[Judicialization of high priced medications in Argentina: quali-quantitative study]. / Judicialización de medicamentos de alto precio en Argentina: estudio cuali-cuantitativo.

INTRODUCTION: The economic consequences of mandatory coverage, through judicial means, of high-priced medications constitutes a growing problem, which merits knowing its local characteristics to provide possible solutions. OBJECTIVE: To identify medications, diseases involved, economic impact and contextual factors of the judicialization of high-priced medications in the Argentine Health System(MEP). METHODS: Quali-quantitative descriptive study that retrospectively analyzed legal protection resources by MEP from three national and provincial databases from January 2017 to December 2020, evaluating the existing relationship between lawsuits with regulatory approval, inclusion in benefit packages and relationship with journalistic articles for the three most frequently prosecuted drugs. RESULTS: 405 lawsuits were included, mainly from the Ministry of National Health. The three most prosecuted medications were nusinersen (21.7%), palbociclib (5.9%) and agalsidase-alfa (4.7%). Only 69.4% of medications were approved for marketing in Argentina at the time of the protection; 45.7% were incorporated into the Single Reimbursement System, and 16.8% had a report from the National Commission for the Evaluation of Health Technologies and Clinical Excellence (CONETEC), which was negative in 87.1% of cases. The average time from request to provision of the medication was 150 days. A temporal correlation was observed between the appearance of the MEP in the national graphic press and the appeals occurrence. CONCLUSIONS: Judicialization focused on very highpriced medications for rare or oncological diseases. The rulings were mostly in favor of the plaintiff, and access times to the medication took a long time. The mass media anticipated the judicial processes.

Introducción: Las consecuencias económicas de la cobertura obligatoria, vía judicial, de medicamentos de alto precio constituye un problema creciente, que amerita conocer sus características locales para aportar posibles soluciones. OBJETIVO: Identificar medicamentos, enfermedades, impacto económico y factores contextuales de la judicialización de medicamentos de alto precio (MEP) Argentina. Métodos: Estudio descriptivo cuali-cuantitativo que analizó retrospectivamente recursos de amparos legales por MEP de tres bases de datos nacionales y provinciales durante 4 años, evaluando relación existente entre amparos con aprobación regulatoria, inclusión de los MEP al paquete de beneficios y relación con notas periodísticas. RESULTADOS: Se incluyeron 405 amparos provenientes principalmente del Ministerio de Salud Nacional. Los tres medicamentos más judicializados fueron nusinersen (21.7%), palbociclib (5.9%) y agalsidasa-alfa (4.7%). Solo el 69.4% de los medicamentos se encontraban aprobados para la comercialización en Argentina al momento del amparo; el 45.7% se encontraban incorporados al Sistema Único de Reintegros y el 16.8% contaban con informe de la Comisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica (CONETEC), negativa en el 87.1% de casos. El tiempo promedio desde la solicitud hasta la provisión del medicamento fue de 150 días. Se observó una correlación temporal entre la aparición del MEP en la prensa nacional gráfica y la presentación de amparos de dicho MEP. CONCLUSIONES: La judicialización se concentró en medicamentos de altísimo precio para enfermedades poco frecuentes u oncológicas. Los fallos fueron mayoritariamente a favor del demandante, siendo los tiempos de acceso al medicamento prolongados. Los medios de comunicación anticiparon los procesos judiciales.

Patología tendinosa en pacientes con placa bloqueada palmar de radio distal: incidencia y resultado clínico del tratamiento / Tendon pathology in patients with distal radius palmar locked plate: incidence and clinical outcome of their treatment

Introducción: El objetivo de este estudio es comunicar la incidencia de complicaciones tendinosas en pacientes con fracturas de radio distal tratados con placa bloqueada palmar y el resultado clínico del tratamiento mediante la sola extracción del implante. Materiales y Métodos: Se realizó una evaluación retrospectiva de 992 pacientes con fracturas de radio distal. Se incluyó a quienes se les extrajo la placa por irritación o rotura tendinosa. La evaluación final de los resultados, una vez extraído el implante, se efectuó con el puntaje DASH y una escala analógica visual de 0 a 10 para dolor en reposo, durante la actividad y para el resultado funcional. Resultados: Treinta y cuatro pacientes tuvieron complicaciones tendinosas: 20 tendinitis de flexores (2%), 13 tendinitis de extensores (1,3%) y una rotura de tendón flexor. Todos fueron tratados sólo con extracción del implante. En la escala analógica visual, los pacientes con tendinitis flexora obtuvieron un puntaje de 1 para dolor en reposo, de 1 para dolor durante la actividad y de 8 para resultado funcional, y un puntaje DASH de 13. La evaluación final promedio de los pacientes con tendinitis extensora fue: dolor en reposo 0, dolor durante la actividad 3, funcional 9 y DASH 15, respectivamente. Conclusiones: La incidencia de complicaciones tendinosas en el tratamiento de las fracturas de radio distal con placas palmares es baja. El tratamiento precoz mediante la sola extracción del implante lleva a la desaparición de los síntomas y evita la rotura tendinosa. Nivel de Evidencia: IV

Introduction: The aim of this paper is to report the incidence of tendon complications in patients with distal radius fractures treated with volar locking plates and the clinical results after plate removal. Methods: A total of 992 patients with distal radial fracture treated with volar locking plates were retrospectively evaluated. Cases with plate removal due to tendon irritation were included in this study. Clinical results were evaluated using DASH score and a visual analogue scale for pain at rest, during activity and functional result. Results: Thirty-four patients had tendon complications: 20 with flexor tendonitis (2%), 13 with extensor tendonitis (1.3%), and a flexor tendon rupture. All cases were treated only with implant removal. Final mean results were: visual analogue scale, 1 for pain at rest, 1 for pain during activity, and 8 for function; DASH score 13 in patients with flexor tendinitis; and 0, 3, 9, respectively, and DASH score 15 for those with extensor tenosinovitis. Conclusions: Tendon complications are infrequent in patients with distal radial fractures treated with volar locking plate. The early removal of the implant improves tendon irritation symptoms and prevents tendon rupture. Level of Evidence: IV

Inestabilidad posterolateral cronica de codo. reconstruccion ligamentaria / Chronic posterolateral elbow instability. ligament reconstruction

Introducción: El objetivo de este trabajo es evaluar los resultados de una serie de pacientes con inestabilidad posterolateral crónica de codo, tratados con reconstrucción del ligamento colateral cubital con injerto tendinoso. Materiales y Métodos: Se presentan 10 pacientes, con una edad promedio de 47 años. El tiempo entre la luxación y la cirugía fue de 16 meses. El pivot shift test bajo anestesia fue positivo en todos los casos. Bajo control radioscópico, siete pacientes tenían un estadio 1 de Horii; dos, estadio 3 y uno tenía un estadio 2. En la mayoría de los casos, se utilizó el tendón del palmar menor. El seguimiento promedio fue de 21 meses. Resultados: La flexo-extensión fue de 126-3º. El dolor fue 0 en reposo y 1 en actividad, según la escala analógica visual. El puntaje DASH promedio fue 12 y el de la Clínica Mayo de 95. Ningún paciente reportó sensación de inestabilidad. El pivot shift test con el paciente despierto fue negativo en todos los casos. Conclusiones: La reconstrucción del ligamento lateral del codo con injerto tendinoso en pacientes con inestabilidad posterolateral crónica es eficaz para lograr la estabilidad articular. Los mejores resultados se observaron en pacientes con estadios 1 y 2 de inestabilidad. No hubo casos de inestabilidad residual.

Introduction: The objective of this paper is to evaluate the results of a series of patients with posterolateral elbow instability treated with reconstruction of the ulnar collateral ligament using tendon graft. Methods: We reported 10 patients with a mean age of 47 years. Time from posterolateral dislocation to surgery was 16 months. The pivot shift test under anesthesia was positive in all patients. Seven patients had stage 1 instability according to Horii, one patient with stage 2 and two patients with stage 3 under fluoroscopy. Palmaris minor was the most common tendon used for reconstruction. Follow-up was 21 months. Results: Flexo-extension was 126-3º. Pain according to visual analogue scale was 0 at rest and 1 in activity. DASH score was 12 and Mayo Clinic score was 95. Sensation of instability was not reported by any patient. The pivot shift test in an awake patient was always negative. Conclusions: Ulnar collateral ligament reconstruction with tendon graft in patients with posterolateral elbow instability is useful to restore joint stability. Best results were observed in patients with stage 1 or 2 instability according to Horii. Residual instability was not observed.

The use of dynamic orthoses in the treatment of the stiff elbow.

The purpose of this study is to evaluate the outcomes of the treatment of stiff elbow with the use of dynamic orthoses. We included 30 patients with stiff elbow with an arc of mobility of 100° or less and a stable and congruent joint without heterotopic ossifications. The dynamic orthosis was designed in our service and consists of an articulated brace with springs. Mean previous mobility was 109°-41°, with an average arc of motion of 68°. Its use began 78 days after surgery or trauma and continued for 75 days. Statistical analysis was performed. Average follow-up was 23 months. Postoperative mobility was 126°-21° with an improvement of 37° of mobility. Ten patients did not recover a functional range of motion. Twenty-three patients were satisfied with the treatment and seven were unsatisfied with the use of the orthosis. Our results suggest that dynamic orthoses are useful in the treatment of stiff elbow. We achieved a mean improvement of 37° in the arc of motion, which in many cases has rendered arthrolysis unnecessary. The major strength of this paper is the practical application of the orthosis and its relatively easy manufacture.

Chronic scapholunate dissociation: ligament reconstruction combining a new extensor carpi radialis longus tenodesis and a dorsal intercarpal ligament capsulodesis.

Scapholunate dissociation (SLD) is the commonest cause of carpal instability and wrist osteoarthrosis. The value of early diagnosis and treatment of this injury is well established in the literature. When a partial or total rupture of the scapholunate ligament is treated with early anatomic reduction and repair, functional results may be good to excellent. However, if this ligament is not addressed acutely then an overall carpal malalignment may seem progressively as a result of failure of the secondary scaphoid stabilizers. Chronic SLD will lead to scapholunate advanced collapse and progressive painful arthritis of the wrist. Although most surgeons agree that operative intervention is indicated, no clear consensus exists on the best treatment for patients with chronic SLD. Several procedures have been described that include some sort of partial fusion, capsulodesis, tenodesis, or bone-ligament-bone graft. If there is no evidence for arthrosis, soft-tissue procedures using either capsulodesis or tenodesis may be carried out in an attempt to preserve radiocarpal and intercarpal motion whereas avoiding fusion. This article describes a scapholunate ligament reconstruction combining a new dorsal extensor carpi radialis longus tenodesis and a dorsal capsulodesis for the treatment of chronic SLD.

Four-corner arthrodesis: influence of the position of the lunate on postoperative wrist motion: a cadaveric study.

PURPOSE: Evaluate the influence of the position of the lunate on postoperative wrist motion in four-corner arthrodesis. METHODS: Six upper cadaveric limbs were evaluated, comparing the total arc of motion in each wrist after simulating four-corner arthrodesis. The lunate was fixed in 3 different positions: neutral (0 degrees ), extended (30 degrees ), and flexed (20 degrees ). Statistical analyses (ANOVA and Bonferroni tests) were carried out to establish the significance of differences in articular motion in these 3 positions. RESULTS: Significant statistical differences were observed in full wrist extension. No significant differences, however, were found in flexion-extension total arc of motion, radial deviation, or ulnar deviation. CONCLUSIONS: According to our results in this cadaveric model, the position of the lunate affects postoperative wrist flexion and extension after four-corner arthrodesis. The flexed lunate position increases postoperative wrist extension and restrains wrist flexion. Inversely, the extended lunate position improves articular flexion and limits extension. Total arc of motion of the fused wrist does not vary in the 3 lunate positions.