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Liquid Mask Product as Tool to Combat COVID-19

The ongoing COVID-19 pandemic has taken its toll on the world.  Even among the healthy there is a sense of fatigue.  This has led to a decline of hygiene and preventative measures that once were prominent at the beginning of the pandemic.  Hand washing, surface cleaning, and proper ventilation is dwindling.  There is a demand for a preventative product that is easy to use and not invasive on the user’s daily life.  This is where a “liquid mask” may prove to be useful.

A “liquid mask” is an approved combination of hydrogen peroxide and hyaluronic acid in both nasal spray and mouth-rinse formulations.  The idea is that the hydrogen peroxide and hyaluronic acid will coat the user’s nasal and oral mucosa disallowing the SARS-CoV-2 virus from getting into the user’s nose or mouth.  This type of product can also be utilized to limit the penetration of the virus deeper into the respiratory tract early in the infection when the virus is limited to the oral and/or nasal cavities.

Currently, the nasal sprays on the market contain various active pharmaceutical ingredient (API) aimed at reducing the viral load of COVID-19 early in the course of infection.  Problems with these products are rooted in their higher price point (often greater than $20/bottle) and their formulation as a nasal spray only.  However, BMG Pharma now has approvals for their “liquid mask”, a hydrogen peroxide and hyaluronic acid combination product, as both a nasal spray and a mouthwash.  The CEO of BMG Pharma, Marco Mastrodonato, commented on the issue of high prices in the “liquid mask” market, citing $10-$20 per product as acceptable.  He also stressed the importance of presenting the product as a daily use hygiene product and not a product that can be used once to prevent COVID-19 infection.

A recent placebo-controlled clinical trial provided some evidence in the efficacy of hydrogen peroxide/hyaluronic acid products.  The trial included 106 asymptomatic patients who were infected with COVID-19.  In the placebo group, 57.8% of participants had a positive PCR swab test after three days while only 31.9% of participants using the hydrogen peroxide/hyaluronic acid nasal spray and mouth wash had a positive PCR swab test after three days (P=0.008).  These results suggest that hydrogen peroxide/hyaluronic acid “liquid mask” products may be effective and become the next big product to hit the market in the fight against COVID-19.

 

References:

1. ‘Liquid Masks’ Could Be A Vital New Resource Against COVID-19. Pharma Intelligence. http://images.intelligence.informa.com/Web/InformaUKLimited/%7B6ac30ea3-89de-442d-b7cc-4a86784d19b1%7D_JN5030_Noesis_-_Article_Design_Final_HR_(1).pdf. Published October 19, 2021. Accessed December 28, 2021.

 

 

Posted: May 2022

HRSA Funding for COVID-19 Runs Out

Health Resources & Services Administration (HRSA) recently announced that they would stop accepting claims for their Uninsured program, ultimately ending reimbursement for health care clinicians who provide testing, treatment, and administration of COVID-19 vaccines to uninsured individuals. The Uninsured program, which began in February of 2020, allowed healthcare professionals to be reimbursed for services primarily related to the vaccination, testing, and treatment of COVID-19 patients at Medicare rates. The program covered many services, including specimen testing. COVID-19 treatment was covered via telehealth appointments, office visits, and Emergency Department visits. From a pharmacy perspective, the Unsured program covered the dispensing rates for FDA-licensed antiviral drugs and administration fees for the COVID-19 vaccines. The program allowed providers to, “seek reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the patient, such as a patient’s private insurance company, Medicare, Medicaid, or the federal government’s COVID-19 Uninsured Program” but not seek reimbursement from the patient themselves. To date, HRSA has paid approximately $18.8B in claims. $11.4B went towards COVID-19 testing, $5.8B for treatment, and $1.6B for vaccinations.

According to the U.S. Census Bureau, there are approximately 28 million uninsured Americans. The creation and funding of the Uninsured program granted them access to testing, treatment, and vaccinations that may have otherwise been inaccessible due to their uninsured status. With providers, hospitals, pharmacies, and other health care centers now unable to receive funding from the government for their uninsured populations, they will have to find funding from other sources, including charging the patients for these services. Large diagnostic testing companies, such as Quest and Curative, announced that they would start charging patients up to $125 per test depending on the type or stop testing the uninsured altogether. On the other hand, large pharmacies such as CVS and Walgreens are continuing to provide free or low-cost testing options for all Americans and continue to state that all COVID-19 vaccines remain free.

The lack of funding will impact uninsured patients access to services. Smaller, independent pharmacies and healthcare providers may not have the financial resources to continue to provide care. There are unused Covid relief dollars that could be reallocated to this program. What is keeping HRSA and Congress from acting?

 

Posted April 2022

National Prescription Drug Take Back Day April 2022

The DEA’s National Prescription Drug Take Back Day has returned!  Scheduled for Saturday, April 30th from 10:00 AM – 2:00 PM, the program aims to educate the public about medication abuse while providing a safe and convenient means of disposing of prescription drugs.  This program, currently on its 22nd run, has removed more than 15.2 million unused medications since its initiation, with over 744,000 pounds being removed during the most recent October 2021 Take Back Day.

The program aims to remove unused, unwarranted, and old drugs from the public, as these medications are often the gateway for drug addiction. According to the Centers of Disease Control and Prevention (CDC), there were 93,000 drug overdoses in the United States last year, with 75% of them being due to opioid use. The Substance Abuse and Mental Health Service Administration (SAMHSA) published a report stating that most people who abuse prescription medications obtained those medications from close friends or family. With over 400 sites in Pennsylvania alone, this program is a free, anonymous way to dispose of your prescription drugs properly. Please be aware that sites cannot accept liquids, needles, or sharps.

To find a participating Drug Take Back Day site near you, use the following link: https://takebackday.dea.gov/

If you are unable to attend the National Prescription Drug Take Back Day, you can dispose of your medications at a year-round location. Visit the DEA Diversion Control Division at Controlled Substance Public Disposal Locations – Search Utility (usdoj.gov) to locate a site near you.

 

Posted April 2022

Acceleration of the Center for Medicare and Medicaid Innovation’s Mission

The National Association of Chain Drug Stores (NACDS) recently published a report aimed at policymakers. The report seeks to explain the benefit of expanding pharmacist services and begins by stating how the pandemic has highlighted both the value of pharmacists in patient care and reduction of healthcare costs. As the current administration works towards their goal of a sustainable and meaningful path for the future, it is important to recognize the valuable services pharmacies and pharmacists provide. These include preventative services such as screenings, vaccinations, and chronic disease management. Pharmacies and pharmacists also provide medication optimization services including medication adherence interventions. Additional services offered by pharmacists include point of care testing, patient education, risk assessments, identification and resolution of medication gaps, and screening of patients for social determinants of health. These services are often overshadowed by the stereotype that pharmacists in community pharmacies simply count pills. As a result, many are unaware of the value that pharmacies and pharmacists can provide to a population, not only during a pandemic, but also afterwards.

The Center for Medicare and Medicaid Innovation’s (CMMI) utilization of pharmacists is imperative to creating value for its beneficiaries. Pharmacy care is not systematically included in existing Medicare fee-for-service, value-based programs, or alternative payment models. There are five key recommendations outlined in the NACDS report, which is aimed towards increasing patient access to clinical pharmacy services and broadly improving healthcare quality, equity, and value through a new pharmacy care model. These five recommendations, are:

Include pharmacies and pharmacists as eligible providers and/or suppliers in existing and future value-based programs and alternative payment models.

  1. Allow pharmacies to be directly paid and/or incentivized for providing care to beneficiaries.
  2. Develop and implement meaningful measures, including standardized pharmacy-level quality metrics, across all value-based programs and alternative payment models.
  3. Support advancements in health information technology, interoperability, and other tools that support coordination across providers.
  4. Test a pharmacy value-based program to increase access to evidence-based community pharmacy care for Medicare beneficiaries.

The passage of the Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015 (MACRA) created new incentives for providers to participate in alternative payment models that meet certain eligibility criteria (known as advanced alternative payment models). These include a five percent bonus for participation in the alternative payment models. The Merit-Based Incentive Payment System (MIPS) was born out of this MACRA. MIPS-eligible, Medicare Part B providers may receive a positive or negative payment adjustment based on their performance across four categories – quality, cost, promoting interoperability, and improvement activities. It should be noted that pharmacists are not MIPS-eligible providers. However, 25 percent of improvement activities and 20 percent of promoting interoperability measures were related to medications, suggesting that community pharmacies are leveraged to positively impact the performance of the MIPS program.

The NACDS report identifies six essential categories that are crucial in designing, implementing, and evaluating alternative payment models:

Patient and Provider Participation

  1. Payment
  2. Care Delivery and Management
  3. Quality and Performance Measurement
  4. CMS Operational Issues
  5. Evaluation

These categories should be consulted whenever designing, implementing, and/or evaluating alternative payment models. The categories have given way to five recommendations for the integration of pharmacy care into value-based programs and alternative payment models.

The first recommendation is to include pharmacies and pharmacists as eligible suppliers and/or providers in existing and future value-based programs and alternative payment models. This would allow pharmacies and pharmacists to serve on care teams that improve access to community-based care through the delivery of patient-centered services. The Centers for Medicare and Medicaid Services (CMS) would have to expand direct payment to pharmacies as suppliers of healthcare services, as pharmacies and pharmacists would be providers for preventative services, chronic disease management, medication optimization services, and beneficiary education and health coaching.

The second recommendation is to allow pharmacies to be directly paid and/or incentivized for providing services that enhance quality of care, improve health outcomes, and reduce the total cost of care to beneficiaries. One issue is that the current models, lack the infrastructure to support sustainable delivery of pharmacy services; these models allow alternative payment model plans to partner with pharmacies, yet do not allow direct participation with pharmacies.  CMS and payers designing value-based programs and alternative payment models should provide direct payments to pharmacies. The following are solutions to direct payment and incentive pharmacies and pharmacists:

  1. Permit pharmacists to be eligible for performance-based or bonus payments linked to outcomes for measures related to preventative care
  2. Test models that allow pharmacist to be paid under Part B for preventative care
  3. Incorporate a one-time or monthly, risk-adjusted care management fee into existing or new model design
  4. Expand incident-to billing opportunities and remove the requirement that incident-to services be provided at the physician’s site of practice

The third recommendation is to develop and implement meaningful measures, including standardized pharmacy-level quality metrics, across value-based programs and alternative payment models, payers, and programs. This would allow for more accurate and consistent evaluation of a pharmacy’s impact in the models and programs.

The fourth recommendation is to increase the support to advance health information technology and software, particularly in interoperability. This would allow pharmacists and other stakeholders involved in a patient’s care to communicate more easily and have a more complete picture of the care given. Currently, the Pharmacist eCare Plan allows for clinical information exchange between pharmacies and others, such as physicians and payers.

The fifth and final recommendation is to test a pharmacy value-based program to increase access to evidence-based community pharmacy care for Medicare beneficiaries.  CMS and payers should design and implement a model focused on pharmacy care to test the impact on quality and beneficiary outcomes and costs.  This model would support the CMS goal of moving more patients and providers into value-based care. It would also aid in advancing the CMMI goal of achieving better care, healthier people, greater equity, and smarter spending.

One challenge related to payment for pharmacy services is that pharmacists are not recognized as Part B providers. For a pharmacist who practices in hospital outpatient setting or a physician’s office and can bill for incident-to billing, the payment is made to the provider or the physician overseeing the pharmacist. The creation of a new system that allows pharmacies to bill as providers for their services also poses a challenge, as they are currently not set up to do so. However, there are opportunities for payment of pharmacy services. One example of this is the per-member-per-month (PMPM) fees being utilized in Iowa and South Dakota. Participating pharmacies are paid a prospective PMPM fee with an opportunity to receive further payment based on shared savings. Minnesota reimburses pharmacies or other providers based on a continuum of patient need.

Overall, the utilization and recognition of pharmacies and pharmacists as providers will be a giant step forward for healthcare on all fronts. Further legislation will need to be passed, but it is clear that pharmacists have a lot to offer in support of CMMI’s Mission.  The savings and increased quality of care are exactly what is needed during and after this pandemic. What are your thoughts on the expansion of the role of pharmacists?

https://www.nacds.org/news/new-nacds-report-demonstrates-how-leveraging-the-expertise-and-accessibility-of-pharmacists-will-help-support-broader-healthcare-transformation-to-advance-quality-and-value/

 

Posted: March 2022

CivicaRx Announces Plans for Generic Insulin

Just days after President Biden called for a cap on insulin prices in his State of the Union Address, CivicaRx announced it is planning to develop and manufacture certain insulin products to be sold at a much lower cost than those currently on the market.  The current plan is for the first insulin to be introduced in 2024.  CivicaRx’s focus is to avoid the gross-to-net pricing framework (rebates) currently used for insulin products.

PBMs utilize their formulary coverage and product exclusions to drive prescription volume and associated brand drug rebates.  PBMs currently exclude lower list price insulins and would be expected to do the same with future low priced CivicaRx insulins.  Patients would still be able to access the product with a prescription and pay the cash price.  Depending on the pharmacy benefit plan, the monthly patient cash price may be much lower than the third-party price for patients with high deductible plans.  Existing manufacturer financial support programs through copay cards reduce the patient cost for Lantus, Novolog, and Humalog.  In combination, these factors generate a preference for the existing brands compared to the potential lower cost CivicaRx insulins

Medicaid currently focuses on the lowest net cost product and will exclude generics in situations where the generic price costs the Medicaid program more than the brand.  Unless CivicaRx versions are less expensive than rebated brands, Medicaid plans will limit coverage for these products.

Medicare Part D plans also benefit from brand rebates (percentage of list price) and DIR fees (percentage-based and flat-fee options).  CivicaRx insulins would be disadvantaged based of the lack of rebates, and possibly on DIR fees, if the PBM could retain a percentage of the brand insulin vs a flat fee on a generic insulin.

Therefore, if there is limited third-party coverage, pharmacies may lack the demand to stock the CivicaRx insulins.

The easiest avenues for gaining market share appear to be:

  • Uninsured cash-paying patients across all pharmacies
  • Hospital inpatient use to lower cost and expand profit opportunities

PHSL supports a competitive market, especially for a necessary treatment where patient costs become an obstacle to care, but there are product adoption concerns based on the initial notice and current market framework. CivicaRx will have obstacles to overcome for wide adoption of the lower cost insulins. Where do you see a fit in the market for CivicaRx’s proposed insulins?

 

 

Posted: March 2022

Virtual Reality in Healthcare

Virtual reality (VR) is defined as a program that immerses the user in a virtual environment with the use of a headset. This requires audio and video components, head tracking to simulate head movement, and a 360-degree view of the virtual world. The imagery must be an entirely fictional reality with actions and images controlled by the system. Virtual reality can sometimes be confused with augmented reality. Virtual reality creates a computer-generated world, while augmented reality layers a digital image on the real world through a device screen like a smart phone. For example, virtual reality would allow you to feel like you are swimming in an underwater environment, while augmented reality would display a fish swimming on the wall in front of you.

Currently, virtual reality is used in healthcare in pain treatment, anxiety treatment, phobia exposure, surgical training, education, and physical fitness. However, more studies are available to support the use of virtual reality in treating pain and anxiety. Virtual reality treats anxiety by two mechanisms: exposure and distraction. Exposure refers to the virtual confrontation of a problematic situation like public speaking, and distraction simply provides some calming event in the virtual world to take focus away from an anxious event. One anxiety study looked at virtual reality exposure to treat social anxiety disorder.1 The patients self-reported anxiety levels pretreatment, posttreatment, and 12 months after treatment. There was significant improvement in anxiety 12 months after treatment without any notable side effects observed. This is encouraging, because this long-lasting effect could justify the costs associated with virtual reality treatment if it eliminates chronic medication use. Virtual reality’s place in therapy could also be justified by eliminating the use of benzodiazepines in anxiety treatment, which are a potentially addictive substance that we would like to limit in healthcare.

When looking at pain treatment, virtual reality works via three mechanisms: distraction, focus shifting, and skill building. Distraction tries to divert the patient’s attention with a passive virtual experience. Focus shifting guides user interaction and creates virtual tasks for the user to complete, which tries to use an active program to shift focus from painful stimuli. Skill building uses the virtual world to learn techniques that could help in the real world, which includes controlled breathing exercises. Studies looking at these pain treatments have shown significant improvement in pain scale ratings with nausea as the only side effect. One potential place in therapy is the replacement of opioids in some patients; eliminating the use of addictive substances could provide motivation to push virtual reality into the mainstream.

In other fields, virtual reality is being used for education in medical, nursing, and pharmacy schools. It is used for patient counseling practice and clinical examination practice. The potential benefit of these uses is eliminating the need for patient actors or simulation mannequins, which may allow universities to save money in the long run. The future goal is to have multiplayer virtual reality, which would allow people from around the world to interact in the same virtual space for teaching or clinical practice. In a related field, virtual reality is being used for surgical training, which allows surgeons to practice their technique without the real-life risks of surgical procedures. Lastly, phobias are another common use for virtual reality where exposure therapy is used to alleviate fears, such as public speaking or spiders.

Two companies currently providing virtual reality therapy are Behavr and XR Health. Behavr is $599 for a 22-week program focusing on mental health or pain treatment. The headset with the pre-loaded programs is sent directly to the patient. The other, XR Health, is $69 for a week for self-use or $89 a week for sessions with a therapist. This site advertised it is covered by many insurances, but it is unclear exactly what the final pricing would look like with a large variance expected between plans. This system is also used for pain or anxiety treatment, and it comes with individualized patient programs pre-loaded on the device. Similarly, Osso VR is a current program offered for use in surgical training, but pricing information is not available. This program rates the success of virtual procedures and tracks improvement and time spent training.

Overall, virtual reality in healthcare is still in the beginning stages of use. There are many encouraging advancements, but it still has a lot of room for growth in the market. Recent advances in virtual reality were driven by the increasing availability and affordability of headsets. With more remote learning and work-from-home opportunities due to COVID, the virtual reality market is poised for expansion.  In the future, access to headsets will continue to increase, and virtual reality will continue to grow in use and programming. How do you think virtual reality can continue to expand its use in healthcare?

 

Reference

  1. Anderson PL, Price M, Edwards S et al.. Virtual reality exposure therapy for social anxiety disorder: a randomized controlled trial. J Consult Clin Psychol. 2013 Oct;81(5):751-60.

 

Posted: February 2022

Interchangeable Biologics in the Drug Compendia

Biologics are therapies aimed to prevent, treat, and cure diseases. They are typically large complex molecules often derived from a living system. Biologics are managed differently than small molecules products by the FDA. The list of all currently approved biologics is available in the FDA’s Purple Book. With biologics, the initial product introduced into the market is labeled as the reference product. The reference product is approved based on a full complement of safety and effectiveness data.

From there, additional products can be developed and become approved as biosimilars. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from the FDA-approved reference product. A biosimilar is compared directly to the reference product in terms of its structural make-up and its function.

A biosimilar can be dispensed when that particular biosimilar product name is written for by the prescriber. In addition to being a biosimilar, a product can also become an interchangeable biosimilar. An interchangeable biosimilar must meet additional requirements based on further evaluation and testing of the product. The FDA provides the following information on interchangeable products: “As part of fulfilling these additional requirements, information is needed to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient. Also, for products administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product will have been evaluated.” Once a product is approved as interchangeable, it can be used in place of a reference product. The ability and procedure for pharmacies to substitute for a biologic are determined by state regulations.

Currently, there are two FDA-approved interchangeable biosimilar products. Semglee (insulin glargine-yfgn) was the first approved interchangeable biosimilar and is interchangeable for Lantus (insulin glargine). The original NDC of Semglee (insulin glargine) was approved as a biosimilar to Lantus in June 2020 under 351(a), the traditional pathway for an innovator biologic. The new Semglee (insulin glargine-yfgn) was approved in July 2021 under 351(k), the biosimilar pathway, which caused the assignment of a 4-character suffix (YFGN) to the chemical name, and which makes it a unique chemical name.  This situation has presented challenges for the drug pricing compendia and with product selection at the pharmacy, because not all Semglee product NDCs have the interchangeable status. The second interchangeable biosimilar product is Cyltezo (adalimumab-adbm), the interchangeable for Humira (adalimumab), which is not currently on the market but is scheduled to launch in July 2023.

Wolters Kluwer’s Medi-Span drug compendium uses the generic product identifier (GPI) to link pharmaceutically equivalent products (i.e., products with the same active ingredient, strength, dosage form, and route of administration). A GPI will link a brand and all its available generics. However, the GPI will not work to link a biologic and its corresponding biosimilars, as each biosimilar has a unique 4-character suffix, and thus a unique chemical name/active ingredient.  Therefore, the biosimilar will not link to its reference product and will instead have its own GPI.  PHSL understands that interchangeability codes are included in a separate substitution file but are not accessible to subscribers of all Medi-Span platforms. Pharmacy systems relying on Medi-Span that do not have access to the substitution file for interchangeability will require additional data within the system or additional configuration efforts by the dispensing pharmacy staff to determine product interchangeability.

Drug pricing compendium First Databank (FDB) contains a similar linkage of brands and generics through their use of the Generic Code Number (GCN) and GCN Sequence Number. While Lantus and interchangeable biosimilar Semglee do not share the same GSN, FDB has introduced fields in which these products can be identified and used by stakeholders: Biologic Name Grouper and Biologic Association Type. Biologic Name Grouper represents a family name that groups reference biologics and their corresponding biosimilar and interchangeable NDCs. Biologic Association Type identifies a product as a reference, biosimilar, or interchangeable. As we referenced above, Semglee currently has NDCs that are considered biosimilars and additional NDCs that meet the criteria for interchangeable biosimilars.  Within FDB, these fields may reduce the issues with Semglee NDCs by providing additional details on the interchangeable status to the reference product Lantus.

Data fields linking biologics, biosimilars, and interchangeable biosimilars are vital for stakeholders to identify and allow for proper substitution of interchangeable products. This can provide significant cost savings to health plans and patients. Providers may also be able to use this data to identify available interchangeable biosimilars for a particular product. On November 22, 2021, an article published in Drug Topics highlighted a policy change adopted by Mayo Clinic in which their prescribers were advised to utilize the lowest cost biosimilar. This policy change was reported to have saved Mayo Clinic approximately $23 million over the first twelve months, which demonstrates the potential for cost savings that can be realized in the biologic market. It will be up to stakeholders to utilize this additional information to create policy, automation, or other innovation to benefit from interchangeable biosimilars. What actions need to be taken by your organization to direct the use of biosimilars or interchangeable biosimilars?

 

Posted February 2, 2022

The Rise of Direct-to-Consumer Healthcare

The UnitedHealth Group (UHG) is pushing into the direct-to-consumer healthcare market through cash-only telehealth services that allow individuals to schedule virtual care appointments with medical professionals and get prescriptions for birth control, erectile dysfunction (ED), hair loss, anxiety and depression, and other common medications (e.g., atorvastatin, metformin, omeprazole, etc.).  These services are available through the Optum Store, its online pharmacy which launched in November 2020.  The Optum Store added mental health services in June 2021, including virtual therapy, medication, and other healthcare support.

The Optum Store offers its mental health services on a subscription basis, with monthly fees starting after an introductory cost of $9 for the first month of service.  Subscriptions are month-to-month and can be cancelled at any time:

  • $59 monthly fee for medication and support
  • $309 monthly fee for therapy
  • $359 per month cost for therapy, medication, and support

All services offer unlimited messaging with the Care Team.

Virtual Care appointments are available through the Optum Store at $55 per visit to treat common conditions such as allergies, illness, infection, injury, pain, and skin problems.  Providers will issue an electronic prescription if needed and send it to the patient’s pharmacy of choice.  For patients who need medication treatment for ED and birth control, consultation services are also included as part of the visit.  The initial provider consultation is free for patient and $15 for subsequent consultations.

Optum also provides pricing options for medication treatment for ED and birth control.  Medications that are offered to treat ED are Viagra®, Cialis®, sildenafil, and tadalafil.  The cost of Viagra® is $80 per tablet, while its generic form, sildenafil, starts at $1 per tablet. Cialis® cost $71 per tablet, while the generic form tadalafil begins at $2.50 per tablet.

Optum offers three different methods of birth control: pills, patches, and rings.  Birth control pills or mini pills start at $10 per month when ordering a six-month supply.  The transdermal patch begins at $95 per month, and the ring starts at $68 per month.  Pricing for birth control depends on the patient’s need and days’ supply (90 or 180 days).

The direct-to-consumer healthcare services offered through Optum rival those provided by Hims & Hers, Ro, and Talkspace.

How does this pricing compare for competitors?

Hims & Hers, a direct-to-consumer telehealth company that provides women and men virtual health services, also offers mental health services at $99 per 50-minute session, which differs from other subscription-based services like Optum.  Hims & Hers does not offer text-based therapy, only video therapy sessions.  Pricing for additional services provided through Hims & Hers depends on the individual’s treatment requirements.

Ro does not have a membership fee for services and charges on a per-visit and per-medication basis.   Ro Online treatment services are $15 per visit, not including medication costs.  The total cost of treatment depends on the drug and the amount of medication the individual needs.  Ro offers three different programs:

  • Roman is a digital health clinic for men experiencing hair loss, erectile dysfunction, cold sores, and other health needs.
  • Rory is a digital health clinic for women offering online reproductive health and beauty services.
  • Zero is an online program provided by Ro to help individuals quit smoking using the combination of prescription medication and nicotine replacement therapy. Ro’s Zero program is $15 per visit; the charges for one month of bupropion and nicotine gum are $45 and $42 respectively.

Talkspace is an online and mobile company that offers therapy services to individuals with or without insurance and currently provides three therapy subscriptions options.  Some insurance providers have contracted with Talkspace to cover subscription costs for covered individuals.

  • Talkspace Unlimited Messaging Therapy Plus service offers no live sessions, but therapists respond daily, five days per week via text, video, and audio messaging for $260 per month.
  • The Unlimited Messaging Therapy Premium plan includes everything the lower-tiered (Plus) program offers with the addition of one 30-minute live session each month for $316 per month.
  • The Unlimited Messaging Therapy Ultimate has everything in the previous plans with the addition of four 30-minute live sessions each month for $396 per month.

Will other PBMs enter this competitive space?

Optum’s path to implementation may have been easier due to their association with UnitedHealth Group and the providers under the OptumHealth organization.  However, CVS Caremark’s acquisition of Aetna makes for a seamless connection to providers and would allow for a similar direct-to-consumer model of healthcare services.  CVS has even announced store closures in an effort to focus on primary health services and grow their online pharmacy.  Likewise, the Express Scripts and Cigna merger provides ESI with the same opportunities to establish a direct-to-consumer healthcare service model.  These competing PBMs could take strategic action to offer direct-to-consumer telehealth services.

Impact

Currently, Optum appears to be one of the most competitive in this space in terms of comprehensive service offering and market positioning, which could provide an early adopter advantage.  Optum can leverage its provider network asset to deliver an integrated offering of low-cost healthcare service and prescription dispensing for commonly diagnosed medical needs.  Optum’s venture into direct-to-consumer healthcare could foreshadow the moves of other PBMs in the future.  The ability to pair primary health services to a pharmacy service may prove to be invaluable for PBMs.  It will be interesting to see how future players in direct-to-consumer healthcare affect the pricing of those services.  What impact do you think this addition will have for Optum and on the future growth trajectory of PBMs?

 

Posted January 2022

Best Buy Health Updates

On Tuesday October 12th, 2021, Best Buy announced the acquisition of Current Health, a U.K. based technology company that offers a digital platform for remote patient monitoring and telehealth services.1 Best Buy Health focuses on bringing healthcare into the home, specifically for aging seniors, by utilizing health technology devices and people-driven services. Best Buy’s healthcare division offers virtual care, such as remote patient care, in-home patient monitoring, and technology solutions for Medicaid members, Medicare patients, and seniors (age 65+ years).

Financial details about the acquisition of Current Health were not disclosed, but Best Buy predicts that they will close this deal by the end of their fiscal year, which is the end of January. Best Buy will combine its large retail reach, extensive experience in supply chain management, and nationwide trusted support services with Current Health’s health technology to create a holistic care ecosystem for seniors.2

Best Buy has been expanding its healthcare initiatives over the past few years. In 2012, the company faced financial ruin due to fierce competition from online retailers, such as Amazon. Best Buy executives avoided closure by recreating their business model into one that focused on excellent customer service and creating strong relationships. They implemented the Geek Squad and agnostic technology solutions to rejuvenate the business. Seeing the success of this model and the value behind personalized customer support, Best Buy created Best Buy Health, an at-home health service aimed towards aging seniors.3

In 2017, Best Buy Health launched Assured Living, a remote monitoring service for seniors at home, and they partnered with a home medical exam producer called TytoCare.4 In 2018, they acquired GreatCall, a tech company that makes smart devices for emergency response services, for $800 million.1,2 Best Buy then acquired BioSensics, a company that produces wearable health sensors, for $21 million, and Critical Signal Technologies, a remote monitoring company.4 Best Buy is also partnered with Workpath for in-home blood draws and with ScriptDrop for medication delivery.2 Additionally, Best Buy now sells a variety of smart medical devices and launched their own senior-focused smartphone called Lively.5,6 Best Buy spent approximately $1 billion in the healthcare space in the last four years.3

Best Buy is not the only retail giant disrupting the healthcare market. Companies such as Amazon, Walmart, AT&T, Comcast, and Apple have also made strides towards advancing their own health divisions. Amazon has established Amazon Care, a health division that offers at-home healthcare and medication management through a mobile app that directly connects with providers, medication delivery, and a 24/7 virtual care team. Walmart opened primary care clinics called Walmart Health for its customers at retail locations. AT&T has been working on strategies for using their wireless network to create remote healthcare tools. Comcast has been developing a health care platform for the television that seniors can use for remote healthcare services. Apple owns the Apple watch and Apple health.7

Will Best Buy be able to compete with these companies? Best Buy’s stock price has increased over the last month by 20%, with a value of $132.11 per share*. They have established trust due to years of providing hands-on help directly in the home via the Geek Squad. Best Buy has a large reach, with almost 1000 in the U.S. and 20,000 Geek Squad Agents. As a comparison, Apple has 272 stores in the U.S. This reach equates to 75% of the U.S. population being located within 15 minutes of a Best Buy store.4,9 Best Buy Health focuses on senior living, an area that other companies are not solely focusing on. This chosen population makes patients covered by Medicare Advantage Plans a key target. There are around 30 million patients enrolled in a Medicare Advantage Program.4 Best Buy also has many technology partnerships to advance their healthcare solutions, and they offer a variety of benefits to their customers, such as social services, care centers, urgent response teams, GreatCall rides, and Geek Squad Agents available 24/7. Finally, Best Buy’s acquired partner, Current Health, has grown their revenue by 3000% year-over-year and grew their new customer network by 40%, leading to the prediction that this merger will only help Best Buy continue to grow.2,8

As with any company trying to break into a new space, Best Buy may face obstacles. Their biggest concern is their ability to scale the business to continue to provide amazing care and customer service. There is always the concern that competitors will enter the senior living market and directly compete against Best Buy.5 Despite potential challenges, Best Buy has many advantages over other competitors, such as having established strong trust from their customers, offering agnostic solutions, utilizing the Geek Squad, and having a massive reach in the U.S. It is likely that Best Buy will continue to disrupt the healthcare and telehealth industry, as trends have reported that baby boomers want to age at home, thereby making healthcare at-home the future.1

Best Buy is focused on senior living, remote monitoring, real-time data, in-home care, and emergency response. Since their primary target is seniors, Best Buy could consider entry into pharmacy, as seniors tend to use the greatest number of medications.  This large number of medications creates a need for medication management services, which pharmacists can provide. Other competitors, such as Amazon Care, already offer some pharmacy services. PHSL will closely watch how Best Buy progresses over time and continue to assess its disruption in the market.

Market price acquired 11/09/2021 at 11:21 AM*

 

References:

  1. Repko M. Best Buy pushes ahead with its health-care strategy by acquiring Current Health. CNBC. https://www.cnbc.com. 2021 Oct. 12 (accessed 2021 Oct. 26).
  2. Landi H. Best Buy ramps up focus on home health care by acquiring Current Health. Fierce Healthcare. https://fiercehealthcare.com. 2021 Oct. 12 (accessed 2021 Oct. 26).
  3. Burdakin A. Best Buy’s healthcare strategy: 5 millions seniors in 5 years. The Motley Fool. https://www.fool.com. 2019 Oct. 1 (accessed 2021 Oct. 26).
  4. Mozart M. Why Best Buy could disrupt senior care more than rivals like Amazon. Senior Housing News. https://seniorhousingnews.com. 2019 Sept. 26 (accessed 2021 Oct. 26).
  5. Perna G. Current Health CEO on what’s exciting, and scary, about being acquired by Best Buy. Health Evolution. https://www.healthevolution.com. 2021 Oct. 20 (accessed 2021 Oct. 26).
  6. Best Buy. Shop smart health products. https://www.bestbuy.com. (accessed 2021 Oct. 26).
  7. Advisory Board. Is ‘big retail’ the next big health care disrupter? https://www.advisory.com. 2020 Feb. 7 (accessed 2021 Oct. 26).
  8. Best Buy Health. https://healthcare.bestbuy.com. (accessed 2021 Oct. 26).

 

 

Posted: November 2021

New Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements Starting November 15, 2021

The FDA approved modifications to the Clozapine REMS program to ensure that the benefit of clozapine outweighs the risk of severe neutropenia that can lead to severe infections. Alterations to the clozapine REMS program will go into effect on November 15, 2021. The new REMS program will help clarify and enhance the prescribing information for clozapine, further explaining how to monitor patients for neutropenia and manage patients with severe neutropenia. The REMS program recommends that patients taking clozapine who shows signs of moderate neutropenia with an Absolute Neutrophil Count (ANC)  <1000µL should discontinue clozapine and restart once ANC levels normalize to ≥1000µL. Patients with severe neutropenia with an ANC <500µL should stop taking clozapine and only resume clozapine if the physician determines the benefit outweighs the risk.  (Clozapine and the Risk of Neutropenia: A Guide for Pharmacists: Table 1 Page 7)

The modifications to the clozapine REMS program will require physicians and pharmacies to re-certify in the clozapine REMS program and make changes to their current monitoring procedures to continue prescribing and dispensing clozapine to patients. Prescribers and pharmacies can re-certify through the clozapine REMS website.

Although patients are not required to take any action due to REMS program changes, prescribers must re-enroll or enroll their patients. Prior to enrolling patients into the REMS program, physicians must make sure their recertification into the clozapine REMS program is complete.

  • For patients currently taking clozapine, healthcare professionals will continue monitoring patients according to the current REMS requirements. However, providers can begin to re-certify and re-enroll all existing patients into the new REMS program now and must have that completed by November 15, 2021.
  • For patents starting clozapine between now and November 15, 2021, prescribers will enroll patients in both the current and new REMS programs.
  • For patients starting clozapine after November 15, 2021, prescribers will only enroll patients in the new REMS program.

The changes also make improvements to the process of submitting ANC results, which will reduce the burden on prescribers and reduce treatment interruptions for patients. Prescribers will now submit ANC documentation monthly, which is a change from daily, weekly, or biweekly documentation, depending on the patient’s monitoring frequency.

Pharmacists and authorized representatives of pharmacies should know that the current “switch” system will no longer be available.  This system allowed pharmacies to send prescription information simultaneously through (1) the Clozapine REMS Program to obtain the Pre-Dispense Authorization (PDA); and (2) their Pharmacy Management System (PMS) to adjudicate with the third party. Pharmacies will need to develop new processes and procedures to complete both transactions when dispensing clozapine.

The REMS Dispense Authorization (RDA) will replace the current Pre-Dispense Authorization (PDA). Pharmacies can access the new RDA forms through either the clozapine REMS website or by calling the REMS Contact Center. The first time a patient fills clozapine under the new REMS program, the RDA for outpatient pharmacies will verify that the pharmacy is certified, the patient is enrolled, and the patient’s treatment is not interrupted or discontinued. For subsequent fills, the RDA will verify that outpatient pharmacies are certified, the patient is enrolled, a Patient Status Form has been completed in the last 37 days, and the patient’s treatment is not interrupted or discontinued. There are no changes for inpatient pharmacies that dispense clozapine for inpatient use.

Wholesalers or distributors will have no changes to their current requirements. However, wholesalers or distributors will have to re-enroll in the Clozapine REMS by November 15, 2021 to purchase and distribute clozapine. Wholesalers and distributors will continue to verify pharmacy certification through the Clozapine REMS.

Sources:

  1. https://www.fda.gov/drugs/drug-safety-and-availability/clozapine-risk-evaluation-and-mitigation-strategy-rems-requirements-will-change-november-15-2021?utm_medium=email&utm_source=govdelivery
  2. https://www.clozapinerems.com/
  3. https://www.newclozapinerems.com/home

 

Posted: October 2021