Translating clinical evidence into value-based payment models: pooled analyses of innovative real-world outcomes agreements for ticagrelor in the United States.

Innovative value strategies for reimbursement of medications include value-based agreements (VBAs) between payers and pharmaceutical manufacturers, which have the potential to improve affordability and patient access to therapy, as well as lead to a reduction in downstream health events and associated medical costs. VBAs link payment for a medication to its performance in real-world clinical practice measured against prespecified outcomes that are aligned to existing evidence. Given its high prevalence, economic burden, and impact on mortality, cardiovascular disease (namely, coronary heart disease) represents an opportunity for VBAs to contribute to improved health outcomes and patient experiences while reducing or containing total medical costs. AstraZeneca developed a VBA framework directly comparing 2 antiplatelet therapies indicated to treat acute coronary syndrome (ACS)-ticagrelor and clopidogrel-based on the PLATO trial, which demonstrated superiority for ticagrelor in reducing the incidence of recurrent myocardial infarction (MI) in patients with ACS. Between 2015 and 2018, 11 contract-years of VBAs utilizing this framework were implemented in commercial and Part D health insurance plans, totaling nearly 32,000 unique patients in which pooled analyses were conducted. Aggregated VBA results indicate that ticagrelor consistently outperformed expectations in reducing recurrent MI vs clopidogrel, while also illustrating how comparative VBA frameworks of this nature may overcome challenges noted for VBAs and be utilized more broadly in future applications.

Relationship between symptom change, relapse activity and disability progression in multiple sclerosis.

BACKGROUND: Symptom changes may serve as a risk factor for relapse activity (RA) and disability progression (DP), which could facilitate multiple sclerosis (MS) treatment decisions. OBJECTIVE: To assess the relationship of symptom change with RA and DP. METHODS: We evaluated the relationship of symptom change with subsequent RA and DP using NARCOMS registry data reported over a five-year period. Symptom change was evaluated using both symptom worsening (SW) and average of Performance Scales (APS) scores. Disability progression was defined as a one-point or more increase in Patient-Determined Disease Steps (PDDS) score between two consecutive updates. Repeated measures logistic regression was used to investigate the relationship between symptom change and RA and DP. RESULTS: SW and APS were both significant predictors of subsequent RA and DP. Both SW and APS have a significant interaction with levels of disability (Mildly Impaired versus Highly Impaired) for the prediction of the subsequent RA or DP. For Mildly Impaired MS subjects, both SW and APS were significant predictors of both RA and DP. However, for Highly Impaired MS subjects, SW did not significantly predict future RA and neither SW nor APS predicted disability progression. CONCLUSION: Changes in self-reported overall symptomatology may precede and predict clinical relapse and future disability progression. The predictive power of symptom changes may only be present at lower levels of disability.

Patient perspectives on switching disease-modifying therapies in the NARCOMS registry.

INTRODUCTION: The evolving landscape of disease-modifying therapies (DMTs) for multiple sclerosis raises important questions about why patients change DMTs. Physicians and patients could benefit from a better understanding of the reasons for switching therapy. PURPOSE: To investigate the reasons patients switch DMTs and identify characteristics associated with the decision to switch. METHOD: The North American Research Committee on Multiple Sclerosis (NARCOMS) Registry conducted a supplemental survey among registry participants responding to the 2011 update survey. The supplemental survey investigated reasons for switching DMT, origin of the discussion of DMT change, and which factors influenced the decision. Chi-square tests, Fisher's exact tests, and logistic regression were used for the analyses. RESULTS: Of the 691 eligible candidates, 308 responded and met the inclusion criteria (relapsing disease course, switched DMT after September 2010). The responders were 83.4% female, on average 52 years old, with a median (interquartile range) Patient-Determined Disease Steps score of 4 (2-5). The most recent prior therapy included first-line injectables (74.5%), infusions (18.1%), an oral DMT (3.4%), and other DMTs (4.0%). The discussion to switch DMT was initiated almost equally by physicians and participants. The primary reason for choosing the new DMT was based most frequently on physician's recommendation (24.5%) and patient perception of efficacy (13.7%). CONCLUSION: Participants frequently initiated the discussion regarding changing DMT, although physician recommendations regarding the specific therapy were still weighed highly. Long-term follow-up of these participants will provide valuable information on their disease trajectory, satisfaction with, and effectiveness of their new medication.

Review: clinical inertia in the management of chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is the third-leading cause of death in the United States. Despite clinical practice guidelines endorsed by national organizations, the management of COPD deviates from guideline recommendations. Patients with COPD are frequently underdiagnosed and misdiagnosed, due in large part to the lack of spirometry testing. When diagnosed, about one third of patients are not receiving any COPD-related drug therapy. Factors that contribute to suboptimal management include provider, patient, and system factors. Physician factors such as understanding and attitude toward the disease, and awareness of guidelines, may affect appropriate management of COPD. Patient factors include medication non-adherence, understanding of the disease, severity of their symptoms, and access to medications. System factors such as insurance coverage may limit aspects of COPD care. To overcome clinical inertia, a multifaceted approach is required. Provider and patient education, the use of health informatics, changes in provider work-flow and the recent development of performance measures, such as the use of spirometry in patients with COPD, can improve the delivery of recommended care for COPD patients.

You wrote the prescription, but will it get filled?

PURPOSE: Despite numerous studies on adherence, there is little research on the first-fill rate of antihypertensive prescriptions. Our study took advantage of the recent increase in electronic prescribing (e-prescribing) and used data from e-prescribing physicians to determine the first-fill failure rate of antihypertensive prescriptions and to assess which factors predict first-fill failure. METHODS: This retrospective study reviewed claims from a Mid-Atlantic managed care organization (MCO). We included adult members with continuous medical and pharmacy coverage who were prescribed an antihypertensive in 2008 by an e-prescribing physician. First-fill failure occurred when the patient did not obtain the antihypertensive medication due to either a denial by the MCO or reversal by the dispensing pharmacist. (Pharmacists reverse claims when a patient fails to pick up a medication.) Multivariate regression analysis determined the clinical and demographic factors associated with failure to fill. RESULTS: The cohort consisted of 14,693 antihypertensive prescriptions, prescribed by 164 e-prescribing physicians for 7061 unique members. There were 2289 out of 14,693 prescriptions (15.6%) that went unfilled, affecting 24.3% of patients. Of the prescriptions not obtained, 1466 (64%) were denied by the MCO and 823 (36%) were reversed. Significant factors associated with first-fill failure were new diagnosis of hypertension, new antihypertensive agent, higher co-payment, and enrollment in a health maintenance organization or preferred provider organization. CONCLUSIONS: Patients newly diagnosed with hypertension and those prescribed a new antihypertensive were at particularly high risk for not obtaining their medication. Because nearly a quarter of patients did not obtain their initial fill of an antihypertensive prescription, future research should determine efficient and cost-effective systems to address first-fill failure in primary care.

Understanding barriers to medication adherence in the hypertensive population by evaluating responses to a telephone survey.

BACKGROUND: Although hypertension is a major risk factor for cardiovascular disease, adherence to hypertensive medications is low. Previous research identifying factors influencing adherence has focused primarily on broad, population-based approaches. Identifying specific barriers for an individual is more useful in designing meaningful targeted interventions. Using customized telephonic outreach, we examined specific patient-reported barriers influencing hypertensive patients' nonadherence to medication in order to identify targeted interventions. METHODS: A telephone survey of 8692 nonadherent hypertensive patients was conducted. The patient sample comprised health plan members with at least two prescriptions for antihypertensive medications in 2008. The telephone script was based on the "target" drug associated with greatest nonadherence (medication possession ratio [MPR] <80%) during the four-month period preceding the survey. RESULTS: The response rate was 28.2% of the total sample, representing 63.8% of commercial members and 37.2% of Medicare members. Mean age was 63.4 years. Mean MPR was 61.0% for the target drug. Only 58.2% of Medicare respondents and 60.4% of commercial respondents reported "missing a dose of medication". The primary reason given was "forgetfulness" (61.8% Medicare, 60.8% commercial), followed by "being too busy" (2.7% Medicare, 18.5% commercial) and "other reasons" (21.9% Medicare, 8.1% commercial) including travel, hospitalization/sickness, disruption of daily events, and inability to get to the pharmacy. Prescription copay was a barrier for less than 5% of surveyed patients. CONCLUSION: Our findings indicate that events interfering with daily routine had a significant impact on adherence. Medication adherence appears to be a patterned behavior established through the creation of a routine and a reminder system for taking the medication. Providers should assess patients' daily schedules and medication-taking competency to develop and promote a medication routine.

Hypertension treatment and control within an independent nurse practitioner setting.

OBJECTIVE: To assess blood pressure (BP) control among patients with hypertension managed by nurse practitioners (NPs) vs physicians. STUDY DESIGN: Cross-sectional study. METHODS: Retrospective medical record reviews were conducted at 3 independent NP-based practices and at 21 physician-based practices. Investigators at each practice identified a sample of patients 18 years or older with a hypertension diagnosis. The primary outcome was controlled BP (<140/90 mm Hg for patients without diabetes mellitus and <130/80 mm Hg for patients with diabetes mellitus). Propensity score matching was used to minimize potential selection bias between NP-treated and physician-treated patients and to balance differences in patient characteristics. Logistic regression analysis was performed to estimate the odds of controlled BP for NP-treated vs physician-treated patients, adjusting for covariates. RESULTS: The NP-treated sample was composed of 684 patients; their mean age was 54.2 years, 62.6% were female, 59.7% were obese, and 19.2% had diabetes mellitus. Before propensity score matching, physician-treated patients were older, less likely to be female, and more likely to have diabetes. The propensity score-matched cohort (n = 623 in each group) had similar baseline characteristics. Among the NP cohort, 70.5% had controlled BP compared with 63.2% among the physician cohort; the mean number of antihypertensive medications was lower among NP-treated patients (1.6 vs 1.8, P = .01). The adjusted odds of controlled BP were slightly lower for physician-treated patients (odds ratio, 0.76; 95% confidence interval, 0.58-0.99). CONCLUSIONS: Comparable controlled BP rates were observed among patients with hypertension receiving care from an NP vs a comparison group receiving care from a physician; the groups had similar baseline characteristics. Our findings support the increasingly important role of NPs in primary care.

Hypertension treatment and control among 28 physician practices across the United States: results of the Hypertension: Assessment of Treatment to Target (HATT) Study.

Chart reviews were conducted at 28 US physician practices to evaluate blood pressure (BP) management. The cross-sectional study included 8250 adult patients diagnosed with hypertension. The primary outcome variable was BP control (BP <140/90 mm Hg for nondiabetic and <130/80 mm Hg for diabetic patients). Mean body mass index was 30.9 kg/m(2), 49% were obese, 54% were women, mean age was 64.9 years, and 25% had diabetes. Mean BP was 132.2/77.8 mm Hg, and 55.8% of study participants had controlled BP. Patients with uncontrolled BP were more likely to be obese or African American, and more than twice as likely to have diabetes. Almost 1 in 5 nondiabetic patients (18%), and 38% of diabetic patients, were above goal BP by >10 mm Hg systolic or >5 mm Hg diastolic; among these patients, 36% used 0 or 1 antihypertensive medication, and 32% used 2 medications. Opportunity exists to improve BP control in this population.

Effect of cardiometabolic risk factors on hypertension management: a cross-sectional study among 28 physician practices in the United States.

OBJECTIVE: This cross-sectional study sought to determine the prevalence of cardiometabolic risk factor clusters (CMRFCs) and their effect on BP control among hypertensive patients from 28 US physician practices. METHODS: Each participating practice identified a random sample of 150-300 adults aged >or= 18 years diagnosed with hypertension. The primary outcome variable was BP control (BP < 140/90 mmHg for non-diabetic and <130/80 mmHg for diabetic patients). CMRFCs included hypertension in addition to obesity, dyslipidemia, and diabetes. RESULTS: Overall, 6,527 hypertensive patients were identified for study inclusion. More than half (54.3%) were female, and mean age was 64.7 years. Almost half (48.7%) were obese (BMI >or= 30 kg/m2). About 1 in every 4 patients (25.3%) had diabetes, and 60.7% had dyslipidemia. Mean blood pressure was 132.5/77.9 mmHg, and 55.0% of all patients had controlled BP; 62.4% of non-diabetic patients, and 33.3% of diabetic hypertensive patients, had BP controlled to recommended levels. Most (81.7%) hypertensive patients had >or= 1 cardiometabolic risk factor, and 12.2% had all 3 risk factors. As compared to hypertensive patients without additional risk factors, adjusted odds ratios for BP control were significantly lower for all combinations of CMRFCs (ORs 0.15-0.83, all p < 0.04), with the exception of patients who had only dyslipidemia in addition to hypertension (OR = 1.09, p = NS). Prescriber adherence to recommended hypertension treatment guidelines for patients with diabetes, heart failure, or prior myocardial infarction was high. Although patients with risk factors were prescribed more antihypertensive medications than those without, hypertensive patients with all 3 risk factors were prescribed a mean of 2.4 antihypertensive medications compared to 1.7 for those with no risk factors; odds of BP control in these patients, however, was 0.23 [95% CI 0.19-0.29] that of patients with no other CMRFCs. CONCLUSIONS: Across 28 US practices, only 18% of hypertensive patients did not have any additional cardiometabolic risk factors. The high prevalence of CMRFCs presents a challenge to effective hypertension management.

Potential value of electronic prescribing in health economic and outcomes research.

Improving access and quality while reducing expenditures in the United States health system is expected to be a priority for many years. The use of health information technology (HIT), including electronic prescribing (eRx), is an important initiative in efforts aimed at improving safety and outcomes, increasing quality, and decreasing costs. Data from eRx has been used in studies that document reductions in medication errors, adverse drug events, and pharmacy order-processing time. Evaluating programs and initiatives intended to improve health care can be facilitated through the use of HIT and eRx. eRx data can be used to conduct research to answer questions about the outcomes of health care products, services, and new clinical initiatives with the goal of providing guidance for clinicians and policy makers. Given the recent explosive growth of eRx in the United States, the purpose of this manuscript is to assess the value and suggest enhanced uses and applications of eRx to facilitate the role of the practitioner in contributing to health economics and outcomes research.

A narrative review of clinical inertia: focus on hypertension.

Clinical practice guidelines report standards of care for the management of medical conditions based on review of evidence-based medicine. The inherent responsibility and challenge for health care providers is devising a patient-specific care plan through adaptations of established treatment recommendations using the latest clinical evidence and clinical decision-making skills. Clinical inertia (CI) is viewed as the failure of health care providers in adherence to or persistence with established treatment recommendations. The ability to implement an appropriate care plan is often limited not by available clinical evidence, but rather by humanistic influences. CI may result from being complacent with moderate to poor control resulting from a multitude of factors. The purpose of this review is to present existing evidence-based literature investigating CI, with an emphasis in hypertension. A literature search was performed using MEDLINE, Embase, and the Cochrane Database of Systematic Reviews. Review of the literature addressing CI finds that many authors offer solutions primarily directed at physician behavior, although it is also influenced by patient- and system-based factors. Programs that increase communication and influence behaviors based on clinical guidelines, such as academic detailing, medication-therapy management, and disease management programs, are warranted to combat CI.

Identifying barriers to hypertension care: implications for quality improvement initiatives.

The role of clinical inertia in the treatment of patients with hypertension was assessed by evaluating health care providers' knowledge, attitudes, and clinical practices regarding hypertension management. A cross-sectional survey was conducted at the Forsyth Medical Group in North Carolina. Participants were physicians (N = 18, 10 sites) and support staff (N = 20, 12 sites), who were surveyed in 2006. Physician and support staff questionnaires consisted of 29 and 15 items, respectively, and were administered by trained interviewers. Though most physicians (94%) cited familiarity with the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7) guidelines and affirmed that hypertension management guidelines are relevant to their patients, no physicians interviewed routinely document patient hypertension management plans. Although 1 in 3 physicians cited the inability to devote enough time to patients for the discussion of hypertension management, physicians predominantly cited patient- and support-staff- related factors as most important to patients not attaining blood pressure (BP) goal. Patient lifestyle modification (89%), education (67%), and medication compliance (56%) were cited as the most important reasons for uncontrolled BP. Only one-third of physicians believe that clinical staff always obtain accurate BP measurements, and 61% believe that resistant hypertension is a reflection of inaccurate BP measurement. Many support staff claimed to be rushed when measuring patient BP, and 65% recommended BP competency training. Contradictions were evident between provider knowledge of hypertension management standards and how this knowledge is applied in clinical practice. Standardized collection of BP is critical to measuring clinical improvement in hypertension. Results are being utilized to develop clinical improvement initiatives including staff education and competency training.

Correlates of hypertension control in a primary care setting.

BACKGROUND: Numerous clinical trials have demonstrated reduction in cardiovascular events as a result of lowering blood pressure (BP). Despite these findings, BP control rates, especially in primary care settings, remain suboptimal. This study describes hypertension control and its predictors, using data from a sample of 631 adult patients drawn from an established primary care practice. METHODS: Data were obtained through chart review and patient survey during a 3-month period. The BP control was the outcome in a logistic regression model identifying demographic and clinical predictors of control. RESULTS: Compared to patients with low Framingham Risk Scores (FRS), individuals with moderate and high scores had reduced odds of achieving control (69% reduction, 95% confidence interval [CI] 0.19-0.65; 82% reduction, 95% CI 0.10-0.36, respectively). Being female reduced the odds of control by 61% (95% CI 0.26-0.66). Having diabetes mellitus (DM) (95% CI 0.21-0.79) or impaired fasting glucose (IFG; fasting glucose >109 but <126 mg/dL) (95% CI 0.10-0.40) reduced the odds of control by 64% and 82%, respectively. For each additional point on a physician-rated patient knowledge scale, the odds of having controlled BP increased 78% (95% CI 1.44-2.56). Each additional co-morbid condition positively associated with control (34% increase in odds, 95% CI 1.15-1.86). Age (95% CI 0.98-1.02) and body mass index (BMI) (95% CI 0.97-1.04) had no effect. CONCLUSIONS: Higher FRS, female sex, DM, and IFG negatively correlated with control. Patient knowledge and number of co-morbid conditions correlated positively. Age and BMI did not correlate with control. The most disturbing finding in our study was that higher risk patients who stand to benefit most from BP control were least likely to be controlled, despite being on more antihypertensive medications. These findings may be helpful to primary care providers in reaching patient hypertension control goals.