In the pharmaceutical industry, it’s critical to deliver medicine quickly to patients that need it most. Managed Access Programs have helped make new treatments more accessible and available to critically or terminally ill patients, but there is still work to be done in addressing rising patient needs. The goal of technology is to expedite and redesign familiar endeavours to make them easier to use for as many people as possible. As a result of technology, transparency, speed, and collaboration are more critical than ever. Mark Layden at CyberGrants discusses why pharma companies should embrace flexibility as often as possible, not only when dire circumstances require it, to ensure that they’re providing the best care and in turn best outcomes for their customers who need it most.
Extract:
‘How Technology is Making an Impact in Improving Managed Access Programs’
In the pharmaceutical industry, it’s critical to deliver medicine quickly to patients that need it most, but lengthy approval times for new treatments is not often something terminally ill patients can wait for. Looking at the big picture, it can take an average of 10 years for a new treatment to go from initial discovery to becoming commercially available in the marketplace. Terminally ill patients do have more direct access to investigational drugs and initial trials thanks to the Right to Try Act. However, the issues around process and approval times for new drugs was further illuminated during the COVID-19 pandemic.
Managed Access Programs, like you find with companies such as Novartis, have helped make new treatments more accessible and available to critically or terminally ill patients, but there’s still work to be done in addressing rising patient needs. In the 1970s, the FDA opened these programs for cardiovascular patients in the US. The advent of the HIV crisis in the 80s and 90s, with its high mortality rate and lack of treatment options, the use of managed access programs broadened significantly. For example, drugs like AZT offered a “parallel track” to allow patients who were not in the clinical trial to still have access to these treatments, saving many lives. Almost 4,000 patients were allowed to access the treatment prior to approval over the course of 6 months.
While the benefits of these programs are obvious and oftentimes lifesaving, there are many issues surrounding how patients access care. For one, differences in national pharmaceutical regulations can make it more difficult for patients to receive medicines. MAPs are generally determined on an individual basis, with requests for 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.
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