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The Department of Health and Human Services (HHS) is planning for the federal Public Health Emergency (PHE) for COVID-19 to expire at the end of the day on May 11, 2023.¹ The end of this era, which began as a declaration under Section 319 of the Public Health Service (PHS) Act, will result in anticipated changes across COVID-19 testing, vaccines, treatments, and Medicaid coverage requirements. The effects that these changes will have on PBMs and payers are considered below.

Tests

The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will end. This implies that PBMs/payers would be able to choose to remove member coverage for COVID-19 at-home tests. Payers will have to weigh the cost-benefit of removing at-home test coverage vs. members potentially electing more costly lab testing or foregoing testing (and the window for early treatment) altogether, which could lead to costlier medical treatments down the road.

Vaccines

As of February 2023, Congress has not agreed to the president’s requests for additional government funding to provide vaccines free of charge.² However, vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and therefore HHS expects that most private insurance plans will fully cover COVID-19 vaccines without a co-pay. PBMs/payers may see their vaccine costs increase due to members potentially having used and now losing access to free COVID-19 vaccines and boosters that had been previously available.  Pfizer has previously announced that their COVID-19 vaccine will cost $110-$130 per dose once the PHE ends.³

Treatments

HHS acknowledges that “out-of-pocket expenses for certain treatments [e.g., Paxlovid and Lagevrio] may change, depending on an individual’s health care coverage, similar to costs that one may experience for other drugs through traditional coverage,”¹ implying that programs like 2022’s federal government purchase and free distribution (throughout select pharmacies) of 20 million courses of Paxlovid will no longer continue. PBMs/payers may therefore see an increase in claims for COVID-19 treatments. The estimated cost of one course of Paxlovid treatment in 2022 was $530⁴, and 2023 costs may be higher.

Medicaid

During the COVID-19 public health emergency, the federal government prohibited states from removing people from the Medicaid program once they had enrolled. In late 2022, Congress communicated to states that they can start removing ineligible people (i.e., due to excess income or relocation out of state) in April 2023. PBMs/payers may see additional membership applications from members’ dependents that lose access to Medicaid once the prohibition is lifted.

What other impacts to PBMs and payers do you expect to see when the Public Health Emergency ends May 11^th?  PHSL will continue to monitor and report upon changes.

¹  https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html

² https://wusfnews.wusf.usf.edu/politics-issues/2023-02-01/how-will-life-change-once-the-covid-19-emergency-ends

3 https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html

⁴ https://www.talktomira.com/post/how-much-does-paxlovid-cost-and-where-to-get-it

Posted: March 2023

The terms brown bagging, white bagging, and clear bagging are frequently used to describe the way in which a specialty medication is obtained prior to patient administration by a healthcare professional.¹ Brown bagging is the term used when a patient obtains their medication from a specialty pharmacy and takes it to the provider’s office for administration of the medication.  White bagging refers to the process by which a provider orders and receives a patient’s medication from a specialty pharmacy and stores it until they ultimately administer the medication to the patient.  One caveat with white bagging is that providers must stock and store medications for each patient separate from the office or hospital stock, which can be logistically burdensome. Clear bagging is similar to white bagging with one key distinction.  Clear bagging involves the provider obtaining the specialty drug from a specialty pharmacy within the same health system.²

Key billing and cost considerations exist for health professionals administering most specialty medications. Physician offices may use a process called buy-and-bill. The “buy” portion refers to the provider being responsible for the ordering and purchasing of a specialty drug.  The “bill” phrase refers to the provider billing third party payers for reimbursement.  The billing process includes reimbursement for the drug, the administration of the drug, and any related services associated with the drug and its administration.  Under the different forms of bagging, the specialty pharmacy will work with the payer to determine the medical vs. pharmacy benefit billing for the drug.  The buy-and-bill method for providers utilizes medical benefit billing and reimbursement. The provider’s office manages the drug inventory to align with patient appointments, as forgetfulness or lack of coordination could impact adherence and health outcomes.  This method means that the provider’s office is responsible for higher upfront costs and the management and storage of the medication. ³ However, this method is also likely to be more profitable for the provider.

The significant expenses associated with specialty medications and their administration has payers searching for a way to cut costs without sacrificing care.  One popular and proven solution is called Site of Care Optimization,⁴ which encourages patients to move from the traditional and higher-priced locations of drug administration to lower cost options.  Magellan’s annual Medical Pharmacy Report highlights the magnitude of the cost savings stating, “Commercial medical benefit drug costs in the hospital outpatient setting were often double that of the physician office. Compared to the commercial population… Oftentimes, administrative code reimbursement is four times more expensive in the hospital than physician office setting for commercial members.”  This presents payers with a phenomenal opportunity to cut costs for patients without sacrificing care.⁵ How do you envision the future of specialty drug delivery and administration?

References:

1. Rayburn K. What is the difference between white, Brown, and clear bagging? Patient Empowerment Network. https://powerfulpatients.org/2022/05/25/what-is-the-difference-between-white-brown-and-clear-bagging/. Published May 25, 2022. Accessed November 2, 2022.

2. Brown bagging versus white bagging: Value-based Cancer Care. Value Based Cancer Care. https://www.valuebasedcancer.com/issues/2013/september-2013-vol-4-no-8/1341-brown-bagging-versus-white-bagging#:~:text=%E2%80%9CBrown%20bagging%E2%80%9D%20is%20when%20a%20patient%20acquires%20specialty,the%20patient%20visits%20the%20physician%E2%80%99s%20office%20for%20administration. Published July 25, 2013. Accessed November 2, 2022.

3. DeMarzo A, Nbpas. What is buy and Bill? Prior Authorization Training. https://www.priorauthtraining.org/what-is-buy-and-bill/. Published March 22, 2021. Accessed November 2, 2022.

4. Orabi C. Site of care optimization: What is it and what do you need to know? CIVIC Infusion | Medical Infusion Specialists. https://www.civicinfusion.com/CIVIC-Blog/site-of-care-optimization-what-is-it-and-what-do-you-need-to-know. Published November 13, 2020. Accessed November 2, 2022.

5. Site of Care Optimization. National Infusion Center Association. https://infusioncenter.org/infusion-center-news/site-of-care-optimization/. Published September 14, 2019. Accessed November 2, 2022.

Posted: February 2023

As we prepare for 2023 formulary exclusions to be implemented, we wanted to look back at 2022 formulary exclusions for Express Scripts (ESI), CVS Caremark, and OptumRx. Based on PHSL’s review, ESI led the way with over 108 formulary exclusions. CVS Caremark added 95 new exclusions, while OptumRx only excluded an additional 80 drugs. Although CVS Caremark excluded nearly 100 new drugs, they noted that 99.61% of their clients would not be impacted by any medication changes because of the formulary removals. The 2022 exclusions, as researched by PHSL, are as:

During the review, PHSL made the following observations:

• ESI focused more attention on dermatologic agents and autonomic & central nervous system products. Examples included Tazorac 0.05% Cream, Fabior, and Ultravate for dermatologic agents. Examples of autonomic & central nervous system products included Dhivy, Baclofen solution, and Lybalvi.
• CVS Caremark’s main focus was on dermatologic agents and pain medications, with 14 exclusions in each category. Examples included ivermectin gel, desonide gel, and for the dermatologic agents. Meloxicam capsules, butalbital-acetaminophen 25-325 mg tablets, and diclofenac potassium 25 mg tablets are some of the pain medications excluded from formulary last
• OptumRx focused on dermatologic agents and chemotherapy agents. Dermatologic agents excluded by OptumRx and other PBMs included Tazorac 0.05% Cream and Fabior. Inqovi, a chemotherapy agent, was excluded from formulary without a formulary alternative. OptumRx advised patients to consult with their provider about clinically appropriate options.
• All three PBMs excluded an oral formulation of diclofenac last With both ESI and CVS excluding diclofenac potassium 25 mg tablets and OptumRx excluding diclofenac 35 mg capsules.
• CVS Caremark greatly restricted coverage of diabetic supplies and needles. Any insulin needle or syringe that was NOT BD Ultra-Fine brand was excluded. Any test strip NOT Accu-Chek or OneTouch brand was excluded. CVS Caremark excluded any glucose monitoring system that was NOT the DEXCOM Continuous Glucose Monitoring System (DEXCOM G6), Omnipod Insulin Infusion Pump, or Omnipod Dash Insulin Infusion Pump.
• In addition, CVS Caremark no longer covered any brand name prenatal . CVS Caremark included four specific prenatal vitamins on their formulary: Prenatal Tab 27-1mg, Prenatal Tab Plus, Prenatal Vitamin Tab Low Iron, and Tricare Tab Prenatal.
• It is important to note that CVS Caremark excluded only a specific NDC for albuterol sulfate CFC- free aerosol (NDC:66993-0019-68), manufactured by PRASCO Laboratories. Manufacturers that are covered include: Glaxosmith, Cipla, Hikma, Teva, Sandoz, Civica, Par Pharma, and Padagis.
• It is important to note that CVS Caremark excluded only a specific NDC for paroxetine HCl ER (NDC:), manufactured by APOTEX. Manufacturers that are covered include: Rhodes Pharma, Kremers Urban, Lupin Pharma, Westminster, and Modavar Pharma.
• OptumRx still requires prior authorization for Hepatitis C, Multiple Sclerosis, and Immunomodulator treatments. Avsola replaced Simponi Aria and Renflexis as preferred immunomodulators. Kesimpta and dimethyl fumarate DR replaced Tecfidera for multiple sclerosis preferred treatments. There was no change in preferred Hepatitis C medications.
• As mentioned in our 2021 Exclusion List Review, ESI continues to use indication-based management for the “inflammatory conditions” drug class.

Each of the major PBMs took a different approach to managing drug expenditures in 2022, with formulary exclusions continuing to play a major role. PBMs exclude products because of clinical, financial, and humanistic reasons. Each PBM makes value judgements and determines what coverage is no longer warranted. This article represents PHSL’s analysis of publicly available information regarding the three PBM’s formulary exclusion lists for 2022. Readers are encouraged to assess the lists for themselves, using the exclusion list source information provided in the links below.

• CVS Caremark 2022 Exclusion List
• Express Scripts 2022 Exclusion List
• OptumRx 2022 Exclusion List

Stay tuned for PHSL’s review of the PBM 2023 formulary exclusion lists, coming soon!  How do you expect that the 2023 formulary exclusions will compare with those in 2022?

Additional Resource:

• 2022 CVS Caremark Formulary Updates | CVS Health Payor Solutions
• CVS Caremark Preferred Drug List
• CVS Caremark Formulary Watch
• 2022 CVS Caremark Formulary

Posted: December 2022

Hearing loss is a critical public health issue. Nearly 30 million adults in the US have some degree of hearing loss. Untreated hearing loss increases the risk of social isolation and depression and is one of the greatest modifiable risk factors for dementia. Although use of hearing aids has increased in the past several years, studies have found that in people over the age of 70 years, only about 18% who owned hearing aids used them. ^1,2

In the past, the only hearing devices available in stores were known as Personal Sound Amplification Products (PSAPs), which are not alternatives to hearing aids. These devices are made for people without any hearing impairment to amplify sounds in certain situations, such as for recreational activities like bird watching or hunting. These are regulated as consumer electronics and not medical devices and may be more variable in terms of quality.⁷

The price of hearing aids has been a major obstacle for people. Traditional Medicare does not cover prescription hearing aids, which can cost between $4,000 and $5,000. Medicare Advantage plans typically include some coverage, but people still pay roughly 79% out of pocket. ¹ There is a large potential market for over the counter (OTC) hearing aids. Roughly 90% of adults with hearing loss can be helped by OTC hearing aids, but sales have been restricted to licensed audiologists and other specialists, which has continued to keep prices high. Effective October 17^th, 2022, consumers can buy OTC hearing aids in stores and online.¹

On August 16^th, 2022, the FDA issued their final rule to establish a regulatory category for OTC hearing aids to improve access and lower prices for millions of Americans.  The goal of the final rule is to foster innovation and competition in the hearing aid technology marketplace. Many manufacturers and retailers have not said much about new products, prices, or distribution yet, but some details have surfaced. Best Buy plans to open hearing centers in more than 300 stores in the 4^th Quarter and has already added an online hearing assessment tool. Customers will be able to use this tool to assess their hearing and choose from nine brands; sales staff who have received specialized training will be able to provide assistance. Prices are said to range from $200 to $3,000, depending on varying functions. Sony also announced a partnership with WS Audiology Denmark, but specifics regarding their products have not been released. Bose Corp. has partnered with Lexie Hearing to create a new self-fitted OTC aid for around $900. Over time these prices are likely to fall as more competition enters the market.^1,3,5

Walmart, CVS, and Walgreens have made OTC hearing aids available on their websites as of October 17^th. Walmart plans to offer a range of various products priced from $199 to $999 per pair and has currently made them available in their vision centers at select stores in Colorado, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, and Texas, and at 474 Sam’s Club Hearing Aid Center locations. CVS plans to have products in stores beginning in November 2022. Walgreens currently has hearing aids available online for $799 with comparable models from specialists ranging from $2,000 to $8,000 per pair. Walgreens also plans to sell these in stores in the future. Hy-Vee plans to start selling over-the-counter hearing aids online and in 34 locations across Iowa, Kansas, Minnesota, Missouri, Nebraska and Wisconsin. Hy-Vee will offer four models ranging in price from $499.99 to $999.99 and plans to make them available in 100 locations by the end of the year.⁵

Because these products are OTC, pharmacists will not be required to consult on these devices, but they are one of the most accessible healthcare professionals and will need to be able to help consumers in their selection when needed. In some cases, pharmacists will need to refer patients to audiologists and physicians for additional evaluation. They may also need to follow up with patients to ensure the device works as expected. To help pharmacists in this new role, the University of Pittsburgh has developed an online program, available for a fee, to teach pharmacists and pharmacy technicians how to help patients safely choose OTC hearing aids. Continuing education courses will also be produced to help pharmacists in recognizing hearing loss, helping patients in not over amplifying their devices, and much more. ^6,8

Sales will be restricted for OTC hearing aids to people 18 years old or older with perceived mild to moderate hearing loss, but there are people to help navigate this new market. The Hearing Loss Association of America published a tip sheet on buying hearing aids. Wirecutter posted a useful guide to selecting various products based on features, which is updated as new products emerge. Johns Hopkins Bloomberg School of Public Health created HearingNumber.org to help people find their level of hearing loss and learn about treatment options. This currently requires an Apple smartphone or tablet, but more options will become available in time.^3,1

There are some important things to think about when buying OTC hearing aids. What kind of functions does the device carry, such as Bluetooth capabilities? Are they sweat or water resistant? Do they include rechargeable batteries, or do batteries need to be replaced? What about return policies? There are some standard features that the FDA has made mandatory, such as the ability to adjust the volume, but return policies have been left to the states to decide.⁴

In the next several months we will likely see many changes coming. People across the country will begin to save hundreds to thousands of dollars while improving their quality of life. This will take time though; more retailers and manufacturers will need to enter the market to see prices continue to drop and to see new innovations arise.

Sources:

1. Hearing aids to be sold over the counter next week | The Seattle Times
2. Hearing Aids | FDA
3. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans | FDA
4. What to Know About Over-the-Counter Hearing Aids – NBC4 Washington (nbcwashington.com)
5. Hearing aids OTC: CVS, Walgreens, Walmart, Best Buy selling over counter devices (axios.com)
6. Over-the-counter hearing aids have been greenlighted by the FDA – your local pharmacist will soon be able to sell you the device you need (yahoo.com)
7. Hearing Aids and Personal Sound Amplification Products: What to Know | FDA
8. Over-the-Counter Hearing Aids: Everything Pharmacies Need to Know (pbahealth.com)

Posted: November 2022

The Federal Trade Commission (FTC) aims to promote competition, educate consumers, and protect them from unfair business practices. In mid-2022, the FTC announced that they will be investigating records from six of the largest pharmacy benefit managers (PBMs) to understand how they operate their businesses. Under section 6(b) of the Federal Trade Commission Act, the FTC has the power to conduct studies without a specific law enforcement purpose. The PBMs to be investigated include Express Scripts, CVS Caremark, OptumRx, Prime Therapeutics, Humana, and MedImpact Healthcare Systems. PBMs collaborate with a variety of pharmaceutical industry sectors including drug manufacturers, insurers, and pharmacies. They negotiate prescription drug costs, develop drug formularies, and contract with pharmacies to dispense medication to patients.

An initial inquiry began on February 11, 2022, when the Commission voted on the proposal to launch a study into PBM practices. The intent was to look at information related to rebates, pricing policies, and fees. The result was a split 2-2 vote. On February 25, 2022, the FTC requested public comments on the impact of PBM practices. The comment period remained opened for 60 days, ending on April 25, 2022. During that time, the FTC received over 24,000 comments.  On June 7, 2022, the FTC voted 5-0 to proceed with the inquiry. As a result, the six largest PBMs will have 90 days from the date they receive an order to provide their records from the previous 5 years. How the PBMs will respond is yet to be determined. The FTC expects this study will identify the PBM’s role in the prescription drug market and their impact on patients, physicians, employers, pharmacies, and payers. The FTC hopes that this study will reveal and further elucidate the numerous practices that PBMs are involved in such as prior authorizations, specialty drug policies, audits, and formulary design.

The FTC will be requesting the following information from PBMs:

• Pharmacy Networks and Reimbursement
  • Top drugs by sales, by prescription volume, specialty drugs, and rebated drugs
  • Post-sale adjustments
  • Development of pharmacy networks
  • Audits of pharmacy networks
• Formularies
  • Prior authorization resolution times and rates
  • Situations when brands are favored over generics
  • Rebated drugs

According to the FTC announcement, the goal of the inquiry is to gain a deeper understanding of PBM practices including fees and clawbacks charged to pharmacies, potential steering of patients to PBM-owned pharmacies, audit practices, prevalence of prior authorizations and other restrictions, and the impact of rebates and fees on formulary design and costs to payers and patients.

This study is being conducted without a specific law enforcement purpose.  The PBMs could be penalized for omitting requested information or falsifying reports.

PHSL expects PBMs to submit terabytes of information to the FTC.  It is unknown how long the analysis by the FTC will take. What will the FTC reveal from this inquiry?  How will that impact PBMs, patients, payers, and pharmacies?

References:

Pharmacy Benefit Managers Practices Controversies What Lies Ahead | Commonwealth Fund

FTC Launches Inquiry Into Prescription Drug Middlemen Industry | Federal Trade Commission

In Reversal, FTC Launches Inquiry Into PBM Industry (ajmc.com)

FTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector | Epstein Becker & Green – JDSupra

Posted: October 2022

Multiple Sclerosis is a chronic disease that affects the central nervous system. As a result, it impacts the way the brain communicates with the rest of our body. The disease is more common in women and adults between 45-74 years of age. MS affects everyone differently. Some individuals may experience symptoms such as fatigue, numbness or tingling, and vision problems while others may not experience any symptoms at all.

MS Work Space is a resource sponsored by Bristol Myers Squibb for use by employers to help support their employees that are living with multiple sclerosis. The website has a resource tool that allows employers to estimate the number of people in their company who may have MS. The MS Estimator first asks about the type of work performed by the employer and then more generalized questions about employees, such as the number of employees in the organization, age range, region of the country they live in, and the male:female ratio. The results are simply a representation and meant for informational and educational purposes only. Additional resources such as a Caregiver Census, Benefits Checklist, and strategies on how to implement a program for employees with MS are available for employers. The Caregiver Census allows employers to understand the importance of caregiving amongst their employees and how it impacts workplace performance. MS Work Space also offers podcast episodes that discuss the nature of the disease and its impact within the working environment. Examples of podcasts that are available include “The Effect of Chronic Diseases like MS on Your Organization,” “Helping Your Employees with MS and Chronic Disease,” and “The Financial Realities of MS for Employers & Employees.”

The goal of MS Work Space is for employers and organizations to recognize the impact as they work toward accommodating people with multiple sclerosis. For example, employers can experience numerous advantages by implementing accommodations like periodic rest breaks, adjustable workstations, fans and portable air conditioners, enlarged keyboards, and/or modified break schedules for their employees impacted by MS. Some of those benefits include increased productivity, decreased costs with new employee training, increased attendance, and more.

This MS platform brings awareness to employers so they can make those accommodations for their employees. PHSL research has not identified any other manufacturer-sponsored employer resources on the web that focus on a specific disease (Please share updates if this changes). Resources for accommodations and support of employees with chronic conditions are often available from national organizations, such as the American Diabetes Association. However, MS Work Space presents unique resources that may not be applicable to all conditions. Other chronic conditions that may benefit from similar employer resources include arthritis, diabetes, cancer, mental health, and behavioral conditions.  Employers may already be identifying opportunities to support employees by offering mobile apps such as “Gympass” and “Talkspace” focused on prevention and management of chronic conditions.  Based on the success of MS Work Space, it will be interesting to see if more manufacturer-sponsored, employer-focused programs emerge.

Posted: October 2022

The Digital Therapeutics Alliance defines digital therapeutics as products that “deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.”  The interest and studies revolving around digital therapeutics have only grown in the last decade.  Curiosity in the possibilities of digital therapeutics used to be confined to academia and technology companies.  Today, pharmaceutical companies are seeing the potential of digital therapeutics and becoming increasingly involved through strategic investments and partnerships with various technological companies¹.

The world of digital therapeutics can be complex and convoluted with the various terms.  It is crucial to understand these terms when discussing digital therapeutics.  Some of these key terms are as follows:

• Digital Health is defined as the space where digital technologies, daily life, and healthcare intersect.
• Digital medicine describes a field concerned with the use of technologies as tools for measurement and intervention in the services of human health. In a broad sense, digital medicine is technology that supports the practice of medicine.
• Prescription digital therapeutics are FDA-authorized software programs that providers may prescribe as a form of treatment².

Digital therapeutics are becoming more widely available.  There are both non-prescription and prescription digital therapeutics.  Some non-prescription products include Daylight®, deprexus ®, and HelloBetter Vaginismus Plus®. Often, a smart device and internet connection is all that is required to utilize the non-prescription products.  Some prescription digital therapeutic products include Insulia®, Nerivio®, and Somryst®^3.  The same general hardware and software requirements for the non-prescription products are needed for the prescription products⁴.  Some digital therapeutics are listed in drug compendia.  Bluestar®, reSET®, EndeavorRx®, and many others are listed in Medi-Span® Price Rx®, where the products are assigned a generic product identifier (GPI) code that can affect reimbursement decisions.

There are many factors that are weighed when it comes to reimbursement of digital therapeutics, but the compendia play a significant role in reimbursement decisions for many payers.  Products that are listed in unique or specific categories, as opposed to more general categories, may have a greater probability of being reimbursed by payers.  The compendia listing is a crucial beginning step in becoming a product on a payer’s formulary.  Without compendia listings, it can prove difficult for a digital therapeutic product to be picked up by a payer.  Similarly, compendia listings are also crucial in having a digital therapeutic product included in an EHR e-prescribing platform and having that product added to a patient record.  Having a product in an EHR may enable the prescriber to perform a real-time benefits investigation.  All these factors, on top of rigorous clinical trial data, prescription status, and intended use, will be utilized by payers to determine the coverage and reimbursements of digital therapeutic products¹.

Reimbursement for digital therapeutics is uncharted territory for many payers.  The temporary solution is a direct-to-consumer model in which users are paying subscription fees, but a value-based model where payment is based on patient outcomes is being investigated.  A great deal of evidence would be required to support claims and demonstrate efficacy.  This shows the importance of digital formularies to create confidence in evidence-backed digital therapeutics for providers and payers to increase utilization.

Digital therapeutics are projected to grow over the next decade.  The past decade has seen trends in digital therapeutic research focused on solutions for cardiovascular diseases such as hyperlipidemia, hypertension, and acute coronary syndrome.  Currently, there is still research dedicated to these cardiovascular diseases, but there is also a focus on a wide range of psychiatric indications, including attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, schizophrenia, depression, and bipolar disorder.  The FDA has taken notice of the rise of digital therapeutics.  As a part of the 21^st Century Cures Act, the FDA Breakthrough Devices Program offers manufacturers an opportunity to collaborate with experts within the FDA to address any premarket concerns and make timely and agreed upon adjustments.  The goal is to give providers and patients quicker access to digital therapeutics while still being confident in the safety and efficacy⁴.  This places digital therapeutics in more of a position to grow and find their role in treatment plans. What do you think the future of digital therapeutics looks like?

References

1. AMCP Partnership Forum: The evolving role of digital therapeutics. https://www.jmcp.org/doi/epdf/10.18553/jmcp.2022.22093. Accessed July 12, 2022.

2. Talking HealthTech. Digital Health, Digital Medicine, and Digital Therapeutics; what is the difference? Talking HealthTech. https://www.talkinghealthtech.com/glossary/digital-health-digital-medicine-and-digital-therapeutics-what-is-the-difference. Accessed July 12, 2022.

3. Product library. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx/product-library/ Published May 27, 2022. Accessed July 12, 2022.

4. Burke J. White Paper: Digital Therapeutics: Past Trends and Future Prospects. https://www.evidera.com/digital-therapeutics-past-trends-and-future-prospects/. Published March 8, 2022. Accessed July 12, 2022.

Posted: October 2022

PHSL President Ann Johnson was consulted on the topic of pharmacy consolidation and the impact on cancer care.  Ann shared, “Although retail pharmacy consolidation might create some inconveniences for patients, the consolidation of pharmacies is not expected to have much of an impact on cancer care in the community setting.  The costs that patients pay for drugs, such as their copays, are set by the health plans and PBMs, not the pharmacies themselves, so pharmacy consolidation will not lead to higher prices for consumers. Likewise, from the pharmacy’s perspective, the amount that the pharmacy is reimbursed is established in their PBM network agreements.”

Read the full text article to learn more about the different points explored by the author and sources.

Nelson, Roxanne. “Consolidation in US Health Care Negatively Impacts Cancer Care – the Lancet Oncology.” The Lancet Oncology, 23 Sept. 2022, www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00598-8/fulltext.

Posted: October 2022

On July 7^th, 2022, California Governor Gavin Newsom announced that California would begin manufacturing their own low-cost insulin.  The administration hopes that the California insulin will be available as soon as early 2024.  This serves as an effort to increase accessibility to crucial medication for many patients.¹  How is California planning on accomplishing this and what effects may this have on the insulin market?

California has dedicated $100 million of its $308 billion budget for the project.  The plan is to use $50 million now to obtain insulin from a currently undetermined manufacturing partner so that it can hit the market as soon as possible.  The remaining $50 million will be used to build an insulin manufacturing facility in California.  Distribution details have yet to be finalized, but the insulin would be available to patients in any state.

How can California do this for $50 million?  Similar to CivicaRx, California intends to partner with established industry participants.²  CivicaRx previously announced a plan to produce biosimilar insulin products at low cash costs to patients.³  This is possible by partnering with a manufacturer that has already developed the technology to make biosimilar insulin products.  CivicaRx has announced a partnership, but California has not yet formed a partnership with a manufacturer.  Doing so would shorten the timeline to develop a biosimilar.

The type of insulin that California hopes to produce is still unclear. Currently, three major pharmaceutical companies, Sanofi, Eli Lilly and Novo Nordisk produce the vast majority of insulins.⁴ Assuming competitive pricing, production of biosimilars to their major products, Lantus, NovoLog, and Humalog could erode the sales of these pharmaceutical firms. These companies already offer patient assistance programs, such as Eli Lilly’s Insulin Value Program, which launched in 2020. Their program initially began as an opportunity to help patients save money on insulin during the pandemic but has since expanded to allow anyone with or without commercial insurance to access their insulins for $35 per month.⁵

California plans to compete with existing and future insulin producers in the coming years.  There are many questions around the timeline, budget, manufacturing capabilities, and target products.  What are California’s chances of success to produce and compete with a lower cost insulin in the U.S. market?  After CivicaRx and California, who will be next to announce intentions to compete for insulin? Share your thoughts in the comments.

Posted: September 2022

Sources:

1. California to make its own low-cost insulin, Gov. Newsom says – CNN
2. California Wants to Make Cheap Insulin. Here’s How It Could Work | WIRED
3. CivicaRx Announces Plans for Generic Insulin | Pharmacy Healthcare Solutions, LLC. (phsirx.com)
4. California’s low-cost insulin plans receive $100m manufacturing boost – Pharmaceutical Technology (pharmaceutical-technology.com)
5. Lilly commits Insulin Value Program, featuring $35 copay card, to suite of affordability solutions for people with diabetes | Eli Lilly and Company

On June 23, 2022, the National Association of Chain Drug Stores (NACDS) sent recommendations to the Biden Administration for the expected transition from government-funded COVID-19 vaccinations to commercially available vaccinations. They outlined five key points.

1. Engage all stakeholders in transparent planning with a clear timeline. This would include regular meetings with stakeholders and the federal government. Also, plan to transition during a time that would not be as busy for pharmacies handling vaccines (NACDS recommends the first quarter of 2023).

2. Work closely with manufacturers, supply chain entities, and other stakeholders to support product availability and meet expected demand. This would include evaluating stability, storage, cold chain, and shipping. This should also include preparing for the return of EUA product before commercial transition. The administration should promote prefilled syringes and packaging options to avoid waste and ensure different NDCs are assigned to commercial and government products.

3. Promote cost-based reimbursement and beneficiary coverage, support long term sustainability and access to COVID-19 vaccinations, and clarify future data reporting requirements.

4. Plan for a public information campaign to educate the public about the transition to the commercial market. This is intended to keep patients informed of changes and challenges they may face in the future.

5. Look ahead and proactively plan for the transition of COVID-19 testing and therapeutics to the commercial market so that patients have access and care throughout this transition.

Current COVID-19 vaccines come in multi-dose vials, and stability limitations lead to discarding waste when single or infrequent doses are needed during times of low demand.  Prefilled syringes could help to avoid waste and clarify initial vs. booster dosing confusion. At this time, most pharmacies are not thinking about the cost of the lost vaccine because the government purchased the vaccines. Cost will become more important with the move to commercial access. Pharmacies will not tolerate the cost associated with waste and discarded vaccines.

A public education campaign is important to assist with the transition. The change from patients receiving a vaccine for free with minimal limitations to patients and providers navigating health insurance coverage rules could decrease immunization initiation or completion and increase patient dissatisfaction. Vaccine manufacturers will succeed with single-use packaging, planning, coordination, and communication with all stakeholders. What issues do you expect for the transition of COVID-19 vaccines from government procured to commercial status?

Published: August 2022