There are an estimated 1.2 million people in the US living with HIV, and roughly 1 in 8 people are undiagnosed. The virus attacks your body’s immune system and weakens its ability to fight infections. When HIV is untreated, it can lead to acquired immunodeficiency syndrome (AIDS), and the body becomes even more at risk for opportunistic infections.

While antiretroviral therapy has been available to treat HIV-positive patients for some time now, certain antiretroviral medications are also FDA-approved to be taken daily to prevent the risk of becoming infected with HIV. This treatment, known as pre-exposure prophylaxis (PrEP), is intended for people who do not currently have HIV but are at risk for contracting HIV. Overall, PrEP has shown to reduce the risk of contracting HIV through sexual contact and injecting drugs by 99% and 74%.

The main goal of any PrEP treatment is to prevent the transmission of HIV to an uninfected person. There are multiple treatments available to help reduce the risk. Regardless of which medication a patient takes, these medications must be taken consistently every day as prescribed. It is also crucial to not skip or miss doses. Possible side effects from PrEP medications primarily include nausea, but in general, these medications are well-tolerated. Despite this, it is still important to tell a healthcare provider about any side effects experienced.

Advances in antiretroviral treatments have made it possible for patients to live healthy, vibrant lives. That said, patient management programs are very valuable to patients whose ability to take their medications as prescribed has direct impact on the long-term success of their treatment.

Prescription drug prices can be expensive. How can the average person save money on prescriptions in a quick, easy way? Pharmacy discount cards are available widely, but what are they and why should people use them? Here are five important things to know about pharmacy discount cards.

1. They can save you money!
   Pharmacy discount cards can be used to lower your costs on medications you need to fill that may not be covered by your employer’s health insurance plan. Using a discount card can save up to 80% off the cash price when you need to fill a non-covered drug. Comparing prices between your insurance and discount card is important to make sure you are not overpaying for your prescription. You should also check other pharmacies as prices do vary from chain to chain as well as independent pharmacy locations.

2. Using them won’t count toward insurance plan deductibles.
   Prescriptions filled using a discount card do not count toward your deductible or out-of-pocket maximum amounts. Discount card transactions fall outside of your health plan policy and should be used when a drug is not covered or if you are uninsured. Discount cards cannot be used in combination with insurance.

3. They are free to use.
   Most pharmacy discount cards do not require membership fees to use their cards, but some programs do require you to provide personal information. Make sure you review their privacy policy to ensure you are comfortable sharing information before using their services. The privacy policy is typically posted on their website.
4. No paperwork necessary.
   With pharmacy discount cards, there are no forms to fill out and no paperwork. When you present your discount card at the pharmacy, you are given the discounted prescription price at the counter and you pay the balance. There is no further obligation on your part to the discount card. You can use the card for future transactions, but typically there is no requirement to do so.

5. They work for pets, too!
   If you have pets, many discount cards extend their benefits to them as well. Many people fill their prescriptions at their veterinary office without realizing they may be overpaying. There are some prescriptions for your dog or cat that can only be filled by a vet, but many can be filled by your local pharmacy and usually at a much lower cost. You can ask your vet to write a prescription for your pet and have it filled at your neighborhood pharmacy. Make sure the vet includes their DEA number as most discount cards require this information to process the prescription.

There are many companies offering to save you money on your prescription drugs, which can sound too good to be true. Pharmacy discount card providers are only compensated when you fill a prescription using their card and the pharmacy benefits from your business. You get to save money on your prescription and improve or maintain your health of you or your loved ones.

In contrast to the conventional drug approval pathway in which drugs are reviewed under a New Drug Application (NDA), approval of a biological product is done under a separate pathway known as the Biologics License Application (BLA). Examples of biologics include therapeutic proteins such as insulin, monoclonal antibodies, vaccines, and blood-derived products. While the NDA and BLA processes are similar, they are not identical. The typical generic drug provisions (e.g., same active ingredient, bioequivalence) do not apply to BLAs. Instead, the single biological product already approved by the United States (US) Food and Drug Administration (FDA) is referred to as the reference product; the new potential biosimilar is then compared to the reference product. For approval as a biosimilar, the manufacturer must demonstrate that the agent is highly similar with no clinically meaningful differences.

In July 2018, the FDA released their Biosimilar Action Plan, described by then FDA Commissioner Dr. Scott Gottlieb, as “aimed at promoting competition and affordability.” Then, in December 2018, the FDA announced the plan to transition biological products that were historically regulated as drugs and approved via NDAs to the biologics pathway, taking effect in March 2020. These products include insulin, human growth hormone, and glucagon, among others. This change was mandated by Congress in the 2009 Biologics Price Competition and Innovation Act, which allowed 10 years for the transition. When considered as drugs under the NDA pathway, it was virtually impossible to develop a generic equivalent due to the nature and the inherent variation in the manufacturing process of these products. On March 23, 2020, the FDA issued a statement noting that this change is now in effect.

However, in the US, even if an agent is determined to be biosimilar, it is not automatically interchangeable (a process by which a product can be substituted for another without the approval of the prescriber). For a biosimilar to be considered interchangeable by the FDA, it must meet even more rigorous requirements and be approved as interchangeable. For products that are biosimilar but not interchangeable, the prescriber still needs to write for the specific product. In addition, even if determined to be interchangeable by the FDA, state pharmacy laws may further regulate what substitutions may be made at the pharmacy level without the approval of the prescriber. Just as a listing of generic equivalents is available through the FDA in their Orange Book, the FDA lists biologics and any respective biosimilars in their Purple Book. Recently converted to an online database format, the Purple Book provides details on reference products, their corresponding approved biosimilars, and whether or not the biosimilar is interchangeable. To date, no biosimilar has been designated as interchangeable.

As described in a previous blog post, the cost of insulin has risen substantially, leading patients to take desperate measures. At a time of economic instability and health uncertainty, these access concerns are even larger. Now that these products have transitioned to the biologic approval pathway, once patent exclusivity has passed, biosimilars can be developed, evaluated, and approved. Moreover, biosimilars can be reviewed further and may be classified as interchangeable, which can further alleviate the burden by allowing substitution at the retail level depending on local laws. This landmark change can promote market competition, potentially driving increased availability and decreased cost. The FDA reports that even having one generic drug on the market can decrease prices to approximately two-thirds of the price without competition. Generally, initial list prices of launched biosimilars have been 15% to 35% lower than their reference products. Most importantly, in their announcement of this change on March 23, the FDA pledged that they are ready to review eligible applications to ensure efficient approval. Ultimately, this revised process will provide an opportunity for other manufacturers to introduce safe and effective product competition without clinically meaningful differences. While this may be challenging in light of the ongoing global pandemic, this change, 10 years in the making, offers hope for patients who use these medications.

Featuring excerpts used with permission from the Magellan Rx Management Medical Pharmacy Trend Report^TM, ©2020. Get a copy of the full report at magellanrx.com/trendreport.

In 2010, plans were just starting to manage drugs on the medical benefit; there were only nine approvals for medical injectable drugs, and biosimilars were talked about but still five years away. Now, the medical benefit is top of mind, and in 2019 alone there were triple that number of approvals—seven of them biosimilars.

For the 10th year in a row, the top five commercial drugs were Remicade, Neulasta, Rituxan, Herceptin, and Avastin. Remicade saw decreases in PMPM due to the introduction of biosimilars Renflexis and Inflectra. We may see similar trends in upcoming data, since all of these top 5 agents now have marketed biosimilars.

How have biosimilars impacted some of the top-spend medical benefit categories?

There are 26 FDA-approved biosimilar products across three different therapeutic categories, of which 17 have been launched. Fifteen of those are oncology or oncology support agents.

Biologic Drugs for Autoimmune Disorders (BDAIDs)

Trend remained relatively flat in this category as Remicade market share decreased, with biosimilars Renflexis and Inflectra beginning to gain market share (market share data for these biosimilars was not available for 2017 and 2018, but we expect to include it in next year’s report).

Oncology & Oncology Support

Oncology spend is a concern for payers, and oncology immunotherapies and gene therapy will continue to contribute to this spend. However, many opportunities for savings are anticipated with the biosimilars for Avastin, Herceptin, and Rituxan.

There are currently several biosimilars on the market in the oncology support category for the long- and short-acting CSFs and the ESAs. The predicted negative forecast growth illustrates their impact. Specifically, Neulasta biosimilars are now on the market, with Fulphila and Udenyca gaining market share.

Payer feedback on current bio-similar strategies

The biosimilars currently on the market proved to have an impact on medical pharmacy strategy, as 40% of plans, based on number of lives, reported they were currently reimbursing based on a maximum allowable cost (equivalent reimbursement for reference and biosimilar). At the time of our survey (summer 2019), there were no oncology bio-similar products on the market, but payers were planning to utilize the same formulary strategies, including step therapy.

What biosimilar strategies should payers be deploying NOW to prepare for the FUTURE?

At Magellan Rx, our 16+ years of total specialty drug management expertise enables us to prepare our customers for what comes next through forward-thinking solutions that keep a pulse on future industry trends. Through successful medical pharmacy management across all sites of service, we can deliver targeted, customized solutions designed to yield substantial drug cost savings while maintaining a high level of clinical quality.

• We’ve seen that health plans can experience a significant shift in utilization to lower-cost biosimilars through implementation of a comprehensive utilization management solution.
• Initial results from our new oncology biosimilar solution show proactive utilization management of oncology drugs via step therapy increases use of less expensive biosimilars. We encourage customers to combine the power of all our oncology solutions—such as utilization management, drug wastage, dose optimization, sophisticated claims editing, enhanced regimen review, site of service management, targeted solutions for oncology immunotherapies and oncology care management—to enhance outcomes and improve member quality of care.

Learn more about our total specialty drug solutions.

Being discharged from the hospital or receiving an unexpected diagnosis can feel lonely and confusing. What’s next? Where do I start? How do I manage all these follow up visits? What was I prescribed?

Data suggests that access to a collaborative team of a pharmacist and care manager can reduce hospital re-admissions by 50 percent. With our data-driven MRx Navigate solution, we are identifying members who might get lost in their care journey, helping to protect them from gaps in care and the risks of non-adherence, and guiding them along their path to wellness.

By fully integrating the many touch points of a member’s health and wellness, our team of clinical professionals works closely together to understand the member’s healthcare needs and assist them to better manage their condition through education, empowerment and specialized support. Our team provides seamless continuity of care and healthcare population management, delivering quality health outcomes and value-based savings.

Jill Anderle, RN, MRx Navigate Care Manager, describes her role by saying, “I care for patients and their loved ones who are often in extremely overwhelming circumstances. By listening closely and validating members’ concerns, I assess gaps in their treatment plan once they are discharged from the hospital. We also teach self-advocacy and connect people to supportive community resources to help prevent unnecessary hospital re-admissions.”

Mental Healthcare Manager Silvia Pantoja considers her role as multifaceted: “I help people who have recently been discharged from a hospital or mental health facility. Besides being a coordinator, educator, facilitator, and advocate, my main focus as a care manager is to empower patients by giving them a greater understanding of their disease.” Silvia helps connect members with therapists, psychiatrists, and other resources and stays in contact with each member to ensure they follow a clear discharge plan.

The MRx Navigate team has connections to extensive resources, helping members with durable medical equipment, like wheelchairs, scheduling follow-up appointments with specialists, and making sure the member’s home is safe and accommodates their new needs. The team’s clinical pharmacists provide drug information, answer questions about new medications, help find options for reducing the costs of drugs, and explain how to take medications appropriately and safely.

The wellness component of MRx Navigate, identifies opportunities for better care and increasing members’ quality of life through educational tools and preventive resources like bio-metric screenings, flu shot clinics, and mobile mammograms. Personal wellness coaches, like Baihly Birdseye, conduct outreach and health coaching. “Focusing on behavior change can not only help resolve illness, but it can also help member s avoid the hospital altogether, possibly preventing even more serious and costly complications. We also want wellness to be fun and engaging,” shares Baihly.

While our everyday lives are becoming faster and more digital is your medical life doing the same? Do you miss filling your prescription because you forgot to call it in? Do you receive texts from pharmacists checking in on your current health conditions? Do you have a health coach a text away to help with your health goals?

Did you know that the average opt-in rate for receiving text messages is less than 2%? With MRx Connect we have seen more than 33% opt in. In addition, 98% of those who have opted in read the text message.

MRx Connect is an engaging digital communication service that helps prevent gaps in care and enhance awareness by sending proactive texts, emails, and chats. By receiving real-time information, people can make better healthcare decisions. MRx Connect messaging can be done in many ways and has shown many great results:

1. Refill Reminders: Receive a text when your prescription is getting low so that you know when to call in a new fill.
2. Flu Shot Reminder: Know when the best time is to receive your flu shot before it is too late in the season.
3. Re-enrollment Reminders: Be aware of when your enrollment is coming up, so you don’t have any gaps in care.
4. Health Coaching: Communicate with a professional health coach, pharmacist, or tech on your current health in real-time and on your own time.

Results:

• 35% engagement rate and improved refill rates for refill reminder for chronic conditions
• 23% of members received flu shots after receiving text message

Digital communication in healthcare allows you to be more aware and adherent to your care. You are never alone in your health journey and by being a click away from receiving answers or direction you are leading an even healthier, more vibrant life.

In January 2020, the United States (US) Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) published Advancing Health through Innovation: New Drug Therapy Approvals 2019. This report provides a summary of a number of approvals and highlights the “game-changers” approved in 2019, solidifying the upward trend in approval volume initially seen in 2017. Compared to 2017 and 2018, in which CDER approved 46 and 59 new drugs, respectively, 48 novel agents were approved in 2019. This number does not include new and expanded uses of already approved drugs, new formulations, new dosage forms, vaccines, blood products, cellular or gene therapy, or the 10 biosimilar approvals. This far exceeds the average of 38 novel approvals per year in the past 10 years. Figure 1 outlines approvals over the past 10 years.

In 2019, the FDA continued its strategic initiatives, with additional approvals of biosimilars and generics (both first-time agents and those off-patent with limited competition), as well as a focus on the expedited approval process, particularly for rare diseases and agents supported by positive patient-reported outcomes. Notably, the FDA hosted a public meeting in April 2019 to receive input on how to tackle barriers associated with the development of treatments for rare diseases, and held another meeting to celebrate “Rare Disease Day” in February 2020. Moreover, this trend is likely to continue, with the FDA releasing several guidances on gene therapy. The new pathway for insulin approval under biologic license applications planned for March 2020 and the launch of internet-based repositories or apps to improve access to information for both providers and patients (e.g., CURE ID in 2019, antiretrovirals in 2020) also highlight strategic initiatives of the FDA.

Last year, all 48 novel drug approvals met their Prescription Drug User Fee Act (PDUFA) goal dates, cementing this as a priority for the Agency. In 2019, 42% were considered first-in-class, and 44% were approved for rare diseases (Orphan Drugs). Priority Review was granted to 58% of novel drugs, 19% received Accelerated Approval (more than doubling the rate of 7% last year), 27% were designated as Breakthrough Therapy, and 35% garnered Fast Track designation. Overall, 60% of all drug approvals in 2019 used expedited development and review methods. In addition, 90% were approved in the first review cycle, and 69% were approved in the US prior to receiving approval in other countries. A breakdown of the types of drugs approved in 2019 is illustrated in Figure 2, with approvals once again dominated by drugs in the expansive oncology spectrum.

Some of the notable 2019 approvals included new advances for the treatment of cystic fibrosis (CF), with the first triple combination therapy and expanded indications of existing CF therapy available to younger patients, and the first new medications in several years for sickle cell disease. Additionally, several approvals targeted rare conditions, such as erythropoietic protoporphyria, neuromyelitis optica spectrum disorder, tenosynovial giant cell tumor, Duchenne muscular dystrophy, and systemic sclerosis-associated interstitial lung disease. Beyond treatments for rare disease and cancer, the FDA also approved agents for more common disorders, including multiple sclerosis, novel treatments for depression, migraine and cluster headaches, epilepsy, several autoimmune conditions, age expansions for diabetes therapy, and a drug-sparing regimen and new prophylaxis option for human immunodeficiency virus-1 (HIV-1). Although down slightly from 2018, the large number of approvals from 2019 represent a continued trend by the FDA to expedite and increase the quantity of annual approvals.

When I was a child visiting my grandparent’s Iowa farm, I would often hear stories of how my mom and her eight brothers and sisters lived during the war efforts of the 1940’s. My grandma described a common purpose—that sense of pride that the family rationed and repurposed. Their singular focus was that the good of the individual was less important than the whole of the country, even the world.

Watching the coronavirus make its way across the world and rapidly grow in the United States, I can’t help but think of those stories. As the shelves of Costco and Sam’s Club stores emptied this weekend, and school closures were announced community by community, it made me realize that our time to step up is now. Our singular, collective focus needs to be mitigation and in order to be successful, mitigation efforts need to be embraced and enacted on by us as individuals.

What is Mitigation?

Mitigation is a strategy to reduce the seriousness or impact of a natural disaster, such as a pandemic. The goals of mitigation include minimizing morbidity and associated mortality, avoiding an epidemic peak that overwhelms healthcare services, keeping the effects on the economy within manageable levels, flattening the epidemic curve to wait for vaccine development and manufacturing to reach populations, and actively pursuing the development of antiviral drug therapies. Practically, mitigation relies on social distancing—measures that are taken to restrict when and where people can gather to stop or slow the spread of infectious diseases such as the coronavirus.  Social distancing measures include limiting large group gatherings, closing buildings and canceling events. However, for mitigation to be successful, individuals, even those who are asymptomatic, must be willing to self-isolate.

Self-Isolation Challenges

In a society as mobile as ours, and where high degrees of social contact is the norm, self-isolation is challenging. For instance, if one has become accustomed to eating meals outside the home, the transition to grocery buying and cooking may seem formidable. If one is used to getting together with friends to play cards, go running, have a beer after work, the loss of those types of activities will create holes in one’s social network.

We are fortunate to have an infrastructure in which many people can work from home and education can be delivered virtually. Workers who cannot isolate because the nature of their work cannot be done virtually, must take precautions. While in the workplace, distancing at least six feet, maintaining high levels of handwashing and the use of hand sanitizers is a must.   When returning home, it is best to avoid being in the presence of those most vulnerable to coronavirus—elders and persons with underlying comorbidities. It is also important to acknowledge that one may feel anxious and may not have all the answers that our members or clients are seeking. Maintain lines of communication with co-workers and supervisors. For those who are new to work at home, talk to coworkers for whom this has been the norm to get some advice on structuring the workplace and the day. And don’t forget that you can use technology to connect with friends. Facetime, Skype and other video conference capabilities are a great way foster your relationships during social isolation.

Mitigation is a critically important strategy to quell the spread of the virus. It has been beneficial in China as new cases are now falling. In areas where community spread is mild, targeted isolation of high-risk people, or those who may have come in contact with the virus, can be implemented. Even inside households, those with symptoms should keep distance from the healthy. And, even if you are asymptomatic, but have been in a high-risk area or where there is growing or wide community spread, it is important to maintain social distancing and self-isolation.

Social distancing and isolation are not easy—but I am trying to look at them as the Victory Gardens of my mother’s childhood. I hope that 50 years from now, my grandchildren will hear stories of how the United States and the world beat back the coronavirus, and I hope that my children who are on this journey with me now will reflect and recognize the importance of a global community, productively working together for the common good.