The rush to find an effective vaccine was the story of 2020 and a major scientific achievement. This week we look at the impact of the vaccine’s development on the Pharmaceutical Industry in 2021. Wesley Winn is a 1994 graduate of UCF. He is a member of the college’s Dean’s Advisory Board and currently is Vice President of Commercial Operations for Hyperion Therapeutics. He is offers his thoughts below…
COVID-19 is a humanitarian crisis. Pharmaceutical organizations will play a fundamentally critical role. Considering recent government interventions to curb pharmaceutical prices and investigations into industry practices, this is an opportunity for the industry to rebrand itself. Also, an opportunity to better align with physicians, health systems and the supply chain to ensure patients have access to acute and preventative COVID-19 therapies.
Some of the questions I explored are the impact of COVID-19 on Pharmaceutical Commercialization as it relates to:
- Health Operations (Physicians and Health Systems): Are stay at home orders leading to treatment disruptions. Are patients reluctant to visit centers for fear of COVID-19 transmission? How will this impact the pharmaceutical sales force model for detailing physicians.
- Payers: What will the impact of job loses mean for commercial private insurance. Will Medicaid funding increase. What about timelines for reimbursing newly approved Food and Drug Administration (FDA) therapies? Will payers support digital health?
- Patients: What is the impact of loss of jobs on loss of benefits? Treatment interruptions and adherence? How will patients afford care?
- Supply Chain: Will the need for repurposed therapies or complex formulations cause shortages in therapies for other disorders and COVID therapies?
- Government and Policy Makers: How will COVID-19 impact the time to market for pharmaceuticals going through trials? What about pharmaceutical pricing pressure?
HEALTH OPERATIONS
The high-tech industry, the healthcare and the pharmaceutical industry will more closely align. Digital health tools and automation will be engines to accelerate transparency. While pharmaceuticals are often the policy focus for cost containment, they make up approximately 10% of healthcare costs. Physician services, clinical spending and U.S. health systems make up the remainder of the costs. The price increases across these sectors is an area for continuing debate.
COVID-19 will continue to shift care out of the most-costly areas of the sector to outpatient and at home care, relying on telemedicine. The government and major private insurance companies are bolstering physician fees to incentivize telemedicine. This coupled by patients’ apprehension to go onsite will continue to drive digital health in a Zoom world. Patients will also demand more transparency into their health. Health apps for monitoring healthcare status and electronic medical records will increase.
Reevaluating the future of work will be a key focus for many industries and pharmaceutical operations will be no exception. There may be less focus on requirements to work on site. Pharmaceutical sale forces are essential to commercializing new products. They are also costly. Expect to see more e-detailing and teller sales. This could decrease the size of pharmaceutical sales forces.
SUPPLY CHAIN
Branded products have longer patent life protections by government and profitable to manufacturers. Profits for generics are very marginal. These products are often manufactured oversees and the raw materials are lean. Repurposed drugs such as malaria medication Hydroxychloroquine may run into shortages for its originally intended purpose. Also, because there is strict federal guidance on pharmaceutical manufacturing practices and inventory management, there has been reported supply chain disruptions. One therapy Veklury (Remdesivir), used to curb COVID-19 ICU mortality was reported to be in a shortage due to manufacturing challenges and ineffective supply chain management by the government. The case and death rates may not have aligned with the allocation of therapy to health centers, with the most need. Clearly an opportunity for business and epidemiological analytics teams.
Supply chain partners will enhance their at home, school or work drug shipment models to create greater access to care. Now that Amazon has entered the drug industry. Drone delivery of medicines are here to stay.
GOVERNMENT POLICY MAKING
According to PHRMA, the major pharmaceutical trade organization. On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace. The average cost of research and development of each successful drug is estimated to be 2.6 Billion. The government has clearly more closely aligned with pharmaceutical companies’ goals to expedite time to market. One example in the United States is the Food and Drug Administration’s recently announced Coronavirus Treatment Acceleration Program (CTAP), which aims to better support companies and scientists looking to field trials, as well as, helping to expeditiously qualify new treatments for use. The policies are already paying dividends as the CEO of Genentech, a San Francisco based biotech mentioned that a trial merging Actemra with Gilead’s Veklury (Remdesivir) was the speediest trial in the company’s storied history. Note Genentech is the first Biotech in history and Remdesivir is being used in 1 out of 2 COVID-19 patients in the hospital. We are going to need more therapies beyond vaccines to combat this pandemic. We will also see more global partnerships in the form of in-licensing and mergers (e.g., Pfizer and BioNtTech for the COVID vaccine).
HEALTH CARE AFFORDABILITY
The are many studies on patient and payer (insurer) dichotomy. Insurers inherently want to keep the patients healthy. It’s is good for patients and profitability; they can bring in premiums as revenue and spend less on care. Patients inherently want the best care possible and may seek out care in the most expensive parts of the system (hospitals, ICU, ER) if needed. For good or bad the system works when people are insured; either private through their employer. Or by the government. Medicare insures people who are 65 years old and above or Medicaid for the indigent population as certain Federal Poverty Line (FPL) income threshold. According to the U.S Bureau of Labor Statistics, more than 16 million people have loss their job due to COVID. Over 50% may not be able to go back, due to their employers lost or closed business during the pandemic. The people with lost jobs may slowly meet the income threshold to qualify for Medicaid. Government spending for healthcare continues to increase contributing to the country’s deficit.
Most countries outside the US have social systems that provide healthcare to their citizens. Of course, nothing is free of charge. Taxation of citizens is one of the revenue streams to pay for care. The COVID-19 pandemic will again put the debate of private free market care and socialistic healthcare back at center stage in the U.S. The Trump led Operation Warp Speed and the recent Biden led American Relief Plan both provide provisions for free COVID testing and vaccines. It may also provide support for more acute therapies. Biden is also refocusing on the Affordable Care Act. While the quick funding of therapies is likely a welcome reversal of the lengthy delays in reimbursement of new therapies. Expect continued pricing pressure on pharmaceuticals as Biden revamps the Obama led the Affordable Care Act. Other industry executives should be consulted to inform the optimal balance of rewarding and encouraging life-saving innovation and ensuring we have a healthy nation.
CONCLUSION
As pharma leaders focus on their pandemic crisis response, it is important to consider the questions posed in this review. The questions and the implications for their respective companies in increasing resiliency and better adapting to the post-COVID-19 world. These questions and opportunities should also be explored by the next generation of leaders in business administration, health care administration and public health programs.