metabolic abnormality of diabetes, insulin resistance, or high levels of triglycerides (TGs). Myalepta should also be covered to treat patients who have confirmed familial partial LD (PL) or acquired PL in adults and children who are at least 12 years old and have persistent significant metabolic abnormalities, even after trying other treatments for at least 12 months. Myalepta should only be reimbursed if prescribed by an endocrinologist or pediatric endocrinologist with expertise in treating LD and if the cost of Myalepta is reduced. When first prescribed, Myalepta should only be reimbursed for 12 months. Reimbursement may be renewed on a yearly basis for patients who show improvement in their blood sugar and/or triglyceride levels.

Avatrombopag (Doptelet)

We recommend that Doptelet not be reimbursed by public drug plans for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP). Evidence from 1 clinical trial showed that Doptelet improved patients’ platelet counts after 6 months of treatment; however, it is not known whether Doptelet can reduce bleeding occurrence, reduce the use of other therapies for ITP used concomitantly with Doptelet, improve symptoms, or improve health-related quality of life when compared to placebo. In addition, evidence from 1 indirect treatment comparison study showed that the comparative efficacy of Doptelet to other established treatments for chronic ITP remains unknown. Patients identified a need for treatments that can reduce the risk of bleeding and improve their quality of life. However, there was not enough evidence to show that Doptelet would meet this need.

Estimation and probabilistic projection of age- and sex-specific mortality rates across Brazilian municipalities between 2010 and 2030.

Mortality rate estimation in small areas can be difficult due the low number of events/exposure (i.e. stochastic error). If the death records are not completed, it adds a systematic uncertainty on the mortality estimates. Previous studies in Brazil have combined demographic and statistical methods to partially overcome these issues. We estimated age- and sex-specific mortality rates for all 5,565 Brazilian municipalities in 2010 and forecasted probabilistic mortality rates and life expectancy between 2010 and 2030. We used a combination of the Tool for Projecting Age-Specific Rates Using Linear Splines (TOPALS), Bayesian Model, Spatial Smoothing Model and an ad-hoc procedure to estimate age- and sex-specific mortality rates for all Brazilian municipalities for 2010. Then we adapted the Lee-Carter model to forecast mortality rates by age and sex in all municipalities between 2010 and 2030. The adjusted sex- and age-specific mortality rates for all Brazilian municipalities in 2010 reveal a distinct regional pattern, showcasing a decrease in life expectancy in less socioeconomically developed municipalities when compared to estimates without adjustments. The forecasted mortality rates indicate varying regional improvements, leading to a convergence in life expectancy at birth among small areas in Brazil. Consequently, a reduction in the variability of age at death across Brazil's municipalities was observed, with a persistent sex differential. Mortality rates at a small-area level were successfully estimated and forecasted, with associated uncertainty estimates also generated for future life tables. Our approach could be applied across countries with data quality issues to improve public policy planning.

Tralokinumab (Adtralza)

CADTH recommends that Adtralza should not be reimbursed by public drug plans for the treatment of moderate to severe atopic dermatitis (AD) in adult and adolescent patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Evidence from 4 clinical trials demonstrated that, in the short term, Adtralza treatment improved severity of AD, itch symptoms, and health-related quality of life (HRQoL) compared to placebo in adults and adolescents with moderate to severe AD; however, it is uncertain if the magnitude of benefit is clinically meaningful to patients and clinicians. Additionally, a clinical trial in adults with severe AD whose disease did not adequately respond to, or were deemed unsafe to receive, a systemic immunosuppressant showed that Adtralza treatment improved severity of AD but not itch, and its effects on other clinical outcomes are unclear. No evidence that directly compared Adtralza to currently available treatments for AD was submitted. The indirect evidence submitted was uncertain due to limitations of the analyses; therefore, it is unclear whether Adtralza offers a clinically meaningful benefit for patients compared to other treatments for AD. The evidence for the effectiveness of Adtralza use in the longer term and in patients who previously received dupilumab and/or Janus kinase inhibitors (JAKis) (i.e., currently existing treatments) was uncertain due to limitations of the study designs and analysis; therefore, the benefits of Adtralza in these scenarios cannot be determined.

Efficient SARS-CoV-2 variant detection and monitoring with Spike Screen next-generation sequencing.

The emergence and rapid spread of SARS-CoV-2 prompted the global community to identify innovative approaches to diagnose infection and sequence the viral genome because at several points in the pandemic positive case numbers exceeded the laboratory capacity to characterize sufficient samples to adequately respond to the spread of emerging variants. From week 10, 2020, to week 13, 2023, Slovenian routine complete genome sequencing (CGS) surveillance network yielded 41537 complete genomes and revealed a typical molecular epidemiology with early lineages gradually being replaced by Alpha, Delta, and finally Omicron. We developed a targeted next-generation sequencing based variant surveillance strategy dubbed Spike Screen through sample pooling and selective SARS-CoV-2 spike gene amplification in conjunction with CGS of individual cases to increase throughput and cost-effectiveness. Spike Screen identifies variant of concern (VOC) and variant of interest (VOI) signature mutations, analyses their frequencies in sample pools, and calculates the number of VOCs/VOIs at the population level. The strategy was successfully applied for detection of specific VOC/VOI mutations prior to their confirmation by CGS. Spike Screen complemented CGS efforts with an additional 22897 samples sequenced in two time periods: between week 42, 2020, and week 24, 2021, and between week 37, 2021, and week 2, 2022. The results showed that Spike Screen can be applied to monitor VOC/VOI mutations among large volumes of samples in settings with limited sequencing capacity through reliable and rapid detection of novel variants at the population level and can serve as a basis for public health policy planning.

A comparative analysis of medication counting methods to assess polypharmacy in medico-administrative databases

BackgroundThe variety of methods for counting medications may lead to confusion when attempting to compare the extent of polypharmacy across different populations. ObjectiveTo compare the prevalence estimates of polypharmacy derived from medico-administrative databases, using different methods for counting medications. MethodsData were drawn from the Québec Integrated Chronic Disease Surveillance System. A random sample of 110,000 individuals aged >65 was selected, including only those who were alive and covered by the public drug plan during the one-year follow-up. We used six methods to count medications: #1-cumulative one-year count, #2-average of four quarters' cumulative counts, #3-count on a single day, #4-count of medications used in first and fourth quarters, #5-count weighted by duration of exposure, and #6-count of uninterrupted medication use. Polypharmacy was defined as ≥5 medications. Cohen's Kappa was calculated to assess the level of agreement between the methods. ResultsA total of 93,516 (85 %) individuals were included. The prevalence of polypharmacy varied across methods. The highest prevalence was observed with cumulative methods (#1:74.1 %; #2:61.4 %). Single day count (#3:47.6 %), first and fourth quarters count (#4:49.5 %), and weighted count (#5:46.6 %) yielded similar results. The uninterrupted use count yielded the lowest estimate (#6:35.4 %). The weighted method (#5) showed strong agreement with the first and fourth quarters count (#4). Cumulative methods identified higher proportions of younger, less multimorbid individuals compared to other methods. ConclusionCounting methods significantly affect polypharmacy prevalence estimates, necessitating their consideration when comparing and interpretating results.

Dostarlimab (Jemperli)

We recommend that Jemperli in combination with carboplatin and paclitaxel be reimbursed by public drug plans for the first-line treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy if certain conditions are met. Jemperli in combination with carboplatin and paclitaxel should only be covered to treat adult patients who have primary stage III or IV endometrial cancer, experience a first disease recurrence and have not previously received systemic anticancer therapy for advanced disease, and/or have received prior neoadjuvant adjuvant systemic anticancer therapy and experience a first recurrence at a minimum of 6 months after completion of treatment. Eligible patients should have confirmed dMMR or MSI-H status of their tumours before starting treatment with Jemperli and have a good performance status. Jemperli should only be reimbursed in combination with carboplatin and paclitaxel if prescribed by clinicians with expertise in advanced uterine cancer. Treatment should be supervised and administered in institutions with expertise in systemic therapy delivery. The cost of Jemperli should be reduced.

Cemiplimab (Libtayo)

CADTH recommends that Libtayo in combination with platinum-based chemotherapy be reimbursed by public drug plans for the first-line treatment of adults with non–small cell lung cancer (NSCLC) whose tumours have no EGFR, ALK, or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or for those with metastatic NSCLC, if certain conditions are met. Libtayo in combination with platinum-based chemotherapy should only be covered to treat adults who have stage IIIB or IIIC NSCLC and are not suitable for curative surgery or definitive chemoradiation or have stage IV NSCLC and have not received prior systemic treatment. Patients’ tumours should have no EGFR, ALK, or ROS1 Patients should have a good performance status. Libtayo should only be reimbursed in combination with platinum-based chemotherapy if prescribed by clinicians with expertise and experience in treating NSCLC. The treatment should be delivered in outpatient specialized oncology clinics with expertise in systemic therapy delivery and management of immunotherapy-related side effects. The price of Libtayo should be negotiated so that its use in combination with platinum-based chemotherapy does not exceed the total drug cost of treatment with the least costly immunotherapy reimbursed in the first-line setting.

Drawing up the public national Rational Pharmacotherapy Action Plan as part of social and health services reform in Finland: a bottom-up approach involving stakeholders

BackgroundEnsuring equal access to medicines and their appropriate and safe use at reasonable costs are core functions of health systems. Despite that, few descriptions of national medicines policies' development processes and implementation strategies have been published. This study aimed to describe the government program-based development of the Rational Pharmacotherapy Action Plan in Finland as a part of the undergoing major health and social service system reform, also covering the implementation of rational pharmacotherapy in the reformed system and processes.MethodsThe data of this qualitative study consisted of public reports and Steering Group meeting memos related to the development of the national Rational Pharmacotherapy Action Plan that the Ministry of Social Affairs and Health coordinated. Qualitative content analysis applying systems theory and the conceptual framework of integrated services as theoretical frameworks was used as an analysis method.ResultsThe national Rational Pharmacotherapy Action Plan covering 2018–2022 was created in a bottom-up development process involving a wide range of stakeholders. Rational pharmacotherapy was redefined by adding equality as the fifth pillar to complement the previously defined pillars of being effective, safe, high-quality, and cost-effective. The Action Plan formed a normative framework for long-term development, with a vision and principles focusing on people-centeredness, better coordination and management of the medication use processes, the continuity of treatment paths and the flow of patient and medicines information through partnerships, and evidence-informed policies and practices.ConclusionThrough intensive stakeholder participation, the bottom-up approach created a national vision and principles of rational pharmacotherapy along with strong commitment to implementing the goals and measures. The concern lies in ensuring the continuity of the Action Plan implementation and achieving a balanced long-term development aligned with the integrated and reformed national social and health services system. The development of the pharmaceutical system has several national and EU-level dependencies requiring political long-term commitment. While the Action Plan differs from the national medicines policy, it forms a good basis for long-term development covering important parts of medicine policy at the micro, meso, and macro levels of the service system.

Implementation of a public use management model in Argentinian National Parks: Lessons learned

This year marks 200 years of diplomatic relations between the United States and Argentina, which has involved cooperation across a wide range of fields, including tourism. In the interest of finding new approaches to improve the capacity of nation­al parks for public use planning and management and develop mutually beneficial ways to deliver higher-quality visitor experiences, the United States of America Embassy in Buenos Aires, the George Wright Society, the US National Park Service, and the Administration of National Parks in Argentina proposed the “Binational Exchange Program to Enhance Visitor Experiences in National Parks” as a co-learning exchange between the two countries. Through a critical review, this article focuses on the application and adaptation of the US Interagency Visitor Use Management Framework for public use management in five national parks in Argentina. The article offers an overview of the framework, summarizes the project developed with the parks, and, more importantly, discusses lessons learned and recommendations for future implementation of the model in Argentina and, possibly, other countries in Latin America.

Infliximab (Remsima SC)

We recommend that Remsima SC be reimbursed by public drug plans as maintenance treatment for adults with moderately to severely active ulcerative colitis (UC) whose disease has had an inadequate response, or who were intolerant, to conventional therapy if certain conditions are met. Remsima SC maintenance treatment should only be covered to treat adults with moderately to severely active UC whose disease has had an inadequate response, or who are intolerant, to conventional therapy. Patients are required to achieve a clinical response to induction therapy with infliximab IV at week 10 of treatment to continue with Remsima SC as maintenance therapy. Remsima SC should only be reimbursed if prescribed by a physician experienced in diagnosing and managing UC and should not be reimbursed if used in combination with other advanced therapies for UC. The cost of Remsima SC should not exceed the drug program cost of treatment with the least costly biologic therapy reimbursed for the treatment of UC.

Inclisiran (Leqvio)

CADTH recommends that Leqvio not be reimbursed by public drug plans as an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) levels in adults who are on a maximally tolerated dose (MTD) of a statin, with or without other LDL-C–lowering therapies, and who have nonfamilial hypercholesterolemia (nFH) with atherosclerotic cardiovascular disease (ASCVD). Evidence from 2 clinical trials showed that treatment with Leqvio lowered bad cholesterol (LDL-C) in adults with nFH with ASCVD who were already being treated with the highest possible dose of statins and in those who cannot tolerate treatment with statins. A post hoc pooled analysis of major adverse cardiovascular events (MACEs) from the ORION-10 and ORION-11 trials precluded the Canadian Drug Expert Committee (CDEC) from determining whether inclisiran reduces the risk of cardiovascular morbidity and death in adults with nFH with ASCVD. Patients identified a need for treatments that are less burdensome, can reduce bad cholesterol (LDL-C) and cardiovascular morbidity and death, and improve health-related quality of life (HRQoL); however, there was not enough evidence to show that Leqvio would reduce cardiovascular morbidity and death or improve HRQoL.

Maralixibat (Livmarli)

CADTH recommends that Livmarli should be reimbursed by public drug plans for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) if certain conditions are met. Livmarli should only be covered to treat patients aged 12 months and older with a diagnosis of ALGS and who have impaired bile flow demonstrated by at least 1 of the following: elevated serum bile acids (sBAs), conjugated bilirubin, or gamma-glutamyl transferase; fat-soluble vitamin deficiency; and/or intractable itch. Patients must experience moderate to severe itch symptoms and must be currently or have been previously treated with systemic medication for itch. Livmarli should only be reimbursed if it is prescribed under the care of a specialist with experience in managing ALGS, if patients experience an improvement in their itching after using Livmarli for 6 months, and if the cost of Livmarli is reduced. Livmarli should be stopped if the patient receives a liver transplant or biliary diversion surgery.

Infliximab (Remsima SC)

We recommend that Remsima SC be reimbursed by public drug plans as maintenance treatment for adults with moderately to severely active Crohn disease (CD) whose disease has had an inadequate response, or who were intolerant to, conventional therapy if certain conditions are met. Remsima SC maintenance treatment should only be covered to treat adults with moderately to severely active CD whose disease had an inadequate response, or who are intolerant, to conventional therapy. Patients are required to achieve a clinical response to induction therapy with infliximab IV at week 10 of treatment to continue with Remsima SC as maintenance therapy. Remsima SC should only be reimbursed if prescribed by a physician experienced in diagnosing and managing CD and should not be combined with a biologic or Janus kinase (JAK inhibitor) treatment for CD. The cost of Remsima SC should not exceed the drug program cost of treatment with the least costly biologic therapy reimbursed for the treatment of CD.