Rx Pulse Newsletter

Report: 1 in 4 New Coronavirus Cases are in Children

Nearly 27% of the cases recorded in the week leading up to September 2nd, 5th, were in children. “After declining in early summer, child cases have increased exponentially, with over 750,000 cases added between August 5 and September 2nd, 5th,” according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

According to the new data, cumulated cases reported in children increased 10% over the two weeks leading up to September 2nd, 5th. More than 5 million cases have been reported in children since the start of the pandemic. Meanwhile, from late June to mid-August, weekly coronavirus-associated hospitalization rates among children and adolescents increased nearly fivefold as the delta variant surged, according to a study from the Centers for Disease Control and Prevention.

Fortunately, the AAP and CHA report said that “it appears that severe illness due to COVID-19 is uncommon among children.” However, “there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”

Cecelia Smith-Schoenwalder. “Report: 1 in 4 New Coronavirus Cases Are in Children,” US News, 2021.

COVID-19 Treatment and Prevention: Win or Bust

Bust: Ivermectin for COVID-19 Treatment

Attention has been raised regarding the use of ivermectin in the treatment of moderate to severe COVID-19 illness. The use of ivermectin for COVID-19 treatment is not approved by the US Food and Drug Administration (FDA), nor is it supported by the Centers for Disease Control and Prevention (CDC), National Institute of Health (NIH) COVID-19 guidelines or the Infectious Disease Society of America (IDSA).

• This medication is currently FDA-approved to treat specific parasitic infections.
• The use of ivermectin in COVID-19 is leading to increased risk of adverse events, including overdose.
• There are significant safety concerns around ivermectin — overdose can cause nausea, vomiting, diarrhea, low blood pressure, allergic reactions, dizziness, balance issues, seizures, coma and even death.

Before the pandemic, ivermectin was dispensed less than 4,000 times each week by American pharmacies. But a recent survey showed the drug, which has no proven effectiveness against COVID-19, was dispensed 88,000 times.

In response to the increase of ivermectin utilization, pharmacy benefit managers such as OptumRx, CVS Caremark and Express Scripts have implemented utilization management strategies such as preauthorization and quantity limits to minimize unnecessary dispensing of ivermectin.

Leah Hope. “FDA, CDC, Doctors Warn Not to Use Ivermectin for COVID Treatment, Prevention,” ABC7 Chicago, 2021.

Win: Pill to Treat COVID-19 Cuts the Risk of Death by Half

A pill has cut the risk of hospitalization or death from COVID-19 by half in a study, Merck and Ridgeback Biotherapeutics said Friday. It would become the first oral medicine that fights viral infection for COVID-19 if approved by the US Food and Drug Administration for emergency use authorization.

“At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%,” Merck said in a news release. “7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo treated patients (53,377). Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.”

Molnupiravir is not a vaccine. It is an oral antiviral, and experts have said developing such a drug could be the next chance to thwart COVID-19. Unlike remdesivir, which is given intravenously to sick patients in the hospital, molnupiravir is a short-term regimen of daily pills to fight the virus early after diagnosis and prevent symptoms from developing after exposure.

Merck has been producing doses while awaiting the study results and expects to produce 10 million by the end of the year.

JoNel Aleccia. “A Pill to Treat COVID-19: 'We’re Talking About a Return to, Maybe, Normal Life,'” CNN Health, 2021.

COVID-19 Vaccines for Kids 5 to 11

Since the end of summer and now that school is back in full swing, COVID-19 cases among kids in the United States have had a significant increase, and the need for vaccination in this population is clear.

As quoted in STAT, William Gruber, a senior vice president of vaccine clinical R&D at Pfizer, said,

Until we actually get control of the pandemic and children are felt to be protected, there are still going to be significant restrictions in terms of masking, after-school activities, all the things that allow children to be children…I see the vaccine as liberating to allow people to get back to their normal lives and that particular aspect can’t be lost in all of this.

Pfizer’s ongoing studies are showing safety and antibody responses for the 5 to 11 age group. The children were given a dose equivalent to one-third of that given to adults and saw the same positive responses and side effect profile. The clinical trials are a promising sign as they will be a foundational piece as Pfizer seeks FDA approval.

Matthew Herper. “Pfizer COVID-19 Vaccine Generates Robust Antibody Response in Children, Without Serious Safety Issues, Company Says,” STAT, 2021.

Pneumococcal Vaccine

More headway is also being made with the pneumococcal vaccine. Merck is undergoing trials for Vaxneuvance, which is proving to have broader coverage than Pfizer’s current mainstay, Prevnar 13. Interchangeability, catch-up and new start trials are all being conducted with Vaxneuvace and are looking promising. The vaccine is integral in protecting against the bacteria that leads to pneumonia, meningitis and other infections, so this new generation of vaccines is a welcome advancement.

Kevin Dunleavy. “Racing Rival Pfizer, Merk’s Vaxneuvance Makes Its Case for an FDA Approval in Children,” FiercePharma, 2021.

Flu Vaccines

As we rapidly enter the heart of the flu season, it is a good time to reevaluate our efforts in decreasing the negative impact from the seasonal flu.

While the overwhelming consensus from the healthcare industry remains in favor of getting the flu vaccine, the current methodology comes down to a bit of a guessing game where the developers are forced to anticipate the best formulation for each year.

Current flu shots are typically formulated from inactivated versions of the influenza virus cultivated in chickens’ cells. A process that has proven to be time-consuming when considering how much vaccine is needed. We’ve seen that in some seasons, this guessing game has not been as successful as others. Now a potential benefit from the advancements made from the COVID-19 vaccines is mRNA flu vaccines.

“In many cases, we guess wrong, which has led to only a 10 to 50 percent efficacy in some seasons. If mRNA technology is used, we would be able to develop vaccines which contain the most common strains of the season with much more precision, which should make the vaccinations far more effective,” Dr. Scott Braunstein, medical director of Sollis Health in Los Angeles, California said.

Utilizing the mRNA technology would allow the scientist and researchers to make the formulation decisions much closer to the actual flu season leading to much more mild flu seasons in the future.

Cathy Cassata. “Why a New mRNA-Based Flu Vaccine May Be the Most Effective Yet,” Healthline, 2021.

COVID-19 Vaccine Advancements

While we know the rate COVID-19 vaccine introductions to the market and their impacts have been nothing short of remarkable, there will still be ongoing questions of how we can improve the vaccine. We know the virus that causes COVID-19 can be transmitted through droplets originating from an infected person’s breath, cough, sneeze, etc. So, the first barrier we have to the virus before it enters the lungs is often our nose.

Based on this concept, Navin Varadarajan, University of Houston M.D. Anderson, Professor of Chemical and Biomolecular Engineering, and his colleagues, are working on initial steps for creating a nasal vaccine.

“Mucosal vaccination can stimulate both systemic and mucosal immunity and has the advantage of being a non-invasive procedure suitable for immunization of large populations,” said Varadarajan.

Varadarajan is working with Xinli Liu, associate professor of pharmaceutics at the UH College of Pharmacy. Their team has created the technology for the nasal delivery coined “NanoSTING” and plans to start working with the FDA later this year.

These advancements would be promising not only for mucosal immunity that wouldn’t be achievable through our current vaccine routes, but also because the NanoSTING components are showing to be more stable and are likely to be more easily distributable throughout the world which could address some of the disparities we see today.

“COVID-19 Nasal Vaccine Candidate Effective at Preventing Disease Transmission,” World Pharma News, 2021.

E-Cigarettes & Smoking Cessation Products

It may be surprising to know that none of the e-cigarette or vape products on the market were officially approved by the FDA. This is because their authority was previously restricted to traditional tobacco products. This has allowed a gap for e-cigarettes and vape devices that have been available and marketed without FDA authorization since 2016.

Stemming from concerns over the safety of e-cigarettes and vape products, there was a court-mandated deadline for the manufacturing companies to submit their applications for approval to the FDA. This mandate came out in mid-2019 and gave the companies until May 2020. However, the deadline was later pushed to September 9, 2020, due to COVID-19.

Once the product applications were submitted to the FDA, they were supposed to have one year to approve or deny each product. This means the FDA final decisions were due by September 9, 2021. The FDA has not completed the review of the nearly 7 million applications, although they report that they have less than 10% remaining to review.

Groups like Campaign for Tobacco-Free Kids have been encouraging the removal of e-cigarettes and vape products from the market due to the increased utilization among young people, particularly teenagers. A researcher at the Center for Tobacco Research acknowledged that there is no safe nicotine use for young people. However, for adult smokers who have struggled with other quit assistance products, e-cigarettes may be beneficial in reducing their health risks compared to standard nicotine usage.

In 2019, Juul stopped selling their popular flavored products. Even though only tobacco and menthol flavors remain available, use among teenagers has continued. Juul’s applications are among those that have not yet been addressed by the FDA.

The FDA has not released its targeted date of completion for the pending product reviews.

Jacqueline Howard. “FDA Takes More Time to Decide on E-Cigarettes,” CNN, 2021.

Chantix

Another popular medication is being recalled due to potentially unsafe levels of a nitrosamine compound, N-nitroso-varenicline, which is thought to increase the risk of cancer. Nitrosamine compounds are common in water and foods, including cured and grilled meats, dairy products and vegetables. We all experience some level of contact with nitrosamines. However, the risk for cancer may be increased with prolonged exposure to high levels.

Chantix, the drug many have used to try and quit smoking, is being voluntarily recalled by Pfizer as a precaution. Earlier this summer, Pfizer identified the compound in some batches and therefore paused distribution of the product. Unfortunately, this recall was subsequently expanded to include all lots of the product, which led to a nationwide shortage. To temporarily address shortages, the FDA allowed one generic manufacturer to re-import its product from Canada in July before they ultimately approved a generic product for the US in August.

We have previously discussed the recalls due to another nitrosamine compound, N-nitrosodimethylamine or NDMA, that had impacted metformin, losartan and even led to ranitidine’s withdrawal from the market.

Eric Sagonowsky. “Pfizer Recalls All Chantix Lots Nationwide over Concerns of Cancer-Causing Impurity,” FiercePharma, 2021.

Most Expensive Drugs

When discussing the most expensive drugs, many are familiar with Zolgensma and its $2.1 million price tag. This ultra-high-cost drug likely overshadows some of the other lesser-known highcost drugs on the market.

The top list usually is made up of high-cost drugs, used mostly for rare conditions that are only available via infusion or must be clinician-administered. These drugs are known as orphan drugs because they treat rare conditions impacting small patient populations, typically less than 200,000 people in the US.

It is interesting to note that three of the top 10 most expensive drugs can be self-administered. The most expensive selfadministered medication is Zokinvy, for the ultra-rare condition Hutchinson-Gilford Progeria Syndrome, which currently impacts only 600 people globally and about 20 people in the US. Zokinvy is an oral drug that costs over $700 per capsule, and with the average dosage, this equates to approximately $86,000 per month. It was just approved late in 2020, so it’s a relatively new arrival to the ultra-high drug list, but at over $1 million a year average cost, it is the second most expensive drug available today.

The other two high-cost, self-administered drugs in the top 10 list are Myalept at number four and Ravicti number nine. Both are for rare genetic conditions: dyslipidemia and urea cycle disorder, respectively.

Angus Liu. “Ultra-Rare Disease Specialists Top 2021’s Pricey Drugs List, but Takeda, Merck KGaA Meds Rank, Too,” FiercePharma, 2021.
Hanna McQueen. “The 10 Most Expensive Drugs in the U.S., Period,” GoodRx Health, 2021.

Transparency in Coverage

In 2020, the Transparency in Coverage rule released by the Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury was part of former President Trump’s executive order “Improving Price and Quality Transparency in American Healthcare to Put Patients First.”

This rule is seen as a significant step forward in putting healthcare price information in the hands of consumers, allowing them to make informed healthcare decisions. However, under the Transparency in Coverage rule, in addition to providing a cost-sharing estimate tool to members, group health plans and health insurers must publicly release negotiated rates for in-network providers, historical out-of-network allowed amounts and billed charges, and drug pricing information.

Consequently, the US Chamber of Commerce and the Pharmaceutical Care Management Association (PCMA) filed separate lawsuits to challenge the transparency rule for health insurers. Both lawsuits focus on the requirements related to disclosure of rates and other pricing information, not the parts related to cost-sharing estimates.

According to PCMA, the transparency rule will drive prescription drug costs higher because disclosing “historical” net prices will directly provide drug manufacturers access to their competitors’ negotiated rebates, discounts and price concessions.

Subsequently, the Biden administration has since delayed the enforcement of certain parts of the transparency rule by six months, allowing insurers until July 1, 2022. The delay applies to the requirement that insurers post machine-readable files containing their in-network rates negotiated with providers and their out of network rates. As of now, there’s no firm deadline for insurers to report data on prescription drug prices.

Katie Keith. “Two New Lawsuits Challenge Insurer Transparency Rule,” Health Affairs, 2021.
Michael Brady. “Insurers to Get a Break on Price Transparency, Surprise Billing,” Modern Healthcare, 2021.
“PCMA Files Litigation to Prevent Higher Prescription Drugs Costs,” PCMA, 2021.
Tara Bannow. “U.S. Chamber Drops Health Insurer Price Transparency Lawsuit,” Modern Healthcare, 2021.
“Transparency in Coverage Final rule Fact Sheet (CMS-0015-F),” CMS, 2021.

Medicare Drug Price Negotiation

The cost of drugs in the United States continues to be an issue. Americans pay significantly more than other countries for the same drugs. Currently, the Biden administration’s plan for lowering prescription drug prices includes a proposal to allow Medicare to directly negotiate drug prices that will be available to commercial plans and employers who want to participate. It will apply to drugs given in doctors’ offices, as well as drugs picked up at retail pharmacies. The plan would also include:

• Drug importation from Canada
• Limiting the ability of drug companies to hike prices on existing drugs
• Putting a cap on out-of-pocket spending for the Medicare prescription drug benefit
• Bringing generic and biosimilar drugs to market more quickly
• Including shortening exclusivity periods
• Creating incentives for doctors to prescribe biosimilars instead of brand-name drugs
• Banning “pay-for-delay” schemes

Furthermore, the Pharmaceutical Research and Manufacturers of America (PhRMA) is against the plan to allow Medicare to negotiate drug prices, saying it would take away consumer choice. According to Stephen Ubl, president and CEO of PhRMA, the policies would limit access to life-saving medications because the plan doesn’t address the cost of treatments being shifted onto vulnerable patients. PhRMA also claims it would also decrease the pharmaceutical industry’s revenue, leading to drug companies developing fewer medicines.

“Building a Better Health Care System,” PhRMA.
Kristi Martin. “Allowing Medicare to Negotiate Drug Prices,” The Commonwealth Fund, 2021.
Nathaniel Weixel. “White House Plan Backs Medicare Drug Price Negotiation,” The Hill, 2021.
Susan Morse. “PhRMA Battles Biden on Proposal for Medicare to Negotiate Drug Prices,” Healthcare Finance, 2021.

According to The National Health Care Anti-Fraud Association, it is estimated that fraud, waste and abuse (FWA) cost the US healthcare system tens of billions of dollars each year. This is due to duplicate claims, data entry errors, forged prescriptions and intentional overcharging, which account for a significant amount of pharmacy spending. FWA can lead to misuse of benefits, safety concerns among plan members, and financial losses for employers and plan members. Furthermore, policy and regulatory changes made during the pandemic, including more access to telehealth and prescription refill limitations removed, have opened additional opportunities for fraud.

Partnering with a pharmacy benefit manager (PBM) that has comprehensive FWA program can improve healthcare performance, financial results and member safety. Since PBMs have access to pharmacy data, physician prescribing habits, and member claims, they are in a unique position to find ways to prevent, detect and address FWA. For example, PBMs can implement controls to avoid unnecessary costs and promote safety. In fact, there are four tools of a FWA program to preserve the integrity of the pharmacy benefit:

• Pre-Payment Claims Review using algorithms and data analytics that flag suspicious and inappropriately submitted claims.
• Pharmacy Audits to help verify the pharmacy claims, as well as identify suspicious patterns.
• Analysis of Industry, Program and Fraud Alerts to inform interventions and action plans.
• Pharmacy, Patient and Prescriber Investigations by an internal investigation unit to look for potential FWA.

PBMs can create highly personalized solutions for plan sponsors by using data analytics and thoroughly evaluating FWA reports. As FWA trends change during a pandemic, it’s vital for plan sponsors to collaborate with a diligent PBM partner who can adjust its program to detect and handle new fraudulent, abusive or wasteful behavior. Collaboration between the plan sponsor and the PBM will lead to the most opportunities for FWA avoidance and early intervention, resulting in lower costs and more effective FWA management.

Carrie Aiken. “Gaining the Upper Hand on Pharmacy Benefit Fraud, Waste and Abuse,” BenefitsPRO, 2021.