Search

Objective: To review the pharmacokinetic (PK)–pharmacodynamic (PD) profiles, disease setting, dosing, and safety of oral and parenteral hypomethylating agents (HMAs) for the treatment of myelodysplastic syndromes/neoplasms (MDS) and acute myeloid leukemia (AML), and to provide a multidisciplinary perspective on treatment selection and educational needs relating to HMA use. Data Sources: Clinical and real-world data for parenteral decitabine and azacitidine and two oral HMAs: decitabine–cedazuridine (DEC-C) for MDS and azacitidine (CC-486) for AML maintenance therapy. Data Summary: Differences in the PK–PD profiles of oral and parenteral HMA formulations have implications for their potential toxicities and planned use. Oral DEC-C (decitabine 35 mg and cedazuridine 100 mg) has demonstrated equivalent systemic area under the concentration-time curve (AUC) exposure to a 5-day regimen of intravenous (IV) decitabine 20 mg/m2 and showed no significant difference in PD. The AUC equivalence of oral DEC-C and IV decitabine means that these regimens can be treated interchangeably (but must not be substituted within a cycle). Oral azacitidine has a distinct PK–PD profile versus IV or subcutaneous azacitidine, and the formulations are not bioequivalent or interchangeable owing to differences in plasma time-course kinetics and exposures. Clinical trials are ongoing to evaluate oral HMA combinations and novel oral HMAs, such as NTX-301 and ASTX030. Conclusions: Treatment with oral HMAs has the potential to improve quality of life, treatment adherence, and disease outcomes versus parenteral HMAs. Better education of multidisciplinary teams on the factors affecting HMA treatment selection may help to improve treatment outcomes in patients with MDS or AML. [ABSTRACT FROM AUTHOR]

The article presents the highlights of the 2023 "American Journal of Managed Care" (AJMC) Chronic Kidney Disease (CKD) Stakeholder Summit. The event was moderated by Ryan Haumschild. Topics include the primary causes of CKD like diabetes and hypertension, the increasing prevalence and incidence of CKD in the U.S., and the standard of care (SOC) for CKD like the use of angiontensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARB).

Emerging evidence has shown a strong link between the effects of chronic oral inflammation and general health. The mouth is the visible gateway to the rest of the body and reflects what is happening deep inside. Periodontal disease has been linked to systemic disease; likewise, systemic disease can have an impact on oral health. In fact, there are over 100 systemic diseases that have oral manifestations, such as cardiovascular disease, stroke, respiratory infections, pancreatic cancer, diabetes, and nutritional problems. This is a bidirectional relationship and the link is inflammation. Oral health problems can have an adverse effect on the quality of life and are more prevalent in older adults, but are not caused by aging. Approximately 75% of baby boomers will enter long-term care facilities with the majority of their natural teeth and this trend is expected to continue. Studies indicate that residents with good oral care require less health care dollar expenditures. Therefore, dental professionals, such as the dental hygienist, should be part of the multidisciplinary team to assist in providing expert regular dental care and training to caregivers and other health care professionals in long-term care facilities. [Copyright &y& Elsevier]

Patients with rare diseases such as Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a hematologic malignancy affecting approximately 1500 new patients per year, experience barriers to care involving both clinical and administrative factors. Optimal patient outcomes depend on timely identification, diagnosis of disease, and treatment initiation. For patients living with Ph+ ALL, the process can be delayed by limited treatment options approved by the US Food and Drug Administration and administrative hurdles that often delay treatment initiation. An overhaul of utilization management processes, such as the requirement for prior authorization (PA) for treatment, are needed to ensure patients have access to appropriate treatments in a timely manner. An AJMC Roundtable in November 2022 brought together a panel of payers and providers to discuss the challenges and shortcomings of current PA processes and to present ideas for potential solutions for improving them. Panelists at the roundtable discussed approaches including the use of guideline-concordant electronic PAs and other digital solutions, expedited approval pathways for use in specific conditions, use of real-world evidence in decision-making, issuance of PA "Gold Cards" to select providers, and a shift to value-based care agreements. Roundtable attendees agreed that, regardless of the strategy for PA-process improvement, there is a need for improved communication between providers and payers to ensure that the decision-making system meets the essential need for timely patient access to optimal care. This article reviews utilization management and guideline-concordant care through the lens of rare diseases and then presents solutions to utilization management challenges to expedite access to therapy. [ABSTRACT FROM AUTHOR]

Purpose The primary objective of the study described here was to compare rates of patient adherence to anticancer medications filled at an internal health system specialty pharmacy (HSSP) vs external specialty pharmacies. The primary outcome was the medication possession ratio (MPR), and the secondary outcomes included proportion of days covered (PDC), and time to treatment (TTT). Methods A retrospective chart review was conducted to compare the MPR, PDC, and TTT for patients who received oral anticancer therapy using prescriptions claim data. A t test or Wilcoxon test was used to explore the effect of demographic and other factors on adherence and TTT. A multiple regression model with backward elimination was used to analyze significant factors to identify covariates significantly associated with the outcomes. Results Of the 300 patients screened for study inclusion, 204 patients whose records had complete MPR and PDC data and 164 whose records had TTT data were included in the analysis. There were significant between-group differences in mean MPR and mean PDC with patient use of the HSSP vs external pharmacies (1.00 vs 0.75 [ P < 0.001] and 0.95 vs 0.7 [ P < 0.001], respectively). Pharmacy type (P = 0.024) and tumor type (P = 0.048) were significantly associated with TTT. Conclusion The multiple regression analysis indicated that oncology patients who filled their anticancer medication precriptions at an internal HSSP at an academic medical center had significantly higher adherence, as measured by MPR and PDC, and quicker TTT than those who filled their prescriptions at an external specialty pharmacy. [ABSTRACT FROM AUTHOR]