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1.
Public Health Nutr ; 27(1): e66, 2024 Feb 02.
Artículo en Inglés | MEDLINE | ID: mdl-38305101

RESUMEN

OBJECTIVE: FoodRx is a 12-month healthy food prescription incentive program for people with type 2 diabetes (T2DM) and experiences of household food insecurity. In this study, we aimed to explore potential users' prospective acceptability (acceptability prior to program use) of the design and delivery of the FoodRx incentive and identify factors influencing prospective acceptability. DESIGN: We used a qualitative descriptive approach and purposive sampling to recruit individuals who were interested or uninterested in using the FoodRx incentive. Semi-structured interviews were guided by the theoretical framework of acceptability, and corresponding interview transcripts were analysed using differential qualitative analysis guided by the socioecological model. SETTING: Individuals living in Alberta, Canada. PARTICIPANTS: In total, fifteen adults with T2DM and experiences of household food insecurity. RESULTS: People who were interested in using the FoodRx incentive (n 10) perceived it to be more acceptable than those who were uninterested (n 5). We identified four themes that captured factors that influenced users' prospective acceptability: (i) participants' confidence, views and beliefs of FoodRx design and delivery and its future use (intrapersonal), (ii) the shopping routines and roles of individuals in participants' social networks (interpersonal), (iii) access to and experience with food retail outlets (community), and (iv) income and food access support to cope with the cost of living (policy). CONCLUSION: Future healthy food prescription programs should consider how factors at all levels of the socioecological model influence program acceptability and use these data to inform program design and delivery.


Asunto(s)
Diabetes Mellitus Tipo 2 , Adulto , Humanos , Alberta , Motivación , Estudios Prospectivos , Abastecimiento de Alimentos , Inseguridad Alimentaria
2.
Vaccine ; 42(4): 891-911, 2024 Feb 06.
Artículo en Inglés | MEDLINE | ID: mdl-38238114

RESUMEN

BACKGROUND: Social networks have an important impact on our health behaviours, including vaccination. People's vaccination beliefs tend to mirror those of their social network. As social networks are homogenous in many ways, we sought to determine in the context of COVID-19 which factors were most predictive of belonging to a mostly vaccinated or unvaccinated social group. METHODS: We conducted a cross-sectional survey among Canadian residents in November and December 2021. Participants were asked about the vaccination status of their social networks their beliefs relating to COVID-19, and various sociodemographic factors. Respondents were split into three groups based on social network vaccination: low-, medium-, and high-risk. Chi-squared tests tested associations between factors and risk groups, and an ordinal logistic model was created to determine their direction and strength. RESULTS: Most respondents (81.1 %) were classified as low risk (i.e., a mostly vaccinated social network) and few respondents (3.7 %) were classified as high-risk (i.e., an unvaccinated social group). Both the chi-square test (29.2 % difference between the low- and high- risk groups [1.8 % vs. 31.0 %], p < 0.001) and the ordinal logistic model (odds ratio between the low- and high-risk groups: 14.45, p < 0.01) found that respondents' perceptions of COVID-19 as a "not at all serious" risk to Canadians was the most powerful predictor of belonging to a predominantly unvaccinated social circle. The model also found that those in mostly unvaccinated social circles also more often reported severe COVID-19 symptoms (odds ratio between the low- and high-risk groups: 2.26, p < 0.05). CONCLUSION: Perception of COVID-19 as a threat to others may signal communities with lower vaccination coverage and higher risk of severe outcomes. This may have implications for strategies to improve public outreach, messaging, and planning for downstream consequences of low intervention uptake.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Pueblos de América del Norte , Humanos , Vacunas contra la COVID-19/uso terapéutico , Estudios Transversales , COVID-19/epidemiología , COVID-19/prevención & control , Canadá/epidemiología , Vacunación , Red Social , Factores de Riesgo
4.
CMAJ Open ; 11(6): E1181-E1187, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-38114260

RESUMEN

BACKGROUND: Endovascular thrombectomy (EVT) has revolutionized ischemic stroke care. We aimed to assess whether neighbourhood socioeconomic status is predictive of access to EVT after receipt of alteplase for ischemic stroke among patients living in Alberta, Canada, and whether this relation is mediated by the distance a person lives to the nearest comprehensive stroke centre (CSC). METHODS: We performed a retrospective study including all people older than 18 years living in Alberta who were admitted to hospital with an ischemic stroke and who received intravenous alteplase treatment between Jan. 1, 2017, and Dec. 31, 2019. Data were obtained through administrative data sets. The primary outcome was treatment with EVT. We assigned neighbourhood deprivation quintile based on the Material and Social Deprivation Index. We used logistic regression modelling to assess for a relation between deprivation and treatment with EVT. We adjusted for age, sex, stroke severity and distance to the nearest CSC. We calculated the average causal mediation effect of distance to the nearest CSC on the relation between neighbourhood deprivation level and treatment with EVT. RESULTS: The study cohort consisted of 1335 patients, of whom 181 (13.6%) had missing data and were excluded from the main regression analysis. Endovascular thrombectomy was performed or attempted in 314 patients (23.5%). In the primary model, patients from the most deprived neighbourhoods were less likely than those from less deprived neighbourhoods to have received EVT (adjusted odds ratio 0.43, 95% confidence interval 0.24 to 0.77). Neighbourhood deprivation level was not significantly associated with EVT when distance to the nearest CSC was included as a covariate. Mediation analysis suggested that 48% of the total effect that neighbourhood deprivation level had on the odds of receiving EVT was attributable to the distance a person lived from the nearest CSC. INTERPRETATION: The results suggest that people from more deprived neighbourhoods in Alberta were less likely to be treated with EVT than those from less deprived neighbourhoods. Improving access to EVT for people living in remote locations may improve the equitable distribution of this treatment.

5.
PLoS Med ; 20(11): e1004309, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37971985

RESUMEN

BACKGROUND: Insulin is the primary treatment for type 1 and some type 2 diabetes but remains costly in the United States, even though it was discovered more than a century ago. High prices can lead to nonadherence and are often sustained by patents and regulatory exclusivities that limit competition on brand-name products. We sought to examine how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend periods of market exclusivity. METHODS AND FINDINGS: We used the publicly available Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. Individual products approved under the same New Drug Application (NDA)-e.g., a vial and pen-were considered as separate products for the purposes of analysis. We recorded all patents and regulatory exclusivities listed in the Orange Book on each product and used Google Patents to extract the timing of patent application and whether patents were obtained on delivery devices or others aspects of the product. The primary outcome was the duration of expected protection, which was determined by subtracting the FDA approval date for each product from its last-to-expire patent or regulatory exclusivity (whichever occurred later). We performed a secondary analysis that considered overall protection on insulin lines-defined as groups of products approved under the same NDA with the same active ingredients manufactured by the same company. We also examined competition from follow-on insulin products-defined as products approved with the same active ingredients as originators but manufactured by different companies (approved via a specific drug approval pathway under section 505(b)(2) of the Food, Drug, and Cosmetic Act). During the study period, the FDA approved 56 individual products across 25 different insulin lines and 5 follow-ons across 3 different insulin lines. Thirty-three (59%) of the 56 products were drug-device combinations. Manufacturers of 9 products approved during the study period obtained patents filed after FDA approval that extended their duration of expected protection (by a median of 6 years). Approximately 63% of all patents on drug-device combinations approved during the study period were related to delivery devices. The median duration of expected protection on insulin products was 16.0 years, and the median protection on insulin lines was 17.6 years. An important limitation of our analysis is that manufacturers may continue to add patents on existing insulin products while competitors may challenge patents; therefore, periods of protection may change over time. CONCLUSIONS: Among several strategies that insulin manufacturers have employed to extend periods of market exclusivity on brand-name insulin products are filing patents after FDA approval and obtaining a large number of patents on delivery devices. Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have access to low-cost drugs.


Asunto(s)
Diabetes Mellitus Tipo 2 , Humanos , Estados Unidos , United States Food and Drug Administration , Preparaciones Farmacéuticas , Aprobación de Drogas , Combinación de Medicamentos , Insulina
6.
Healthc Policy ; 19(1): 99-113, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37695711

RESUMEN

Background: This paper aims to assess the extent to which the COVID-19 vaccine's speed to market affected Canadian residents' decision to remain unvaccinated. Method: A cross-sectional survey conducted in late 2021 asked participants whether they had received the vaccine and their reasons for abstaining. Results: Of the 2,712 participants who completed the survey, 8.9% remained unvaccinated. Unvaccinated respondents who selected "They made the vaccine too fast" (59.8%), were significantly more likely to identify as white, believe that the COVID-19 pandemic was not serious and have an unvaccinated social circle. Conclusion: Should the COVID-19 vaccine rapid regulatory process be expanded, more patients may refuse treatment than if traditional timelines are followed.


Asunto(s)
COVID-19 , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/uso terapéutico , Vacilación a la Vacunación , Estudios Transversales , Canadá
7.
JAMA ; 330(7): 650-657, 2023 08 15.
Artículo en Inglés | MEDLINE | ID: mdl-37505513

RESUMEN

Importance: Glucagon-like peptide 1 (GLP-1) receptor agonists were first approved for the treatment of type 2 diabetes in 2005. Demand for these drugs has increased rapidly in recent years, as indications have expanded, but they remain expensive. Objective: To analyze how manufacturers of brand-name GLP-1 receptor agonists have used the patent and regulatory systems to extend periods of market exclusivity. Evidence Review: The annual US Food and Drug Administration's (FDA) Approved Drug Products With Therapeutic Equivalence Evaluations was used to identify GLP-1 receptor agonists approved from 2005 to 2021 and to record patents and nonpatent statutory exclusivities listed for each product. Google Patents was used to extract additional data on patents, including whether each was obtained on the delivery device or another aspect of the product. The primary outcome was the duration of expected protection from generic competition, defined as the time elapsed from FDA approval until expiration of the last-to-expire patent or regulatory exclusivity. Findings: On the 10 GLP-1 receptor agonists included in the cohort, drug manufacturers listed with the FDA a median of 19.5 patents (IQR, 9.0-25.8) per product, including a median of 17 patents (IQR, 8.3-22.8) filed before FDA approval and 1.5 (IQR, 0-2.8) filed after FDA approval. Fifty-four percent of all patents listed on GLP-1 receptor agonists were on the delivery devices rather than active ingredients. Manufacturers augmented patent protection with a median of 2 regulatory exclusivities (IQR, 0-3) obtained at approval and 1 (IQR, 0.3-4.3) added after approval. The median total duration of expected protection after FDA approval, when accounting for both preapproval and postapproval patents and regulatory exclusivities, was 18.3 years (IQR, 16.0-19.4). No generic firm has successfully challenged patents on GLP-1 receptor agonists to gain FDA approval. Conclusions and Relevance: Patent and regulatory reform is needed to ensure timely generic entry of GLP-1 receptor agonists to the market.


Asunto(s)
Diabetes Mellitus Tipo 2 , Aprobación de Drogas , Medicamentos Genéricos , Receptor del Péptido 1 Similar al Glucagón , Hipoglucemiantes , Patentes como Asunto , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/economía , Aprobación de Drogas/legislación & jurisprudencia , Medicamentos Genéricos/economía , Medicamentos Genéricos/uso terapéutico , Receptor del Péptido 1 Similar al Glucagón/agonistas , Preparaciones Farmacéuticas/economía , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Patentes como Asunto/legislación & jurisprudencia , Estados Unidos , Equivalencia Terapéutica , Comercio , Competencia Económica/economía , Competencia Económica/legislación & jurisprudencia , Factores de Tiempo
8.
Health Aff (Millwood) ; 42(3): 398-406, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36877911

RESUMEN

Between 1986 and 2020 the Food and Drug Administration (FDA) approved fifty-three brand-name inhalers for asthma and chronic obstructive pulmonary disease (COPD), but by the end of 2022 only three of those inhalers faced independent generic competition. Manufacturers of brand-name inhalers have created long periods of market exclusivity by obtaining multiple patents, many on the delivery devices rather than the active ingredients, and by introducing new devices that contain old active ingredients. Limited generic competition for inhalers has raised questions about whether the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, for challenging patents is adequately facilitating the entry of complex generic drug-device combinations. For the fifty-three brand-name inhalers approved during the period 1986-2020, generic manufacturers filed challenges authorized by the Hatch-Waxman Act, which are known as paragraph IV certifications, on only seven products (13 percent). The median time from FDA approval to first paragraph IV certification was fourteen years. Paragraph IV certifications resulted in approved generics for only two products, each of which experienced fifteen years of market exclusivity before generic approval. Reform of the generic drug approval system is critical to ensuring the timely availability of competitive markets for generic drug-device combinations such as inhalers.


Asunto(s)
Asma , Enfermedad Pulmonar Obstructiva Crónica , Estados Unidos , Humanos , Medicamentos Genéricos , Asma/tratamiento farmacológico , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Aprobación de Drogas , Nebulizadores y Vaporizadores
9.
Can J Diabetes ; 47(1): 58-65.e2, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36184371

RESUMEN

OBJECTIVES: Our aim in this study was to describe patterns and patient-level factors associated with use of sodium-glucose cotransporter-2 inhibitors (SGLT2is) among adults with diabetes being treated in Alberta, Canada. METHODS: Using linked administrative data sets from 2014 to 2019, we defined a retrospective cohort of adults with prevalent or incident type 2 diabetes with indications for SGLT2i use and who did not have advanced kidney disease (glomerular filtration rate <30 mL/min per 1.73 m2) or previous amputation. We describe medication dispensation patterns of SGLT2is over time in the overall cohort and among the subgroup with cardiovascular disease (CVD). Multivariable logistic regression was used to determine patients' characteristics associated with SGLT2i use. RESULTS: Of the 341,827 patients with diabetes (mean age, 60.7 years; 45.6% female), 107,244 (31.3%) had CVD. The proportion of patients with an SGLT2i prescription increased in a linear fashion to a maximum of 10.8% (95% confidence interval [CI], 10.7% to 10.9%) of the eligible cohort by the end of the observation period (March 2019). The proportion of filled prescriptions was similar for patients with CVD (10.4%; 95% CI, 10.1% to 10.6%) and for those without CVD (10.9%; 95% CI, 10.8% to 11.0%). Patients' characteristics associated with lower odds of filling an SGLT2i prescription included female sex, older age and lower income. CONCLUSIONS: The use of SGLT2is is increasing among patients with diabetes but remains low even in those with CVD. Policy and practice changes to increase prescribing, especially in older adults, may help to reduce morbidity and mortality related to cardiovascular and renal complications.


Asunto(s)
Enfermedades Cardiovasculares , Diabetes Mellitus Tipo 2 , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Femenino , Anciano , Persona de Mediana Edad , Masculino , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/complicaciones , Estudios de Cohortes , Estudios Retrospectivos , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Enfermedades Cardiovasculares/tratamiento farmacológico , Glucosa , Sodio/uso terapéutico , Alberta/epidemiología
10.
Healthc Policy ; 18(2): 14-26, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36495532

RESUMEN

Background: Patenting medicine-delivery devices (inhalers and pens) is controversial when it extends market protections beyond that of the underlying therapeutic agent. We evaluated how common device patenting is, internationally. Method: Using a product sample (n = 88) and an international patent database, we assessed the issue's scope. Results: When comparing the 88 patent portfolios for each product in each country, Canada was found to be among the most impacted, with 90% of the portfolios containing at least one device patent and 35% of the portfolios containing device patents exclusively. Conclusion: Patenting of delivery devices impacts major pharmaceutical manufacturing centres worldwide. International consensus among stakeholders (regulators and payors) is needed on which device modifications represent meaningful clinical value.


Asunto(s)
Preparaciones Farmacéuticas , Humanos , Canadá
12.
J Clin Hypertens (Greenwich) ; 24(10): 1316-1326, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-36125169

RESUMEN

In this study on medication adherence among newly diagnosed patients with uncomplicated, incident hypertension, we conducted a retrospective cohort study using available administrative and laboratory data from April 1, 2012 to March 31, 2017 in Alberta, Canada to understand the extent to which baseline laboratory assessment and/or subsequent follow-up was associated with persistence with antihypertensive therapy. We determined the frequency of baseline and follow-up testing and compared the rates of medication persistence by patient-, neighbourhood-, and treatment-related factors. Of 103 232 patients with newly diagnosed, uncomplicated hypertension who filled their first prescription within our study timeframe, 52.5% were non-persistent within 6 months. Persistent patients were more often female and residing in neighbourhoods with higher social status (with exception to rurality). Aside from older age, the strongest predictor of persistence was performance of laboratory testing related to hypertension with an apparent effect in which higher levels of medication persistence were seen with more frequent laboratory testing. We concluded that medication persistence was far from optimal, dropping off considerably after 6 months for more than half of patients. Medication persistence is a substantial barrier to realizing the full societal benefits of antihypertensive treatment. Ongoing follow up with patients, including laboratory testing, may be a critical component of better long term treatment persistence.


Asunto(s)
Antihipertensivos , Hipertensión , Humanos , Femenino , Antihipertensivos/uso terapéutico , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Estudios Retrospectivos , Análisis de Datos , Cumplimiento de la Medicación
13.
CMAJ ; 194(23): E801-E806, 2022 06 13.
Artículo en Inglés | MEDLINE | ID: mdl-35697373

RESUMEN

BACKGROUND: In March 2020, the Government of Canada introduced measures to reduce intensifying shortages of prescription drugs during the beginning of the COVID-19 pandemic. We sought to assess the extent to which a decline in drug shortages was observed in the months after this policy change. METHODS: Our data source was the Drug Shortages Canada Database, which reports shortages by drug product, including shortage start and duration. Using a cross-sectional design, we tracked shortage rates of drug products using a 30-day moving average from Apr. 15, 2017, to Apr. 1, 2022. We used autoregressive integrated moving average modelling with a ramp function to determine the significance of trend changes after policy implementation. RESULTS: We found that of the 13 329 drug products at risk for shortage, 44.7% (n = 5953) had at least 1 shortage event in the past 5 years. Average daily shortage prevalence rates rose from 901 in April 2017 to a peak of 2345 by April 2020. Significant declines (p = 0.02) ensued shortly thereafter, dropping to a rate of 1611 shortages by the end of the first year after policy implementation. However, we did not observe a significant reduction in shortage rates in the second year (p = 0.2), with rates plateauing below 1500 and then rising back above 1600 by the end of March 2022. INTERPRETATION: Drug shortages are common in Canada, including during the initial months of the COVID-19 pandemic. We observed substantial improvements after the implementation of the new measures, but gains appear to have plateaued. Continued vigilance is needed to sustain improvements.


Asunto(s)
COVID-19 , Industria Farmacéutica , COVID-19/epidemiología , Estudios Transversales , Humanos , Pandemias , Prevalencia
14.
Health Aff (Millwood) ; 41(6): 787-796, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-35579925

RESUMEN

Inhalers are the mainstay of treatment for asthma and chronic obstructive pulmonary disease (COPD). These products face limited generic competition in the US and remain expensive. To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action. More than half of all patents were on the inhaler devices, not the active ingredients or other aspects of these drug-device combinations. Manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another ("device hops"). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years (across device hops on fourteen originator products). Regulatory and patent reform is critical to ensure that the rewards bestowed on brand-name inhaler manufacturers better reflect the added clinical benefit of new products.


Asunto(s)
Asma , Enfermedad Pulmonar Obstructiva Crónica , Asma/tratamiento farmacológico , Medicamentos Genéricos , Humanos , Nebulizadores y Vaporizadores , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Estados Unidos , United States Food and Drug Administration
15.
CMAJ Open ; 10(2): E390-E399, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35440486

RESUMEN

BACKGROUND: Few studies have categorized high-cost patients (defined by accumulated health care spending above a predetermined percentile) into distinctive groups for which potentially actionable interventions may improve outcomes and reduce costs. We sought to identify homogeneous groups within the persistently high-cost population to develop a taxonomy of subgroups that may be targetable with specific interventions. METHODS: We conducted a retrospective analysis in which we identified adults (≥ 18 yr) who lived in Alberta between April 2014 and March 2019. We defined "persistently high-cost users" as those in the top 1% of health care spending across 4 data sources (the Discharge Abstract Database for inpatient encounters; Practitioner Claims for outpatient primary care and specialist encounters; the Ambulatory Care Classification System for emergency department encounters; and the Pharmaceutical Information Network for medication use) in at least 2 consecutive fiscal years. We used latent class analysis and expert clinical opinion in tandem to separate the persistently high-cost population into subgroups that may be targeted by specific interventions based on their distinctive clinical profiles and the drivers of their health system use and costs. RESULTS: Of the 3 919 388 adults who lived in Alberta for at least 2 consecutive fiscal years during the study period, 21 115 (0.5%) were persistently high-cost users. We identified 9 subgroups in this population: people with cardiovascular disease (n = 4537; 21.5%); people receiving rehabilitation after surgery or recovering from complications of surgery (n = 3380; 16.0%); people with severe mental health conditions (n = 3060; 14.5%); people with advanced chronic kidney disease (n = 2689; 12.7%); people receiving biologic therapies for autoimmune conditions (n = 2538; 12.0%); people with dementia and awaiting community placement (n = 2520; 11.9%); people with chronic obstructive pulmonary disease or other respiratory conditions (n = 984; 4.7%); people receiving treatment for cancer (n = 832; 3.9%); and people with unstable housing situations or substance use disorders (n = 575; 2.7%). INTERPRETATION: Using latent class analysis supplemented with expert clinical review, we identified 9 policy-relevant subgroups among persistently high-cost health care users. This taxonomy may be used to inform policy, including identifying interventions that are most likely to improve care and reduce cost for each subgroup.


Asunto(s)
Trastornos Mentales , Alta del Paciente , Adulto , Atención Ambulatoria , Atención a la Salud , Humanos , Estudios Retrospectivos
17.
Clin Infect Dis ; 74(2): 347-351, 2022 01 29.
Artículo en Inglés | MEDLINE | ID: mdl-33914860

RESUMEN

One reason expressed in surveys of people reporting coronavirus disease 2019 (COVID-19) vaccine hesitancy is how rapidly these vaccines have reached the market. To estimate the length of time the COVID-19 vaccine spent in research and development as compared to other novel vaccines, we apply previously established methods for estimating medical product development times, using the key associated patent filings cited by the manufacturer as the marker of when commercial development activity began. Applying these methods to a cohort of recently approved innovative vaccines and comparing them to the first-approved COVID-19 vaccine (BioNTech/Pfizer), we found key patent filings for the technology in this COVID-19 vaccine occurred 10.0 years prior to regulatory authorization. By this metric, the development timelines for innovative vaccines have been shortening since the 1980s, and the COVID-19 vaccine comfortably fits within this pattern. Vaccine development timelines have now even drawn to parity with many of the most commonly used drugs.


Asunto(s)
COVID-19 , Vacunas , Vacunas contra la COVID-19 , Humanos , SARS-CoV-2
18.
PLoS One ; 16(10): e0258013, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34679120

RESUMEN

BACKGROUND: The private versus public contribution to developing new health knowledge and interventions is deeply contentious. Proponents of commercial innovation highlight its role in late-stage clinical trials, regulatory approval, and widespread distribution. Proponents of public innovation point out the role of public institutions in forming the foundational knowledge undergirding downstream innovation. The rapidly evolving COVID-19 situation has brought with it uniquely proactive public involvement to characterize, treat, and prevent this novel health treat. How has this affected the share of research by industry and public institutions, particularly compared to the experience of previous pandemics, Ebola, H1N1 and Zika? METHODS: Using Embase, we categorized all publications for COVID-19, Ebola, H1N1 and Zika as having any author identified as affiliated with industry or not. We placed all disease areas on a common timeline of the number of days since the WHO had declared a Public Health Emergency of International Concern with a six-month lookback window. We plotted the number and proportion of publications over time using a smoothing function and plotted a rolling 30-day cumulative sum to illustrate the variability in publication outputs over time. RESULTS: Industry-affiliated articles represented 2% (1,773 articles) of publications over the 14 months observed for COVID-19, 7% (278 articles) over 7.1 years observed for Ebola, 5% (350 articles) over 12.4 years observed for H1N1, and 3% (160 articles) over the 5.7 years observed for Zika. The proportion of industry-affiliated publications built steadily over the time observed, eventually plateauing around 7.5% for Ebola, 5.5% for H1H1, and 3.5% for Zika. In contrast, COVID-19's proportion oscillated from 1.4% to above 2.7% and then declined again to 1.7%. At this point in the pandemic (i.e., 14 months since the PHEIC), the proportion of industry-affiliated articles had been higher for the other three disease areas; for example, the proportion for H1N1 was twice as high. CONCLUSIONS: While the industry-affiliated contribution to the biomedical literature for COVID is extraordinary in its absolute number, its proportional share is unprecedentedly low currently. Nevertheless, the world has witnessed one of the most remarkable mobilizations of the biomedical innovation ecosystem in history.


Asunto(s)
COVID-19/epidemiología , Ebolavirus , Fiebre Hemorrágica Ebola/epidemiología , Subtipo H1N1 del Virus de la Influenza A , Gripe Humana/epidemiología , Publicaciones Periódicas como Asunto , SARS-CoV-2 , Infección por el Virus Zika/epidemiología , Virus Zika , Humanos
19.
Value Health ; 24(9): 1328-1334, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34452713

RESUMEN

OBJECTIVES: To describe the main features of a pharmaceutical market in which the duration of guaranteed monopoly periods would correspond to a new pharmaceutical product's value. METHODS: After reviewing patent and regulatory exclusivity-based mechanisms for protecting prescription drug markets from competition to incentivize drug innovation in developed countries, we model market protection mechanisms within the current framework to give the longest-lasting market protections to drug developers that bring the most affordable products to market with highest public health and clinical value. RESULTS: An approach tying pharmaceutical market exclusivity to value would have 3 main features. First, it would be based on regulatory exclusivity (ie, the drug regulator refrains from authorizing generic entry for a certain amount of time), rather than patents. Second, the duration of exclusivity period would be pegged to the magnitude of a product's anticipated health impact and its proposed price by using modified methods from the field of health technology assessment. Third, the duration of the value-based exclusivity period would be reassessed routinely 3 years after the product's launch to account for its real-world effectiveness. CONCLUSIONS: Linking a drug's proposed price to the duration of its regulatory-based exclusivities would both incentivize the development of high impact, low-cost products and motivate drug developers to introduce these products at lower prices.


Asunto(s)
Desarrollo de Medicamentos , Patentes como Asunto , Medicamentos bajo Prescripción/economía , Evaluación de la Tecnología Biomédica , Análisis Costo-Beneficio , Desarrollo de Medicamentos/legislación & jurisprudencia , Control de Medicamentos y Narcóticos , Medicamentos Genéricos , Reforma de la Atención de Salud , Humanos , Salud Pública
20.
CJC Open ; 3(6): 703-713, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34169249

RESUMEN

BACKGROUND: A range of first-line similarly effective medications ranging in price are recommended for treating uncomplicated hypertension. Considering drug costs alone, thiazides and thiazide-like diuretics are the most cost-efficient option. We determined incident prescribing of thiazides for newly diagnosed hypertension as first-line treatment in Alberta, factors that predicted receiving thiazides vs more costly medications, and how much could be saved if more patients were prescribed thiazides. METHODS: Using a retrospective cohort design, factors predicting receiving thiazides vs other agents were determined using mixed effects logistic regression. Cost savings were simulated by shifting patients from other antihypertensive medications to thiazides and calculating the difference. RESULTS: Within our cohort of 89,548 adults, only 12% received thiazides as first-line treatment whereas 44% received angiotensin converting enzyme inhibitors, 17% received angiotensin receptor blockers, 16% received calcium channel blockers, and 10% received ß-blockers. Antihypertensive medications were typically prescribed by office-based, general practitioners (88%). Being male and receiving a prescription from a physician with ≥ 20 years of practice and a high clinical workload were associated with increased odds of receiving nonthiazides. In the extreme case that all patients received thiazides as their first prescription, spending would have been reduced by a maximum of 95% (CAD$1.8 million). CONCLUSIONS: Only 12% of Albertan adults with incident, uncomplicated hypertension were prescribed thiazides as first-line treatment. With the opportunity for drug cost savings, future research should evaluate the risk of adverse events and side effects across the drug classes and whether the costs associated with managing those risks could offset the savings achieved through increased thiazide use.


CONTEXTE: De nombreux médicaments tous aussi efficaces les uns que les autres, mais de prix variable, sont recommandés pour le traitement de première intention de l'hypertension non compliquée. Si l'on tient compte du coût du médicament seulement, les thiazides et les diurétiques apparentés aux thiazides sont les options les plus économiques. Nous avons évalué le taux de prescription d'un thiazide pour le traitement de première intention de l'hypertension nouvellement diagnostiquée en Alberta, les facteurs de prédiction de la prescription d'un thiazide plutôt que d'un autre médicament plus coûteux, ainsi que les économies qui pourraient être réalisées si on prescrivait un thiazide à un plus grand nombre de patients. MÉTHODOLOGIE: Dans le cadre de notre étude de cohorte rétrospective, nous avons déterminé les facteurs de prédiction de la prescription d'un thiazide plutôt que d'un autre agent à l'aide d'une régression logistique à effets mixtes. Nous avons simulé les économies qui pourraient être réalisées en faisant passer à un thiazide les patients à qui un autre médicament antihypertenseur a été prescrit et en calculant la différence. RÉSULTATS: Dans notre cohorte de 89 548 adultes, seulement 12 % des patients ont reçu un thiazide en première intention; 44 % ont reçu un inhibiteur de l'enzyme de conversion de l'angiotensine; 17 %, un antagoniste des récepteurs de l'angiotensine; 16 %, un inhibiteur calcique; et 10 %, des bêtabloquants. Les agents antihypertenseurs sont généralement prescrits par des omnipraticiens en cabinet (88 %). Le fait d'être un homme et le fait d'obtenir une prescription auprès d'un médecin exerçant depuis au moins 20 ans et ayant une lourde charge de travail clinique étaient associés à une probabilité supérieure de recevoir un agent autre qu'un thiazide. Dans le cas extrême où tous les patients se verraient prescrire un thiazide en première intention, la réduction des dépenses pourrait atteindre 95 % (soit 1,8 million de dollars canadiens). CONCLUSIONS: En Alberta, un thiazide a été prescrit en première intention à seulement 12 % des adultes venant de recevoir un diagnostic d'hypertension non compliquée. Compte tenu des économies qui pourraient être réalisées si un thiazide était prescrit dans ce contexte, il conviendrait d'effectuer des recherches plus poussées pour évaluer le risque de manifestations indésirables et d'effets secondaires associé aux différentes classes de médicaments, et pour déterminer si les coûts liés à la prise en charge de ce risque annuleraient les économies réalisées en augmentant le recours aux thiazides.

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