Real-World Budget Impact of Listing a Biosimilar of Rituximab.

BACKGROUND: The approval of new biosimilars by national health agencies is expected to generate significant cost savings for health care systems. This is particularly the case with the biosimilar of rituximab approved for the Canadian market in 2019. However, several uncertainties remain regarding utilization of this agent. OBJECTIVES: To determine the proportion of total annual drug expenses for each indication for rituximab in the hospital setting and to determine potential savings related to introduction of a biosimilar. METHODS: A budget impact analysis was performed through 3 real-world scenarios, based on data obtained from a large university teaching hospital for a 12-month period. RESULTS: This study involved data for 420 patients. Annual expenses for rituximab for all indications represented 7.7% of total annual drug spending for the hospital, of which 5.0% was related specifically to indications approved by Health Canada. More than 6% of the annual drug expenses was attributable to the use of rituximab for oncologic indications, including 1.8% for uses not approved by Health Canada. Overall, each 10% reduction in the price of a biosimilar of rituximab (relative to the reference rituximab) would result in annual savings of about 0.8% of total drug expenses in the hospital if a biosimilar was used for all real-world indications, whether approved by Health Canada or not. CONCLUSIONS: The introduction of a biosimilar of rituximab to the Canadian market would generate significant savings. To properly assess the potential savings that this agent could generate in the limited budget environment of a hospital, it seems important to consider all of the indications for which it could be used.

CONTEXTE: On s'attend à ce que l'approbation de médicaments biosimilaires par les agences de santé nationales génèrent des économies importantes pour les systèmes de soins de santé. C'est particulièrement le cas pour le biosimilaire du rituximab approuvé pour le marché canadien en 2019. Cependant, plusieurs incertitudes demeurent quant à son utilisation. OBJECTIFS: Déterminer la proportion des dépenses pour chaque indication du rituximab par rapport à la dépense totale annuelle en médicaments dans un contexte hospitalier et déterminer les économies potentielles liées à l'introduction d'un biosimilaire. MÉTHODE: Une analyse d'impact budgétaire a été réalisée à partir de trois scénarios basés sur des données obtenues dans un grand centre hospitalier universitaire sur une période de 12 mois. RÉSULTATS: Cette étude a examiné les données de 420 patients. Les dépenses annuelles relatives au rituximab, toutes indications confondues, représentaient 7,7 % des dépenses annuelles totales de l'hôpital. De cellesci, 5 % étaient liées en particulier aux indications approuvées par Santé Canada. Plus de 6 % des dépenses annuelles en médicaments étaient imputables à l'utilisation du rituximab à des fins oncologiques, y compris 1,8 % pour des utilisations que Santé Canada n'a pas approuvées. De manière générale, chaque réduction de 10 % du prix d'un produit biosimilaire du rituximab (parent du rituximab référence) entraînerait des économies annuelles d'environ 0,8 % du total des dépenses en médicaments dans cet hôpital si les produits biosimilaires étaient utilisés pour toutes les indications, qu'elles soient approuvées ou non par Santé Canada. CONCLUSIONS: L'introduction d'un biosimilaire du rituximab sur le marché canadien engendrerait des économies importantes. L'évaluation adéquate des économies générées par un biosimilaire pour un hôpital ayant un budget limité nécessite la prise en compte de toutes les indications pour lesquelles il pourrait être utilisé.

Ranking of healthcare programmes based on health outcome, health costs and safe delivery of care in hospital pharmacy practice.

OBJECTIVES: To establish a consensual and coherent ranking of healthcare programmes that involve the presence of ward-based and clinic-based clinical pharmacists, based on health outcome, health costs and safe delivery of care. METHODS: This descriptive study was derived from a structured dialogue (Delphi technique) among directors of pharmacy department. We established a quantitative profile of healthcare programmes at five sites that involved the provision of ward-based and clinic-based pharmaceutical care. A summary table of evidence established a unique quality rating per inpatient (clinic-based) or outpatient (ward-based) healthcare programme. Each director rated the perceived impact of pharmaceutical care per inpatient or outpatient healthcare programme on three fields: health outcome, health costs and safe delivery of care. They agreed by consensus on the final ranking of healthcare programmes. KEY FINDINGS: A ranking was assigned for each of the 18 healthcare programmes for outpatient care and the 17 healthcare programmes for inpatient care involving the presence of pharmacists, based on health outcome, health costs and safe delivery of care. There was a good correlation between ranking based on data from a 2007-2008 Canadian report on hospital pharmacy practice and the ranking proposed by directors of pharmacy department. CONCLUSIONS: Given the often limited human and financial resources, managers should consider the best evidence available on a profession's impact to plan healthcare services within an organization. Data are few on ranking healthcare programmes in order to prioritize which healthcare programme would mostly benefit from the delivery of pharmaceutical care by ward-based and clinic-based pharmacists.

Fluticasone inhalation in moderate cases of bronchopulmonary dysplasia.

OBJECTIVE: This randomized, controlled trial was designed to determine the efficacy of inhaled fluticasone propionate on oxygen therapy weaning in a population of preterm infants who were born at <32 weeks of gestation and experienced moderate bronchopulmonary dysplasia (BPD). METHODS: Thirty-two infants who were < or =32 weeks of gestation, had moderate BPD that required supplemental oxygen (fraction of inspired oxygen > or =0.25), and were aged between 28 and 60 days were randomized. Fluticasone propionate 125 microg twice daily for 3 weeks and once daily for a fourth week was delivered to infants who weighed between 500 and 1200 g. The dosage was doubled for infants who weighed > or =1200 g. RESULTS: Compared with placebo, treatment had no effect on either duration of supplemental O2 therapy or ventilatory support as assessed by survival analysis. At 28 days, a trend toward a lower cortisol/creatinine ratio in the treatment group was noted compared with placebo (25.1 +/- 18.9 vs 43 +/- 14.4). In the fluticasone group at 28 days, the systolic arterial pressure (78 +/- 3 vs 68 +/- 3 mm Hg) and diastolic arterial pressure (43 +/- 3.4 mm Hg vs 38 +/- 2.0 mm Hg) were higher compared with baseline fluticasone values. The chest radiograph score was lower than baseline (2.8 +/- 1.4 vs 3.7 +/- 2.2) in the fluticasone group at 28 days. This study has a statistical power of 1.0 to detect a significant difference in the duration of oxygen supplementation of >21 days between the study groups. CONCLUSION: We conclude that fluticasone propionate reduces neither supplemental O2 use nor the need for ventilatory support in this patient population. However, fluticasone does have a positive radiologic effect in lowering chest radiograph scores. In addition, our data point to a possible association among inhaled fluticasone treatment and higher arterial blood pressure. Thus, the results of this investigation do not support the use of inhaled corticosteroids in the treatment of oxygen-dependent infants who have established moderate BPD.

Functional tests for primary aldosteronism: value of captopril suppression.

With the introduction of more simple screening tests such as the aldosterone/renin ratio, the detection rate of primary aldosteronism has increased considerably. Until now, no reference values have been available for reporting the aldosterone/renin ratio using plasma aldosterone values expressed in SI units (pmol/L) and plasma active renin (ng/L) measured by immunoradiometric assay. We studied 153 subjects who had either normal blood pressure, essential hypertension, or primary aldosteronism. Essential hypertensive patients usually have aldosterone/renin (pmol/L/ng/L) ratios below 100, whereas ratios for patients with primary aldosteronism are above 140. Results that fall between 100 and 140 suggest a need for repeat testing. Patients with elevated aldosterone/renin ratios require confirmatory testing to demonstrate nonsuppressive autonomous aldosterone production. To this end, salt loading is widely used, but this approach may be contraindicated in patients with severe hypertension. The captopril suppression test appears as effective as salt loading in confirming a diagnosis of primary aldosteronism. In addition, the captopril test is safe, well tolerated, and cost-effective.