American Health and Drug Benefits最新文献

Background: Corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIG) have been standard-of-care treatments for chronic inflammatory demyelinating polyneuropathy (CIDP) for more than 2 decades. Despite guideline recommendations for best clinical practices, heterogeneity in patient presentation and the course of treatment for CIDP remains. There is limited literature regarding the real-world treatment patterns of and costs associated with CIDP.

Objective: To analyze and describe the real-world treatment patterns of and economic burden associated with CIDP.

Methods: This retrospective cohort study evaluated the treatment patterns and CIDP-related healthcare costs over a 2-year follow-up period for patients with newly diagnosed CIDP who had commercial insurance, using claims data from the IMS LifeLink PharMetrics Plus Claims database between 2009 through 2014. Treatment-naïve patients with newly diagnosed CIDP were evaluated for 2 years postdiagnosis, which captured the treatments used and the resource utilization. The patients were defined as receiving active CIDP therapy (ie, IVIG, immunosuppressants, oral or intravenous steroids, or plasma exchange) or active surveillance.

Results: Of the 525 patients identified with newly diagnosed CIDP, 55.2% of patients were prescribed only steroid therapy, and 25.3% of patients were prescribed an IVIG therapy during the 2-year follow-up. The median time to the initial treatment was shortest for patients receiving plasma exchange alone (0.03 months) or in combination with a steroid (0.03 months), followed by IVIG plus another therapy (0.53 months), and then IVIG alone (0.71 months). Initiating therapy with steroids alone took the longest mean time (6.51 months) to start the treatment. The median length of time to receive therapy was longest for the steroid plus plasma exchange cohort (21.8 months), followed by the steroid plus immunosuppressant cohort (10.1 months), and the 2 IVIG cohorts (9.04 months for IVIG alone and 9.82 months for IVIG plus another therapy). The mean total CIDP-specific 2-year follow-up costs were highest for the cohort that received IVIG alone ($119,928) or with an additional therapy ($133,334) and lowest for patients who received active surveillance ($3723) or steroids alone ($3101).

Conclusions: Steroid therapy was initiated later and resulted in a shorter duration of treatment than other treatment options for patients with CIDP, which may reflect diagnostic uncertainty, disease severity or remission, therapeutic challenge to determine diagnosis, or the side-effect profile of steroids. The use of steroids alone was the most common prescribed treatment for CIDP. Further research is needed to understand the rationale for treatment decisions in this patient population and their potential impact on patients and health plans.

Background: Atopic dermatitis is a chronic inflammatory skin disease that affects up to 13% of children and 10% of adults in the United States. Among patients and their families, atopic dermatitis has a considerable effect on quality of life and represents a substantial economic burden.

Objective: To describe the impact and challenges of atopic dermatitis and to provide nondermatologists in the healthcare community an enhanced understanding of atopic dermatitis to facilitate treatment and pharmacy benefit discussions.

Discussion: Atopic dermatitis is a heterogeneous disease, and its diagnosis is hampered by a lack of objective diagnostic criteria. The current management guidelines address the distinct clinical phenotypes as a single disease and do not incorporate recent clinical advances, such as the targeting of specific inflammatory processes. The treatment guidelines for atopic dermatitis are complex and challenge healthcare providers, patients, and caregivers. Novel treatments can provide additional therapeutic options for patients with atopic dermatitis.

Conclusions: Treatment options for atopic dermatitis are expanding with the development of novel anti-inflammatory therapies. An increased understanding of these advancements is necessary to optimize care for patients with atopic dermatitis.

Background: The amount of total knee arthroplasty (TKA) procedures performed in the United States has been increasing steadily and is projected to reach 3 million procedures annually by 2030 in patients aged ≥65 years. A rise in TKA procedures will increase spending on osteoarthritis treatments, which is currently the second highest category of spending for Medicare patients. Because TKA procedures account for a substantial amount of total osteoarthritis spending, payers and providers are examining methods to reduce spending on the procedure while improving clinical outcomes. Customized individually made implants have been shown to improve clinical outcomes, such as physical function and limb alignment, compared with off-the-shelf implants; however, the economic impact of customized implants has yet to be established.

Objective: To analyze TKA episode expenditures among Medicare fee-for-service (FFS) members who received a customized or an off-the-shelf implant.

Methods: Members undergoing a TKA procedure using the customized implant technology were identified in the Medicare FFS database and were propensity matched (1:5) to a cohort of members who received off-the-shelf implants. Reimbursement for the initial procedure (ie, customized and off-the-shelf procedure), a preoperative computed tomography scan, and 12-month postoperative healthcare utilization were analyzed. The overall episode expenditures were used to construct a budget impact model to calculate the per-member per-month (PMPM) spending for Medicare FFS beneficiaries.

Results: The average total episode spending was significantly lower among the customized implant cohort ($18,585) compared with the off-the-shelf implant cohort ($20,280; a $1695 difference; P <.0001). This savings resulted in $0.08 PMPM savings for the Medicare FFS program when a portion (10%) of eligible members received the customized implant technology. A sensitivity analysis, which varied with the customized implant market penetration and the percent of customized implant-eligible procedures, indicated that the savings could be as great as $0.28 PMPM.

Conclusion: The results of this analysis demonstrate that the use of customized implants in TKA procedures can achieve substantial savings versus off-the-shelf procedures for the Medicare FFS program, and this savings is primarily driven by a lower average initial procedure cost and lower postoperative spendings for inpatient services and skilled-nursing facility costs.

Background: Publicly funded prescription drug programs, such as state pharmacy assistance programs, provide critical benefits for the care of individuals, but they are frequently limited in their resources to optimize patient outcomes. The application of quality metrics to prescription drug claims may help to determine whether prescribers' adherence to national standards can be augmented through academic detailing.

Objective: To evaluate changes in diabetes drug prescribing patterns after an academic detailing educational intervention in 2013 and 2014 for prescribers in the Pennsylvania Pharmaceutical Assistance Contract for the Elderly (PACE) program.

Methods: We used a retrospective, quasiexperimental study design that applied interrupted time series and segmented regression analysis, and examined PACE pharmacy claims data for 1 year before and 1 year after the academic detailing intervention. Four diabetes prescribing metrics were evaluated at monthly intervals for a sample of 574 prescribers who received academic detailing and for a propensity score-matched comparison sample of 574 prescribers who did not receive the intervention.

Results: The prescribers who received academic detailing did not differ significantly after the intervention from the providers who did not receive the intervention in their prescribing trends for the 4 diabetes metrics. The observed time series patterns suggest that diabetes-related ceiling effects were likely, with relatively small room for improvement at the group level during the study period.

Conclusion: The results of this study did not demonstrate group differences in prescribing trends that were attributable to the intervention. However, many prescribers in the detailed group had been exposed to similar educational outreach by PACE before 2013, which limits the interpretation of this finding. In addition, the diabetes quality metrics had been the standard of care during the preceding decade, with a broad dissemination of the treatment guidelines to the provider community. These results are consistent with a ceiling effect in the measured metrics, suggesting that most prescribers in both groups were largely following core diabetes guidelines before and after the intervention.

Background: Payers often consider cost-effectiveness studies for new drugs when making decisions on coverage, formulary position, and budgets; however, cost-effectiveness studies are often calculated using estimated pricing before a drug's launch. If the drug's price changes on or after launch, or if rebate programs are initiated, cost-effectiveness studies need to be updated to prevent payers from making decisions using inaccurate value assumptions, which can lead to unexpected financial impacts and potentially delay patient access to drugs.

Objective: To evaluate how lower at-launch drug pricing versus initial estimated pricing affects cost-effectiveness ratios and potentially influences treatment decisions, using the case study of brodalumab, a biologic drug indicated for the treatment of moderate-to-severe plaque psoriasis.

Methods: We compared the estimated cost-effectiveness of brodalumab, which was published in a December 2016 Institute for Clinical and Economic Review (ICER) report based on estimated pricing, with the drug's cost-effectiveness based on its actual pricing after its approval.

Discussion: The 2016 ICER report on the cost-effectiveness of targeted immunomodulators indicated for the treatment of moderate-to-severe plaque psoriasis, brodalumab's price was estimated to be $4267 by averaging the cost of its likely competitors. Brodalumab's effectiveness as a treatment for moderate-to-severe plaque psoriasis is high in clinical trials, but its estimated cost placed it as the fourth most cost-effective targeted immunomodulatory drug in the ICER report. On its approval in February 2017, brodalumab's newly estimated base price was $3900, based on its prelaunch price. Calculations using this base price placed brodalumab as the most cost-effective option among targeted immunomodulators in this setting. At the time this current article was written, brodalumab's cost was $3500, making it even more cost-effective.

Conclusion: Because payers, providers, and patients are all concerned with achieving better outcomes for the often painful and disfiguring disease of plaque psoriasis, while controlling costs, updating cost-effectiveness data when new pricing information becomes available may reveal significant cost differences to help stakeholders make better decisions about their population's healthcare outcomes and costs.

Background: Little data exist regarding how pharmacist-led collaborative drug therapy management protocols are implemented in health systems. Barriers to collaborative drug therapy management protocol implementation exist, but they can be overcome by effective protocol education and communication, allowing pharmacists to manage more patients with chronic disease states, thereby enhancing quality health outcomes for patients and reducing health resource utilization.

Objective: To determine the preferred method of provider education regarding the implementation of a pharmacist-led type 2 diabetes collaborative drug therapy management protocol, and to assess pharmacist and provider satisfaction with the protocol implementation.

Methods: This single-center, prospective cohort study included pharmacists practicing within a pharmacist-led type 2 diabetes collaborative drug therapy management protocol, as well as providers practicing at 4 primary care clinics within a health system. All providers received an e-mail regarding education about the protocol. In addition, providers at 2 of the clinics received education about the protocol at a provider meeting, and providers at the other 2 clinics received a personalized provider report card. The personalized provider report card identified patients within the provider's panel who met criteria for referral to a pharmacist under the new protocol. The referred patients were tracked for 2 months, and provider and pharmacist satisfaction with the protocol were assessed.

Results: A total of 54 patients were referred for pharmacist management per the protocol. The majority (89%) of patients were referred by providers who received a personalized provider report card. Nearly all (96%) of the providers were satisfied with the protocol-driven services, and most (67%) pharmacists were satisfied with their role in managing patients with type 2 diabetes under the collaborative drug therapy management protocol.

Conclusion: The majority of patients with type 2 diabetes who were referred for pharmacist management per the protocol were referred by providers who received personalized provider report cards. Provider and pharmacist satisfaction with the new pharmacist-led protocol was high.

Background: Omadacycline is an oral and intravenous (IV) once-daily aminomethylcycline antibiotic that is approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). It has broad-spectrum activity against common causative pathogens of ABSSSI, including methicillin-resistant Staphylococcus aureus. Omadacycline has been shown to be noninferior to linezolid for the treatment of adults with ABSSSI across 2 phase 3 clinical trials. To date, no studies have assessed the budget impact for omadacycline in the treatment of ABSSSI.

Objectives: To estimate the potential budget impact of introducing omadacycline as a treatment option in patients who present to the emergency department (ED) with ABSSSI from the hospital perspective (Medicare payer) in the United States. The ED's and observation units were assumed to be hospital-owned.

Methods: The base case of this decision model-based analysis was conducted from the perspective of a hospital for a theoretical cohort of 1 million covered Medicare members over a 3-year time horizon. Scenario analyses included the economic impact of (1) shifting inpatient care to the outpatient setting with omadacycline and (2) reducing hospital length of stay (LOS) among hospitalized patients with omadacycline IV to oral therapy relative to the current inpatient standard of care. Costs are presented in 2017 US dollars with no adjustments for inflation, based on the cost model estimates.

Results: The annual total incremental cost following the introduction of omadacycline as a treatment of ABSSSI was $11,168, $39,918, and $88,777 in years 1, 2, and 3, respectively. The incremental cost per member treated (cost per case) rose by $0.49, $1.74, and $3.86 over 3 years. Reducing hospital LOS by 1 day among hospitalized patients with omadacycline resulted in incremental costs of $4311, $15,231, and $33,919 in years 1, 2, and 3, respectively. Under the assumption that patients may be discharged sooner when an oral formulation of the same drug with which they are being treated is available, reducing hospital LOS by 2 days reduced costs by $2546, $9455, and $20,939 in years 1, 2, and 3, respectively. Shifting inpatient care to the outpatient setting with omadacycline reduced costs by $38,777, $139,885, and $310,784 in years 1, 2, and 3, respectively.

Conclusion: This hypothetical, model-based study determined that omadacycline would result in a modest increase in total cost over 3 years when introduced as a treatment for ABSSSI in adults who present to the ED for their care.