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1.
Clin Ther ; 2024 Jul 21.
Artículo en Inglés | MEDLINE | ID: mdl-39039006

RESUMEN

PURPOSE: Variations in US commercial health plan coverage policies affect how patients access medications. Plans may vary in treatment access criteria, line of therapy, and prescriber requirements. In this study, we examined coverage of esketamine hydrochloride (Spravato) for major depressive disorder (MDD) and treatment-resistant depression (TRD) to answer the following question: how do US commercial health plans cover esketamine, and how do they guide prompt patient access to the drug? METHODS: We used information from the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes coverage policies issued by 18 large commercial health plans in the United States. Esketamine coverage policies for MDD and TRD active in December 2022 were collated and analyzed. We compared coverage policies according to step therapy protocols, patient subgroup restrictions, and prescriber requirement criteria, evaluating patient access using the number of restrictions and proportion of plans including each criterion. FINDINGS: Plans more often imposed step therapy requirements for access to esketamine for TRD than for MDD, with line of treatment of ≤9 steps for MDD compared with 1 to 5 steps for TRD. Plans also varied with respect to the therapies they required patients to first try and experience treatment failure before granting access to esketamine for both indications. Clinical coverage requirements varied in thresholds and rating scales used to assess severity of depressive symptoms. IMPLICATIONS: Plans vary in terms of line of therapy and clinical coverage requirements for access to esketamine. Variation in health plan coverage policies may result in inequitable access and added complexity for patients and clinicians navigating care, which may delay access to urgent treatment. GOV IDENTIFIERS: Not applicable.

2.
J Pers Med ; 14(6)2024 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-38929814

RESUMEN

Current United States Preventive Services Task Force (USPSTF) recommendations include routine screening for breast, cervical, colorectal, and lung cancer; however, two out of every three cancer cases occur in other indications, leading to diagnoses in advanced stages of the disease and a higher likelihood of mortality. Blood-based multi-cancer early detection (MCED) tests can impact cancer screening and early detection by monitoring for multiple different cancer types at once, including indications where screening is not performed routinely today. We conducted a survey amongst healthcare providers (HCPs), payers, and patients within the U.S. health system to understand the current utilization of cancer screening tests and the anticipated barriers to widespread adoption of blood-based MCED tests. The results indicated that the community favors the adoption of blood-based MCED tests and that there is broad agreement on the value proposition. Despite this recognition, the survey highlighted that there is limited use today due to the perceived lack of clinical accuracy and utility data, high out-of-pocket patient costs, and lack of payer coverage. To overcome the hurdles for future widespread adoption of blood-based MCED tests, increased investment in data generation, education, and implementation of logistical support for HCPs will be critical.

3.
Inquiry ; 61: 469580241249092, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38742676

RESUMEN

Healthcare organizations increasingly engage in activities to identify and address social determinants of health (SDOH) among their patients to improve health outcomes and reduce costs. While several studies to date have focused on the evolving role of hospitals and physicians in these types of population health activities, much less is known about the role health insurers may play. We used data from the National Longitudinal Survey of Public Health Systems for the period 2006 to 2018 to examine trends in health insurer participation in population health activities and in the multi-sector collaborative networks that support these activities. We also used a difference-in-differences approach to examine the impact of Medicaid expansion on insurer participation in population health networks. Insurer participation increased in our study period both in the delivery of population health activities and in the integration into collaborative networks that support these activities. Insurers were most likely to participate in activities focusing on community health assessment and policy development. Results from our adjusted difference-in-differences models showed variation in association between insurer participation in population health networks and Medicaid expansion (Table 2). Population health networks in expansion states experienced significant increases insurer participation in assessment (4.48 percentage points, P < .05) and policy and planning (7.66 percentage points, P < .05) activities. Encouraging insurance coverage gains through policy mechanisms like Medicaid expansion may not only improve access to healthcare services but can also act as a driver of insurer integration into population health networks.


Asunto(s)
Aseguradoras , Seguro de Salud , Medicaid , Salud Poblacional , Humanos , Estados Unidos , Estudios Longitudinales , Seguro de Salud/estadística & datos numéricos , Medicaid/estadística & datos numéricos , Aseguradoras/estadística & datos numéricos , Aseguradoras/tendencias , Determinantes Sociales de la Salud
4.
AANA J ; 92(1): 41-48, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38289686

RESUMEN

We sought to establish commercial rate benchmarks specific to certified registered nurse anesthetist (CRNA) anesthesia delivery models (QZ), quantify any payer disparities discovered between CRNAs and anesthesiologists, and determine payer alignment with nondiscrimination provisions of the Affordable Care Act (ACA). The Lewin Group administered the exploratory, descriptive study of QZ billing practices by surveying a targeted cross-section of 345 CRNAs known for QZ billing. Forty-one respondents reported information from 1,089 CRNAs and 351,920 cases with 127,888 commercial claims billed under 144 unique commercial contracts as performed in 2019. There was a 24% payer disparity in rates negotiated reported between anesthesia providers: CRNAs overall average of $58.62; $55.33-$64.57, compared with anesthesiologist average of $77.01 overall; $73.79-$80.76. Other findings included QZ payment adjustments, denials for reimbursement, and exclusion from plan participation. The study found disparities in rate and discriminatory payer practices specific to CRNA contracting and reimbursement, which suggests payer misalignment with nondiscrimination provisions of the ACA.


Asunto(s)
Anestesiólogos , Médicos , Estados Unidos , Humanos , Enfermeras Anestesistas , Patient Protection and Affordable Care Act , ARN Complementario
5.
Expert Rev Pharmacoecon Outcomes Res ; 24(2): 293-301, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37883069

RESUMEN

OBJECTIVE: To understand the use of alternative payment models to address the reimbursement challenges of cell and gene therapies (CGT) in the U.S.A.. METHODS: A literature search focused on CGT reimbursement in the U.S. market was conducted to identify information gaps and inform survey development. U.S. developers (n = 100) and payers (n = 195) were invited to complete an online survey between June and August 2022. RESULTS: The overall response rate was 16%; payer respondents represented 98 plans covering 338 million lives. Most developers (81%) and payers (84%) had implemented or were planning to implement at least one alternative payment model. Payers pursued these models to 'reduce product performance uncertainties' (81%), 'align therapy costs with benefits' (58%), and 'manage actuarial uncertainty' (54%). Developers aimed to 'streamline patient access' (92%) and 'mitigate budget impact' (77%). Common perceived barriers included increased administrative burden (developers 79% and payers 67%), defining performance measures (developers 71%, payers 83%) and addressing patient mobility (developers 71% and payers 63%). Both parties expressed a willingness to use real-world evidence for contract adjudication. CONCLUSION: Although limited by the number of participants, this survey indicates early discussions coupled with understanding motivations are essential for developing contracts that appeal to both parties and ensure patient access.

6.
J Comp Eff Res ; 12(12): e230073, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37916709

RESUMEN

A decision analytic model was constructed to assess the cost-effectiveness of obinutuzumab plus bendamustine followed by obinutuzumab maintenance therapy (O-B-O) in Chinese patients with relapsed and refractory follicular lymphoma (rrFL). O-B-O was associated with a dominant or more favorable cost-effectiveness than the conventional therapies. Survival outcomes, quality of life of progression-free survival, and subsequent treatment costs for progressive disease were the main drivers of the cost-effectiveness of O-B-O. The cost-effectiveness proportions of O-B-O relative to conventional therapies under the recommended cost-effectiveness threshold ranged from 61.0% to 99.9%. Thus, O-B-O was highly cost-effective for treating patients with rrFL in China compared with conventional therapies.


Asunto(s)
Anticuerpos Monoclonales Humanizados , Clorhidrato de Bendamustina , Linfoma Folicular , Humanos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Clorhidrato de Bendamustina/uso terapéutico , Análisis Costo-Beneficio , Pueblos del Este de Asia , Linfoma Folicular/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Calidad de Vida , Anticuerpos Monoclonales Humanizados/uso terapéutico
7.
Heliyon ; 9(10): e20842, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37886771

RESUMEN

This study aimed to develop reference curves of aerobic parameters of 20 m shuttle run test for Tunisian soccer players. The study was conducted in the 2022/2023 pre-season. The reference curves of the maximal aerobic speed (MAS) and the maximal oxygen uptake (VO2max) were developed according to the Lambda, Mu and Sigma (LMS) method, using data from 742 Tunisian premier league soccer players aged 11-18 years. Measured variables included: weight, height, body mass index and maximal heart rate (HRmax). HRmax was measured when the participants completed the maximal aerobic speed. VO2max was estimated using the 20 m shuttle run test protocol (speed increment every minute). Our results presented the smoothed percentiles (3rd, 10th, 25th, 50th, 75th, 90th and 97th) of MAS (km/h) and VO2max (ml/kg•min⁻1) according to age. In addition, raw data showed that VO2 max was positively correlated with age (r = 0.333; P < 0.001), height (cm) (r = 0.279; P < 0.001), weight (kg) (r = 0.266; P < 0.001), practice period (years) (r = 0.324; P < 0.001) and BMI (kg/m2) (r = 0.10; P < 0.05). However, it was negatively correlated to HRmax (bpm) (r = -0.247; P < 0.001). Only the measurements within the age group [12-12.99] are significantly higher (p < 0.001; ES = 0.63) compared with the previous age group [11-11.99]. Finally, regarding prevalence, our findings showed that 15.5 % of the players in our sample had VO2max values above the 87.7th percentile cut-off, while only 0.3 % exceeded the 99.18th percentile. The development of normative curves could help coaches and physical trainers to more accurately detect weaknesses in the aerobic performance of their players in order to sustain high-intensity repetitive actions during a soccer match.

8.
Health Care Anal ; 31(3-4): 156-168, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37498417

RESUMEN

Rising health insurance costs and the cost of living crisis are likely leading to an increase in unpaid health insurance bills in many countries. In Switzerland, a particularly drastic measure to sanction defaulting insurance payers is employed. Since 2012, Swiss cantons - who have to cover most of the bills of defaulting payers - are allowed by federal law to blacklist them and to restrict their access to medical care to emergencies.In our paper, we briefly describe blacklisting in the context of the Swiss healthcare system before we examine the ethical issues involved in light of what is known about its social and health impacts. We found no evidence that blacklisting serves as an effective way of recovering unpaid health insurance contributions or of strengthening solidarity within the health insurance system. Furthermore, the ambiguous definitions of what constitutes an emergency treatment and the incompatibility of the denial of medical care with the obligation to provide professional assistance complicate the implementation of blacklists and expose care providers to enormous pressure.Therefore, we conclude that blacklists and the (partial) denial of medical care not only pose profound ethical problems but are also unsuitable for fulfilling the purpose for which they were introduced.


Asunto(s)
Atención a la Salud , Seguro de Salud , Humanos , Costos y Análisis de Costo , Suiza
9.
Surg Endosc ; 37(10): 7642-7648, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37491660

RESUMEN

INTRODUCTION: Obesity is an increasingly prevalent public health problem often associated with poorly controlled gastroesophageal reflux disease. Fundoplication has been shown to have limited long-term efficacy in patients with morbid obesity and does not address additional weight-related co-morbidities. Roux-en-Y gastric bypass (RYGB) is the gold standard operation for durable resolution of GERD in patients with obesity, and is also used as a salvage operation for GERD after prior foregut surgery. Surgeons report access to RYGB as surgical treatment for GERD is often limited by RYGB-specific benefit exclusions embedded within insurance policies, but the magnitude and scope of this problem is unknown. METHODS: A 9-item survey evaluating surgeon practice and experience with insurance coverage for RYGB for GERD was developed and piloted by a SAGES Foregut Taskforce working group. This survey was then administered to surgeon members of the SAGES Foregut Taskforce and to surgeons participating in the SAGES Bariatrics and/or Foregut Facebook groups. RESULTS: 187 surgeons completed the survey. 89% reported using the RYGB as an anti-reflux procedure. 44% and 26% used a BMI of 35 kg/m2 and 30 kg/m2 respectively as cutoff for the RYGB. 89% viewed RYGB as the procedure of choice for GERD after bariatric surgery. 69% reported using RYGB to address recurrent reflux secondary to failed fundoplication. 74% of responders experienced trouble with insurance coverage at least half the time RYGB was offered for GERD, and 8% reported they were never able to get approval for RYGB for GERD indications in their patient populations. CONCLUSION: For many patients, GERD and obesity are related diseases that are best addressed with RYGB. However, insurance coverage for RYGB for GERD is often limited by policies which run contrary to evidence-based medicine. Advocacy is critical to improve access to appropriate surgical care for GERD in patients with obesity.


Asunto(s)
Derivación Gástrica , Reflujo Gastroesofágico , Seguro , Obesidad Mórbida , Cirujanos , Humanos , Derivación Gástrica/métodos , Reflujo Gastroesofágico/cirugía , Reflujo Gastroesofágico/complicaciones , Obesidad Mórbida/cirugía , Obesidad Mórbida/complicaciones , Estudios Retrospectivos , Resultado del Tratamiento
10.
J Shoulder Elbow Surg ; 32(11): 2222-2231, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37247779

RESUMEN

BACKGROUND: The incidence of shoulder arthroplasty has continued to increase over the past decade. In response, commercial payers have implemented strategies to control the medical requirement of these surgeries in attempt to contain the growing costs. For example, most payers require a prolonged trial of conservative management prior to shoulder arthroplasty for patients who may otherwise be surgical candidates. However, little is known regarding the evidence used to support these indications. The purpose of this study was to analyze the references used by commercial payers to substantiate their coverage policies for shoulder arthroplasty. METHODS: Ten of the leading commercial payers for total shoulder arthroplasty were identified. Publicly available coverage policies were searched on the internet or requested directly from the payer via email or telephone. Cited references were reviewed independently by two authors for type of document, level of evidence, and mention of the efficacy of conservative management. RESULTS: A total of 5 coverage policies were obtained with 118 references. The most common reference type was primary journal article (n = 70; 59.3%) followed by review or expert opinion articles (n = 35; 29.7%). Most references were of level IV evidence (n = 60; 52.2%), with only 6 (5.2%) of level I or II evidence. Only 4 (3.5%) references mentioned the efficacy of conservative management in patients who may be candidates for shoulder arthroplasty. CONCLUSION: The majority of references used to substantiate the coverage policies for shoulder arthroplasty among major commercial payers within the United States are of low scientific evidence and fail to demonstrate the success of required nonoperative intervention strategies. Our study underscores the need for high-quality, comparative trials that evaluate the outcomes of conservative management vs. shoulder arthroplasty in end-stage glenohumeral osteoarthritis patients in order to determine the most cost-effective treatment algorithm.

11.
Int J Technol Assess Health Care ; 38(1): e79, 2022 Nov 02.
Artículo en Inglés | MEDLINE | ID: mdl-36321447

RESUMEN

Advances in the digitization of health systems and expedited regulatory approvals of innovative treatments have led to increased potential for the use of real-world data (RWD) to generate real-world evidence (RWE) to complement evidence from clinical trials. However, health technology assessment (HTA) bodies and payers have concerns about the ability to generate RWE of sufficient quality to be pivotal evidence of relative treatment effectiveness. Consequently, there is a growing need for HTA bodies and payers to develop guidance for the industry and other stakeholders about the use of RWD/RWE to support access, reimbursement, and pricing. We therefore sought to (i) understand barriers to the use of RWD/RWE by HTA bodies and payers; (ii) review potential solutions in the form of published guidance; and (iii) review findings with selected HTA/payer bodies. Four themes considered key to shaping the generation of robust RWE for HTA bodies and payers were identified as: (i) data (availability, governance, and quality); (ii) methodology (design and analytics); (iii) trust (transparency and reproducibility); and (iv) policy and partnerships. A range of guidance documents were found from trusted sources that could address these themes. These were discussed with HTA experts. This commentary summarizes the potential guidance solutions available to help resolve issues faced by HTA decision-makers in the adoption of RWD/RWE. It shows that there is alignment among stakeholders about the areas that need improvement in the development of RWE and that the key priority to move forward is better collaboration to make data usable for multiple purposes.


Asunto(s)
Evaluación de la Tecnología Biomédica , Confianza , Evaluación de la Tecnología Biomédica/métodos , Reproducibilidad de los Resultados
12.
BMC Pregnancy Childbirth ; 22(1): 700, 2022 Sep 12.
Artículo en Inglés | MEDLINE | ID: mdl-36096759

RESUMEN

BACKGROUND: Maternal mental health conditions (MMHCs), which include depression and anxiety disorders during pregnancy and through five years postpartum, are among the most common obstetric complications in the United States overall and in Texas in particular. In the context of potential expansion of postpartum Medicaid coverage from 60 days to one year, we sought to capture the societal, financial burden of untreated MMHCs. METHODS: We estimated the economic impact of untreated maternal mental health conditions (MMHCs) among births in Texas in 2019 using a cost-of-illness model. RESULTS: We found that MMHCs affected 13.2% of mothers and, when left untreated, cost $2.2 billion among mothers and children born in Texas in 2019 when following the birth cohort from conception through five years postpartum. We found that MMHCs affected 17.2% of mothers enrolled in Texas' Medicaid for Pregnant Women and cost $962 million. In addition, the prevalence of MMHCs and resulting costs varied considerably among women of different races and ethnicities. Employers and health care payers, including Medicaid, bore most of these costs. CONCLUSIONS: The Texas Health and Human Services Commission's (HHSC) efforts to increase awareness about MMHCs and increase access to care represent an important step toward improving maternal and child health and maximizing benefits to Texas HHSC, employers, and insurers.


Asunto(s)
Trastornos Mentales , Salud Mental , Niño , Femenino , Humanos , Salud Materna , Medicaid , Trastornos Mentales/epidemiología , Trastornos Mentales/psicología , Embarazo , Texas/epidemiología , Estados Unidos/epidemiología
13.
Int J Cardiol ; 365: 61-68, 2022 10 15.
Artículo en Inglés | MEDLINE | ID: mdl-35905826

RESUMEN

Regulatory approvals of, and subsequent access to, innovative cardiovascular medications have declined. How much of this decline relates to the final step of gaining reimbursement for new treatments is unknown. Payers and health technology assessment (HTA) bodies look beyond efficacy and safety to assess whether a new drug improves patient outcomes, quality of life, or satisfaction at a cost that is affordable compared to existing treatments. HTA bodies work within a limited healthcare budget, and this is one of the reasons why only half of newly approved drugs are accepted for reimbursement, or receive restricted or "optimised" recommendations from HTA bodies. All stakeholders have the common goal of facilitating access to safe, effective, and affordable treatments to appropriate patients. An important strategy to expedite this is providing optimal data. This is demonstrably facilitated by early (and ongoing) discussions between all stakeholders. Many countries have formal programmes to provide collaborative regulatory and HTA advice to developers. Other strategies include aligning regulatory and HTA processes, increasing use of real-world evidence, formally defining the decision-making process, and educating stakeholders on the criteria for positive decision making. Industry should focus on developing treatments for unmet medical needs, seek early engagement with HTA and regulatory bodies, improve methodologies for optimal price setting, develop internal systems to collaborate with national and international stakeholders, and conduct post-approval studies. Patient involvement in all stages of development, including HTA, is critical to capture the lived experience and priorities of those whose lives will be impacted by new treatment approvals.


Asunto(s)
Calidad de Vida , Evaluación de la Tecnología Biomédica , Humanos
14.
Health Policy ; 126(9): 853-864, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35773063

RESUMEN

Strategic purchasing is a popular and frequently proposed policy for improving the efficiency and adaptiveness of health systems. The COVID-19 pandemic shocked health systems, creating a test of the adaptability and resiliency of their key features. This research study explores (i) what role purchasing systems and agents played in the COVID-19 pandemic, (ii) if it was strategic, and (iii) how it has contributed to a resilient health system. We conducted a qualitative, comparative study of six countries in the European Union-focusing on three as in-depth case studies-to understand how and when strategic purchasers responded to seven clearly defined health system "shocks" that they all experienced during the pandemic. We found that every case country relied on the federal government to fund and respond to the pandemic. Purchasers often had very limited, and if any then only passive, roles.


Asunto(s)
COVID-19 , Europa (Continente)/epidemiología , Programas de Gobierno , Humanos , Pandemias/prevención & control , Investigación Cualitativa
15.
Orphanet J Rare Dis ; 17(1): 181, 2022 05 07.
Artículo en Inglés | MEDLINE | ID: mdl-35526001

RESUMEN

Rare disease patients face many challenges including diagnostic delay, misdiagnosis and lack of therapies. However, early access to diagnosis and therapies can modify the management and the progression of diseases, which in return positively impacts patients, families and health care systems. The International Rare Diseases Research Consortium set up the multi-stakeholder Working Group on developing methodologies to assess the impact of diagnoses and therapies on rare disease patients. Using the patients' journey on the diagnostic paradigm, the Working Group characterized a set of metrics, tools and needs required for appropriate data collection and establishment of a framework of methodologies to analyze the socio-economic burden of rare diseases on patients, families and health care systems. These recommendations are intended to facilitate the development of methodologies and to better assess the societal impact of rare diseases.


Asunto(s)
Diagnóstico Tardío , Enfermedades Raras , Humanos , Enfermedades Raras/diagnóstico , Enfermedades Raras/terapia
16.
Popul Health Manag ; 25(4): 472-479, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35353618

RESUMEN

In the United States, the top 1% and top 5% of health care spenders account for 23% and 50% of total health care spending, respectively. These high spenders have been coined the term super utilizers (SU). The aim of this study was to identify the characteristics associated with these patients to aid in developing public health interventions aimed at transitioning patients out of the SU category and thus ultimately helping to control health care costs. The authors utilized the Utah All-Payer Claims Database and Utah Population Database from 2013 to 2015 to identify demographics, comorbid conditions, health care utilization, and cost characteristics of persistent super utilizers (PSU) (≥3 hospitalizations per year for 3 years) of health care compared with persistent nonsuper utilizers (PNSU) (<3 hospitalizations per year for 3 years). Multivariable logistic regression was utilized to identify the characteristics associated with PSU versus PNSU. Higher outpatient/Emergency Department/noninpatient (eg, visits with imaging and Centers for Medicare & Medicaid Services preventive visits) health care utilization and spending, and prevalence of comorbid disease and psychosocial conditions were associated with PSU. In multivariable analysis, factors such as heart disease, chronic kidney disease (CKD), diabetes, alcohol abuse, and depression were statistically significantly associated with higher odds of PSU, with the most noteworthy being CKD (odds ratio [OR] 6.85, 95% confidence interval [95% CI] 5.84-8.02; P < 0.001), alcohol abuse (OR 5.90, 95% CI 4.49-7.69; P < 0.001), and heart diseases (OR 4.41, 95% CI 3.74-5.18; P < 0.001). The annual health care cost of a PSU is about 11.5 times greater than a PNSU ($54,776 vs. $4801; P < 0.001).


Asunto(s)
Alcoholismo , Insuficiencia Renal Crónica , Adulto , Anciano , Atención a la Salud , Costos de la Atención en Salud , Humanos , Medicare , Aceptación de la Atención de Salud , Estudios Retrospectivos , Estados Unidos/epidemiología , Utah/epidemiología
17.
J Comp Eff Res ; 11(7): 499-511, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35296149

RESUMEN

Aim: The credibility and value of real-world evidence (RWE) are either supported or undermined by the algorithms (i.e., operational definitions) used. Methods: We conducted a targeted evidence review of key RWE decision makers' published recommendations on RWE algorithms through April 2021. Stakeholders were regulatory bodies, other governmental agencies and payer organizations. Results: Our review identified recommended criteria: relevance, validity, reliability, responsiveness, transparency and replicability, safety, feasibility and quality process. Stakeholders routinely recommended accuracy measures, subgroups evaluation and specific considerations for assessing exposures and covariates and the underlying real-world data (RWD) quality. Conclusion: The importance of stakeholder guidance on fit-for-purpose RWE algorithms is growing. We highlight gaps that future guidance and stakeholder recommendations could address.


Asunto(s)
Algoritmos , Proyectos de Investigación , Recolección de Datos , Toma de Decisiones , Humanos , Reproducibilidad de los Resultados
18.
Curr Oncol ; 28(6): 5278-5294, 2021 12 11.
Artículo en Inglés | MEDLINE | ID: mdl-34940080

RESUMEN

BACKGROUND AND OBJECTIVES: Molecular genetic testing using tissue biopsies can be challenging for patients due to unfavorable tumor sites, the invasive nature of a tissue biopsy, and the added time of booking a repeat biopsy (re-biopsy). Centers in Canada have found insufficient tissue rates to be approximately 10%, and even among successful biopsies, insufficient DNA in tissue samples is approximately 16%, triggering the lengthy process of re-biopsies. Using aNSCLC as an example, this study sought to characterize the health and budget impact of alternative liquid-biopsy(LBx)-based comprehensive genomic profile (CGP) testing in tissue-limited patients (TL-LBx-CGP) from a Canadian publicly funded healthcare perspective. MATERIAL AND METHODS: An economic model was developed to estimate the incremental cost and life-years gained as a population associated with adopting TL-LBx-CGP. The eligible patient population was modeled using a top-down epidemiological approach based on the published literature and expert clinician input. Treatment allocation was modeled based on biomarker prevalence in the published literature, and the availability of funded therapies. Costs included molecular testing, as well as drug, administrative, and supportive costs, and relevant health data included median overall survival and median progression-free survival data. RESULTS: Incorporation of TL-LBx-CGP demonstrated an overall impact of $14.7 million with 168 life-years gained to the Canadian publicly funded healthcare system in the 3-year time horizon.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Canadá , Carcinoma de Pulmón de Células no Pequeñas/patología , Genómica , Humanos , Biopsia Líquida , Neoplasias Pulmonares/genética , Neoplasias Pulmonares/patología
19.
Health Policy ; 125(12): 1550-1556, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34763929

RESUMEN

Transformative cell and gene therapies have now launched worldwide, and many potentially curative cell and gene therapies are in development, offering the prospect of significant health gains for patients. Access to these therapies depend on decisions made by health technology assessment (HTA) and payer organizations. We sought to describe the emerging cell and gene therapies market access landscape by analyzing 17 US commercial payer medical policies, and HTA reports from five European countries and Canada. We found that some US health plans applied coverage restrictions more often than others (four plans applied restrictions in all decisions, while four plans applied restrictions in <30% of decisions). The European and Canadian HTA bodies recommend access to fewer therapies than US health plans, reflecting a more stringent approach in the context of limited evidence and high scientific uncertainty that is commonly associated with these treatments. Our findings suggest that patient access to approved cell and gene therapies is restricted in all regions studied, though the nature of these restrictions differs between US health plans and the European/Canada HTA recommendations. Payers, HTA groups, pharmaceutical companies, and other stakeholders should collaborate to more clearly define the "uncertainties" and develop market access policies that balance benefits of early access with ongoing data collection to close evidence gaps over time.


Asunto(s)
Evaluación de la Tecnología Biomédica , Canadá , Europa (Continente) , Humanos , Estados Unidos
20.
Artículo en Inglés | MEDLINE | ID: mdl-34501602

RESUMEN

OBJECTIVE: The Hyde Amendment and related policies limit or prohibit Medicaid coverage of abortion services in the United States. Most research on cost-related abortion barriers relies on clinic-based samples, but people who desire abortions may never make it to a healthcare center. To examine a novel, pre-abortion population, we analyzed a unique qualitative dataset of posts from Reddit, a widely used social media platform increasingly leveraged by researchers, to assess financial obstacles among anonymous posters considering abortion. METHODS: In February 2020, we used Python to web-scrape the 250 most recent posts that mentioned abortion, removing all identifying information and usernames. After transferring all posts into NVivo, a qualitative software package, the team identified all datapoints related to cost. Three qualitatively trained evaluators established and applied codes, reaching saturation after 194 posts. The research team used a descriptive qualitative approach, using both inductive and deductive elements, to identify and analyze themes related to financial barriers. RESULTS: We documented multiple cost-related deterrents, including lack of funds for both the procedure and attendant travel costs, inability to afford desired abortion modality (i.e., medication or surgical), and for some, consideration of self-managed abortion options due to cost barriers. CONCLUSIONS: Findings from this study underscore the centrality of cost barriers and third-party payer restrictions to stymying reproductive health access in the United States. Results may contribute to the growing evidence base and building political momentum focused on repealing the Hyde Amendment.


Asunto(s)
Solicitantes de Aborto , Aborto Inducido , Aborto Legal , Atención a la Salud , Femenino , Accesibilidad a los Servicios de Salud , Humanos , Medicaid , Embarazo , Estados Unidos
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