Prescription Drug Plan Research Articles

Online Provision of Part D Medication Therapy Management Program Information.

Low rates of beneficiary participation in medication therapy management (MTM) programs may be partly due to lack of awareness and understanding of the MTM program. To address this, the Centers for Medicare & Medicaid Services (CMS) requires Medicare Part D sponsors to provide online information about their MTM programs. An early study conducted in 2014 found low compliance rates, with only 59.5% of a small convenience sample of Part D plan contract websites compliant with CMS requirements. The current study provides a more recent evaluation of compliance with website requirements using a random sample of Part D plan contracts. To (a) evaluate Part D sponsors' compliance with MTM program website elements that are required and suggested by CMS and (b) investigate the use of elements recommended by the National Institute on Aging (NIA) for websites for older adults. A random sample of 184 Part D plan contract MTM program websites was selected from a list of 624 approved Part D plan contracts for 2016. Duplicate and inaccessible websites were excluded. The remaining websites were reviewed to determine compliance with CMS-required, CMS-suggested, and NIA-recommended elements. Descriptive statistics were reported at the Part D contract level for compliance with individual elements, category elements (CMS-required, CMS-suggested, and NIA-recommended), and overall compliance. Overall compliance by category was also reported by Part D plan type. Of the 184 MTM websites that were reviewed, 106 remained after excluding duplicate (n = 67) and inaccessible (n = 11) websites: 81 from Medicare Advantage prescription drug (MAPD) plans, 16 from prescription drug plans (PDPs), and 9 from Medicare-Medicaid plans (MMPs). Overall, 51% of Part D plan contract MTM websites were compliant with all of the 14 CMS-required elements. The only element in the CMS-suggested elements category, "accessibility by clicking through a maximum of two links," had a compliance rate of 79%. For the NIA-recommended elements category, 46% of the Part D plan contract MTM websites were compliant with the 4 elements. Medicare Part D plan sponsors are providing information about their MTM programs on plan websites. However, only 51% of Part D plan websites are fully compliant with CMS guidance, providing all required elements. No outside funding supported this study. The authors have no financial or other relationships to disclose. The original research on a small and nonrandom sample of Part D plan contracts was presented during AMCP Nexus 2014; October 7-10, 2014; in Boston, MA. The results presented here are a larger and random sample of Part D plan contracts.

Health Care Effect of Disease-Modifying Antirheumatic Drug Use on Patients with Rheumatoid Arthritis.

Disease-modifying antirheumatic drugs (DMARDs) are recommended as the standard of care for patients with rheumatoid arthritis (RA) due to their ability to reduce pain and disability; however, DMARD use is low in some subgroups of the RA population. To identify characteristics associated with DMARD use in the overall cohort of patients with RA and newly diagnosed RA patients. This retrospective observational study used claims from a large national health plan. Use of DMARDs was measured according to the Healthcare Effectiveness Data and Information Set (HEDIS) as the proportion of patients with RA receiving DMARDs. Following HEDIS measure technical specifications, we identified patients aged 18-89 years with continuous enrollment during 2014 (measurement year) with ≥ 2 claims for RA outpatient visits and/or discharges on different dates between January and November 2014. Additionally, we identified a subset of patients newly diagnosed with RA in 2014 based on absence of any claims for RA or DMARDs in 2013. Descriptive analyses and bivariate associations were used to compare demographic and clinical characteristics of patients with RA with or without DMARD use in 2014. Health care resource utilization (HCRU) and costs were compared in 2014 for patients enrolled in Medicare Advantage Prescription Drug (MAPD) plans during both 2014 and 2015. Regression models were used to evaluate patient and provider characteristics associated with DMARD use in 2014 and the effect on HCRU and costs. Among the 33,880 patients identified with RA in 2014, most patients received a DMARD (75.2%); 29.4% of patients newly diagnosed with RA had been treated with DMARDs in 2014. Patients with DMARD use, on average, were younger (aged 67 years ± 10.7 vs. 69 years ± 10.7) and healthier (Deyo-Charlson Comorbidity Index [DCCI] 2.4 ± 1.9 vs. 2.6 ± 2.1) and included a greater proportion of women (75.9% vs. 71.0%) than those with no DMARD use (P < 0.0001). Use of DMARDs (P < 0.0001) was associated with 14.5% fewer hospitalizations and 18.0% fewer emergency department visits. Although total costs increased by 15.0% with use of DMARDs, when the cost of DMARDs was excluded, the total cost decreased by 13.7% (P < 0.0001). Female gender (32.2%), higher claims-based index for RA severity score (47.0%), higher RxRisk-V score (26.7%), visit to a rheumatologist (34.3%), and use of glucocorticoids (17.7%) increased the odds of DMARD use (P < 0.0001). Use of certain classes of medication, such as nonsteroidal anti-inflammatory drugs (12.3%), opioids (19.5%), antidepressants (20.0%), muscle relaxants (12.5%), and anticonvulsants (15.5%), were associated with lower use of DMARDs (P < 0.0001). We found significant differences in demographic and clinical characteristics between patients with and without DMARD use, which can potentially inform treatment decisions regarding DMARD use as deemed necessary by the provider. Future research should investigate the reasons for lack of treatment. This study was supported by funding from Eli Lilly to Humana as a collaborative research project involving employees of both companies. Boytsov, Saverno, Zhang, and Gaich are employees of Eli Lilly. Nair, Bhattacharya, Abbott, and Dixon are employees of Humana, which received funding from Eli Lilly to complete this research.

The Economic Impact of Mitral Regurgitation on Patients With Medically Managed Heart Failure

The objective of this study was to quantify the financial healthcare burden of mitral regurgitation (MR) on medically managed heart failure (HF) patients. Data from the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases were analyzed. Included patients had a minimum of 1 inpatient or 2 outpatient claims for HF with a 6-month preperiod (baseline). A 6-month postperiod (landmark) after HF index was used to capture MR diagnosis and severity. Following the landmark period, patients had to have 12 months of continuous medical and prescription drug plan enrollment with at least 2 records of HF medication refills. A therapeutic intensity score was calculated based on HF medication usage. Medically managed HF patients were separated into 3 cohorts: without MR (no MR), insignificant MR (iMR), and significant MR (sMR). Healthcare utilization and all-cause expenditures were modeled to quantify the burden of MR. All models controlled for baseline demographics, co-morbid conditions, and HF therapeutic intensity. Medically managed incident HF patients with sMR had significantly more hospital days (1.91 vs 1.72 days; p = 0.0096) and annual expenditures ($23,988 vs $21,530; p < 0.0001) compared with no MR patients. No differences were identified when comparing iMR and no MR. When evaluating HF admissions, sMR patients had an estimated 50% greater HF admissions rate (0.036 vs 0.024; p < 0.0001) compared with no MR patients. Additionally, HF admits for iMR were 23% more than those with no MR (0.029 vs 0.024; p = 0.0064). In conclusion, evidence of MR in retrospective claims significantly increases the healthcare impact of medically managed HF patients. Both utilization and financial burden is more pronounced when MR is clinically significant.

Abstract 3366: SEER-CAHPS: A national population-based data resource to evaluate patient-centered cancer care

Abstract Background: Delivery of patient-centered cancer care includes a focus on the preferences and values of individuals with cancer. SEER-CAHPS is a new data resource developed by the National Cancer Institute (NCI) linking cancer registry data from NCI’s Surveillance, Epidemiology and End Results (SEER) program with Medicare claims and patient experience of care collected by the Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS®) survey. We report on the unique data available in SEER-CAHPS for population-based assessments of patient experience and discuss several studies of patient-centered care conducted using these data. Methods: SEER-CAHPS includes SEER cancer registry data from 1973-2013 (including type/stage of cancer at diagnosis, patient sociodemographic characteristics, and mortality), Medicare fee-for-service (FFS) claims data from 2002-2015, and Medicare CAHPS survey responses from 1997-2015 (including patient-reported health status and experience of care ratings). CAHPS data in SEER-CAHPS include global ratings of overall care, personal doctor, specialist, health plan, and prescription drug plan and composite ratings of Doctor Communication, Care Coordination, Getting Needed Care, and Getting Care Quickly. The data also contain optional survey weights to account for the CAHPS sampling design. Results: SEER-CAHPS currently includes 249,474 individuals with a history of cancer documented in SEER. Individuals enrolled in both FFS Medicare (36,284 with a CAHPS survey prior to cancer diagnosis, 64,642 with a survey after diagnosis) and Medicare Advantage (70,378 with a survey before cancer diagnosis, 78,170 with a survey after diagnosis) are included. The database also includes 805,124 CAHPS respondents without cancer from SEER regions (FFS: 326,476; MA: 478,648). These data allow assessments of the impacts of patient sociodemographic and clinical characteristics, treatment patterns, and self-reported general and mental health status on patient experience of care. SEER-CAHPS has been used to examine factors associated with experiences in individuals diagnosed with cancer during their last year of life; experiences of cancer survivors; and experiences of dually eligible (Medicare-Medicaid) cancer patients. A recent analysis focused on associations of their experiences of care with receipt of guideline-concordant follow-up care among people with colorectal cancer. Online information (https://healthcaredelivery.cancer.gov/seer-cahps/) provides details on variables in SEER-CAHPS, instructions for obtaining these data, and other researcher resources. Conclusions: SEER-CAHPS is an important population science resource for assessing treatment patterns, unmet needs, and other factors to enhance patient-centered cancer care. Citation Format: Michael T. Halpern, Michelle Mollica, Lisa M. Lines, Julia Cohen, Erin E. Kent. SEER-CAHPS: A national population-based data resource to evaluate patient-centered cancer care [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 3366.

Drug rebates in Medicare Part D: Excess patient costs in the case of hepatitis C treatments.

Medicare Part D was implemented as a prescription drug benefit in 2006. Since then, high-cost new therapies have emerged, resulting in large increases in prices for pharmaceutical products, share of government spending from pharmaceutical products, and patient out of pocket costs. The objectives of this study were to: 1) evaluate the role of pharmacy benefit managers who are intermediaries in the processing and payment of prescription drug plans, and 2) to analyze the formulary selections of Medicare Part D plans in the context of differing wholesale acquisition costs, list prices and potential rebates, while building on prior work on the out of pocket costs associated with rebates. Hepatitis C was used as a case study to compare the list prices, clinical merits, and preferred drug coverage frequency of select pan-genotypic direct acting agent Hepatitis C treatments. The treatments were then put through a hypothetical 2018 Medicare Part D standard cost structure to illustrate differences in out-of-pocket costs to consumers at various list prices among treatments. Hepatitis C treatments with lower list prices were offered as covered benefit less frequently than high list price treatments, despite being clinically superior and lower out-of-pocket cost. Consumers, regulators and policy advocates need to work to limit the impact of financial conflicts of interest and perverse incentives of pharmaceutical rebates in drug selection. This is especially true for high-cost treatments with substantial out-of-pocket cost implications for consumers, which also prevent widespread access, hindering public health goals.

Treatment and outcomes for patients (pts) with selected advanced/metastatic cancers by place of care.

e20717 Background: Place of care may be an important factor affecting treatment &amp; economic outcomes for pts in advanced stages of cancer. This retrospective observational study compared treatment patterns, healthcare resource use &amp; costs, and overall survival (OS) for pts treated for selected cancers in the hospital outpatient department (HO) vs community oncology practices (CP) including physician offices &amp; freestanding ambulatory centers. Methods: Claims data from a large national health plan were used to identify adult pts with newly diagnosed advanced/metastatic non small cell lung cancer (aNSCLC), metastatic breast (mBC) or metastatic colorectal cancer (mCRC) between 07/2012 &amp; 12/2016, who initiated anticancer therapy in HO or CP settings. Pts enrolled in Medicare Advantage Prescription Drug (MAPD) or commercial plans for ≥ 6 months prior &amp; ≥ 30 days after start of first line (1L) (index date) were included. OS was evaluated among pts enrolled in MAPD and costs were evaluated among pts enrolled ≥ 6 months pre- &amp; post-index, by cancer type &amp; by place of care. Outcome analyses were adjusted using multivariable models. Results: Among 8,333 eligible pts, there were 4,618, 2,304 &amp; 1,411 pts with aNSCLC, mCRC &amp; mBC, respectively and each cohort was evenly split by place of care. No notable differences in baseline characteristics or the most commonly used 1L, 2L or 3L regimens were observed by place of care for the 3 cancers. For aNSCLC pts, mean 1L treatment duration was shorter (96 v 102 days, P = 0.02) and time between 1L &amp; 2L was longer (125 v 106 days, P = 0.04) in the HO than the CP setting, respectively. For mBC, mean 1L treatment duration was longer in the HO setting (156 v 190 days, P &lt; 0.01). Adjusted total all cause healthcare costs were higher in HO than CP for mBC ( P &lt; 0.01) &amp; mCRC ( P &lt; 0.01), but no significant difference in median OS was observed between HO &amp; CP settings for the 3 cancer types. Conclusions: This study showed no major differences between HO &amp; CP settings in baseline characteristics, the first 3 lines of therapy, or adjusted median OS for aNSCLC, mCRC, or mBC cohorts. However, total costs were higher in the HO setting for mCRC &amp; mBC pts. These findings may be useful for healthcare decision &amp; policy makers but warrant further evaluation.

Change in Proportion of Days Covered for Statins Following Implementation of a Pharmacy Student Adherence Outreach Program.

Nearly half of statin users discontinue therapy within the first year of treatment. Nonadherence to statin therapy may lead to an increased risk of atherosclerotic cardiovascular disease and, thus, higher costs due to hospitalizations. Value-based care models, such as accountable care organizations (ACO), are measured on adherence rates to statins through proportion of days covered (PDC). However, there is little research describing pharmacy student-based interventions within value-based care models. To (a) identify mean change in PDC for statins following implementation of a pharmacy student adherence outreach program and (b) identify the proportion of patients converted to PDC ≥ 0.80 following the implementation of the outreach program. This single-center retrospective quasi-experimental study included patients actively enrolled in a Humana Medicare Advantage Prescription Drug (MA-PD) plan who completed at least 1 adherence outreach telephone call performed by a pharmacy student between January 1, 2017, and December 31, 2017. 99 patients met inclusion criteria. Atorvastatin was the most commonly prescribed statin (43%), followed by simvastatin (38%). Sixty-four percent of patients had a baseline PDC of < 0.80. Mean (SD) PDC was 0.66 (±0.24) before the pharmacy student adherence outreach intervention, and 0.79 (± 0.23)-a 0.13 increase-after the pharmacy student adherence outreach intervention (P < 0.001). Among patients who had PDC < 0.80 at baseline, 35% of patients (n = 35) were converted to PDC ≥ 0.80 (P < 0.001), and 5% of patients with a baseline PDC ≥ 0.80 had a decrease in PDC to < 0.80 following the intervention. Among patients enrolled in a Humana MA-PD plan within an ACO, mean PDC for statins increased following exposure to a pharmacy student adherence outreach program. One third of patients converted their PDCs to ≥ 0.80 following the intervention. Value-based care programs may consider incorporating pharmacy student services to improve adherence to statins. No outside funding supported this research. The authors have no financial conflicts of interest to disclose. At the time of conducting this research, all authors were employed at Nova Southeastern University. Preliminary results were presented as a poster at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Psychometric evaluation of the Medicare Advantage and prescription drug plan disenrollment reasons survey.

To develop and assess the reliability and validity of composite measures of reasons for disenrollment from Medicare Advantage (MA) and prescription drug plans (PDPs). Medicare beneficiaries who responded to the Medicare Advantage and Prescription Drug Plan Disenrollment Reasons Survey. Separate multilevel factor analyses of MA and PDP data suggested groupings of survey items to form composite measures, for which internal consistency and interunit reliability were estimated. The association of each composite with an overall plan rating was examined to evaluate criterion validity. Five composites were identified: financial reasons for disenrollment; problems with prescription drug benefits and coverage; problems getting information and help from the plan; problems getting needed care, coverage, and cost information; and problems with coverage of doctors and hospitals. Beneficiary-level internal consistency reliability exceeded 0.70 for all but one composite (financial reasons); plan-level internal consistency reliability exceeded 0.80 for all composites; average interunit reliability for plans with≥30 survey completes exceeded 0.75 for 3 of 5 composites. As expected, greater endorsement of reasons for disenrollment was associated with lower overall plan ratings. The Disenrollment Reasons Survey provides a reliable and valid assessment of beneficiaries' reasons for leaving their plans. Multiple reasons for disenrollment may indicate especially poor experiences.

Abstract 151: Therapeutic Intensity in Medically Managed Incident Heart Failure Patients with and without Mitral Regurgitation: A Claims Based Analysis

Background: Understanding the therapeutic intensity of medically managed heart failure (HF) patients with and without secondary MR can be challenging when using claims data. This research showcases the development of a therapeutic intensity score (TIS) and reports the impact of the score on annual all-cause inpatient hospitalizations. Methods: This study included data from the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases from October 2011 to September 2016. Inclusion criteria were patients who had a minimum of 1 inpatient or 2 outpatient claims for HF with a 6-month pre-period (baseline). A 6-month post-period (landmark) after HF index was used to capture MR diagnosis and severity. Following the landmark period, patients were required to have 12 months of continuous medical and prescription drug plan enrollment with at least two records of HF medication refills. Additional exclusions (age under 18, chordal rupture, hospice, etc) were applied. TIS was calculated based on the patient’s pharmacologic regimen. Drug categories included but were not limited to: ACE inhibitors, angiotensin receptor blockers, beta blockers, and diuretics. Within drug categories, each prescription fill was assigned 1 point for low doses, 2 points for moderate doses, and 3 points for high doses. The highest point totals from each drug category were summated across categories with the maximum score being 24. HF patients were separated into three cohorts: without MR, not clinically significant MR (nsMR), and significant MR (sMR). Annual all-cause inpatient hospitalizations were modeled using the ordinary least squares method and MR, TIS, demographics, and comorbid conditions were included as covariates. Results: HF patients with sMR had the highest TIS at a mean of 6.9, followed by nsMR at 6.5 and no MR at 5.9. Based on the regression model, having clinically significant MR was associated with an increase (0.22 [0.05, 0.38]; P=0.0112) in annual all-cause inpatient hospitalizations. Additionally, every point increase of TIS was associated with an increase (0.20 [0.18, 0.21]; P&lt;0.0001) in annual all-cause inpatient hospitalizations. Conclusion: While clinically significant MR is an important factor in healthcare utilization, the intensity of heart failure medication should also be considered when estimating the burden of illness. A 5 point increase in TIS is associated with an increase in one inpatient admission per year.

Abstract 216: Evolution of Medicare Formulary Coverage Changes for Antithrombotic Therapies after Guideline Revisions

Introduction: The 2014 ACC/AHA/HRS atrial fibrillation (AF) guideline recommends either warfarin or direct oral anticoagulants (DOACs) as first-line antithrombotic therapies for patients with non-valvular AF. In 2016, the American College of Chest Physicians (CHEST) venous thromboembolism (VTE) guideline recommended DOACs over warfarin in non-cancer patients. Formulary coverage and utilization management can be used to promote guideline recommended medications, but the impact of these guidelines is unknown. Methods: We used Medicare Prescription Drug Plan Formulary Files, which include data on all Medicare Advantage and Part D plans, to compare coverage in the second quarters of 2013 (pre-guidelines), 2015 (post-ACC/AHA/HRS AF guideline), and 2017 (post-CHEST VTE guideline) for warfarin and each of the following DOACs: apixaban, dabigatran, edoxaban, and rivaroxaban. We determined formulary coverage and, among formularies that provided coverage, formulary restrictiveness based on use of utilization management strategies (i.e., cost-sharing tier level 3 or higher, prior authorization requirement, or step therapy requirement). Formularies were categorized as unrestrictive if no strategies were used, restrictive if any strategy was used, and no coverage. Results: In 2013, 2015, and 2017, there were 314, 389, and 378 Medicare formularies, respectively. All but one plan provided unrestrictive coverage of warfarin in all 3 time periods (Figure). Among DOACs, in 2013, 12% and 38% of formularies provided unrestrictive and restrictive coverage of apixaban, 20% and 78% of dabigatran, and 25% and 62% of rivaroxaban, whereas by 2017, 24% and 70% provided unrestrictive and restricted coverage of apixaban, 24% and 73% of dabigatran, and 30% and 69% of rivaroxaban ( p &lt; .001). From 2013 to 2017, formularies providing restrictive or unrestrictive coverage for at least one DOAC increased from 84% to 100% ( p &lt; .001). Most plans restricted DOAC coverage by increased tier-level cost-sharing, which increased over time, while prior authorization requirements decreased. Conclusions: After guidelines recommended DOACs as first-line or preferred therapy for AF and VTE, unrestrictive coverage increased, but the vast majority of plans restrict coverage by requiring high patient cost-sharing through tier placement.

Impact of medication synchronization programs on proportion of days covered (PDC) scores and Medicare Part D medication-related adherence metrics

ObjectivesThis study aimed to determine if patients enrolled in a medication synchronization program have improvements in proportion of days covered (PDC) score for 3 of the Centers for Medicare and Medicaid Services adherence metrics medication classes: statins, renin-angiotensin-aldosterone system antagonists, and noninsulin diabetes medications. MethodsThis retrospective cohort study used data from members of a Medicare Advantage Prescription Drug plan, who took at least 1 of the key metric medications and had sufficient data to calculate a PDC score. The exposed cohort (“sync”) consisted of patients who enrolled in the medication synchronization program within the plan’s preferred pharmacy network, and the control group consisted of those who did not enroll in the program but met all other criteria. The primary end point was the change in PDC score from 2015 (baseline) to 2017 for each medication class. Secondary end points included the proportion of members with PDC scores of at least 85% and the association of adherence with annual medical and pharmacy costs. ResultsThe largest PDC score increases for the entire study population were seen in all 3 sync groups (RASA, diabetes, and statin) with corresponding statistically significant PDC score increases of 1.6%, 4.8%, and 2.9%, compared with −0.4%, 0.5%, and 1.3% changes in the control groups. In the multiple linear regression analysis, there were significant PDC score differences in the changes from baseline between the sync and control RASA, diabetes, and statin groups (P = 0.005, P = 0.01, and P < 0.001, respectively). The proportion of members achieving the acceptable PDC score threshold increased by 1.1% in the control group and by 4.1% in the sync group. ConclusionIn a population of patients with high baseline adherence, this medication synchronization program was associated with a statistically significant increase in adherence scores for statin, RASA, and noninsulin diabetes medications. There was no significant change in medical or pharmacy costs from the health plan perspective.

Amyotrophic lateral sclerosis among patients with a Medicare Advantage prescription drug plan; prevalence, survival and patient characteristics

Objective: To estimate amyotrophic lateral sclerosis (ALS) prevalence, 5-year survival, and explore factors associated with survival in a Medicare population. Methods: A validated administrative claims algorithm was used to classify individual’s ages 18–89 years at index date (first claim with a diagnosis of motor neuron disease or ALS between 1 January 2007 and 31 December 2011) with Medicare Advantage prescription drug coverage into mutually exclusive categories: ALS, no ALS, and possible ALS. Crude prevalence and cumulative survival from index date to the date of death, disenrollment or end of the study were calculated. Cox-proportional hazards were used to estimate and explore factors associated with survival. Results: Of 2631 eligible individuals, the algorithm identified 1271 (48 %), 1157 (44 %), 203 (8 %) as ALS, no ALS and possible ALS, respectively. The 5-year period prevalence and the 2011 point prevalence of ALS were 20.5 and 11.8 per 100,000, respectively. Evidence of death was documented in 81%, 35%, and 1.6% of the ALS, no ALS or possible ALS groups, respectively. Unadjusted median survival time was 388, 542 and 1473 days for the ALS, no ALS and possible ALS groups, respectively. Seeing a psychiatrist or neurologist at the index visit, having respiratory or genitourinary comorbidities, and the number of pre-index acute inpatient admissions were associated with shorter survival. Conclusions: Surveillance data from a Medicare population demonstrated a higher prevalence of ALS. Results highlight the need for effective ALS treatment options and resources for patients with ALS who will likely face limited therapeutic choices and care options at the end of life.

Favorable Formulary Placement of Branded Drugs in Medicare Prescription Drug Plans When Generics Are Available

This study examines Medicare Part D prescription drug plans to assess how often branded products were given more favorable formulary placement than generic products.

HSR19-109: The Healthy Days Measure in a Metastatic Castration-Resistant Prostate Cancer Population Treated With Novel Oral Therapies

Background: Health-related quality of life (HRQoL) is an important patient-reported outcome to assess in patients with prostate cancer (PC). A variety of general and disease-specific measures have been developed, but there is a lack of evidence on performance of the Centers for Disease Control and Prevention (CDC) Healthy Days (HDs) measure in a population with metastatic disease relative to other validated scales. Objective: To report and understand general HRQoL using the HDs instrument in patients with metastatic PC taking novel oral therapies and compare results to validated scales. Methods: Patients currently enrolled in a Medicare Advantage or Prescription Drug plan treated with enzalutamide or abiraterone acetate were eligible for inclusion. Patients undertook a telephone-based survey including 2 HRQoL questionnaires (Short-Form 36, version 2 [SF-36] survey and the CDC HDs measures), the Service Satisfaction with Cancer Care (SCA) instrument, and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Higher scores indicated higher HRQoL on all surveys, except the HDs scale, where higher numbers indicated lower HRQoL (ie, unhealthy days). Pearson correlations with SF-36 and HDs measures and SCA and FACIT-Fatigue were assessed. Results: 1,745 patients were eligible to participate; 269 completed the survey and were included in the analysis. The mean (standard deviation) age was 74.4 (±7.3) years and 82% were Caucasian. Patients had lower physical HRQoL and a higher number of physically unhealthy days, compared to mental health impacts on both scales. The mean Physical Component Summary (PCS) and Mental Component Summary (MCS) norm-based scores for the SF-36 were 39.9 (±10.6) and 53.4 (±10.4). The mean number of physically and mentally unhealthy days reported in a 30-day period were 9.2 (±11.3) and 3.9 (±7.7), respectively. The unadjusted correlations between scores were all statistically significant (P&lt;.05). Conclusions: The SF-36 and HDs measures both indicated physical health was impacted more than mental health in these patients. The correlations with both HRQoL measures and the other scales were similar in terms of magnitude and significance. This indicates that the HDs instrument may be a useful measure for assessment of general HRQoL in patients with metastatic PC and provides an understanding of general HRQoL in this population that can be utilized to identify opportunities for enhancing patient-centered care.

Machine-Based Expert Recommendations And Insurance Choices Among Medicare Part D Enrollees.

Choosing a health insurance plan is difficult for many people, and patient-centered decision support may help consumers make these choices. We tested whether providing a patient-centered decision-support tool-with or without machine-based, personalized expert recommendations-influenced decision outcomes for Medicare Part D enrollees. We found that providing an online patient-centered decision-support tool increased older adults' satisfaction with the process of choosing a prescription drug plan and the amount of time they spent choosing a plan. Providing personalized expert recommendations as well increased rates of plan switching. Many people who could have accessed the tool chose not to, and the characteristics of people who used the tool differed from those who did not. We conclude that a patient-centered decision-support tool providing personalized expert recommendations can help people choose a plan, but different approaches may be necessary to encourage more people to periodically reevaluate their options.

Osteoporosis Medication Use: A Comparison of Elderly Females Living in Long-term Care Facilities Versus Community Dwellers.

OBJECTIVE: This study compares patterns of evidence-based osteoporosis medication use among females in community and long-term care settings enrolled in Medicare Part D.<br/> DESIGN: Pooled cross-sectional study.<br/> SETTING: Medicare beneficiaries enrolled in Medicare Parts A and B, and Part D stand-alone prescription drug plans from January 1, 2006, through December 31, 2008, or death.<br/> PARTICIPANTS: Female Medicare Part D enrollees 70 years of age and older with osteoporosis or prior hip fracture.<br/> INTERVENTIONS: NA.<br/> MAIN OUTCOME MEASUREMENTS: Use of bisphosphonates, calcitonin, teriparatide, and raloxifene was tracked by residential status over the three-year period.<br/> RESULTS: The study sample comprised 96,408 female Part D enrollees with osteoporosis. Prevalence of evidence-based medication use was 42.3% in 2006 and dropped slightly to 40.4% in 2008. In unadjusted comparisons, long-term care residents were significantly less likely to use any osteoporosis medication compared with community dwellers (40.6% vs. 53.1%). After adjustment for differences in individual characteristics, utilization was still lower among long-term care residents (relative risk [RR] = 0.89, 95% confidence interval [CI] 0.87-0.91). Bisphosphonates were the top choice among medication users, but were prescribed much less often to long-term care residents (RR = 0.79, 95% CI 0.75-0.83) compared with community residents.<br/> CONCLUSION: Prevalence of evidence-based osteoporosis medication use is low in older women enrolled in Part D whether community-dwelling or long-term care residents, but long-term nursing facility residents are more likely to be treated with nonbisphosphonates. Many events that may affect osteoporosis medication use occurred after 2008; therefore, future studies using more recent data are warranted to examine osteoporosis medication use after 2008.

Trends In Coverage For Disease-Modifying Therapies For Multiple Sclerosis In Medicare Part D.

The high cost of multiple sclerosis (MS) disease-modifying therapies can negatively affect access for patients through increased payer restrictions and higher out-of-pocket spending. Our objective was to describe changes in pharmacy benefit coverage and cost-sharing amounts for MS disease-modifying therapies in the Medicare Part D program, using enrollment-weighted Prescription Drug Plan Formulary files for the period 2007-16. Among therapies available throughout the study period, the rate of prior authorization use increased from 61-66percent of plans to 84-90percent. The share of plans with at least one therapy available without limitations declined from 39percent to 17percent. The projected cumulative out-of-pocket spending for 2019 was $6,894. The therapy with the highest out-of-pocket spending was generic glatiramer acetate. Policy makers need to consider both access restrictions and a growing cost-sharing burden as potential consequences of high and rising drug prices for people with MS.

Osteoporosis Medication Use: A Comparison of Elderly Females Living in Long-term Care Facilities Versus Community Dwellers

OBJECTIVE: This study compares patterns of evidence-based osteoporosis medication use among females in community and long-term care settings enrolled in Medicare Part D.<br/> DESIGN: Pooled cross-sectional study.<br/> SETTING: Medicare beneficiaries enrolled in Medicare Parts A and B, and Part D stand-alone prescription drug plans from January 1, 2006, through December 31, 2008, or death.<br/> PARTICIPANTS: Female Medicare Part D enrollees 70 years of age and older with osteoporosis or prior hip fracture.<br/> INTERVENTIONS: NA.<br/> MAIN OUTCOME MEASUREMENTS: Use of bisphosphonates, calcitonin, teriparatide, and raloxifene was tracked by residential status over the three-year period.<br/> RESULTS: The study sample comprised 96,408 female Part D enrollees with osteoporosis. Prevalence of evidence-based medication use was 42.3% in 2006 and dropped slightly to 40.4% in 2008. In unadjusted comparisons, long-term care residents were significantly less likely to use any osteoporosis medication compared with community dwellers (40.6% vs. 53.1%). After adjustment for differences in individual characteristics, utilization was still lower among long-term care residents (relative risk [RR] = 0.89, 95% confidence interval [CI] 0.87-0.91). Bisphosphonates were the top choice among medication users, but were prescribed much less often to long-term care residents (RR = 0.79, 95% CI 0.75-0.83) compared with community residents.<br/> CONCLUSION: Prevalence of evidence-based osteoporosis medication use is low in older women enrolled in Part D whether community-dwelling or long-term care residents, but long-term nursing facility residents are more likely to be treated with nonbisphosphonates. Many events that may affect osteoporosis medication use occurred after 2008; therefore, future studies using more recent data are warranted to examine osteoporosis medication use after 2008.

Implementation of a Health Plan Program for Switching From Analogue to Human Insulin and Glycemic Control Among Medicare Beneficiaries With Type 2 Diabetes

Prices for newer analogue insulin products have increased. Lower-cost human insulin may be effective for many patients with type 2 diabetes. To evaluate the association between implementation of a health plan-based intervention of switching patients from analogue to human insulin and glycemic control. A retrospective cohort study using population-level interrupted times series analysis of members participating in a Medicare Advantage and prescription drug plan operating in 4 US states. Participants were prescribed insulin between January 1, 2014, and December 31, 2016 (median follow-up, 729 days). The intervention began in February 2015 and was expanded to the entire health plan system by June 2015. Implementation of a health plan program to switch patients from analogue to human insulin. The primary outcome was the change in mean hemoglobin A1c (HbA1c) levels estimated over three 12-month periods: preintervention (baseline) in 2014, intervention in 2015, and postintervention in 2016. Secondary outcomes included rates of serious hypoglycemia or hyperglycemia using ICD-9-CM and ICD-10-CM diagnostic codes. Over 3 years, 14 635 members (mean [SD] age: 72.5 [9.8] years; 51% women; 93% with type 2 diabetes) filled 221 866 insulin prescriptions. The mean HbA1c was 8.46% (95% CI, 8.40%-8.52%) at baseline and decreased at a rate of -0.02% (95% CI, -0.03% to -0.01%; P <.001) per month before the intervention. There was an association between the start of the intervention and an overall HbA1c level increase of 0.14% (95% CI, 0.05%-0.23%; P = .003) and slope change of 0.02% (95% CI, 0.01%-0.03%; P < .001). After the completion of the intervention, there were no significant differences in changes in the level (0.08% [95% CI, -0.01% to 0.17%]) or slope (<0.001% [95% CI, -0.008% to 0.010%]) of mean HbA1c compared with the intervention period (P = .09 and P = 0.81, respectively). For serious hypoglycemic events, there was no significant association between the start of the intervention and a level (2.66/1000 person-years [95% CI, -3.82 to 9.13]; P = .41) or slope change (-0.66/1000 person-years [95% CI, -1.59 to 0.27]; P = .16). The level (1.64/1000 person-years [95% CI, -4.83 to 8.11]; P = .61) and slope (-0.23/1000 person-years [95% CI, -1.17 to 0.70]; P = .61) changes in the postintervention period were not significantly different compared with the intervention period. The baseline rate of serious hyperglycemia was 22.33 per 1000 person-years (95% CI, 12.70-31.97). For the rate of serious hyperglycemic events, there was no significant association between the start of the intervention and a level (4.23/1000 person-years [95% CI, -8.62 to 17.08]; P = .51) or slope (-0.51/1000 person-years [95% CI, -2.37 to 1.34]; P = .58) change. Among Medicare beneficiaries with type 2 diabetes, implementation of a health plan program that involved switching patients from analogue to human insulin was associated with a small increase in population-level HbA1c.

Comparative Effectiveness of Medication Therapy Management Eligibility Criteria Across Racial/Ethnic Groups.

Previous research indicates that eligibility criteria for medication therapy management (MTM) services in Medicare prescription drug (Part D) plans, defined under the Medicare Modernization Act (MMA), are associated with racial/ethnic disparities and ineffective in identifying individuals with medication utilization issues. Our study's objective was to determine the comparative effectiveness of MTM eligibility criteria under MMA and in the Affordable Care Act (ACA) in identifying patients with medication utilization issues across racial/ethnic groups. ACA and MMA MTM eligibility criteria were compared on proportions of eligible individuals among patients with medication utilization issues. Multinomial logistic regression was conducted to control for patient/community characteristics. Need-based and demand-based analyses were used to determine disparities due to need and demand for healthcare. Main/sensitivity analyses were conducted for the range of eligibility thresholds. Medicare data (2012-2013) linked to Area Health Resources Files. A total of 964 610 patients 65 years or older. Medication safety/adherence measures, developed primarily by the Pharmacy Quality Alliance, were used to determine medication utilization issues. Higher proportions of patients were eligible based on ACA than MMA MTM eligibility criteria. For example, in 2013, proportions based on ACA and MMA MTM eligibility criteria would be 99.7% and 26.2%, respectively, in the main analysis (p < .001); in the demand-based main analysis, ACA criteria were associated with 13.6% and 9.8%, respectively, higher effectiveness than MMA criteria among non-Hispanic blacks and Hispanics than non-Hispanic whites. ACA MTM eligibility criteria are more effective than MMA criteria in identifying older patients needing MTM, particularly among minorities. J Am Geriatr Soc 67:581-587, 2019.