Drug manufacturers and partners look toward advancements in post-COVID world
With a global pandemic barely in the rearview mirror, the gaze of the pharmaceutical industry is clearly focused on what lies ahead.
The tough lessons taught by COVID-19 have reshaped the global pharmaceutical supply chain and how manufacturers approach bringing new treatments to market. Pharma has also placed emphasis on coordination and communication with downstream stakeholders like distributors, payors, physicians, pharmacies and the ultimate end user—the patient.
As much disruption as the crisis caused almost two years ago, the pandemic also heralded the introduction of new and innovative treatments, revealed the flexibility and strength of the global drug supply chain, and triggered widespread adoption of digital technologies that are here to stay.
With 2022 right around the corner, the industry, which hasn’t lost sight of COVID-19 and its treatment pipeline, which includes 670+ drugs in development programs and 470+ trials being reviewed by the FDA, according to the FDA’s Coronavirus Treatment Acceleration Program (CTAP). The industry is buzzing with all the innovation, and not just as it relates to COVID-19.
2021 was a pivotal year for the biosimilar marketplace. In July 2021, the FDA approved Viatris’ Semglee (insulin glargine-yfgn) to be the first interchangeable biosimilar product available on the market and the first biosimilar to enter pharmacies and be covered under patients’ pharmacy benefit. Biosimilars may continue to break new ground as we head into 2022 and 2023, that is when blockbuster drugs like Eylea (aflibercept) which is indicated to treat wet age-related macular degeneration; Humira (adalimumab) used to treat several conditions like arthritis and plaque psoriasis; Stelara (ustekinumab), which also targets plaque psoriasis as well as psoriatic arthritis; and Prolia (denosumab) that focuses on osteoporosis and is used to treat bone cancer and bone problems in cancer patients, will start to see biosimilar competition.
Biosimilars now have a proven track record of giving physicians and patients clinically equivalent treatment options at a lower cost. In fact, biosimilars entering the market are generally 15 to 25 percent cheaper than innovator drugs (based on WAC price). And according to the Association of Accessible Medicine (AAM), biosimilars saved $7.9 billion dollars in 2020 alone, more than tripling the $2.5 billion saved in 2019. With more competition expected in existing therapeutic markets and additional markets set to open up, experts anticipate more savings in the future.
“The surge in biosimilars is exciting from a customer perspective,” Jan Burkett, President, Strategic Global Sourcing at AmerisourceBergen, said. “Patients and physicians are looking for more affordable options. We expect that trend to continue in cancer care and in other disease areas, and that will allow for more choice and savings in the marketplace. In our view, that’s a win-win.”
New Therapies Ahead
There are also several new therapies in the FDA pipeline expected to debut next year that may offer hope for patients with hemophilia A and hemophilia B, which is often considered one of the more high-cost healthcare claims due to the severity of the condition and the current course of treatment.
New treatments for Alzheimer disease, atopic dermatitis, and inflammatory conditions like Crohn disease are also in the pipeline. Additionally, orphan drugs constitute 47% of the therapies in the specialty pipeline compared to 31% for oncology and 22% for other conditions.
Yet the big guns the industry are focused on is cell and gene therapy (CGT). The cell and gene therapy market is forecast to hit $25 billion a year by 2023. Nine CGT therapies are likely to get regulatory approval by the end of next year, equaling the nine gene therapies approved in the previous 11 years.
“Specific to cell and gene therapies there is a lot more than just development of the treatments that is going to require a unique orchestration,” said Willis Chandler, who was recently appointed President of Manufacturer Services and Commercial Solutions at AmerisourceBergen. “Logistics support, cryogenic storage and transportation capabilities and a need for an almost real-time supply are the starting point. Ultimately, because these treatments are going to be costly, there will need to be a structure for access and reimbursement that will require relationships between manufacturers, payors, suppliers, physicians and patients.”
Chandler, who previous to his current role spent more than two decades working in a range of provider settings from health systems to an independent pharmacy, expects that data and analysis will play a key role in the success of CGTs in the coming years. To that end, AmerisourceBergen has been positioning itself to better serve manufacturers and providers through investments in technology to better streamline what Chandler called a fragmented process toward a complete end-to-end service.
Building a Stronger Service Pipeline
As part of that strategy, AmerisourceBergen in April invested in TrakCel, a leading supplier of cellular orchestration solutions that support the cell and gene therapy industry. AmerisourceBergen and TrakCel are now working to build a digital blueprint and solution roadmap that will enable more seamless integrations and workflows, with an initial focus on enhancing patient access to these therapies. In June, AmerisourceBergen completed its $6.275 billion acquisition of the majority of Walgreen’s Boots Alliance’s Alliance Healthcare businesses as part of its plan to broaden its reach.
“We understand and anticipate there will be a real move to cell and gene therapies,” Chandler said. “It’s clear, coming out of COVID, that decentralized clinical trials are here to stay and more and more care is moving into the home, so we are positioning ourselves to support the manufacturer through commercialization—even to identifying patients in practices that would benefit from these advanced therapies.”
The adoption of more digital tools that capture and analyze huge amounts of data will help support connection points between providers and payors, particularly in the wake of the pandemic.
“There is a lot of data when you look at the healthcare system but not much analytics and insight,” he said. “What we’re doing is bringing all these disparate sources of data together with our consulting expertise to help make better decisions in a product’s life cycle as it moves from development to within a patient’s home.”
60% of the current pipeline of new treatments are coming from small and mid-size companies. In the past, those smaller organizations would typically be acquired by a larger pharma before the drug would go to market. Yet, more pharma and biopharma startups are opting to remain independent, creating a need for partners like AmerisourceBergen that can provide a wider range of support from funding to infrastructure.
“We take a very collaborative and bespoke approach with these manufacturer partners – big, small and everything in between,” said Chandler. “While we have size, scale and can offer a breadth of services as manufacturers look to commercialize, we pride ourselves on being able to develop personalized relationships, get creative, stay nimble, and drive successful results for our partners.”
More manufacturers, both big and small, are proactively contacting AmerisourceBergen for its expanded services.
“They come to us not just with a new product they want to launch, but for the services they need to help that launch be successful,” Burkett said. “And we’re honored to be part of that journey.”