Bulk ordering with SmartSync can keep your independent pharmacy’s shelves stocked.

What are your patients’ biggest frustrations when it comes to their medications? Cost? Insurance coverage? How about availability? Have you had to tell a patient their prescription is delayed because you are out of an item they need? We have an answer for that! It’s called SmartSync, AAP’s customized intelligence-based bulk ordering program. SmartSync makes ordering pharmacy stock easy. Read more.

Featured article provided by InfiniTrak

What do dispensers need to know about the FDA letter regarding exemptions for small businesses?

As pharmacies have been preparing for the final deadline for DSCSA Interoperability, the FDA has once again thrown another curveball. DSCSA regulations are already confusing, and this new exemption only adds to that confusion.

The FDA has issued a Small Business Exemption for small dispensers. They define a small dispenser as having fewer than 25 full-time pharmacists and pharmacy technicians. Small dispensers meeting these criteria now have until November 27, 2026, to be compliant with the Enhanced Drug Distribution Security requirements. This means that small dispensers will have extra time to be compliant with serialization, product verification and product tracing.

It is important to note all the other DSCSA regulations will still be in place and enforced on November 27, 2024. In fact, this Small Business Exemption for DSCSA makes it easier for the Boards of Pharmacy and FDA to strongly enforce the remaining requirements of the law which include:

• Collecting and saving all transactional (T3) data for at least six years
• Reconciling all drugs with your T3 data
• Verifying trading partners are licensed
• Documentation of standard operating procedures for DSCSA
• Identifying and investigating any suspect product
• Reporting illegitimate product to the FDA with Form 3911
• Obtaining GLNs for every physical location
• Confirming product identifiers are on the smallest salable unit for every product

Small dispensers who qualify for the exemption, will have to meet the above requirements, but may not have to:

• Collect and receive serialized data (EPCIS)
• Conduct a product verification on suspect product (VRS)
• Conduct product tracing on a suspect product

Overall, most of the law is still on track for the November 27, 2024, deadline. Pharmacies need to be prepared for this new complex law which will impact how the pharmacy conducts business. The difference is small dispensers have been given a little more time for the interoperable aspects of the law.

InfiniTrak provides complete DSCSA compliance, including the interoperable phase of the law. All dispensers, large and small, can achieve compliance now with the Infinitrak platform. InfiniTrak’s association with many of the industry partners offers affordable discounted pricing.

Most pharmacies are continuing to move forward towards full compliance now rather than later. As a result, the pharmacies are delivering a higher level of patient safety and benefiting from the added value provided by the InfiniTrak platform.

Website users logging in to RxAAP.com now have a convenient new tool to manage their pharmacy information. The brand-new User Dashboard on RxAAP.com now appears first for all users who use log-in credentials to access the site. This data is accessible to AAP Members and API Customers logging in. Visitors from the general public will still see content from the standard home page. 

The dashboard allows our pharmacies to view all their purchasing data, rebate information, AAP programs and benefits in one place. Please note that financial information is visible only to those with an executive password.  

When you are logged in, you can see which programs your pharmacy is participating in, like ProfitAmp business analytics, SmartSync bulk-ordering and Scan & Toss ordering system. 

Plus, you can view your financial and operational data from API Warehouse and our national primary wholesaler, all in one location, including purchase amounts and rebate deposit dates. 

In the Communication Preferences section, you can update your contact information and manage your email subscriptions by choosing which categories of messages you wish to receive, like weekly newsletters, financial notices and order shipping delays. You’ll also learn about AAP’s ongoing initiatives and find a link to refer other community pharmacies to AAP or API. 

Contact information for your Territory Manager, Member Support Representative and API Customer Service Team can all be found on your User Dashboard, too. Click here and log in now to check it out. 

AAP is one of the largest independent pharmacy co-ops in the U.S., with more than 2,000 Members. AAP offers competitive pricing through our subsidiary, API Warehouse and the collective buying power through our multiple prime vendor agreement options. Learn more about how AAP can help your independent community pharmacy not only survive but thrive. Contact AAP today. 

Do you have a Google Business Profile?

When you do a search online, odds are you are using Google to do it. So, when you search your store online, what is the first thing you see? It needs to be a Google Business Profile. That’s how you manage your independent pharmacy’s online listing.

Your Google Business Profile gives customers a map and directions to your store, helps you respond to reviews, and updates your contact information and opening hours. It should look like this.

All this makes your customer’s ability to find your information quick and easy. Without the profile, customers need to click into a search result and possibly visit a few different pages on your website to find your phone number or directions. And the best part is it’s easy to set up. Take a few minutes to make sure your customers can easily find you.

Top Pharmacy News Story #1: Medicare kicks off first price review

The federal government is set to begin price negotiations on the ten costliest prescription drugs covered by Medicare this week. The negotiations, as mandated by the Inflation Reduction Act, are scheduled to run through Aug. 1 before final prices are announced on Sept. 1. It’s uncharted territory for Medicare, which has never before been able to directly haggle with drugmakers over prices.

The ten drugs under negotiation are Eliquis, Jardiance, Xarelto, Januvia, Enbrel, Imbruvica, Farxiga, Entresto, Stelara, Fiasp and Novolog. Together, these ten drugs accounted for $50.5 billion, or 20%, of Medicare Part D spending from June 1, 2022, to May 31, 2023 according to the CMS.

Top Pharmacy News Story #2: A third class-action lawsuit has been filed against PBMs by independent pharmacies

Another class action lawsuit has been filed against Express Scripts alleging that the massive pharmacy benefit manager, one of the largest in the world, colluded with several smaller PBMs to rig reimbursement rates and shake down pharmacies for higher fees.

The lawsuit claims that Express Scripts used its dominant market position to push rival PBMs to impose excessive back-end fees on pharmacies and then share the revenue with Express Scripts. Express Scripts announced one such arrangement in 2019 with Prime Therapeutics, a smaller PBM.

The other two lawsuits were filed against UnitedHealth Group and its PBM, OptumRx and CVS Health, Caremark and Aetna.

Independent pharmacies do not need to sign up to benefit from the potential class action. The plaintiffs involved will ask the Court to allow it to pursue its claims on behalf of other pharmacies. If the Court permits that, pharmacies across the U.S. will be able to share in any money or other legal relief that is obtained.

Top Pharmacy News Story #3: City of Boston Sues Major PBMs Over Role in Opioid Crisis

The City of Boston, the Boston Public Health Commission and the Boston Housing Authority filed a lawsuit in Suffolk County Superior Court and names some of the largest PBMs in the US, including Express Scripts and OptumRx.

Boston’s lawsuit accuses the pharmacy benefit managers of colluding with drug makers to maximize profits by prioritizing the prescribing of addictive opioids despite the risks. The companies, the lawsuit alleges, profited from deals with drug makers that made it easier to prescribe opioids in exchange for financial incentives.

The defendants deny the allegations.

Flu is on the rise while RSV in children may be peaking

The CDC announced on Friday that flu cases are rising while RSV cases in children and the elderly may be at the peak.

In the meantime, COVID-19 continues to cause the most hospitalizations and kills about 1,000 every week.

According to IBM’s Predictive Flu 14-day Trigger, these will be the top risk-of-flu predictions for the next week:

Top Markets for Projected Flu Activity (Next 2 Weeks):

• Columbus (OH)
• Zanesville (OH)
• Marquette (WI)
• Providence-New Bedford (RI)
• New York (NY)
• Salt Lake City (UT)
• Colorado Springs-Pueblo (CO)
• Helena-Great Falls-Missoula (MT)
• Seattle-Tacoma (WA)

WSJ reports Cigna and Humana in talks to merge

On Wednesday, the Wall Street Journal reported that Cigna and Humana are discussing a stock-and-cash deal to merge. The merger may be completed as soon as the end of the year.

The rumored deal comes after reports in November that Cigna was exploring the possibility of selling it’s Medicare Advantage business. A Cigna spokesperson at the time said the company does not comment on “rumors or speculation.” 

The Cigna-Humana deal, however, will likely face anti-trust challenges over their PBM businesses. The combination of Express Scripts and Humana’s PBM would control about 35% of the market.

Neither company has yet to conform WSJ’s report.

Thousands of California pharmacies stop flavoring kids’ meds while awaiting new CBP rules

More than 3,000 California pharmacies earlier this month suspended their practice of flavoring medication because they’re awaiting new rules from the California Board of Pharmacy. CBP is charged with applying federal guidance that characterized the service as drug compounding, meaning the mixing of prescription medication.

The suspension of flavoring services by pharmacies follows new guidance from the United States Pharmacopeia, even though in 2010, the California Board of Pharmacy explicitly stated in its lawbook that drug compounding does not include “the addition of flavoring agent(s) to enhance palatability.”

California’s Board of Pharmacy is now preparing rules that will adopt the federal guidance. While these rules will not ban flavoring, pharmacists must comply with more stringent regulations when providing the service.

On Tuesday, the FDA approved the updated Novavax COVID-19 vaccine. The shot is expected to roll out weeks after updated vaccines from Pfizer’s and Moderna’s

Novavax’s single-strain vaccine targets omicron subvariant XBB.1.5, for emergency use in people ages 12 and up.

The Centers for Disease Control and Prevention is now including Novavax’s shot in the same recommendation it issued last month for updated vaccines from Pfizer and Moderna. That recommendation says all Americans ages six months and older can receive an updated Covid jab.

Novavax announced that doses of the shot will likely be available within the next few days.

Top news stories of the week of Sept. 29, 2023

U.S Government Shutdown: What is and who can be affected (courtesy of Reuters.com)

Landmark lawsuit would claw back the PBM clawbacks (courtesy of NCPA.org)

A class-action lawsuit has been filed against CVS Health, Caremark and Aetna to recover millions of dollars for independent pharmacies in what lawyers say are wrongfully assessed pharmacy DIR fees for Medicare Part D prescriptions.

The suit claims that Caremark violated federal antitrust laws and state laws governing contracts while assessing DIR fees. The lawsuit also claims Caremark’s arbitration agreement is unenforceable.

NCPA will provide more information on the case as it develops. In the meantime, the lawyers representing the independent pharmacies will be at the NCPA Annual Convention in Orlando, October 14-17. If you would like to join the class-action lawsuit, this will be your first chance to speak to the attorneys. They will be available to meet with you privately to discuss other actions you can take to recoup wrongfully assessed DIR fees.

Remember, AAP Members and API Customers can save $100 when using the promo code “Buy100.” Register for the convention here.

National and state news affecting independent pharmacies

National Pharmacy News

This week, PBM’s were in the spotlight at the Capitol. During the House Committee on Oversight and Accountability hearing about PBMs, lawmakers from both sides of the aisle agreed that PBMs have too much power and very little transparency.

“Instead of fierce competition, now just three PBMs control 80% of the market, and each of the three major PBMs is owned by a major health insurer and owns or is owned by a pharmacy,” stated committee Chair James Comer (R-Ky.). “This means that when they negotiate with a health insurer, they are either negotiating with themselves or one of their direct competitors. The committee has made it a priority to expose the anticompetitive tactics by PBMs that are increasing healthcare costs for Americans and harming patient care.” Read more about the hearing.

State Pharmacy News

Florida: Florida lawmakers approved the rules to implement several provisions of the Prescription Drug Reform Act (SB 1550). The rules increase accountability among PBMs. They include all application forms for PBMs seeking to operate in Florida in 2024. Any PBM that attempts to continue operating in Florida next year, and has not been approved as an insurance administrator, can be fined up to $10,000 per violation per day. Read more.

Washington: The Washington State Pharmacy Association (WSPA), NCPA, and NACDS are celebrating a settlement of a six-year lawsuit with the state of Washington. The state agreed to these terms among others:

• Conduct a cost of dispensing study to move to cost-based dispensing fees
• Provide more than $60 million in retroactive payments to pharmacies in Washington State’s fee-for-service Medicaid program
• Use, for now, Oregon’s cost-based dispensing fees and tiers from July 1, 2023, going forward, until a new cost-based dispensing fee obtains necessary state and CMS approval.

Read more.

Top pharmacy news stories of the week

Walmart cuts pharmacist pay and hours

In a plan to reduce costs, Reuters is reporting that Walmart is asking some of its 16,000 pharmacists across the country to voluntarily take pay cuts and reduce their work hours. The cuts, which are aimed at pharmacists in higher wage brackets, show how current demand for expensive weight loss GLP-1 medications, coupled with Walmart’s $3.1 billion opioid settlement, are adding to the company’s financial woes.

Walmart states that it was reducing the number of hours it was offering some pharmacists, claiming a drop-off in demand for medications during the summer and requests from pharmacists for a less demanding job. Read more.

CMS selects first drugs for Medicare price negotiation

The Centers for Medicare & Medicaid Services has released the first ten drugs that will be available for price negotiation under Medicare Part D. Under the Inflation Reduction Act, Medicare will be able to negotiate the prices of prescription drugs with participating drug companies beginning this year and in 2024, which will become effective in 2026. 

The drugs are:

• Eliquis
• Jardiance
• Xarelto
• Januvia
• Farxiga
• Entresto
• Enbrel
• Imbruvica
• Stelara
• Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

HHS officials call for reclassification of marijuana to Schedule III drug

Bloomberg is reporting that officials with the U.S. Department of Health and Human Services are recommending easing restrictions on marijuana and reclassifying it under the Controlled Substances Act. A top official with the department wrote a letter to a Drug Enforcement Agency administrator saying that marijuana should be classified as a Schedule III drug, which means it has a low potential for abuse. Marijuana is currently a Schedule I drug, meaning it has no medically accepted use and a high potential for abuse. The decision to reclassify marijuana resides with the DEA, which could take months to complete its evaluation.

After announcing last week that it was selling off Winn-Dixie and Harveys Supermarkets to Aldi, and Fresco y Más to an investment company, the news broke this week that Southeastern Grocers is selling the pharmacy business to CVS and Walgreens.

According to internal emails obtained by the Tampa Bay Times, Southeastern Grocers told its pharmacists that it will sell all of its Winn-Dixie and Harveys pharmacy business by the end of the year.

“Prior to the closing of the proposed merger agreements recently announced, Southeastern Grocers has entered into agreements to transfer prescription files to certain CVS Pharmacies and Walgreens,” confirmed Southeastern Grocers communication director Meredith Hurley in an email. Read more.

AAP is helping our Members prepare for the 2024 DIR Fee Hangover

According to a survey by NCPA, approximately 98 percent of pharmacists are concerned about the upcoming 2024 DIR fee hangover and the impact it could have on their pharmacies. Many are even worried that it could lead to pharmacy closures. So, the time to prepare is NOW!

Here are five useful tips to help you prepare.

#1. According to NCPA, the first tip for preparing for the DIR fee hangover is going back to your accounting basics and understanding your cashflow.

There are many key performance indicators, or KPIs, in pharmacy. One cash flow KPI is the Current Ratio, which is current assets divided by current liabilities. How you classify those current assets and liabilities is vital to an accurate ratio. The industry average is around 2.5 to 1, so $2.50 of cash, receivables and inventory for every $1 of current debt. It is wise to know your ratio and aim for a 3 or 3.5 to 1 current ratio going into 2024. This would give you a cash flow cushion to hopefully weather any DIR unknowns.

#2. Our second tip to help you thrive during the 2024 DIR hangover is by increasing your gross margin. The average pharmacy gross margin is anywhere from 23-24%. Increasing this margin will go a long way to improving your cash flow.

One way to increase revenue is to find niches markets, such as women’s health, travel vaccines, pet meds, or nutritional supplements, to fill the holes in your community’s healthcare. Offering unique services to your patients will go a long way to improving your gross margin.

#3. You can find our third tip in the EnlivenHealth DIR Fee Hangover Playbook. To predict the DIR fees that PBMs will attempt to collect in the first quarter of 2024, look at the DIR fees collected from the same timeframe in 2023. (This should be easy to do in your third-party reconciliation platform.) Once you have that number, set it as your savings benchmark. That’s the amount of cash you need to set aside by the beginning of 2024 to avoid the sting of the DIR Fee Hangover.

#4. Our fourth tip is keeping your expenses in check. Your expenses are one of the most important factors to your cash flow and bottom line. When you are trying to figure out the best ways to combat the DIR hangover, your time is best spent focusing on the expenses that will make a big impact: cost of goods sold and wages.

Maximize your PVA

Make sure you are maximizing your purchasing with your Prime Vendor Agreement (PVA). AAP now offers multiple options for stores to help create a buying plan to fit your needs. A good PVA can increase your margin percentage. Contact our team to see which PVA option is right for you.

Keep wages in check

Technology and automation are two ways to help run payroll effectively. Check out the AAP Preferred Partners to see if any of them can help with your store’s needs.

#5. Our fifth tip is to open a business line of credit. If you are worried about cash flow next year, it can be a useful tool to have available for short-term cash flow issues. 

Funds are typically drawn from the line of credit by using a business checking account, a small business credit card or even a mobile banking app.

But a word of caution, these can be dangerous cash flow tools in a pharmacy because they are NOT free money. Lines of credit are usually higher-interest debt. These are not mid- or long-term debt cash flow solutions for a pharmacy, and you shouldn’t rely on them for those needs.

Any time access to a line of credit is utilized, there must be a plan in place on how and when it will be paid back. Long-term cash flow issues within a pharmacy should not be addressed with short-term debt solutions such as a line of credit.

If we learned anything from the COVID-19 pandemic, it’s that independent pharmacists are innovators. Preparing now will help you thrive in 2024.

UPS Teamsters members approve five-year contract

The Teamsters Union members voted to approve the tentative contract agreement reached last month, ending contentious labor negotiations that threatened to disrupt package deliveries for thousands of pharmacies nationwide.

The Teamsters said in a statement that within the highest voted election ever, 86% of the votes casts were in favor of ratifying the contract.

The union ratified more than 40 supplemental agreements except for one that covers about 170 members in Florida. The national master agreement will go into effect as soon as that supplement is renegotiated and ratified, it said.

UPS said voting results for contracts covering employees under two local unions are expected soon. The new contract sets a new standard for pay and benefits.

“Our members just ratified the most lucrative agreement the Teamsters have ever negotiated at UPS,” Teamsters General President Sean M. O’Brien said in a statement. “This contract will improve the lives of hundreds of thousands of workers.” Read more.

Top pharmacy news stories of the week:

PBS News Hour Story: How the prescription drug supply chain is killing local pharmacies

Understanding the independent pharmacy business in the U.S.

August legislative recess is here

FDA Approves First Postpartum Depression Pill

The Food and Drug Administration approved the first-ever pill for postpartum depression. In trials, the treatment improved depression symptoms among new mothers as early as three days after they started the medication.

The medication, called zuranolone, is taken daily for two weeks. In clinical trials involving women who experienced postpartum depression, the drug improved symptoms — such as anxiety, difficulty sleeping, loss of pleasure, low energy, guilt or social withdrawal. Read more.

By understanding the independent pharmacy business, we can work to make the most of our distinct advantages to meet consumer needs

McKinsey & Company conducted a consumer survey of more than 1,000 people and leads us to better understanding the independent pharmacy business in the U.S. They published their findings in this article, laying out how the retail pharmacy landscape has changed over the years, how consumer preferences have evolved, and how different types of retail pharmacies may respond as a result.

The U.S. retail pharmacy landscape faces saturated retail locations, ongoing labor shortages, inflationary pressure and a leveling-off of generic drug penetration. To effectively compete in this environment, all independent and community pharmacies can strive to better understand and adapt to changing consumer preferences.

This study gives us a snapshot of the market, where we are trailing the big chains and where we can make substantial gains.

How the retail pharmacy landscape has evolved

Over the past two decades, the retail pharmacy landscape has evolved substantially. This survey breaks down the retail pharmacy sector into four categories: retail chains, regional pharmacies such as mass retail and grocers, independent pharmacies, and mail-order and online pharmacies.

According to McKinsey & Company, the number of independent pharmacies has decreased by nearly 50 percent since 1980, leveling off at about 20,000 locations since 2000. While filling about 48,000 prescriptions a year, independent and community pharmacies remain viable through effective collaboration with other independents and wholesalers. This cooperation has taken the form of support from wholesalers like API Warehouse, pharmacy service administrative organizations, and group-purchasing organizations like AAP.

Understanding the independent pharmacy business in the U.S. is key for retail pharmacies. We can ensure we understand and meet consumers’ needs so we are a preferred destination. Click here to read the full report and gain more insight to understanding and improving your pharmacy’s business.

Your weekly Rx roundup of news stories affecting independent pharmacy

Top Stories

PBM reform bill advances in Senate vote

UPS and Teamsters Union Reach Tentative Contract

NCPA’s Month of Action Starts August 1

Join your colleagues all over the country for NCPA’s Month of Action and get the attention of the people whose vote matters to your pharmacy’s future. Invite your Congressional rep or Senator for visit while they are form for the August recess. Make sure they understand how important it is to keep pressure on PBMs and fight for a competitive and fair business environment.

Pressure is working. In the past week, Senate Finance Committee approved legislation that includes strong PBM reforms, passing the Modernizing and Ensuring PBM Accountability Act by a vote of 26-1. Now it’s on the way to the full Senate before it can proceed to the House of Representatives. Keep the momentum going by contacting your lawmaker today and getting them to visit your pharmacy. The fight isn’t over, so let’s put the action in Month of Action.

Pfizer’s New Migraine Treatment Now Available in U.S. Pharmacies

After FDA approval in March, Zavzpret is now available in U.S. pharmacies. The medication is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for acute migraine treatment in adults. For the nearly 40 million Americans living with migraines, this approval provides an alternative option for relief, especially for those who have contraindications or poor responses to triptans and other acute migraine medications. Read more.

UPS and Teamsters Union have reached a tentative contract, potentially averting a strike that threatened to disrupt package deliveries for independent pharmacies nationwide.

The agreement was announced Tuesday, the first day that UPS and the Teamsters returned to the bargaining table after negotiations broke down earlier in July.

Negotiators for UPS and the Teamsters Union had already reached tentative agreements on several issues, including cameras and air conditioning in the delivery trucks. But clashes continued over increasing pay for part-time workers, who make up more than half of the UPS employees represented by the union.

Teamsters will begin voting on the new five-year contract Aug. 3 and concludes Aug. 22.

Your weekly independent pharmacy news update

AAP is at RBC this week

The AAP is in Boston this week at RBC. Come meet with our team and get updates on the AAP Prime Vendor Agreement, ProfitAmp, AlignRx and more. Plus, relax and enjoy some fun with Virtual Reality, cornhole and a golf putting green!

New Jersey joins in the fight against PBMs

New Jersey Governor Phil Murphy signed three bills to help make prescription drugs more affordable for New Jerseyans. The three bills will work together to cap certain out-of-pocket costs, establish greater oversight of Pharmacy Benefit Managers, and promote transparency across the pharmaceutical supply chain. Read more.

Birth control goes OTC

The U.S. Food and Drug Administration approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy. Opill is the first daily oral contraceptive approved for use in the U.S. without a prescription. Approval of this progestin-only oral contraceptive pill provides consumers a choice to purchase oral contraceptives without a prescription at independent and community pharmacies.  Read more.

Your weekly independent pharmacy news update

Preparing for this fall’s tripledemic

To prevent a repeat of last winter’s “tripledemic” of respiratory illnesses, Americans will be encouraged to roll up their sleeves not just for flu shots but for two other vaccines, one of them entirely new.

The three shots — flu, Covid and R.S.V. — may help to reduce hospitalizations and deaths later this year. But there are uncertainties about how the vaccines are best administered, who is most likely to benefit, and what the risks may be.

For older and immunocompromised Americans, all three vaccines are vital. Yet it’s unclear how many Americans will opt for the shots. 71% of adults ages 65 and older got a flu shot this past winter, but only about 43% chose to get the Covid booster.

The misery of the past winter may help change minds. The flu may have led to as many as 58,000 deaths, peaking in December, according to the C.D.C. Covid claimed roughly 50,000 lives between November and March.

R.S.V. kills up to 10,000 people each year, most of them older. Infections this year peaked in November and resulted in about twice as many hospitalizations, including children, as in prepandemic years.

Only the Covid and flu vaccines were available last fall. The R.S.V. vaccines for adults are new, and in clinical trials proved to be highly effective against infection of the lower respiratory tract, which includes the lungs.

FDA approves Alzheimer’s drug Leqembi

The Food and Drug Administration fully approved the Alzheimer’s treatment Leqembi, which will expand access to the expensive drug for older Americans.

Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.

Leqembi is the first Alzheimer’s antibody treatment to receive full FDA approval. It is also the first such drug to receive broad coverage through Medicare. Read more.

Five Adalimumab biosimilars launched on July 1 in the U.S.

July 1 marked the launch of five different adalimumab (Humira) biosimilars, setting off the first round of therapeutic alternatives into the market, including adalimumab-abdm (Cyltezo), adalimumab-aqvh (Yusimry), adalimumab-bwwd (Hadlima), adalimumab-adaz (Hyrimoz), and adalimumab-fkjp (Hulio). These medications join adalimumab-atto (Amjevita), the first adalimumab biosimilar that launched earlier this year.¹ Read more at Drug Topics.

CMS issues revised guidance to Medicare Drug Price Negotiation Program

CMS recently issued revised guidance to Medicare Drug Price Negotiation Program. CMS noted that the majority of the comments received from supply chain entities on this topic, including manufacturers and pharmacies, supported the use of a standardized, published pricing metric to calculate the refund due from the manufacturer to the pharmacy for the pass through of the maximum fair price as required under the program. Read more.

Your weekly independent pharmacy news update

Senate considers bill to combat high DIR fees

The Protect Patient Access to Pharmacies Act (S. 2052) was introduced this week to the U.S. Senate. This bill addresses the abusive business practices by pharmacy benefit managers (PBMs) that have resulted in the growth of pharmacy direct and indirect remuneration (DIR) fees and have led to pharmacy closures.

The bill, supported by NCPA and APhA among others, will help to secure Medicare patients’, who are typically seniors, freedom to receive medications and care from the pharmacy of their choice by improving enforcement of the “any willing pharmacy” law. This law is intended to prevent the exclusion of pharmacies from Part D plan networks.

The Patient Access Act is only the most recent effort working toward DIR fee relief as the Centers for Medicare and Medicaid Services’ (CMS) proposed rule made in early 2022 goes into effect in the beginning of 2024. CMS’ proposed rule will work to reduce the financial burden on independent pharmacies and increase transparency in the PBM industry. Read more.

Approval for GLP-1-based weight loss pills on the FDA horizon?

The buzz about Eli Lilly’s experimental pill for weight loss is growing. Retatrutide helped people lose an average of 15% of their body weight after 36 weeks on the highest dose in a mid-stage trial, and as much as 24% of their weight over 48 weeks — the biggest reduction reported to date in clinical trials of a new class of obesity treatments. These results are rivaling what’s seen with currently approved injectable therapies like Wegovy over longer durations.

The drug, orforglipron, had similar side effects as others in the class, known as GLP-1 receptor agonists: primarily gastrointestinal events like nausea, constipation and vomiting, researchers reported in a study published in the New England Journal of Medicine. Read more.

Your weekly independent pharmacy news update

AAP Member Featured in Drug Topics Podcast

AAP Member Greg Mitchell sat down with Drug Topics to discuss the importance of being connected to your community when running a rural pharmacy. You can listen to the entire podcast here.

FDA Committee Recommends Development of Monovalent, XBB-Containing Vaccines for the Fall

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has unanimously recommended that COVID-19 vaccines being developed for this fall should only include protection against the XBB variant.

Trial results showed that among 101 participants who had previously received 4 doses of a COVID-19 vaccine, an XBB-containing vaccine was more effective against the currently circulating XBB variants. Read more.

ACA preventive care mandate maintained, for now

A federal appeals court maintained a freeze on a ruling that struck down the Affordable Care Act’s mandate that employers and insurers fully cover preventive health services while a legal challenge to the rule continues to wind through the courts.

The decision from the New Orleans-based U.S. 5th Circuit Court of Appeal means that over 150 million people’s health care coverage for certain cancer screenings, behavioral counseling and HIV prevention by the U.S. Preventive Services Task Force will remain in place for the time being.

Biden names Mandy Cohen — former North Carolina health secretary — to lead CDC

President Biden named Dr. Mandy Cohen as the next leader of the Centers for Disease Control and Prevention. Dr. Cohen served in top positions in state and federal government and in the private sector. She served as health secretary in North Carolina, where she worked on expanding access to health care for low-income residents and became the face of the state’s COVID-19 response during the public health emergency. Read more.

AAP Member in the News

We are proud of AAP Member, Kevin Duane, and his fight against PBMs. His advocacy helped pass legislation in Florida and now he’s moved into the national spotlight.

If you didn’t catch his testimony before the bi-partisan U.S. House of Representatives Oversight Commitee, you can watch it here.

FDA approves first oral antiviral for treatment of COVID-19 in adults

FDA gave full approval of the oral antiviral, Paxlovid, for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19. This includes those at risk for hospitalization or death. Paxlovid is the fourth drug — and first oral antiviral pill — approved by the FDA to treat COVID-19 in adults. The U.S. government will continue to oversee the distribution of Paxlovid, and U.S. residents eligible for the medication will continue to receive the medicine at no charge, according to Pfizer. Read more.

N.Y. federal appeals court clears the way for Purdue Pharma bankruptcy deal

In a landmark ruling Tuesday, a federal appeals court in New York cleared the way for a bankruptcy deal for Purdue Pharma. The deal will shield members of the Sackler family, who own the company, from future lawsuits.

The 2nd Circuit Court of Appeals spent more than a year reviewing the case after a lower court ruled it was improper for Purdue Pharma’s bankruptcy deal to block future opioid-related lawsuits against the Sackler family. The Sacklers earned billions of dollars from the sale of OxyContin and other opioid pain medications.

This latest ruling overturns the lower court’s December 2021 decision and clears the way for a deal hashed out with thousands of state and local governments. Read more.

FTC deepens inquiry into PBMs

(Courtesy of NCPA) As part of its ongoing inquiry into pharmacy benefit managers (PBMs) and their impact on the accessibility and affordability of prescription drugs, the Federal Trade Commission issued compulsory orders to two group purchasing organizations that negotiate drug rebates on behalf of other PBMs. The orders will require these entities to provide information and records on their business practices. Having previously issued compulsory orders to the six largest PBMs in the U.S. healthcare industry, the FTC yesterday issued two additional orders to Zinc Health Services, LLC, and Ascent Health Services, LLC.

House panel advances transparency and PBM bills

(Courtesy of Axios) On Wednesday, a House Energy and Commerce Committee advanced a health markup in a unanimous 27-0 vote to:

• Codify and strengthen Trump-era rules for hospitals and insurers to make health care prices available and more transparent.
• Impose new transparency requirements on PBMs and ban “spread pricing” in Medicaid, where PBMs charge more than they pay for a drug and keep the difference. Read more.

1 in 5 older adults skipped or delayed medications last year because of cost

(Courtesy of NBC News) A growing number of older adults say they can’t afford their prescription medications, a study published Thursday in JAMA Network Open found.

About 1 in 5 adults ages 65 and up either skipped, delayed, took less medication than was prescribed, or took someone else’s medication last year because of concerns about cost, according to the study. 

“That was pretty surprising,” said lead study author Stacie Dusetzina, a health policy professor at Vanderbilt University in Nashville, Tennessee. A study published in the journal Medical Care found that in 2016 about 1 in 7 older adults were not taking their medication as prescribed because of cost.

“So a pretty big jump,” Dusetzina said. 

The study’s findings were based on a national survey taken by more than 2,000 older adults from June 2022 through September 2022. Read more.