Month: June 2021

Critical Thinking: Case Study – Cost Containment (120 points)

Choose a current event pertaining to an effort to contain costs or review this case study:

Russi, A., Chiarion-Sileni, V., Damuzzo, V., Di Sarra, F., Pigozzo, J., & Palozzo, A. C. (2017). Case study on an ipilimumab cost-containment strategy in an Italian hospital . International Journal of Technology Assessment in Health Care, 33(2), 199-205.

Your report should address the following substantive requirements:

· Description of what occurred, who was affected, and rationale

· Assessment of the case from the following perspectives:

. Health reform – illustrate how this case and your role as administrator are different now due to changes in health law and expectations from health reform.

. How cost containment plays a factor in your decision.

· Recommendations for implementation of procedures or partnerships to continue containing costs and increasing efficiency.

Your well-written report should meet the following structural requirements:

Be 5-6 pages in length, not including the cover or reference pages.

· Formatted according to Saudi Electronic University and APA writing guidelines.

· Provide support for your statements with in-text citations from a minimum of four scholarly articles in the last 5 years. Two of these sources may be from the class readings, textbook, or lectures, but two must be external.

· Use correct terminology pertaining to the law and ethics

· Utilize the following headings to organize the content in your work.

. Introduction and Description,

. Assessment,

. Recommendations, and

. Conclusion.

International Journal of Technology Assessment in Health Care, 33:2 (2017), 199–205. c© Cambridge University Press 2017 doi:10.1017/S0266462317000332

CASE STUDY ON AN IPILIMUMAB COST-CONTAINMENT STRATEGY IN AN ITALIAN HOSPITAL Alberto Russi Hospital Pharmacy, Veneto Institute of Oncology

Vanna Chiarion-Sileni Melanoma and Esophageal Cancer Unit, Veneto Institute of Oncology

Vera Damuzzo School of Hospital Pharmacy, University of Padova

Francesca Di Sarra Hospital Pharmacy, Veneto Institute of Oncology

Jacopo Pigozzo Melanoma and Esophageal Cancer Unit, Veneto Institute of Oncology

Angelo Claudio Palozzo Hospital Pharmacy, Veneto Institute of Oncology angelo.palozzo@iov.veneto.it

Objectives: Ipilimumab is the first licensed immune checkpoint inhibitor for treatment of melanoma. The promising results of the registration clinical study need confirmation in real practice and its clinical success comes together with a relevant budget impact due to the high price of this drug. The aim of this work is to describe a new model of economical sustainability of ipilimumab developed in an Italian reference center for melanoma treatment. Methods: This retrospective, observational, and monocentric study was carried out at the Veneto Institute of Oncology. Ipilimumab was administered to fifty-seven patients with advanced melanoma. Overall survival, progression free survival, and toxicity were evaluated. A local management procedure was evaluated together with the cost-saving strategies implemented by the Italian Medicines Agency (AIFA). Results: We demonstrated that the use of ipilimumab for metastatic melanoma in real practice had an efficacy and toxicity similar to that reported in the literature. In this scenario, our management model (centralization of compounding + drug-day) permitted savings up to the 11.1 percent of the gross cost for the drug (calculated assuming that no cost saving procedures were applied) while the policy of cost containment designed by AIFA produced an additional 6.2 percent of savings. Conclusions: In real practice conditions, the centralized administration of ipilimumab allows to replicate the results of clinical studies and in the meantime to contain the cost associated with this drug. The local strategy of management can be readily applied to most of the high cost drugs compounded in the hospital pharmacy. Impact of findings on practice: (i) We describe a new model of economic sustainability (drug-day, centralization of compounding, payback systems) of an expensive and innovative drug, ipilimumab, for treatment of melanoma within an Italian cancer center. (ii) This pivotal study demonstrated that a cost containment strategy is feasible and it needs the cooperation of all healthcare providers (oncologists, pharmacists, nurses, and technicians) to guarantee the full efficiency of the process.

Keywords: Cost-saving strategies, Vials-sharing, Drug-day, Oncology, Managed entry agreements

Costs containment strategies are identified as an important added value in pharmaceutical care as drugs constitute a large portion of the total health expenditure budgets. The introduc- tion of new drugs, especially biological ones, largely con- tributes to the increase of the importance of pharmaceutical budget (1;2).

In this scenario, the hospital pharmacist becomes a deci- sion maker, combining the needs that stem from the different processes of clinical care and the cost-containment poli- cies imposed by national and regional healthcare authorities. In addition, pharmacists develop local strategies of cost- containment. One of the best known strategies to meet this aim is to set up a centralization of cytotoxic drug prepara- tion: it encourages standardization processes, it guarantees a higher quality of care, and it helps to avoid medication errors, which can be fatal in the oncology ward (3). In addition, centralization reduces production wastes, is less

time-consuming, and it requires a lower number of operators exposed to chemotherapeutic drugs during the preparation process (4;5). Centralization processes became of urgent need when expensive drugs for cancer treatment entered into the market because a cost-containment policy is mandatory to guarantee the sustainability of the National Healthcare System (NHS).

A drug-day consists in handling all treatments with a deter- minate drug on one specific day of the week. This tool, when combined with centralization of compounding, optimizes the use of drug’s vials (through vial sharing), it does not require dosage modification, as compared with dose banding, and it ensures cost-savings.

In addition to the local management of compounding, these expensive drugs also trigger the need for wider eco- nomic strategies to sustain their cost. In Italy, manage- ment strategies have been developed both on a national and

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regional basis. The national point of view is held by the Ital- ian Medicines Agency (AIFA) (6). AIFA chose to keep can- cer drugs prices similar to other European countries while ne- gotiating an effective system of risk sharing/payback (Man- aged Entry Agreement) with the pharmaceutical industries (7). Hence, for each indication of a certain drug there is a specific payback system that depends either on the clinical outcome (payment-by results, risk sharing, success fee) or on a financial agreement (capping mechanism, cost-sharing) (6;8;9).

To manage this system, AIFA developed a national elec- tronic register (AIFA register) (6). The AIFA register permits the determination of whether a patient is eligible for the treat- ment, the monitoring of the use of the drug (asking periodic revaluation of outcomes), and the ascertainment of the rea- son behind treatment discontinuation (i.e. toxicity, progression, death, medical decision). The AIFA register is also an eco- nomic tool as it contains a platform used by pharmacists to request drug cost reimbursement directly from the pharma- ceutical company. This platform contains the algorithms that evaluate whether the cost of a treatment may be refunded in accordance with the payback deals negotiated by AIFA and the pharmaceutical company during the authorization process.

Therefore, the AIFA register is a tool to guarantee the ap- propriateness of the treatment, but it also permits the adjust- ment of the economic risk of each treatment.

The regional perspective described in this study is held by our regional authority (i.e., Veneto). The Veneto health policy has imposed that ipilimumab must be admin- istered in only one cancer center in Veneto region, which is our institute, the Veneto Institute for Oncology (10). In this way, the centralization of treatment compounding is ensured. This decision was prompted by the National Health System Recommendation n°14 aimed at preventing errors during preparation and distribution of cancer treat- ments.

AIM OF THE STUDY The aim of this work was to evaluate how national and local strategies may affect the containment of costs related to cancer drugs. Ipilimumab was chosen as a suitable drug for this pur- pose, because it is innovative, has a fixed schedule of treatment (four injections for each patient), it is subject to national cost- containment strategies (payback and pharmacovigilance man- aged through the AIFA register), and it has a high impact on hospital’s budget plan.

At the same time, this study represents a pilot study for an ongoing multicentric project involving twenty-one Italian hos- pital pharmacies nation-wide with the aim to investigate clin- ical and economical performances of ipilimumab in the real practice.

ETHICS APPROVAL Ethics approval was obtained from the local Ethic Committee, and all patients signed an informed consent before enrolment.

MATERIALS AND METHODS

Study Design and Patient Characteristics This study consists of a pilot observational, monocentric, retro- spective study carried-out at the Veneto Institute of Oncology (IOV), an Organisation of European Cancer Institutes accred- ited cancer center in Italy.

At first, the clinical course of the patients receiving ipili- mumab was analyzed. This preliminary step was fundamental to ensure that the improvement generated by our management model stems from a study population having a clinical behavior similar to bigger cohorts. As a result, this analogy may guaran- tee the applicability of our model in other Institutes.

The second part of the study describes the economic man- agement model applied in our institute to manage the cost of ipilimumab and how this local strategy is paralleled by na- tional cost-containment strategies. National and regional poli- cies were described previously in the Introduction while the local management, which is suitable for application at the sin- gle cancer institute level, is the focus of this study and it is a virtuous example of collaboration between different healthcare professionals.

Patients diagnosed with cutaneous, uveal, or mucosal ad- vanced melanoma (n = 57) received ipilimumab (Yervoy®) 3 mg/kg in a four cycle schedule, once every 3 weeks. Pa- tients should have previously received at least one line of chemotherapy. Patients were enrolled over 16 months from April 2013 to September 2014, and then were followed-up un- til May 2015. The patient characteristics retrieved for this study include age, gender, Eastern Cooperative Oncology Group Per- formance Status (ECOG PS), site(s) of metastatic disease, lines of prior therapy as well as the number of ipilimumab doses received, date of enrolment, and date of death. These data were obtained by the clinical pharmacist analyzing the elec- tronic medical records of patients, which constitutes a key tool for sharing information between clinical oncologists and pharmacists.

Pharmaceutical Data In our center, ipilimumab was administered following the drug- day procedure to maximize vial sharing. Indeed, patients were planned to start treatment in groups of four or more on the same day of the week. All patients were registered in the AIFA reg- ister. For each treated patient and each drug-day, we recorded the number of ipilimumab vials (Yervoy 50 mg/10 ml) actually used and the number that would have been used if the drug-day had not been established. Gross-cost represents the cost that would have been paid to treat the study population in absence of

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centralization of compounding and drug-day (representing the regional and local strategy of cost containment, respectively). Net-cost is the number of ipilimumab vials actually used. We considered ex-factory price of ipilimumab excluding taxes as approved by AIFA (11). Evaluation of payback system was per- formed subtracting the cost of the vials reimbursed from the net cost of ipilimumab therapy. In the analysis, we considered only drug-related costs, without considering other institutional direct or indirect costs, because we developed cost-containment strategies designed to reduce the economic resources reserved to drug purchase.

Efficacy and Toxicity Assessment Efficacy of ipilimumab treatment was evaluated in terms of overall survival (OS) and progression-free survival (PFS). Tu- mor assessment by spiral total body computed tomography (CT) (in case of suspected brain metastases at CT scan, a brain magnetic resonance imaging [MRI] was added) was performed at baseline and repeated at week 12, 24, and 36 according to immune related criteria (irRC). Responses were assessed ac- cording to the immune-related response criteria and classified as complete response (irCR), partial response (irPR), stable disease (irSD), or progressive disease (irPD). Laboratory tests were carried out at baseline, after 12-16-24 weeks, and then ev- ery 3 months. Toxicity was recorded at each visit graded using Common Terminology Criteria for Adverse Events (CTCAE version 4.0).

Statistical Analysis PFS and OS were calculated using Kaplan-Meier estimates from the first dose of ipilimumab to the date of progression or death by any cause, respectively. Differences in OS were esti- mated using the Log-Rank test. Differences in medians of gross and net costs of treatment were assessed using the Signed Rank Test as variables were not normally distributed. Values were expressed as median with corresponding two-sided 95 percent confidence interval. Data were considered statistically signifi- cant for p ≤ .05.

RESULTS

Patients’ Clinical Characteristics The study cohort included fifty-seven patients, among whom 53 percent were diagnosed with lung metastases (n = 30), 30 percent with liver metastases (n = 17), and 25 percent had brain metastases (n = 14). Patient characteristics are summarized in Table 1. The patients analyzed had a median age of 64.26 ± 11.57 years (range, 35–85 years) with a prevalence of males (63 percent). Most of the patients had cutaneous melanoma (n = 49): five uveal melanoma and three mucosal melanoma. Seventy-four percent of the patients completed the four cycles of ipilimumab (n = 42, 74 percent).

Table 1: Patient baseline characteristics and toxicities

N % Patients enrolled 57 Age (mean, range) 64 (35-85)

Gender Male 36 63 Female 21 37

ECOG PS 0 42 74 1 14 25 NV 1 1

BRAF mutation status mutated 17 30 WT 27 47 NV 13 23

Site of metastasis lung 30 53 brain 14 25 liver 17 30

No. of cycles received 1 4 7 2 4 7 3 7 12 4 42 74

ADR, all grades 82 ADR ADR, grade G3 8 14 Survival rate at 1 year = 41 10 24 Note. Baseline characteristics and summary of toxicities of all ipilimumab-treated pa- tients. All data are presented as number (N) and (%). EGOG PS, Eastern Cooperative Oncology Group Performance Status, primary lesion pre- sented a mutation in the V600 codon of BRAF gene (BRAF mutational status); ADR, adverse drug reaction.

An important aspect of the analysis was the percentage of patients who did not complete the treatment. Approximately a quarter (26 percent) of patients (n = 15) did not receive the four-cycles planned due to disease progression (n = 6), toxic- ities (n = 6) or death due to progression (n = 3). Of note, the cost of eight out of these fifteen patients who discontinued the treatment was eligible for payback according to a payment-by- results scheme. In particular, four patients completed the sec- ond cycle, while four received only one cycle. The main cause of discontinuation before the third dose was progression (n = 3; 37.5 percent), followed by toxicities (n = 3; 37.5 percent) and death (n = 2; 25 percent).

Efficacy and Toxicity of Ipilimumab in Real Practice In terms of efficacy, the median OS of the fifty-seven patients enrolled in our study was 12.7 months (95 percent confidence interval [CI], 8.93–16.47), with a 1-year survival rate of 50 per- cent. As the identification of predictive markers for OS in ipili- mumab therapy is an unmet need, we sought to identify whether

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Figure 1. Association between survival and ECOG PS. The possible association between survival and the EGOG PS of patients were investigated. We divided the cohort into two groups depending on the ECOG PS of patients (ECOG = 0 [n = 42] and ECOG = 1 patients [n = 14]). Difference in survival among groups was analyzed according to Log-Rank test and depicted using Kaplan-Meier curves. Statistical significance for p ≤ .05. OS: overall survival.

some of the clinical characteristics of the patients may predict survival. Albeit the number of patients enrolled is inadequate to have sufficient statistical power of prediction: nevertheless, we tried an explorative approach. To this end, patients were strati- fied on the basis of the ECOG performance status and, indeed, patients with an ECOG PS higher than 0 showed a poorer, albeit not statistically significant, survival than patients with ECOG PS equal to 0 (p = .075) (Figure 1). As some patients were treated with a BRAF inhibitor before ipilimumab, the associa- tion between BRAF mutational status and OS was investigated but no statistical difference was found (Figure 2). Finally, it was hypothesized that the metastatic site may affect the survival, but neither the presence of lung or brain metastasis alone could predict OS (Supplementary Figure 1).

The incidence of progression in the cohort of patients was also calculated. Median PFS was 4.4 months (IC 95 percent: 2.85–6.02), with a progression rate of approximately 80 percent in 12 months.

As one of the causes of treatment withdrawal is the on- set of adverse drug events (AE), the toxicity profile of ip- ilimumab treatment in our patients was also analyzed. Al- most all patients developed at least one AE, but the majori- ties were low grade toxicities easily managed with oral corti- costeroids. The most common AE were cutaneous with pru- ritus and erythema (thirty-one patients experiencing this type of AE, forty events, 49 percent of total AE) and gastrointesti- nal (thirty-one patients experiencing this type of AE, thirty-six events, 44 percent of total AE, mainly diarrhea). No grade 4 AE were recorded. Three of the eight patients experiencing high grade toxicity had to discontinue the treatment for this reason.

Figure 2. Association between survival and genetic characteristics of the tumor. Association between the presence of BRAF mutation in primary melanoma and survival of patients was assessed. Patients were clus- tered into two groups according to the mutational status of their primary melanoma: BRAF-mutated (n = 17) and BRAF wildtype (n = 27). Difference in survival among groups was analyzed according to Log-Rank test and depicted using the Kaplan-Meier curves. Statistical significance for p ≤ .05. OS: overall survival.

Pharmacoeconomic Evaluation The model of cost-management of high cost cancer therapy ex- emplified in this study relies on three levels of cost containment strategies. The first level is based on the risk sharing deal be- tween the Italian Medicines Agency and the producer. The ap- plied mechanism of payback is called payment by results (PbR) and it is applicable when a therapeutic failure is certified by the AIFA register. Eight out of fifty-seven patients of our cohort were eligible for PbR. The total cost sustained to treat these patients corresponds to the 6.2 percent of the total gross cost spent for the treatment of the entire cohort and this value was refunded by the pharmaceutical industry after the pharmacist filled out the reimbursement form in the AIFA register. The payback system significantly reduced the net-cost sustained for treatment of the study population (p = .016) (Figure 3).

The regional authority has mandated to compound and ad- minister all ipilimumab-based therapy at one cancer center in the region. Centralization of treatments is the second level of cost containment and it is necessary for the set-up of local man- agement strategies.

The local strategy of cost containment comprises three methods: planning of the stock, drug day and vial sharing. In accordance with clinical oncologists, ipilimumab treatment was planned for 1 day (drug-day) of the week, once every 21 days. For each drug-day, physicians provided the hospital pharmacy in advance with the number of patients to be treated and their weights. This allows stock planning the of ipilimumab vials of pharmacy to an amount equal to that required for one day of administration, thus reducing the inventory value of the phar- maceutical stock. As ipilimumab is available as 50 and 200 mg vials, the smaller packages were preferred to minimize a drug

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Figure 3. Economic evaluation of cost-containment strategies. Box plot represents the gross cost, the net cost, and the net cost minus the reimbursement received according to payback system. Gross-cost represents the cost that would have been paid to treat the study population in absence of any cost containment strategy. Net-cost is the number of ipilimumab vials actually used. Box plots report median, first, and third quartiles. Outliers are plotted as individual points. Significance of cost variation according to different cost-containment strategies were assed using Wilcoxon Signed Rank Test. Values were considered statistically significant for p < .05.

waste. In addition, all therapies were prepared under the same biological cabinet so that any residual drug from one patient can be used for the subsequent one. This procedure is called vial sharing and it maximizes the efficiency of compounding while exploiting the over-fill of each vial of ipilimumab.

Considering the ex-factory price (excluding taxes), the gross cost for treating the study population was 4,088,500.00 euro, which is reduced to 3,633,750.00 by the drug-day strat- egy (comprehensive of vial sharing and overfill). This reduction is equal to the 11.1 percent of gross cost and the difference in the median is statistically significant (p < .001) (Figure 3). The cost sustained to treat one average patient (75 kg, 3 mg/kg, 4 cycles) is equal to 74,098.00 euro in the case of drug-day com- pared with 83,371.00 when no cost-containment strategies are applied.

In conclusion, the synergy between national, regional, and local management strategies permits the reduction of the gross cost of ipilimumab by 17.3 percent, corresponding to the cost sustained to treat 6 average patients.

DISCUSSION Cost containment strategies are important as costs in oncology care and the numbers of new expensive therapies are constantly rising. In addition, drug waste from unused or partially used vials, during batch or single production, can further concur in increasing these costs. Given these premises, it is of primary

importance to develop cost-containment strategies to ensure that the National Health System will continue to guarantee public access to cancer treatments. To this aim, a model of economic evaluation of an expensive and innovative drug, ipil- imumab, for treatment of melanoma was described. To propose this model to other cancer centers, it was demonstrated that the clinical characteristics and outcome of the patients enrolled in this study were comparable to those of patients treated in clinical trials and expanded access of ipilimumab.

Indeed, the response rates and global toxicities recorded in our study are similar or slightly higher compared with the published results (12;13), despite the higher average age of our sample. The challenge remains to identify predictive markers of response, given that a large percentage of patients do not benefit from treatment yet (14–19). Concerning the type of AE, no new type of toxicity, besides those already reported in liter- ature for ipilimumab, was observed and the incidence of grade 3–4 toxicity was similar to that reported in literature (20;21). Toxicity was generally managed using established treatment al- gorithms (22); therefore, ipilimumab is generally well tolerated and manageable also in real practice settings.

One of the worries was related to the delay of treatment for 10–19 days to start with cohorts of at least 5 or more patients for each drug-day. Considering that the efficacy and safety profile of the patients is comparable with published data, our model of drug administration can be proposed and used more extensively without detrimental effects on clinical results. The

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model proposed is constituted by a three-step approach where the management of expensive drugs is determined by national, regional, and local policies. The Italian payback system per- mits savings of 6.2 percent of gross cost while the combination of regional and local policies permits an additional savings of 11.1 percent. The difference between the medians of gross- and net-costs is statistically significant.

The savings is an effect of vial-sharing and exploitations of vial overfill; however, it is not easy to discriminate between these two contributions, as the only read-out variable we have is the number of ipilimumab’s vials actually used, which is af- fected by both factors. The economic impact of ipilimumab was previously studied by the National Centre for Pharma- coeconomics (Ireland), who, in 2011, concluded that the cost- effectiveness of ipilimumab for advanced melanoma treatment in adults who had received prior therapy was not demonstrated; therefore, they cannot recommend reimbursement at the price submitted by the producer (23). However, the centralization of ipilimumab treatments on a regional basis and a vial sharing policy permits savings up to 11 percent of the gross cost (17.3 percent in case of treatment withdrawal incidence of 14 per- cent). This brings us to reconsider the negative recommenda- tion given by other regulatory agencies.

Besides the economic aspects, this management model has also produced consistent results in terms of quality of care because, being a hub-center, our institute provides a full di- agnostic, therapeutic, and assistance service to these patients and ensures a complete reconciliation of the concurrent thera- pies and management of toxicity by an expert team. Also from a professional point of view, centralization minimizes the ex- posure of personnel to the drugs, giving the compounding task only to highly specialized operators.

Finally, it is worth noting that this is a monocentric study conducted on fifty-seven patients in a melanoma unit located in an Italian oncology hospital. As a result, there are some limitations we need to point out: the small cohort of pa- tients enrolled and the retrospective and monocentric nature of our evaluation. This study was not structured to directly extend the results to wider context, but it constitutes a first step toward a nationwide multicenter study aimed at compar- ing different models for management of expensive and inno- vative cancer treatments. The final aim of this project will be to delineate a Best Operating Practice guideline. The re- cruitment phase of participating centers and the analysis of the data collected have just ended. The preliminary results obtained from the multicenter study confirms those obtained in this pivotal monocenter work (Russi et al. unpublished results).

CONCLUSION This pivotal study demonstrated that a cost containment strat- egy is feasible and it needs the cooperation of all healthcare

providers (oncologists, pharmacists, nurses and technicians) to guarantee the full efficiency of the process.

SUPPLEMENTARY MATERIAL Supplementary Figure 1: https://doi.org/10.1017/S0266462317000332

CONFLICTS OF INTEREST Dr. Chiarion-Sileni reports being a Consultant, outside the sub- mitted work, for Bristol Meyer Squibb, Merck, Novartis, and Roche. Drs. Damuzzo, Di Sarra, Palozzo, Pigozzo, and Russi have nothing to disclose.

REFERENCES

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2. Fasola G, Aprile G, Marini L, Follador A, Mansutti M, Miscoria M. Drug waste minimization as an effective strategy of cost-containment in oncol- ogy. BMC Health Serv Res. 2014;14:57.

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4. Hyeda A, da Costa ES. A preliminary analysis of the reduction of chemotherapy waste in the treatment of cancer with centralization of drug preparation. Rev Assoc Med Bras. 2015;61:368-374.

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8. Messori A, De Rosa M, Pani L. Alternative pricing strategies for cancer drugs. JAMA. 2015;313:857.

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16. Valpione S, Moser JC, Parrozz

Ethics Case Study GBU 358: Business Law & Ethics

Spring 2019

McDonald’s Corporation operates the largest fast-food restaurant chain in the United States and in the world. It produces such famous foods as the “Big Mac,” “Chicken McNuggets,” the “Egg McMuffin,” fries, milkshakes, and other high caloric foods. A recent McDonald’s survey showed that 22% of its customers are “Super Heavy Users,” meaning that they eat at McDonald’s ten times or more a month. Significantly, Super Heavy Users make up approximately 75% of McDonald’s sales. The survey also found that 72% of McDonald’s customers are “Heavy Users,” meaning that they eat at McDonald’s at least once a week. Though internal McDonald’s data showed a direct correlation between heavy consumption and obesity following the survey, this statistical information was not made available to the public.

Jasmine Brandon consumed McDonald’s foods her entire life during school lunch breaks and before and after school, approximately five times per week, ordering two meals per day. When Brandon was 19 years old, she sued McDonald’s corporation for causing her obesity and the health problems associated with her condition. In her lawsuit, she alleged that McDonald’s, through its advertising campaigns and other publicity, created the impression that its food products were nutritious, of a beneficial nature, and easily part of a healthy lifestyle if consumed on a daily basis.

Consider:

1. Consider the various legal issues you have studied this semester. What potential legal claim(s) might Brandon’s case present? Explain.

2. Do you think Brandon’s potential legal claim(s) will prevail? Why or why not? Use any applicable legal principles you’ve learned this semester to support your position.

3. What non-legal arguments can you make supporting McDonald’s obligation to inform consumers about the correlation between heavy consumption and obesity? Offer both ethical arguments and arguments favoring corporate social responsibility.

4. What non-legal arguments can you make opposing McDonald’s obligation to inform consumers about the correlation between heavy consumption and obesity? Offer both ethical arguments and arguments opposing corporate social responsibility.

5. Consider your responses to Questions 3 and 4. In your opinion, which argument is more “correct” and why?

6. Pretend you serve as a corporate officer for McDonalds with full command over the corporation’s business operations. How might you prevent any allegations of legal, ethical, or social irresponsibility from other heavy users in the future? Explain why your plan for resolution would effectively resolve similar conflicts.

Ethics Case Study Rubric GBU 358: Business Law and Ethics

Spring 2019

Marginal Proficient Exemplary

Objective: Student will identify and analyze the success of potential legal claims.

☐ – Does not identify significant legal claims. – Offers insufficient legal rules necessary to analyze each claim. – Fails to apply the facts for rule analysis/claim prediction. Significant omissions that obscure clarity.

☐ – Identifies most potential legal claims. – Offers basic legal rules necessary to analyze each claim. – Adequately applies facts for rule analysis/claim prediction. Minor omissions, but none that obscure clarity.

☐ – Identifies all potential legal issues. – Offers all legal rules necessary to analyze each claim and explains them to the reader. – Thoroughly and clearly applies all facts for rule analysis/claim prediction. No omissions.

Objective: Student will identify and analyze ethical/social obligations supporting disclosure.

☐ – Does not identify significant dilemmas. – Fails to offer (or sufficiently explain) applicable ethical principles AND social responsibility arguments favoring disclosure. – Fails to consider the consequences of applying each ethical principle or social responsibility argument favoring disclosure.

☐ – Identifies the most significant dilemmas. – Offers some applicable ethical principles AND arguments favoring social responsibility. – Sufficiently explains the consequences of applying each ethical principle or social responsibility argument favoring disclosure.

☐ – Identifies all dilemmas. – Offers numerous applicable ethical principles AND arguments favoring social responsibility. Explains them to the reader. – Thoroughly explains the consequences of applying each ethical principle or social responsibility argument favoring disclosure.

Objective: Student will identify and analyze ethical/social obligations opposing disclosure.

☐ – Does not identify significant dilemmas. – Fails to offer or sufficiently explain applicable ethical principles AND social responsibility arguments opposing disclosure. – Fails to consider the consequences of applying each ethical principle or social responsibility argument opposing disclosure.

☐ – Identifies the most significant dilemmas. – Offers some applicable ethical principles AND social responsibility arguments opposing disclosure. – Sufficiently explains the consequences of applying each ethical principle or social responsibility argument opposing disclosure.

☐ – Identifies all dilemmas. – Offers numerous applicable ethical principles AND arguments opposing social responsibility. Explains them to the reader. – Thoroughly explains the consequences of applying each ethical principle or social responsibility argument opposing disclosure.

Objective: Student will demonstrate and explain his or her ethical awareness.

☐ – Does not clearly state preference regarding disclosure. – Offers minimal explanation for position. Little to no supporting justification.

☐ – Clearly states preference regarding disclosure. – Offers adequate explanation for position. Some supporting justification.

☐ – Clearly states preference regarding disclosure. – Offers significant explanation for position. Significant justification with detailed reasoning.

Objective: Student uses ethical principles to formulate solutions.

☐ – Does not formulate and implement a clear resolution plan regarding disclosure. – Offers minimal explanation to support methods of resolution. Little to no justification.

☐ – Formulates a resolution plan that adequately explains the execution of decisions regarding disclosure. – Offers sufficient explanation to support methods of resolution. Some supporting justification and reliance on ethical/social principles.

☐ – Formulates a resolution plan that explains, in detail, the execution of decisions regarding disclosure. – Offers significant explanation to support methods of resolution. Significant justification and reliance on ethical/social principles.