Magellan Rx has been a market leader in developing forward-thinking solutions to combat rising specialty spend on the medical benefit for nearly 20 years. With a passion for solving complex pharmacy challenges, such as biosimilar management, we roll up our sleeves and tackle what is truly driving trend while ensuring a high quality of care for the members we serve.

Building on the success of our industry-first medical pharmacy program, including management of medical benefit oncology drug spend, we began to focus on advancing biosimilar utilization in 2015. Our goal was to empower health plan customers with education and strategies that turned biosimilar availability into cost savings while maintaining clinical quality. From the high-cost autoimmune category to oncology and beyond, our philosophy to biosimilar management involves three key components:

• Proactive Management: Assessing and developing clinical protocols while educating and communicating with network providers
• Medical Pharmacy Execution: Leveraging Magellan Rx’s innovative medical management expertise by incorporating biosimilars into key utilization management programs such as medical prior authorization and provider reimbursement/fee schedule management
• Expert Opinion: Continuously working to gain insights from our advisory board of specialists and Expert Clinical Network of key opinion leaders

But first, what is a biosimilar?

According to the U.S. Food and Drug Administration (FDA), a biosimilar is a drug type that is highly similar to an FDA-approved biologic, or reference product, with regards to its purity, molecular structure, and bioactivity. The biosimilar approval pathway starts with an application submission that includes analytical studies, animal studies, and at least one clinical study. A biosimilar is approved by the FDA after evaluation and testing to show it is as safe and effective as its reference product.

As of April 2021, there are now 29 FDA-approved biosimilar products across three different categories—20 have been launched to date, and 18 are oncology or oncology support.

Magellan Rx’s approach

In 2015, ahead of the first biosimilar approval in the U.S., our work began with a committee of experts to review the biosimilar landscape and potential impacts for payers. By 2016, we had established our first biosimilar-over-reference policy on the medical benefit, and in 2017 additional clients opted into the strategy with more growth in biosimilar savings.

The program was expanded in 2018 to include infliximab—the biosimilar for Remicade, a top spend drug used to treat autoimmune conditions such as rheumatoid arthritis and inflammatory bowel disease—by leveraging a comprehensive utilization management solution. As part of this initiative, our team of highly-trained pharmacists worked with physician offices and hospitals to ensure appropriate utilization for each patient’s unique situation.

Also in 2018, we established an Oncology Biosimilar Workgroup to prepare for future launches in this high-spend category (in fact, oncology and oncology support accounts for more than 40% of total medical pharmacy spend across the Commercial, Medicare, and Medicaid lines of business¹). We aimed to educate health plan customers, members, and providers through individualized strategies that consider clinical, financial, and regulatory factors. The oncology biosimilar program was launched in 2019 as oncology biosimilars hit the market, with early adopter implementation that resulted in maintaining or expanding member access to clinically-effective treatments while delivering significant drug spend savings.

Due to the success of the infliximab program and proactive approach to the launch of oncology biosimilars, we experienced a rapid expansion in 2020 as clients, representing millions of lives, began to adopt these innovative solutions. Oncology biosimilar utilization surged, and the (measured by the number of prior authorizations approved for the first two therapies with biosimilars compared to the reference brands) for early adopters. We also showcased results in research presented at the 2020 AMCP Annual and AMCP NEXUS industry events.

So far in 2021, biosimilar uptake continues to increase. Our team of experts previewed results from the oncology biosimilar program at the 2021 AMCP Annual event and spoke to The Center for Biosimilars on strategies that payers are using to promote biosimilar adoption.

Looking ahead, Magellan Rx remains committed to the biosimilar-first strategy and will continue to expand the program to include additional categories and available biosimilar agents as they are approved by the FDA. For more on payer management concerns related to biosimilars, read page 24 of the latest Magellan Rx Management Trend Report.  For up-to-date pipeline news, check out the MRx Pipeline Report. Have questions or want to implement a solution to meet the needs of your unique population? Connect with us today!

To learn more about Magellan Rx’s work, click here. 

1. Magellan Rx Management Medical Pharmacy Trend Report™, © 2021.

In January 2021, the United States (US) Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: New Drug Therapy Approvals 2020. This report provides a summary of a number of approvals and highlights the novel therapies approved in 2020, continuing the generally upward trend in approval volume seen over the past decade, despite the impact of coronavirus disease 2019 (COVID-19). Compared to 2018 and 2019, in which CDER approved 59 and 48 new drugs, respectively, 53 novel agents were approved in 2020. This number does not include new and expanded uses of already approved drugs, new formulations, new dosage forms, vaccines, blood products, cellular or gene therapy, or biosimilar approvals. Once again, the number of approvals exceeded the average of 41 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

Despite the ongoing pandemic the FDA continued their strategic initiatives to expedite the safe review of treatments in 2020. With the unprecedented challenges incurred in 2020, the FDA acknowledged that maintaining their commitment to bringing forth innovative therapies was difficult. Remarkably, the numbers reported by the FDA do not include the several emergency use authorizations (EUAs) issued by the FDA for COVID-19.

Last year, all 53 novel drug approvals again met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2020, 40% were considered first-in-class, and 58% were approved for rare diseases (Orphan Drugs), the latter of which increased from 44% in 2019. Priority Review was granted to 57% of novel drugs, 23% received Accelerated Approval, 42% were designated as Breakthrough Therapy (up from 27% in 2019), and 32% garnered Fast Track designation. Overall, 68% of all drug approvals in 2020 used expedited development and review methods. In addition, 92% were approved in the first review cycle, and 75% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2020 is illustrated in Figure 2, with agents within the oncology spectrum representing over one-third of 2020’s novel approvals.

The notable 2020 approvals encompassed new advances for the treatment of infectious diseases, including a new medication class for the treatment of human immunodeficiency virus-1 (HIV-1). Garnering perhaps the most attention, the FDA also approved the first medication for hospitalized patients with COVID-19. Unique infectious diseases in the US also received attention, with a new drug for malaria, two new options for the Ebola virus, and a new treatment for Chagas disease approved in 2020. In the neurology arena, there were multiple approvals of agents for more common conditions, such as migraine or Parkinson’s disease. Moreover, there were significant advances for rare neurological conditions, including the first oral agent for spinal muscular atrophy and new treatments for rare seizure disorders. In addition, two immunological agents were approved for the treatment of neuromyelitis optica spectrum disorder. Additional treatment options emerged for several autoimmune conditions in 2020 as well. Not surprisingly, numerous advances were made within the oncology umbrella, including both novel approvals and new or expanded indications for several existing agents. With over half of the novel approvals being classified as Orphan Drugs, in 2020, the FDA has fortified their dedication to providing innovative and often targeted treatment options for all individuals.

In contrast to the conventional drug approval pathway in which drugs are reviewed under a New Drug Application (NDA), approval of a biological product is done under a separate pathway known as the Biologics License Application (BLA). Examples of biologics include therapeutic proteins such as insulin, monoclonal antibodies, vaccines, and blood-derived products. While the NDA and BLA processes are similar, they are not identical. The typical generic drug provisions (e.g., same active ingredient, bioequivalence) do not apply to BLAs. Instead, the single biological product already approved by the United States (US) Food and Drug Administration (FDA) is referred to as the reference product; the new potential biosimilar is then compared to the reference product. For approval as a biosimilar, the manufacturer must demonstrate that the agent is highly similar with no clinically meaningful differences.

In July 2018, the FDA released their Biosimilar Action Plan, described by then FDA Commissioner Dr. Scott Gottlieb, as “aimed at promoting competition and affordability.” Then, in December 2018, the FDA announced the plan to transition biological products that were historically regulated as drugs and approved via NDAs to the biologics pathway, taking effect in March 2020. These products include insulin, human growth hormone, and glucagon, among others. This change was mandated by Congress in the 2009 Biologics Price Competition and Innovation Act, which allowed 10 years for the transition. When considered as drugs under the NDA pathway, it was virtually impossible to develop a generic equivalent due to the nature and the inherent variation in the manufacturing process of these products. On March 23, 2020, the FDA issued a statement noting that this change is now in effect.

However, in the US, even if an agent is determined to be biosimilar, it is not automatically interchangeable (a process by which a product can be substituted for another without the approval of the prescriber). For a biosimilar to be considered interchangeable by the FDA, it must meet even more rigorous requirements and be approved as interchangeable. For products that are biosimilar but not interchangeable, the prescriber still needs to write for the specific product. In addition, even if determined to be interchangeable by the FDA, state pharmacy laws may further regulate what substitutions may be made at the pharmacy level without the approval of the prescriber. Just as a listing of generic equivalents is available through the FDA in their Orange Book, the FDA lists biologics and any respective biosimilars in their Purple Book. Recently converted to an online database format, the Purple Book provides details on reference products, their corresponding approved biosimilars, and whether or not the biosimilar is interchangeable. To date, no biosimilar has been designated as interchangeable.

As described in a previous blog post, the cost of insulin has risen substantially, leading patients to take desperate measures. At a time of economic instability and health uncertainty, these access concerns are even larger. Now that these products have transitioned to the biologic approval pathway, once patent exclusivity has passed, biosimilars can be developed, evaluated, and approved. Moreover, biosimilars can be reviewed further and may be classified as interchangeable, which can further alleviate the burden by allowing substitution at the retail level depending on local laws. This landmark change can promote market competition, potentially driving increased availability and decreased cost. The FDA reports that even having one generic drug on the market can decrease prices to approximately two-thirds of the price without competition. Generally, initial list prices of launched biosimilars have been 15% to 35% lower than their reference products. Most importantly, in their announcement of this change on March 23, the FDA pledged that they are ready to review eligible applications to ensure efficient approval. Ultimately, this revised process will provide an opportunity for other manufacturers to introduce safe and effective product competition without clinically meaningful differences. While this may be challenging in light of the ongoing global pandemic, this change, 10 years in the making, offers hope for patients who use these medications.

In January 2020, the United States (US) Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: New Drug Therapy Approvals 2019. This report provides a summary of a number of approvals and highlights the “game-changers” approved in 2019, solidifying the upward trend in approval volume initially seen in 2017. Compared to 2017 and 2018, in which CDER approved 46 and 59 new drugs, respectively, 48 novel agents were approved in 2019. This number does not include new and expanded uses of already approved drugs, new formulations, new dosage forms, vaccines, blood products, cellular or gene therapy, or the 10 biosimilar approvals. This far exceeds the average of 38 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

In 2019, the FDA continued its strategic initiatives, with additional approvals of biosimilars and generics (both first-time agents and those off-patent with limited competition), as well as a focus on the expedited approval process, particularly for rare diseases and agents supported by positive patient-reported outcomes. Notably, the FDA hosted a public meeting in April 2019 to receive input on how to tackle barriers associated with the development of treatments for rare diseases, and held another meeting to celebrate “Rare Disease Day” in February 2020. Moreover, this trend is likely to continue, with the FDA releasing several guidances on gene therapy. The new pathway for insulin approval under biologic license applications planned for March 2020 and the launch of internet-based repositories or apps to improve access to information for both providers and patients (e.g., CURE ID in 2019, antiretrovirals in 2020) also highlight strategic initiatives of the FDA.

Last year, all 48 novel drug approvals met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2019, 42% were considered first-in-class, and 44% were approved for rare diseases (Orphan Drugs). Priority Review was granted to 58% of novel drugs, 19% received Accelerated Approval (more than doubling the rate of 7% last year), 27% were designated as Breakthrough Therapy, and 35% garnered Fast Track designation. Overall, 60% of all drug approvals in 2019 used expedited development and review methods. In addition, 90% were approved in the first review cycle, and 69% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2019 is illustrated in Figure 2, with approvals once again dominated by drugs in the expansive oncology spectrum.

Some of the notable 2019 approvals included new advances for the treatment of cystic fibrosis (CF), with the first triple combination therapy and expanded indications of existing CF therapy available to younger patients, and the first new medications in several years for sickle cell disease. Additionally, several approvals targeted rare conditions, such as erythropoietic protoporphyria, neuromyelitis optica spectrum disorder, tenosynovial giant cell tumor, Duchenne muscular dystrophy, and systemic sclerosis-associated interstitial lung disease. Beyond treatments for rare disease and cancer, the FDA also approved agents for more common disorders, including multiple sclerosis, novel treatments for depression, migraine and cluster headaches, epilepsy, several autoimmune conditions, age expansions for diabetes therapy, and a drug-sparing regimen and new prophylaxis option for human immunodeficiency virus-1 (HIV-1). Although down slightly from 2018, the large number of approvals from 2019 represent a continued trend by the FDA to expedite and increase the quantity of annual approvals.

On January 31, 2020, the United States (US) issued a public health emergency for 2019 novel coronavirus (2019-nCoV), a new virus first identified in Wuhan City, Hubei Province, China. This comes on the heels of the World Health Organization (WHO) declaring the coronavirus outbreak an international public health emergency. The disease now called coronavirus disease 2019 (COVID-19), which is a new type of coronavirus without a vaccine or medications to prevent or treat it, has resulted in thousands of confirmed cases and hundreds of deaths in China. This human respiratory illness is moving quickly with cases reported in a number of other countries and continents. In the US, while the number of confirmed cases are currently low, safety measures are being enacted to keep the risk of transmission low. As ongoing investigations seek to learn more about this infection, US public health agencies have dedicated coronavirus sites. They actively update these sites as new information becomes available and communicate up-to-date guidance. 

• Centers for Disease Control and Prevention (CDC): https://www.cdc.gov/coronavirus/2019-nCoV/index.html
• Food and Drug Administration (FDA): https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19
• World Health Organization (WHO): https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Disclaimer: The content in this blog article is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your healthcare provider.

In January, the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: 2018 New Drug Therapy Approvals. This report provides a benchmark for approvals and highlights the game-changers approved in 2018. Compared to 2016 and 2017, in which CDER approved 22 and 46 new drugs, respectively, in 2018 a total of 59 novel agents were approved. This number does not even include new and expanded uses of already approved drugs, new formulations, new dosage forms, or the seven biosimilar approvals. This marks the largest number of novel approvals in over two decades and far exceeds the average of 33 novel approvals per year in the past 10 years, surpassing the record setting approvals in 2017. Figure 1 outlines approvals and filings over the past 10 years.

Several potential explanations may account for this uptake in approvals in the past couple years. The FDA’s leadership, with its continued strategic initiatives, may be partly responsible for the increase. In early 2017, the FDA was criticized following the lower than average approvals seen in 2016. Public interest in opioid abuse and dependence treatment, access to drugs for rare diseases, drug shortages, and competition potentially affecting pricing have also put the FDA at the forefront of the public’s mind, further challenging the FDA to demonstrate action in the public’s interest. Finally, additional defined methodology for evaluating data in rare diseases, such as real-world and patient reported outcomes, may also have played a role.

Last year, all 59 novel drug approvals met their Prescription Drug User Fee Act (PDUFA) goal dates. In 2018, 32% were considered first-in-class and 58% were approved for rare diseases (Orphan Drugs). Priority Review was granted to 73% of new drugs, 7% received Accelerated Approval, 24% were designated as Breakthrough Therapy, and 41% garnered Fast Track designation. Furthermore, 95% were approved in the first review cycle, and 71% were approved in the US prior to approval in other countries. A breakdown of the types of drugs approved in 2018 is illustrated in Figure 2, with drugs in the expansive oncology spectrum once again dominating the approvals.

Some of the notable 2018 approvals included the first non-opioid drug approved to reduce opioid withdrawal symptoms, a new antiretroviral for multidrug resistant human immunodeficiency virus-1, a new class of drugs for migraine (calcitonin gene-related peptide receptor antagonists), the first FDA-approved drug derived from marijuana, the first treatment approved for multiple sclerosis in children, expanded options for cystic fibrosis, and the first antibiotic approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs.

Among the several Orphan Drugs approvals were drugs for Fabry disease, phenylketonuria, X-linked hypophosphatemia, Lennox-Gastaut syndrome, Dravet syndrome, hemophagocytic lymphohistiocytosis, adenosine deaminase deficiency, and Lambert-Eaton myasthenic syndrome.

Although 2019 approvals have begun more slowly, given the substantial number of approvals in 2018, it appears that the large number of approvals from 2017 was not an anomaly but, perhaps, the continuation of a trend.