ABSTRACT
Background. A challenge the healthcare system faced during the COVID-19 pandemic was ensuring appropriate use of therapeutics. Hydroxychloroquine (HCQ), azithromycin, and ivermectin are FDA-approved for rheumatic, antibacterial, and antiparasitic conditions, respectively. During the pandemic, these drugs were used for COVID-19 treatment, despite unproven benefit and lack of clinical guideline support. Payer-based formulary edits of these agents during the COVID-19 pandemic were reviewed to determine effectiveness in supporting appropriate use. Methods. After local discovery of COVID-19 the University of Rochester Medical Center and a local payor in the upstate New York area, Excellus BlueCross BlueShield, disseminated education about the unproven role of these agents in treatment or prevention of COVID-19. In March 2020, May 2020 and February 2021, respectively, Excellus BCBS placed a quantity limit (QL) on prescriptions for HCQ, azithromycin and ivermectin and prior authorization (PA) for ivermectin in October 2021 for all formularies except Medicare. The QL for HCQ and azithromycin were in effect until December 2020. An exception process was available for individuals who required a higher quantity. Data was gathered retrospectively for claims and total drug utilization amongst Excellus BCBS members through February 2022. Results. Use of HCQ increased by 56.5% prior to QL implementation. After HCQ QL was implemented, HCQ use returned to near pre-pandemic baseline, and most (88%) claims were processed. For azithromycin, after the QL limit was implemented, while overall usage dropped, most claims (77%) were processed. Prior to QL and PA, ivermectin usage quadrupled. Following implementation of the ivermectin QL, usage was stable and a minority (41%) of ivermectin claims were processed. The month that PA was implemented, usage dropped by 81%, and 9% of claims were processed. Conclusion. Formulary edits resulted in returning use of HCQ to pre-pandemic levels despite an initial rise in use. The edits may have curtailed azithromycin use as well. A QL was associated with stabilization in ivermectin use but ultimately usage did not decrease until PA was required. Formulary edits consistent with local messaging appeared to help control use of unproven therapeutics for COVID-19.
ABSTRACT
Objective: Paediatric neurologists are concerned about the risk of COVID-19 in children with demyelinating disorders receiving immunomodulatory treatment. To investigate this, we collected data via the UK Childhood Neuro-Inflammatory Disorders (UK-CNID) network of the British Paediatric Neurology Association (BPNA). Methods: Survey of paediatric neurologists managing unvaccinated UK children (<18 years) with a demyelinating disorder (multiple sclerosis [MS];neuromyelitis optica spectrum disorder [NMOSD] and myelin oligodendrocyte glycoprotein antibody disease [MOGAD]) on immunomodulatory therapy with SARS-CoV-2 infection confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR) of nasopharyngeal swabs between March and December 2020. Results: Of 151 UK children (MS 98, MOGAD 37, NMOSD 16) with a median age of 9 years (range 6-18y), with a demyelinating disorder, nine (6.0%) had a positive PCR for SARS-CoV-2. Five had MS and four MOGAD. Four were from south Asian or south-east Asian, four were White and one was mixed White and south Asian. Seven children had COVID-19 symptoms;two were asymptomatic. Two required a brief hospital admission for typical COVID-19 respiratory symptoms and the remaining five had mild symptoms including fever, rash, cough and headache. One with MOGAD, treated with azathioprine, developed transverse myelitis 12 days after COVID-19 onset. She recovered fully with a course of corticosteroids. MS patients were on following disease modifying therapies;dimethylfumarate (n=2), fingolimod (n=1);natalizumab (n=1) and ocrelizumab (n=1). MOGAD cases were on the following immune therapy: combination of oral prednisolone and intravenous immunoglobulin (n=2), prednisolone steroids (n=1) and azathioprine (n=1). Conclusions: In contrast to adult patients, who often have underlying co-morbidities and advanced neurological disabilities, we have identified that children treated for demyelinating disorders appear to have a milder COVID-19 course. Whilst the number of children treated for demyelinating disorders that developed COVID-19 is low, the overall mild course described may provide reassurance to neurologists, patients and family members.
ABSTRACT
Objective: To review the referral pathway and outcomes of Vagal Nerve Stimulation (VNS) in Paediatric patients with epilepsy Methods: This was a retrospective chart review including all patients under the age of 16 who were referred to the VNS service between January 2018 to June 2020 (30 months). Results: A total of 62 patients were identified, out of which 16 completed pathway of referral, neurological, neurosurgical assessment, and VNS Insertion. Thirty new referrals were assessed for VNS in this time frame, out of which 27 underwent Neurosurgical assessment. Pathway waiting time from time of referral to Neurological assessment was 2 to 4 weeks on average and 4 to 8 weeks on average for neurosurgical assessment. VNS models used were Sentiva 1000 and 106 Aspire. Majority showed good response to VNS;5 children showed 50% reduction in seizure frequency. Patients with genetic generalised epilepsy presenting with generalised tonic clonic seizures showed the best response. Post-operative complications included shortness of breath, voice change, cough and headache, and 2 patients had wound infections. As expected, there was no significant difference in seizure control and side effects between the two devices. However, the remote programming capability of the Sentiva 1000 offered significant benefit with reduced hospital and improved school attendance especially during the Covid 19 pandemic. Unfortunately, we had 2 cases of SUDEP involving patients with severe disability.
ABSTRACT
Introduction: In 2009 an expert consensus guideline for the management of children on KDT was published;the majority of centres supported initiating KDT in a hospital setting. In 2018 these guidelines were revisited and 92% of centres supported initiating KDT in the outpatient setting in selective situations. Method: We compared the data for KDT compliance for children starting the diet across three time periods, using cessation of KDT as a proxy for adherence: (1) 2009 to 2015: 147 families were advised to start the diet in the hospital setting. (2) April 2017 to February 2020: 102 families could choose to start in the hospital or home environment. (3) April 2020 to June 2020: 12 families in the first 3 months of the COVID-19 'lockdown' advised to start at home. All case notes of consecutive patients from three specified time periods were reviewed. Percentage differences were analysed using the "N-1" Chi-squared test. Results: Cessation of KDT within 3 months of initiation was a) 44/147 (30%) vs 32/102 (31%) p=0.8663 and b) 44/147 (30%) vs 5/12 (42%) p=0.3886. The numbers of children unable to complete the 3 month trial period were 15/147 (10%) vs 13/102 (12.7%) p=05057. Within the second group a higher proportion of those opting to start in hospital ceased therapy early, 6/37 (16%) compared to 7/65 (10.7%), however this was not clinically significant (p=04406). Conclusion: In the two large groups of children studied, starting KDT in the home setting was equally as effective as starting in hospital at achieving adherence at 3 months. In the smaller group starting therapy remotely during the COVID restrictions there was a trend towards less adherence;this may reflect their epilepsy, change to support, teaching using remote platforms (rather than in person), difficulties accessing novel foods or small sample size.