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 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%.

Utilization Management Trends in Medicare Part D Oncology Drugs, 2010-2020.

This study examines the exposure of Medicare Part D beneficiaries to utilization management, such as prior authorization, for oral oncology drugs.

Added Therapeutic Benefit of Top-Selling Brand-name Drugs in Medicare.

Importance: The Inflation Reduction Act of 2022 authorizes Medicare to negotiate prices of top-selling drugs based on several factors, including therapeutic benefit compared with existing treatment options. Objective: To determine the added therapeutic benefit of the 50 top-selling brand-name drugs in Medicare in 2020, as assessed by health technology assessment (HTA) organizations in Canada, France, and Germany. Design, Setting, and Participants: In this cross-sectional study, publicly available therapeutic benefit ratings, US Food and Drug Administration documents, and the Medicare Part B and Part D prescription drug spending dashboards were used to determine the 50 top-selling single-source drugs used in Medicare in 2020 and to assess their added therapeutic benefit ratings through 2021. Main Outcomes and Measures: Ratings from HTA bodies in Canada, France, and Germany were categorized as high (moderate or greater) or low (minor or no) added benefit. Each drug was rated based on its most favorable rating across countries, indications, subpopulations, and dosage forms. We compared the use and prerebate and postrebate (ie, net) Medicare spending between drugs with high vs low added benefit. Results: Forty-nine drugs (98%) received an HTA rating by at least 1 country; 22 of 36 drugs (61%) received a low added benefit rating in Canada, 34 of 47 in France (72%), and 17 of 29 in Germany (59%). Across countries, 27 drugs (55%) had a low added therapeutic rating, accounting for $19.3 billion in annual estimated net spending, or 35% of Medicare net spending on the 50 top-selling single-source drugs and 11% of total Medicare net prescription drug spending in 2020. Compared with those with high added benefit, drugs with a low added therapeutic rating were used by more Medicare beneficiaries (median 387 149 vs 44 869) and had lower net spending per beneficiary (median $992 vs $32 287). Conclusions and Relevance: Many top-selling Medicare drugs received low added benefit ratings by the national HTA organizations of Canada, France, and Germany. When negotiating prices for these drugs, Medicare should ensure they are not priced higher than reasonable therapeutic alternatives.

Cancer history, insurance coverage, and cost-related medication nonadherence in Medicare beneficiaries, 2013-2018.

BACKGROUND: Cancer survivors are at risk of financial hardships and cost-related medication nonadherence, particularly among those without adequate insurance coverage. OBJECTIVE: To examine the association between cancer history and cost-related medication nonadherence, as well as the association between insurance coverage and nonadherence among Medicare beneficiaries. METHODS: We used the 2013-2018 Medicare Current Beneficiary Survey Public Use File, a survey on the health, health service utilization, access to care, and satisfaction among a nationally representative sample of Medicare beneficiaries. Cost-related medication nonadherence was defined as often or sometimes reporting any of the following: (1) took smaller dose of medication, (2) skipped doses to make medication last, (3) delayed medication because of cost, and (4) not get medication because of cost. Logistic regression was used to estimate the odds ratio of cost-related nonadherence associated with cancer history, adjusting for survey year and sociodemographic characteristics of the respondents, including age, sex, race and ethnicity, highest grade completed, income level, marital status, and number of chronic conditions. We also included Medicare Part D, an interaction between Part D and the low-income subsidy, and Medicare Advantage in the model to examine the effect of insurance coverage on cost-related nonadherence. RESULTS: From 2013 to 2018, there were 12,492 cancer survivors and 53,262 respondents without a history of cancer in our sample, and 16.5% reported cost-related medication nonadherence. After adjusting for characteristics of the respondents, cancer survivors were more likely than those without a history of cancer to report cost-related medication nonadherence (adjusted OR = 1.10; 95% CI = 1.02-1.19). Having unsubsidized Part D-Part D without the low-income subsidy-was associated with a greater likelihood of reporting cost-related medication nonadherence (adjusted OR = 1.63, 95% CI = 1.49-1.78), while having subsidized Part D was not (adjusted OR = 0.96; 95% CI = 0.85-1.08). Finally, being on Medicare Advantage was associated with lower likelihood of reporting cost-related nonadherence compared with traditional fee-for-service Medicare (adjusted OR = 0.86; 95% CI = 0.80-0.92). CONCLUSIONS: Expanding the low-income subsidy and capping out-of-pocket drug expenditure can be effective policy options to reduce cost-sharing burden and cost-related nonadherence. DISCLOSURES: For this study, Li was partially supported by a research grant from the National Cancer Institute (R01CA225647). The sponsor had no role in the design or implementation of the study, analysis or interpretation of the data, or drafting or approval the manuscript. The authors report no conflicts of interest.

Promotional Payments Made to Urologists by the Pharmaceutical Industry and Prescribing Patterns for Targeted Therapies.

OBJECTIVE: To measure the association between market-level promotional payments to urologists by the manufacturers of abiraterone and enzalutamide and national prescribing patterns. METHODS: A 20% national sample of the 2015 Part D event file was used to identify patients filling their first prescription for abiraterone and enzalutamide and their prescribing physicians. The 2015 Open Payments data were used to characterize promotional payments made to physicians at the market level. Generalized linear models were then used to measure the relationship between market-level payments to urologists and the physician specialty prescribing abiraterone or enzalutamide for the first time RESULTS: In 2015, 2318 men filled a prescription for abiraterone or enzalutamide by a urologist or medical oncologist. Increasing market-level promotional payments to urologists for abiraterone or enzalutamide was strongly associated with a urologist prescribing either drug-24.3% versus 5.8% of those residing in the markets with highest and lowest level of promotional payments to urologists, respectively (P <.01). Neither the number of urologists residing in a market nor other promotional payment measures (ie, to medical oncologists for these drugs, or to all physicians for all other drugs) were associated with a urologist prescribing either drug. CONCLUSION: Promotional payments to urologists at the market level are strongly associated with the specialty of the physician prescribing abiraterone or enzalutamide for the first time. Future work should elucidate the effects of the shift in prescribing patterns on quality of care and financial hardship for men with advanced prostate cancer.

Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability: An Ancillary Study of the Look AHEAD Study.

Importance: Intensive lifestyle interventions focused on diet and exercise can reduce weight and improve diabetes management. However, the long-term effects on health care use and spending are unclear, especially for public payers. Objective: To estimate the association of effective intensive lifestyle intervention for weight loss with long-term health care use and Medicare spending. Design, Setting, and Participants: This ancillary study used data from the Look AHEAD randomized clinical trial, which randomized participants with type 2 diabetes to an intensive lifestyle intervention or control group (ie, diabetes support and education), provided ongoing intervention from 2001 to 2012, and demonstrated improved diabetes management and reduced health care costs during the intervention. This study compared Medicare data between study arms from 2012 to 2015 to determine whether the intervention was associated with persistent reductions in health care spending. Exposure: Starting in 2001, Look AHEAD's intervention group participated in sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists with the goal of reducing weight 7% in the first year. Sessions occurred weekly in the first 6 months of the intervention and decreased over the intervention period. The controls participated in periodic group education sessions that occurred 3 times per year in the first year and decreased to 1 time per year later in the trial. Main Outcomes and Measures: Outcomes included total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility. Results: This study matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages). Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women). There was no statistically significant difference in total Medicare spending between groups (difference, -$133 [95% CI, -$1946 to $1681]; P = .89). In the intervention group, compared with the control group, there was statistically significantly higher Part B spending (difference, $513 [95% CI, $70 to $955]; P = .02) but lower prescription drug costs (difference, -$803 [95% CI, -$1522 to -$83]; P = .03). Conclusions and Relevance: This ancillary study of a randomized clinical trial found that reductions in health care use and spending associated with an intensive lifestyle intervention for type 2 diabetes diminished as participants aged. Intensive lifestyle interventions may need to be sustained to reduce long-term health care spending. Trial Registration: ClinicalTrials.gov Identifier: NCT03952728.

Estimating the Use of Potentially Inappropriate Medications Among Older Adults in the United States.

OBJECTIVES: Inappropriate prescribing of medications is common in health care, and is an important safety concern, especially for older adults, who have a high burden of comorbidity and are at greater risk for medication-related adverse events. This study aims to estimate the extent and cost of potentially inappropriate prescribing of medications to older adults in the United States. DESIGN: A cross-sectional study. SETTING: Medicare Part D Prescription Drug Program data set (2014-2018). PARTICIPANTS: Older adults who were enrolled in Medicare Part D Prescription Drug Program between 2014 and 2018. MEASUREMENTS: Potentially inappropriate medications were identified using the 2019 American Geriatrics Society Beers Criteria®. RESULTS: In 2018, 7.3 billion doses of potentially inappropriate medications were dispensed. The most common medications by number of doses dispensed were proton pump inhibitors, benzodiazepines, and tricyclic antidepressants, and the top five unique medications by reported spending were dexlansoprazole, esomeprazole, omeprazole, dronedarone, and conjugated estrogens. From 2014 to 2018, 43 billion doses of potentially inappropriate medications were dispensed, with a reported spending of $25.2 billion. CONCLUSION: Potentially inappropriate medication use among older adults is both common and costly. Careful attention to potentially inappropriate medication use and deprescribing when clinically appropriate could reduce costs and potentially improve outcomes among older adults.

Maximizing the impact of, and sustaining standing orders protocols for adult immunization in outpatient clinics.

BACKGROUND: Low adult immunization rates leave adults at risk from infectious disease, and the resulting complications of vaccine-preventable diseases. Standing orders protocols (SOPs) for adult immunization have not been implemented widely in clinics serving adult patients. Our purpose was to evaluate the impact of SOPs on adult immunization rates and identify challenges to sustaining adult immunization coverage rates after implementation of SOPs. METHODS: Baseline adult vaccination rates were calculated for the year prior to SOPs implementation in 5 diverse clinics. Vaccines included in the implemented standing orders included Tdap, influenza, pneumococcal, human papillomavirus, herpes zoster, and hepatitis B. Adult vaccination rates were tracked for 1 year after SOPs implementation. RESULTS: Sites generally sustained modest gains in coverage rates (4%-8% increase) after SOP implementation, but greater success was found in practices that used SOPs as a foundation on which additional interventions were built. Challenges to increasing coverage rates included prioritization of acute and chronic conditions over adult vaccination, Medicare Part D reimbursement policies, electronic medical record issues related to data reporting and programming for patient alerts, and the lack of interoperability between the state immunization information system (missing patient vaccination history) and electronic medical record. CONCLUSIONS: SOPs may provide a good starting point for increasing adult immunization coverage rates. Using additional interventions, quality-based metrics, or incentives could lead to sustained adult immunization prioritization.

Associations Between Chronic Disease, Polypharmacy, and Medication-Related Problems Among Medicare Beneficiaries.

BACKGROUND: Mismanaged polypharmacy among older adults costs the health care system approximately $2 billion each year. Medication therapy management (MTM), a service designed to optimize medication use, improve health outcomes, and reduce associated costs, is available to eligible Medicare beneficiaries. Yet, it remains unclear which beneficiaries benefit most from this service. OBJECTIVE: To assess associations between patient characteristics, chronic disease, polypharmacy, and medication-related problems (MRPs) in a sample population of Medicare beneficiaries. METHODS: This study was a retrospective cross-sectional analysis of 1 Medicare Part D plan provider for the year 2015. Medicare beneficiaries were included if they were eligible to receive MTM services and excluded if they were aged under 65 years or the dataset had no count of MRPs for the beneficiary. A negative binomial regression assessed the relationship between age, sex, and chronic health conditions with MRPs. Second and third negative binomial regressions assessed the relationship between age, sex, and polypharmacy with MRPs. RESULTS: A sample of 27,765 Medicare beneficiaries had a mean (SD) age of 76 (±7) years, were predominantly female (59%), and used a mean (SD) of 11 (±4) chronic medications. Beneficiaries with certain conditions were more likely to incur an MRP than those without, including depression (OR = 1.58; 95% CI = 1.51-1.64), congestive heart failure (OR = 1.26; 95% CI = 1.20-1.31), diabetes (OR = 1.24; 95% CI = 1.18-1.29), end-stage renal disease (OR = 1.38; 95% CI = 1.25-1.52), respiratory conditions (OR = 1.25; 95% CI = 1.19-1.31), and hypertension (OR = 1.09; 95% CI = 1.01-1.18). Medicare beneficiaries with polypharmacy (11 or more medications) were 1.86 (95% CI = 1.80-1.93) times more likely to experience an MRP than those taking fewer medications. For every additional medication, the odds of incurring an MRP increased by 10% (OR = 1.11; 95% CI = 1.10-1.1.11). CONCLUSIONS: The diagnosis of depression presented with the strongest association with MRPs. Diabetes, congestive heart failure, end-stage renal disease, respiratory conditions, and hypertension also presented with significant associations with MRPs. Beneficiaries with polypharmacy (11 or more medications) were almost 2 times more likely to experience an MRP than those taking fewer medications. Addition of a chronic medication resulted in a 10% increase in the odds of incurring an MRP. MTM programs may find a greater number of MRPs among those diagnosed with depression in their MTM-eligible patient populations. DISCLOSURES: No outside funding supported this research. Silva Almodóvar reports fees from SinfoniaRx, outside the submitted work. Nahata has nothing to disclose.

Increased Cost With Use of Brand-Name Bowel Preparation by Patients With Medicare Part D From 2013 to 2015.

High-quality bowel preparation (prep) before colonoscopy is essential for the success of the procedure.1 Bowel preps should be safe, tolerable, efficacious, and allow for visualization of polyps 5 mm or larger.2 Full-volume (4 L) polyethylene glycol-3350 with electrolyte solution (PEG-ELS) has been considered a standard bowel prep regimen, with good safety and efficacy profiles, and is available as a generic.2.

Analysis of Proposed Medicare Part B to Part D Shift With Associated Changes in Total Spending and Patient Cost-Sharing for Prescription Drugs.

Importance: The US Department of Health and Human Services (HHS) has proposed to reform drug pricing in Medicare Part B, which primarily covers physician-administered drugs and biologic agents. One HHS proposal would shift coverage of certain drugs from Medicare Part B to Part D, which is administered by private prescription drug plans. Objective: To estimate the association of changes of a shift in Medicare Part B to Part D with total drug spending and patient cost-sharing. Design, Setting, and Participants: Retrospective drug cohort study of the 75 brand-name drugs associated with the highest Part B expenditures among fee-for-service Medicare beneficiaries in 2016. Main Outcomes and Measures: Estimated total Medicare spending in Part B and Part D; annual out-of-pocket costs in Part B and under the standard 2018 Part D benefit; and proportion of drugs in Part D's protected drug classes (immunosuppressants for prophylaxis of organ transplant rejection, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics). Results: At 2018 prices, total Medicare Part B spending for the 75 brand-name drugs with the highest Part B expenditures was estimated to be $21.6 billion annually. Under the proposed policy, total Part D drug spending for these drugs was estimated to range between $17.6 billion and $20.1 billion after rebates, corresponding to a 6.9% to 18.3% decrease in drug spending in Part D compared with Part B. Of the 75 drugs studied, 33 (44.0%) drugs, accounting for $9.5 billion (43.9%) in Part B spending, were in protected Part D classes where plans must cover essentially all drugs. For 67 drugs with available information, the prices for 65 (97.0%) were a median of 45.8% to 59.7% lower in comparator high-income countries than Part B drug prices. Median patient cost-sharing in Part B for all 75 brand-name drugs was $4683 (interquartile range [IQR], $1069-$9282) per year. Shifting Part B drugs to the 2018 standard Part D benefit was projected to decrease out-of-pocket costs by a median of $860 (IQR, -$3884 to $496) among Medicare beneficiaries without Medicaid or Part B supplemental insurance (Medigap). For beneficiaries who would qualify for the low-income subsidy program in Part D, cost-sharing would be lower in Part D than in Part B for all drugs. For beneficiaries with Medigap insurance, estimated Part D out-of-pocket costs exceeded average Medigap premium costs by a median of $1460 for those with Part D coverage and by a median of $1952 for those without Part D coverage. Conclusions and Relevance: Although the HHS proposal to shift certain drugs from Medicare Part B to Part D may reduce total drug spending, it may increase out-of-pocket costs for some Medicare beneficiaries, including those with Medicare supplement insurance. The Department of Health and Human Services should ensure that the proposed reforms benefit both patients and payers.

Using Group-based Trajectory Models and Propensity Score Weighting to Detect Heterogeneous Treatment Effects: The Case Study of Generic Hormonal Therapy for Women With Breast Cancer.

BACKGROUND: We extend an interrupted time series study design to identify heterogenous treatment effects using group-based trajectory models (GBTMs) to identify groups before a new policy and then examine if the effects of the policy has consistent impacts across groups using propensity score weighting to balance individuals within trajectory groups who are and are not exposed to the policy change. We explore this by examining how adherence to endocrine therapy (ET) for women with breast cancer was impacted by reducing copayments for medications by the introduction of generic ETs among women who do not receive a subsidy (the "treatment" group) to those that do receive a subsidy and are not exposed to any changes in copayments (the "control" group). METHODS: We examined monthly adherence to ET using the proportion of days covered for women diagnosed with breast cancer between 2008 and 2009 using SEER-Medicare data. To account for baseline trends, we characterize adherence for 1 year before generic approval of ET using GBTMs, within each groups we generate inverse probability treatment weights of not receiving a subsidy. We compared adherence after generic entry within each GBTM using a modified Poisson model. RESULTS: GBTMs for adherence in the 1-year pregeneric identified 6 groups. When comparing patients who did and did not receive a subsidy we found no overall effect of generic introduction. However, 1 of the 6 identified adherence groups postgeneric adherence increased [the "consistently low" (risk ratio=1.91; 95% confidence interval=1.34-2.72)]. CONCLUSIONS: This study describes a new approach to identify heterogenous effects when using an interrupted time series research design.

Industry Payments to Physicians and Prescriptions of Brand-Name Proton-Pump Inhibitors.

OBJECTIVE: To characterize the association between industry payments and prescriptions of 2 brand-name proton-pump inhibitors (PPIs). STUDY DESIGN: Cross-sectional retrospective. SETTING: Physicians nationwide. SUBJECTS AND METHODS: We identified all physicians receiving industry payments for Dexilant and Nexium 2014-2015 from the Open Payments database. We linked this to records of prescriptions for PPIs paid for by Medicare Part D these same years and compared the proportion of prescriptions written for Dexilant and Nexium in industry-compensated vs nonindustry compensated physicians. The number and dollar amount of payments were associated with the rate of drug prescriptions. RESULTS: We identified 254,452 physicians prescribing PPIs; 8586 and 2766 physicians received industry payments for Dexilant and Nexium, respectively. A total of 5052 of 7876 (64%) physicians compensated for Dexilant prescribed Dexilant vs 39,778 of 246,571 (16%) noncompensated physicians ( P < .001). For Nexium, 2525 of 2654 (95%) compensated physicians prescribed Nexium, compared to 123,913 of 252,067 (49%) noncompensated physicians. For both Dexilant and Nexium, there was a significant correlation between the number (ρ = 0.22, P < .001 and ρ = 0.12, P < .001) and dollar amount (ρ = 0.22, P < .001 and ρ = 0.13, P < .001) of payments and the percentage of prescriptions written for the compensated drug. Industry payments for Nexium remained associated with rate of prescription even after generic esomeprazole became available. CONCLUSION: Both the number and dollar amount of industry payments were associated with increased prescriptions for both Dexilant and Nexium. Although unable to show causality, this study suggests that industry payments may increase physician prescriptions of costly, brand-name drugs.