Benefits and Cost of a $35 Insulin Cost-Sharing Cap for Medicare Patients

BACKGROUND: To improve insulin affordability, Congress is considering capping insulin cost-sharing to $35 per 30-day supply for Medicare patients. The potential benefits and cost of this cap are unclear. Additionally, it is unknown whether the benefits of this cap would vary between Medicare patients with type 1 versus type 2 diabetes. METHODS: We conducted a cross-sectional analysis of the IQVIA Longitudinal Prescription Database, which reports prescriptions dispensed from 92% of U.S. pharmacies, and the Optum Clinformatics Data Mart, a national claims database from Medicare Advantage patients. The IQVIA analysis included patients who only had dispensed insulin prescriptions paid by Medicare in 2019. We estimated the proportion of Medicare patients who would benefit from an insulin cost-sharing cap of $35 per 30-day supply. Among these patients, we calculated the mean annual decrease in insulin out-of-pocket spending. We summed this decrease across patients to estimate the cap's cost to the federal government. The Optum analysis included Medicare Advantage patients with diabetes and at least 1 dispensed insulin prescription in 2019. We used linear regression to compare the proportion of patients who would benefit from a $35 cap and annual savings among these patients by diabetes type, adjusting for demographic characteristics and payer type. RESULTS: The IQVIA analysis included 2,227,229 patients who only had dispensed insulin prescriptions paid by Medicare in 2019. Mean (SD) age was 69.2 (11.4) years. The $35 cap would benefit 887,051 (39.0%) of patients, lowering annual insulin out-of-pocket spending by $338, from $687 to $349. Across all patients in the sample, aggregate savings (i.e., the cap's cost to the federal government) would be $299,402,402, or a mean of $134.4 per patient. Among the 60,300 Medicare Advantage patients in the Optum Analysis, mean age was 72.6 (9.3) years; 2,686 (4.5%) had type 1 diabetes and 57,614 (95.6%) had type 2 diabetes. The $35 cap would benefit a higher proportion of patients with type 1 diabetes (64.0%) compared with patients with type 2 diabetes (59.4%). Among patients with type 1 diabetes who would benefit from the cap, annual savings would be greater ($284) compared with their counterparts with type 2 diabetes ($231; p<.001 in adjusted analyses for all comparisons). CONCLUSIONS: A $35 insulin cost-sharing cap would benefit a sizable proportion of Medicare patients using insulin and may particularly lower out-of-pocket spending for patients with type 1 diabetes. The estimated cost of this cap to the federal government would be $134.4 per Medicare patient using insulin.

Improved renal cancer prognosis among users of drugs targeting renin-angiotensin system

Purpose We explored renal cell cancer (RCC) survival among users of antihypertensive medication as hypertension is proposed to be a risk factor for RCC and ACE-inhibitors and angiotensin receptor blockers (ARBs) have been associated with improved prognosis of RCC. Methods Finnish cohort of 13,873 participants with RCC diagnosed between 1995–2012 was formed from three national databases. RCC cases were identified from Finnish Cancer Registry, medication usage from national prescription database and co-morbidities from Care Registry of Healthcare. Logistic regression was used to calculate odds ratios for metastatic tumor extent at the time of diagnosis. Risk of RCC specific death after diagnosis was analyzed using Cox regression adjusted for tumor clinical characteristics. Results A total of 5,179 participants died of RCC during the follow-up. No risk association was found for metastatic tumor extent for any drug group. ACE-inhibitors, but no other drug group were associated with decreased risk of RCC specific death overall (HR 0.88, 95% CI 0.82–0.95) compared to non-users. In time-dependent analysis high-dose use of ACE-inhibitors (392 Defined Daily Dose (DDD)/year), HR 0.54, 95% CI 0.45–0.66) and ARBs (786.1 DDD/year, HR 0.66, 95% CI 0.50–0.87) associated with improved RCC survival. No information of TNM-classification or tobacco smoking was available. Conclusion ACE-inhibitors and ARBs in high dose associated with improved RCC specific survival. This may reflect overall benefit of treating hypertension with medication targeting renin-angiotensin system (RAS) system among RCC patients. Further studies are needed to explore the role of RAS in RCC.

Maternal Antibiotic Use and Infections During Pregnancy and Offspring Asthma: The Norwegian Mother, Father and Child Cohort Study and a Nationwide Register Cohort

Maternal antibiotic use during pregnancy has been linked to asthma risk in children, but the role of underlying infections remains unclear. We investigated the association of maternal antibiotic use and infections during pregnancy with offspring risk of asthma. We used two population-based cohorts: the Norwegian Mother, Father and Child Cohort Study (MoBa) (n=53 417) and a register cohort (n=417 548). Asthma was defined based on dispensed asthma medications at 7 and 13 years from the Norwegian Prescription Database. Self-reported information on antibiotic use and infections during pregnancy was available in MoBa, while registrations of dispensed prescriptions was used to classify use of antibiotics in the register-based cohort. Maternal antibiotic use during pregnancy was associated with asthma at 7 years in both cohorts (aRR 1.23, 95% CI 1.11 - 1.37 in MoBa and aRR 1.21, 95% CI 1.16 - 1.25 in the register-based cohort) and asthma at 13 years in the register cohort (aRR 1.13, 95% CI 1.03-1.23) after adjusting for maternal characteristics. In MoBa, the estimate was attenuated after adjusting for infections during pregnancy. Maternal lower and upper respiratory tract infections (aRR 1.30, 95% CI 1.07 - 1.57 and aRR 1.19, 95% CI 1.09 - 1.30, respectively) and urinary tract infections (aRR 1.26, 95% CI 1.11 - 1.42) showed associations with asthma at 7 after adjusting for confounders, but estimates decreased after adjustment for antibiotics during pregnancy. Our findings suggest that both maternal antibiotic use and infections during pregnancy might be associated with an increased risk of asthma in childhood.

Oral anticoagulation in atrial fibrillation patients at intermediate risk of stroke: a nationwide registry-based cohort (Atrial Fibrillation in Norway – AFNOR)

Background The effect of oral anticoagulants (OAC) on prevention of stroke must be carefully balanced against the potential risk of bleeding in patients with atrial fibrillation (AF). The net benefit of OAC in AF patients at intermediate risk of stroke remains unclear. Aim We aimed to determine whether the rates of ischemic and haemorrhagic stroke differ between users and non-users of OAC in a nationwide cohort of AF patients at intermediate risk of stroke. Method We investigated the association between initiation of OAC treatment and rates of ischemic and haemorrhagic stroke in a cohort of Norwegian patients with non-valvular AF aged ≥18 years with one non-sex CHA2DS2-VASc risk factor registered from 2011 to 2018, linking data from the Norwegian Population Registry, Patient Registry, Prescription Database and Cause of Death Registry. Individuals using OAC at baseline were excluded. Each individual had at least a three years look-back period for identification of their first non-sex CHA2DS2-VASc risk factor, after which they entered the study cohort and were followed until occurrence of stroke, death, emigration, higher CHA2DS2-VASc score or end of follow-up on December 31, 2018. Individuals were defined as exposed to OAC from the first redeemed prescription of OAC with a reimbursement code for AF and throughout follow-up. Rates of ischemic and haemorrhagic stroke were calculated as the number of stroke cases per 100 person-years, with 95% confidence intervals (CI). Results During 2011–2018, a total of 61,631 individuals with AF and intermediate risk of stroke were included (mean age 63,8±7,6 years (SD); 37% women), of whom 75% initiated OAC treatment. In total, 1709 ischemic strokes (405 cases in OAC users and 1304 in non-users) were registered during 214,738 person-years, and 378 haemorrhagic strokes (251 cases in OAC users and 127 in non-users) during 213,487 person-years. The rate of ischemic stroke was 0.39 (95% CI, 0.35–0.43) and 1.19 (95% CI, 1.12–1.25) per 100 person-years in OAC users and non-users, respectively. The haemorrhagic stroke rate was 0.24 (95% CI, 0.21–0-27) and 0.12 (95% CI, 0.10–0.14) per 100 person-years in OAC users and non-users, respectively. Both ischemic and haemorrhagic stroke rates were highest among those over 65 years of age (Figure 1). Conclusion In a nationwide cohort of Norwegian AF patients at intermediate risk of stroke, three out of four initiated treatment with OAC. Use of OAC was associated with a considerably lower rate of ischemic stroke compared to non-OAC use. Although haemorrhagic stroke rates were increased in the OAC-users vs. non-users, the hemorrhagic stroke rates were generally low. FUNDunding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Vestre Viken Health Trust Figure 1. Rates of ischemic and haemorrhagic stroke per 100 person-years in AF-patients at intermediate risk of stroke (CHA2DS2-VASc score 1 in men, score 2 in women) by OAC use during 2011 to 2018. Age corresponds to age at attainment of the first non-sex CHA2DS2-VASc risk factor.

Sex differences in psychotropic and analgesic drug use before and after initiating treatment with acetylcholinesterase inhibitors

Background/aims The aim was to explore the impact of sex on prevalence, patterns and trends in the prescription of psychotropics and analgesics in users of acetylcholinesterase inhibitors (AChEIs), before and after AChEI initiation, compared to the general population. Methods A prospective study applying data from the Norwegian Prescription Database (NorPD) in the period 2004–2016. Prescription of antidepressants, antipsychotics, analgesics including opioids, benzodiazepines and z-hypnotics in persistent AChEI users was studied in a follow-up period from four years before to two years after AChEI initiation in men and women of four age groups: 37–64, 65–72, 73–80 and 81–88 years. Results Use of antidepressants, antipsychotics and weaker analgesics increased in both sexes during the follow-up period in 11.764 persistent AChEI users. Women with pre-dementia and dementia stages of AD showed a prescription pattern with more use of psychotropics and opioids than men, except for antipsychotics. Conclusion Female sex showed to have a significant influence on the prescriptions of psychotropics and analgesics in AD patients in a pre-dementia and dementia stage. The exception is for antipsychotics, that men used more than women. The prescription pattern showed a higher extent of polypharmacy of psychotropics and/or opioids in women than in men. The total prescription pattern of analgesics could indicate an undertreatment of pain in pre-dementia and dementia stages, most pronounced in men.

NSAID use is not associated with Parkinson’s disease incidence: A Norwegian Prescription Database study

Objective Whether use of nonsteroidal anti-inflammatory drugs (NSAIDs) reduce the risk of incident Parkinson’s disease (PD) remains unresolved. Here, we employed the Norwegian Prescription Database to examine whether NSAID use is associated with a lower incidence of PD. Methods We compared the incidence of PD among users of NSAIDs in a population-based retrospective study using the Norwegian Prescription Database from 2004 to 2017. In total 7580 PD patients were identified using dopaminergic therapy over time as proxy for PD diagnosis. Analyses were performed with minimum 90 and 365 defined daily dose (DDD) NSAID exposure, respectively. Time-dependent Cox regression model and a binary logistic regression analysis with a 5-year lag until PD diagnosis were performed for all NSAIDs. Results There was overall no decrease in incidence of PD among NSAID users compared to controls. Using a minimum of 90 or 365 DDD threshold of exposure produced similar results. Analysis of individual NSAIDs did not show difference in PD incidence compared to controls Age-specific incidence rates of PD were comparable to reported age-specific incidence rates in previous studies. Interpretation Our findings provide no evidence that cumulative high exposure to NSAIDs affects the risk of developing PD.

Can the implementation of the Opioid Start Talking form impact the amount of opioid use in patients after ankle fracture repair?

Objective: As part of 2018 legislation aimed at fighting the opioid epidemic, the Michigan Department of Health and Human Services (MDHHS) published the “Opioid Start Talking” (OST) Form on June 1, 2018. We examined if the implementation of the OST form led to an identifiable decrease in patient opioid use. Specifically, we examined the opioid prescription quantities in patients who sustained ankle fractures that required open reduction internal fixation (ORIF).Design: Retrospective. Hospital medical records and Michigan Automated Prescription Database (MAPS) were analyzed for similar ankle fracture patients operated on by two surgeons prior to and after the initiation of the OST form. Records allowed us to track opioid filling through MAPS for 120 days after surgery in two groups: preimplementation (PRE) and post-implementation (POST) OST groups. The gathered data were analyzed by the investigators along with a staff statistician.Setting: Single-institution orthopedic practice.Patients, participants: Seventy eight patientsMain outcome measure: Average morphine milligram equivalent (MME) per patient encounter.Results: Seventy eight patients were included in the final analysis after applying the exclusion criteria. There were 38 patients in the pre-OST form period and 40 in the post-OST form period groups. The pre-OST and post-OST groups were well matched between the two surgeons. There was no evidence of a statistically significant difference found in the median MME between patients from the pre-period group to the post-period group (median 59 vs 50, P = 0.61). In regard to the injury pattern, the bimalleolar MME median was 50 (38 = 25th percentile, 67 = 75th percentile; min-max 0-175) and the trimalleolar median MME was 63 (39 =25% percentile, 81 = 75th percentile; min-max 0-249) with a P value of 0.20.Conclusions: Overall, the administration of the OST form to patients with ankle fractures did not result in a decrease in MMEs prescribed within 120 days of surgery. Although it is a start in the battle against the opioid epidemic, further evaluation of the effectiveness of the OST form is necessary.

Pre-injury dispensing of psychoactive prescription drugs in a ten years trauma population: a retrospective registry analysis

Background The use of psychoactive prescription drugs is associated with increased risk of traumatic injury, and has negative impact on clinical outcome in trauma patients. Previous studies have focused on specific drugs or subgroups of patients. Our aim was to examine the extent of psychoactive drug dispensing prior to injury in a comprehensive population of trauma patients. Methods The Oslo University Hospital Trauma Registry provided data on all trauma patients admitted to the trauma centre between 2005 and 2014. We linked the data to Norwegian Prescription Database data from 2004. Opioids, benzodiazepines, z-hypnotics, gabapentinoids, and centrally acting sympathomimetics dispensed during the year before trauma of each patient were identified. We determined the pre-trauma annual prevalence of dispensing and mean annual cumulative defined daily doses (DDD) for each drug class, and compared results with corresponding figures in the general population, using standardised ratios. For each drug class, dispensing 14 days preceding trauma was analysed in patients sustaining severe injury and compared with patients sustaining non-severe injury. Results 12,713 patients (71% male) were included. Median age was 36 years. 4891 patients (38%) presented with severe injury (Injury Severity Score > 15). The ratio between annual prevalence of dispensed prescriptions for trauma patients and the general population, adjusted for age and sex, was 1.5 (95% confidence interval 1.4–1.6) for opioids, 2.1 (2.0–2.2) for benzodiazepines, 1.7 (1.6–1.8) for z-hypnotics, 1.9 (1.6–2.2) for gabapentinoids, and 1.9 (1.6–2.2) for centrally acting sympathomimetics. Compared with the general population, mean annual cumulative DDD of opioids and benzodiazepines dispensed to trauma patients were more than two and three times as high, respectively, in several age groups below 70 years. The prevalence of dispensing 14 days pre-trauma was higher in severely injured patients for opioids, benzodiazepines, and z-hypnotics compared with patients without severe injury. Conclusions Our results support previous findings that the prevalence of psychoactive drug use is high among trauma patients. In terms of both frequency and amounts, the pre-injury dispensing of psychoactive drugs to trauma patients supersedes that of the general population, especially in younger patients.

Adherence Level to Arterial Hypertension Treatment: A Cross-Sectional Patient Survey and Retrospective Analysis of the NHS Prescription Database

One of the major problems in cardiology practice is poor adherence to antihypertensive medication. This study aimed to evaluate medication adherence; we also aim to investigate the predictors of intentional and unintentional non-adherence. We issued a survey containing questions about patient demographics, blood pressure control, pharmaceutical care, and adherence level to medication. Retrospective analysis of the prescription database of the National Health Service of the Republic of Latvia was performed. The prevalence of non-adherence was 45.9%. The lowest adherence rate (38.2%) was found among patients taking medication for 2–4.9 years. Even though 84.7% of respondents had a blood pressure monitor at home, only 25.3% of them reported measuring blood pressure regularly. There were differences between the groups of adherent patients in terms of the patients’ net income (p = 0.004), medication co-payments (p = 0.007), and whether the pharmacist offered to reduce the costs of drug therapy (p = 0.002). Roughly half of the prescriptions (50.4%) containing perindopril were purchased by patients from pharmacies. The medication adherence level and blood pressure control at home were assessed as low. Intentionally non-adherent respondents discontinued their medication because of fear of getting used to medicines. The pharmacists’ behaviour in terms of offering to reduce the costs of medications used was influenced by socio-economic factors.