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Improving Diversity in Our Clinical Trials for Long-term Health Equity

June 01, 2022
2:19 pm

Across the healthcare industry work is taking place to address health disparities. The Healthcare Leadership Council (HLC) has delved specifically into social determinants of health, broadband access, disparities in care delivery, vaccine acceptance, behavioral health, and workforce and clinical trial diversity. Amgen, an HLC member, is a leader in improving clinical trial diversity as a means to ensure better outcomes for those of diverse racial and ethnic backgrounds. This recent post below lays out the company’s comprehensive strategy, strengthened by collaboration, to address systemic issues which affect participation in research.

Improving Diversity in Our Clinical Trials for Long-term Health Equity

Darryl Sleep, Amgen’s senior vice president and Global Medical and Chief Medical Officer

Last April, Amgen stood with PhRMA as the first-ever industry-wide Principles on Clinical Trials Diversity officially took effect. The goals of these Principles are to expand participation among diverse patient populations by increasing understanding and awareness about clinical trials and improving access. Since then, we’ve already seen two very significant positive outcomes. First, improving diversity and representation in clinical trials has evolved from a niche issue into a core industry commitment. Second is the development of enthusiastic, industry-wide initiatives to improve how sponsors approach and improve diversity and representation in clinical trials. We are sharing best practices and de-identified aggregated clinical trial data to continue advancing this work via our cross-industry collaborations and partnerships. In this purpose, there is no holding back; we are all dedicated to making long-overdue changes that will result in diversity and representation in clinical trials becoming a reality and not just an ideal.

Clinical trials are a critical part of the long and careful process of developing new medicines. This research is complex and multidisciplinary and there isn’t a single accelerator that can be used to address the systemic issues that deter people from participating. Instead, we need a range of different levers to update decades-old processes and create new best practices.

I want to use the one-year anniversary of the PhRMA Principles to share some highlights about the data-driven efforts we’ve taken at Amgen to lead the way in breaking down barriers and help us find new medicines supported by clinical trials that are representative of all patients who suffer from serious illnesses.

We have a dedicated team
While the push for more diversity and inclusion in clinical trials is not new to Amgen, we accelerated our efforts in 2020 with the formation of RISE (Representation in ClInical ReSEarch), a team dedicated to addressing the systemic issues that deter people from participating in research, especially those who have been historically excluded due to race, ethnicity, sex, age, and other factors. We have significant momentum with our goals as programs and teams across Amgen, including RISE, Global Medical, Advocacy, Compliance, and Global Development, trial execution and data & analytics teams work together to create greater equity through diversity and proportional representation in clinical trials.

Ongoing learning to gain understanding and insights
Communication and information-sharing are fundamental to driving change. The output from our Health Equity Summit: Disrupting Health Disparities through Partnership and multiple Community Advisory Boards focused on direct insights from Black, Indigenous and People of Color (BIPOC) which provided information on barriers, strategies, and tactics that can apply across communities. We are using these insights to directly inform the design and implementation of a long-term, study-agnostic community engagement plan – a critical step in building sustainable, trusted relationships. Additionally, our patient-focused advisory councils with representation of racial and ethnic minorities will inform our clinical trial design and execution.

Building foundational capabilities
Logistical and financial barriers, gaps in awareness, and lack of trust all impact participation in clinical trials. We are partnering with organizations and diverse suppliers to thoughtfully build our enrollment support capabilities, including providing transportation, and other potential support capabilities, as well as finding optimal ways to support staff at clinical trial sites. Taking a holistic approach to tackling these industry-wide issues will help us move the needle.

New partnerships and collaborations
Collaborative partnerships play a significant role in advancing understanding of the science and our ability to positively engage patient communities in clinical trials. Toward that end, we are engaged in a number of efforts including:

  • A pilot program of the American Cancer Society Cancer Action Network to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials, including navigators to help patients address logistical and financial challenges to enrolling and completing those clinical trials.
  • The CEO Roundtable on Cancer’s Going for Gold initiative, in partnership with Historically Black Colleges and Universities (HBCUs) and Hispanic Serving Institutions (HSIs), that focuses on equitable cancer care.
  • A collaboration with The Digital Medicine Society (DiMe) to drive inclusion in digital clinical trials by providing the tools and framework necessary to successfully engage underrepresented populations during the planning process for clinical trials that include a technology device for participation.
  • Creation of the HBCU BioTech Fellowship program, a professional development program that will prepare and empower 50 students (and soon-to-be graduates) from Historically Black Colleges and Universities for careers at Amgen.

Measuring progress in our own trials
We have undertaken important steps including a baseline study that will help us measure progress for trials currently underway as well as for new trials on the horizon. Additionally, we have a number of tools in development to help us measure and evaluate best practices for improvement in enrollment of participants from diverse racial and ethnic backgrounds.

Recognizing differences in disease incidence, exposure and response to medicines
We have long been committed to unlocking the potential of biology for all patients suffering from serious illnesses using advanced human genetics to unravel the complexities of disease. Accordingly, we are using data on human diversity in our own labs and with research partners. Together, we will better understand incidence of obesity, cardiovascular disease from risk factors such as elevated Lp(a), inflammatory diseases such as atopic dermatitis and lupus, and multiple cancers in diverse populations.

In addition, we are seeking to understand and actively address the social determinants of health (SDOH) that contribute to wide health disparities and inequities that impact disease burden and access to healthcare.

Reaching the finish line will allow us to get new medicines faster to patients who need them. It will also help doctors assure their patients that the medication they’re being prescribed was studied in people like them, with results that indicate they are likely to benefit. We’re not there yet, but we’re taking informed steps with care, with the scientific expertise for which we are known, and with humility. Every day, we dedicate ourselves to serving patients by transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. As we work to fulfill our own values and PhRMA’s Principles, we’ll get closer to serving all patients, beginning with clinical trials that include people of all races and ethnicities who will benefit.

For more information, please visit Clinical Trial Diversity & Representation.

Americans Deserve the Full Truth About Medicare-For-All and its Ramifications for their Healthcare

May 05, 2022
4:24 pm

So much of the nation’s discussion about the Medicare-for-all concept takes place through a political prism.  It’s important, though, to fully understand what such a drastic change to our healthcare system would mean for patients and the care on which they depend.  We welcome Barclay Berdan, the chief executive officer of Texas Health Resources, a faith-based non-profit healthcare system, to share his expertise on the subject.

Americans Deserve the Full Truth About Medicare-For-All and its Ramifications for their Healthcare

by Barclay Berdan, chief executive officer, Texas Health Resources

Everyone, advocates and opponents alike, acknowledges that changing our healthcare system from the status quo to a Medicare-for-all concept would bring about a seismic transformation in the way Americans receive care. Given that such an idea has become a frequent talking point in policy and political circles, it’s critical that the public understand the full ramifications of such a complete remake of American healthcare.

Today, roughly 160 million people in this country have private health insurance that is sponsored by an employer. Almost 14 million have purchased private health plans through the Affordable Care Act marketplaces. Even within the Medicare program, 26 million beneficiaries have elected to enroll in private Medicare Advantage plans. Under the predominant Medicare-for-all proposals we’ve seen, these private plans would all go away and be replaced by a single government-run health coverage infrastructure. We would be remiss if we didn’t give thought to how this could affect patient access to hospitals and physicians.

Hospitals are required to think about what we call payer mix. Private health insurance reimburses at a higher rate for healthcare services than Medicare and Medicaid do.  In fact, historically, Medicare and Medicaid payments are less than the actual cost hospitals absorb in providing those services. (According to one study, in 2017, those combined Medicare and Medicaid underpayments totaled nearly $77 billion.).  Hospitals, which generally operate on very thin margins, can afford to keep their doors open and provide care to Medicare and Medicaid patients because of those comparatively-higher private plan reimbursements.

So what happens if every single American becomes a Medicare beneficiary?  Our first concern has to be those communities that are in greatest risk of losing their hospitals even under the current healthcare financing system.  According to the Center for Healthcare Quality and Payment Reform, 130 rural hospitals have closed in the past decade and another 900 are in danger of ceasing operations in the near future.  Many of these healthcare providers have low financial reserves and could not absorb a significant revenue loss.

Then, there are the current and future healthcare workforce shortages that were only exacerbated by the COVID-19 pandemic.  A Mercer study tells us that, just four years from now, we will have a shortage of 3.2 million healthcare workers. Within a system financed entirely by the federal government, how will salary rates be set for healthcare professions and will they be sufficient to encourage more people to pursue health-related jobs?  And will we have enough personnel to meet what will be an expected rise in utilization under a system in which presumably everyone is covered for every healthcare service (or, will a Medicare-for-all system have to impose restrictions on utilization, a topic that has been severely under-discussed up to now).

Of course, it is always possible that, in creating a Medicare-for-all program, Congress could establish reimbursement rates that are sufficiently high to fully replace the loss of private plan payment levels.  That would, however, raise a plethora of questions about total cost for a Medicare-for-all program and the taxes required to pay for it.

The point being that we are likely to hear a lot about Medicare-for-all in the weeks and months ahead. We need more than political rhetoric, though, to rationalize completely overturning a healthcare system that is currently utilized by most Americans.  Tough questions about ramifications and possible consequences need to be asked and answered before we even consider moving from point A to a radically different point B. In the meantime, we should look at how to improve the current system to provide better care to those who don’t currently have access to it, roughly 10 million uninsured individuals without access to subsidies. Also, the administration’s action this month to improve the Affordable Care Act’s coverage affordability for families was an important step.  It is abundantly clear that we can improve both health care and health by improving what we have.

 

Understanding State Laws for Interchangeable Biosimilars

October 15, 2021
12:40 pm

An important development in the biopharmaceutical world, with significant ramifications for patients, is the progress being made on biosimilars.  These are products with the same safety and efficacy as FDA-approved biologic medications, but potentially less costly for patients.  Below, executives with Cardinal Health, a global manufacturer and distributor of healthcare products and a Healthcare Leadership Council member, discuss the laws governing the interchangeability of biologics and biosimilars and how pharmacists can provide the medication that best meets their patients’ needs.

Understanding State Laws for Interchangeable Biosimilars

by Sonia T. Oskouei, PharmD, BCMAS, DPLA, Vice President, Biosimilars, Cardinal Health and Jeff Baldetti, Director, Biosimilars, Cardinal Health

Earlier this year, the FDA approved Semglee (insulin glargine-yfgn), the first interchangeable biosimilar in the US. The approval represented a significant milestone since the development of the Biologics Price Competition and Innovation Act in 2009 for a few reasons: it is the first interchangeable biosimilar to be approved in the US, it’s the first official biosimilar for an insulin product, and it’s the first biosimilar that will primarily be dispensed in retail pharmacies. With the approval comes the significant opportunity to help expand access to high-quality, lower-cost treatment options for patients with diabetes.

What Are Interchangeable Biosimilars?
Biosimilars are biologic products that are highly similar to, and as safe and effective as, existing FDA-approved biologics. Interchangeability is a regulatory designation that is unique to the US and is achieved through the submission of additional data (which per FDA guidance, may be in the form of switching studies). Interchangeability designation does not denote clinical superiority, as all biosimilars- whether interchangeable or not- meet the FDA’s rigorous regulatory standards for approval.

Why is Interchangeability Important?
The most important aspect of interchangeability is the implication associated with the designation. Interchangeability designation ultimately allows “pharmacist-level substitution,” whereby a pharmacist can automatically substitute the branded biologic with the biosimilar (as done routinely with brand and generics), per state laws. Given these implications, the designation is likely to have the greatest impact on biosimilars dispensed by pharmacists in the retail/specialty pharmacy setting (e.g., products billed under the pharmacy benefit).

Biosimilars are developed with the promise of increasing access and lowering costs for biologic therapies, which represent the most expensive drug category in the world. Interchangeability designation can position pharmacists to further enhance patient accessibility to biologics at a lower cost through automatic substitution authority.

State Pharmacy Laws
Currently, all 50 states and the District of Columbia have laws pertaining to interchangeability; however, pharmacy laws and practices vary from state to state, including requirements related to provider notification/permission, patient communication, and documentation practices. In addition, some states require that interchangeable products can only be swapped if the cost is lower, which adds a need for pharmacists to understand the managed care landscape, including PBM/payer formularies and policies and their impact on patient out-of-pocket costs. With the launch of an interchangeable version of Semglee (insulin glargine-yfgn) expected later this year, plus more interchangeable biosimilars seeking approval, it is critical for pharmacists to understand state requirements and prepare to operationalize these new treatment options.

Resources for Pharmacists
To help pharmacists navigate individual state laws regarding interchangeability, Cardinal Health has created an interactive map that provides pharmacists with key information to help prepare for interchangeability so they’re able to appropriately educate and support their patients with treatment options. The map details how each state defines interchangeability, clarifies the requirements pharmacists must follow to substitute biosimilars, and defines what healthcare providers and pharmacists need to know about switching to a biosimilar.

 

 

 

Why We Don’t Need and Shouldn’t Want a Public Option

August 11, 2021
2:07 pm

Earlier this year, Senator Patty Murray (D-WA), the chair of the Senate Health, Education, Labor and Pensions Committee, and Congressman Frank Pallone (D-NJ), chairman of the House Energy and Commerce Committee, announced their intent to introduce legislation creating a government-run public health insurance option to compete with private insurers and asked interested organizations to offer perspectives on the issue.  In the Healthcare Leadership Council’s (HLC) written response, I told the lawmakers that a public option “is an unnecessary and potentially damaging policy alternative” that “creates a distorted playing field on which private health plans could not adequately compete.”

But this requires some elaboration.

When Congress debated the Affordable Care Act in 2010, heavy Democratic majorities in the Senate and House rejected the notion of a public option.  Today, the country and Congress are more evenly divided and there is even less reason to make such a significant change to our health coverage system.  We are enjoying exceptional stability in which there has been minimal change in monthly premiums in the individual health insurance market for three consecutive years.  And we shouldn’t forget that 160 million Americans have health insurance provided by their employers, a benefit worth $800 billion annually in personal value to American families.  While there is widespread agreement that we need to continue working toward even greater coverage affordability and accessibility, a public option creates more problems than it solves.

In the HLC response to Senator Murray and Congressman Pallone, I detailed several other likely consequences that would occur if a public option was created:

  • A public option offering comparably low, taxpayer-subsidized premiums and reduced out-of-pocket costs would create a scenario in which private plans could not reasonably compete, creating political pressure to make the public option available to all consumers. One study projects this would lead to 123 million people enrolled in the government-run program by 2025, completely destabilizing a private insurance market that – according to a November 2020 Gallup poll – Americans still prefer.
  • Patients would likely see decreased access to healthcare providers should a public option come into existence.  When Oregon was deliberating the creation of a state public option, an analysis written by President Biden’s administrator of the Centers for Medicare and Medicaid Services (when she was managing director of a health policy analysis firm) found that the public option would likely reduce provider payment rates in order to achieve lower monthly premiums for enrollees.  This would be devastating for hospitals, particularly for smaller rural providers.
  • If a goal of the public option is to reduce the number of uninsured in the country, it’s likely to fail.  A KNG Health Consulting analysis of the public option concept found that roughly 90 percent of enrollees would be comprised of individuals who were already covered by employers or a commercial non-group plan.  In other words, it would simply erode the already-successful private marketplaces.

As I told the lawmakers, there are better, less disruptive, more patient-centered policy alternatives.  Among them, use premium tax credits and cost-sharing protections to strengthen access to coverage and care for lower-income consumers.  Establish a permanent health reinsurance program to support the cost of care for those with significant medical needs.  Encourage innovation in state Medicaid programs to emphasize whole person and value-based care as well as care coordination.

In other words, we can have a better health coverage system that serves the needs of every American, but the public option concept would make quality healthcare less, not more, accessible.

Investing in Non-Traditional Access to Care

May 25, 2021
2:26 pm

Even before COVID-19, our healthcare system was evolving to expand remote and in-home care.  The pandemic has underscored the importance of providing quality care to people where they are.

Leading by example, Mayo Clinic, a Healthcare Leadership Council member, and Kaiser Permanente have partnered to invest in Medically Home Group, a technology-enabled services company which offers a virtual and physical care delivery model including a 24/7 medical command center staffed by an array of clinicians and an integrated care team in the community who deliver care to patients at their bedside. Using this platform, providers can address clinical conditions of greater acuity without the patient needing to enter the hospital. Results have shown that patients who still need to be hospitalized using the integrated Medically Home model have a lower need for recurring hospitalization at 30 and 90 days following a care episode.

Gianrico Farrugia, M.D., president and CEO of Mayo Clinic stated, “Our partnership with Kaiser Permanente and Medically Home will create the next generation of patient-centric, compassionate health care that seamlessly integrates advanced technology with clinical expertise. By bringing best-in-class clinicians and services to patients in their homes, we’ll be able to provide more people with individualized care that’s tailored to meet their specific needs.”

This model increases health system capacity and resiliency and helps close gaps in care for vulnerable populations. Medically Home estimates that 30% of hospitalized patients can benefit from this model. Both Mayo Clinic and Kaiser Permanente have launched programs to ensure complex, comprehensive care is available outside hospital walls, engaging patients in their homes and integrating information such as social determinants of health into their care plans. This is the way of the future, and Mayo Clinic and Kaiser Permanente are demonstrating how healthcare institutions can effectively expand their reach beyond traditional settings.