Managed care considerations for the treatment of chronic cough.

Chronic cough (CC), defined as a daily cough lasting longer than 8 weeks in adults, is a common condition in the United States. CC is a diagnosis of exclusion associated with a substantial economic burden related to increased healthcare and medication utilization, decreased work productivity, a greater incidence of cough-related comorbidities, and reduced quality of life. CC treatment guidelines recommend stepwise treatment with specific nonpharmacologic therapies and pharmacologic agents. However, many patients may still have incomplete or no symptom relief, encounter response attenuation over time, or experience intolerable adverse effects. New targeted therapies for refractory CC are currently under development, including the purinergic 2X3 receptor antagonists gefapixant, BLU-5937, and sivopixant (S-600918) and the neurokinin-1 receptor antagonist orvepitant. These targeted agents may have improved efficacy and safety profiles, helping fill unmet treatment needs. If approved, managed care organizations must develop formulary placement and utilization management criteria based on clinical guideline recommendations, expert opinion, and cost-effectiveness analyses to support the clinically appropriate use of these targeted therapies for best patient outcomes.

Reducing economic burden and improving quality of life in pulmonary arterial hypertension.

Pulmonary arterial hypertension (PAH) is a rare, progressive disorder associated with a poor prognosis if not treated appropriately. Fortunately, new treatment options have significantly improved survival rates and prognosis. Despite these advances, many patients do not receive the diagnosis until years into their disease or are inappropriately diagnosed. Early referral to specialized treatment centers that allows for early diagnosis and initiation of treatment significantly improves patient outcomes including survival as well as reduction in hospital admissions, which are a main driver of economic burden of disease. It is important that evidence-based guidelines are followed and treatment is individualized based on patient-specific factors. Pharmacologic therapies carry a very high cost for PAH; however, extensive utilization of management strategies may hinder access to medication and may lead to disease progression. Cost containment strategies may help to facilitate care coordination for earlier diagnosis and initiation of treatment, adherence to PAH medications, and patient education to ensure they are using medications appropriately to optimize therapy. Managed care pharmacists can play a crucial role in the multidisciplinary team in terms of medication safety, adherence, patient education, and follow-up to improve patient engagement that leads to improved outcomes.

Wixela Inhub: A Generic Equivalent Treatment Option for Patients with Asthma or COPD.

PURPOSE: The purpose of this review is to discuss the development of Wixela™ Inhub™, a generic equivalent of Advair Diskus®, a fixed-dose combination of fluticasone propionate/salmeterol powder for oral inhalation for patients with asthma whose symptoms are not controlled with inhaled corticosteroids alone and for those with chronic obstructive pulmonary disease (COPD) who are at a high risk for exacerbations. We provide an overview of the Inhub device and the bioequivalence studies that have been conducted to date. Briefly, the in vitro performance, improvements in forced expiratory volume in 1 s, and the fluticasone propionate/salmeterol dose strengths for Wixela Inhub and Advair Diskus were comparable. CONCLUSION: The bioequivalence demonstrated by the totality of clinical and in vitro data supports the use of Wixela Inhub and provides a treatment option for patients with asthma or COPD.

The Wixela™ Inhub™ device has been developed as a generic equivalent of Advair Diskus^®, and provides a combination treatment for patients with asthma whose symptoms are not controlled with inhaled corticosteroids alone and for those with chronic obstructive pulmonary disease (COPD) who are at a high risk for exacerbations. We provide information about the Inhub device and studies conducted to show how Inhub and Diskus are comparable products. Based on the similar results between the two devices, Inhub can be used as a treatment option for patients with asthma or COPD.

Topical (local) antibiotics for respiratory infections with sore throat: An antibiotic stewardship perspective.

WHAT IS KNOWN AND OBJECTIVE: The overuse and misuse of antibiotics, especially for viral, and self-limiting, respiratory tract infections such as sore throat, increases the risk of the development and spread of antimicrobial resistance within communities. Up to 80% of sore throat cases have a viral aetiology, and even when the infection is bacterial, most cases resolve without antibiotics. However, antibiotics are still frequently and often inappropriately prescribed for the treatment of sore throat. Furthermore, topical (local) antibiotics for treatment of sore throat are widely available over the counter. The objective of this systematic review was to establish the evidence for the benefits, risk of harm and antimicrobial resistance associated with topical (local) antibiotics used for patients with sore throat. METHODS: Eligible studies included those in patients with sore throat of any aetiology receiving the topical (local) antibiotics tyrothricin, bacitracin, gramicidin or neomycin where the antibiotic was topically/locally applied via the nasal cavity or throat. Nasal applications were included as these are occasionally used to treat upper respiratory tract infections that may involve sore throat. There was no restriction or requirement regarding comparator. The outcomes of interest included efficacy, safety, and in vitro culture and antimicrobial resistance data. RESULTS AND DISCUSSION: This systematic review found sparse and mainly poor-quality evidence relating to the use of topical (local) antibiotics for sore throat, and it was not possible to establish the benefits, risk of harm or impact of use on antimicrobial resistance. WHAT IS NEW AND CONCLUSIONS: Further research is necessary to ascertain the risks and benefits of topical (local) antibiotics, their contribution to antimicrobial resistance and the risk of harm. We do, however, question whether it is appropriate and rational to use topical (local) antibiotics for the treatment of sore throat caused by respiratory tract infections in the absence of robust evidence.

The Challenge of Variable Costs in Decisions Based on Cost-Effectiveness Evidence: A Case Study for Brodalumab.

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.

Defining Value in Cancer Care: AVBCC 2013 Steering Committee Report.

The AVBCC Annual Meeting experiences exponential growth in attendance and participation as oncologists, payers, employers, managed care executives, patient advocates, and drug manufacturers convened in Hollywood, FL, on May 2-5, 2013, for the Third Annual Conference of the Association for Value-Based Cancer Care (AVBCC). The conference presented an all-inclusive open forum for stakeholder dialogue and integration across the cancer care continuum, facilitating an open dialogue among the various healthcare stakeholders to align their perspectives around the urgent need to address value in cancer care, costs, patient education, safety, outcomes, and quality. The AVBCC 2013 Steering Committee was held on the first day of the conference to define value in cancer care. The committee was divided into 7 groups, each representing a key stakeholder in oncology. The goal of the Steering Committee was to define value from the particular point of view of each of the stakeholder groups and to suggest how that particular perspective can contribute to the value proposition in oncology, by balancing cost, quality, and access to care to improve overall patient outcomes. The following summary highlights the major points addressed by each group.

Health plan pharmacy director: considerations for treatment and management of RSV disease.

RSV immunoprophylaxis presents a challenge for MCOs. Despite its demonstrated ability to protect high-risk infants against serious RSV infection and to reduce morbidity, immunoprophylaxis with palivizumab incurs high costs that MCOs must grapple with every year. If MCOs, physicians, and professional organizations can agree on common guidelines for RSV management, then MCOs will be able to provide affordable treatment for those children at high risk.

Prevalence and economic implications of chronic pain.

Chronic pain is a major public health issue that affects the quality of life and productivity. It is costly and has a significant impact on health resource utilization. Management of chronic pain requires a multidisciplinary approach that focuses on disease management and takes into account the need for ongoing support by family members and other caregivers. Managed care pharmacies can play an important role in pain management to effect positive outcomes and reduce health resource utilization.

The use of therapeutic interchange for biologic therapies.

Therapeutic interchange is the practice of switching or dispensing drugs that are chemically distinct but therapeutically similar in terms of their efficacy, safety, and tolerability profiles. The stated goal of therapeutic interchange is to achieve an improved or neutral outcome with the new agent while reducing overall treatment costs. Until recently, most interchange programs have been limited to switches within drug classes, such as angiotensin-converting enzyme (ACE) inhibitors, proton pump inhibitors (PPIs), HMG-CoA reductase inhibitors (statins), and selective serotonin reuptake inhibitors (SSRIs), and generally to drugs that use the same routes of administration. Therapeutic interchange now is being applied to some biologic agents, such as those used to treat psoriasis and rheumatoid arthritis (RA). In some cases, these agents differ in structure and mode of administration. Patients who require a biologic agent are often difficult to manage, and the comorbidities that are prevalent in these patients further complicate management and agent selection. Population-based outcomes among various agents may not appear notably different, but because there is no a priori means to determine the effects of a given biologic agent on any individual patient, therapeutic interchange is inadvisable once a patient receiving RA or psoriasis therapy has been stabilized. However, if a biologic agent has been designated as preferred on a formulary, it is reasonable to initiate treatment with that agent in a patient who is naive to biologic therapy if that agent is not contraindicated. Respectful, two-way communication between health care professionals and managed care organizations (MCOs) will help ensure that a patient receives the appropriate therapy at the right time.