As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the regulatory process for approving new ones. More distant in time, but also of extreme importance is the effect on the launch of new medicines that have been approved.
Drugs coming to market are important in several respects. First, they may represent advances in either safety or efficacy over previous treatments – or they can even be bringing new treatments in a category where there are very few or no viable treatment options. Second, they represent hope to patients whose needs are not being met in the current treatment environment. Third, they may have a financial impact for the company and they set shareholder expectations for return. Finally, they underscore the innovation of a company that is vital to its brand.
But a new drug launch in the time of COVID-19 comes with definite challenges. Recently in the U.S. Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. And in Europe bluebird bio announced that it would delay the treatment of the first patient in Germany with its new approved gene therapy until the second half of 2020.
Why would COVID-19 affect a drug launch? Some of the factors involved include:
- Risk Associated with Routine Medical Visits – There has been an observation that catheterization laboratories have seen a steep drop in utilization since the pandemic began, which could indicate that people are avoiding going to the doctor right now out of fear of contagion, even when experiencing something as serious as symptoms of a heart attack. In particular, patients who are older or who are experiencing a serious illness that might put them at increased risk may avoid going to the medical office for a routine visit. Since healthcare providers are the gatekeepers to prescriptions, it necessarily would impact uptake of any new medication.
- Loss of Insurance – Millions of people are losing their jobs, and often with it, their access to health insurance not only for the care, but to cover the cost of new prescriptions. The magnitude of job loss is going to seriously impair the ability of people to access their existing medicines, much less be evaluated for new (and likely more expensive) treatments.
- Concerns Related to Starting New or Switching Therapies Now – Switching a therapy to a new medicine, or starting any new medication, may require follow up evaluation. If people are avoiding non -urgent medical care based on fear of COVID-19 transmission, their desire to switch medications that might necessitate follow up is likely to dampen any desire to start a new therapy.
- Physician Practices Under Stress – Many practitioners are on the front lines or are in institutions that are under siege, dealing with issues from the inherent lack of personal protective equipment to patient need to demands for tests that are not available. This is not to mention their own health status and those of their families. Many individual practices are not seeing patients.
- Company Sales Forces Operating in Virtual Environment – Prescribers are introduced to new medicines and learn about their many aspects through visits from sales representatives. By necessity, these are occurring in a virtual environment, but it’s a conversion that will take time to establish itself, with the technical side being only part of the challenge. It is one thing to take a discussion of orders online, it is quite another to master the art of developing a relationship in a virtual setting.
While the challenges are many, there is one counterweight that may address some of what might otherwise impede access to care – the increasingly rapid facilitation of access to telemedicine. Every day the the impacts of the pandemic take on new aspects. And each day we are without a vaccine means these effects are going to linger. While telemedicine is not a panacea, it is one means of addressing the issue of access based on concerns that patients have for stepping into the healthcare environment. There is little question that the pandemic has motivated the healthcare system to turn to telemedicine as a solution and to have payers firm up efforts to reimburse for its use. Hopefully as we collectively travel through this new terrain, over time we will address the loss of access to healthcare due to financial constraints. There is no question that delay of new medicine launches for now may be a short-term necessity, but we are going to have to deal with the fact that we are in the midst of long-term problems to every aspect of the healthcare system on which we are going to rely.