Maximizing Technology, Time & Teamwork for Critical Impact, Now
No question, the last eight weeks have been tough on everyone. As a pharma company, Novartis felt a duty to respond and call to be part of the solution. The Novartis purpose is to re-imagine medicine to improve and extend people's lives. The Novartis' purpose statement is aligned with four key areas: holding themselves to the highest ethical standards, being part of the solution on pricing and access to medicines, helping tackle global health challenges, and being a responsible citizen.
Now more than ever before, their commitment to purpose has been put to the test, as they find themselves at the forefront of addressing the Coronavirus (COVID-19) pandemic on a global level. Their response has taken many forms. They are involved in various research collaborations, working with other stakeholders in biopharma, biotech, and academia.
The impact of the Coronavirus (COVID-19) outbreak continues to disrupt our society daily, for many becoming a matter of life or death. While Novartis has research & development activities evaluating potential solutions to address the pandemic, managed or expanded access programs have become more critical than ever - a beacon of hope for epicenters, physicians, and patients in urgent need of treatment and relief from the seemingly endless fight against COVID-19.
We recently had the pleasure of chatting with Paul Aliu, Global Head of Medical Governance, Chief Medical Officer at Novartis. Paul has been instrumental in quickly mobilizing Novartis's managed access program to respond effectively to the COVID-19 crisis. Along with his team, Paul manages a high volume of both individual patient, institutional and governmental requests on an annual basis. Paul walked us through key components, methodologies, strategies, and how managed/expanded access programs have made an impact during this global pandemic.
How Novartis mobilized managed access programs to respond to the COVID-19 crisis
Novartis has committed expertise and assets to the fight against COVID-19 pandemic alongside the Bill & Melinda Gates Foundation. In addition to a whole consortium of folks looking into possible solutions, therapeutics, vaccines, repurposing of medicines, and an evolution of all their currently marketed products to explore options for repurposing these treatments for COVID-19. Internally as a company, Novartis has screened its entire compound library and started three phase III programs for promising compounds for which the science is promising to potentially address COVID-19. Novartis is also engaged in investigator-initiated trials, receiving proposals from different researchers and institutions from all over the world interested in conducting trials with Novartis compounds.
By mid-march Novartis started to see requests from epicenters where there were a high number of patients coming in, many from intensive care units, rapidly progressing, with severe COVID-19 cases. This is how the whole response effort began to take shape. Many of the compounds that were being requested happened to be under evaluation, in-house, where the science did suggest potential clinical utility for COVID-19.
In some cases, the drugs were already approved for other indications (but of course not for COVID 19), so they were readily available. In the case of repurposing drugs, regulations for many countries where the requests originated from required that they be used via the compassionate use/managed access mechanism. In a matter of weeks, hundreds of requests from different epicenters began flowing in.
To date, Novartis has received over 1,000 individual patient requests and over 70 requests from governments or other institutions, specifically for these 2 to 3 compounds. Novartis estimates internally that within a 7-8 week period, over 2,500 patients have been able to access Novartis drugs through their managed access program for COVID-19. All the while, the Novartis team continues to respond to non-COVID related requests that come in through the web portal.
Workflows and Processes for Quickly and Efficiently Response
It is never easy to face a crisis head-on, but when the unimaginable occurs proper preparation can be the difference between success and failure. Paul emphasized the importance of having a dedicated, core team no matter how small. This dedicated team plays a huge role in the continued success of the managed access programs and the ability to quickly respond when needed.
One of the main functions of the dedicated team is to manage the overall workflows. In a time of crisis, this team is best suited to look at the entire process as a whole and identify opportunities for simplification and efficiency gains. When a request comes in, it needs to be reviewed and approved by the relevant medical responsible for that compound, go through a contracting process notably for the physician to ensure collection of patient’s consent and the safety reporting requirements, then the drug supply piece, and subsequently the reporting of data/outcomes.
Through the efforts of the dedicated team and their ability to leverage the greater Novartis community, they were able to make significant reductions to turn-around times. Reducing stand review and approval from over 5 days to less than 5 hours. The team leveraged the network of senior medical associates across different geographies so as requests came in there was an associate ready to review. They worked closely with legal teams to waive the contract and implement general conditions of supply, reducing the contracting period which often resulted in delays of anywhere between 2 to 10 days. This expedited the time of drug shipment, which was occurring mostly within 24 hrs from the initial receipt of the request.
Understanding the process, knowing the pain points and opportunities for efficiency proved to be invaluable. Novartis created a specific COVID-19 workflow within the system to allow for rapid turnaround of those requests (approving in 3 to 4 hours, and shipping drugs to countries, sites, and centers within 12 to 24 hours).
Key Insights & Lessons Learned
- Be Prepared. Get your ducks in a row in regards to your workflows, system, processes, roles & responsibilities.
- Assemble the Response Team. Utilizing a small team that could pull together the correct stakeholders and decision-makers was highly important.
- Leverage Expertise. Understand the breadth and level of expertise in the organization for easy leveraging and pull together in a time of crisis
- Employ Agile Technology. Having the right technological tools was of the utmost importance when it came time to pivot at a moment's notice with a systematic approach versus manually.
- Maintain Robust Processes. Have a deep understanding of your workflows and process in place and recognize where you can be flexible for expediting timelines when necessary.
- Take Smart Risks. When the COVID-19 crisis hit we quickly set up small dedicated teams/task forces to evaluate what could be simplified and identify smart risks in response to the urgency of the situation.
- Harnesses the Power of Purpose. Recognize the high level of motivation from employees to get involved. Everybody wants to be part of the solution.
- Find a Solution Partner. Ensure the solution you have in place is tailor-made for the size of your organization and how your organization is structured internally.
- Clarity in roles and responsibilities. Clearly define roles, responsibilities, and expectations so everybody knows how to react should a crisis occur.
- Share Information. Provide a dedicated link for COVID-19, or other crisis, in a centralized location for easy access to information.
- Do Not Reinvent the Wheel Leverage existing processes and tweak to meet the needs of the moment.
- Reach out to Existing Network. Use regularly scheduled webinars and calls to connect with dedicated champions and the medical associates in the regions and countries.
Measuring Success of this process and Managed Access as a whole
- Metric #1 - Clinical Trial. Beyond COVID-19 measures of success, the clinical trial is always going to be the gold standard to evaluate the safety and efficacy of a drug.
- Metric #2 – Time. How quickly can the product be provided to the patient? Effectiveness is based on the provision of the product to the patient as quickly as possible, following a thorough medical review.
- Metric #3 - Number of Patients Reached. How many patients we are reaching and ultimately treating.
- Metric #4 - Number of Approved Requests. What proportion of the requests are we able to effectively approve and how many times are we likely to say yes (% approval rate).
- Metric #5 – Outcomes/Benefits. Measuring outcomes - has the patient derived benefit? (based on the physician’s assessment). How can you qualify or quantify that benefit?
Listen to the complete conversation between Paul Aliu, along with Zach Gendron, Senior Account Executive at CyberGrants and expert on managed/expanded access program technology, here.
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