Peter Karns General Manager CyberGrants, LLC
Since the 1970s, Managed Access Programs (MAPs) have empowered patients by allowing them access to potentially lifesaving treatments for serious illnesses. From the HIV/AIDs crisis of the late twentieth century onwards, terminally ill patients have been allowed to participate in experimental trials with investigational drugs, saving hundreds of lives in the process.
Eligibility for participating in MAPs are generally determined on an individual basis, with requests for access to developing drugs made by individual physicians and approved based on criteria determined by the pharmaceutical company. These criteria include exhaustion of alternative therapy/treatment options, ineligibility for or inability to access ongoing clinical trials, sufficient data to ensure the potential benefit of treatment outweighs the risk, and that such access be allowed by local laws and regulators. While this process is certainly lengthy, it’s often shorter than the traditional drug approval process which can take a decade to move a product from discovery to commercial availability.
Another barrier to how patients access care is the lack of a universal regulatory protocol for the use of experimental drugs to treat patients. Many pharmaceutical companies aim to keep their products currently under discovery out of MAPs for fear that reporting of adverse effects in these trials could have a negative impact on future approvals and commercialization. This can make it difficult for requestors to even know what options are available to them as the pool is severely limited.
And even though MAPs democratize access to a certain extent, certain privileged mitigating factors can also affect who has access to these programs. The ethical questions surrounding this access plagues medical practitioners and pharmaceutical companies alike who are ostensibly working to help people regardless of their privilege. Terminally ill patients with more access to financial resources, social capital, or who exist within privileged networks ultimately have a better chance than those without to access lifesaving treatments even if they are suffering from the same severity of illness.
This uneven playing field was made even more so treacherous thanks to the COVID-19 pandemic which exposed major fault lines in the global healthcare infrastructure. The relentless pace of the disease’s spread and sheer volume of deaths, increased pressure on the pharmaceutical industry to exhaust all potential treatment avenues in pursuit of a treatment for a global scourge. Adding to the urgency of the pandemic were global lockdowns and related supply chain disruptions; forcing businesses from enterprises to single-person operations to adopt digitalization in unique ways to continue to function. MAPs were no different, as pharmaceutical companies began to field an exponential number of individual treatment requests from overwhelmed medical practitioners the world over.
By mid-March 2020, Novartis had received thousands of proposals from individual doctors and governments requesting access to proprietary compounds as treatments for COVID-19. We were able to work with Novartis to develop and launch an end-to-end SaaS system – called GEMS – to manage these requests. GEMS streamlined the approval and distribution process, leading to significant reductions in turnaround time for processing and approving requests. The review and approval process dropped from five days to five hours, waiving certain legal conditions to reduce delays. This resulted in an expedited drug shipping process, usually with a 24-hour turnaround time, allowing the company to grant access to 2500 patients globally within a 7-8-week period.
Leveraging SaaS technology in this way allowed Novartis to build tailored workflows to address the variables within the managed access process. The broad applicability of this solution accelerated the process allowing those in need to easily apply through a singular landing page while centralizing requests to better streamline the approval process for grantors. The technology can even be applied to other aspects of clinical discovery and pharmaceutical development process.
Beyond the managed access process, this technology can easily be used to streamline the process for managing initial and recurring prescription requests. A major focus for pharmacies and pharmaceutical companies is using technology to improve the patient experience of chronically ill patients who may require coordination between disparate parties to ensure their care needs are being met. Workflows like GEMs can be repurposed to store patient information on a single record, improving communication and the relationships between all involved parties.
Another area where this technology can be applied effectively is in the case of standard clinical trials. Clinical trials require the coordination of numerous parties in the drug development process to secure the necessary regulatory approvals to ensure patient safety and compliance. Additionally, the pandemic exposed how important it is for companies to have a flexible management system to handle unexpected scenarios that complicate application routing and approval. Technology like GEMS is a step towards more dynamic workflow management by allowing users to tag specific individuals to ensure the approval process meets no avoidable roadblocks in getting care to patients. The transparency fostered by the platform’s hubs gives all users holistic insights into the status, progress and results of these approval chains, ideally reducing bottlenecks that increase wait times and delay approvals.
The goal of any technology is to redesign familiar endeavors to make them easier to use for as many people as possible. Its growth, transparency, speed and collaboration are more critical than ever to broad industrial innovation – especially the high stakes world of pharmaceuticals. Pharma companies should embrace flexibility as often as possible to ensure that they’re providing the best care and in turn best outcomes for their customers who need it the most.
About the Author
Peter Karns loves helping team members achieve career objectives and enabling clients to reach business objectives. He works with clients, the CyberGrants team and industry experts to develop and lead the future of the company’s products and drive secure and efficient funds disbursement. In his personal life, Pete has four children and loves the outdoors as a backpacker and fisherman. He also plays a leadership role at his church, marshaling resources for maximum impact in the community.
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