Drugmakers face uphill battle in Medicare negotiation suits

By Karissa Waddick - A federal judge last week dealt the first major blow to plaintiffs challenging the Biden administration’s Medicare drug price negotiations, declining to temporarily halt implementation of the program and questioning a leading argument in the case. Read Full Article…

VBA Article Summary

1. Judge Newman's Decision: Judge Michael Newman, appointed by former President Trump, denied a preliminary injunction requested by the U.S. Chamber of Commerce against Medicare negotiations, asserting that they failed to demonstrate a "strong likelihood of success" or evidence of immediate harm. Newman’s ruling did not directly address the merits of the case but indicated skepticism towards the argument that Medicare negotiations infringe on the Fifth Amendment’s Due Process Clause. Furthermore, Newman emphasized that participation in Medicare is voluntary, a crucial aspect underlined in his ruling, which is among the initial significant decisions in cases challenging the Inflation Reduction Act's Medicare drug pricing program.

2. Questionable Constitutional Claims: Pharmaceutical companies, including Merck, Bristol Myers Squibb, and AstraZeneca, have launched extensive legal challenges against the Medicare drug pricing program, claiming violations of various constitutional provisions, with a focus on the First and Fifth Amendments. Legal expert Robin Feldman notes that some of these claims, like those associated with the First Amendment and the notion of compelled speech, may be hard to substantiate. Additionally, attempts to apply the Fifth Amendment’s Takings Clause to patents (suggesting that the program forces companies to surrender patented drugs without just compensation) lack precedent and have previously met with skepticism, even among conservative Supreme Court justices.

3. Critique of Industry Lawsuits: Feldman highlights weaknesses in the industry’s constitutional claims against the Medicare drug pricing program. The assertion that the program violates the First Amendment by compelling companies to agree to a "fair price" is seen as a stretch since this would require viewing contracts as a form of compelled speech. Furthermore, applying the Takings Clause to patents, as suggested by some complaints, is unprecedented and not supported by previous judicial skepticism, as patents are not traditionally viewed as private property. Feldman also expresses doubt regarding the viability of “regulatory takings” claims, where firms argue their property's value has been diminished by government action without fair compensation. These cases are infrequent, and proving them, especially when companies still secure reasonable returns, is inherently challenging.

Court strikes down Trump-era rule that allowed insurers to not count copay assistance

By Noah Tong - Patient advocacy groups are declaring victory after a federal judge struck down a Trump-era policy that allowed health insurers not to count drug manufacturer copay assistance toward a beneficiary’s out-of-pocket costs. Read Full Article…

VBA Article Summary

1. Restrictions on Copay Accumulators: A recent legal case against the Department of Health and Human Services resulted in a favorable decision for patients and advocacy groups like the HIV+Hepatitis Policy Institute, the Diabetes Leadership Council, and the Diabetes Patient Advocacy Coalition. The Court’s ruling will now limit the use of copay accumulators - insurance features where manufacturer payments don’t contribute to patient deductibles or out-of-pocket maxima. As per the decision, insurers can only apply these accumulators to branded drugs with available generic equivalents, and even this application is subject to state laws.

2. Victory for Patients: Advocacy groups celebrated the ruling as a significant win for patients who have faced increasing out-of-pocket prescription drug costs due to the utilization of copay accumulators by insurers. The Court's decision, which overruled a previous 2021 regulation authorizing such practices, is viewed as a protective measure for patients struggling to afford essential medications. The ruling not only acknowledges but also rectifies the financial burdens placed on patients, who, according to George Huntley of the Diabetes Leadership Council, have been "forced to pay thousands of dollars in extra costs each year."

3. Urgent Implementation Called For: Following the court's decision, advocacy groups urge immediate enforcement by both the Biden administration and state authorities. They are calling for a proactive stance to ensure that patients continue to benefit from various forms of support in paying for critical medicines. The enforcement is imperative to preventing insurers and Pharmacy Benefit Managers (PBMs) from undermining the valuable copay assistance that totaled nearly $19 billion last year, as per analysis from IQVIA. With the court highlighting that insurers should not have sole discretion in determining cost-sharing inclusions, it’s crucial for the administration to support the enforcement and further protect patients from excessive out-of-pocket expenses.

Survey: What Women Want Out of Their Health Benefits

By Marissa Plescia - Women make up nearly 60% of the workforce, yet they’re often not getting what they need out of their health benefits, a new survey shows. The survey, published Tuesday, was from Parsley Health, a virtual primary care company that serves employers. It included responses from 1,271 women ages 18 to 60. All of the women were employed full-time and had health insurance. Read Full Article…

VBA Article Summary

1. Demand for Holistic Healthcare: According to a recent survey, 49% of employed women prefer comprehensive support from a single doctor instead of receiving referrals to various specialists. Women are seeking healthcare benefits that offer solutions tailored to specific health concerns they frequently face, such as fatigue, stomach ailments, or mental health issues. About 44% express the need for solutions that directly address these unique health challenges.

2. Desire for Root Cause Diagnosis & Care Management: Many women in the workforce are dealing with chronic conditions ranging from gastrointestinal, autoimmune, mental health, to cardiometabolic and hormonal issues. The survey finds that 40% of women desire access to doctors who can diagnose the root cause of their conditions. Furthermore, 39% of respondents call for enhanced care management services, including well-organized treatment plans and efficient scheduling of visits, to better navigate their health challenges.

3. Health Issues Impacting Employment & Productivity: The survey indicates a significant correlation between women’s health and their professional lives. Approximately 47% of women reported that health problems have negatively impacted their productivity at work within the past 60 days. Furthermore, 43% have had to take one or more days off due to health-related concerns during the same time frame. With fatigue, headaches, mental health, and stomach issues being the top health concerns, there's an urgent call for employers to offer better healthcare benefits; as revealed by the survey, 71% of working women would consider leaving their current jobs for improved benefits.

Provider Due Diligence: Key to Avoiding Catastrophic Cyberattacks

By Remy Samuels - With the increased frequency of cyberattacks, including within the retirement industry, plan sponsors have a fiduciary responsibility to ensure that providers with whom their plans are working are taking cybersecurity seriously. Read Full Article…

VBA Article Summary

1. In-Depth Vendor Cybersecurity Assessment: In light of the recent Moveit breach, which exposed sensitive personal information, it is imperative to rigorously evaluate the cybersecurity practices of potential vendors through detailed Requests for Proposals (RFPs) and annual due diligence. Robert Massa emphasizes that plan sponsors need to ask pointed questions regarding a vendor's cybersecurity policies, preventive measures against unauthorized access, and their history and handling of breaches. This process should help sponsors understand how data is handled, stored, and protected during transit and encryption by the vendors.

2. Importance of Cybersecurity Insurance and Service Organization Control (SOC) Reports: With the cybersecurity insurance market undergoing significant changes, plan sponsors must scrutinize the coverage levels and deductibles of their service providers carefully. Jon Meyer and Allison Brecher highlight the critical role of cybersecurity insurance in providing financial coverage and expert assistance in case of a breach. Plan sponsors should also actively review SOC reports, as advised by Massa, to evaluate the effectiveness of controls implemented by service organizations, thereby ensuring the protection of clients' assets. These reports provide assurance regarding the operational risks involved when outsourcing to third parties.

3. Understanding and Monitoring Subcontractors and Third-Party Entities: Plan sponsors should extend their due diligence to understanding the operations of subcontractors and third-party entities engaged by their primary vendors, as these entities can also pose significant risks. Knowing how data is shared and protected, even when sent overseas, is crucial for sponsors to ensure comprehensive security. Following breaches like that of Moveit, sponsors are advised to proactively communicate with vendors to ascertain the impact on their data and operations, emphasizing the importance of understanding and monitoring the practices of all entities involved in handling sensitive information.

Boehringer launches 81% discounted biosimilar of AbbVie's Humira

By Reuters - Germany's Boehringer Ingelheim on Monday launched an unbranded version of its biosimilar of AbbVie's (ABBV.N) Humira with a list price 81% cheaper than the blockbuster rheumatoid arthritis drug. Read Full Article…

VBA Article Summary

1. Introduction of Branded Biosimilar, Cyltezo: In July, Boehringer launched Cyltezo, a branded biosimilar to Humira, with a 5% discounted price of $6,922 per month. Notably, the FDA designates Cyltezo as interchangeable with Humira, making it a unique, readily substitutable option without prescriber consultation. This breakthrough offers alternative treatment choices in a market previously dominated by Humira, which recorded a staggering $21.2 billion in sales in 2022.

2. Competitive Market Dynamics: Eight other biosimilars to Humira, from companies like Novartis’ Sandoz and Amgen, were also introduced in the U.S. market this year. Many competitors are actively seeking the FDA’s interchangeability status to strengthen their market positions against both Humira and Cyltezo. Moreover, companies are adopting dual pricing strategies; for instance, Sandoz's Humira biosimilar, Hyrimoz, offers a 5% discount on its branded version while providing an 81% discount on the unbranded variant.

3. Lower-Cost Version Availability and PBM Considerations: Boehringer is planning to roll out a more affordable version of Cyltezo for Pharmacy Benefit Managers (PBMs) and healthcare

5 FDA decisions to watch in the fourth quarter

By Ned Pagliarulo and Jonathan Gardner - The next three months could bring a raft of important Food and Drug Administration decisions. The agency is set to decide on new genetic medicines for sickle cell disease, including what would be the first CRISPR-based treatment cleared in the U.S. Expanded use of a multiple myeloma cell therapy is also on the table, as is a confirmatory approval for Amgen’s KRAS-targeting lung cancer drug Lumakras. Read Full Article…

VBA Article Summary

1. Onpattro’s Expansion:

   Expansion Context - Alnylam’s drug Onpattro, initially approved for treating nerve pain in patients with ATTR amyloidosis, is seeking expanded approval for addressing cardiovascular complications in cardiomyopathy of ATTR amyloidosis patients. This expansion is crucial for Alnylam's goal of achieving consistent profitability.

   FDA's Dilemma - Despite some positive patient data, the FDA officials have expressed skepticism over the reported improvements in exercise duration and quality of life. The drug’s efficacy is also measured against Pfizer’s Tafamidis, which has shown substantial benefits, including reducing the risk of death and cardiovascular-related hospitalizations.

   Anticipated Decision - While expert advisers to the FDA recommended approval with a 9-3 vote, the final decision, expected by October 8, is uncertain with analysts, like Stifel’s Paul Matteis, estimating a 50-50 chance of approval.

2. Innovative Sickle Cell Disease Treatments:

   Promising Therapies - Exa-cel and Lovo-cel, developed by Vertex Pharmaceuticals with CRISPR Therapeutics and Bluebird bio respectively, are under FDA review. These innovative therapies aim to significantly reduce or eliminate the painful episodes experienced by sickle cell disease patients by genetically altering patients’ stem cells.

   Approval Timeline - The FDA is slated to make a decision on Exa-cel by December 8, and on Lovo-cel by December 20. Particularly, if approved, Exa-cel would mark the first CRISPR-based medicine cleared for use in the United States.

   Advisory Review - A panel of advisers will review Exa-cel on October 31, while Lovo-cel will not undergo a similar process.

3. Abecma for Multiple Myeloma:

   Expanded Clearance - Abecma, a CAR-T treatment for multiple myeloma co-developed by Bristol Myers Squibb and 2Seventy Bio, is awaiting FDA’s approval for expanded use in patients exposed to triple-class multiple myeloma. This expansion could potentially open a larger market for the drug.

   Supply Improvement - Initially, the production of Abecma could not meet the demand, leading to rationed availability. However, the supply chain has improved, aligning with the anticipated increase in demand following potential expanded clearance.

   Decision Date - The FDA is anticipated to deliver its decision regarding the expanded use of Abecma by December 16.

Ozempic hype forces employer calls on obesity coverage

By Alex Olgin and Dan Gorenstein - Spending on a new class of diabetes and weight loss medications hit nearly $7 billion in the first half of the year, as people are clamoring for these highly effective drugs. Employer health insurance plans are shouldering the bulk of that financial burden as half of Americans get their coverage through work. Read Full Article…

VBA Article Summary

1. Increasing Financial Burdens: Employers are grappling with escalating health care expenses as the costs of obesity medications surge, jeopardizing company prescription drug budgets. While employers aim to provide access to these beneficial but expensive drugs, they are also compelled to restrain overall health insurance costs. Unexpectedly high prices and the rapid adoption of new obesity treatments have left companies like the University of Texas System and Ascension unable to sustain coverage, prompting them to discontinue it.

2. Connecticut's Innovative Approach: Facing tripled spending on obesity medications, Connecticut's health plan for public employees has sought to manage escalating costs while maintaining access to essential treatments. State Comptroller Sean Scanlon has spearheaded an initiative to collaborate with Intellihealth, a specialist in obesity care. Through this partnership, employees can receive covered treatments provided they engage with Intellihealth for care guidance. This approach allows for the exploration of various treatment options, including new obesity medications or alternative lower-cost therapies, coupled with lifestyle and behavior modifications.

3. Seeking Cost-Effective Solutions: To mitigate the financial impact of obesity medications, some employers are exploring alternative approaches, such as directing employees towards diet programs, offering lower-cost medication options, or implementing insurer pre-approval requirements. However, experts caution that immediate savings may be limited as significant benefits, like preventing costly medical emergencies, will only manifest in the long term. The market dynamics are also unpredictable, with the entrance of new pharmaceutical competitors potentially leading to either price reductions or increases. Employers thus face the complex challenge of balancing the provision of valuable health benefits with managing rising costs in the upcoming years.

Drugmakers agree to negotiate drug prices with government, White House says

By Berkeley Lovelace Jr. - Major drug companies including Johnson & Johnson, Merck and Bristol Myers Squibb have committed to participate in Medicare drug price negotiations with the federal government, the Biden administration said Tuesday. Read Full Article…

VBA Article Summary

1. First-Time Price Negotiations: For the first time in history, Medicare, under the Inflation Reduction Act, will engage in direct price negotiations with pharmaceutical companies for selected high-cost prescription drugs, beginning with an initial list of 10 medications. These medications include widely-used drugs like Eliquis, Xarelto, Januvia, and Enbrel, which together demanded a significant out-of-pocket expenditure of $3.4 billion from approximately 9 million Medicare enrollees last year. This negotiation initiative is designed to significantly reduce the financial burden on older individuals by ensuring more affordable access to essential medications.

2. Delayed Implementation & Benefits: While this move is celebrated as a positive step forward for individuals on Medicare, the benefits won't be immediate. The government will commence negotiations with drug manufacturers starting next year, with the newly-negotiated prices scheduled to take effect in 2026. Consequently, Medicare beneficiaries will have to wait until the implementation to start experiencing the cost-saving benefits of this initiative, necessitating patience and strategic planning from older individuals who rely on these crucial medications for their health and well-being.

3. Industry Resistance & Legal Challenges: The introduction of direct price negotiations has not been welcomed unanimously, encountering resistance from prominent players in the pharmaceutical industry. Companies like Merck and Johnson & Johnson have initiated lawsuits against the federal government, opposing the negotiation provision embedded in the Inflation Reduction Act. These companies argue that the allowance of Medicare to influence drug prices negatively impacts their profit margins, potentially leading to decreased investment in the research and development of new drugs. This opposition presents a legal hurdle that needs to be navigated carefully to ensure that the new policy can be implemented as planned without undermining the industry's capacity for innovation and development of new treatments and therapies.

Wellness Wire - A New Normal

By Berkeley Lovelace Jr. - I read a quote by Ronne Brown, "We deserve to live in environments that bring out the softness in us not the survival in us." Yet, too many times we witness the reality of harsh physical and emotional environments. Many among us are grappling with life-situation fatigue and dealing with environments that perpetuate a fight-or-flight survival response. Read Full Article…

VBA Article Summary

1. Chronic Stress and Unhealthy Coping Mechanisms: Stress and anxiety, often cortisol-induced, have become pervasive in our lives, prompting individuals to resort to unhealthy coping strategies like overindulgence in food, substance abuse, and excessive technology use. These practices not only exacerbate stress but also contribute to a detrimental cycle impacting both mental and physical health. Alarmingly, for many, this cycle of stress and unhealthy coping is not an anomaly but rather a distressing norm.

2. Cultivating Allyship and Altruism for Workplace Wellness: As part of fostering a healthier approach to workplace wellness, this article proposes a shift towards promoting allyship through altruism, a practice that necessitates active listening, support, encouragement, and advocacy amongst colleagues, regardless of their differences. Allyship requires a selfless focus on the needs of others, underpinned by a commitment to embracing diversity and uplifting those in need of compassion, support, or recognition. By fostering a culture where allyship is prevalent, workplaces can ensure that every individual feels a sense of belonging and support, vital for mental health and overall well-being.

3. Addressing Individualism, Isolation, and Offering Support: In a world where individualism is often mistaken for a desire for isolation, it is crucial to acknowledge that while some prefer working alone, they might still crave inclusion and collaboration. Recognizing when someone is struggling and needs support is imperative, although it may be challenging due to the complexities and demands of our lives. Offering support can start with initiating a conversation, expressing concern, actively listening without judgment, and providing reassurance and patience. It’s essential to create an atmosphere where seeking help is normalized, and individuals feel secure enough to ask for it without fear of shame or judgment.