Identification of Patients with Statin Intolerance in a Managed Care Plan: A Comparison of 2 Claims-Based Algorithms.

BACKGROUND: While statins are safe and efficacious, some patients may experience statin intolerance or treatment-limiting adverse events. Identifying patients with statin intolerance may allow optimal management of cardiovascular event risk through other strategies. Recently, an administrative claims data (ACD) algorithm was developed to identify patients with statin intolerance and validated against electronic medical records. However, how this algorithm compared with perceptions of statin intolerance by integrated delivery networks remains largely unknown. OBJECTIVE: To determine the concurrent validity of an algorithm developed by a regional integrated delivery network multidisciplinary panel (MP) and a published ACD algorithm in identifying patients with statin intolerance. METHODS: The MP consisted of 3 physicians and 2 pharmacists with expertise in cardiology, internal medicine, and formulary management. The MP algorithm used pharmacy and medical claims to identify patients with statin intolerance, classifying them as having statin intolerance if they met any of the following criteria: (a) medical claim for rhabdomyolysis, (b) medical claim for muscle weakness, (c) an outpatient medical claim for creatinine kinase assay, (d) fills for ≥ 2 different statins excluding dose increases, (e) decrease in statin dose, or (f) discontinuation of a statin with a subsequent fill for a nonstatin lipid-lowering therapy. The validated ACD algorithm identified statin intolerance as absolute intolerance with rhabdomyolysis; absolute intolerance without rhabdomyolysis (i.e., other adverse events); or as dose titration intolerance. Adult patients (aged ≥ 18 years) from the integrated delivery network with at least 1 prescription fill for a statin between January 1, 2011, and December 31, 2012 (first fill defined the index date) were identified. Patients with ≥ 1 year pre- and ≥ 2 years post-index continuous enrollment and no statin prescription fills in the pre-index period were included. The MP and ACD algorithms were applied to the population, and concordance was examined using individual (i.e., sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) and overall performance measures (i.e., accuracy, Cohen's kappa coefficient, balanced accuracy, F-1 score, and phi coefficient). RESULTS: After applying the inclusion criteria, 7,490 patients were evaluated for statin intolerance. The mean (SD) age of the population was 51.1 (8.5) years, and 55.7% were male. The MP and ACD algorithms classified 11.3% and 5.4% of patients as having statin intolerance, respectively. The concordance of the MP algorithm was mixed, with negative classification of statin intolerance measures having high concordance (specificity 0.91, NPV 0.97) and positive classification of statin intolerance measures having poor concordance (sensitivity 0.45, PPV 0.21). Overall performance measures showed mixed agreement between the algorithms. CONCLUSIONS: Both algorithms used a mix of pharmacy and medical claims and may be useful for organizations interested in identifying patients with statin intolerance. By identifying patients with statin intolerance, organizations may consider a variety of options, including using nonstatin lipid-lowering therapies, to manage cardiovascular event risk in these patients. DISCLOSURES: This study was funded by Regeneron Pharmaceuticals and Sanofi US. Boklage is employed by, and owns stock in, Regeneron, and Charland is employed by Sanofi. Bellows has received fees from Avenir for advisory board membership and grants from Myriad Genetics, Biogen, Janssen, and National Institutes of Health. Brixner reports advisory board and consultancy fees and grants from Sanofi. Mitchell reports consultancy fees from Sanofi. Study concept and design were contributed by Bellows, Boklage, Charland, and Brixner. Bellows, Sainski-Nguyen, and Olsen took the lead in data collection, along with Mitchell. Data interpretation was performed by Mitchell, along with the other authors. The manuscript was written by Bellows, Sainski-Nguyen, and Olsen and revised by all the authors.

Evaluation of health plan member use of an online prescription drug price comparison tool.

BACKGROUND: Health plans have implemented tiered copayment systems to incentivize members to use less expensive medications. However, members need drug price information to make comparisons among therapeutic alternatives. Many health plans and pharmacy benefit management companies have implemented online prescription drug price comparison tools to provide such information. There has been little published evaluation of these tools. OBJECTIVE: To evaluate use of an online price comparison tool- MyPharmacyTools (MPT)- by the measures of (a) the extent to which the tool was used, (b) changes in use over the first year after implementation, and (c) the types of members who were most likely to use the tool. METHODS: Data were provided by a 500,000-member integrated health plan with approximately 156,250 enrolled families. The sample included only families with continuous eligibility for all members from July 1, 2006, through June 30, 2008; use of 1 of 7 common copayment structures; and use of the pharmacy benefit in every quarter of the study period. Data collected on each member, using pharmacy claims for the time period July 1, 2007, through June 30, 2008, included annual drug costs (total, out-of-pocket, plan-paid, and mail order) and number of unique drugs and unique generic drugs taken during the third quarter of 2007. Data collected also included whether the member had each of several selected chronic diseases (as inferred from drug claims for the third quarter of 2007) and demographics. Age, gender, and family size were taken from eligibility files. Other demographic data were imputed to members from the demographics of the ZIP code in which they resided. MPT was made available to members on July 1, 2007. Use of MPT was measured as the number of times members logged into the site for each quarter during the subsequent year. Statistical analyses were conducted at the family rather than at the individual level, and families were defined as users if any family member used MPT at least once during the year. Between-group comparisons were evaluated with t-tests, Pearson chi-square tests, and analyses of variance. RESULTS: Data were analyzed for 8,909 families composed of 28,537 health plan members, of which 464 (5.2%) families used MPT at least once between July 2007 and June 2008. A total of 141 families used MPT in the first quarter it was available, 170 families used it in the second quarter, 185 families in the third quarter, and 182 families during the fourth quarter. Users had significantly higher mean [SD] total drug costs ($4,477 [$9,647] vs. $2,848 [$3,473], P < 0.001) and used significantly more unique drug products (7.7 [5.7] vs. 5.9 [4.5], P < 0.001) and unique generic drug products (5.0 [3.9] vs. 3.9 [3.2], P < 0.001) than did nonusers. Users were significantly more likely than nonusers to use drugs for behavioral diseases (47.0% vs. 39.7%, P = 0.002), hypercholesterolemia (35.8% vs. 27.0%, P < 0.001), gastric disorders (32.8% vs. 23.0%, P < 0.001), diabetes (18.3% vs. 12.8%, P < 0.001), epilepsy (21.1% vs. 10.6%, P < 0.001), cardiovascular problems (48.3% vs. 37.5%, P < 0.001), and asthma (14.0% vs. 10.7%, P = 0.025). Families that used MPT were less likely to have a female subscriber than were nonusers (39.7% vs. 49.0%, P < 0.001). Otherwise, here were no statistically significant demographic differences between users and nonusers. Families using MPT in more quarters of the year had higher out-of-pocket (P < 0.001) and mail order drug costs (P < 0.001), took a larger number of drugs (P = 0.003) and generic drugs (P = 0.019), were more likely to use drugs for diabetes (P = 0.049) and cardiovascular disease (P = 0.013), and used drugs for a greater number of chronic diseases (P = 0.049), compared with less frequent MPT users. CONCLUSIONS: About 5% of families in a sample from a large integrated health plan used an online prescription drug cost comparison tool during the first year it was available. Use increased over the year. Users were more likely to have several chronic diseases, took more prescription drugs, and had higher drug costs than nonusers. Further, users with more chronic diseases and more prescriptions were more likely to use the tool consistently throughout the year. These results indicate that the tool was successful in reaching health plan members who could most benefit from comparative prescription drug price information.

Description of the outcomes of prior authorization of palivizumab for prevention of respiratory syncytial virus infection in a managed care organization.

BACKGROUND: Respiratory syncytial virus (RSV) is the leading cause of upper and lower respiratory tract infections in infants and young children. Most children are exposed to the virus before they are 2 years old and experience such symptoms as cough, fever, and irritability. In a select population of infants, the virus can cause hypoxemia and hospitalization. To avoid hospitalization, good infection control practices should be employed, and for those infants at high risk, prophylaxis with palivizumab is indicated. Palivizumab has been shown to reduce hospitalization rates in high-risk infants by 50%. Because of the high cost of palivizumab, it is prudent to use this medication in the population in which it will be most effective. The American Academy of Pediatrics (AAP) established the criteria for those infants who would benefit the most from palivizumab prophylaxis, and these criteria were the foundation for a prior authorization (PA) program to determine coverage of palivizumab in a health plan of approximately 500,000 members. OBJECTIVE: To (a) analyze the appropriateness of this PA program for palivizumab used prophylactically for RSV, and (b) determine the financial cost associated with the medication and disease for this health plan. METHODS: A 3-year, retrospective study was conducted from the 2005- 2006 RSV season through the 2007-2008 season. The primary endpoint outcome was the hospitalization rate associated with RSV infection. Secondary endpoints included the cost of palivizumab and RSV-related emergency room (ER) utilization. Infants were placed into 2 groups: those who received PA approval for use of palivizumab and those who were denied coverage in the PA process. Disease-related hospitalization and ER visits were identified by at least 1 administrative claim containing either a primary or secondary ICD-9-CM code for any of the following: RSV (079.6), acute bronchiolitis caused by RSV (466.11), or pneumonia caused by RSV (480.1). Drug cost was defined as the health plan's allowed amount, which is based on a predefined fee schedule for the Current Procedural Terminology (CPT) code 90378 for palivizumab. Hospital and ER costs are the health plan allowed amounts (health plan plus member cost) based on the reimbursement rates determined by diagnosis related group (DRG) and other coding, and the plan-allowed amount based on DRGs includes all services and drugs provided in the specific encounter. Drug cost avoided was calculated as the average cost of palivizumab treatment per episode multiplied by the number of infants denied coverage of palivizumab over the 3-year study period. RESULTS: Over 3 RSV seasons through May 2008, the PA program received 1,090 requests for coverage of palivizumab, of which 348 (31.9%) were denied. Of 742 PA-approved infants, 629 received at least 1 dose of palivizumab. The mean (SD) gestational age of the PA-denied group was 34.4 (2.5) weeks versus 32.5 (4.0) weeks for the PA-approved group (P < 0.001). In the PA-denied group, 14 infants (4.0%) were subsequently hospitalized with an RSV infection, and 5 (1.4%) had an RSV-related ER visit versus 40 (6.4%) hospitalized and 14 (2.2%) with ER visits for infants in the PA-approved group (P = 0.055 and P = 0.019, respectively); 15 (4.3%) of the PA-denied group had either a hospitalization or an ER visit versus 42 (6.6%) in the PA-approved group (P = 0.060). One patient in the palivizumab PA-approved group died. Over the 3 RSV seasons, the mean number of palivizumab doses and mean allowed palivizumab cost per treatment episode (per infant per season) were 3.64 and $6,950, respectively, and the average allowed palivizumab cost was $7,702 per utilizing infant. Total per infant costs for palivizumab, RSV hospitalizations, and RSV-related ER visits were $8,534 for infants receiving palivizumab compared with $223 for those denied palivizumab coverage (P = 0.002). Drug cost avoidance associated with the PA program was estimated to be $2,418,600 (348 infants times $6,950 palivizumab cost per episode) over the 3 RSV seasons. CONCLUSION: In a 500,000-member health plan, a PA program to restrict palivizumab use in accordance with AAP recommendations was associated with estimated palivizumab drug cost avoidance of more than $2.4 million over 3 years. There was no significant difference in the RSV-related hospitalization rate for the PA-denied versus the PA-approved groups, but the PA-denied group had a slightly lower rate of RSV-related ER visits.

Humanistic, utilization, and cost outcomes associated with the use of botulinum toxin for treatment of refractory migraine headaches in a managed care organization.

BACKGROUND: Few patients with migraine syndrome receive treatment with preventive medication regimens, and some of these patients fail to gain adequate migraine relief. Botulinum toxin has been suggested to be effective in the treatment of migraine for a select population. An integrated health system created a medical policy and a supporting preauthorization form that permits coverage of botulinum toxin for the off-label treatment of migraine for patients who (1) fail at least 3 drug classes for acute treatment, (2) fail at least 4 different preventive medication classes, and (3) receive consultation from a neurologist. OBJECTIVES: To (1) evaluate the impact of botulinum toxin therapy on quality-of-life (QOL) measures evaluated by direct member survey results, and (2) assess the use and cost of migraine-related medications and overall medical and pharmacy services pre- and post-botulinum toxin therapy. METHODS: The study was a retrospective analysis of administrative claims data from a 500,000-member integrated health system for the time period January 1, 2003, to October 31, 2007. Administrative claims data were used to identify members with a billing code (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]) for migraine (346.xx), tension headache (307.81), or headache (784.0) diagnosed by a neurologist. Administrative claims data for these patients were then queried for the use of botulinum toxin for dates of service from January 1, 2003, through October 31, 2006. A survey was sent to the identified patients (N=54) to assess 6 QOL measures associated with the use of botulinum toxin. Self-reported symptomatic improvement was assessed using a 5-point Likert scale for 6 questions regarding headache severity, headache frequency, use of rescue medications, productivity/absenteeism, recreational activities, and life enjoyment. For the subset of patients (n = 32) who maintained health plan eligibility from 18 months before through 18 months after the first botulinum toxin therapy claim (index date), medical and pharmacy claims data were used to assess the utilization and cost of specific medications and overall pharmacy and medical costs for the 18-month pre-index and post-index periods. Cost was defined as allowed charge, which is the sum of plan cost and member cost. RESULTS: Of 54 surveys sent to all patients identified as having used botulinum toxin for the treatment of migraine from January 1, 2003, to October 31, 2006, 34 surveys were returned (63%). Almost 3 of 4 respondents (73%) reported moderate or better improvement in overall migraine or headache QOL measures, and 27% reported little or no improvement. For the 32 patients with continuous eligibility for the total observation period of 36 months, the average migraine-related pharmacy utilization, excluding botulinum toxin, increased by 50.5%, from 1.84 claims per patient per month (PPPM) in the 18-month pre-index period to 2.77 claims PPPM in the 18-month post-index period (P = 0.011) and by 59.5% by mean days supply (42.58 days to 67.93, P=0.008). Total migraine-related pharmacy cost increased by 80.9%, from $142.08 PPPM to $256.97 PPPM (P=0.013). Acute-treatment migraine-related pharmacy utilization increased from 1.23 claims PPPM to 1.92 claims PPPM (P=0.004). There was no significant change in either the number of claims for migraine prophylaxis medications (0.61 PPPM to 0.85 PPPM, P=0.121) or the use of hospital emergency room services related to migraine or headache (0.07 PPPM vs. 0.10 PPPM, P=0.449). The mean migraine-related and nonmigraine-related (i.e., all-cause) combined medical/hospital and pharmacy expense, including botulinum toxin, increased by 111.3%, from $651.13 PPPM in the pre-index period to $1,376.05 PPPM in the post-index period (P<0.001). CONCLUSION: The majority of patients who received botulinum toxin for refractory migraine reported improvement in disease-specific symptoms and overall QOL, but total medical and pharmacy costs were higher in the period after treatment, and there was no reduction in the use of other migraine-related medications.

Utilization and drug cost outcomes of a step-therapy edit for generic antidepressants in an HMO in an integrated health system.

OBJECTIVE: Antidepressants do not differ significantly in their ability to treat depression. Excluding the tricyclic antidepressants (TCAs), these drugs also do not differ significantly in their incidence of adverse events. Therefore, the initial choice of antidepressant medication should be based, in part, on cost. The objective of this study was to evaluate the impact on utilization and costs of a generic steptherapy edit for antidepressant drugs excluding TCAs in a health maintenance organization (HMO) in an integrated health system (IHS). METHODS: The pharmacy department of the 440,000-member HMO in an IHS collaborated with the Behavioral Health Clinical Program to design an intervention that required generic antidepressants as first-line pharmacotherapy. Under the GenericStart! Program, a brand-name antidepressant was covered only after trial with a generic antidepressant, excluding TCAs. A step-therapy edit was added to the pharmacy claims processing system on January 1, 2005. All new starts, defined as members with no claims history of antidepressant treatment within the preceding 6 months, were required to use a generic antidepressant. The member copayment was waived for the first prescription. All generic antidepressants were in tier 1 of the drug formulary, with an average copayment of $5 to $10. All brand-name antidepressants were in either tier 2 (preferred brand), with an average copayment of $20 to $25 or 25% coinsurance, or tier 3 (nonformulary brand), with an average copayment of $40 to $45 or 50% coinsurance. Pharmacy claims data from a national pharmacy benefit manager (PBM) without interventions for antidepressants in 2004 or 2005 were used for the comparison group. RESULTS: The generic antidepressant dispensing rate increased by 20 points (32.5% to 52.5%) in the intervention group but only 7.4 points (24.9% to 32.3%) in the comparison group in 2005 compared with 2004. The principal measure of antidepressant drug cost per day of therapy in the intervention group decreased by 11.7% (from $2.40 to $2.12) in 2005 compared with 2004 versus a 2.7% decrease (from $2.60 to $2.53) in the comparison group (P <0.001). Days of antidepressant drug therapy per member per month (PMPM) dropped by 1.5% (from 1.74 to 1.71) in the intervention group versus a decrease of 5.0% (from 1.37 to 1.30) in the comparison group in 2005 compared with 2004. The combination of change in drug cost and utilization resulted in a 13.0% decrease in antidepressant drug cost, from $4.16 PMPM in 2004 to $3.62 in 2005, compared with a 7.6% decrease (from $3.57 to $3.30 PMPM) in the comparison group. The 9.0% difference in drug cost per day represents drug cost savings of approximately $0.36 PMPM or $1,880,562 in 2005 dollars for this HMO of approximately 440,000 members. CONCLUSION: A step-therapy edit requiring HMO members to use a generic antidepressant, excluding tricyclics, prior to use of a brand-name antidepressant resulted in drug cost savings of 9.0% for the entire class of antidepressants, equal to $1,880,562 ($0.36 PMPM) in 2005 dollars in the first year of the intervention. A small (-1.5%) decrease in use of antidepressants occurred in the intervention group, which was less than the 5.0% decrease in utilization of antidepressants in the comparison group.