Home

Prescription E-Labels are Past Due

November 30, 2021
12:32 pm

Now decades into the digital age, most tasks can be completed electronically – ordering food, booking appointments, transferring funds, and even signing contracts. In the healthcare world, medical records and laboratory results can be accessed online rapidly and securely. Technological advancements have made these activities convenient, user-friendly and efficient.

And yet, there are corners of American healthcare that have continued to utilize paper as though the digital option is not available. More than 100 billion pages of paper are printed and distributed as package inserts for medications delivered to pharmacies each year. While this is environmentally wasteful, there are also safety implications with this process. Labels can be revised multiple times a year, and when that change is approved it can take up to a year for the updated paper copy to make it through the supply chain to the pharmacists. The delay can lead to conflicting information being provided to pharmacists and result in erroneous prescriptions negatively impacting the health of patients.

The National Institute of Health manages the National Library of Medicine’s DailyMed website, and has been posting the electronic prescribing information it receives from the FDA since 2005. In fact, in 2014 the FDA recommended that the default method of providing prescribing information be switched from paper to electronic, but the proposed rule has continuously been blocked by Congress. Most providers already rely on real-time electronic updates, as FDA-approved changes are immediately updated on DailyMed. It is not surprising that the physical labels, which are printed so small they are nearly impossible to read, usually get thrown away without a second glance as the most up-to-date information is readily available online.

Moving to a digital form is not just more convenient for prescribers, but for patients as well. If a medication comes with a QR code, the patient can access the updated information and be alerted to any changes or product recalls. They could also use a search function to jump to text with personalized information, augment the font, or watch videos that explain how to administer the medication. The opportunities to engage patients, increase medication adherence, reduce environmental impact and save money are infinite. The time for prescription e-labels is well past due.

The Parallel Roads of Representation and Access

October 28, 2021
1:28 pm

Guest post by: Dana Dornsife, Founder and CEO, Lazarex Cancer Foundation

There are many avenues to addressing health disparities, an essential health policy objective. To determine the most appropriate strategies, it is important to first identify gaps in the healthcare delivery process. Access to healthcare services is universally seen as a disparity that must be confronted. However, even after improved access is achieved, it is equally important for the most effective treatments to be available.  Some treatments are less effective for racial or ethnic minorities and that is because only five percent of racial or ethnic minorities participate in clinical trials.

Representation in clinical trials is vital for the creation of therapies and medications that are effective for all races and ethnicities. This is why the Lazarex Cancer Foundation was founded in 2006, to improve patient access to clinical trials for new cancer treatments. Lazarex’s vision is that everyone affected by cancer will have hope, dignity, support and the most advanced treatments made available to them at all stages of their journey. To make this a reality there are currently three programs available through the foundation:

  1. The Lazarex Care program focuses on improving the outcome of cancer care for advanced stage cancer patients, and the medically underserved, by identifying FDA clinical trial options, providing assistance with out-of-pocket costs for clinical trial participation and a travel companion, and facilitating community outreach and engagement.
  2. IMPACT was created to generate a sustainable proof of concept action plan to transform the status quo of clinical trial recruitment, enrollment, retention, minority participation, completion, and translational science – providing equitable and timely access to cancer discovery for all patients.
  3. Lazarex Cancer Wellness HUBs (pilot) revolve around place based and culturally appropriate community outreach & engagement in the poorest neighborhoods of Philadelphia and Los Angeles. Lazarex Cancer Wellness HUBs provide a “safe space” for community members to talk about health concerns in relation to cancer, explore options from prevention through treatment and clinical trials, and gain access to the treatments and resources they need to improve their cancer outcomes.

The Healthcare Leadership Council recently presented Lazarex with its Redefining American Healthcare award, recognizing programs throughout the country that are transforming care delivery.

While cancer does not discriminate, Black, Asian, Latinx, Pacific Islanders and Native Americans face disproportionately higher rates of mortality from cancers that could be survived when diagnosed and treated early. Helping cancer patients participate in FDA therapeutic clinical trials and ensuring appropriate representation will lead to more discoveries that have positive results for all patients.

While the Lazarex Cancer Foundation’s focus is on clinical trials, it is recognized that there must be representation along the continuum of care within the workforce as well. Whether it be scientists or providers, representation in every facet of the healthcare experience is vital to improving outcomes for a diverse population.

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.