IN THE NEWS
Over the last year we have all seen how quickly things can change as the world focused efforts to create, produce and distribute COVID-19 vaccines quickly and safely.
Our entire team strives to stay informed so that we can share information with you, your clients and their employees. We’ve compiled a brief list of COVID-19 resources that we’ve found to be useful:
- NFP - Latest Insights on COVID-19
- Covid-19 Vaccine Rollout: State by State - The New York Times
- COVID-19 Vaccines: Infographic | Johns Hopkins Medicine
- Coronavirus Disease 2019 (COVID-19) | CDC
Access to information has been important during this pandemic and we have seen all three of our major PBM partners make new resources available to plan sponsors and members.
- The Express Scripts COVID-19 Information Center continues to be updated regularly with articles, FAQs, videos and much more.
- The Express Scripts Member Resource Center is a great portal as well, providing member centric news, FAQs, tips for using home delivery and vaccine resources by state.
- The OptumRx COVID-19 webpage continues to be updated regularly with articles, FAQs, videos and much more.
- Additionally, they offer an assortment of materials you can use to communicate with your members, such as member FAQ, email templates and flyers.
- The CVS COVID-19 Payor Resource Center continues to be updated regularly with information on vaccination, testing, treatment, FAQs, videos and much more.
- Additionally, they offer a toolkit you can use to communicate with your members, including items such as member FAQ, web banners and flyers.
COVID-19 Notable News
Women may produce more antibodies in response to vaccinations and some recent reports suggest this may play a role in the side effects experienced following COVID-19 vaccines. In reviewing data from over 13 million COVID-19 vaccinations, the CDC identified that 79% of side effects reported where experienced by women even though they accounted for only 61% of the vaccines administered. Researchers with the CDC also noted that all 19 of the people with an anaphylactic reaction to the Moderna vaccine were female and nearly all (94%) of those who experienced anaphylaxis with the Pfizer vaccine were female as well.
Rate of reporting reactions might play a factor as it is suggested women may be more likely to report their side effects, but research on many other vaccines suggests that women mount a greater immune response compared to men. The enhanced immune response is believed to be linked to estrogen and its impact on antibody production. In contrast, it is believed that testosterone has a more suppressive influence on the body’s immune response.
Vaccine makers are beginning trials to test the COVID-19 vaccine in children. Both Pfizer and Moderna have started testing in children 12 and older, although results have not yet been released. AstraZeneca and Johnson&Johnson also have plans to extend their trials to include children 6 months and older.
The Pfizer-BioNTech vaccine is already authorized for use in the 16 – 18 year old age group and they’ve now started testing in children under 12 years old. They’ll begin with testing three dosages of the vaccine (10mcg/20mcg/30mcg) in each of 3 age groups (5 – 11 years, 2 – 4 years and 6 months – 2 years) to determine the ideal effective dose. Once Pfizer has identified this ideal effective dosage, they plan to conduct a trial with it with 4,500 children randomly assigned either a vaccine series or saline shots.
During some vaccine trials, vaccines are tested in animals before being tested in children. The pandemic has given scientists a unique situation since millions of people have already received these vaccines, and there is already real world safety data available. This has increased the confidence in extending trials now to children.
Fewer smokers seemed to be trying to quit during the pandemic. We know that smoking is one of the underlying medical conditions that could increase people’s risk of developing severe cases of COVID-19. At the beginning of the vaccine rollout some states, such as New Jersey, were even prioritizing smokers among those eligible to receive vaccines. The nonprofit North American Quitline Consortium (NAQC) found a steep drop in calls during 2020 to the National Cancer Institute-operated portal that connects callers to local quitlines. Calls in all 50 states, DC, Puerto Rico and Guam decreased by 27% compared to 2019. That translates to roughly 190,000 calls, which is the lowest call volume seen since 2007. In recent years annual call numbers have ranged from 700,000 – 900,000 per year. The largest drop, 39%, occurred in the three-month period from April to June during the height of lockdowns and when infections and deaths were skyrocketing. At the same time, the nonprofit noted, cigarette sales increased after years of steady decline, according to data from the Treasury Department. Sales of cigarettes had been decreasing by 4% to 5% annually since 2015. However, there was a slight increase of 1% in the first 10 months of 2020 compared to the same period in 2019.
Quitting smoking is hard enough when everything is going well in life. The stress and anxiety during the pandemic prevented people from being able to think about quitting and decreased motivation to quit. Anecdotally, quit line counselors have reported that smokers who called during the pandemic seemed to need much more emotional support. Quit lines also received calls from former smokers who were feeling anxious they would relapse. Lastly, cigarette smoking continues to be the leading cause of preventable deaths in the US, accounting for more than 480,000 deaths each year, according to the CDC.
Novel Medical Advances
The COVID-19 pandemic definitely brought us all a variety of novel challenges but we have also seen some great new technologies or established technologies used in novel ways. Many scientists and researchers worked tirelessly to find solutions — whether that was with vaccine or drug development, virus detection for testing or applying technology for everyday use. We believe the COVID-19 pandemic will have many lasting effects, but want to discuss just three of these novel medical advances.
The technology to use DNA or mRNA to create vaccines has been studied for decades, but the COVID-19 pandemic became a chance to evaluate how far it had advanced. The efficacy rates for the mRNA vaccines (at around 94%) are above and beyond what health officials had hoped for. Vaccines that are based on the genetic code of a virus or bacteria have several advantages over traditional vaccine preparations.
- Vaccines that are made with DNA and mRNA don’t use a whole virus or bacteria, but instead use only the genetic code. This means the time for production can be much shorter than for a traditional vaccine.
- Vaccines that are gene-based typically elicit a more complete immune response that can be adaptable to mutations because they stimulate both antibody and T cell responses. There is current research on the applications of these types of vaccines for use in conditions like HIV, malaria and even cancer.
Disease Detection Using Wearable Smart Devices
The ubiquitous nature of our favorite wearable smart devices has proved to be useful to researchers who are in need of real-time data. The devices (like smartwatches, fitness trackers, etc.) collect all kinds of biometric information like activity levels, heart rate and even temperature. Previously, these devices have been useful in tracking chronic health conditions, but the pandemic offered a unique chance for researchers to test their ability to gather real-time data in a developing infectious disease situation. Researchers found that the devices could help detect symptoms of illness before a person notices them, but the symptoms are not unique to COVID-19 or any specific condition. They found that the wearable devices could help identify that a person is generally ill, but not detect what that illness is. It’s possible this information would still prompt some people to seek treatment earlier, or prompt some people to take precautions (wear a mask, maintain distance, stay home) to avoid infecting anyone else with whatever they might have. The researchers acknowledge that there are gaps in smart device utilization as typically they are used by a younger, wealthier population, but what they’ve learned could still impact this use of technology even after COVID-19 isn’t the threat it is today.
New Drug Development
We know that the cause of many diseases can be traced back to the disruption of specific proteins in the body. We also know that proteins are not working alone, there can be hundreds of proteins or genes involved in an intricate pathway to complete a cell’s work in the body. Researchers are looking at the expanded web of interacting proteins to identify more drug targets. For example, a team of researchers mapped out a collection of proteins being effected by the COVID-19 virus and identified nearly 70 compounds. From this they found Aplidin, a drug already FDA approved for cancer, tested to be more effective than remdesivir in cases of COVID-19. Several countries have current phase 3 trials in process now for Aplidin and its application in COVID-19. This strategy can be applied to many other diseases and may be able to identify new uses for old drugs or even entirely new drugs for conditions without effective treatments.
New Drug Release – Long Acting HIV Injection
FDA has approved Cabenuva, the first injectable, complete HIV regimen for adults that does not require daily tablets. This approval will allow some patients the option of receiving once monthly injections in lieu of a daily oral treatment regimen. This is to replace a current antiretroviral regimen in those who have achieved viral suppression (a viral load less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure. However it is not for use in patients that are not virally suppressed (HIV-1 RNA greater than 50 copies/mL). So essentially someone can be transitioned over to Cabenuva after they are stable on HIV therapy and their HIV viral load is undetectable. This regimen was preferred by 9/10 clinical trial participants when compared to their prior daily oral regiments. Reasons included greater convenience, having to think about HIV treatment only 12 times a year, and not having pill bottles that could reveal their HIV status to others. This monthly injectable combination will cost about $4,000 each month or more than $47,500/year and must be administered by a healthcare provider. In 2018 there were ~36,400 newly infected patients living with HIV in the US and in 2019 about 1.7 million people worldwide became newly infected.Sources: “FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV,” US Food and Drug Administration, 2021. Liz Highleyman. “FDA Approves Cabenuva, the First Complete Long-Acting Injectable HIV Treatment,” POZ, 2021.
Weight Loss Management/Obesity Coverage
Weight-loss drugs have often been dismissed as cosmetic or vanity treatments and were historically excluded from a plan’s pharmacy benefit. However, we are seeing more plans make the decision to now include coverage of in their prescription benefit. Since obesity is not identified as a therapeutic indication, it is very often missed as an important treatment opportunity. As Type 2 diabetes, heart disease, cancer and other serious medical problems are linked to obesity, the coverage of prescription drugs to supplement weight management becomes more and more valuable. New therapies, studies and innovation have proven that obesity needs more focused attention, especially in the Rx space.
Currently, pharmacy benefit managers are offering new programs to help tackle obesity and weight management as the progression of this disease leads to cardiovascular and diabetes comorbidities.
Express Scripts is expanding its SafeGuardRx platform offering to include the Weight Management Care Value program. According to the company, the program offers support including:
- Dedicated, personalized coaching from Therapeutic Resource Center clinicians
- Access to anti-obesity medication from any in-network pharmacy
- Digital tools:
- Connected scale that automatically transfers weigh-in data for review
- Personalized and behavior-based weight-loss program
- App-based peer support group
CVS has collaborated with digital health apps such as Kurbo, Naturally Slim, WW and Vida.
Digital program for children and teens ages 8-17 that teaches users how to make healthier choices and lifestyle changes through weekly video coaching, in-app chat, messaging, games and educational videos.
A digital behavior change program meant to reduce chronic disease risk of members, starting by changing their relationship with food. NS teaches members clinically proven skills to achieve an maintain weight loss, manage stress, sleep better and move more.
Digital nutrition solution with integrated mental health skils-development and personalized health coaching that aims to change long-term behaviors that affect weight loss.
Digital weight loss and wellness program based on nutritional and behavioral science for weight management through coaching, community, customized food plans and tools to log food, activity and sleep.
Optum offers a collaboration with the Real Appeal program. Its approach is based on clinical studies focusing on lasting lifestyle change. The formula is simple: small, steady, sustainable steps are the path to a healthier future. The program provides:
- Ongoing support and guidance
- Online coaching, group sessions and community
- Small steps for lifelong change
- Chart daily progress with nutrition and exercise trackers
- Resources to keep you motivated
- 24/7 online access and support, including a mobile app
- Success kit: weight scale, food scale, exercise DVDs, helpful guides and more
Healthcare Trends to Watch in 2021
Mental Health Crisis
Prior to COVID-19, mental health needs were a major issue in healthcare, however, the number of individuals experiencing declining mental health increased as a result of the pandemic. GoodRx reported that not only have 63% of 1,000 people surveyed said their depression/anxiety symptoms worsened, but that depression/anxiety meds in general reached an all-time high for 2020. As we emerge from the pandemic, it will be important to continue the dialogue about mental health and well-being, as well as minimizing the stigma so that people who need support will go and get the help they need.
Importance of Pharmacists
According to CVS Health, pharmacists are expected to become a key player in a number of areas, especially in vaccine distribution. Since people listen to and act on the advice and recommendations of the pharmacists, they offer key opportunities to counsel patients about their health directly. This will continue to have a positive impact on the social determinants of health.
Mitigating High Price Therapies
Revolutionary medicines and treatments are being introduced to the market at exorbitant prices; it's not unusual to see new pharmaceuticals costing $1 million or more. This presents a significant cost problem for pharmacy benefit managers. CVS expects value-based contracting to take off in a major way to counter those costs, for example, for its $2 million gene therapy Zolgensma, Novartis is offering insurers a five-year payment plan with refunds if the drug fails to meet expectations. The potential for these therapies, according to CVS, is obvious, but many payers want to see some kind of proof before forking over hundreds of thousands of dollars.
According to CVS executives, diabetes risk is higher among disadvantaged groups, such as Black patients, and addressing it would need local and community-based solutions. Groups at the highest risk for the disease are less likely to live in places with easy access to a supermarket, which increases their risk of unhealthy eating. Access and affordability are the two most significant barriers to resolving this issue. One the bright side, retail clinics and ambulatory treatment centers are on the rise, and they can help with access by meeting patients where they are located. For example, CVS offers a Minute Clinic where patients can walk in and receive a variety of resources to help them manage their diabetes, such as tests, provider appointments, and referrals to diabetes educators that can help with lifestyle changes. Ideally, CVS is trying to create one-stop-shop experience that is easier for many diabetes patients to incorporate into their everyday lives.Sources: Paige Minemyer. “4 of the Biggest Healthcare Tends CVS Health Says to Watch in 2021,” FierceHealthcare, 2021.