Journal of managed care & specialty pharmacy最新文献

Background: Nirmatrelvir-ritonavir is an approved treatment for mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Age is the leading risk factor for severe COVID-19, making treatment access particularly important for the Medicare population. Part D plans must include COVID-19 antivirals on formularies. However, unlike Medicare Advantage prescription drug (MAPD) plans, which assume risk for both medical and pharmacy costs, standalone prescription drug plans (PDPs) have a financial disincentive to cover them in the preferred tier. As reimbursement transitions to Part D plans in 2025, it is important for plans to understand the budget impact of providing treatment access at different formulary tiers.

Objective: To examine challenges to preferred tier access to nirmatrelvir-ritonavir in Part D and their impact on COVID-19 treatment abandonment and hospitalization rates.

Methods: Using a combination of actuarial and budget impact models, we estimated the potential impact of Part D formulary tier placements of nirmatrelvir-ritonavir on plan budgets, therapy abandonment, and hospitalizations using real-world prescription data from Milliman's Prescription Drug Consolidated Database. Potential impacts were summarized separately for PDP, MAPD, and the Medicare fee-for-service program in 2025.

Results: Specialty tier placement of nirmatrelvir-ritonavir resulted in savings to the Medicare program of $2.14 billion compared with $2.22 billion for preferred tier placement. Compared with placement in the specialty tier, nirmatrelvir-ritonavir positioned at the preferred brand tier saves the Medicare program an additional $80.7 million by reducing patient abandonment by 62% and COVID-19-related hospitalization costs by $2.14 billion after accounting for the increase in net Part D plan liabilities. These savings consist of (1) a net cost reduction, after accounting for medical cost offsets, of $65.1 million for MAPD plans, (2) an increase in net Part D liability of $710.9 million for PDPs, and (3) cost savings to Medicare fee-for-service from reduced COVID-19-related hospitalizations of $726.5 million.

Conclusions: Coverage of nirmatrelvir-ritonavir, on any tier, is cost-saving for the Medicare program overall. Preferred coverage with lower patient cost-sharing results in additional savings and improved patient outcomes from lower hospitalizations and mortality rates. Individual Medicare plans should consider the overall clinical and cost impacts of nirmatrelvir-ritonavir on the health system when determining formulary tier placement. Better alignment of incentives for PDPs is needed to address the financial barriers to expanding access for therapies that can improve clinical outcomes and produce savings to the Medicare program.

Background: Patients with type 1 diabetes (T1D) have a greater than 50% lifetime risk of developing comorbid chronic kidney disease (CKD). Glycemic control can reduce diabetes-related complications and slow CKD progression. Adding sotagliflozin to insulin therapy reduced A1c by 0.46% compared with insulin monotherapy in patients with T1D. However, the long-term economic value for patients with both T1D and CKD remains unknown.

Objective: To evaluate the cost-effectiveness of sotagliflozin as an add-on to insulin in patients with T1D and CKD from a US payer perspective.

Methods: A Markov model was generated for individuals diagnosed with both T1D and comorbid CKD stage 3 from a US payer's perspective. Clinical and economic outcomes were assessed over 30 years and included number of patients prevented from dialysis and transplantation, life-years, quality-adjusted life-year (QALY) gains, incremental costs, incremental cost-effectiveness ratio (ICER), and net monetary benefit. Dynamic pricing, through genericization, was incorporated to account for the economic impacts of market entry by generics.

Results: Sotagliflozin add-on therapy improved survival, extending life expectancy by 1.27 years (13.08 with sotagliflozin vs 11.81 with insulin monotherapy). During the first 10 years after treatment initiation, dialysis and transplant utilization decreased by 3.06 (99.35 vs 102.41) and 1.73 (30.59 vs 32.32) per 1,000 patients, respectively. QALYs per patient increased by 0.63 (7.70 vs 7.07), largely driven by prolonged time in pre-end-stage renal disease health states (0.59; 6.75 vs 6.16). Total costs rose by $72,914 ($484,674 vs $411,760), primarily because of pharmacy costs increasing by $69,060 ($96,242 vs $27,364). The ICER was $115,677 per QALY and the model was most sensitive to pharmacy costs.

Conclusions: Sotagliflozin is a cost-effective adjunct to insulin therapy for T1D and CKD patients, providing clinical benefits and falling below the $150,000/QALY willingness-to-pay threshold in 59% of probabilistic sensitivity analysis simulations.

Background: Multiple sclerosis (MS) is a chronic neuroinflammatory and neurodegenerative disease. Emerging evidence suggests that chronic disease processes within the central nervous system are important drivers of the ongoing disability accumulation in people with MS (pwMS). Chronic lesion activity driven by smoldering neuroinflammation is considered one of the neuropathological hallmarks of disease progression in worsening disability. Our understanding of the role of chronic active lesions (CALs) in MS pathology has expanded with improvements in imaging technology. Three in vivo imaging biomarkers of CALs are available to detect CALs: paramagnetic rim lesions (PRLs), 18 kDa translocator protein (TSPO)-positron emission tomography rim-positive lesions, and the magnetic resonance imaging (MRI)-defined slowly expanding lesions (SELs).

Objective: To evaluate associations between CALs and measures of worsening disability in pwMS.

Methods: A systematic literature search was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using PubMed, Embase, and the Cochrane Library on April 21, 2023. The review included randomized controlled trials, retrospective studies, and prospective cross-sectional and longitudinal studies conducted during 2010-2023 reporting the outcomes of interest. Studies evaluating people with any MS phenotype were included if they reported any associative analysis between CALs and clinical outcomes.

Results: A total of 30 of 149 unique studies identified in the literature met the inclusion criteria. Of these 30 publications, 18 were based on PRLs, 9 on MRI-defined SELs, 1 on PRLs and MRI-defined SELs simultaneously, and 2 on TSPO-positive lesions. PRLs were associated with disability worsening in 17 studies, as measured by clinical disability scales. MRI-defined SELs were associated with worsening disability in 10 studies.

Conclusions: CALs are frequently associated with disease progression and disability accumulation. CALs may provide an indicator of disease severity and may assist with the assessment of treatment efficacy.

Background: The National Comprehensive Cancer Network guidelines list combination immunotherapy as the preferred first-line (1L) treatment for unresectable or metastatic melanoma over BRAF and MEK inhibitor (BRAFi/MEKi) therapy, regardless of BRAF mutation status. However, the economic impact of 1L treatment with nivolumab plus relatlimab (NIVO + RELA) vs BRAFi/MEKi therapies for BRAF-mutated advanced melanoma has not been assessed.

Objective: To compare the health care costs, cost per progression-free life-year (PFLY), and cost per life-year (LY) of NIVO + RELA vs dabrafenib plus trametinib (DAB + TRAM), encorafenib plus binimetinib (ENCO + BINI), and vemurafenib plus cobimetinib (VEM + COBI) as 1L treatment for BRAF-mutated, unresectable or metastatic melanoma.

Methods: A cost-per-outcome model compared the economic value of NIVO + RELA vs each BRAFi/MEKi therapy. Clinical inputs were derived from previous matching-adjusted indirect comparisons using individual patient data from the BRAF-mutant subgroup of RELATIVITY-047 and published data pooled from COMBI-d, COMBI-v, COLUMBUS, and coBRIM. LYs, PFLYs per investigator, and treatment duration were estimated using the restricted mean survival time. Health care costs (2024 US dollars), including drug acquisition and administration costs, disease management costs over the preprogression and postprogression periods, and adverse event management costs, were calculated over 5 years. Several scenario analyses were performed, including adding subsequent treatment costs.

Results: Over 5 years, NIVO + RELA was associated with improved PFLYs and LYs compared with DAB + TRAM (mean PFLY: 1.94 vs 1.82 years, mean LY: 3.41 vs 2.77 years), ENCO + BINI (1.87 vs 1.78 years and 3.40 vs 2.91 years, respectively), and VEM + COBI (2.12 vs 1.80 years and 3.39 vs 2.63 years). The estimated total costs over 5 years were lower for NIVO + RELA vs DAB + TRAM ($300,479 vs $519,770), ENCO + BINI ($343,996 vs $572,556), and VEM + COBI ($296,361 vs $317,851). Main cost drivers were drug acquisition and administration costs. NIVO + RELA had lower costs per PFLY and per LY than DAB + TRAM ($155,107 vs $285,617 and $88,203 vs $187,699, respectively); ENCO + BINI ($183,628 vs $322,113 and $101,151 vs $196,924); and VEM + COBI ($139,688 vs $176,645 and $87,315 vs $121,086). The sensitivity analyses' results supported the base-case results.

Conclusions: NIVO + RELA showed improved LYs and PFLYs at lower cost than all 3 BRAFi/MEKi comparators over 5 years. These results support the economic value of NIVO + RELA for patients with previously untreated, BRAF-mutated, unresectable or metastatic melanoma.

Background: Cost-related nonadherence (CRN), that is, not taking medication as prescribed to save money, may remain disproportionately high among individuals with multiple chronic conditions, particularly during periods of economic stress, such as the COVID-19 pandemic. However, the impact of economic hardship 3 years after the pandemic on CRN levels among individuals with multiple chronic conditions is still largely unknown.

Objective: To examine changes in CRN prevalence in 2020 (pandemic) and 2021 to 2023 (post-pandemic years 1, 2, and 3) relative to 2019 (pre-pandemic) among adults with multiple chronic conditions in the United States.

Methods: This is a repeated cross-sectional study using data from the National Health Interview Survey, 2019-2023. Our study sample included 27,413 US adults aged 18 to 64 years with 2 or more of any of 14 chronic conditions and who were prescribed medication. CRN (dependent variable) is a binary measure with values "1" if respondents endorsed 1 of the 4 cost-saving behavior questions-not purchasing medicine refills, delaying refills, splitting pills, or skipping doses to save money-and "0" otherwise. Analyses include survey-weighted CRN prevalence estimates by year and linear probability models assessing prevalence changes in 2020-2023 relative to 2019, overall, and by multiple chronic conditions subgroups (2, 3, and ≥4 conditions).

Results: The overall CRN prevalence in 2019 was 18.9%, 16.7% in 2020, 13.5% in 2021, 14.5% in 2022, and 15.5% in 2023. CRN decreased in all years relative to 2019 but only significantly by 2.2% (P = 0.001) in 2021 and by 1.4% (P = 0.049) in 2022. The subgroup analysis shows variation in these results, with a significant reduction in CRN in 2021, relative to 2019, limited to those who reported 3 chronic conditions.

Conclusions: Fewer adults with multiple chronic conditions reported CRN 1 and 2 years after the pandemic relative to the pre-pandemic in the United States, but those with 4 or more conditions remain vulnerable after the pandemic.

Background: Health plans have acknowledged there is a significant unmet need to improve prior authorization (PA) processes to increase patient access to life saving nonstatin therapies. Outcomes from a series of regional working groups in the United States provided recommendations for developing standardized patient eligibility criteria and a checklist for streamlining the PA process.

Objective: To (1) develop a standardized PA checklist to streamline collection of adequate PA documentation by prescribers, regardless of health insurance plan type, and (2) measure the impact of the PA checklist in clinical practice in a controlled observational study.

Methods: A working group of thought leaders representing payers and providers was assembled by PRIME Education, in collaboration with the Academy of Managed Care Pharmacy, the American Society for Preventive Cardiology, and the Preventive Cardiovascular Nurses Association. The working group developed and finalized a PA checklist for PCSK9 inhibitors that was integrated into the electronic medical record for 2 large community health care systems with geographic representation of patients with cardiovascular disease: Random chart audits were conducted prior to (historical controls) and 6 months after (post-intervention) implementation of the checklist (n = 100 each set). Primary study endpoints were rates of approvals and time to approval/receipt of prescribed drug. Statistical analyses measured changes in PA documentation outcomes, including treatment history and authorization approvals/denials. Survey questions provided to health care provider teams before and after integration of the PA checklist measured changes in prescriber attitudes on effectiveness and efficiency of the PA checklist.

Results: Following implementation of the PA checklist, a 19% absolute increase in initial PA approvals and a 2-day overall reduction in time-to-treatment with prescribed PCSK9 inhibitor therapy were observed. Documentation of side effects (54%; P < 0.0001), statin contraindications (31%; P < 0.0001), and prior lipid therapies failed (20%; P < 0.0001) also increased postimplementation. In surveys, prescribers reported greater efficiency and effectiveness of the PA process when using the standardized PA checklist.

Conclusions: Time-to-treatment for nonstatin therapies for eligible patients with hypercholesterolemia was decreased in 2 community health systems following integration of a standardized PA checklist developed through a collaboration between patients and providers.

Zavegepant is the first intranasal calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine and offers a new nonoral option for patients. This article reports the findings of a comprehensive literature review to assess zavegepant's safety and effectiveness. Evidence synthesis involved reporting findings from clinical trials and evaluating comparative effectiveness. This review was prepared by the University of Connecticut School of Pharmacy Academy of Managed Care Pharmacy (AMCP) Student Chapter. The student author group won the AMCP National Pharmacy and Therapeutics competition for their zavegepant product review in March 2024.

Background: To improve health inequities, it is necessary to understand the impact of social determinants of health (SDoH), or social risk factors, including race and economic status, on multiple myeloma (MM) treatment patterns.

Objective: To identify SDoH factors leading to gaps in frontline treatment in Medicare beneficiaries with newly diagnosed MM (NDMM).

Methods: This retrospective study used data from various sources, including claims data, individual-level SDoH measures (eg, race, dual-eligibility [DE] status for Medicare and Medicaid, low-income subsidy [LIS] status, and special needs plan eligibility) from the Humana Research database population during the time frame from 2016 to 2023, and community-level SDoH measures from the Agency for Healthcare Research Quality database. Treatment pattern outcomes included treatment within 90 days of first MM diagnosis, time from diagnosis to frontline treatment, frontline treatment regimen type, daratumumab-containing frontline regimens, and duration of frontline therapy. Multivariable regression was used to evaluate the association between SDoH factors and MM treatment patterns.

Results: Of 4,483 individuals identified with NDMM, 31.9% were Black race and 24.1% had DE/LIS status. More than half of individuals in the study resided in areas that were above the national median for receiving public assistance, having less than high school education, having no health insurance, and having no Internet. In the overall cohort, 1,941 (43.3%) patients had no treatment within 12 months of diagnosis, 811 of whom had no evidence of symptomatic disease (ie, asymptomatic smoldering MM). Median time to treatment initiation (TTI) from diagnosis was 2.7 months, and 51.2% of patients received treatment within 90 days of diagnosis. Lower odds for treatment initiation within 90 days were observed for Black patients (vs White patients; odds ratio [OR] = 0.865 [CI = 0.752-0.995]), DE/LIS patients (vs non-DE/LIS; OR = 0.696 [CI = 0.599-0.809]), and by special needs plan enrollment (vs nonenrollment; OR = 0.717 [CI = 0.547-0.940]), but community-level SDoH was generally not independently associated with TTI. Among 2,523 patients who received frontline treatment within 12 months of diagnosis (treated cohort), TTI and duration of treatment were similar between the overall cohort and DE/LIS and non-White subgroups. Secular trends were observed in frontline treatment regimens, which were mostly triplets, and evolved over time to comprise fewer doublet regimens and more quadruplets, with an increase in daratumumab-based regimens.

Conclusions: Inequities in timely frontline NDMM treatment were observed for non-White patients and those with DE/LIS status. Combinations of community-level SDoH, but no one single factor, may underlie these inequities.

Precision medicine in oncology using actionable molecular biomarkers to guide treatment selection has been associated with favorable outcomes; however, many potentially eligible patients do not receive it. This Academy of Managed Care Pharmacy Market Insights program sought to characterize unmet needs in biomarker testing among managed care stakeholders, to develop best practice and consensus recommendations to support addressing these needs, and to gain insights on potential quality measures related to biomarker testing. The program used a modified Delphi process and included in-depth interviews with expert panelists, a national survey of managed care professionals, and a consensus survey of experts. Areas of unmet need in biomarker testing identified were education, guidelines and protocols, timeliness, process, and equity. Twenty-two best practices were suggested by managed care experts and other stakeholders; 9 of these best practices achieved consensus. These consensus recommendations addressed biomarker test ordering and test performance, treatment decisions based on biomarker testing, cost-effectiveness of biomarker testing, and health disparities in access to biomarker testing. Opportunities for education and improvements in infrastructure to implement these recommendations were identified. Further investigation is needed to develop quality measures; although, valuable insights were gained.