Real-world lessons: combining cancer registry and retail pharmacy data for oral cancer drugs.

BACKGROUND: Recent cancer care advances have introduced new oral therapies, and yet population registries lack detailed treatment data, hampering investigations into therapy uptake, adherence, and outcomes. OBJECTIVE: This study aimed to assess the representativeness and completeness of linking Surveillance, Epidemiology, and End Results (SEER) cancer registry data with data from two major retail pharmacy chains, collectively covering a large segment of the US market. METHODS: A deterministic data linkage between 11 SEER cancer registries and retail pharmacy data (excluding mail order fills) was conducted for individuals diagnosed with selected cancers from 2013 to 2017, with follow-up through 2019. Descriptive characteristics of the linked and unlinked populations were examined. In a selected subcohort of older women (aged ≥65) with first and only primary breast cancer who had Medicare Part D claims for tamoxifen, we further validated the linkage using Medicare Part D event data as the reference standard. RESULTS: Among 758 068 eligible individuals, only 6.4% were linked to CVS/Walgreens data; the linkage percentage varied by age, sex, race, ethnicity, registry, and cancer type. Within the subcohort of 5963 older women with breast cancer and a claim for tamoxifen in Part D data, 25% were identified as tamoxifen users in retail pharmacy data. Out of these 1490 women, 749 (50.3%) had complete longitudinal tamoxifen dispensing information from retail pharmacy data. CONCLUSION: Retail pharmacy data show promise in identifying oral anticancer treatments, enhancing SEER registry efforts, but they require further validation. We propose an evaluation framework, sharing insights and potential use cases for this resource.

Greenhouse Gas Emissions and Costs of Inhaler Devices in the US.

This study assesses mean emissions and costs and estimated total yearly emissions and costs for US-branded inhalers prescribed to Medicare Part D and Medicaid beneficiaries.

Use of Muscle Relaxants After Surgery in Traditional Medicare Part D Enrollees.

BACKGROUND: Surgeons have come under increased scrutiny for postoperative pain management, particularly for opioid prescribing. To decrease opioid use but still provide pain control, nonopioid medications such as muscle relaxants are being used, which can be harmful in older adults. However, the prevalence of muscle relaxant prescribing, trends in use over time, and risk of prolonged use are unknown. STUDY DESIGN: Using a 20% representative Medicare sample, we conducted a retrospective analysis of muscle relaxant prescribing to patients ≥ 65 years of age. We merged patient data from Medicare Carrier, MedPAR, and Outpatient Files with Medicare Part D for the years 2013-2018. A total of 14 surgical procedures were included to represent a wide range of anatomic regions and specialties. RESULTS: The study cohort included 543,929 patients. Of the cohort, 8111 (1.5%) received a new muscle relaxant prescription at discharge. Spine procedures accounted for 12% of all procedures but 56% of postoperative prescribing. Overall, the rate of prescribing increased over the time period (1.4-2.0%, p < 0.001), with increases in prescribing primarily in the spine (7-9.6%, p < 0.0001) and orthopedic procedure groups (0.9-1.4%, p < 0.0001). Of patients discharged with a new muscle relaxant prescription, 10.7% had prolonged use. CONCLUSIONS: The use of muscle relaxants in the postoperative period for older adults is low, but increasing over time, especially in ortho and spine procedures. While pain control after surgery is crucial, surgeons should carefully consider the risks of muscle relaxant use, especially for older adults who are at higher risk for medication-related problems.

Oncology drug pricing: potential Medicare savings on cancer-directed and supportive care medications through the Mark Cuban cost plus drug model.

Prescription drug costs within oncology remain a challenge for many patients with cancer. The Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022, aiming to provide transparently priced medications at reduced costs. In this study, we sought to describe the potential impact of MCCPDC on Medicare Part-D oncology spending related to cancer-directed (n = 7) and supportive care (n = 26) drugs. We extracted data for drug-specific Part-D claims and spending for 2021. Using 90-count purchases from MCCPDC, we found potential Part-D savings of $857.8 million (91% savings) across the 7 cancer-directed drugs and $28.7 million (67% savings) across 21/26 (5/26 did not demonstrate savings) supportive care drugs. Collectively, our findings support that alternative purchasing models like MCCPDC may promote substantial health care savings.

The association between polypharmacy and health-related quality of life among older adults with prostate cancer.

INTRODUCTION: Older adults with prostate cancer (PC) are at risk of polypharmacy, which further complicates disease management and health-related quality of life (HRQoL). This study evaluated the association between polypharmacy and HRQoL among Medicare beneficiaries with PC. MATERIALS AND METHODS: This observational, retrospective study analyzed data from the Surveillance, Epidemiology, and End Results (SEER) Medicare Health Outcomes Survey (MHOS) data resource. Beneficiaries aged ≥65 and enrolled in Medicare Advantage Organizations were included if they had a PC diagnosis and continuously enrolled in Part D for 12 months prior to the completion of MHOS. Polypharmacy was determined based on the unique number of concurrent Part D prescriptions during 12 months before survey: no polypharmacy (NP, n = 0-4), polypharmacy (PP, n = 5-9), and excessive polypharmacy (EPP, n ≥ 10). HRQoL was assessed using the Physical and Mental Component Summary T-scores (PCS and MCS, respectively) in MHOS. ANOVA and Pearson's Chi-Square tests were performed to assess variances between polypharmacy and continuous/categorical variables. Multivariate linear regression models with generalized estimating equations were used to assess the association between polypharmacy and HRQoL. The severely impaired HRQoL cohort was identified based on normalized z-scores of PCS and MCS. Odds ratios were calculated to prioritize drug-drug and class-class pairs associated with patients with severely impaired HRQoL. RESULTS: Data from 16,573 beneficiaries (24,126 records) showed that 44.4% had PP and 10.1% had EPP. Beneficiaries with PP and EPP had significantly lower mean PCS and MCS scores compared to those without polypharmacy (p < 0.001). After adjusting for covariates, beneficiaries with EPP had clinically significantly lower PCS (adjusted marginal difference: -8.47 [-9.00, -7.94]) and MCS (adjusted marginal difference: -4.32 [-4.89, -3.75]) compared to the NP group. Top-ranked drug-drug pairs like tiotropium bromide and oxycodone/acetaminophen exhibited significant associations with HRQoL decline. Analysis of class-class pairs highlighted (1) corticosteroid hormone receptor agonists and opioid agonists and (2) benzodiazepines and adrenergic beta2-agonists as having significant associations with HRQoL decline. DISCUSSION: Polypharmacy exhibits a significant association with HRQoL declines among older adults with PC.

Online Tools to Decrease Out-of-Pocket Prescription Costs for Patients: A Practical Guide for Urologists.

INTRODUCTION: Patients who seek urologic care have recently reported a high degree of financial toxicity from prescription medications, including management for nephrolithiasis, urinary incontinence, and urological oncology. Estimating out-of-pocket costs can be challenging for urologists in the US because of variable insurance coverage, local pharmacy distributions, and complicated prescription pricing schemes. This article discusses resources that urologists can adopt into their practice and share with patients to help lower out-of-pocket spending for prescription medications. METHODS: We identify 4 online tools that are designed to direct patients toward more affordable prescription medication options: the Medicare Part D Plan Finder, GoodRx, Amazon, and the Mark Cuban Cost Plus Drug Company. A brief historical overview and summary for patients and clinicians are provided for each online resource. A patient-centered framework is provided to help navigate these 4 available tools in clinic. RESULTS: Among the 4 tools we identify, there are multiples tradeoffs to consider as financial savings and features can vary. First, patients insured by Medicare should explore the Part D Plan Finder each year to compare drug plans. Second, patients who need to urgently refill a prescription at a local pharmacy should visit GoodRx. Third, patients who are prescribed recurrent generic prescriptions for chronic conditions can utilize the Mark Cuban Cost Plus Drug Company. Finally, patients who are prescribed 3 or more chronic medications can benefit from subscribing to Amazon RxPass. CONCLUSIONS: Prescription medications for urologic conditions can be expensive. This article includes 4 online resources that can help patients access medications at their most affordable costs. Urologists can provide this framework to their patients to help support lowering out-of-pocket drug costs.

The Inflation Reduction Act: Implications for Medicare spending and access to biologic therapies for chronic rhinosinusitis with nasal polyposis and asthma.

KEY POINTS: In 2021, Medicare spending on biologics was $926 million in Part B (FFS) and $1.3 billion in Part D (FFS/MA). Between 2017 and 2021, annual Medicare spending on biologics increased by approximately 200%. Between 2023 and 2025, Medicare Part D OOP costs for biologics will decrease by an estimated 50%-60%.

Out-of-Pocket Cost Modeling of Adjuvant Antiestrogen and Radiation Therapy After Lumpectomy for Early-Stage Breast Cancer Across Medicaid and Medicare Plans.

PURPOSE: The optimal adjuvant therapy (antiestrogen therapy [ET] + radiation therapy or ET alone, or in some reports radiation therapy alone) in older women with early-stage breast cancer has been highly debated. However, granular details on the role of insurance in the out-of-pocket cost for patients receiving ET with or without radiation therapy are lacking. This project disaggregates out-of-pocket costs by insurance plans to increase treatment cost transparency. METHODS AND MATERIALS: Several radiation therapy schedules are accepted standards as per the National Comprehensive Cancer Network guidelines. For our financial estimate model, we used the 5-fraction and 15-fraction radiation therapy and ET prescribed over a 5-year duration. The total aggregate out-of-pocket costs were determined from the sum of treatment costs, deductibles, and copays/coinsurance based on Medicaid, Original Medicare, Medigap Plan G, and Medicare Part D Rx plans. The model assumes a Medicare- and/or Medicaid-eligible patient ≥70 years of age with node-negative, early-stage estrogen-receptor-positive breast cancer. Patient out-of-pocket costs were estimated from publicly available insurance data from plan-specific benefit coverage materials using a 5-year time horizon. RESULTS: Original Medicare beneficiaries face a total out-of-pocket treatment charge of $2738.52 for ET alone, $2221.26 for 5-fraction radiation therapy alone, $2573.92 for 15-fraction radiation therapy alone, $3361.26 for combined ET+ 5-fraction radiation therapy, and $3713.92 for combined ET + 15-fraction radiation therapy. Medigap Plan G beneficiaries have an out-of-pocket charge of $1130.00 with radiation therapy alone and face an out-of-pocket of $2270.00 for ET alone and combined ET+ radiation therapy. For Medicaid beneficiaries, all treatments approved by Medicaid are covered without limit, resulting in no out-of-pocket expense for either adjuvant treatment option. CONCLUSIONS: This model (based on actual cost estimates per insurance plan rather than claims data), by estimating expenses within Medicare and Medicaid plans, provides a level of transparency to patient cost. With knowledge of the costs borne by patients themselves, treatment decisions informed by patients' individual priorities and preferences may be further enhanced.

Nationwide, County-Level Analysis of the Patterns, Trends, and System-Level Predictors of Opioid Prescribing in Surgery in the US: Social Determinants and Access to Mental Health Services Matter.

BACKGROUND: The diversion of unused opioid prescription pills to the community at large contributes to the opioid epidemic in the US. In this county-level population-based study, we aimed to examine the US surgeons' opioid prescription patterns, trends, and system-level predictors in the peak years of the opioid epidemic. STUDY DESIGN: Using the Medicare Part D database (2013 to 2017), the mean number of opioid prescriptions per beneficiary (OPBs) was determined for each US county. Opioid-prescribing patterns were compared across counties. Multivariable linear regression was performed to determine relationships between county-level social determinants of health (demographic, eg median age and education level; socioeconomic, eg median income; population health status, eg percentage of current smokers; healthcare quality, eg rate of preventable hospital stays; and healthcare access, eg healthcare costs) and OPBs. RESULTS: Opioid prescription data were available for 1,969 of 3,006 (65.5%) US counties, and opioid-related deaths were recorded in 1,384 of 3,006 counties (46%). Nationwide, the mean OPBs decreased from 1.08 ± 0.61 in 2013 to 0.87 ± 0.55 in 2017; 81.6% of the counties showed the decreasing trend. County-level multivariable analyses showed that lower median population age, higher percentages of bachelor's degree holders, higher percentages of adults reporting insufficient sleep, higher healthcare costs, fewer mental health providers, and higher percentages of uninsured adults are associated with higher OPBs. CONCLUSIONS: Opioid prescribing by surgeons decreased between 2013 and 2017. A county's suboptimal access to healthcare in general and mental health services in specific may be associated with more opioid prescribing after surgery.

A summit on amplifying voices of patients, caregivers, and people with disabilities in Inflation Reduction Act drug price negotiations.

On September 18, 2023, Cancer Support Community convened patient and caregiver advocates, health care providers, policy experts, and health care innovators and thought leaders for a roundtable discussion on the need to ensure that patients, people with disabilities, and caregivers have a voice in defining "clinical benefit" for the purpose of Medicare Part D drug price negotiations and future health care policies that impact patients. The meeting featured presentations from Lara Strawbridge, Deputy Director for Policy at the Medicare Drug Rebate and Negotiations Group in the Center for Medicare, regulatory expert, Dr Monique Nolan, Counsel at Arnold and Porter, LLP, and 3 panel discussions: IRA Implementation-What Matters to Patients, a discussion of policies expected to impact patients and caregivers who are likely to rely heavily on high-cost drugs or biologics to treat cancer or other chronic illnesses, as well as the future development of novel therapies; The Science of Measuring Patient Experience, a discussion of current science of measuring patient experience and how it should be incorporated into the definition of clinical benefit; and Developing an Infrastructure for External Feedback, a discussion of actions and goals for patient engagement, advocacy opportunities, and how to best coordinate such efforts. This article represents an analysis of relevant resources as well as highlights from these sessions and subsequent discussions. It also outlines principles for engaging patient and provider advocacy organizations, whether in policy, media, or online discussions, surrounding the implementation of the Medicare Drug Price Negotiation Program.

Why Does the Inflation Reduction Act Exclude Expensive Cancer Treatments in Price Negotiations?

PURPOSE: The Inflation Reduction Act (IRA) includes provisions for price negotiations of certain high-spending drugs in Medicare Parts B and D. This provision received considerable attention from those interested in the costs of cancer care since Medicare covers most patients with cancer and many cancer drugs are expensive. We simulate how many cancer drugs may be eligible for IRA price negotiations and examine the reasons that many are likely to be excluded from negotiation. METHODS: This study uses 2021 Medicare Fee-for-Service Part B and Part D prescription drugs expenditure data. Cancer drugs were identified using the SEER Program list of cancer medications. Our measures included total spending, beneficiary users, and spending-per-beneficiary for all cancer drugs covered under Medicare. Each drug was evaluated for eligibility on the basis of IRA negotiation provisions, including estimated loss of patent exclusivity, current competitors, and orphan drug designation. RESULTS: We found that very few cancer drugs will meet the IRA eligibility thresholds to be included in negotiations. We estimate that only 2.2% of beneficiaries with cancer will see lower costs because of the IRA negotiations. The main reason for this is that although novel cancer drug treatments are priced high, they generally treat relatively few beneficiaries and thus do not meet negotiation eligibility criteria, which are primarily based on a ranking of total spending. CONCLUSION: The IRA negotiation provisions will have limited impact on cancer drug prices and will likely leave most patients with cancer exposed to high drug costs.

Characterizing Opioid Prescribing Trends of Medical Oncologists From 2013 to 2019: Analysis From the Centers for Medicare & Medicaid Services Medicare Part D Prescribers Database.

PURPOSE: Opioid prescribing trends in medical oncology are poorly defined past 2017, the year after the CDC updated opioid prescription guidelines in noncancer settings. We aim to characterize pain management by medical oncologists by analyzing opioid and gabapentin prescribing trends from 2013 to 2019, identify physician-related factors associated with prescribing patterns, and assess whether CDC guidelines for nononcologic settings changed prescribing patterns. METHODS: The Centers for Medicare & Medicaid Services (CMS) Medicare Part D Prescribers-by Provider, CMS Medicare Part D Prescribers-by Provider and Drug, and CMS Medicare Physician National Downloadable files from 2013 to 2019 were merged by National Provider Identification. The database included physicians' sex, years of practice, regions, and practice settings. Multivariable binary logistic regression identified significant predictors of total opioid, long-acting opioid, and gabapentin prescriptions. RESULTS: Binary logistic regression modeling revealed no significant difference in mean daily total opioid prescriptions from 2013 to 2017. Daily opioid prescriptions by medical oncologists decreased significantly after 2017 (P < .001). Increased opioid prescribing was associated with physician male sex (P < .001), practicing over 10 years (P < .001), and practice in nonurban areas (P < .001). Opioid prescribing was greatest in the South and Midwest United States (P < .001). The same patterns were observed with total long-acting opioid prescriptions, whereas gabapentin prescribing increased from 2013 to 2019 (P < .001). CONCLUSION: Opioid prescriptions by medical oncologists decreased significantly from 2013 to 2019, but this decrease was most substantial from 2017 to 2019. These results may imply that the 2016 CDC guidelines influenced medical oncologists, particularly more junior physicians in urban settings, to manage chronic cancer pain with alternative therapies.

The effect of prescription drug insurance on the incidence of potentially inappropriate prescribing: Evidence from Medicare Part D.

The Medicare Part D program has been documented to increase the affordability and accessibility of drugs and improve the quality of prescription drug use; however, less is known about the equity impact of the Part D program on potentially inappropriate prescribing-specifically, incidences of polypharmacy and potentially inappropriate medication (PIM) use based on different racial/ethnic groups. Using a difference in the regression discontinuity design, we found that among Whites, Part D was associated with increases in polypharmacy and "broadly defined" PIM use, while the use of "always avoid" PIM remained unchanged. Conversely, Blacks and Hispanics reported no changes in such drug utilization patterns.

Sociodemographic and spending characteristics of Medicare beneficiaries taking prescription drugs subject to price negotiations.

BACKGROUND: The 2022 Inflation Reduction Act authorizes Medicare to negotiate the prices of 10 drugs in 2026 and additional drugs thereafter. Understanding the sociodemographic and spending characteristics of beneficiaries taking these specific drugs could be important describing the impact of the legislation. OBJECTIVE: To describe sociodemographic and spending characteristics of Medicare beneficiaries who use the 10 prescription drugs ("negotiated drugs") that will face Medicare drug price negotiations in 2026. METHODS: A 20% sample of Medicare Part D beneficiaries from 2020 (n = 10,224,642) was used. Sociodemographic and spending characteristics were descriptively reported for beneficiaries taking the negotiated drugs, including subgroups by low-income subsidy (LIS) status and by drug, and for Part D beneficiaries not taking negotiated drugs. RESULTS: Part D beneficiaries taking a negotiated drug compared with Part D beneficiaries not taking a negotiated drug overall had similar sociodemographic characteristics, more comorbidities (3.9 vs 2.2) and higher mean [median] Medicare ($33,882 [$18,251] vs $12,366 [$3,429]) and out-of-pocket (OOP) spending ($813 [$307] vs $441 [$160]). There was variation in characteristics by LIS status. The mean age was highest among non-LIS beneficiaries taking a negotiated drug compared with LIS beneficiaries taking a negotiated drug and beneficiaries not taking a negotiated drug (76.2 vs 69.9 vs 71.4). Among beneficiaries using negotiated drugs, a higher percentage of LIS beneficiaries compared with non-LIS was female (59.7% vs 48.0%), was Black (20.9% vs 6.6%), and resided in lower-income areas (39.1% vs 20.3%). Mean [median] annual Part D OOP spending for negotiated drugs was $115 [$59] for beneficiaries with LIS and $1,475 [$1,204] for beneficiaries without LIS. There were also differences depending on which negotiated drug was used. Drugs for cancer and blood clots had the highest proportions of White users, whereas type 2 diabetes and heart failure drugs had the highest proportions of Black users and beneficiaries residing in lower-income areas. Annual Part D OOP costs were lowest for sitagliptin (LIS: $104 [$60], non-LIS: $1,391 [$1,153]) and highest for ibrutinib (LIS: $649 [$649], non-LIS: $6,449 [$6,867]). Among non-LIS beneficiaries, 24% (22% to 76%) had more than $2,000 in OOP costs. CONCLUSIONS: Inflation Reduction Act OOP spending caps and LIS expansion will lower prescription drug costs for beneficiaries with OOP costs exceeding $2,000 who are mostly White and live in higher-income areas, insulin users who are disproportionately Black with multiple chronic conditions, and beneficiaries with low incomes. However, these provisions will not impact the 76% of non-LIS beneficiaries using negotiated drugs who have OOP costs that are still substantial but below $2,000. Negotiations could reduce OOP costs through reduced coinsurance payments for this group, which is older and has more chronic conditions compared with beneficiaries not taking negotiated drugs. Part D plan design, spending, and utilization changes should be monitored after negotiation to determine if further solutions are needed to lower OOP costs for this group.

Associations between pharmaceutical industry payments to physicians and prescription of PARP inhibitors in the United States.

PURPOSE: To evaluate the association between industry payments to physicians related to poly (ADP-ribose) polymerase inhibitors (PARPis) and physicians' prescribing behaviors for PARPis. METHODS: This panel-data analysis used the publicly accessible Open Payments Database and Medicare Part D database between 2017 and 2021. All physicians who reported >10 claims for either olaparib, rucaparib, or niraparib were included in this study. Non-research payments for the PARPis to the physicians from the PARPi manufacturers were extracted from the Open Payments Database. Associations between the physicians' receipt of payments and likelihood of prescribing PARPis were assessed with logistic generalized estimating equations (GEEs). Dose-response associations between the number of payments and prescription volumes and Medicare expenditures were evaluated with linear GEEs. RESULTS: Of the 1686 eligible physician prescribers, 68.7% received one or more non-research payments related to any of the three PARPis from the manufacturers between 2017 and 2021. Median annual payments per physician were $57 for olaparib, $39 for rucaparib, and $62 for niraparib. Receipt of payments for each PARPi was associated with higher odds of prescribing olaparib (odds ratio [OR]: 1.30 [95% CI: 1.14-1.48], p < 0.001), rucaparib (OR: 2.07 [95% CI: 1.58-2.72], p < 0.001), and niraparib (OR: 1.49 [95% CI: 1.22-1.81], p < 0.001). Dose-response effects were observed between the number of annual payments and the number of prescriptions and/or Medicare expenditures for olaparib and rucaparib. CONCLUSION: Non-research payments to physician prescribers of PARP inhibitors from the manufacturers were significantly associated with increased prescriptions and Medicare expenditures for olaparib and rucaparib in the United States.

Trends in Proportion of Medicare Part D Claims Subject to 340B Discounts, 2013-2020.

Importance: Despite controversy surrounding the 340B program, no study has analyzed trends in the proportion of Medicare Part D pharmacy claims eligible for 340B discounts. Objective: To describe trends in the proportion of Medicare Part D claims that are prescribed by 340B-affiliated clinicians and filled in 340B pharmacies. Design and Setting: This longitudinal, retrospective cohort study included 2013 to 2020 claims data from a 5% random sample of Medicare Part D beneficiaries from the Centers for Medicare & Medicaid Services and 6292 nine-digit national drug codes that were used by at least 1000 Part D beneficiaries in a given year. Data analysis was completed from November 2022 to April 2023. Main Outcomes and Measures: For each drug and year, there were 3 outcomes: (1) proportion of total Part D claims that were prescribed by a 340B-affiliated clinician; (2) proportion of claims prescribed by a 340B-affiliated clinician that were filled in a 340B pharmacy; and (3) proportion of total Part D claims under the 340B program (ie, prescribed by a 340B-affiliated clinician and filled in a 340B pharmacy). Results: The proportion of prescriptions written by a 340B-affiliated clinician doubled from 9.4% in 2013 to 19.3% in 2020. The capture of 340B prescriptions by 340B pharmacies, defined as the proportion of claims prescribed by 340B-affiliated clinicians that were filled by 340B pharmacies, increased from 18.4% in 2013 to 49.9% in 2020. As a result, the total proportion of 340B claims in Part D increased from 1.7% in 2013 to 9.6% in 2020. Rates of 340B prescribing and capture increased consistently across therapeutic classes. In 2020, the antiviral therapeutic class was the class with the largest proportion of 340B claims (16.1%), followed by targeted antineoplastics (15.7%). Conclusions and Relevance: This cohort study demonstrated that from 2013 to 2020, the share of Medicare Part D claims prescribed by a 340B-affiliated clinician increased; however, the rate at which 340B-eligible prescriptions were filled at 340B pharmacies increased at a faster rate, driving the overall increase in 340B claims. Despite these trends, only half of 340B-eligible prescriptions were subject to the 340B discount in 2020.

The story of the development of generic lenalidomide: How one company thwarted the Hatch-Waxman Act to generate billions of dollars in revenue.

Lenalidomide (Revlimid®) was originally approved by the Food and Drug Administration (FDA) in 2005, however, a generic version was not available until 2022. In that time, the price of lenalidomide has increased more than 20 times, and in 2021 alone, it accounted for >$5.8 billion dollars in Medicare Part D spending. This was a direct consequence of legal tactics employed by the manufacturer to thwart development of generic formulations of lenalidomide. In this report, we review the clinical development of lenalidomide, provide background on generic drug manufacturing in the United States (US), describe the steps that the manufacturer took to prevent entry of generic lenalidomide into the US market, and advocate for legislative reform of the FDA approval process and patent law protections in the US.

Opportunities for Savings in Risk Arrangements for Oncologic Care.

Importance: As the US accelerates adoption of alternative payment through global payment models such as Accountable Care Organizations (ACOs) or Medicare Advantage (MA), high spending for cancer care is a potential target for savings. Objective: To quantify the extent to which ACOs and other risk-bearing organizations operating in a specific geographic area (hospital referral region [HRR]) could achieve savings by steering patients to efficient medical oncology practices. Design, Setting, and Participants: This observational study included serial cross-sections of Medicare beneficiaries with cancer from 2010 to 2018. Data were analyzed from August 2021 to March 2023. Main Outcomes and Measures: Total spending and spending by category in the 1-year period following an index visit for a patient with newly diagnosed (incident) or poor-prognosis cancer. Results: The incident cohort included 1 309 825 patients with a mean age of 74.0 years; the most common cancer types were breast (21.4%), lung (16.7%), and colorectal cancer (10.0%). The poor prognosis cohort included 1 429 973 (mean age, 72.7 years); the most common cancer types were lung (26.6%), lymphoma (11.7%), and leukemia (7.3%). Options for steering varied across markets; the top quartile market had 10 or more oncology practices, but the bottom quartile had 3 or fewer oncology practices. Total spending (including Medicare Part D) in the incident cohort increased from a mean of $57 314 in 2009 to 2010 to $66 028 in 2016 to 2017. Within markets, total spending for practices in the highest spending quartile was 19% higher than in the lowest quartile. Hospital spending was the single largest component of spending in both time periods ($20 390 and $19 718, respectively) followed by Part B (infused) chemotherapy ($8022 and $11 699). Correlations in practice-level spending between the first-year (2009) and second-year (2010) spending were high (>0.90 in all categories with most >0.98), but these attenuated over time. Conclusions and Relevance: These results suggest there may be opportunities for ACOs and other risk-bearing organizations to select or drive referrals to lower-spending oncology practices in many local markets.

Changes in the Use of Long-Term Medications Following Incident Dementia Diagnosis.

Importance: Dementia is a life-altering diagnosis that may affect medication safety and goals for chronic disease management. Objective: To examine changes in medication use following an incident dementia diagnosis among community-dwelling older adults. Design, Setting, and Participants: In this cohort study of adults aged 67 years or older enrolled in traditional Medicare and Medicare Part D, patients with incident dementia diagnosed between January 2012 and December 2018 were matched to control patients based on demographics, geographic location, and baseline medication count. The index date was defined as the date of first dementia diagnosis or, for controls, the date of the closest office visit. Data were analyzed from August 2021 to June 2023. Exposure: Incident dementia diagnosis. Main Outcomes and Measures: The main outcomes were overall medication counts and use of cardiometabolic, central nervous system (CNS)-active, and anticholinergic medications. A comparative time-series analysis was conducted to examine quarterly changes in medication use in the year before through the year following the index date. Results: The study included 266 675 adults with incident dementia and 266 675 control adults; in both groups, 65.1% were aged 80 years or older (mean [SD] age, 82.2 [7.1] years) and 67.8% were female. At baseline, patients with incident dementia were more likely than controls to use CNS-active medications (54.32% vs 48.39%) and anticholinergic medications (17.79% vs 15.96%) and less likely to use most cardiometabolic medications (eg, diabetes medications, 31.19% vs 36.45%). Immediately following the index date, the cohort with dementia had a greater increase in mean number of medications used (0.41 vs -0.06; difference, 0.46 [95% CI, 0.27-0.66]) and in the proportion of patients using CNS-active medications (absolute change, 3.44% vs 0.79%; difference, 2.65% [95% CI, 0.85%-4.45%]) owing to an increased use of antipsychotics, antidepressants, and antiepileptics. The cohort with dementia also had a modestly greater decline in use of anticholinergic medications (quarterly change in use, -0.53% vs -0.21%; difference, -0.32% [95% CI, -0.55% to -0.08%]) and most cardiometabolic medications (eg, quarterly change in antihypertensive use: -0.84% vs -0.40%; difference, -0.44% [95% CI, -0.64% to -0.25%]). One year after diagnosis, 75.2% of the cohort with dementia were using 5 or more medications (2.8% increase). Conclusions and Relevance: In this cohort study of Medicare Part D beneficiaries, following an incident dementia diagnosis, patients were more likely to initiate CNS-active medications and modestly more likely to discontinue cardiometabolic and anticholinergic medications compared with the control group. These findings suggest missed opportunities to reduce burdensome polypharmacy by deprescribing long-term medications with high safety risks or limited likelihood of benefit or that may be associated with impaired cognition.