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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.

Time to Discuss a “Health Equity Moonshot”

March 31, 2021
5:41 pm

This month, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the health inequities witnessed during the COVID-19 pandemic.  The topics discussed in that hearing warrant our sustained attention.

I’m particularly focused on the testimony of Eugene Woods, the president and CEO of Atrium Health (a Healthcare Leadership Council member), a North Carolina-based health system. Out of the tragedies we have witnessed during COVID-19, which have disproportionately affected racial and ethnic populations as well as areas with high rates of poverty and comparably limited healthcare access, Mr. Woods sees an opportunity to do something significant and transformative.

As he put it, “The COVID-19 pandemic has come at a great cost to the world. We should view this reality as an investment that allows us to emerge stronger.  Through unity and collaboration, government and industry are capable of great things. This has been, and still is, a core tenet of American exceptionalism.”

In his testimony, Mr. Woods offered the notion of a private-public collaboration not unlike the efforts that put astronauts on the moon or the Cancer Moonshot Initiative of a few years ago.  In fact, he referred to it as a “health equity moonshot” and suggested four priorities to address the equity gaps that have existed for too long but were made glaringly obvious during the pandemic.  They are:

  • Extending health coverage access beyond the current Public Health Emergency by utilizing innovative private models and government-based structures.
  • Creating worldwide standards for data collection and full data interoperability to enable real-time analytics.
  • Making broadband available to every rural and urban community in the country.
  • Using technology to support sustained well-being, particularly in underserved communities.

If we truly believe in the goal of accessible, high-quality healthcare for every American, then this is an idea that should receive extensive attention and discussion.  To quote Mr. Woods again, “While COVID-19 and the public health emergency we have faced may fade over time, the health inequities the pandemic uncovered will persist if we don’t take this moment to come together around an ambitious goal.”

An Innovative Approach in Minnesota to Close the Gap Between Mental Health Needs and Treatment

February 25, 2021
8:15 am

It has always been important to improve access to treatment for mental health and substance use disorders.  Now it’s imperative.

Even before the arrival of COVID-19, national numbers raised serious concerns.  Twenty percent of Americans reported experiencing depression or an anxiety disorder while also having substance abuse issues. Drug overdose deaths have more than tripled since 1990, and almost 21 million Americans have at least one addiction with only one of every 10 receiving treatment for the condition.  The pandemic has worsened our society’s struggles. According to the Kaiser Family Foundation, in August of 2020, 53 percent of adults reported that their mental health had been negatively impacted as a result of the changes wrought by COVID-19. This, in turn, has caused the number of people with substance use disorders to rise.

Now, more than ever, investments must be made to ensure access to treatment and innovative ideas must be pursued to address these mental health challenges.  One such innovation is taking place in Minnesota.

One clear obstacle patients face is the lag time between the initial request for care and the availability of specialists and treatment programs. While this wait time is occurring, there is a heightened risk of suicide, drug overdose, or a change of heart about pursuing treatment. Recognizing this dilemma, M Health Fairview initiated a new program to bridge this gap. The program is designed to provide same-day access to either in-person care or virtual care with trained providers.  Additionally, the health system has included a mobile unit that proactively brings the support directly into the community. Emergency Medicine Physician and Psychiatrist Dr. Richard Levine emphasized that this program does not replace any type of care, but rather simply provides the stability patients need in their transition from initial treatment to longer-term care.

These are difficult times for so many Americans. Health providers like M Health Fairview are demonstrating innovation and leadership in meeting the urgent needs of those with mental health or substance use disorders.