Case 2: The Economics of Asthma and Role of Managed Care in Improving Outcomes (CE)

Physician Credit

Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the University of Cincinnati. The University of Cincinnati is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation

The University of Cincinnati designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

If you have any questions, please contact Deborah Cole - coledr@uc.edu at 513-558-2016.

Pharmacy Credit

Pharmacy Times Office of Continuing Professional Education is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This program is approved for 1.0 contact hour (0.1 CEU) under the ACPE universal program number of 0290-9999-11-022-H01-P. This program is available for CE credit through April 8, 2012.

If you have any questions regarding pharmacy credits, please contact ceinfo@pharmacytimes.com.

This activity is supported by an educational grant from Merck & Co, Inc.

Case 2 : The Economics of Asthma and Role of Managed Care in Improving Outcomes

Gene L. Colice, MD

Director of Pulmonary, Critical Care, and Respiratory Services

Washington Hospital Center

Washington, DC

Gene L. Colice, MD reports consultancy, advisory board, and speaker’s bureau assignments from Abbott, Boehringer Ingelheim, Genentech, GlaxoSmithKline, MedImmune, Pearl Therapeutics, Pfizer, and Teva.

The planning staff from the University of Cincinnati, The American Journal of Managed Care, and the Pharmacy Times Office of Continuing Professional Education have no relevant financial relationships to disclose.

Activity Overview

Asthma still exacts a severe national burden through patient morbidity and mortality, rising healthcare costs, and employee absenteeism. There is a need to improve the management of asthma to improve outcomes and alleviate the burden on the patient and healthcare system. This activity will provide managed care healthcare professionals an overview of the unmet needs in asthma, discuss the pharmacoeconomic implications of therapy as they relate to clinical outcomes, and identify strategies that can help improve patients and providers achieve asthma control.

Please note the case presentation and supporting material have been created to be an engaging CE activity, and as such the case and questions will appear throughout. These questions are provided for your reference to be able to relate material presented back to a patient case presentation, and are not answerable on the case page. To answer the questions you will need to go to the posttest section, which will again reiterate the questions and provide you the opportunity to answer them.

How to Obtain Credit:

To receive your CE certificate, participants must view the entire activity online, complete the online 10‐ question posttest with a score of 70% or better, and complete the evaluation form. After successful completion of the online posttest and evaluation form, participants may immediately print their certificates.

Release Date: April 8, 2011

Expiration Date: April 8, 2012

Estimated time to complete: 1 hour

Type of Activity: Application

Targeted Audience:

This activity is designed for medical directors, pharmacy directors, and other managed care professionals who oversee the care of patients with asthma.

Educational Objectives

After completing this activity, the participant should be able to:

• Describe the significance of unmet needs among people with asthma and elucidate contributing factors to poor asthma control
• Discuss the pharmacoeconomics of asthma therapy as it relates to clinical outcomes
• Identify strategies for improving asthma control

Economics of Asthma Therapy

Approximately 23.3 million Americans have asthma.¹ In 2010, costs were estimated at $5.5 billion for hospital care, $5.9 billion for prescription care, and $4.2 billion for physicians’ services.¹ Numerous studies have evaluated the clinical and economic aspects of asthma interventions and policies.² The general consensus is that appropriate use of inhaled corticosteroids (ICSs) is cost-effective. Further, appropriate use of the combination of an ICS plus a long-acting beta₂-agonist (LABA) is also considered cost-effective.^3-5 One study, however, has suggested that higher-dose ICS therapy plus a LABA may not be cost-effective.⁶ In this study, low-dose ICS therapy plus a LABA (100 or 250 μg fluticasone plus 50 μg salmeterol) and high-dose ICS therapy plus a LABA (500 μg fluticasone plus 50 μg salmeterol) was compared with the next best alternative treatment. Patients receiving the lower dose combination had better asthma control, while patients given the higher dose did not fare much better than patients in a control group who received other medications.

The addition of omalizumab may also be cost-effective for patients with severe, unstable allergic asthma.⁷ The British-based National Institute for Health and Clinical Excellence recently published a health technology assessment of omalizumab, and suggested that omalizumab may be cost-effective for patients with certain characteristics including severe, unstable allergic asthma and past severe asthma exacerbations.⁸

One of the problems with cost-effectiveness studies is that they often do not take adequately into account the high level of noncompliance that exists in the asthma patient community. There are numerous reasons for noncompliance. Patients may simply forget to take their medications, or they may not be able to complete recommended environmental control measures such as removing the carpeting in their house or avoiding outdoor work during high pollen season. In addition to these situations, there are many other potential barriers to good adherence (Table).⁹

Factor

Comments

Gender

· Females typically more nonadherent; sex difference disappears with increasing age

Ethnicity

· African Americans are at higher risk for nonadherence, even when controlling for socioeconomic status

Socioeconomic status

· Income is inversely proportional to adherence

· Living in a neighborhood with high crime increases risk of nonadherence

Age

· The risk of nonadherence increases with age

Psychological issues

· Depression, depressive symptoms, anxiety, emotional issues, cognitive and behavioral problems all worsen adherence

Fear

· Fears of side effects, the “medical establishment,” and being labeled with a chronic disease increase nonadherence risk

Misperception

· Patients do not understand role of controller medications

Patient preferences and personality traits

· Patients with tendencies to seek information and have control in medical decision making are less likely to adhere to controllers

Disease severity

· Patients with less severe disease are less likely to be adherent

Reprinted with permission from Howell G. J Asthma. 2008;45(9):723-729.

The full extent to which poor adherence impacts overall asthma burden and costs is not certain. However, a recent study by Navaratnam et al illustrates the problem that poor adherence can have on asthma control and overall costs, even in patients with mild forms of asthma. In a year-long analysis of claims submitted by patients with mild asthma, patients were categorized as being high control ⁄ high adherence (no exacerbations ⁄ >60% days of recorded ICS use; n = 483) or low control ⁄ low adherence patients (exacerbations reported ⁄ <60% days of recorded ICS use; n = 258).10 Compared with the low control⁄low adherence group, the high control ⁄ high adherence group had fewer asthma treatment days (3.9 vs 2.9, respectively; P <.0001) and lower overall asthma charges ($3345 vs $2655, respectively; P <.0001) in the post-index period (365 days after first ICS prescription fill). The high control ⁄ high adherence group had higher pharmaceutical-related charges ($1085) than the low control ⁄ low adherence group ($129) (P <.0001), but overall charges were smaller due to the reduced need for inpatient and outpatient care.¹⁰

Treatment adherence is critical for asthma control, and it is stressed throughout the guidelines developed by the National Asthma Education and Prevention Program (NAEPP). The guidelines promote education, adherence, and a step-wise approach to treatment (ie, step-up and step-down regimens).¹¹

Proper adherence to treatment guidelines is also cost-effective, as shown in the Gaining Optimal Asthma ControL (GOAL) trial. This randomized, controlled trial suggested that step-up treatment with ICS/LABA therapy achieved guideline-derived asthma control in a majority of patients.¹² The step-up based intervention was also found to be cost-effective.¹³ The question still remains as to how disease management programs and other medical policies developed by managed care organizations can replicate the GOAL trial intervention or others at the patient level, and whether similar effectiveness and cost-effectiveness would be observed in the real world (where patients are generally less adherent to the guidelines).

CASE STUDY

A 19-year-old male with moderate, persistent asthma made an appointment with his primary care physician and asked for a prescription renewal of his SABA. The patient has been taking ICS monotherapy for the past 3 years to control his asthma with moderate success. However, the patient confessed that he has not been very compliant with therapy in the past, and it was only recently that he started having more severe asthma symptoms and has become more compliant with therapy.

1) The GOAL trial used a step-up approach to treatment that mirrors the guidelines. That trial found the step-up approach to therapy to be clinically effective but not cost-effective.

a) True

b) False

2) Based on study results, which therapeutic regimen has the least support for cost-effectiveness?

a) ICS monotherapy

b) ICS plus a LABA

c) Omalizumab

d) High-dose ICS therapy plus a LABA

3) In 2010, the estimated cost of hospital care related to asthma was:

a) $4.2 billion

b) $5.5 billion

c) $5.9 billion

d) Over $10 billion

4) Which of the following is associated with poor patient adherence to asthma treatment?

a) Mild asthma

b) Low income

c) Depression

d) All of the above

5) Overall asthma-related costs were determined to be greater in patients with high asthma control and high adherence.

a) True

b) False

Managed Care Plans and Improving Control

Asthma treatment should be considered a team effort, and each member of the team (eg, patient, physician, nurse educator, pharmacist, and managed care representative should be aware of the many factors that are involved in controlling asthma. Therefore, a good managed care program should give all persons involved in treatment an opportunity to actively contribute. Many well-designed, education-based interventions are considered cost-effective by their authors, but it can be difficult to put policy interventions into practice.

Whatever overall asthma management plan is in place, it should follow evidence-based guidelines. For example, Dall et al¹⁴ conducted an extensive evaluation of the effectiveness of a voluntary disease management program for patients in the military health system. They determined that a disease management program should result in: (1) reduced emergency and hospital services; (2) appropriate use of medical visits and pharmacologic agents; (3) reduced annual per capita medical expenditures; and (4) increased overall satisfaction with the program, including the perception that the program helped increase patients’ understanding of disease, self-management skills, and quality of life. Interestingly, after examining the medical claims from over 23,000 patients with asthma, they found that enrollment in a disease management program reduced annual medical cost by $453 per patient.

Ramos et al initiated a managed care program designed to reduce costs.¹⁵ They noted that the majority of costs were from a minority of patients, and most of their resources were attributed to those “high utilizing” patients. In this program, a strong focus was placed on patients who have not been able to successfully control their asthma. Their plan encouraged the use of costly additions such as an asthma case manager and/or a house inspection by an environmental specialist for patients who continue to have poor asthma control.

Another study that examined the costs associated with a managed care program was conducted by Cloutier et al.¹⁶ They assessed the return on investment for a 3-year asthma management program (“Easy Breathing”) among children living in a poor urban setting (n = 3298). Startup costs for the program were $28.95 per child for the first year; continuing operating costs were $10.28 per year per child for the last 2 years. The authors determined that if Medicaid managed care plans were charged $10.28 per child with asthma per year, at-risk health plans would save $26.44 per child with asthma each year. The potential return on investment for years 2 and 3 was calculated to be $3.58 per US dollar spent. It should be noted, however, that not all managed care programs are deemed successful.¹⁷ Polisena et al found that their asthma action plan was associated with greater costs compared with a control group without demonstrating superior outcomes. Furthermore, managed care plans must be flexible to allow for changes in guidelines and preferred medications and also assess asthma outcomes, such as asthma control, when possible.

The accompanying case study should illustrate that a patient with asthma exacerbations may often have multiple factors that contribute to the worsening condition, and multiple factors that may impede adherence to treatment.

CASE STUDY (continued)

The patient started his second year of college 3 months ago and began living in an older apartment building with 4 roommates. Two months ago, he noticed his lungs felt “tighter” and he began to use his ICS therapy more regularly. While the increased use of his ICS relieved symptoms temporarily, over the past month he started using his rescue inhalant (ie, SABA) much more frequently— 3 or 4 times daily (previously he only had to use it 1 or 2 times per month). He suspects that the stress of school, along with the dirty apartment, has exacerbated his asthma. He is doubtful that his landlord or his roommates will be very helpful in making the apartment and the building cleaner. He currently has 9 months left on his lease.

6) If environmental and stress factors have been controlled and the symptoms persist, the patient may benefit from:

a) Step-wise decrease in pharmacologic therapy

b) A consultation with an asthma specialist

c) Change from a SABA to another recue inhalant, such as an anticholinergic

d) All of the above

7) Which of the following likely aggravated this patient’s asthma?

a) Moving to new apartment

b) Dust and particulates

c) Stress

d) All of the above

8) For this patient, an educational brochure on how to clean a house and how to limit exposure to dust mites, pollen, and mold would be sufficient to improve his asthma.

a) True

b) False

9) A good disease management program for asthma should:

a) Reduce utilization of medical and related emergency services

b) Reduce annual medical expenditures

c) Help patients decrease allergen and irritant exposures in the home and workplace

d) All of the above

10) Because a majority of the costs of asthma can be attributed to a minority of patients, some managed care plans may opt to provide extra care and incentives for those “high cost” patients.

a) True

b) False

Educational Disclaimer:

Continuing professional education (CPE) activities sponsored by Pharmacy Times Office of CPE are offered solely for educational purposes and do not constitute any form of professional advice or referral. Discussions concerning drugs, dosages, and procedures may reflect the clinical experience of the author(s) or they may be derived from the professional literature or other sources and may suggest uses that are investigational in nature and not approved labeling or indications. Participants are encouraged to refer to primary references or full prescribing information resources.

The author(s), reviewer(s), and editor(s) have made extensive efforts to ensure that the information including treatments, drugs, and dosage regimens is accurate and conforms to the standards accepted at the time of publication. However, healthcare professionals should always consult additional sources of information and exercise their best professional judgment before making clinical decisions of any kind. In particular, the reader is advised to check the product information provided by the manufacturer of a drug product before prescribing or administering it, especially if the drug is unfamiliar or is used infrequently.

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Instructions

After reading “Case 2: The Economics of Asthma and Role of Managed Care in Improving Outcomes,” select the 1 best answer to each of the posttest questions.

A statement of continuing education hours will be provided to those physicians and pharmacists who successfully complete and return the answer form and program evaluation and receive a passing grade of 70% or higher.

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References:

1. American Lung Association. Trends in asthma morbidity and mortality: February 2010. http://www.lungusa.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf. Accessed January 25, 2011.
2. Campbell JD, Spackman DE, Sullivan SD. Health economics of asthma: assessing the value of asthma interventions. Allergy. 2008;63(12):1581-1592.
3. Akazawa M, Stempel DA. Single-inhaler combination therapy for asthma: a review of cost effectiveness. Pharmacoeconomics. 2006;24(10):971-988.
4. Shih YC, Mauskopf J, Borker R. A cost-effectiveness analysis of first-line controller therapies for persistent asthma. Pharmacoeconomics. 2007;25(7):577-590.
5. Shepherd J, Rogers G, Anderson R, et al. Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and over. Health Technol Assess. 2008;12(19):1-254.
6. Campbell JD, Borish L, Haselkorn T, et al. The response to combination therapy treatment regimens in severe/difficult-to-treat asthma. Eur Respir J. 2008;32(5):1237-1242.
7. CampbellJD, Spackman DE, Sullivan SD. The costs and consequences of omalizumab in uncontrolled asthma from a USA payer perspective. Allergy. 2010;65(9):1141-1148.
8. National Institute for Clinical Excellence. NICE technology appraisal guidance 133: omalizumab for severe persistent allergic asthma; 2007. www.nice.org.uk/TA133. Accessed January 28, 2011.
9. Howell G. Nonadherence to medical therapy in asthma: risk factors, barriers, and strategies for improving. J Asthma. 2008;45(9):723-729.
10. Navaratnam P, Friedman H, Urdaneta E. The impact of adherence and disease control on resource use and charges in patients with mild asthma managed on inhaled corticosteroid agents. Patient Prefer Adherence. 2010;4:197-205.
11. National Heart, Lung, and Blood Institute. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. August 2007. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. accessed March 2, 2011.
12. Bateman ED, Boushey HA, Bousquet J, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004;170(8):836-844.
13. Briggs AH, Bousquet J, Wallace MV, et al. Cost-effectiveness of asthma control: an economic appraisal of the GOAL study. Allergy. 2006;61(5):531-536.
14. Dall TM, Askarinam Wagner RC, Zhang Y, Yang W, Arday DR, Gantt CJ. Outcomes and lessons learned from evaluating TRICARE's disease management programs. Am J Manag Care. 2010;16(6):438-446.
15. Ramos C, Ciaccio C, Portnoy JM. Asthma control is enhanced when health plans and providers cooperate. Pediatr Ann. Mar. 2009;38(3):135-142.
16. Cloutier MM, Grosse SD, Wakefield DB, Nurmagambetov TA, Brown CM. The economic impact of an urban asthma management program. Am J Manag Care. 2009;15(6):345-351.
17. Polisena J, Tam S, Lodha A, Laporte A, Coyte PC, Ungar WJ. An economic evaluation of asthma action plans for children with asthma. J Asthma. 2007;44(7):501-508.

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