News & Events

Ann Johnson to Present at ASAP 2021 Virtual Midyear Conference

PHSL President Ann Johnson will be presenting at the American Society for Automation in Pharmacy (ASAP) 2021 Virtual Midyear Conference taking place on July 22 – 23. Ann will review the basics of the 340B drug program and the role of third-party administrators (TPAs) and accumulator software in managing 340B Program requirements for covered entities and contract pharmacies. She will also review the changing market dynamics and conflicting industry perspectives.

Ann can be reached for questions by contacting PHSL here.

ComputerTalk for the Pharmacist May/June 2021

PHSL Vice President Melissa Krause and Senior Consultant Patricia Milazzo contributed to the May/June 2021 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Melissa and Patty discuss opportunities for pharmacists to leverage their role in the COVID-19 pandemic response in order to expand and be reimbursed for clinical services.

Click here to read the article “The Pandemic: An Opportunity for Pharmacy?” You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

ComputerTalk for the Pharmacist January/February 2021

PHSL President Ann Johnson and Co-founder Tim Kosty contributed to the January/February 2021 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Tim discuss the operational challenges of COVID-19 vaccine administration likely to be encountered, including patient acceptance, distribution challenges, administration reimbursement, billing guidance, and NDC code differences for EUA and commercial products.

Click here to read the article “COVID-19 Vaccines – Operational Considerations”. You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

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

It’s that time of year again, PHSL’s annual review of the PBM formulary exclusion list updates!  Express Scripts (ESI), CVS Caremark, and OptumRx have published their formulary exclusion lists for 2021.  Based on PHSL’s calculations, ESI leads the way with 117 new formulary exclusions. CVS Caremark added 62 new exclusions.  OptumRx will exclude an additional 38 drugs.  The new 2021 exclusions, as researched by PHSL, are as follows:

FormularyExclusions

During the review, PHSL made the following observations:

  • OptumRx focused more attention on the respiratory class this year, excluding an additional 9 agents. Examples of excluded agents include ProAir Respiclick, Incruse Ellipta, and Xopenex HFA.
  • ESI seemed to focus on the oncology class for formulary exclusions in 2021, with products such as Avastin, Rituxan, and Herceptin no longer included on the formulary.  For Avastin, ESI prefers the biosimilars (Mvasi and Zirabev).  Similarly, ESI prefers the biosimilar Ruxience, instead of innovator Rituxan and biosimilar Truxima.  ESI also selected two biosimilars (Kanjinti and Trazimera) instead of innovator Herceptin and biosimilars Ogivri and Ontruzant.
  • CVS focused on women’s health, in particular the menopausal symptom category, with seven formulary exclusions.  Examples include Premarin Cream and Estring.
  • Although initially only available as authorized generics, additional generic manufacturers are now producing albuterol sulfate inhalers.  Because of these generic launches, all three PBMs are now excluding brand agents ProAir, Proventil, and Ventolin, and this once brand-competitive space is now genericized.
  • All three major PBMs have chosen to exclude Udenyca (biosimilar to Neulasta) in 2021.  CVS and ESI also included Neulasta as exclusions in 2021.  ESI prefers two biosimilars (Fulphila and Zietenzo), OptumRx prefers brand Neulasta and biosimilar Ziextenzo, and CVS prefers Zienxtenzo as well.  Sandoz’s Ziextenzo is benefiting from these changes, but with the volume of pegfilgrastim billed through the medical benefit, these changes may represent only a fraction of the total market.
  • As mentioned in our 2020 Exclusion List Review, ESI continues to use indication-based management for the “inflammatory conditions” drug class. Reviewing the updates to that category, Cosentyx is no longer a preferred agent for 2021.

Each of the major PBMs has taken a different approach to managing drug spend in 2021, and formulary exclusions continue to play a major role.  PBMs exclude products because of clinical, financial, and humanistic reasons.  They are making value judgments and have decided covering these products is no longer warranted.  This article represents PHSL’s analysis of publicly available information regarding the three PBMs’ formulary exclusion lists for 2021.  Readers are encouraged to assess the lists for themselves.  Links to the exclusion list source information are provided below.

 

Posted January 2021

2021 Winter Newsletter:

Rare Disease Drugs Led the Way for 2020

Rare Disease Drugs Led the Way for 2020

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.

NewDrugApprovals

Posted January 2021

2021 Winter Newsletter:

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

 

Lack of Adoption for Pharmacist Clinical Services Presented by Melissa Krause at ASAP

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.

ComputerTalk for the Pharmacist November/December 2020

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/.

ComputerTalk for the Pharmacist September/October 2020

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/.

PHSL Receives WOSB and WBE Certification

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

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