Do you have a lot of info on Epi pens and the issues with mylan and its exorbitant prices?
EpiPen, a brand name for an epinephrine auto-injector, is a medical device used to deliver a controlled dose of epinephrine (also known as adrenaline) to treat acute allergic reactions, including anaphylaxis. Mylan, a global pharmaceutical company, acquired the right to sell and market EpiPen in 2007.

After Mylan acquired EpiPen, the company significantly increased the price of the device over several years. For example, the price of a two-pack of EpiPens in the United States rose from around $100 in 2007 to approximately $600 in 2016. This steep price increase led to public outcry and widespread criticism, given that there were few alternatives on the market and that EpiPens are a life-saving device for many people with severe allergies.

The key issues associated with Mylan’s pricing of the EpiPen include:

1. Monopoly Pricing: During the period of the price hikes, Mylan held a near-monopoly on the epinephrine auto-injector market in the U.S. This lack of competition allowed the company to set higher prices.

2. Access and Affordability: With exorbitant prices, the affordability of EpiPens decreased for many individuals and families, even those with health insurance. High deductibles and copays often led to out-of-pocket expenses that some people couldn’t afford.

3. Insurer and Pharmacy Benefit Manager Practices: Complex interactions between pharmaceutical companies, insurers, and pharmacy benefit managers (PBMs) may have contributed to the high costs. Rebates, fees, and other agreements between these entities are often not transparent, leading to questions about how prices are determined.

4. Political and Legal Scrutiny: The pricing controversy led to hearings in the United States Congress, where Mylan’s CEO was called to testify. Mylan faced accusations of price gouging and exploitation of its market position. In addition to political scrutiny, Mylan faced legal challenges through class-action lawsuits and settlements related to its pricing practices.

5. Market Response: In response to the controversy, Mylan increased the availability of EpiPen coupons and generic versions, which were slightly less expensive. Additionally, the public outcry and negative press led to increased interest in finding alternative epinephrine auto-injectors and spurring competition in the market.

6. Antitrust Concerns: There were concerns that Mylan engaged in anticompetitive practices to maintain its market dominance, which became a subject of investigation by federal agencies.

In the years following the height of the controversy, the U.S. Food and Drug Administration (FDA) approved additional epinephrine auto-injectors from other companies, including a generic version that Mylan itself began to offer, which has helped to provide more options for consumers and apply some downward pressure on prices. Despite these developments, the issue remains a critical example of the complexities and challenges of pharmaceutical pricing in the U.S. healthcare system.
Where Can I access the company MIlans Business info?
To access detailed business information about Mylan (now part of Viatris after merging with Upjohn, a division of Pfizer, in 2020), you have several options depending on the type of information you are looking for:

1. Company Website: Viatris, the new entity, has a corporate website where you can find information about their business, including press releases, company profiles, product information, and corporate responsibility initiatives. The URL is https://www.viatris.com.

2. Annual Reports and SEC Filings: Publicly traded companies are required to file regular reports with the U.S. Securities and Exchange Commission (SEC). These include annual reports (Form 10-K), quarterly reports (Form 10-Q), and other important disclosures. You can find these filings on the SEC’s EDGAR database at https://www.sec.gov/edgar.shtml or on the investor relations section of the Viatris website.

3. Investor Relations: The investor relations section of the Viatris website will also contain a wealth of information, including presentations, financial statements, stock information, and details about mergers and acquisitions.

4. Business Databases: Comprehensive business databases such as Bloomberg, Reuters, S&P Global Market Intelligence, or Hoovers provide detailed company profiles, financials, analyst reports, and more. Access to these databases typically requires a subscription or access through an academic or public library.

5. News Articles and Analysis: Business news websites, financial newspapers, and journals often cover companies like Mylan/Viatris and can provide insights into their business operations, strategic moves, and industry position. Examples include The Wall Street Journal, Financial Times, Bloomberg, Reuters, and CNBC.

6. Academic and Industry Reports: For more detailed analysis or historical perspectives, you might look for academic articles or industry reports from research firms. These can sometimes be found through university libraries or by purchasing reports directly from market research companies.

7. Court Documents and Legal Filings: If you’re interested in legal issues involving Mylan, such as litigation or settlements, you can look for court documents. These are often available through court databases or services like PACER (Public Access to Court Electronic Records) in the United States.

Remember to verify the information you obtain through multiple sources to ensure accuracy, especially if you are using it for investment decisions or academic research.
I have to do a business IA with this prompt: To what extent has the exorbitant price of Epi-pens been ethically and economically adequate? In this IA I will evaluate if the increase in price was a good Idea economically, image-wise, and ethically. Give me sources that would help with this endeavor
An Internal Assessment (IA) of this nature will require you to draw upon a variety of sources for both qualitative and quantitative analysis. Here are several types of sources that you can consider to support your investigation:

1. Academic Journal Articles: You can find peer-reviewed articles on the ethical implications of drug pricing and case studies on Mylan’s EpiPen through academic databases such as JSTOR, PubMed, or Google Scholar. These articles can provide insight into the broader context of pharmaceutical ethics and pricing strategies.

2. Industry Reports and Analysis: Look for healthcare and pharmaceutical industry reports from established market research companies such as IMS Health, IQVIA, or Frost & Sullivan. These reports can provide economic analysis and industry trends that contextualize Mylan’s pricing strategy.

3. News Articles: For timely information on public and industry reactions, use reputable news sources like The New York Times, The Washington Post, Bloomberg, and Reuters. Focus on op-eds, editorials, and investigative pieces that discuss the aftermath of the price hike and public sentiment.

4. Government Reports and Testimonies: Access transcripts from U.S. Congressional hearings where Mylan’s CEO testified about the EpiPen pricing, as well as any relevant reports from the U.S. Government Accountability Office (GAO) or Federal Trade Commission (FTC) that provide an analysis of the situation.

5. Ethical Guidelines: Refer to ethical codes of conduct from organizations like the American Medical Association (AMA) or the Pharmaceutical Research and Manufacturers of America (PhRMA) to discuss industry standards for ethical behavior.

6. Financial Statements: Review Mylan’s financial statements from before and after the price hike to evaluate economic performance. These can often be found in annual reports or SEC filings.

7. Scholarly Books: Books on pharmaceutical economics, corporate ethics, or case study collections on business ethics can provide theoretical frameworks for analyzing Mylan’s actions.

8. Public Opinion Data: If available, look for public opinion polls or surveys that gauge consumer and patient reactions to the EpiPen price increases, as these can help assess the impact on Mylan’s image.

9. Business Ethics Texts: Academic texts on business ethics may offer models for evaluating the ethical dimensions of business decisions, which can be applied to the EpiPen case.

When selecting sources, aim for a balanced mix of perspectives, including those that may justify Mylan’s decision from a business standpoint as well as those that critique it on ethical grounds. It’s important to critically evaluate each source’s reliability, potential bias, and relevance to your investigation.

A thorough IA will involve not only gathering information from these various sources but also synthesizing it to build a nuanced argument that addresses the research question. Remember to cite all of your sources appropriately according to the citation style required by your educational program.
Can you do this yourself?
As an AI language model, I don’t have the ability to directly access external databases or conduct original research as a human would. However, I can provide an outline and guide you through the steps needed to write a strong Internal Assessment (IA) based on the prompt provided. Here’s an example of how you could structure your analysis:

Title: To What Extent Has Mylan’s Pricing of EpiPens Been Ethically and Economically Justifiable?

Introduction

- Introduce the topic and provide background information on Mylan and the EpiPen.
- Present a thesis statement that gives an overview of your position on whether the pricing strategy was ethically and economically justified.

Section 1: Economic Analysis

- Present data on the cost of EpiPen production versus retail price.
- Analyze Mylan’s financial performance pre- and post-EpiPen price hike using their financial statements.
- Discuss the economic rationale behind Mylan’s pricing strategy in terms of profit maximization, market conditions, and R&D recoupment.

Section 2: Ethical Considerations

- Explore the ethical implications of pharmaceutical pricing, referencing established ethical frameworks or guidelines within the industry.
- Discuss Mylan’s corporate social responsibility (CSR) status and public health obligations.
- Weigh the human rights aspect of access to life-saving medication against corporate profitability.

Section 3: Brand Image and Public Reaction

- Assess the impact of the pricing strategy on Mylan’s corporate image using case studies, news articles, opinion polls, and public statements.
- Discuss the extent to which negative publicity can affect economic performance in the pharmaceutical industry.
- Consider any steps Mylan took to mitigate backlash, such as introducing generic versions or providing discounts.

Section 4: Alternatives and Competition

- Examine the availability of alternative products and how competition (or lack thereof) affected Mylan’s pricing strategy.
- Discuss the role of patents, FDA regulations, and market entry barriers for competitors.

Section 5: Legal and Regulatory Outcome

- Review any legal actions or regulatory responses that resulted from the price increases, such as antitrust investigations or congressional hearings.

Conclusion

- Summarize your findings and restate your thesis in light of the evidence presented.
- Discuss the broader implications for the pharmaceutical industry.
- Provide a reasoned judgment on the ethical and economic adequacy of Mylan’s pricing strategy.

References

- Include a reference list formatted according to the citation style prescribed by your educational program.

To conduct your research, use the types of sources I mentioned previously. Keep in mind the importance of evaluating the credibility of sources, maintaining a balanced perspective, and avoiding plagiarism by properly citing all the information you gather.
what if I gave you evidence, could you give me a good IA then?
If you provide specific evidence or data points, I can help you integrate that information into the structure of an IA, discuss how to analyze it within the given sections, and suggest ways to interpret the findings in your conclusion. However, it’s essential for the integrity of your academic work that the final IA be written by you; I can guide and support you with prompts and advice but cannot produce the IA for you.

For example, you might have the following evidence:

1. Historical pricing data for EpiPen.
2. Financial statements of Mylan showing profit margins before and after the price hike.
3. Scholarly articles on the ethics of drug pricing.
4. Public reactions in the form of social media trends, opinion polls, or news articles.
5. Congressional hearing transcripts and FDA statements regarding Mylan’s pricing strategy.

Here’s how you might analyze and integrate this evidence:

Section 1: Economic Analysis

Analyze the historical pricing data to show the trend over time. Contrast it with Mylan’s financial statements to evaluate how the pricing affected their profit margins and overall financial health. This could include charts or tables showing the correlation between EpiPen prices and Mylan’s revenue or profitability.

Section 2: Ethical Considerations

Use the scholarly articles to provide the ethical frameworks for pharmaceutical pricing. Discuss where Mylan’s actions fit within these frameworks, considering both the rights of the company to recoup investments and the rights of patients to affordable access to life-saving medication.

Section 3: Brand Image and Public Reaction

Present the public reactions by showing evidence from social media, opinion polls, or relevant news articles. Discuss the short-term and potential long-term effects of the public’s perception of Mylan on their brand image and consumer trust.

Section 4: Alternatives and Competition

Consider the evidence of market alternatives, if any, to the EpiPen during the timeframe of the price hikes. Discuss if Mylan’s pricing could have been influenced by the lack of competition or if their strategy created an opportunity for competitors to enter the market.

Conclusion

Synthesize the findings from the economic, ethical, and brand image analyses to create a nuanced perspective on the justification of Mylan’s pricing strategy. Use the evidence to support your final judgment about the adequacy of Mylan’s approach from both an ethical and economic standpoint.

Remember, critical thinking and proper evaluation of the evidence are key to a strong IA. Always consider multiple perspectives and potential biases in the evidence, and relate your findings back to your research question.
analyze my IA and tell me if it is good The pricing of pharmaceutical products, especially those that are life-saving, is a matter of paramount importance that intersects the domains of ethics and economics. In the case of EpiPens, a device critical for individuals suffering from severe allergic reactions, the pricing strategy by Mylan Pharmaceuticals has come under intense public and academic scrutiny. EpiPens are not merely commodities but essential healthcare tools for patients at risk of anaphylaxis. Thus, the ramifications of their pricing extend beyond the balance sheets of Mylan and into the homes and lives of countless patients. This study seeks to examine the extent to which Mylan’s decision to raise EpiPen prices has been ethically and economically justifiable. Through a lens scrutinizing the evidence of Mylan’s actions, the literature on pharmaceutical pricing practices, and the broader impact on society, this analysis will interrogate the moral and economic dimensions of Mylan’s decisions, address the resulting public outcry, and evaluate whether Mylan’s pricing practices can be deemed re asonable within a market-based healthcare system.

### Body Paragraph 1: Mylan’s Price Increases and Public Response

In 2007, Mylan Pharmaceuticals acquired the rights to manufacture EpiPens, and in the years that followed, the company implemented a price increase exceeding 400%. This drastic escalation drew widespread indignation from consumers, healthcare providers, and policymakers alike. Such a decision by Mylan to raise prices has been perceived as capitalizing on the vulnerable position of patients who, for the sake of their own survival, are compelled to bear the financial burden indiscriminately—which is noteworthy, given that individuals at risk of anaphylaxis are advised to carry two EpiPens at all times. The literature reveals that these cost increments far exceeded the amounts necessary to sustain any purported enhancements to the product, thereby raising questions about the motives behind such pricing strategies and the ethical considerations disregarded by Mylan.

### Body Paragraph 2: Economic Impacts and Market Dynamics

Economically, the EpiPen scenario underscores the complexity of pharmaceutical pricing and market dynamics where a single player can command significant market share. Mylan’s pricing strategy, examined in light of Emma Westermann-Clark’s analysis, illustrates how dominance in the market can lead to decisions that adversely affect the consumption behavior of patients. Westermann-Clark observed a trend where over half of the EpiPen prescriptions went unfilled once the cost surpassed $300 for a two-pack—an alarming statistic that signals a clear disruption in the access to essential medication due to pricing policies. This data suggests an economic environment where market forces and profit motives overshadow patient well-being and access to care.

### Body Paragraph 3: Socioeconomic Disparities and Access

The pricing of EpiPens not only reflects on corporate ethics and economic principles but also on wider socioeconomic disparities and issues of access. When prices soar, it is often the economically marginalized and vulnerable populations that bear the disproportionate impact. Westermann-Clark highlighted how socioeconomic factors play a significant role in patient access to epinephrine autoinjectors, indicating that children from higher-income homes were more likely to be prescribed EAIs. This skew suggests that Mylan’s pricing strategy could exacerbate existing inequalities in healthcare access and outcomes, raising the ethical question of whether such a fundamental aspect of medical care should be subject to the whims of market economics and corporate profit maximization.

### Body Paragraph 4: Mylan’s Responses to Criticism

Despite considerable criticism, Mylan’s responses to public concern over EpiPen pricing indicated a resistance to accept accountability. The company’s communication strategy involved issuing a mix of opaque and sometimes contradictory statements. While Mylan CEO Heather Bresch accepted “full responsibility” for the price hikes at one point, the company also shifted blame onto the complexities of the healthcare system. This obfuscation and lack of transparency do little to engender trust or demonstrate a commitment to ethical practices and patient-oriented values, characteristics that are especially important when a company has such a significant influence on public health.

### Body Paragraph 5: Ethical Considerations and Virtue Ethics Analysis

From an ethical standpoint, Mylan’s EpiPen pricing strategy can be subjected to further scrutiny through the lens of virtue ethics. Virtue ethics posits that moral behavior is predicated upon the cultivation of virtuous character traits. Assessing Mylan’s actions against Pritchard’s virtues for morally responsible engineers, one finds the company’s commitment to openness, cooperation, and informative communication wanting. Mylan’s decision to eschew cooperation with Medicaid’s Drug Rebate Program and to hinder competition through aggressive legal strategies provides evidence of behavior that conflicts with the expected virtues. Such actions suggest a veering away from morally responsible business conduct, reinforcing concerns regarding the ethical adequacy of the company’s pricing decisions for EpiPens.
### Body Paragraph 6: Stakeholder Impact Analysis

Stakeholder theory asserts that companies have a responsibility not only to their shareholders but also to a wider community that includes consumers, employees, suppliers, and society at large. Mylan’s decision to increase the price of EpiPens significantly affected various stakeholders, most notably the consumers who depend on this medication for life-threatening allergy attacks. Several stakeholders, including health insurance companies that bear the increased costs and schools mandated to stock EpiPens, face financial strain due to the monopolized pricing strategy. Additionally, shareholders and investors initially may have greeted the profit surge with approval, yet the subsequent reputational damage to Mylan and the legal repercussions negatively impacted long-term shareholder value. This analysis evidences the intricate web of stakeholder interests that Mylan affected and the subsequent need for corporate strategies that balance profit with social responsibility.

### Body Paragraph 7: Corporate Culture and Ethical Climate

Corporate culture heavily influences decision-making processes and the ethical climate within an organization. Mylan’s aggressive pricing strategy, along with the defensive stance taken against criticism, suggests a corporate culture prioritizing financial results over patient accessibility and ethical considerations. A robust corporate culture nurtures standards of behavior that align with social welfare and ethical norms. However, the evidence suggests Mylan’s internal environment favored market dominance and profit maximization, raising questions about the ethical compass and the integrity of the organizational culture. The dissonance between Mylan’s actions and the expectations of a socially responsible entity reveals a culture that undermined the values of fairness and transparency, which are vital for sustaining trust and respect among stakeholders.


### Body Paragraph 8: Long-Term Sustainability and Corporate Responsibility

Myriad actors within the pharmaceutical industry have increasingly recognized the significance of long-term sustainability and corporate responsibility as critical components of their operational ethos. Mylan’s initial financial success with EpiPen price increases belies a deeper concern for long-term viability, as prices that marginalize consumers can lead to legal repercussions and shifts in public policy that favor market competition. Sustainable practices necessitate pricing strategies that consider affordability and access while still incentivizing innovation. By prioritizing short-term gains over sustainable pricing, Mylan risked its future market position and eroded trust—both of which are fundamental to the long-term success and corporate responsibility that stakeholders increasingly demand from modern pharmaceutical companies.

### Body Paragraph 9: The Role of Regulation and Industry Standards

The Mylan EpiPen saga underscores the need for enhanced regulation and industry-wide standards that prevent exploitative pricing of essential medications. While market forces play a pivotal role in price determination, the pharmaceutical industry faces unique moral imperatives, given the life-or-death nature of its products. The outcry resulting from Mylan’s pricing strategy suggests that self-regulation is insufficient when it comes to essential drugs. Thus, interventions such as price caps, increased transparency requirements, and incentives for generic drug production emerge as necessary measures to protect consumers and ensure fair market practices. These regulations serve to deter market abuse and ensure that the pharmaceutical industry upholds its ethical obligation to society while safeguarding economic interests.

### Body Paragraph 10: Alternative Models for Pricing and Distribution

The backlash against Mylan’s pricing strategy suggests the need for alternative models for pharmaceutical pricing and distribution. Strategies such as value-based pricing and tiered pricing schemes could align the cost of drugs like EpiPens more closely with their actual value and cost of production, while also considering the patients’ ability to pay. Additionally, implementing differential pricing across markets can ensure wider access to medication, particularly for vulnerable populations. Mylan’s experience highlights the importance of adopting innovative and equitable models that balance profitability with social responsibility, allowing pharmaceutical companies to maintain a positive image, adhere to ethical standards, and cater to diverse demographic needs.

### Body Paragraph 11: Impact on Research and Development

Research and development (R&D) in the pharmaceutical industry is a double-edged sword—while it is essential for innovation and the creation of life-saving drugs, it also serves as a frequent justification for high drug prices. In Mylan’s case, the argument that EpiPen price increases were necessary to fund R&D falls short when considering the subsequent pricing controversies and minimal changes made to the EpiPen during Mylan’s tenure. This draws attention to the need for transparency and accountability in the allocation of revenues toward genuine innovation, rather than using R&D as a blanket rationale for disproportionate price hikes on essential medications.

### Body Paragraph 12: Ethics of Profit in the Pharmaceutical Industry

An ethical conundrum emerges when considering the role of profit in the pharmaceutical industry. While companies like Mylan are accountable to their shareholders to generate profits, there is a moral expectation to do so within the bounds of social good, especially when dealing with products that are life-saving. Profits gained at the expense of access to critical medicine call into question the ethical practices of the firm. The EpiPen situation serves as a stark reminder that profit motives must be balanced with the moral duty to safeguard human life, necessitating a re-examination of how profits are earned and the extent to which they are permitted to influence life-or-death decisions in healthcare.
Your Internal Assessment draft provides a well-structured and comprehensive analysis of Mylan’s pricing strategy for EpiPens, with each body paragraph dedicated to a different aspect of the issue. Here’s a qualitative assessment of the strengths and areas that could be improved:

Strengths:

1. Complex Analysis: You have delved into several dimensions of the issue, including public response, economic impacts, socioeconomic disparities, ethical considerations, corporate culture, and long-term sustainability. This multi-faceted approach is essential for a thorough analysis.

2. Use of Sources and Literature: You have referenced specific academic work, such as Emma Westermann-Clark’s analysis, which adds credibility and depth to your arguments.

3. Ethical Frameworks: The application of virtue ethics and stakeholder analysis provides a strong theoretical foundation to assess the ethical implications of Mylan’s pricing strategy.

4. Focus on Stakeholders: You have identified a variety of stakeholders and explored how they were affected by the price increases, demonstrating an understanding of the broader impact of corporate decisions.

5. Regulatory Implications: Addressing the need for regulation and suggesting alternative pricing models show that you are looking beyond the case study to consider systemic changes that could prevent similar situations in the future.

Areas for Improvement:

1. Evidence and Data Integration: Make sure that the evidence presented is accurately represented and directly supports the claims. For instance, ensure that the statistic “over half of the EpiPen prescriptions went unfilled” is correctly cited and used within context.

2. Balanced Arguments: While critical assessment is vital, an IA should also discuss potential counterarguments or justifications for Mylan’s pricing from an economic or business standpoint. This might include the costs of production, distribution, marketing, and R&D.

3. Quantitative Analysis: Provide more specific financial data or quantitative analysis to support economic arguments. For example, how did the price increase correlate with Mylan’s financials—as evidenced by their profit margins, stock prices, or other financial metrics?

4. Clear Linkage to Research Question: Ensure each paragraph clearly ties back to the central question of whether Mylan’s decision was ethically and economically justifiable.

5. Conclusion: While this part of the IA isn’t included in your summary, it must tie all the evidence and argumentation back to your initial thesis, providing a clear and concise answer to your research question.

6. Consistency in Terminology: Make sure terms like “corporate ethics,” “ethical considerations,” or “virtue ethics” are consistently defined and applied throughout the paper to avoid confusion.

7. Be Cautious with Generalizations: Avoid making broad claims without sufficient evidence. For example, the assertion that Mylan “eschew cooperation with Medicaid’s Drug Rebate Program” should be supported with concrete examples.

Overall, your IA demonstrates a robust investigation into Mylan’s pricing strategy and its multifaceted implications. By incorporating the final pieces of evidence, refining your arguments for balance and depth, and ensuring that your data is accurately cited, you will strengthen your analysis. Remember to conclude with a strong, evidence-backed summation of your findings, reiterating the ethical and economic adequacy of Mylan’s pricing decisions.
Can you do this for me if I give you enough evidence?
I can certainly guide you through structuring your Internal Assessment (IA) and advise you on how to incorporate the evidence you have, develop your arguments, and interpret the information. However, as an AI developed by OpenAI, I am not able to conduct independent research, access external databases, or produce homework or assignments for you in entirety.

For your IA on Mylan’s EpiPen pricing, I can help by suggesting how you might analyze the evidence you provide, how to draw conclusions, and the ways to articulate your thoughts coherently within the sections of the essay. Ultimately, your role is to synthesize this information, ensure that the arguments are supported by the evidence, and write the final IA in your own words.

Feel free to share the specific evidence you have, and I can offer suggestions on integrating it into the structure of the IA, pointing out potential lines of argumentation you could develop, and what econometric or analytical tools you might use to evaluate the data. I can also help by posing critical questions that may deepen your analysis and by identifying where you might need additional information or clarification.
Epinephrine autoinjectors (EAIs) were developed in the 1970s and were first approved by the US Food and Drug Administration (FDA) in the United States in 1987 with the EpiPen® (Mylan, Canonsburg, PA, USA). EAIs available in the USA include: EpiPen; epinephrine injection, United States Pharmacopeia autoinjector, generic (Mylan); epinephrine injection, USP autoinjector (Impax Generics, Hayward, CA, USA); and Auvi-Q® (Kaléo, Richmond, VA, USA).

The annual direct costs in year 2010 in the USA for EAIs are estimated to be $294 million, accounting for about 25% of the $1.2 billion annual cost to treat SARs including anaphylaxis.5,6 The average wholesale price (AWP) of each EAI is included in Table 2, except for the Auvi-Q. Accurate wholesale pricing for the Auvi-Q is not available as it is distributed through a single specialty pharmacy network. The complexity of drug pricing is beyond the scope of this article. Costs for the EpiPen were relatively stable until Mylan acquired this product from Merck (Kenilworth, NJ, USA) in 2007. The AWP since that time for two EpiPens has increased 545% from $113.27 to 730.33.4 This price increase persists even after accounting for inflation (Figure 1).7,8 Although the out-of-pocket expenses for individual subjects may have decreased since the public outcry about EpiPen costs in 2016, the effective date of the most recent AWP available is May 16, 2016 and does not reflect the impact of price cuts or patient assistance programs.7

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Object name is jaa-11-153Fig1.jpg
Figure 1
AWP for the EpiPen® 2001–2016.

Notes: AWP of an EpiPen 2-pack, or AWP of two EpiPens when sold individually, 2001–2016. The dotted line represents AWP in actual US dollars. The solid line represents AWP in constant year 2016 US dollars to adjust for inflation. Data were obtained from the Red Book Online System7 and converted into constant US dollars using the Consumer Price Index for medical care from the US Bureau of Labor Statistics.32 The most recent AWP available was effective date 5/16/16.

Abbreviation: AWP, average wholesale price.

Table 2
Average wholesale prices for epinephrine autoinjectors in the USA

Manufacturer Drug name NDC number Package size Dose AWP package price (US) Effective date
Mylan EpiPen® 49502-0500-02 2 ea 0.3 mg/0.3 mL 730.33 5/16/2016
Mylan EpiPen Jr. 49502-0501-02 2 ea 0.15 mg/0.3 mL 730.33 5/16/2016
Mylan Epinephrine injection, USP autoinjector 49502-0102-02 2 ea 0.3 mg/0.3 mL 375 12/15/2016
Mylan Epinephrine injection, USP autoinjector 49502-0101-02 2 ea 0.15 mg/0.3 mL 375 12/15/2016
Impax Generics Epinephrine injection, USP autoinjector 54505-0101-02 2 ea 0.15 mg/0.15 mL 494.01 10/1/2015
Impax Generics Epinephrine injection, USP autoinjector 54505-0102-02 2 ea 0.3 mg/0.3 mL 494.01 10/1/2015
Kaleo Auvi-Q® 60842-0022-01 2 ea 0.15 mg/0.15 mL 5400a n/a
Kaleo Auvi-Q 60842-0023-02 2 ea 0.3 mg/0.3 mL 5400a n/a
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Notes:

aAccurate AWP for Auvi-Q was not available because it is distributed through a single specialty pharmacy network.
Abbreviations: AWP, average wholesale price; ea, each; NDC: national drug code.

Use of the AWP is controversial, but it is often used as a proxy for societal cost in cost-effectiveness analyses.9 An economic analysis published in 2011 utilized the 2006–2007 AWP of the EpiPen to estimate the annual cost of EAIs for food-induced SARs.10 According to the International Society for Pharmacoeconomics and Outcomes Research good research practices guidelines from 2010:

Pharmaceutical prices used in the vast majority of cost-effectiveness analyses are either based on AWPs in the USA or government-negotiated prices in Europe. The former are not only imperfect measures of actual prices paid (e.g., ignoring discounts and rebates), but may also greatly overestimate societal opportunity costs because of the implicit inclusion of producer surplus created through patent-protected monopoly pricing.11

In summary, AWP is used as an approximation for societal drug costs, despite its limitations. The United States Department of Veterans Affairs (VA) Health Economics Resource Center (HERC) discusses the challenge of determining medication costs for research purposes. The HERC states, “We recommend using 121% of the drug costs reported in the Federal Supply Schedule, 152% of the VA cost, or 64% of AWP. To find the cost of a generic label prescription drug, we recommend using 27% of AWP.”9 Federal Supply Schedule prices are publicly available.12

Several factors limit the ability of newer products to garner and maintain a better market share versus Mylan’s EpiPen. First, the EpiPen has name recognition. Second, training for the use of each device is different. To illustrate, the epinephrine injection, USP autoinjector from Impax Generics requires the removal of two caps rather than just one. Although learning to use a new device can be challenging, novel design elements can improve safety and usability. An example is that the Auvi-Q has unique features including its rectangular shape intended to fit into a pocket, a retractable needle, and voice instructions. Third, insurance coverage differs for each EAI. According to the Managed Markets Insight and Technology database, the EpiPen has unrestricted access for 61% of commercial lives among 4624 commercial health plans.13 In contrast, Auvi-Q has unrestricted access for “19% of commercial lives in all locations” among these same commercial health plans.8 Even though Auvi-Q is not covered by many commercial insurance plans, the manufacturer offers it with $0 copayment to all commercially insured and Medicaid patients through a specialty pharmacy network distributor. Fourth, EAIs are rated “BX” by the FDA indicating that “data that have been reviewed by the Agency are insufficient to determine therapeutic equivalence” and when ordered may not be substituted by a pharmacist, one for another.14

The impact of copayments, coupons, and patient assistance programs on prices that subjects pay at the pharmacy counter requires further research. Pourang et al found that copayments did not affect the likelihood of an EAI being dispensed once it was prescribed in the Kaiser Permanente Health Maintenance Organization.15 However, while the authors indicate that nearly 30% of copayments exceeded $30, they did not consider higher copayments. Data are not available on prescription:dispense ratios for subjects with exceedingly high copayments or for uninsured and underinsured subjects who may pay retail prices. More than 50% of EpiPen prescriptions are abandoned or not filled when the cost exceeds $300 for a 2-pack.5 Two generic EAIs manufactured by Mylan have an AWP of $375. Two generic EAIs manufactured by Impax Generics have an AWP of $494.01. Patients with any commercial insurance plan or Medicaid receive Auvi-Q for $0 copayment through the specialty pharmacy network, ASPN Pharmacies LLC (200 Park Avenue, Suite 300, Florham Park, NJ 07932, 973-295-3289). All uninsured subjects who make <$100,000 annually have no copayment for Auvi-Q; uninsured subjects whose incomes exceed $100,000 pay no more than $360 for Auvi-Q.

Socioeconomic factors impact access to EAIs. Children from high-income versus low-income homes are 8.35 times more likely to be prescribed EAIs.16 Medicaid-enrolled children are less likely to receive EAIs prior to arrival at an emergency department.17 In another study, Caucasian versus non-Caucasian children were more likely to receive epinephrine early during an SAR.18 Early use of epinephrine was defined as epinephrine administered before arrival to the emergency department. Owning an EAI greatly increased the odds of early epinephrine treatment (odds ratio 12.67, 95% CI: 4.46–35.96). The authors did not assess insurance status but indicate that this finding suggests that there might be an economic influence on access to EAIs.18 Fleming et al examined the out-of-pocket costs for medications associated with food allergy and found higher costs for Caucasian and higher-income subjects.18 They hypothesize that Medicaid-enrolled children may have lower out-of-pocket costs, that is, lower copayments. To reduce or eliminate insurance copayments, Fromer suggests that epinephrine be classified as a preventive medicine by the US Preventive Services Task Force (USPSTF).5

Decision analysis software (TreeAge Pro, Williamstown, MA, USA) has been used to evaluate the cost of generic EAIs versus the EpiPen using a model that tracked spending for individual subjects over 20 years, with the assumption that each subject needs two 2-packs yearly, one each for home and school or work.19 The cost for the EpiPen over a 20-year model duration totals $58,667 (95% CI: $57,745–$59,588) versus $45,588 for the generic EAI (95% CI: $44,873–$46,304). The model also incorporates other food allergy-related costs, such as specialist visits, grocery costs, and loss of work time for parents of food-allergic children. These costs are assumed to be the same for all subjects regardless of the type of EAI prescribed.

The price of EAIs also affects school districts and communities. The Michigan legislature mandated that all public schools stock EAIs. It estimated the cost for two EAI 2-packs, one adult and one pediatric, at $140, while the “recently reported costs for commercial sources” was $1200, according to the authors of the article. The annual calculated cost to Michigan public schools based on these two cost estimates ranges from $565,460 to $4,846,800.20

A 2007 WAO survey of its House of Delegates indicates that EAIs are available in 59% of 44 countries surveyed.21 Those without EAIs employed other methods for the self-administration of epinephrine.22 These include the use of ampules of epinephrine 1:1000 (1 mg/mL) with an empty 1 cc syringe to be drawn up as needed or prefilled syringes containing various amounts of epinephrine. Both options are much less expensive than EAIs; for example, a vial of epinephrine 1:1000 (1 mg/mL) (Hospira, Lake Forest, IL, USA) had an AWP of $2.52 and retail price of ~$12 in 2016.7 Epinephrine ampules may not be available in all countries. Both options also allow for tailored dosing of epinephrine, above or below the standard 0.15 or 0.3 mg doses contained in most FDA-approved EAIs. This may be beneficial for children weighing <15 kg (33 pounds) or for large or obese subjects. Of note, in November 2017, the FDA approved an infant version of the Auvi-Q, Auvi-q 0.1mg, for children weighing 7.5–15 kg (16.5–33 pounds). It has a shorter needle and a smaller dose of epinephrine (0.1 mg versus 0.15 mg contained in other “junior” products).

Market forces appear to influence the cost of EAIs. For example, some US companies are offering low-cost alternatives. Symjepi™ (Adamis, San Diego, CA, USA) is an epinephrine prefilled syringe (EPS) that contains 0.3 mg of epinephrine, with a user-friendly design. It was approved by the FDA in June 2017 for subjects 30 kg (66 pounds) or more and is expected to be available at a lower cost than the current EAIs. A “junior” version is expected to follow. The concept of prefilled syringes is not new. The Ana-Kit® (Hollister-Stier Laboratories, Spokane, WA, USA) consisted of a syringe filled with 1 mL of epinephrine 1:1000 (1 mg/mL) housed in a protective case for subcutaneous injection before it was removed from the US market.23,24 The Ana-Kit syringe had 0.1 mL graduations so that smaller doses could be administered depending on the subject’s age. The instructions recommended the following doses: “Adults and children over 12 years: 0.3 mL; 6–12 years: 0.2 mL; 2–6 years: 0.15 mL; infants to 2 years: 0.05–0.1 mL.”25 An appropriate dose could be administered by pushing the syringe plunger until it stopped. A second dose could be administered as appropriate, after rotating the rectangular plunger ¼ turn to the right, to line up with a rectangular slot in the syringe.25 An advantage of the prefilled Symjepi syringe is that it is housed in a dark blue plastic encasement to protect the epinephrine from ultraviolet light degradation. Epinephrine degrades with exposure to ultraviolet light, oxygen in ambient air, and excessive heat.26–28 EPSs stored at room temperature in a pencil box maintain acceptable US Pharmacopeia concentrations (90%–115% of label claim), pH, and sterility for 3 months.22 The stability is limited to 2 months in high-temperature and low-humidity climates.22,29 In addition, some physicians and other health care professionals provide subjects with prefilled syringes wrapped in aluminum foil.28,30 These can be transported in a crush-resistant eyeglass case.

Snap Medical Industries (Dubin, OH, USA) has developed EpinephrineSnap-V® (a kit containing a vial of epinephrine 1:1000 [1 mg/mL] and empty syringes) and the EpinephrineSnap convenience kit (a kit containing an ampule of epinephrine 1:1000 [1 mg/mL] and empty syringes). The Focus Health Group, located in Knoxville, TN, USA, has been contracted to commercialize these products. The AWP of this product is $1567 although information from company officials states that the average price of EpinephrineSnap is $80 and the EpinephrineSnap-V is $130, with discounted group purchasing organization pricing available (Personal communication, November 1, 2017). Use of these options may not be as practical as is an EAI. The reason is that an epinephrine ampule or vial with an empty syringe requires more skill to properly draw up the epinephrine and administer it under emergency circumstances. Parents of individuals with a history of an SAR take longer to draw up epinephrine from an ampule (average 142±13 seconds) compared to emergency department nurses (29±0.09 seconds; p<0.05).31 The epinephrine dose drawn up by parents also ranged 40-fold as compared to twofold for emergency department nurses.31 The EpinephrineSnap products are geared toward use by emergency medical technicians and other health care professionals rather than individual subjects.

The rising cost of EAIs has made self-administered epinephrine potentially unavailable to some subjects. There are no data on deaths attributed to inability to afford EAIs. Lower-cost alternatives such as EPSs and epinephrine kits are entering the US market. EAIs have advantages, such as ease of use, but they are expensive. More research is needed on the complexity of drug pricing and on the optimal methods to determine individual and societal costs. Classifying EAIs as USPSTF preventive medicines could improve access by reducing or eliminating copayments.
Based on the evidence provided, your IA can analyze several key points related to Mylan’s pricing of EpiPens. Here’s how you might interpret and integrate this evidence into your analysis:

Background and Significance:

- Introduce the development of EAIs and their FDA approval, highlighting their importance for individuals at risk of anaphylaxis.
- Present data on the annual costs of EAIs in the USA and their proportion of the total cost to treat severe allergic reactions.

Mylan’s Pricing Strategy:

- Discuss the 545% price increase of EpiPens after Mylan’s acquisition of the product from Merck, placing emphasis on its impact on consumers.
- Highlight that the AWP increase persisted even after accounting for inflation, suggesting that the increase was not solely due to external economic factors.

Economic Impact Analysis:

- Use Table 2 and Figure 1 to illustrate and analyze Mylan’s price changes over time.
- Investigate the economic theories that might explain Mylan’s ability to raise prices, such as market power and name recognition.
- Address the AWP’s use as a proxy for societal costs despite its limitations.

Public Response and Accessibility:

- Evaluate the consequences of the price increase on prescription fill rates, particularly when the cost exceeded $300 for a 2-pack of EpiPens.
- Discuss socioeconomic factors that impact access to EAIs, and consider whether Mylan’s pricing strategy has exacerbated health disparities.

Corporate Ethics and Responses to Criticism:

- Assess Mylan’s responses to criticism, considering the ethics of their pricing practices and communication strategy.
- Explore Mylan’s resistance to accept accountability and the impact on their corporate image and trust among stakeholders.

Regulatory Implications and Market Dynamics:

- Analyze factors limiting the ability of newer EAIs to gain market share against Mylan’s EpiPen.
- Consider the role of FDA ratings and insurance coverage differences, and discuss how these factors influenced Mylan’s market dominance.

Alternatives and Cost-Savings Measures:

- Explore different EAI products and their costs, offering a broader view of the market landscape for epinephrine delivery systems.
- Discuss the impact of alternative pricing models and cost-saving measures (coupons, patient assistance programs) on out-of-pocket expenses.

Long-term Implications and Societal Costs:

- Consider decision analysis models that compare long-term costs of generic EAIs versus EpiPen.
- Evaluate the financial burden on school districts and communities due to EpiPen pricing, which could have broader economic and social ramifications.

Discussion and Critical Analysis:

- Reflect on Mylan’s pricing decisions from both economic and ethical standpoints. Integrate academic literature, economic principles, and ethical theories to support your analysis.
- Critically examine the evidence to draw conclusions about the justifiability of Mylan’s pricing strategy, considering the various stakeholders affected.

To ensure a thorough analysis, corroborate these points with additional literature, empirical studies, and theoretical frameworks as needed. Remember to present a balanced view by acknowledging potential counterarguments or business justifications provided by Mylan or other stakeholders within the pharmaceutical industry. Your final IA should present well-supported conclusions based on the evidence and address the larger implications for ethical and economic practices in pharmaceutical pricing.
take away the parts that need improvment and include the ones you just told me using the specific evidence continue whereyou left off