Benefit restrictions and gout treatment.

BACKGROUND: Gout is a chronic rheumatic disease that can have serious sequelae, including persistent pain, nerve compression, joint destruction and deformities if left untreated. Febuxostat, initially introduced in the United States in 2009, was the first new treatment option for gout in over 40 years. With the introduction of a new drug into a therapeutic class that is composed of generically available options, utilization management will be a common strategy employed in an effort to contain cost; however, the effects of these strategies are not known for chronic gout treatment. OBJECTIVE: To evaluate the effect of utilization management strategies on chronic gout treatment. METHODS: This retrospective analysis examined claims data from a large, national pharmacy benefits manager with a client base that includes commercial HMOs, Medicaid, Medicare Part D, and self-insurers. The study population included patients aged 18 years or older who had at least 1 rejected claim for febuxostat in the 16-month identification period from March 1, 2009, through June 30, 2010. Outcomes of interest were the proportion of patients who filled a febuxostat prescription and proportion of patients who filled a prescription for another chronic gout treatment within 1 month of the febuxostat claim rejection date (the index date). Multivariate logistic regression models were used to assess factors affecting patient response to a rejected febuxostat claim. RESULTS: Of 1,034 patients with rejected febuxostat claims, 95% had claims denied due to utilization management: 36% due to step therapy, 25% due to lack of drug coverage, 18% due to quantity or other limits (i.e., fill limit exceeded, days supply exceeding benefit maximum, or maximum days supply limit exceeded), 16% due to prior authorization requirements, while 5% were due to "other reasons" unrelated to the utilization management strategies of interest. "Other reasons" included over 100 possible rejection reasons such as fill dispensed too soon, missing/invalid days supply, group not having benefit, physician not covered, non-matched group, not a network pharmacy, non-matched member, claim/member birth date not matching, and missing/invalid prescriber identifier. Subsequently, 474 (46%) of these patients filled a febuxostat prescription within 1 month of a rejected claim; 364 (35%) had not filled a prescription for any chronic gout medication within a month of the febuxostat claim rejection. Those filling a febuxostat prescription had higher pre-index total 6-month pharmacy costs than those not filling a chronic gout prescription ($1,718 vs. $988; P < 0.001) . They also had a higher number of pre-index drug claims (25 vs. 18; P < 0.001). The regression model found the following variables to be statistically significant in positively influencing the likelihood of patients filling a febuxostat prescription within a month of a febuxostat claim rejection: (a) self-insured coverage (compared with commercial HMO coverage); (b) pre-index total prescription costs of at least $1,800; (c) claim rejection due to quantity or other limit (compared with lack of drug coverage); (d) claim rejection due to "other reason" (compared with lack of drug coverage); and (e) 1 and ≥1 pre-index colchicine claim. Patients with projected febuxostat copay of $100 to $149 were found to be less likely to fill febuxostat compared with patients with a projected copay of $0 to $19. CONCLUSION: Utilization management strategies likely result in gaps in gout treatment; 35% of patients with a denied febuxostat claim in this study population did not fill a prescription for any chronic gout therapy within a month of the claim denial. These findings are important in the consideration of benefit design in gout treatment.

Evaluation of a drug-drug interaction: fax alert intervention program.

BACKGROUND: Clinicians often encounter information about drug-drug interactions (DDIs) during clinical practice. This information is found within product information (hardcopy and electronic) and various electronic systems. Prescribers may receive medication-related communications in practice that are distributed by facsimile (fax), mail, or telephone from pharmacies and pharmacy benefit managers (PBMs). The purpose of this study was to determine if near-real time fax alerts for potential drug-drug interactions (PDDIs) would influence prescribing. METHODS: A prospective study, in cooperation with a pharmacy benefit manager (PBM), was conducted targeting 18 clinically important PDDIs. Fax alerts included an individualized letter to the prescriber with a list of the interacting drugs, PDDI evidence summaries with citations, and recommended clinical management strategies. Among the 18 PDDIs, 13 PDDIs could be assessed for prescription therapy changes using pharmacy claims data. A prospective cohort design was used to evaluate changes in prescription dispensing 90-days following a PDDI fax alert. RESULTS: A total of 8,075 fax alerts were sent to prescribers and there were 4,712 alerts for the 13 PDDIs that could be assessed for change using pharmacy claims data. There were 2,019 patients (interventions) for which fax alerts were sent to their prescribers who were matched with a control group consisting of patients with the same PDDIs but for whom no fax alert was sent. Overall, this study found 154 (7.6%) of patients in the fax alert group compared to 132 (6.5%) in the control group had changes in therapy (p = 0.177). CONCLUSIONS: This fax alert intervention program observed no statistically significant differences in prescribing with a fax alert compared to the control group. If PBMs chose to send individualized, evidence-based information to clinicians regarding drug-drug interactions, this study suggests it may not be an effective intervention to mitigate harm.

Prevalence of prostatitis-like symptoms in a managed care population.

PURPOSE: We calculated the prevalence of symptoms typically associated with chronic prostatitis/chronic pelvic pain syndrome in men in a managed care population in the Pacific Northwest. MATERIALS AND METHODS: A questionnaire mailing to 5,000 male enrollees 25 to 80 years old in the Kaiser Permanente Northwest (Portland, Oregon) health plan was performed. The questionnaires included screening questions about the presence, duration and severity of pelvic pain, and the National Institutes of Health Chronic Prostatitis Symptom Index. Chronic prostatitis/chronic pelvic pain syndrome symptoms were defined in 2 ways: 1) presence of any of the following for a duration of 3 or more months: pain in the perineum, testicles, tip of penis, pubic or bladder area, dysuria, ejaculatory pain; and 2) perineal and/or ejaculatory pain, and a National Institutes of Health Chronic Prostatitis Symptom Index total pain score of 4 or more. Prevalence estimates were age adjusted to the total Kaiser Permanente Northwest male population. RESULTS: A total of 1,550 questionnaires were returned. The prevalence of chronic prostatitis/chronic pelvic pain syndrome symptoms was 7.5% for definition 1 and 5.9% for definition 2. Mean National Institutes of Health Chronic Prostatitis Symptom Index scores were 17 for definitions 1 and 2. Of those with prostatitis-like symptoms, 30% met criteria for having both definitions present. The prevalence of prostatitis-like symptoms using either of the 2 diagnoses was 11.2%. CONCLUSIONS: This population based study indicates that approximately 1 in 9 men have prostatitis-like symptoms. Application of 2 different definitions for prostatitis-like symptoms identified unique groups of men, with limited overlap in the groups.

Incidence and clinical characteristics of National Institutes of Health type III prostatitis in the community.

PURPOSE: Few population-based epidemiological studies of prostatitis have been performed. We used coded physician diagnoses and subsequent chart reviews to estimate the incidence and clinical characteristics of physician diagnosed National Institutes of Health (NIH) type III prostatitis. MATERIALS AND METHODS: Computer searches of the Kaiser Permanente Northwest (Portland, Oregon) database were performed on the 2-year interval May 2002 to May 2004 to identify new diagnoses of chronic prostatitis (International Classification of Diseases, 9th Revision code 601.1) and prostatitis not otherwise specified (International Classification of Diseases, 9th Revision code 601.9). Of the 1,223 men identified with these coded diagnoses, chart reviews were performed on a random subset of 413 (33.8%). Patients were categorized based on NIH prostatitis definitions of type I/II-evidence of pyuria and/or bacteriuria on urinalysis or culture, type III-presence of at least 1 of the pain or urinary symptoms in the NIH Chronic Prostatitis Symptom Index (pain in the perineum, testicles, tip of penis, pubic or bladder area, dysuria, ejaculatory pain, incomplete emptying, urinary frequency), type IV-inflammation on prostate biopsy and Other-symptoms other than those listed. RESULTS: Of the 413 patients 57 were previously diagnosed with prostatitis (prevalent cases), 46 had no evidence of a prostatitis diagnosis in the medical record and 7 were treated by physicians outside of the Kaiser Permanente Northwest plan. Of the remaining 303 the distribution was 58 type I/II, 189 type III, 33 type IV and 23 Other. The incidence of physician diagnosed type III prostatitis was 3.3 per 1,000 person-years. If those with isolated urinary symptoms were excluded from analysis, the incidence decreased to 2.8 per 1,000 person-years. The mean age of those with type III prostatitis was 52.9 years (range 29 to 82). The most common presenting symptoms were dysuria, urinary frequency and perineal pain. Symptom duration at presentation was less than 3 months in 44%, 3 months or greater in 31% and unspecified in 25%. The majority (78%) of new prostatitis diagnoses was made by primary care physicians. CONCLUSIONS: These data indicate that prostatitis is commonly diagnosed in the community setting, and that type III prostatitis accounts for the majority of these diagnoses. The duration and complexity of symptoms are less than those reported in established prostatitis research cohorts. Most prostatitis diagnoses in the community are made by nonurologists.

Prevalence of interstitial cystitis symptoms in a managed care population.

PURPOSE: We calculated the prevalence of symptoms typically associated with interstitial cystitis (IC) in men and women in a managed care population in the Pacific Northwest. MATERIALS AND METHODS: International Classification of Diseases-9 based queries of the Kaiser Permanente Northwest, Portland, Oregon database were used to identify subjects with IC exclusion criteria, who were excluded from further analysis. A total of 10,000 questionnaires, including 5,000 for women and 5,000 for men, were mailed to subjects with codes indicating bladder symptoms and to those with none of the codes. The questionnaires included questions about the presence of IC symptoms and the O'Leary-Sant interstitial cystitis questionnaire. IC symptoms were defined in 2 ways, that is as 1) pelvic pain at least 3 months in duration plus urgency or frequency at least 3 months in duration and 2) the same criteria plus pain increasing as the bladder fills and/or pain relieved by urination. RESULTS: The prevalence of IC symptoms according to definitions 1 and 2 was 11.2% and 6.2% in women, and 4.6% and 2.3% in men, respectively. Symptoms were long-standing (duration greater than 1 year in 80% of cases) and bothersome (severity score 5 or greater in greater than 50%). Mean O'Leary-Sant interstitial cystitis questionnaire scores were 15.94 in subjects with definition 1 IC symptoms, 18.97 in those with definition 2 IC symptoms and 6.69 in those with no IC symptoms (p <0.001). Symptoms were most common and most severe in subjects previously diagnosed with IC. CONCLUSIONS: The prevalence of IC symptoms is 30 to 50-fold higher in women and 60 to 100-fold higher in men than the prevalence of a coded physician diagnosis of IC in the same population. Although these findings are not conclusive, they imply that IC may be significantly under diagnosed.

Prevalence and incidence of interstitial cystitis in a managed care population.

PURPOSE: We calculated the prevalence and incidence of physician diagnosed interstitial cystitis (IC) in men and women in a managed care population in the Pacific Northwest. MATERIALS AND METHODS: A computer search of the Kaiser Permanente Northwest (Portland, Oregon) database was performed for January 1998 to May 2002. The prevalence of IC in patients 25 to 80 years old was calculated using the 4 definitions of 1) patients assigned a diagnosis of IC, 2) patients assigned a diagnosis of IC without any of the consensus IC exclusion criteria, 3) patients who had also had undergone cystoscopy and 4) patients who had specifically undergone cystoscopy with hydrodistention for IC. A second database search was performed 1 year later (May 2003) to identify incident cases of IC. RESULTS: The prevalence of IC was 197 per 100,000 women and 41 per 100,000 men for definition 1, 158 per 100,000 women and 28 per 100,000 men for definition 2, 99 per 100,000 women and 19 per 100,000 men for definition 3, and 45 per 100,000 women and 8 per 100,000 men for definition 4. Using definition 2 the 1-year incidence of IC was 21 per 100,000 women and 4 per 100,000 men. The female-to-male ratio for each estimate was 5:1. CONCLUSIONS: The prevalence and incidence of interstitial cystitis is significantly higher for women and men than previously published estimates. Men account for a higher proportion of patients with IC than has previously been recognized.