Focused review: ropivacaine versus bupivacaine for epidural labor analgesia.

Neuraxial analgesia is frequently administered to women in labor. For many years, bupivacaine has been used because of its long duration of action, lack of excessive motor block, and minimal fetal and neonatal effects. However, bupivacaine is one of the most cardiotoxic local anesthetics in current use and motor block is still a problem. Many local anesthetics such as bupivacaine exist in 2 forms, levorotatory and dextrorotatory. Ropivacaine, an amide local anesthetic produced in the pure levorotatory form addresses some of the concerns related to bupivacaine. In this article, we present the literature comparing ropivacaine and bupivacaine to determine whether there is an advantage to using one of these local anesthetics for labor analgesia. We found that there is no advantage to the routine use of ropivacaine for labor analgesia.

[Cost-efficacy analysis of fixed combinations of prostaglandin/prostamide for treating glaucoma]. / Análisis coste-eficacia de las combinaciones fijas de prostaglandinas/prostamida para el tratamiento del glaucoma.

OBJECTIVE: To assess the cost-efficacy of three fixed-combination glaucoma treatments currently available in Spain [bimatoprost with timolol (BT)- Ganfort, latanoprost with timolol (LT)- Xalacom, and travoprost with timolol (TT)- DuoTrav]. METHODS: Because no studies are available that give a direct comparison of these drugs, a systematic review was carried out to assess their efficacy. Resource consumption and costs were estimated using a model of usual local practice. For each of the three drugs, average and incremental cost-efficacy ratios were determined in terms of euros per percentage point of reduction of intraocular pressure (IOP) over a three-month period. RESULTS: BT reduced IOP by 35.1%, LT by 35.0% and TT by 34.7%. Average cost-efficacy was estimated to be euro 5.34 per percentage point of IOP reduction with BT, euro 5.40 with LT, and euro 5.45 with TT. Incremental cost-efficacy (incremental cost per incremental percentage point of IOP reduction) was estimated to be euro 94.65 for LT vs. TT, and was negative for BT vs. TT and BT vs. LT, since in both cases BT was more efficacious and less expensive. CONCLUSIONS: Compared to travoprost/timolol and latanoprost/timolol, bimatoprost/timolol appears to be the most economic alternative, with equal or better efficacy and safety results.

Pharmacoeconomic analysis of prostaglandin and prostamide therapy for patients with glaucoma or ocular hypertension.

BACKGROUND: To determine monthly cost and cost effectiveness of bilateral prostaglandin/prostamide therapy for lowering intraocular pressure (IOP) in patients taking bimatoprost 0.03% (Lumigan, Allergan, Inc.), latanoprost 0.005% (Xalatan, Pfizer, Inc.), or travoprost 0.004% (Travatan, Alcon Laboratories, Inc.). METHODS: Drops in five new 2.5-mL bottles were counted and then averaged for each drug. Average retail price was determined by surveys of pharmacies. Drop count, average retail price, average wholesale price, and IOP reduction data were used to compute annual cost, and cost effectiveness (annual cost-per-mm Hg of IOP reduction) of the three drugs. RESULTS: Drops per 2.5-mL bottle averaged 113 for bimatoprost 0.03%, 84 for latanoprost 0.005%, and 83 for travoprost 0.004%. Average retail cost (2005) per bottle was $69.99 for bimatoprost 0.03%, $61.69 for latanoprost 0.005%, and $66.37 for travoprost 0.004%. The monthly retail cost of bilateral therapy was $37.92 for bimatoprost 0.03%, $44.75 for latanoprost 0.005%, and $49.25 for travoprost 0.004%. Cost effectiveness ranges were $57 to $65 per mm Hg reduction in IOP per year for bimatoprost, 0.03%, $67 to $90 per mm Hg for latanoprost 0.005%, and $74 to $84 per mm Hg for travoprost 0.004%. CONCLUSION: Bimatoprost 0.03% had the lowest monthly and annual costs and the greatest cost effectiveness for lowering IOP compared with latanoprost 0.005% and travoprost 0.004%.

Refill rates and budget impact of glaucoma lipid therapy: a retrospective database analysis.

BACKGROUND AND OBJECTIVE: Drugs in the lipid class of glaucoma medications, including bimatoprost, travoprost and latanoprost, are effective at lowering intraocular pressure. In addition to clinical efficacy, the budget impact of long-term therapy with each medication is important for patients, physicians and managed-care decision makers to differentiate between the products and make informed decisions regarding the choice of therapy. This study aimed to determine the average number of days between refills for latanoprost, travoprost and bimatoprost, and to estimate the potential effect of differences in refill rates on pharmacy budgets. METHODS: In this retrospective database analysis of pharmacy records, the dispensing patterns of patients with glaucoma lipid therapies were obtained. Patients with a pharmacy prescription for the 2.5 mL bottle of latanoprost, travoprost or bimatoprost between September 2002 and December 2002, and receiving continuous treatment defined as having at least one prescription for the same lipid agent and bottle size 1 year later between September 2003 and December 2003, were included in this study. The main outcome measures were mean number of days between refills, mean number of refills, cost per patient per year (based on the average wholesale price [AWP]), and annual refill cost differences between cohorts. RESULTS: The mean number of days between refills was 46.74 days, 53.65 days and 51.98 days for latanoprost, travoprost and bimatoprost, respectively (p < 0.0001, ANOVA). The mean number of refills per year was 7.1, 6.2 and 6.4 for latanoprost, travoprost and bimatoprost, respectively. Based on this and the AWP, the average cost per patient per year was $US435.16 for latanoprost, $US385.58 for travoprost and $US397.44 for bimatoprost. The cost savings per year if the population of patients using latanoprost (n = 79,820) used bimatoprost or travoprost instead would be approximately $US3.0-$US3.9 million. CONCLUSION: A statistically significant difference in mean days between refills was found among the three studied drugs. Latanoprost presented the highest annual cost followed by bimatoprost and travoprost.

The cost-effectiveness of bimatoprost, latanoprost and timolol in treatment of primary open angle glaucoma in five European countries.

OBJECTIVE: The objective of this cost-effectiveness analysis is to evaluate cost-effectiveness ratios of the intraocular pressure (IOP)-lowering agents bimatoprost, latanoprost and timolol in five major European countries: France, Germany, Italy, Spain and the UK. METHODS: The cost-effectiveness analysis is based on achievement of IOP targets between 13 and 18 mm Hg. Thus, the cost-effectiveness ratios express the costs of having one patient successfully achieving IOP target. The perspective of the analysis is that of the health care sector payer, including costs of medicine and costs of ophthalmologist visits. The time frame is first year of glaucoma treatment. Four treatment strategies are analysed: Timolol as first line with add-on latanoprost or bimatoprost if IOP targets are not met, and latanoprost and bimatoprost as first line with add-on timolol. RESULTS: In the UK, Spain, Italy and Germany the timolol first with add-on of bimatoprost is the least expensive treatment. This strategy dominates both strategies involving latanoprost (as add-on to timolol or as first line) in these four countries. The incremental cost-effectiveness ratio of bimatoprost first-line therapy versus timolol with add-on bimatoprost varies from each country and target (from 305 pounds sterlings to 43,720 euros per patient). In France the timolol first line and latanoprost add-on is not dominated and is the cheapest alternative. The incremental cost-effectiveness ratio of timolol with add-on bimatoprost versus add-on latanoprost lies between 71 euros and 355 euros per patient depending on target (18 and 13 mm Hg, respectively). CONCLUSION: First-line treatment of latanoprost is dominated in all countries. In four out of five countries the timolol first-line therapy with add-on latanoprost is also dominated. Based on this pharmacoeconomic analysis, the most cost-effective strategy seems to be timolol first line with add-on bimatoprost if target is not met after 3 months.

Estimated comparative costs of achieving a 20% reduction in intraocular pressure with bimatoprost or latanoprost in patients with glaucoma or ocular hypertension.

BACKGROUND: Although the probability of treatment success should be the primary factor guiding the choice of an intraocular pressure (IOP)-lowering medication, treatment cost is also important to physicians, patients and third-party payers. The objective of the present study was to compare the cost effectiveness of bimatoprost with that of latanoprost in the treatment of glaucoma and ocular hypertension. METHODS: Estimated yearly costs and cost per treatment success for bimatoprost ophthalmic solution 0.03% once daily (Lumigan), Allergan, Inc., Irvine, CA, USA) were compared with those for latanoprost ophthalmic solution 0.005% once daily (Xalatan), Pfizer, Inc., New York, NY, USA). The pharmacoeconomic model was based on medical resource costs and the percentage of patients achieving > or =20% decrease in IOP from baseline at 8:00 am, 12:00 pm and 4:00 pm after 6 months of treatment (clinical success rate). Calculations were also made using the average success rate throughout the day and the average success rate minus the percentage of patients who withdrew from treatment as a result of adverse events. RESULTS: After 6 months of treatment, the clinical success rates were significantly higher with bimatoprost than with latanoprost (p < or = 0.003). The average expected yearly cost per patient was similar for bimatoprost (US1151 dollars) and latanoprost (US1193 dollars). The cost per treatment success, however, averaged US568 dollars less with bimatoprost (US1501 dollars/success) than with latanoprost (US2069 dollars/success). This was true even when the percentage of patients who withdrew from treatment as a result of adverse events was subtracted from the clinical success rate. CONCLUSION: The greater efficacy of bimatoprost resulted in a lower cost per treatment success than was seen with latanoprost. This remained true even when responder rates were adjusted by subtracting the percentage of patients who withdrew from treatment as a result of adverse events.

Efficiency of instillation methods for prostaglandin medications.

PURPOSE: The aim of this study was to determine the most efficient methods for instillation of prostaglandin analogs. METHODS: Drops were dispensed at room temperature from 2.5-mL bottles of bimatoprost, travoprost, and latanoprost. Two determinations of drop count were each made from bottles held vertically, at a 45-degree angle, and horizontally. The total volumes of medication dispensed from each bottle were measured. RESULTS: The mean number of drops dispensed was 111.0, 105.1, and 76.1 drops for bimatoprost bottles; 81.4, 101.1, and 85.3 drops for travoprost bottles; and 94.3, 88.4, and 67.1 drops for latanoprost bottles, held vertically, at 45 degrees, and horizontally, respectively. The mean volume of medication dispensed per 2.5-mL bottle was 3.17 mL for bimatoprost, 2.54 mL for travoprost, and 3.02 mL for latanoprost. The most efficient instillation methods provided 56 days of bilateral therapy per 2.5-mL bottle for bimatoprost, 51 days for travoprost, and 47 days for latanoprost, with corresponding yearly medication costs of $408 for bimatoprost, $449 for travoprost, and $475 for latanoprost. Yearly savings of $109 to $192 could be achieved by using the most efficient instillation methods, representing 5.6 months of medication saved for patients using bimatoprost, 3.0 months for patients using travoprost, and 4.9 months for patients using latanoprost. CONCLUSIONS: Health care providers are urged to instruct glaucoma patients in the most efficient method of instillation. For bimatoprost and latanoprost, vertical instillation is recommended, with 45 degrees nearly as efficient, and for travoprost, instillation at 45 degrees is recommended.

A cost analysis of orthopedic foot surgery: can outpatient continuous regional analgesia provide the same standard of care for postoperative pain control at home without shifting costs?

BACKGROUND AND OBJECTIVES: Same-day surgery is common for foot surgery. Continuous regional anesthesia for outpatients has been shown effective but the economic impact on the perioperative process-related healthcare costs remains unclear. METHODS: One hundred twenty consecutive patients were included in this assessor-blinded, prospective cohort study and allocated according to inclusion criteria in the day-care or in the in-patient group. Standardized continuous popliteal sciatic nerve block was performed in both groups for 48 h using an elastomeric pump delivering ropivacaine 0.2 % at a rate of 5 ml/h with an additional 5 ml bolus every 60 min. Outpatients were discharged the day of surgery and followed with standardized telephone interviews. The total direct health costs of both groups were compared. Moreover, the difference in treatment costs and the difference in terms of quality of care and effectiveness between the groups were compared. RESULTS: Total management costs were significantly reduced in the day-care group. There was no difference between the groups regarding pain at rest and with motion, persistent pain after catheter removal and the incidence of PONV. Persistent motor block and catheter inflammation/infection were comparable in both groups. There was neither a difference in the number of unscheduled ambulatory visits nor in the number of readmissions. CONCLUSIONS: Day-care continuous regional analgesia leads to an overall positive impact on costs by decreasing the incidence of unplanned ambulatory visits and unscheduled readmissions, without compromising on the quality of analgesia, patients' satisfaction, and safety.

An economic evaluation of bupivacaine plus fentanyl versus ropivacaine alone for patient-controlled epidural analgesia after total-knee replacement procedure: a double-blinded randomized study.

BACKGROUND AND OBJECTIVES: Total-knee replacement (TKR) surgery is one of the most painful orthopedic procedures after surgery. Opioid has been commonly combined with a local anesthetic to improve the quality of pain relief, but the treatment has opioid-related side effects. This study compared the cost effectiveness of patient-controlled epidural analgesia (PCEA) with 0.0625% bupivacaine plus fentanyl (BF) 3 microg/mL versus 0.15% ropivacaine alone (R) during the first 48 hours after TKR procedure. METHODS: This prospective randomized double-blinded study was performed on 70 patients who underwent unilateral TKR procedure and received either BF or R after surgery. Visual analog scale (VAS) pain score at rest and upon movement, side effects, and cost of treatment were compared. RESULTS: Overall pain at rest and upon movement between groups was not significantly different (P = 0.58, 95% CI = 4.4 to -7.8 and P = 0.8, 95% CI = 6.4 to -8.2, respectively). Patients in the BF group experienced more pruritus and had more vomiting episodes than those in the R group (P = .015), whereas no difference occurred in other side effects. Nevertheless, patient satisfaction with pain management was higher in the BF group compared with that in the R group. In addition, pain treatment with bupivacaine and fentanyl was 18% less costly compared with ropivacaine alone. CONCLUSIONS: Considering the economic evaluation, we conclude that PCEA with 0.0625% bupivacaine plus fentanyl 3 microg/mL is more cost effective and provides more patient satisfaction than PCEA with ropivacaine alone. However, use of epidural ropivacaine alone causes fewer opioid-related side effects, particularly pruritus and vomiting.

Benefit-risk assessment of ropivacaine in the management of postoperative pain.

Ropivacaine is a long-acting amide-type local anaesthetic, released for clinical use in 1996. In comparison with bupivacaine, ropivacaine is equally effective for subcutaneous infiltration, epidural and peripheral nerve block for surgery, obstetric procedures and postoperative analgesia. Nevertheless, ropivacaine differs from bupivacaine in several aspects: firstly, it is marketed as a pure S(-)-enantiomer and not as a racemate, and secondly, its lipid solubility is markedly lower. These features have been suggested to significantly improve the safety profile of ropivacaine, and indeed, numerous studies have shown that ropivacaine has less cardiovascular and CNS toxicity than racemic bupivacaine in healthy volunteers. Extensive clinical data have demonstrated that epidural 0.2% ropivacaine is nearly identical to 0.2% bupivacaine with regard to onset, quality and duration of sensory blockade for initiation and maintenance of labour analgesia. Ropivacaine also provides effective pain relief after abdominal or orthopaedic surgery, especially when given in conjunction with opioids or other adjuvants. Nevertheless, epidurally administered ropivacaine causes significantly less motor blockade at low concentrations. Whether the greater degree of blockade of nerve fibres involved in pain transmission (Adelta- and C-fibres) than of those controlling motor function (Aalpha- and Abeta-fibres) is due to a lower relative potency compared with bupivacaine or whether other physicochemical properties or stereoselectivity are involved, is still a matter of intense debate. Recommended epidural doses for postoperative or labour pain are 20-40 mg as bolus with 20-30 mg as top-up dose, with an interval of >or=30 minutes. Alternatively, 0.2% ropivacaine can be given as continuous epidural infusion at a rate of 6-14 mL/h (lumbar route) or 4-10 mL/h (thoracic route). Preoperative or postoperative subcutaneous wound infiltration, during cholecystectomy or inguinal hernia repair, with ropivacaine 100-175 mg has been shown to be more effective than placebo and as effective as bupivacaine in reducing wound pain, whereby the vasoconstrictive potency of ropivacaine may be involved. Similar results were found in peripheral blockades on upper and lower limbs. Ropivacaine shows an identical efficacy and potency to that of bupivacaine, with similar analgesic duration over hours using single shot or continuous catheter techniques. In summary, ropivacaine, a newer long-acting local anaesthetic, has an efficacy generally similar to that of the same dose of bupivacaine with regard to postoperative pain relief, but causes less motor blockade and stronger vasoconstriction at low concentrations. Despite a significantly better safety profile of the pure S(-)-isomer of ropivacaine, the increased cost of ropivacaine may presently limit its clinical utility in postoperative pain therapy.

Ropivacaine.

Ropivacaine (Naropin, AstraZeneca) is a long-acting amide local anaesthetic released for clinical use in 1996. Similar to bupivacaine, ropivacaine is equally effective for s.c. infiltration, epidural and peripheral nerve block for surgery, obstetric and post-operative analgesia. Ropivacaine differs from most other amide-type local anaesthetics in that it is marketed as a pure S-enantiomer, instead of as a racemate. This feature improves the safety of ropivacaine, and, indeed, studies have shown ropivacaine to have less cardiovascular and CNS toxicity than bupivacaine. Ropivacaine is nearly identical to bupivacaine in onset, quality and duration of sensory block, but it produces less motor block. Whether or not the motor sparing effect of ropivacaine is due to a lower relative potency compared to bupivacaine is a matter of intense debate. Despite a better safety profile, the increased cost of ropivacaine may limit its clinical utility.

Cost analyses of remifentanil, mivacurium and ropivacaine - a systematic review.

Remifentanil, mivacurium and ropivacaine are the latest innovations in clinical anaesthesia and have gained increasing importance in daily practise due to their unique pharmacodynamic and pharmacokinetic properties. However, drug acquisition costs for these agents are considerably higher in most countries than for comparable substances. This review provides a systematic, critical appraisal of pharmacoeconomic studies with remifentanil, mivacurium and ropivacaine, primarily based on prospective, randomised trials. Results from analyses using cost-minimising techniques stress the issue of the higher drug acquisition costs. However, studies using a more sophisticated method (e.g., cost-effectiveness analysis) indicate comparable costs or even financial advantage in favour of the newer investigative drugs remifentanil, mivacurium and ropivacaine.

Comparison of 0.5% intrathecal bupivacaine with 0.5% intrathecal ropivacaine in the treatment of refractory cancer and noncancer pain conditions: results from a prospective, crossover, double-blind, randomized study.

BACKGROUND AND OBJECTIVES: Intrathecal (IT) administration of bupivacaine (BUP) for treatment of "refractory" pain has sometimes been associated with unacceptable side effects. This study was undertaken to determine if IT-ropivacaine (ROP) can reduce the rate and intensity of these side effects e.g., urinary retention, paresthesia, and particularly, paresis with gait impairment. A prospective, crossover, double-blind, randomized study. METHODS: Twenty-one patients were enrolled, 9 dropped out of the study, and data were analyzed from 12 patients. Patients were treated by insertion of IT tunneled nylon catheters, continuous infusion of 0.5% ROP followed by 0.5% BUP or 0.5% BUP followed by 0.5% ROP solutions from an external electronic pump. Each local anesthetic was infused for 7 days, and their order of infusion randomized. The comparative efficacy of the ROP and BUP IT infusions was assessed from the daily doses of IT ROP and IT BUP, oral and parenteral opioids, and daily scores of nonopioid analgetic and sedative drug consumption. Self-reported pain intensity (visual analogue scale [VAS] mean scores) and scores of Bromage relaxation, ambulation, nocturnal sleep pattern, rates of side-effects attributable to the IT drugs, the patients' assessment of the IT ROP v the IT BUP periods of the trial, and the comparative daily cost of IT ROP v IT BUP were recorded. RESULTS: The daily doses of the local anesthetics used were 23% higher for ROP than for BUP. Further, the daily cost was approximately equals 3 times higher for ROP than for BUP. No other significant differences between IT ROP and IT BUP were found. CONCLUSION: The results of this study do not support the hypothesis that IT infusion of 0.5% ROP has advantages over IT infusion of 0.5% BUP when administered for relief of "refractory" pain.

An adherence based cost-consequence model comparing bimatoprost 0.01% to bimatoprost 0.03%.

OBJECTIVES: Estimate the long-term direct medical costs and clinical consequences of improved adherence with bimatoprost 0.01% compared to bimatoprost 0.03% in the treatment of glaucoma. METHODS: A cost-consequence model was constructed from the perspective of a US healthcare payer. The model structure included three adherence levels (high, moderate, low) and four mean deviation (MD) defined health states (mild, moderate, severe glaucoma, blindness) for each adherence level. Clinical efficacy in terms of IOP reduction was obtained from the randomized controlled trial comparing bimatoprost 0.01% with bimatoprost 0.03%. Medication adherence was based on observed 12 month rates from an analysis of a nationally representative pharmacy claims database. Patients with high, moderate and low adherence were assumed to receive 100%, 50% and 0% of the IOP reduction observed in the clinical trial, respectively. Each 1 mmHg reduction in IOP was assumed to result in a 10% reduction in the risk of glaucoma progression. Worse glaucoma severity health states were associated with higher medical resource costs. Outcome measures were total costs, proportion of patients who progress and who become blind, and years of blindness. Deterministic sensitivity analyses were performed on uncertain model parameters. RESULTS: The percentage of patients progressing, becoming blind, and the time spent blind slightly favored bimatoprost 0.01%. Improved adherence with bimatoprost 0.01% led to higher costs in the first 2 years; however, starting in year 3 bimatoprost 0.01% became less costly compared to bimatoprost 0.03% with a total reduction in costs reaching US$3433 over a lifetime time horizon. Deterministic sensitivity analyses demonstrated that results were robust, with the majority of analyses favoring bimatoprost 0.01%. Application of 1 year adherence and efficacy over the long term are limitations. CONCLUSIONS: Modeling the effect of greater medication adherence with bimatoprost 0.01% compared with bimatoprost 0.03% suggests that differences may result in improved economic and patient outcomes.

Safety and efficacy of aliskiren in the treatment of hypertension: a systematic overview.

INTRODUCTION: Aliskiren is the first orally active direct renin inhibitor approved for the treatment of hypertension. Aliskiren's inhibitory effect on angiotensin I generation, through renin blockade, is highly specific and long-lasting (24 hours). This feature differentiates aliskiren from traditional antihypertensive drugs. AREAS COVERED: This paper reviews the results of various clinical trials which investigate the safety and efficacy of aliskiren on blood pressure (BP) reduction and clinical end points. EXPERT OPINION: Aliskiren is suitable for once-daily administration. Its antihypertensive effect is comparable or superior to that of other antihypertensive agents at recommended doses. The tolerability profile of aliskiren is placebo-like at the licensed doses of 150 and 300 mg. In particular, the discontinuation of therapy due to clinical adverse events occurs similarly among patients treated with either aliskiren or placebo. Aliskiren is not recommended in association with ACE-inhibitors or angiotensin II receptor blockers in patients with type 2 diabetes and renal impairment. Pending disclosure of full results, the early termination of the ALTITUDE seems to confirm previous concerns about the safety of the dual pharmacological blockade of the renin-angiotensin system in these patients. Aliskiren is a well-tolerated antihypertensive drug that may help to achieve the recommended targets of BP control.

Failure to intensify hypertension therapy after rejected aliskiren claims.

BACKGROUND: Failure to intensify therapy when indicated is a serious problem in the management of hypertension. Patients having an antihypertensive prescription rejected because of utilization management tools may be at a high risk of failing to intensify their therapy when it is warranted. OBJECTIVE: The goal of this study was to investigate the patterns of therapy change after rejected aliskiren claims because of utilization management tools such as prior authorization, step therapy, and restrictive formulary. METHODS: A retrospective study was conducted using data from a large national pharmacy benefits manager. Patients with a rejected aliskiren claim because of utilization management and who were naive to aliskiren treatment before having a rejected aliskiren claim were included. Patients were followed up for 6 months after the initial rejected aliskiren claim to see whether there was a therapy change. Therapy change was defined as titration of old regimens, fulfillment of aliskiren, or fulfillment of a new antihypertensive medication not used previously. RESULTS: A total of 1955 patients were identified (mean age, 64.5 years; 54.4% female). Six months after having rejected aliskiren claims, 36.8% overcame the utilization management and filled aliskiren; 45.1% filled a new antihypertensive medication not used previously; and 10.8% patients titrated old antihypertensive medications. More than one quarter of patients (28.4%) had no change in their antihypertensive treatment. Logistic regression analysis revealed that patients rejected because of prior authorization (odds ratio = 4.00 [95% CI, 1.89-8.44]) or step therapy (odds ratio = 2.59 [95% CI, 1.26-5.32]) were more likely to have a therapy change compared with patients rejected because of a restrictive formulary. CONCLUSIONS: A significant number of patients had no therapy change 6 months after having rejected aliskiren claims because of utilization management tools, indicating potential clinical inertia or lack of therapy intensification in hypertension management. Patients with restrictive formularies were least likely to have a therapy change. More aggressive follow-up with patients with a rejected claim may be warranted to reduce treatment gaps.