Cost avoidance from health system specialty pharmacist interventions in patients with multiple sclerosis.

BACKGROUND: Specialty pharmacists monitor patients taking multiple sclerosis (MS) disease-modifying therapies (DMTs) to evaluate response to therapy and intervene on adverse effects. These interventions have the potential to avoid health care costs by discontinuing inappropriate therapies and avoiding downstream health care utilization. OBJECTIVE: To calculate the costs avoided by specialty pharmacist interventions in MS. METHODS: A retrospective observational cohort study including patients at the Vanderbilt MS Clinic who received a specialty pharmacist intervention between February 1, 2022, and July 31, 2022, was performed. A panel of 3 investigators categorized each intervention based on the potential for cost avoidance: (1) no cost avoidance, (2) direct cost avoidance, and (3) indirect cost avoidance. A single intervention may have one or both cost avoidance types. Direct costs avoided included the cost of the potential service or medication avoided due to the intervention. Medication costs were calculated using the range of the average wholesale price and average wholesale price - 20%. For indirect costs avoided, the range of costs of a consequence (self-care, ambulatory visit, emergency department visit, hospitalization, or death) occurring had the intervention not been performed were multiplied by the range of probabilities for the consequence occurring (from zero [0] to very likely [0.5]). Self-care indirect cost savings equated to $0. Descriptive statistics summarized types of pharmacist interventions, the patients impacted, and costs avoided. In patients with an intervention that resulted in cost avoidance, chart review was performed to collect patient demographics, disease history, and MS-related health care usage during the 12 months prior to the pharmacist intervention. RESULTS: 485 pharmacist interventions in 354 individual patients were included. Fifty interventions in 38 individual patients (76% female, median age 51 years, 68% White) resulted in cost avoidance. The total estimated costs avoided in 6 months ranged from $123,733 to $156,265. In total, $138,410 were direct costs and $1,890 were indirect costs. Reasons for direct costs avoided (n = 13) were often safety monitoring (69%) or common side effects management (23%). Indirect costs avoidance (n = 37) resulted primarily from interventions on common side effects management (57%) and safety monitoring (22%). Self-care was the most common type of indirect cost avoided (n = 27). Interventions resulting in costs avoided were commonly seen in patients with relapsing-remitting MS (82%). The median time from MS diagnosis was 15 years and 42% of patients had previously trialed 1 other MS DMT. CONCLUSIONS: There is a potential for significant health care savings after specialty pharmacist interventions in MS, primarily from preventing the dispensing of inappropriate therapies.

A cross-sectional analysis of persistence to disease-modifying therapies in treatment naïve and experienced patients with relapsing multiple sclerosis at a health-system specialty pharmacy.

BACKGROUND: Patients with relapsing multiple sclerosis (RMS) are maintained on disease-modifying therapy (DMT) to prevent disease progression. Reported persistence rates to DMTs are varied and concerningly low. Limited data exists on long-term persistence rates and reasons for DMT discontinuation in patients with RMS. This study evaluated long-term DMT persistence, rates and reasons for DMT discontinuation or switch, specialty pharmacist involvement in DMT treatment transitions, and predictors associated with non-persistence in treatment naïve and experienced patients. METHODS: We performed a single-center retrospective, cross-sectional review of patients with RMS and ≥3 fills of DMT from a health-system specialty pharmacy (May-October 2017). Patients were followed for 3 years to determine DMT persistence, defined as the time a patient remained on index DMT. Descriptive statistics were used to summarize sample characteristics and outcomes. The Kaplan-Meier estimation method was used to estimate the probability of remaining persistent and we used the Cox proportional hazards regression model to analyze the primary outcome. Rates and reasons for DMT discontinuation were identified via pharmacy claims and confirmed via chart review of the electronic health record. RESULTS: The study included 540 patients, of which 41 (7.6%) were treatment naïve. Over 3 years, 193 (36%) patients remained on index DMT. The probability of remaining persistent for 3 years was 0.51 (95% confidence interval [CI] 0.47-0.56) and median time on index DMT was 642 days (interquartile range 317-1096). For the 347 patients that did not continue index DMT: 91 (26%) discontinued, 136 (39%) switched to a new DMT, 92 (27%) transferred care to a new specialty pharmacy or provider, 21 (6%) were lost to follow-up, and 7 (2%) died. Common reasons for DMT discontinuation or switch were insurance formulary change, side effects, clinical decline, and stable disease. Specialty pharmacists initiated 6 (7%) DMT discontinuations and 49 (36%) DMT switches. A strong non-linear relationship existed between age and risk of non-persistence (p = 0.003). Patients on an injectable index DMT were 1.5 times more likely to be non-persistent than those on an oral DMT (95% CI 1.1-2.1, p = 0.012) and patients with non-commercial insurance were 1.4 times more likely to be non-persistent (95% CI 1.02-2.0, p = 0.040). CONCLUSIONS: Long-term persistence to DMTs is low, with many patients switching or discontinuing DMT treatment. Specialty pharmacists identify the need for DMT discontinuation or switch and are uniquely positioned to assist during therapy transitions.

Inclusion in limited distribution drug network reduces time to dalfampridine access in patients with multiple sclerosis at a health-system specialty pharmacy.

BACKGROUND: Dalfampridine improves walking speed in patients with multiple sclerosis (MS), but accessing specialty medications such as dalfampridine can be hindered by insurance restrictions, high costs, and limited distribution networks (LDNs) imposed by manufacturers. Some integrated health-systems specialty pharmacies (HSSPs) embed pharmacists in clinics and dispense medications from their internal pharmacies if included within the LDN. OBJECTIVE: To assess access to dalfampridine in patients at an HSSP before and after gaining admission to the LDN. METHODS: This study was conducted at Vanderbilt Specialty Pharmacy (VSP), an integrated HSSP at Vanderbilt University Medical Center (VUMC) with 2 clinical pharmacists embedded in the MS clinic. VSP gained access to the dalfampridine LDN on May 1, 2018, at which time the embedded pharmacists began to manage the comprehensive therapy initiation process. We performed a retrospective review of adult patients with MS who were prescribed dalfampridine from March 2010 to December 2018. Eligible prescriptions were new starts (no previous use) or restarts (after previous use and discontinuation). Prescriptions were classified as pre-VSP and post-VSP, which differentiates before and after VSP gained access to dispense dalfampridine. Study outcomes were insurance approval, initiation of therapy, and time from treatment decision to medication access. We used a proportional odds logistic regression model for time to medication access using the following covariates: pre-VSP versus post-VSP time period, insurance prior authorization (PA) denied versus approved/not needed, and baseline timed 25-foot walk. RESULTS: We included 262 patients and 290 prescriptions (260 pre-VSP and 30 post-VSP). In pre-VSP and post-VSP prescriptions, 97% were approved by insurance, and 93% of patients started therapy. Median time to medication access was 22 days (IQR = 11-45) for pre-VSP prescriptions and 1 day (IQR = 0-3) for post-VSP prescriptions. In the proportional odds logistic regression model, the odds of having a longer medication access time were significantly higher for pre-VSP prescriptions (OR = 83.219, P < 0.001) and prescriptions whose PA was initially denied (OR = 9.50, P < 0.001); 25-foot walk time was not significant (OR = 0.95, P = 0.277). CONCLUSIONS: After obtaining access to dispense dalfampridine, the time to access therapy was reduced, suggesting that LDNs delay patient access to therapy at HSSPs. DISCLOSURES: No funding was provided for this study. The authors have no conflicting interests to disclose. Preliminary results have been previously presented at the American Society of Health-Systems Pharmacy Midyear Meeting in December 2019, the Vanderbilt Health Systems Specialty Pharmacy Outcomes Research Summit in August 2020, and the National Association of Specialty Pharmacy Annual Meeting in September 2020.

Adherence to Disease-Modifying Therapies at a Multiple Sclerosis Clinic: The Role of the Specialty Pharmacist.

BACKGROUND: Disease-modifying therapy (DMT) delays disease progression and improves quality of life for patients with multiple sclerosis (MS), but adherence to DMT is often suboptimal. Vanderbilt Specialty Pharmacy (VSP) embeds pharmacists within an outpatient MS clinic to provide medication management and address barriers to adherence. OBJECTIVE: We evaluated rates and predictors of adherence to DMT among patients with MS at an integrated specialty pharmacy. METHODS: We included patients with MS who filled ≥3 DMT prescriptions from VSP during the study period. Adherence was defined as medication possession ratio (MPR) or proportion of days covered (PDC) ≥0.8. Reasons for nonadherence were collected from pharmacy claims and electronic medical records. RESULTS: The study included 653 patients. Average MPR and PDC were 0.93 and 0.94, respectively. Eighty-eight percent of patients achieved MPR ≥0.8; 89% achieved PDC ≥0.8. Using financial assistance and having $0 out-of-pocket cost were associated with higher odds of achieving MPR and PDC ≥0.8 (P < .05). Of the 12% of patients who were nonadherent, most were unreachable for refills. CONCLUSIONS: Ensuring financial assistance and low out-of-pocket costs are associated with high adherence to DMT within an integrated specialty clinic, but more work is needed to address adherence in unreachable patients.

An Integrated Health-System Specialty Pharmacy Model for Coordinating Transitions of Care: Specialty Medication Challenges and Specialty Pharmacist Opportunities.

Adherence and persistence to specialty medications are necessary to achieve successful outcomes of costly therapies. The increasing use of specialty medications has exposed several unique barriers to certain specialty treatments' continuation. Integrated specialty pharmacy teams facilitate transitions in sites of care, between different provider types, among prescribed specialty medications, and during financial coverage changes. We review obstacles encountered within these types of transitions and the role of the specialty pharmacist in overcoming these obstacles. Case examples for each type of specialty transition provide insight into the unique complexities faced by patients, and shed light on pharmacists' vital role in patient care. This insightful and real-world experience is needed to facilitate best practices in specialty care, particularly in the growing number of health-system specialty pharmacies.

Outcomes of Less Intensive Glycemic Target for a Subcutaneous Insulin Protocol in Hospitalized Patients.

BACKGROUND: This study looked at the effect of replacing an intensive subcutaneous insulin correction protocol (old subcutaneous insulin correction protocol [OP]) with a less intensive protocol (new subcutaneous insulin correction protocol [NP]) in a tertiary hospital with the hypothesis that using the NP will result in less hypoglycemia and improved hospital outcomes. METHODS: The charts for 200 hospitalized patients managed with the OP (glycemic target 90-116 mg/dL for intensive care and 90-130 mg/dL for nonintensive care patients) and 200 with the NP (glycemic target 150-200 mg/dL) were reviewed. Data were collected and analyzed using Fisher's exact test and Student's t test. The primary outcome was the difference in hypoglycemia rates between the 2 protocols. Hypothesis test P values of <0.05 were deemed significant. RESULTS: There was no statistically significant difference in age, sex, ethnicity, body mass index, level of hospital care or use of scheduled insulin for the 2 groups (P > 0.05 for all). Average blood glucose values were 160.45 and 169.98 mg/dL for the OP and NP, respectively (P = 0.063). There were 14 readings ≤ 40 mg/dL in the OP compared with 6 in the NP (P = 0.046). With the OP, 27 patients required dextrose treatment compared to 11 with the NP (P = 0.0097). The average length of hospitalization was longer for the NP compared with the OP (13.16 versus 6.56 days, P = 0.00085). CONCLUSIONS: A less intensive subcutaneous insulin correction protocol in hospitalized patients resulted in similar glucose values with less severe hypoglycemia. However, it was associated with longer length of hospitalization.

Evaluation of Modification of Diet in Renal Disease Study and Cockcroft-Gault equations for sitagliptin dosing.

BACKGROUND: Assessment of kidney function is necessary to determine appropriate dosing regimens. While the Cockcroft-Gault (CG) equation is used to calculate the estimated creatinine clearance (eCLCr) for drug dosing, the Modification of Diet in Renal Disease (MDRD) Study equation has recently been advocated. Sitagliptin is a dipeptidyl-peptidase IV inhibitor with dose adjustments based on eCLCr. We assessed discordance in sitagliptin doses recommended using MDRD and CG equations. METHODS: Adult patients with type 2 diabetes mellitus were included. Estimated glomerular filtration rate (eGFR) individualized for body surface area (eGFR-BSA) and eCLCr were calculated by the MDRD and CG equations, respectively, and sitagliptin dose was determined. Discordance in doses recommended by method were compared overall and by subgroup based on eCLCr category. RESULTS: A total of 121 patients were included: 52% male, 90% white, mean age 61 ± 12 years, weight 93 ± 19 kg, BSA 2.0 ± 0.22 m2 and body mass index (BMI; calculated as kg/m2) 33 ± 7. Mean eGFR-BSA was 76 ± 19 ml/min and eCLCr was 68 ± 17 ml/min. Discordance in sitagliptin dose was observed in 11 patients (9%) with MDRD compared with CG. All patients with eCLCr =50 would have received a higher dose using MDRD, while patients with eCLCr >50 would have received a lower dose. CONCLUSIONS: Overall there was agreement in sitagliptin dose using MDRD and CG equations. Discrepancies resulted in underestimation of sitagliptin dose at eCLCr above 50 ml/min and overestimation at lower eCLCr. Clinical implications are the potential for excessive dosing of sitagliptin and other agents with similar dose stratification by eCLCr in individuals with kidney dysfunction.

Role of aggressive LDL reduction in patients with coronary heart disease.

The aim of the present study was to integrate research evidence with the care of the patient with coronary heart disease (CHD) and place into perspective the importance of intensive statin therapy. We reviewed five major trials and select related post hoc analyses that examined the beneficial effects from intensive low-density lipoprotein (LDL) reduction on combined morbidity and mortality end points in patients with stabilized CHD and those with recent acute coronary syndrome.Accumulating evidence since the publication of the pivotal Heart Protection Study and Adult Treatment Panel III supports a more intensive LDL reduction than that recommended in the 2004 Adult Treatment Panel III update. An LDL reduction of 49% from baseline in statin-naïve patients with stable CHD or a 41% to 44% reduction in LDL from postadmission values in patients with acute coronary syndrome improves composite morbidity and mortality end points.Current evidence suggests that a more intensive LDL reduction of approximately 45% to 50% from a patient's baseline in acute and stable CHD is warranted. The decrease in recurrent events associated with the use of statin regimens that can achieve this degree of reduction in LDL may offer a financial incentive for managed care healthcare systems; however, statin therapy should be selected upon careful consideration of both dose and agent.