News & Events

According to the FDA, there were 53 novel drug approvals in 2020, with 32% receiving FDA fast track status, 57% receiving priority review status, and 23% obtaining accelerated approval.  This count does not include vaccines, plasma products, or gene therapy products.  With so many 2020 drug approvals receiving priority review, it is likely that many of the drugs could provide a significant advance in medical care.

Many of the newly approved agents that received priority review status are indicated for rare disease states.  Oncology approvals continue to outpace approvals for other disease states, with approximately 37% of drugs approved in the oncology space, whether for diagnosis or treatment.

Six new infectious disease agents were approved, which is a positive step in developing new therapies to combat malaria, Ebola, HIV-1, COVID-19, and a rare parasitic disease known Chagas disease.  Artesunate has been approved by the FDA to treat severe malaria in the U.S.  Ebanga and Imazeb were approved to treat Ebola, while Rukobia was approved to treat HIV-1.  One treatment for COVID-19, Veklury, received fast track and priority review due to the Coronavirus pandemic. The FDA approved Lampit, a treatment for pediatric patients with Chagas disease, a rare parasitic disease, which if left untreated, can lead to congestive heart failure.

What does 2021 hold?  PHSL highlights three top trends to watch for in this year’s drug approval space:

1. COVID-19 – Will additional therapeutics to treat infections be approved?
2. Alzheimer’s – Will the drought for new treatments end in 2021?
3. Delays – The pandemic has already impacted trials, inspections, and launches in 2020. Will more of the same persist in 2021?

A full listing of 2020 approvals, by approval type, is shown in the chart below.

Posted January 2021

2021 Winter Newsletter:

2021 Formulary Exclusion Lists: A Review of Express Scripts, CVS Caremark, and OptumRx

PHSL Vice President Melissa Krause presented at the American Society for Automation in Pharmacy (ASAP) 2021 Virtual Annual Conference on January 14, 2021. Melissa discussed what has prevented pharmacists’ clinical services from widespread adoption, with a focus on evaluating various clinical services and determining whether they provide hard or soft dollar savings.

Click here to view Melissa’s presentation slides.

PHSL President Ann Johnson and Senior Consultant Patricia Milazzo contributed to the November/December 2020 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Patricia share their predictions for the upcoming year, including the role of pharmacists in COVID-19 vaccination, 340B guidance, and USP compounding guidelines.

Click here to read the article “Predictions for 2021”. You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

PHSL Senior Consultant Patricia Milazzo contributed to the September/October 2020 edition of ComputerTalk for the Pharmacist. In her Viewpoints article, Patty discusses the FDA’s Inactive Ingredient Database and the pharmacist’s role in managing patients with allergies and intolerances to inactive ingredients.

Click here to read the article “Inactive Ingredients and Drug Therapy Safety”. You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

Pharmacy Healthcare Solutions, LLC (PHSL) is pleased to announce national certification as a Women’s Business Enterprise (WBE) and as a Women-Owned Small Business (WOSB) by WBENC East, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC).

PHSL asks any current clients with supplier diversity initiatives to contact Ann or Melissa for a copy of the certification. We would welcome the opportunity to have our WBE and WOSB certification listed with your company!

PHSL President Ann Johnson noted that “working in the healthcare industry, most key leadership roles are held by men; PHSL is proud of their commitment to become a certified women-owned business. We believe that it is important for diversity in the workplace and hope that our current and future clients feel the same.”

“PHSL is thankful to WBENC for their assistance in pursuing these certifications,” said Melissa Krause, Pharm D., “We are proud to have been recognized as a business committed to investing in and advancing the careers of women in the field. We look forward to continuing our relationships with current and future clients through opportunities via supplier diversity initiatives in the pharmacy, life sciences, and healthcare industries.”

WBENC’s national standard of certification implemented by the WBENC East is a meticulous process including an in-depth review of the business and site inspection. The certification process is designed to confirm the business is at least 51% owned, operated, and controlled by a woman or women.

By including women-owned businesses among their suppliers, corporations and government agencies demonstrate their commitment to fostering diversity and the continued development of their supplier diversity programs.

Founded in 1997, WBENC is the nation’s leader in women’s business development and the leading third-party certifier of businesses owned and operated by women, with more than 13,000 certified Women’s Business Enterprises, 14 national Regional Partner Organizations, and over 300 Corporate Members. More than 1,000 corporations representing America’s most prestigious brands as well as many states, cities, and other entities accept WBENC Certification. For more information, visit www.wbenc.org.

Posted September 30, 2020

2020 Fall Newsletter:

Manufacturers Strategies Leading Changes to 340B Contract Pharmacy Arrangements

AstraZeneca and Eli Lilly are taking aggressive steps to reduce the risk of paying duplicate discounts in the 340B drug program and are challenging the contract pharmacy system currently in place. The 340B program provides covered entities with significant discounts on pharmaceuticals. Pharmaceutical manufacturers are required to participate in the 340B program as an OBRA 90 Medicaid rebate requirement.

On September 1, 2020, Lilly stopped providing hospitals with 340B discounts if the hospital was ordering product for a contract pharmacy versus dispensing the product at an in-house pharmacy. Lilly’s insulin products were excluded from this arrangement. Similarly, AstraZeneca announced that changes would go into effect on October 1, 2020. Both manufacturers will continue to provide discount pricing to covered entities and their child sites. For covered entities that do not have an on-site dispensing pharmacy, AstraZeneca noted that covered entities can arrange for a contract pharmacy of their choosing to receive 340B pricing on behalf of the covered entity. Lilly has similarly announced that covered entities can apply for an exception if they do not have an in-house pharmacy.

Based on their new tactics, these manufacturers are challenging the proliferation of contract pharmacy arrangements. Contract pharmacy arrangements have ballooned in the past few years, and approximately 28,000 pharmacies act as contract pharmacies for at least one covered entity, with some acting as contract pharmacies for multiple covered entities. Walgreens alone has over 6,000 locations acting as 340B contract pharmacies. In total, about half of all US pharmacies serve as a contract pharmacy for at least one covered entity.

Before 1996, a covered entity had to have an in-house pharmacy to participate in the 340B drug program. In 1996, covered entities without an in-house pharmacy could set up an arrangement with a single contract pharmacy. However, starting in 2010, covered entities were permitted to expand their reach through the establishment of multiple contract pharmacy arrangements with an unlimited number of pharmacies. Based on the recent manufacturer-announced changes, it appears that manufacturers are seeking to return to the pre-2010 days of a single contract pharmacy arrangement.

By continuing to provide discount pricing directly to covered entities and their child sites, manufacturers view themselves as still participating in the program. HRSA may feel otherwise. In a September 21st letter to Lilly, HRSA notes that they have significant concerns with Lilly’s new policy but has yet to make a final determination regarding potential actions. The letter goes on to state that a lawsuit against Lilly is one potential consequence. Will Lilly and AstraZeneca continue to fight against providing 340B discounts to contract pharmacies? Will other manufacturers follow their lead? Did this letter prevent or slow other manufacturers from implementing similar policies? Will HRSA sue the manufacturers? As Lilly and AstraZeneca leap boldly into the future, we await the effects that this change will have not only on other manufacturers, but also on the 340B industry as a whole.

Posted September 30, 2020

2020 Fall Newsletter:

PHSL Receives WOSB and WBE Certification

PHSL Consultants Alan Sekula and Ashley Ellek contributed to the July/August 2020 edition of ComputerTalk for the Pharmacist. In the Viewpoints article, Alan and Ashley discuss the Medicare Part D Senior Savings Model, a voluntary program to cap the patient cost of insulin, and the impacts on patients, Medicare Part D Plans, and potential future expansion.

Click here to read the article entitled “CMS Announces New Part D Insulin Savings Plan”. You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

As hospitals continue to battle and get the COVID-19 pandemic under control, drug shortages have been a consistent problem.  The FDA has seen an increase in the number of drugs that are failing to meet the demand to treat these patients.  FDA-approved products are being used to treat both intubated and non-intubated patients.  Hospitals have been struggling to get these medications, and the need for these FDA-approved products is now becoming more urgent.  The FDA normally mitigates drug shortage issues by looking into the global pharmaceutical supply chain.  Pharmaceutical manufacturers are stepping up by reviewing their own supply chains, evaluating how they can increase capacity or otherwise help fill gaps in the market, all while working on potential vaccines and treatments for COVID-19.

However, due to the severity and unknown stress that the pandemic will cause on the pharmaceutical supply chain, the FDA is finding other ways to solve these drug shortages.  The FDA has decided to release temporary guidelines for both FDA registered outsourcing facilities and compounding pharmacies.  The FDA hopes that increased flexibility on the rulings to produce these FDA-approved products will help to alleviate supply issues.  This relaxation will allow for outsourcing facilities and compounding pharmacies to produce drug products for the hospitals in dire need of drug products to treat COVID-19 patients.

FDA guidelines have been released for FDA-registered outsourcing facilities and compounding pharmacies.  The FDA is relaxing the rules, and both parties can essentially compound exact or nearly exact copies of FDA-approved drug products used to treat COVID-19 patients. The copy can only contain one of the active ingredients and must be from the list of drug products currently in shortage used to treat COVID-19 patients. There are 15 drug products currently listed in shortage, as shown below.

The FDA requires that the hospitals have documentation proving that the drug products have been difficult to obtain and that the hospital is using the drug products to directly treat COVID-19 patients. For compounding pharmacies, a patient-specific prescription from the hospital is not needed, and hospitals must simply confirm and provide information that the medication will be used to treat a COVID-19 hospitalized patient. The FDA would like the compounding pharmacy to retrieve de-identified information from the hospital regarding which patients received the compounded drug products.  This could aid in tracking adverse events needing to be investigated. The FDA also provided guidance on expiration dates and stability testing for these drug products and has streamlined the process for outsourcing facilities.  Although the beyond-use-dating and expiration dating guidance will reduce some barriers and help compounding pharmacies to supply drug products that hospitals need, stability programs and testing must still be in place to protect patients.

For outsourcing facilities and compounding pharmacies, this is an opportunity to help with the current COVID-19 drug shortage problems. The reduced regulations will allow additional stakeholders in the pharmaceutical drug chain to produce these products. These rules can be retracted by the FDA at any point in time and are not permanent, so for manufacturers that originally produced these drug products, it will be important to update the FDA on when supply can meet the demand. The original manufacturers will want to have their drug products taken off the list as soon as possible. For other manufacturers struggling to meet supply for drug products for COVID-19 patients, these guidelines show that the FDA is willing to allow other sources to produce the drug products. Currently, there is a list of outsourcing facilities that are producing some of these drug products in shortage.

For the time being, the pharmaceutical drug supply chain will be strained during COVID-19. The relaxation of rules and regulations on the sourcing of drug products for hospitals will allow for drug shortages to be mitigated. However, the rules will put pressure on the original manufacturers to regain control of their product supply and meet the demand. Based on the current drug shortages and importation challenges, expect to see more manufacturers focus on their US operations in the coming years.  Manufacturers may begin seeking alternative active pharmaceutical ingredient (API) sources or moving finished pharmaceutical manufacturing to the US.  As the COVID-19 pandemic begins to slow down, how will the drug supply chain change in the near future, and will it need to be prepared for a potential second wave?

Posted June 16, 2020

2020 Summer Newsletter:

Surescripts Real-Time Prescription Benefit for Pharmacy Tool: Big Advance or a Non-starter?

In early June, Surescripts announced the launch of its new Real-Time Prescription Benefit for Pharmacy Tool, which allows “pharmacists to access information on out-of-pocket prescription costs and therapeutic alternatives at the point of dispensing.”[1]   Surescripts promotes that the tool will enable pharmacists to “collaborate with patients and prescribers on choosing an alternative medication that is both clinically appropriate and affordable.”  The tool accesses the patients’ prescription benefit information to provide days’ supply constraints and potentially less expensive formulary alternatives.

The premise behind this service is the pharmacist is willing to provide therapeutic substitution recommendations to the prescriber and patient at the point of dispensing.  If this tool gains momentum, expect drugs with a prior authorization to be placed at a significant disadvantage.  In many cases, the pharmacy patient will have just come from the provider’s office with a prescription, where the expectation is the provider should have had this discussion with the patient prior to writing the prescription.  We expect pharmacists to continue to submit prescriptions to the payers for adjudication and only suggest therapeutic substitutions if a claim is rejected and/or the patient voices a concern, which is standard operating procedure today.

The new Surescripts tool provides pharmacists with the opportunity to evaluate options before contacting the prescriber.  The cost to the pharmacist is unknown at this time.  More than likely, the pharmacist will contact the prescriber and let the prescriber evaluate and prescribe a different product if warranted. With continued reductions in pharmacy reimbursement, we do not expect widespread adoption of this new tool in pharmacy practice.  This new tool repackages the Real Time Benefits Check (RTBC) available to prescribers and will likely be a non-starter in pharmacy practice.  As is currently seen in the prescriber space, the validity and usability of this tool will depend on payers’ ability to provide updated formulary and pricing information to Surescripts in a timely manner.  If prescriber uptake of these RTBCs occurs, the use in pharmacies would not be needed.

[1] https://surescripts.com/news-center/press-releases/!content/surescripts-empowers-pharmacies-with-benefits-based-prescription-price-transparency-tool, Accessed June 15, 2020.

Posted June 16, 2020

2020 Summer Newsletter:

New FDA Guidance Will Impact Supply Shortages

PHSL Co-founder Tim Kosty contributed to the May/June 2020 edition of ComputerTalk for the Pharmacist. In his Viewpoints article, Tim discusses the California Consumer Privacy Act (CCPA), including specific provisions and the potential impact on consumer privacy laws.

Click here to read Tim’s article entitled “CCPA: Requirements and Consequences”. You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.