Elaborate biologic approval process delays care of patients with moderate-to-severe asthma.

Background: mAbs (biologics) are indicated in patients with poorly controlled moderate-to-severe asthma. The process of prior authorization and administration of a biologic requires exceptional commitment from clinical teams. Objective: Our aim was to evaluate the process of approval and administration of biologics for asthma and determine the most common reasons associated with denials of biologics and delays in administration. Methods: We examined the records of patients with asthma who were prescribed biologics from January 2018 to January 2020 at 2 centers, Montefiore Medical Center (Bronx, NY) and Scripps Clinics (San Diego, Calif). Demographics, insurance information, and details on the approval process were collected. Results: After querying of electronic health records, the records of 352 and 70 patients with moderate-to-severe asthma were included from Montefiore and Scripps, respectively. Most patients at Montefiore (58.2%) were insured under Managed Care Medicaid (MC Medicaid), whereas most patients at Scripps (61.4%) had commercial insurance. The median times from prescription to administration of a biologic were similar: 34 days (interquartile range [IQR] = 18-63 days) and 34 days (IQR = 22.5-56.0 days) (P = .97) for Montefiore and Scripps, respectively. However, the median approval time for Montefiore was 6 days (IQR = 1-20 days) and that for Scripps was 22 days (IQR = 10-36 days) (P < .001). Approval times for prescriptions requiring appeals were significantly longer than for prescriptions approved after the initial submission: 23 days versus 2.5 days and 40.5 days versus 15.5 days (for Montefiore and Scripps, respectively [P < .001 for both]). Conclusions: Lengthy appeals contribute to delays between prescribing and administering a biologic. Site-specific practices and insurance coverage influence approval timing of the biologics for asthma.

Liver Transplantation in Elderly Recipients: Is Age Just a Number?

BACKGROUND: The proportion of older patients on the liver transplant waitlist continues to increase. With limited existing data to guide liver transplant evaluation of elderly patients, we aimed to study selection practices and outcomes of patients ≥70 years old. We hypothesized that 1-year patient and graft survival would not differ between appropriately selected elderly patients and those who are younger. METHODS: All patients referred for liver transplantation between 2018 and 2020 were stratified into elderly (age ≥70) and young (age <70) cohorts. Evaluation data pertaining to medical, surgical, and psychosocial risk assessment were reviewed. Recipient characteristics and post-operative outcomes, primarily 1-year graft and patient survival, were compared, with a median follow-up of 16.4 months. RESULTS: 322 patients underwent transplant out of 2331 referred. Elderly patients represented 230 of these referrals and 20 underwent transplant. The most common reasons for denial of elderly patients were multiple medical comorbidities (49%), cardiac risk (15%) and psychosocial barriers (13%). The median MELD of elderly recipients was lower (19 vs 24, P = .02), and proportion of hepatocellular carcinoma was higher (60% vs 23%, P < .001). There was no difference in 1-year graft (elderly 90.9% vs young 93.3%, P = .72) or patient survival (elderly 90.9% vs young 94.7%, P = .88). DISCUSSION: Liver transplant outcomes and survival are not affected by advanced age in carefully evaluated and selected recipients. Age should not be considered an absolute contraindication for liver transplant referral. Efforts should be made to develop guidelines for risk stratification and donor-recipient matching that optimize outcomes in elderly patients.

Social, political, and economic determinants of access to biologics: A scoping review of structural determinants in the clinical disparities literature.

BACKGROUND: The number of biologics among new medication approvals is increasing. Social, political, and economic factors influence access to these expensive medications. Disparities in access to new medications can exacerbate health disparities. The notion of "structural determinants" provides a theoretical framework for broadly evaluating the integration of upstream social, political, and economic determinants in the clinical study of access. OBJECTIVE: To review the literature on access to FDA approved biologic medications with particular focus on the integration of social, political, and economic determinants into study design and interpretation. METHODS: We used PRISMA guidelines to review studies on racial and socioeconomic disparities in biologic access through August 2020. We assessed whether the design or interpretation of studies considered key economic determinants of access: the biologics supply chain, trade agreements, patents, drug research and development, insurance reimbursement, and non-insurance drug policies. RESULTS: 100 studies met our inclusion criteria. Sixty-six studies considered insurance reimbursement, but trade law, patents, and other key economic determinants were rarely considered. The literature focuses on a small number of older biologics. CONCLUSIONS: A small number of studies model the integration of structural determinants into clinical research on access to biologics, but overall this literature has many limitations and lacks integration of structural determinants. Increased interdisciplinary collaboration, availability of manufacturer data, and use of disease registries can help create structurally grounded understandings of the relationship between the political economy of expensive medications and clinical disparities.

Neurological outcomes following awake and asleep craniotomies with motor mapping for eloquent tumor resection.

OBJECTIVE: Cortical mapping has been used as a tool to ensure maximal safe resection of intracranial tumors for several decades. Post-surgical motor and language deficits, including seizures, weakness, aphasia, and dysarthria have been well-documented in patients undergoing these operations, particularly on eloquent cortical regions. However, it is not known whether awake versus asleep cortical mapping contributes to differences in postoperative neurological deficits. METHODS: A comprehensive review of the literature utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was completed for articles describing cortical mapping for tumor resection. We critically assessed all articles published in the last 20 years describing complications of patients who had undergone either awake or asleep motor mapping for eloquent brain tumor resection. Studies were analyzed for number of patients, follow-up duration, rates of transient and permanent motor and sensory deficits in the perioperative period, and outcomes at one-month follow-up. RESULTS: Thirty-one studies met inclusion criteria, 24 of which reported long-term post-operative follow-up data. Follow-up among selected studies ranged from one month to four years. Nine of the 31 studies directly compared the postoperative outcomes of awake versus asleep mapping. The rate of transient deficits among patients who underwent awake and asleep mapping was 31.6% and 32.7%, respectively. The rate of permanent deficits was 10.8% in awake mapping patients and 12.7% in asleep mapping patients. Qualitative analysis showed that motor and sensory complications occurred at similar rates. CONCLUSIONS: Review of the current evidence suggests that the rates of transient and permanent postoperative neurologic deficits among awake versus asleep cortical mapping groups are similar. Thus, use of both techniques is reasonable to minimize perioperative morbidity.