Biosimilars shake up US drug market in 2023 and other notes from around the interweb: How specialty drug ‘solution stacking’ can rein in pharmacy benefit costs. Brokers and employer groups alike know that 5% to 10% percent of insured workers and their dependents drive 50% to 60% of the cost of pharmacy claims. A few members with prescriptions for a specialty drug with a five-figure price tag can easily represent the majority of an entire group’s pharmacy spend. These drugs are often lifesaving or provide a dramatic quality of life improvement for those who take them. No one would question the necessity of using them. But when a group can mitigate some of the cost without affecting the clinical outcome, it can be a game changer. The broker who unlocks these savings becomes a trusted ally. Biosimilars shake up US drug market in 2023 and beyond despite ‘problem of complexity’. Despite the glacial pace of biosimilar uptake in the United States so far, their use is expected to cut drug costs by $54 billion over the next decade, noted a presenter at the 2022 Rheumatology Nurses Society Conference. “We think biosimilars will drive down drug costs by about $54 billion over the next 10 years,” Christopher Palma, MD, ScM, assistant professor in the department of allergy/immunology and rheumatology at the University of Rochester, in New York, told attendees. Part of the reason for this optimism, according to Palma, is the expected entry of as many as 11 Humira (adalimumab, Abbvie) biosimilars into the U.S. marketplace through the end of 2023. AbbVie’s blockbuster Humira is currently the highest-grossing drug in the world, netting the company $16 billion in U.S. revenue and $19.8 billion in global revenue in 2020 alone. Click To Learn More AHIP study claims hospitals charge double for specialty drugs compared to pharmacies. Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry. The study (PDF), released Wednesday by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products. The study was released a day before a scheduled meeting Thursday of the Federal Trade Commission on whether to probe the competitive impact of PBM contracts and how they could disadvantage independent and specialty pharmacies. “The data are clear, specialty pharmacies lower patient costs by preventing hospitals and physicians from charging patients, families, and employers excessively high prices to buy and store specialty medicines themselves,” said Matt Eyles, president, and CEO of AHIP, in a statement. Simplifying Medical Benefit Drug Management Complexities. For the first time ever, specialty medications make up 50% or more of plan sponsors’ total drug spend, despite accounting for only 4% of total pharmacy prescriptions. And within the specialty space, about 40% of drugs are billed through the medical benefit. The current specialty pipeline is full of medications that will…

Because plan sponsors don't know how to calculate how much money PBMs make, it gives PBMs all the incentive they need to overcharge. How many businesses do you know want to cut their revenues in half? That's why traditional pharmacy benefit managers, and their stakeholders, don't offer a fiduciary standard of care and instead opt for hidden cash flow opportunities to generate their service fees. Want to learn more? Click to Join Us Here is what some participants have said about the webinar. "Thank you, Tyrone. Nice job, good information." David Stoots, AVP "Thank you! Awesome presentation." Mallory Nelson, PharmD "Thank you, Tyrone, for this informative meeting." David Wachtel, VP "...Great presentation! I had our two partners at the presentation as well. Very informative." Nolan Waterfall, Agent/Benefits Specialist A snapshot of what you will learn during this 30-minute webinar: Hidden cash flows in the PBM IndustryBasic to intermediate level PBM terminologiesSpecialty pharmacy cost-containment strategiesExamples of drugs that you might be covering that are costing youThe #1 metric to measure when evaluating PBM proposals Understanding how pharmacy benefit managers make money and how much you pay them for their services is a key element in running an efficient pharmacy benefits program. Join us to learn more. See you Tuesday, 08/09/22 at 2 PM ET! Sincerely,TransparentRxTyrone D. Squires, CPBS  10845 Griffith Peak Drive, Suite 200  Las Vegas, NV 89135 Office: (866) 499-1940Mobile: (702) 803-4154 P.S. Yes, it's recorded. I know you're busy ... so register now and we'll send you the link to the session recording as soon as it's ready. 

Pharmacogenomics is increasingly relevant and other notes from around the interweb: Government declines to appeal ruling in PBM accumulator programs. The Final Rule would have required a manufacturer to count the value of patient cost-sharing assistance in best price and average manufacturer price unless the manufacturer “ensure[d]” that the full value passed to the patient, as opposed to the plan. The Final Rule was vacated on the grounds that it violated the text of the Medicaid rebate statute. We issued a client alert on the ruling available here. The government had 60 days from the date of the ruling to appeal, and that deadline passed on July 18, 2022. Because the government has decided to not appeal the ruling, the Final Rule remains invalidated and will not go into effect. Doctors use more brands if they're on the pharma dole: JAMA. The study offers more evidence that doctors who collect more payments from drugmakers prescribe more brand-name drugs. Harvard Medical School researchers matched Part D Medicare claims in Massachusetts with data on pharma payments to Massachusetts physicians, zeroing in on prescriptions for statin drugs. The widely used class of cholesterol drugs is also widely available in generic form. The conclusion? The higher the payments from drugmakers, the more prescribers used brands, rather than generics. Overall, Massachusetts doctors prescribed branded statins 22.8% of the time. Doctors who collected no money from pharma prescribed brands at a rate of just 17.8%. Doctors who did saw their percentage of brand prescribing rise with every $1,000 in pharma payments reported, the JAMA Internal Medicine study said. Click To Learn More Precision Medicine vs Trial and Error: Why Pharmacogenomics is Increasingly Relevant. Pharmacogenomics looks at how genetic influences affect an individual’s response to therapeutic medications. Rather than taking the approach that therapy for all people with a certain health condition should begin with the same medication at the same dose, pharmacogenomics has the potential to enable personalized medicine selection and dosing to a degree not previously possible. As of late 2021, 180 approved drugs were labeled by the U.S. Food and Drug Administration (FDA) with genetic factors. While many pharmaco-economic studies suggest that pharmacogenomic testing is cost-effective, a growing body of evidence also highlights the clinical impact of pharmacogenomics. Estimates indicate that more than 98% of people in the U.S. carry at least one high-risk genomic variant in one of the 12 most-tested pharmacogenetic genes. The presence of such variants suggests that treatment with relevant medications may need to be altered to avoid side effects or optimize efficacy. Therefore, the traditional one-size-fits-all, trial-and-error approach to medication management is inherently risky. Two firefighters admit role in $50 million prescription fraud scheme. According to the indictment, from July 2014 through April 2016, the conspirators recruited teachers, firefighters, police officers and state troopers enrolled in the state health benefits program to obtain very expensive and medically unnecessary compounded medications, including pain, scar, anti-fungal, and libido creams, as well as vitamin combinations from a Louisiana pharmacy. The pharmacy benefits administrator…

Fake medications cause in excess of 1,000,000 passings every year, as per the World Health Organization (WHO)[i]. It's a sufficient scourge that a large gathering of specialists grouped together in 2019 to pronounce the ascent in "misrepresented and unsatisfactory meds" nothing short of a "public health crisis," one that kills 250,000 youngsters every year. Is drug importation a valid prescription? A few fake[ii] medications contain an inadequate measure of active ingredients important to battle a specific illness. Many fakes start in China and India and contain inactive as well as poisonous fixings, for example, printer ink, paint, and arsenic. What's more regrettable, without knowing the private subtleties of the bundling, separating what's genuine from fake is exceedingly difficult. Radio Frequency Identification (RFID) Tags What's more, the risk is developing, unfortunately. A report by Pfizer distinguished 29 phony meds in 75 nations in 2008. By 2018, there were 95 fakes in 113 nations. As per the WHO, one out of each and every 10 medications sold in non-developed nations is fake or unacceptable, bringing about substantial numbers of unnecessary passings consistently. In any case, the issue isn't simply in the undeveloped world. In 2018, as a component of a weeklong anti-counterfeiting operation, Canadian authorities examined almost 3,600 packages and tracked down that 87% contained fake or unlicensed healthcare items. Beginning around 2008, INTERPOL eliminated more than 105 million fake or substandard medications from dissemination and made more than 3,000 captures of people involved. Conclusion - Is Drug Importation a Valid Prescription? Drug importation comes with an increased level of risk. That risk has been explained above. The benefits outweigh the risks of drug importation provided proper precautions have been made to mitigate said risks (i.e. members taking a fake or substandard medication). Avoid including drugs in an importation program which require refrigerationImport drugs from Tier 1 countries only: Australia, Canada, United Kingdom, New ZealandRequire Radio Frequency Identification (RFID) in the importation drug supply chain. RFID is used to accurately count, correct, and track all individual items and cartons across the supply chain. This starts in the factory where items are tagged at source, goes on to the distribution center where orders are sorted and finally sent out to pharmacies.Incorporate a first-fill program to ensure no breaks in drug therapy. First-fill programs account for the longer delivery timeframes associated with the importation of authentic drugs.Don't sacrifice safety for price among importation vendors. A prescription drug benefit program is expensive to support. It will get more expensive over time as cell and gene therapies replace first generation specialty and biologic drugs. Healthcare plan sponsors must stack solutions in their cost management process to ensure annual costs are affordable. There is a myriad of solutions available to get drug costs in line with expectations. Drug importation is one solution for every plan sponsor to consider. [i] The WHO member state mechanism on substandard and falsified medical products. World Health Organization. www.who.int/publications/i/item/WHO-MVP-EMP-SAV-2019.04. Published April 2019. Accessed October 26, 2021. [ii] Fake medicines. INTERPOL. www.interpol.int/en/Crimes/Illicit-goods/Shop-safely/Fake-medicines. Accessed…

Doctors use more brand drugs when on the pharma dole and other notes from around the interweb: How specialty drug ‘solution stacking’ can rein in pharmacy benefit costs. Brokers and employer groups alike know that 5% to 10% percent of insured workers and their dependents drive 50% to 60% of the cost of pharmacy claims. A few members with prescriptions for a specialty drug with a five-figure price tag can easily represent the majority of an entire group’s pharmacy spend. These drugs are often lifesaving or provide a dramatic quality of life improvement for those who take them. No one would question the necessity of using them. But when a group can mitigate some of the cost without affecting the clinical outcome, it can be a game changer. The broker who unlocks these savings becomes a trusted ally. Doctors use more brands if they're on the pharma dole: JAMA. The study offers more evidence that doctors who collect more payments from drugmakers prescribe more brand-name drugs. Harvard Medical School researchers matched Part D Medicare claims in Massachusetts with data on pharma payments to Massachusetts physicians, zeroing in on prescriptions for statin drugs. The widely used class of cholesterol drugs is also widely available in generic form. The conclusion? The higher the payments from drugmakers, the more prescribers used brands, rather than generics. Overall, Massachusetts doctors prescribed branded statins 22.8% of the time. Doctors who collected no money from pharma prescribed brands at a rate of just 17.8%. Doctors who did see their percentage of brand prescribing rise with every $1,000 in pharma payments reported, the JAMA Internal Medicine study said. Click To Learn More AHIP study claims hospitals charge double for specialty drugs compared to pharmacies. Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry. The study (PDF), released Wednesday by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products. The study was released a day before a scheduled meeting Thursday of the Federal Trade Commission on whether to probe the competitive impact of PBM contracts and how they could disadvantage independent and specialty pharmacies. “The data are clear, specialty pharmacies lower patient costs by preventing hospitals and physicians from charging patients, families, and employers excessively high prices to buy and store specialty medicines themselves,” said Matt Eyles, president, and CEO of AHIP, in a statement. Simplifying Medical Benefit Drug Management Complexities. For the first time ever, specialty medications make up 50% or more of plan sponsors’ total drug spend, despite accounting for only 4% of total pharmacy prescriptions. And within the specialty space, about 40% of drugs are billed through the medical benefit. The current specialty pipeline is full of medications that will be billed under the medical benefit or, in some cases, both medical and pharmacy benefits. Of these drugs,…

Simplifying medical benefit drug management complexities and other notes from around the interweb: How specialty drug ‘solution stacking’ can rein in pharmacy benefit costs. Brokers and employer groups alike know that 5% to 10% percent of insured workers and their dependents drive 50% to 60% of the cost of pharmacy claims. A few members with prescriptions for a specialty drug with a five-figure price tag can easily represent the majority of an entire group’s pharmacy spend. These drugs are often lifesaving or provide a dramatic quality of life improvement for those who take them. No one would question the necessity of using them. But when a group can mitigate some of the cost without affecting the clinical outcome, it can be a game changer. The broker who unlocks these savings becomes a trusted ally. PBMs are Creating GPOs and Stirring Debate as to Why. In 2019, Express Scripts PBM (pharmacy benefit manager) formed Ascent Health Services GPO (group purchasing organization), based in Switzerland. In 2020, CVS Caremark formed Zinc GPO. And in 2021, OptumRx formed Emisar Pharma Services, based in Ireland. With pharmacy benefits for approximately 75% of U.S.-covered lives under their control, why would these PBMs need GPOs — to capitalize on their scale to get better drug prices? “In each case, there’s what the PBM said, and then you have to do your best to fill in the blanks of what could possibly be going on,” says Howard Deutsch, principal at ZS Associates, a global professional services firm with offices in Boston. “They haven’t said a heck of a lot. They’ll say things about serving customer needs, but nowhere will you find some particular customer need that is better served by the existence of this new entity.” Click To Learn More AHIP study claims hospitals charge double for specialty drugs compared to pharmacies. Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry. The study (PDF), released Wednesday by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products. The study was released a day before a scheduled meeting Thursday of the Federal Trade Commission on whether to probe the competitive impact of PBM contracts and how they could disadvantage independent and specialty pharmacies. “The data are clear, specialty pharmacies lower patient costs by preventing hospitals and physicians from charging patients, families, and employers excessively high prices to buy and store specialty medicines themselves,” said Matt Eyles, president, and CEO of AHIP, in a statement. Simplifying Medical Benefit Drug Management Complexities. For the first time ever, specialty medications make up 50% or more of plan sponsors’ total drug spend, despite accounting for only 4% of total pharmacy prescriptions. And within the specialty space, about 40% of drugs are billed through the medical benefit. The current specialty pipeline is full of medications that…

PBM selection decisions often boil down to price. It’s a common mistake as the actual cost of PBM services encompasses more than just price. There are four primary drivers of pharmacy cost price being the most obvious. Equally important drivers of pharmacy cost include product mix, utilization, and cost share. Let’s take an in-depth look at 5 things to do immediately about drivers of pharmacy costs. Price Contract nomenclature sets the foundation for prices in a pharmacy benefit management agreement. Without the constituent elements being spelled out, a fiduciary standard of care or radical transparency, pricing proposals are almost worthless. The price an employer pays for a prescription drug claim includes several components such as list prices, contractual discounts, acquisition costs, administrative fees, and rebates, for example. Price receives a lot of attention deservedly so. However, far too little attention is being paid to what matters most, which is the final plan cost. A substantial chunk of what an employer pays for its pharmacy benefit is attributed to how well the PBM performs clinically. Clinical effectiveness can easily be the difference between underperformance or overperformance in a pharmacy benefit program. Product Mix Product Mix refers to the complete range of products that is offered for dispensation by a pharmacy. In other words, small molecule brand and generic, specialty including biologic and biosimilar drugs make up product mix. The formulary, and adherence to it, is the key determinant of product mix. Everyone knows that generic drugs are far less costly compared to brand drugs. But, did you know that for every 1% increase in GDR or generic dispense rate an employer can expect as much as a 2.5% decrease in gross ingredient costs[i]? A non-fiduciary PBM is counting on its clients not knowing or caring about how GDR impacts cost and that you will be mesmerized by the optics of large rebates or discount guarantees. GDRs, which hover in the 80% - 86% range, are too low and costly. The non-fiduciary PBM benefits from its share of rebates on brand drugs that never should have been dispensed in the first place. Without exception the most heavily advertised and rebated drugs have therapeutic alternatives which cost up to 90% less than the rebated products. Not only is the non-fiduciary PBM counting on you being mesmerized by artificially high discounts and rebates, but it is also counting on you not placing a dollar value on poor product mix. A pharmacy benefit manager’s (or PBM) essential job ought to be uncomplicated: act in the best interest of patients and clients while delivering lowest net cost. Instead, non-fiduciary PBMs are leveraging information failure to their financial advantage[ii]. Click Here Now To Learn More Utilization Contrary to mainstream opinion, utilization has little to do with the number of prescription drug claims being paid. Drug manufacturers concern themselves more with days’ supply and from which sites drugs are being dispensed. Hence, drug utilization consists of the number of utilizers, days’ supply, and channel mix (i.e. retail vs.…

How specialty drug ‘solution stacking’ can rein in pharmacy benefit costs and other notes from around the interweb: How specialty drug ‘solution stacking’ can rein in pharmacy benefit costs. Brokers and employer groups alike know that 5% to 10% percent of insured workers and their dependents drive 50% to 60% of the cost of pharmacy claims. A few members with prescriptions for a specialty drug with a five-figure price tag can easily represent the majority of an entire group’s pharmacy spend. These drugs are often lifesaving or provide a dramatic quality of life improvement for those who take them. No one would question the necessity of using them. But when a group can mitigate some of the cost without affecting the clinical outcome, it can be a game changer. The broker who unlocks these savings becomes a trusted ally. PBMs are Creating GPOs and Stirring Debate as to Why. In 2019, Express Scripts PBM (pharmacy benefit manager) formed Ascent Health Services GPO (group purchasing organization), based in Switzerland. In 2020, CVS Caremark formed Zinc GPO. And in 2021, OptumRx formed Emisar Pharma Services, based in Ireland. With pharmacy benefits for approximately 75% of U.S.-covered lives under their control, why would these PBMs need GPOs — to capitalize on their scale to get better drug prices? “In each case, there’s what the PBM said, and then you have to do your best to fill in the blanks of what could possibly be going on,” says Howard Deutsch, principal at ZS Associates, a global professional services firm with offices in Boston. “They haven’t said a heck of a lot. They’ll say things about serving customer needs, but nowhere will you find some particular customer need that is better being served by the existence of this new entity.” Click To Learn More AHIP study claims hospitals charge double for specialty drugs compared to pharmacies. Hospitals on average charge double the price for the same drugs compared to those offered by specialty pharmacies, according to a new insurer-funded study released as federal regulators ponder a probe into the pharmacy benefit management industry. The study (PDF), released Wednesday by insurance lobbying group AHIP, comes as specialty pharmacies have grown in use among PBMs and payers to dispense specialty products. The study was released a day before a scheduled meeting Thursday of the Federal Trade Commission on whether to probe the competitive impact of PBM contracts and how they could disadvantage independent and specialty pharmacies. “The data are clear, specialty pharmacies lower patient costs by preventing hospitals and physicians from charging patients, families, and employers excessively high prices to buy and store specialty medicines themselves,” said Matt Eyles, president, and CEO of AHIP, in a statement. FTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector. On June 7, 2022, the Federal Trade Commission (FTC) unanimously voted to initiate a study into how business practices employed by some pharmacy benefit managers (PBMs) may impact prescription drug pricing and patient access to drugs. In the pharmaceutical…

A pharmacy benefit manager’s (or PBM) essential job ought to be uncomplicated: act in the best interest of patients and clients while delivering lowest net cost. Instead, non-fiduciary PBMs are leveraging information failure to their financial advantage. Information failure or Asymmetric Information is a type of market failure where individuals or firms have a lack of information about economic decisions[i]. Learn More The Pharmacy Benefit Manager Transparency Act of 2022 was introduced by Senate Commerce Science, and Transportation Committee and Senate Judiciary Committee to shine a light on the Pharmacy Benefit Manager market and empower the Federal Trade Commission (FTC) and state attorneys general to stop unfair and deceptive PBM business practices. I propose three reasons why the PBM Transparency Act won’t reduce drug Costs. Non-Fiduciary PBMs are Protecting Rebate Spreads by Creating Group Purchasing Organizations (“GPOs”). For example, a report[ii] by Nephron research says, “contracting entities are shifting discounts from the rebate profit pool 99% of which flows to clients to fee pools that may be retained by the PBM. In other words, non-fiduciary PBMs have shifted their management fee to GMFs or group purchasing organization management fees. They’ve also shielded themselves from spread pricing revenue loss by powering discount cards.Non-Fiduciary PBMs are Protecting Ingredient Cost Spreads by Sharing Pharmacy Network Access. One initiative, called Inside Rx, offers discounts on brand name drugs to a select group of consumers typically those under age 65, aren’t on government insurance programs such as Medicaid or Medicare, or are under or uninsured. Through a collaboration that comprises drug companies, Express Script’s pharmacy network, and tech partner GoodRx, the program is designed to make drugs affordable for patients with high-deductible insurance plans, or no insurance at all. The truth is that it is a huge revenue source and in some cases the margins are larger than core PBM services.Non-Fiduciary PBMs are Protecting Overall Gross Margins Leveraging 100% Markups on Medical Benefit Drug Claims. It’s no secret prescription drugs cost more under the medical benefit then they do under the pharmacy benefit. In the turf war between hospitals and health insurers over physician practices, hospitals are winning by a long shot. But they'd be ill advised to get too comfortable. A slew of recent activity shows that insurers are clawing their way back, whether by outright purchases of medical practices or targeting outpatient facilities that employ doctors. UnitedHealth Group has long led the charge to buy medical practices, absorbing several a year into its OptumCare subsidiary. National insurer Humana and, most recently, Anthem have also gotten into the game. Each of these two national insurers also maintains ownership in a pharmacy benefit manager. Conclusion - Three Reasons Why the PBM Transparency Act Won’t Reduce Drug Costs John F. Kennedy said, “The greater our knowledge increases the more our ignorance unfolds.” Most self-insured employers, and their advisers, don’t know what they don’t know. Pharmacy Benefit Managers provide transparency and disclosure to a level demanded by the competitive market and generally rely on the demands of…

Florida Takes Additional Actions to Lower Prescription Drug Prices and other notes from around the interweb: Florida Takes Additional Actions to Lower Prescription Drug Prices for Floridians. The Executive Order directs all executive agencies to include provisions in all future contracts and solicitations with these PBMs, services that include the following: prohibit spread pricing for all PBMs; prohibit reimbursement clawbacks for all PBMs; directs agencies to include data transparency and reporting requirements, including a review of all rebates, payments, and relationships between pharmacies, insurers, and manufacturers; and directs all impacted agencies to amend all contracts to the extent feasible with these same provisions. A copy of Executive Order 22-164 can be found HERE. 300 drugs now in generic 'cartel' probe. What started as an antitrust lawsuit brought by states over just two drugs in 2016 have exploded into an investigation of alleged price-fixing involving at least sixteen companies and three hundred drugs, Joseph Nielsen, an assistant attorney general and antitrust investigator in Connecticut who has been a leading force in the probe, said. His comments represent the first public disclosure of the dramatically expanded scale of the investigation. The unfolding case is rattling an industry that is portrayed in Washington as the white knight of American health care. “This is most likely the largest cartel in the history of the United States,” Nielsen said. He cited the volume of drugs in the schemes, that they took place on American soil and the “total number of companies involved, and individuals.” The lawsuit and related cases picked up steam last month when a federal judge ruled that more than one million emails, cellphone texts and other documents cited as evidence could be shared among all plaintiffs. Click To Learn More The drug rebate curtain. Lawyers for PBMs carefully define what a "rebate" means. For example, according to one template, "inflation payments" are not considered rebates. PBMs receive inflation payments from drug companies to cover year-over-year hikes to a drug’s list price. If employers don't ask about inflation payments, PBMs keep them by default. The state of Delaware, however, modified its contract in 2015 to ensure those inflation payments are routed back to Delaware’s state employees, according to a copy of the contract that is publicly available. Formulary Steering Prevents Members from Accessing Generics. A suit, first obtained by Stat, was filed by Alexandra Miller, who worked at CVS for nearly two decades before leaving the company three years ago. Miller says that when she reported the behavior to a superior, she was told that the company had decided the benefits of the alleged scheme outweighed the likelihood of being caught. Miller claims that CVS' SilverScripts Part D subsidiary as well as its Caremark pharmacy benefit manager and retail pharmacies worked together to prevent access to generics, which allowed it to pocket higher rebates because members were pushed to buy branded medications rather than lower-cost options.