Does a One-Size-Fits-All Cost-Sharing Approach Incentivize Appropriate Medication Use? A Roundtable on the Fairness and Ethics Associated with Variable Cost Sharing.

BACKGROUND: Tiered formularies, in which patients pay copays or coinsurance out-of-pocket (OOP), are used to manage costs and encourage more efficient health care resource use. Formulary tiers are typically based on the cost of treatment rather than the medical appropriateness for the patient. Cost sharing may have unintended consequences on treatment adherence and health outcomes. Use of higher-cost, higher-tier medications can be due to a variety of factors, including unsuccessful treatment because of lack of efficacy or side effects, patient clinical or genetic characteristics, patient preferences to avoid potential side effects, or patient preferences based on the route of administration. For example, patients with rheumatoid arthritis may be required to fail low-cost generic treatments before obtaining coverage for a higher-tier tumor necrosis factor alpha inhibitor for which they would have a larger financial burden. Little is known about stakeholders' views on the acceptability of greater patient cost sharing if the individual patient characteristics lead to the higher-cost treatments. OBJECTIVE: To identify and discuss the trade-offs associated with variable cost sharing in pharmacy benefits. METHODS: To discuss the trade-offs associated with variable cost sharing in pharmacy benefits, we convened an expert roundtable of patient, payer, and employer representatives (panelists). Panelists reviewed background white papers, including an ethics framework; actuarial analysis; legal review; and stakeholder perspectives representing health plan, employer, and patient views. Using case studies, panelists were asked to consider (a) when it would be more (or less) acceptable to require higher cost sharing; (b) the optimal distribution of financial burdens across patients, all plan members, and employers; and (c) the existing barriers and potential solutions to align OOP costs with medically appropriate treatments. RESULTS: Panelists felt it was least acceptable for patients to have greater OOP costs if the use of the higher-cost treatment was due to biological reasons such as step therapy (6 = unacceptable, 9 = neutral, 2 = acceptable) or diagnostic results (5 = unacceptable, 10 = neutral, and 2 = acceptable). In contrast, panelists felt it was more acceptable for patients to pay greater OOP costs when treatment choice was based on preferences to avoid a side-effect risk (1 = unacceptable, 3 = neutral, and 13 = acceptable) or the route/frequency of administration (1 = unacceptable, 1 = neutral, and 15 = acceptable). Five guiding principles emerged from the discussion: When patients have tried lower-cost therapies unsuccessfully, the benefits of higher-cost treatments were certain and significant, the cost difference between treatments was aligned with improved benefits, and penalties due to bad luck were mitigated, then cost-sharing differences should be minimized but not eliminated. CONCLUSIONS: Patient OOP costs can affect the use of both inappropriate and appropriate medications. This study identified 5 guiding principles to determine when it was more (or less) acceptable for patients with the same or similar conditions to have different OOP costs. Barriers that hinder the alignment of care and patient cost sharing exist. Policies that facilitate the alignment of patient cost sharing with appropriate care are needed. DISCLOSURES: Funding for this roundtable was provided by the National Pharmaceutical Council (NPC). Graff and Dubois are employed by the NPC. Shih was employed by the NPC at the time of this study. Barker, Dieguez, Sherman, and Larson received consulting fees for participation in this study. Larson also reports receiving grants and other payment from multiple major pharmaceutical manufacturers outside of this study. The NPC employees developed the study design and chose the case studies in collaboration with the white paper authors. The roundtable was facilitated by Dubois, and the meeting summary and manuscript were written by Graff and Shih, with revisions by all roundtable participants. The abstract for this article was previously presented as a poster at the following meetings: Stakeholder perspectives on balancing patient-centeredness and drug costs in the design of pharmacy benefits. Presented at: Academy of Managed Care Pharmacy 27th Annual Meeting & Expo; San Diego, California; April 8, 2015. Considering efficiency and fairness in the design of prescription drug benefits: seeking a balanced approach to improve patient access to medically appropriate medication and manage drug costs. Presented at: AcademyHealth Annual Research Meeting; Minneapolis, Minnesota; June 15, 2015. Study concept and design were contributed by Shih, Dubois, and Graff, along with Barker and Dieguez. Barker and Dieguez took the lead in data collection, assisted by Graff, Shih, and Dubois. Data interpretation was performed by Shih, Larson, Sherman, and Graff, with assistance from Dubois. The manuscript was written and revised by Graff and Shih, with assistance from the other authors.

Beyond the cost of biologics: employer survey reveals gap in understanding role of specialty pharmacy and benefit design.

BACKGROUND: Advances in biotechnology have led to the development of many new medical therapies for a variety of diseases. These agents, known as biologics or specialty drugs, represent the fastest-growing segment of pharmaceuticals. They have often proved effective in cases where conventional medications have failed; however, they can cost up to $350,000 per patient annually. Employers sponsor a significant proportion of plans that provide healthcare benefits, but surveys on benefit coverage have neglected to measure employers' understanding of these drugs or their use. OBJECTIVE: To establish a baseline understanding of specialty pharmacy drug benefit coverage from the perspective of the employer (ie, commercial benefit plan sponsors). METHODS: The Midwest Business Group on Health (MBGH), a Chicago-based, nonprofit coalition of more than 100 large employers, in collaboration with the Institute for Integrated Healthcare, conducted a national web-based survey to determine the extent of employer understanding of specialty pharmacy drug management. MBGH, along with 15 business coalitions nationwide, distributed the survey to their employer members. A total of 120 employers, representing more than 1 million employee lives, completed the survey online. The results were then analyzed by MBGH. RESULTS: Of the 120 employers surveyed, 25% had "little to no understanding" of biologics, and only 53% claimed a "moderate understanding" of these agents. When asked to rank the effectiveness of biologics-related disease management support for their employees, 45% of the participating employers did not know whether productivity had increased, and 43% did not know whether their employees had experienced increased quality of life as a result of taking these drugs. The majority (76%) of employers continued to rely heavily on print medium to communicate with their covered population. Overall, the vast majority of employers (78%) claimed either "little to no understanding" or a "moderate understanding" of specialty pharmacy. CONCLUSIONS: That the majority of employers admit they do not understand specialty pharmacy indicates that efforts are needed to fill in this knowledge gap to enable employers to design useful or appropriate drug benefit programs and manage them more effectively to control costs and optimize their employees' healthcare outcomes. Efforts to educate employers will require continued evaluation to ensure an effective communication between them and their employees while this area of medicine continues to grow.

Menopausal symptom perception and severity: results from a screening questionnaire.

BACKGROUND: Although it is widely acknowledged women experience symptoms during their transition from reproductive to postreproductive stage, there is inconsistency as to the prevalence of symptoms as well as their severity ratings. AIM AND OBJECTIVES: The purpose of this study was to describe symptom perception and severity in mid-life women volunteering for an intervention study for menopause symptom management. DESIGN: A cross-sectional descriptive design was used to provide data on presenting symptoms in a sample of women negotiating the menopausal transition. METHODS: A community-based sample of Caucasian women aged 43-55 years was recruited from national nursing media, local media and a variety of local community sources. A screening questionnaire was administered to determine qualification for study entry based upon symptom severity scores from the questionnaire. This report includes results from the screening questionnaire. RESULTS: One hundred and sixty-five women were screened to obtain 110 qualified participants with mean age of 49.3 SD 3.04 years who were 4.7 SD 7 months past their last menstrual period. Sleep difficulties, forgetfulness and irritability were perceived by the highest number of women while sleep difficulties, night sweats, irritability and forgetfulness were rated the most severe. CONCLUSIONS: Findings from this study expand understanding of the menopause symptom experience, because few reports include symptom severity reports. All aspects of the symptom experience are necessary to develop appropriate interventions and to evaluate them. RELEVANCE TO CLINICAL PRACTICE: Providing education about menopause symptoms is central to nursing practice of mid-life women. Therefore, nurses must keep abreast of current knowledge to prepare women for their transition to postreproductive phase or to reassure women who are surprised to find hot flashes are not the only symptoms encountered.