Biologic DMARDs for children excluded from most national essential drug lists

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05 October 2021

3 minutes to read

Source / Disclosures

Disclosures: Kraus does not report any relevant financial disclosures. Please see the study for relevant financial information from all other authors.


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According to data published in Pediatric rheumatology.

“The World Health Organization (WHO) developed the Model List of Essential Medicines (WHO EML)” intended to meet the priority health needs of a population “in 1977, an influential model since adapted by countries around the world. ” Raphaël Kraus, MD, FRCPC, FAAP, from the University of Toronto, and colleagues wrote. “Subsequently, the WHO published a model list specifically delineating essential medicines for children (WHO EMLc). These Essential Medicines Lists (EMLs) guide countries’ selection of drugs to fund, store, prescribe and distribute.

Biologic DMARDs used to treat juvenile rheumatic disease are excluded entirely from national essential drug lists in almost two-thirds of all countries around the world, according to data from Kraus R, et al. Rheumatol pediatrician. 2021; doi: 10.1186 / s12969-021-00608-z.

“The Lancet Commission, ‘Essential Medicines for Universal Health Coverage’, says countries ‘must implement a comprehensive set of policies to achieve affordable prices …’ and equity of access,” they said. added. “A single database of 138 national EMLs (71% of 195 countries) and associated national characteristics was recently compiled and demonstrates significant variations between countries for included drugs. We hypothesized that biological DMARDs are under-represented compared to conventional DMARDs in the WHO model and existing national EMLs.

To analyze the presence of biologic ARMDs in essential drug lists, as well as national characteristics that may contribute to their absence inclusion, compared to conventional DMARDs, Kraus and colleagues used a previously compiled database, constructed in June 2017 and updated in January. 2020. All essential medicines lists have been included regardless of publication date and language. In total, the researchers included 138 national lists published between 2001 and 2017.

The researchers further aimed to include all biological and conventional systemic DMARDs used in routine care for juvenile idiopathic arthritis, systemic lupus erythematosus, juvenile scleroderma dermatomyositis, systemic vasculitis and autoinflammatory disorders. Some newer drugs, such as JAK inhibitors, have been excluded due to their “limited clinical use,” the researchers wrote.

National data collected included WHO region, population, life expectancy, infant mortality, gross domestic product (GDP) per capita, health expenditure per capita, Gini index as a measure of income inequality and the corruption perception index. The researchers used regression modeling to examine how certain characteristics explained the differences between the lists.

According to the researchers, the 138 national lists ranged from 44 to 980 drugs, with a median of 308 and an average of 366.9. All included countries have listed at least one conventional DMARD. Eleven countries – or 7.97% – included the 10 conventional DMARDs, while 83.33% had five or more. GDP per capita was associated with the total number of conventional ARMs included (1 = 1.02; 95% CI: 0.39-1.66).

Meanwhile, when it comes to biologic DMARDs, only three countries – or 2.2% – have listed 10 or more, while 15 – or 10.9% – have listed five or more, and only 47 – or 34.1% – listed at least one. Up to 65.9% of countries have not reported any biological DMARDs.

European location (1 = 1.3; 95% CI, 0.08-2.52), life expectancy (1 = –0.7; 95% CI, -1.22 to -0.18), health expenditure per capita (1 = 1.83; 95% CI, 1.24-2.42) and conventional DMARDs listed (1 = 0.70; 95% CI, 0.33-1.07) were associated with the total number of biological DMARDs included in a national list.

“Although biological DMARDs are under-represented in national SCIs and are more likely to be listed by high-income countries, this does not preclude their inclusion by less prosperous countries,” wrote Kraus and colleagues. “For example, only nine of the 42 countries (21.4%) listing rituximab (the most commonly listed biologic) are categorized as high income countries; 33 of the 42 (78.6%) are therefore low- or middle-income economies.

“This indicates the potential for other countries to consider listing biological DMARDs, which would ultimately lead to a reduction in their costs and a resulting increase in their profitability, thus making them more attractive to government agencies and others. health payers, ”they said. added. “Costs to healthcare payers are expected to decline further as the biosimilar market grows, which will stimulate price competition and improve patient access to biologic therapies. The inclusion of these drugs in a system of universal prescription drug coverage would ultimately reduce the economic impact and improve the quality of life of children with systemic inflammatory disease.


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