Free Product Distribution for Clinical Trials: New Opportunities to Leverage Existing Expertise
Jun 24, 2019
Editor’s note: Chris Ramos, director of business development at EnvoyHealth, contributed to this post.
Pharmaceutical and biotech manufacturers have long used tools like free-drug patient assistance programs, quick-start programs, and temporary supply programs to provide free product to patients who either cannot afford or cannot access the medication they need. Many brands have been incorporating these programs into their broader patient access strategy for years. EnvoyHealth, utilizing our noncommercial pharmacy and leveraging the specialty-pharmacy expertise of our parent company, Diplomat, has supported our manufacturer partners in delivering these programs to the patients who need them.
As the healthcare ecosystem continues to evolve, the methods, tools, and services necessary to meet patients’ needs are becoming more complex. In May 2018, the Right to Try Act¹ was signed into law, allowing patients with life-threatening conditions to gain access to certain unapproved medications. In addition, expanded access and compassionate use programs provide an alternate pathway for manufacturers to respond to these unique patient needs.
Another avenue for access is through investigator-initiated trials (IITs), which can provide proof-of-concept for clinical development programs. For those not familiar with IITs, these clinical trials are developed and executed under the direction of independent physician researchers.
It’s important to stay informed of all these avenues for access. Not only do service providers and pharmaceutical companies need to keep pace with current legislative changes, but they also need to stay ahead of the market to ensure they can provide support for patients, caregivers, and providers the moment changes take place.
EnvoyHealth identified an increasing need from our manufacturer partners for dedicated clinical trial supply and logistics support, due in large part to the financial burden created by procurement, shipment, and logistics management. In figures published by CenterWatch², the budgets of recent investigator-initiated clinical trials have ranged from as little as $10,000 to more than $6.5M, with the average study costing approximately $125,000. Due to the financial commitment required for clinical trial drug distribution, it is critical to ensure the sponsoring organization has a partner with the experience to place necessary controls on product handling, dispensing, returns, and incineration.
Leveraging our pharmacy expertise, EnvoyHealth offers our partners a cost-effective alternative to managing clinical trial logistics. The same study from CenterWatch showed that over 90 percent of manufacturers had dedicated teams focused on investigator-initiated clinical trial logistics, which was up from about 50 percent just 10 years prior. For some of our manufacturer partners, this includes not only product distribution, but also the distribution of product and the ancillary supplies needed by the clinical trial sites to administer the product. Our customers came to us with a need and we delivered.
This is one of many examples of EnvoyHealth maintaining significant rigor and focus on meeting patients, caregivers, providers, and partners where we provide the most value. From providing unique tools for ensuring end-user engagement to examining ways we can bridge the gap between clinical trials and patient access, we are focused on innovation that keeps pace with the healthcare ecosystem, and that ensures we are ready for future changes.
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 U.S. Food and Drug Administration, “Right to Try,” May 2019, fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try.
 CenterWatch News Online, Ronald Rosenberg, “Renewed attention for investigator-initiated trials,” December 2015, centerwatch.com/news-online/2015/12/15/renewed-attention-investigator-initiated-trials.