News & Events

If I am experiencing symptoms consistent with coronavirus, should I take ibuprofen?

With the most current information available, the World Health Organization (WHO) has stated they are not recommending against taking Ibuprofen. This means that you can still take ibuprofen to manage symptoms. Please refer to the diagram below for the WHO statement.

If I am experiencing symptoms consistent with coronavirus, should I take naproxen or other NSAIDs?

Yes, as long as you follow normal guidelines for daily intake of these medications. There has been no information that naproxen or other NSAIDs have an adverse impact with respect to COVID-19.

These questions arose after a March 17^th WHO announcement where they recommended against the use of ibuprofen (Motrin, Advil, among other brands) for patients with COVID-19 symptoms, due to a concern that anti-inflammatory drugs could worsen the COVID-19 infection. Likewise, acetaminophen (Tylenol, among other brands) is still safe to use as directed.  The theory hypothesized that ibuprofen could increase an enzyme, ACE2, that is used by the virus to infect the host. There is no evidence that other medications impacting that pathway, such as ACE inhibitors and ARBs, play any role in COVID-19 either.  Patients should continue to use prescribed medications as directed by their physicians.

For more information from WHO about COVID-19, visit https://www.who.int/news-room/q-a-detail/q-a-coronaviruses.

Posted March 20, 2020

2020 Spring Newsletter:

Coronavirus Preparation Tips

Market Effects from COVID-19

COVID-19 have you Quarantined? – Weekend Activities for your To-Do List

PHSI President Ann Johnson and Co-founder Don Dietz contributed to the January/February 2020 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Don review new formulary exclusion lists from Express Scripts, CVS Caremark, and OptumRx, and discuss their impact on pharmacies and patients.

Click here to read Ann and Don’s article entitled “2020 Formulary Exclusion Lists — Why All the Changes?” You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

Based on the FDA’s count, there were 48 novel drug approvals in 2019 with 60% receiving FDA fast track status, priority review, or accelerated approval.  This count does not include vaccines, plasma products, or gene therapy products.  When the majority of drugs are being reviewed in an expedited time frame, it is a strong indicator that the market is shifting towards the specialty drug space.  The high number of expedited approvals begs the question, “how much of an advantage is an expedited approved when everyone else is getting the same treatment?”

Many of the newly approved agents are first-in-class and indicated for rare disease states.  Oncology approvals continue to outpace approvals for other disease states, with approximately 20% of drugs approved for the oncology space, whether for diagnosis or treatment.

Three new infectious disease agents were approved in 2019, which is a positive step in developing new therapies to combat antibiotic resistance.  Because of the Generating Antibiotics Incentives Now Act (GAIN Act), three agents (Fetroja, Recarbrio, and Xenleta) received priority review as Qualified Infectious Disease Products (QIDPs).  With the rise of antibiotic resistance, the need for new antibiotic innovation is increasingly important, and the FDA’s Safety and Innovation Act (FDASIA) seeks to promote their development.

What does 2020 hold?  PHSL highlights five top trends to watch out for in this year’s drug approval space:

1. Digital Drugs – expect to see an increase in the approval of digital therapeutics and digitally enabled drugs, as technology moves into the mainstream pharmacy space.
2. NASH Drugs – Drugs indicated to treat nonalcoholic steatohepatitis (NASH), or a fatty liver, are expected to be approved in 2020. With a high price tag and potentially huge patient market, payers should monitor these approvals closely.
3. Gene Therapy – targeted therapies based on patients’ genetic factors promises to be a key area. This high-dollar space may be a cash cow for those targeting disease states with a sizeable patient population.
4. Biosimilars – Will 2020 be the first year that an “interchangeable” biosimilar is approved? If not, we expect the number of biosimilar approvals to steadily increase, creating a more commodity-like atmosphere in the biologic space in products with multiple biosimilar competitors.
5. Expedited Reviews and Approvals – As seen in 2019, expect the FDA to continue approving many products via the fast track, breakthrough, priority review, or accelerated approval processes. With the high number of specialty drugs being approved, this may become the new norm of drug approval.

A full listing of 2019 approvals, by approval type, is shown in the chart below.

Posted February 2020

For Immediate Release
Pharmacy Healthcare Solutions, LLC of Pittsburgh
Adds Experienced Industry Thought Leader to Staff

Patricia Milazzo, RPh joins PHSL as a Senior Consultant   

PITTSBURGH (January 17, 2020) – Pharmacy Healthcare Solutions, LLC (PHSL) is pleased to announce the hiring of Patricia Milazzo, RPh as a Senior Consultant.

Patty has over 30 years of experience in the U.S. and global healthcare industries. Her industry background includes clinical drug information creation and technology use, PBM (Prescription Benefit Management) design, and oversight of major drug data systems. She has extensive experience with government agencies, including FDA (Food and Drug Administration) and Medicare/Medicaid programs. Patty has held leadership positions in National Council for Prescription Drug Programs (NCPDP) and Pharmacy Quality Alliance (PQA) and has served as an author of various white papers and industry blogs.  Patty holds a B.S. in Pharmacy from Purdue University and is a licensed pharmacist.

Prior to joining PHSL, Patty was Senior Director at Wolters Kluwer Clinical Effective, overseeing global teams responsible for drugs’ clinical and pricing information.  Patty previously worked at CVS Health (CVS Caremark) in roles related to formulary and client benefits development and management, mail order dispensing oversight, and drug file and data management.

“Patty brings a new depth of drug compendia knowledge to our consulting team.  As a leading drug compendia authority in the industry, Patty’s contributions will provide innumerable benefits to our clients,” noted PHSL President, Ann Johnson.

PHSL Vice President, Melissa Krause, said “We are pleased to welcome Patty to our team of consultants.  We have enjoyed getting to know Patty at industry events over the years and value her expertise in the areas of compendia, health informatics, pharmacies, and payers.”

ABOUT PHARMACY HEALTHCARE SOLUTIONS, LLC (PHSL)

Founded in 1996, Pharmacy Healthcare Solutions provides pharmacy consulting solutions in a variety of areas including, but not limited to, product and program development, market research, operational efficiency, claims-data analysis, and training program construction. www.phsirx.com

PHSI Co-Founder Tim Kosty presented at the American Society for Automation in Pharmacy (ASAP) 2020 Annual Conference. The California Consumer Privacy Act (CCPA) introduces the most stringent consumer privacy protections in the country, offering California consumers new rights to learn what personal information covered businesses have collected, sold, and disclosed. Is the CCPA a preview of new consumer privacy laws, or a one-off California regulation? Tim will review the requirements that covered businesses must comply with, system changes required, and potential unintended consequences for businesses and consumers. Click here to view Tim’s presentation slides.

For Immediate Release
Pharmacy Healthcare Solutions, LLC of Pittsburgh
Announces New Company President and Vice President

Ann Johnson, Pharm.D. and Melissa Krause, Pharm.D., Respected Pharmacy Consulting Professionals, Will Lead the 24-year-old Company   

PITTSBURGH (January 9, 2020) –  Pharmacy Healthcare Solutions, LLC (PHSL) is pleased to announce the promotion of Ann Johnson, Pharm.D. to President and Melissa Krause, Pharm.D. to Vice President.

Former President Tim Kosty, R.Ph., MBA, and former Vice President Don Dietz, R.Ph., MS, remain committed to the company they founded in 1996. Kosty and Dietz will assume the titles of co-founders and remain close advisors to Johnson and Krause.

“Ann and Melissa both possess a rare mix of healthcare informatics expertise and business prowess. We are excited to see where their leadership takes this company in the next decade and beyond,” said Kosty. “Their commitment to this company and the clients we serve is seen in their high standard of excellence in their work every day.”

Dietz stated, “Both Melissa and Ann have been dedicated to the growth and success of Pharmacy Healthcare Solutions since joining the company as student pharmacists at the beginning of their careers.  Their desire to go ‘above and beyond’ to meet our clients’ needs positions us for future growth.”

Johnson has been with the company since 2010 and Krause since 2004.

“This is an exciting time for the pharmacy industry and Pharmacy Healthcare Solutions,” said Johnson.  “I am excited to expand our service offerings and continue to provide our clients with the high level of service they have come to expect from our consultants.”

Krause added, “I am eager to help lead Pharmacy Healthcare Solutions into the future.  We have an excellent team of professionals committed to our mission to serve our clients as invaluable advisors.”

Under Johnson and Krause’s leadership, PHSL will continue to serve clients in the pharmacy, payer, pharmaceutical manufacturer, and health informatics industries.

ABOUT PHARMACY HEALTHCARE SOLUTIONS, LLC (PHSL)

Founded in 1996, Pharmacy Healthcare Solutions provides pharmacy consulting solutions in a variety of areas including, but not limited to, product and program development, market research, operational efficiency, claims-data analysis, and training program construction. www.phsirx.com

PHSI President Tim Kosty and Vice President Don Dietz contributed to the November/December 2019 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Tim and Don discuss how the oversupply of pharmacists along with evolving technology may lead to new offerings of innovative clinical services.

Click here to read Tim and Don’s article entitled “2020: Clinical Services Out of Necessity?” You can read full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

On December 1, 2019, changes will go into effect that impact pharmacies, pharmaceutical manufacturers, and wholesalers. The United States Pharmacopeia (USP) introduced its new chapter <800> on handling hazardous drugs. Regulatory agencies worldwide will begin enforcement on December 1, 2019.

The USP initially announced a June 1, 2019 rollout for chapter <800>, but a six-month extension has provided pharmacies, long-term care facilities, and other affected entities increased time to bring their facilities and standard operating procedures up to code.

Several important considerations exist for pharmacies and other entities that handle hazardous drugs:

• New requirement for externally vented, negative pressure labs for manipulations (other than counting or repackaging) of hazard drugs (HDs)
  • Splitting/crushing (HD) tablets no longer allowed in regular workspace
• New requirements for designated areas for receipt, unpacking, and storage of HD

For more information on compounding and handling hazardous drugs, full chapters are available for free download at: https://www.usp.org/compounding.

While facilities dedicate significant energy, time, and resources into finalizing compliance, new regulations on hazardous waste (HW) disposal from the Environmental Protection Agency (EPA) have already gone into effect. August 21, 2019 marked the federal effective date of EPA’s Resource Conservation and Recovery Act (RCRA) Part 266 Subpart P policy on hazardous waste pharmaceuticals.

New requirements for HW management under Subpart P may prove costly for both pharmacies that produce over 220 lb. of hazardous waste in one calendar month and for manufacturers that function as reverse distributors.  Key takeaways include:

• Sewer prohibition: HW pharmaceuticals may not be disposed of down the drains or flushed
• Requirements for EPA-approved HW transporters for shipment of non-creditable HW pharmaceuticals
  • Non-creditable HW pharmaceuticals —defined as pharmaceuticals that do not have a reasonable expectation to be used/reused or reclaimed—must be shipped using an EPA-approved HW transporter
  • Potentially creditable HW pharmaceuticals—those in original packaging, undispensed, and expired less than one year–have a reasonable expectation to receive manufacturer credit. Potentially creditable products can be shipped from healthcare facilities using common carriers (e.g., UPS, USPS, FedEx)
• New standards for residues remaining in “empty” containers:
  • “Empty” containers are defined as empty vials, syringes, unit-dose, and stock/dispensing bottles smaller than 1 liter or 10,000 pills
  • Residues of empty containers are not regulated as HW, but containers larger than these sizes are deemed as HW.

PHSI’s view is that manufacturers and distributors of bulk package-sized hazardous drugs, such as warfarin and spironolactone, should take a closer look at the new EPA and USP <800> regulations. Buyers may become more hesitant to purchase large quantities of hazardous pharmaceuticals. Hazardous drugs deemed broken/leaking, repackaged, dispensed, and expired past 1 year automatically become classified as non-creditable HW. An increase in generated hazardous waste each month may result in a healthcare facility becoming required to abide by all sections of Subpart P.  Subpart P went into effect on Aug 21, 2019 in Iowa, Alaska, Indian Country, and some U.S. territories. Remaining states have until July 21, 2021 to adopt the new regulations. Check with your state for specifics.

PHSI would like to thank our student, Carissa Dolan, LECOM Pharm.D. Candidate, for her contributions to this article.

Posted November 2019

2019 Fall Newsletter:

2020 Formulary Exclusion Lists

2020 Formulary Exclusion Lists:

A Review of Express Scripts, CVS Caremark, and OptumRx

It’s that time of year again, PHSI’s annual review of the PBM formulary exclusion list updates!  Express Scripts (ESI), CVS Caremark, and OptumRx have published their formulary exclusion lists for 2020.  Based on PHSI’s calculations, OptumRx leads the way with 246 new formulary exclusions.  Of those 246 exclusions, 169 (69%) were for brands that have covered generic equivalents.  CVS Caremark added 100 new exclusions; 32 of those 100 exclusions (32%) were for brands with available generics.  ESI will exclude an additional 35 drugs, 13 (37%) of which are multisource brands.  The new 2020 exclusions, as researched by PHSI, are as follows:

Excluded multisource brands with available generics are as follows:

During the review, PHSI made the following observations:

• OptumRx seemed to pay more attention to the topical corticosteroids class this year, excluding an additional 13 agents that may not have specific generic equivalents. Examples of excluded agents include Psorcon cream, Ultravate lotion, and Cloderm cream.
• With the 2020 additions, OptumRx more than tripled the number of drugs on its list of excluded brand-name medications with generic equivalents. The total number of drugs on OptumRx’s list of excluded brand-name medications with generic equivalents is now approximately double that of ESI’s list.  Optum indicates that “these brand-name medications have been identified as having available generic equivalents covered at Tier 1 on the formulary.”  This change may signal OptumRx’s increased commitment to reduce unnecessary drug spend.
• ESI seemed to focus on the hematological class for 2020, with approximately 14% of the new exclusions coming from this category. ESI’s list of agents excluded for 2020 includes Jadenu, Jadenu Sprinkle, Nuwiq, Granix, and Mulpleta.  PHSI believes that ESI may be leading the PBM charge as it relates to hematological agent exclusion.  With many new hematological products expected to launch, we anticipate that this will become a more tightly controlled category in subsequent years.
• CVS focused heavily on the dermatological category for 2020 exclusions, with an additional 19 dermatology agents being added to the exclusion list. Examples of excluded agents include mupirocin cream, Acanya, Finacea Gel, and fluocinonide cream 0.1%.
• CVS is making a strong push to exclude high cost dietary supplement agents. Twenty-five dietary supplements were added to the exclusion list for 2020, with folic acid being the preferred on-formulary alternative.  Because these products are not FDA-approved and often have high costs, this can be an effective way to manage plan drug spend.  Examples of excluded dietary supplements include Xyzbac, Mebolic, Dexifol, and Vasculera.
• CVS Caremark is becoming manufacturer-specific in their formulary exclusions; they note five products where specific NDCs are excluded. For example, CVS’s formulary excludes benzonatate NDCs 69336-0126-15 and 69499-0329-15.  Excluded NDC 69336-0126-15 has a per-unit WAC of $71.42, while pharmaceutically equivalent GPI competitors have WAC pricing of $2.20 per unit.  For a product that may be reimbursed at a non-MAC rate, choosing the correct manufacturer’s product can have impactful reimbursement consequences for payers.
• With the launch of lower cost generic tadalafil, all three major PBMs have chosen to exclude brand Cialis in 2020.
• As mentioned in our 2019 Exclusion List Review, ESI continues to use indication-based management for the “inflammatory conditions” drug class. Reviewing the updates to that category, Inflectra and Renflexis are no longer preferred agents for 2020.

Each of the major PBMs has taken a different approach to managing drug spend in 2020 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 PHSI’s analysis of publicly available information regarding the three PBMs’ formulary exclusion lists for 2020.  Readers are encouraged to assess the lists for themselves.  Links to the exclusion list source information are provided below.

• CVS Health 2020 Exclusion List
• Express Scripts 2020 Exclusion List
• OptumRx 2020 Exclusion List

Posted November 2019

2019 Fall Newsletter:

Last Call for USP Chapter <800>

PHSI Consultant Ashley Ellek contributed to the September/October 2019 edition of ComputerTalk for the Pharmacist. In the Viewpoints article, Ashley discusses upcoming Drug Supply Chain Security Act (DSCSA) deadlines for wholesalers and the impact on manufacturers and pharmacies. The article also outlines requirements for pharmacies coming in November 2020.

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