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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.

 

 

 

Lawmakers Have a Drug Pricing Solution Right in Front of Them

October 04, 2021
10:52 am

As Congress continues to deliberate on drug pricing proposals that many would call extreme, even radical – empowering the federal government to set prices instead of having prices negotiated in the marketplace – a leading health policy research firm has issued findings that should lead lawmakers to turn toward solutions that would not undermine medical innovation but would have a significant impact on the actual costs consumers experience at the pharmacy counter.

In 2020, Senator Chuck Grassley (R-IA), then chairman of the Senate Finance Committee, introduced the Prescription Drug Pricing Reduction Act (PDPRA)  which, for a time, enjoyed bipartisan support.  The bill would have, among other provisions, capped out-of-pocket costs for Medicare Part D beneficiaries at $3,100 annually, allowed beneficiaries to spread those costs over a full year instead of facing heavy charges up front, and reduced coinsurance levels in the initial coverage phase of Part D from 25 to 20 percent.

Avalere, the highly-respected health policy research firm, has performed some new analysis on what the Prescription Drug Pricing Reduction Act would do for Part D enrollees (those who do not qualify for low-income assistance), and it’s striking.

The Avalere study found that the provisions of the PDPRA would provide beneficiaries a 23 percent reduction in out-of-pocket costs compared to current law.  The research showed even greater cost reductions for Black (25%), Hispanic (25%) and North American Native (26%) beneficiaries.

And as the Avalere authors point out, the impact of lower out-of-pocket costs goes beyond financial security: “A large body of research has identified relationships between out-of-pocket costs for prescription drugs, treatment adherence, and health outcomes.  In addition, non-adherence to treatment can have a significant impact on patient outcomes, resulting in higher costs of care, disease progression, and adverse events.  As policymakers further consider reforms to Part D, assessing the impact of reforms on different patient populations, based on disease/condition, race, and reason for entitlement is an essential step to understanding all the possible impacts on access, affordability, health outcomes, and health disparities.”

This research should serve as an invitation for lawmakers to pull back from extreme approaches and the significant consequences that can impact patients and the future of our healthcare system and instead look to common-sense solutions that will directly achieve a bipartisan objective – reducing the amount of money seniors are paying out of pocket for the medicines they need.

The Problematic Push to Slow Medicare Advantage’s Positive Health Impact

September 23, 2021
3:40 pm

In the complex deliberations on Capitol Hill to assemble a social spending package that can pass both houses, one of the prominent proposals being discussed is the expansion of Medicare benefits to include dental, vision, and hearing coverage.  The cost would be significant, over $300 billion over 10 years based on an earlier estimate.  There are valid arguments to be made for closing gaps in current Medicare coverage. Where millions of Medicare beneficiaries need to be concerned, though, is in one of the ideas being tossed around to pay for this coverage expansion, placing the financial burden on Medicare Advantage (MA) plans and those who rely on them for their healthcare.

Some have suggested financing these additional benefits by excluding them from the benchmark that Medicare uses to determine payment rates for Medicare Advantage plans.  The USC-Brookings Schaeffer Initiative for Public Policy, in fact, published an essay advocating this approach.

Let’s break down exactly what this means and clarify the ramifications of such a step.  Under this approach, Congress would be creating new defined benefits for Medicare beneficiaries, but it would not be funding those benefits for MA plans.  MA plans receive rebates from the government by submitting bids for the coming plan year that are lower than the benchmark.  Those rebates are generally funneled back into additional benefits for enrollees and initiatives to address social determinants of health (more on that in a moment).  If the range of defined Medicare benefits expands but that is not reflected in the benchmark, that will mean a significant shrinkage of rebates to MA plans.

Put succinctly, for the first time ever, Medicare would be segmenting its beneficiary population into different groups with different levels of benefits. Medicare Advantage plans and enrollees will be paying for expanded benefits for those in conventional fee-for-service Medicare, and there will be consequences for doing that.

Today, more than four of every 10 Medicare beneficiaries – over 26 million in all – are enrolled in an MA plan, with that number growing annually.  And as more seniors enroll in these plans, the collective health of the over-65 population improves.  Research has shown that MA plans surpass conventional fee-for-service Medicare on multiple clinical quality measures and patient experience standards.

Just as importantly, as health experts come to the increasing realization that non-clinical social determinants can have an even greater impact on health than clinical care, more Medicare Advantage plans are providing coverage for transportation, housing, nutrition and social support services. This can make a profound difference in the lives of at-risk seniors. If, however, lawmakers choose to take dollars out of Medicare Advantage in order to fund proposed dental, hearing and vision benefits, something has to give.

No one is suggesting that Congress shouldn’t address existing gaps in Medicare coverage, but there needs to be greater foresight in determining how to pay for it.  It makes little sense to undermine a program that is providing quality healthcare to our most vulnerable age group and is addressing the social determinants that affect lives and health.

Technological Solutions for Vaccine Credentialing Critical to Nation’s Progress

September 20, 2021
10:47 am

Proof of COVID-19 vaccination has become, it’s an understatement to say, a political hot button issue across the country.  Nonetheless, as more private employers insist that their workforces be vaccinated and schools across the country reopen for in-person learning, vaccination credential are going to be increasingly viewed as vital to protecting public safety.

As Politico and other news outlets reported last week, the electronic health records company Epic (a Healthcare Leadership Council member) is in the process of implementing a technological solution that will give tens of millions of Americans the ability to easily carry their coronavirus testing and vaccination status with them through a smartphone app or printed document.

People with Epic’s MyChart phone app will be able to keep that testing and vaccination data stored on their smartphone and, if they don’t have a smartphone, they will be able to print out a QR code that will provide access to that information.  If a person doesn’t have their vaccination status stored in their medical record, MyChart can pull that data from a state registry. Right now, about 40 health systems with 17 million active MyChart users have access to this solution.

There has been considerable progress in this area from private sector health data companies.  Change Healthcare (also a Healthcare Leadership Council member) introduced a no-fee, privacy-protecting portable Vaccination Record that provides a security-enabled and durable record of vaccinations and allows consumers to easily see, save and share their vaccination record whenever the need arises.

Controversies aside, getting this country back to normal requires not only widespread vaccinations for COVID-19, but also documentation of vaccination in order to protect public safety.  The private sector is swiftly and effectively answering this need for consumer-friendly solutions.

Addressing Children’s Behavioral Health Through School Telehealth Programs

August 25, 2021
2:44 pm

Children are the future, however what does the future hold for our children? The CDC estimates that as many as one out of five children experience a mental disorder in a given year and mental health has become an important public health issue. The Wall Street Journal recently highlighted the rising rates of depression and anxiety resulting from digital addiction, which worsened exponentially during quarantine. The author stated that the digital drug of choice is the equivalent of the hypodermic needle for a wired generation.

Providing behavioral health services to children, particularly those living in rural communities, is challenging. However, a partnership between Blessing Health System and Teladoc Health has led to a pilot telehealth program in Missouri for a school district of 11,000 students. As a hybrid model, school nurses are able to connect with the local health system and create appropriate treatment plans based on the acuity of each situation. The school system has already seen the benefit of virtual health technology through decreased absences.

There were many factors in ensuring this pilot was effective. The school district’s Wi-Fi needed to be upgraded to guarantee reliability with the technology. School counselors were included in the program to integrate the behavioral health aspect. Parents were educated about the conveniences of telehealth and how register their children. The program now intends to expand even more into behavioral health and into more schools.

This is a prime example of how effective partnerships between health systems, technology companies and school systems can be for local communities. As children return to in-person learning, and potential long-term effects of quarantine appear, programs such as this one weave a safety net and keep parents, teachers and healthcare providers in sync.