A Personalized Approach to High-MED Opioid Management
April 19, 2022
Successful opioid management includes a tailored strategy that takes into account: Each injured worker’s current medication regimen The patient’s medical history and unique circumstances Evidence-based treatment guidelines The personalized approach to managing a high-MED population helped Mitchell Pharmacy Solutions clients collectively reduce average daily MED levels by more than 15% over the two years reviewed. This two-pronged program included setting customized MED levels per patient and adding greater controls for higher risk patients. 1. Prospective Utilization Review: Trigger of thorough clinical review if custom MED levels were surpassed 2. Retrospective Utilization Review: Comprehensive review of high risk patients and development of clinical plan, often including prescriber intervention Download the full case study to learn how to implement these strategies in your own pharmacy program. Download
The Long, Winding Road of Drug Pricing
April 11, 2022
One of the most persistent and complex challenges facing workers’ compensation claims administrators and insurers is managing prescription drug costs. The problems around prescription drugs are pervasive throughout the health care industry, have been around for over a century, and cover a wide range of issues including accessibility, efficacy and cost. For workers’ compensation payors, cost has been the most challenging issue. Annual price increases for half the drugs covered by Medicare outpaced inflation in 2019 and 2020. In 2021, ASH Clinical news reported that the median wholesale price for 645 brand name drugs increased 4.8%, just slightly above the reported average inflation rate for 2021. According to a Kaiser Health Network Morning Briefing, more than 450 drugs saw price increases of 5% or more at the beginning 2022. In 2020, the Kaiser Family Foundation reported that drug price increases outpaced inflation for half of the drugs covered by Medicare. JAMA, the Journal of the American Medical Association, published a study documenting brand name drug price increases over a ten-year period. The study noted, “Using 2007-2018 net pricing data on branded pharmaceutical products in the US, list prices increased by 159% and net prices increased by 60%”. Those increases amount to three and one-half times the annual inflation for the same period. Generic drugs are not immune to their own unique pricing challenges. While not impacted by inflation as heavily and broadly, market competition in the generic space that would tend to reduce costs over time has been inhibited by alleged anti-competitive behavior among generic manufacturers. Led by the Attorney General in Connecticut, 46 states, the District of Columbia and three U.S. territories, filed suit in June of 2020 against 26 generic manufacturers alleging a wide-spread and coordinated effort to interfere with competition and drive up the cost of generic drugs. As quoted in the referenced article, “Through phone calls, text messages, emails, corporate conventions, and cozy dinner parties, generic pharmaceutical executives were in constant communication, colluding to fix prices and restrain competition.” Further, Connecticut Attorney General William Tong said, “They took steps to evade accountability.” This is not a new problem in the prescription drug world. One of the first cases of drug price fixing was alleged in 1941. Twenty years after the discovery of insulin, three companies, Eli Lilly & Company, Sharpe & Dohme, and E. R. Squibb were indicted on charges of violating an anti-trust law by “unlawfully combin[ing] and conspir[ing] to bring about arbitrary, uniform and non-competitive prices for insulin and to prevent free and normal competition in its sale throughout the United States.” The researchers who developed the first insulin were more interested in helping humankind than profiteering. In 1923, three of the researchers who discovered insulin assigned their U.S. patents for the insulin formula to the University of Toronto for $1.00 each (equates to about $16 today). Yet, insulin prices remain problematic. Today, most state legislatures across the country have filed bills to reduce the out-of-pocket cost for health care consumers who use insulin. Prices have remained so persistently and inexplicably high that non-profit drug manufacturers are hoping to spur competition within the insulin market. CivicaRx, a newly formed, non-profit drug manufacturer based in Utah, publicly announced in early March of this year, that they have begun the process to begin manufacturing insulin that they hope to bring to market in 2024 with a list price up to 80% less than current insulin products currently being sold. Another area of concern, not limited to the workers’ compensation market but more persistent as a percentage of claims, is high-cost topical creams and topical compounds. Upon review of our internal Mitchell Pharmacy Solutions data, payors in the workers’ compensation system frequently see topical and compounded creams that are not FDA-approved but are billed at amounts that often exceed $2,000 for a 30-day supply. Based on recent reported action by the US Department of Justice, it appears they are working to eradicate and prosecute purveyors of these creams in the federal workers’ compensation and health care systems. On July 31, 2020, the US Department of Justice (USDOJ) Eastern District of Tennessee announced the sentencing of five individuals convicted of multiple counts of fraud in a compound cream scheme that cost the U.S. Tricare system, private insurers and self-insured employers more than 30 million dollars. In July of 2021, the USDOJ Western District of Arkansas, announced a Louisiana doctor pleaded guilty to workers’ compensation fraud for a topical patch and compounded pain cream scheme that netted over 1 million dollars. Additionally, the USDOJ Southern District of Texas released a statement on June 17, 2021, announcing the indictment of seven individuals in a compounding drug scheme. The indictment claims the defendants defrauded federal government programs of over 110 million dollars. States are starting to take action against these abusive practices. The Arkansas Board of Pharmacy revoked the license of a pharmacy involved in a topical pain cream fraud. Other states workers’ compensation programs have or are enacting strict fee schedules on topical creams and patches, including compounded creams. Colorado was the first to enact a specific fee schedule for topicals. South Carolina will become the latest with the adopting of its new fee schedule effective April 1, 2022. Over the last several years there has been a lot of legislative activity around drug price transparency and rebates. The efforts are primarily directed at Pharmacy Benefit Manager (PBM) services within the commercial and government health care markets, but in some states, workers’ compensation PBMs are also subject to the regulation. Unfortunately, most state laws only target the PBMs and wholesalers but fail to require accountability from manufacturers and dispensers. Price transparency could be a useful tool if the entire supply chain was subject to the same transparency rules, but most of the laws are only getting half the picture. Rebate reporting is generally a part of these transparency reports. Rebates are offered by manufacturers to health plans to encourage the plan to include a particular brand drug on their formulary. The rebate practice, in theory, should reduce costs when brand manufacturers with drugs that treat the same condition will offer discounts to get on a formulary. However, workers’ compensation programs mandate the use of generic medications and if there is a formulary, the formulary is chosen by the state and not by the payor. In non-formulary states, the workers’ compensation PBM develops a formulary based on treatment guidelines, medical necessity, and lower-cost generic medications as mandated. In the instances where a doctor prescribes a medically necessary brand name medication, a workers’ compensation PBM may receive a rebate, but the rebate is driven by the actions and decisions of a physician and not anything controlled by the workers’ compensation PBM. There is also some legitimate question as to whether or not rebates are increasing drug costs. A recent study by Matrix Global Advisors, as reported by the Coalition for Affordable Drugs, found the price increases from 2018 to 2021 for rebated drugs and non-rebated drugs were similar. The study concluded, “The market-based strategies most likely to constrain prices are robust competition among drug manufacturers and insurance-design mechanisms that incentivize cost-effective treatments.” This is an important point to consider. In a state where an injured worker has the choice of pharmacy provider, there are no market forces at play since the injured worker has no financial stake in the cost of the care and no incentive to shop around for the most affordable option. In fact, the inverse is true. The injured worker’s right to choose may ultimately increase costs. In the workers’ compensation pharmacy world, robust competition does exist among the various PBMs providing pharmacy benefit services for injured workers and decreasing costs for payors. That competition works best when states allow employers to direct the pharmacy care to contracted pharmacies. Most workers’ compensation pharmacy networks include 90% or more of the local pharmacies in a given state. Injured workers benefit from convenient access to care while the payors and the workers’ compensation system enjoy fiercely competitive pricing on drugs. Additionally, network pharmacies can help guide adherence to generic mandates, drug formularies and treatment guidelines at the point of dispensing. The pharmacy networks can also control areas of potential fraud and abuse around compounded creams and topicals. The PBM can screen medications for efficacy, medical necessity and can contract for reasonable, market-based pricing. While there has been some political reticence to embrace direction of pharmacy care for injured workers, the benefits of managed care and the resultant improvement in care and control of costs, fraud and abuse, may outweigh the potential inconvenience of an injured worker having 10% or less fewer pharmacies to choose from. It has been a long and winding road that got us to where we are today in pharmacy care for injured workers, but a systemic, managed and directed approach to providing pharmacy care to injured workers may increase market competition, increase adherence to state formularies and treatment guidelines, has the potential to reduce fraud and abuse and improve overall outcomes for injured workers by increasing the efficacy of the pharmacy care they receive.
South Carolina Approves Fee Schedule Changes
April 5, 2022
The South Carolina Workers’ Compensation Commission approved changes to the Medical Services Provider Manual, effective April 1, 2022. The changes adopted include differences in the proposed rules for pharmacy released by the Commission in December 2021. One of the biggest changes from the proposed rule to the adopted language involved prescription topical medications. The new reimbursement rule for non-compound prescription topical medications is $240 for a 30-day supply, pro-rated based on the number of day supply dispensed, not to exceed 90 days, plus a single dispensing fee of $5. Additionally, physicians are urged to prescribe therapeutically equivalent medications or over the counter (OTC), when available, in lieu of a prescription-strength topical medication. The reimbursement proposed for topical compound medications was consistent with the adopted language by the Commission. Reimbursement is a $5 dispensing fee plus the lesser of Average Wholesale Price (AWP) for each ingredient’s original National Drug Code (NDC), or $240 for a 30-day supply, pro-rated based on the number of days dispensed, not to exceed 90 days. Prior authorization is required for compound drugs for each dispensing. Automatic refilling is not allowed, and refills may require documentation of effectiveness and functional improvement. And similar to the rules for prescription topical medications, the Commission urges physicians to prescribe therapeutically equivalent medications or OTC when available in lieu of a prescription-strength topical medication. Other pharmacy-related changes that are effective April 1, 2022 include reimbursement limitations for non-prescription strength patches. Non-prescription strength patches shall be reimbursed as the lesser of actual cost + 20% or $70 for a 30-day supply, pro-rated based on the number of days dispensed. For a complete summary of the changes and links to the full fee schedule, please visit. If you have any additional questions about this information, please contact your client services manager.
Business Insurance: “Drug Formularies Not a Top Legislative Priority this Year”
April 4, 2022
Symbicort Generic Approval on March 15, 2022
March 29, 2022
Recently the U.S. Food and Drug Administration (FDA) approved a generic formulation of Symbicort (budesonide and formoterol fumarate dihydrate) metered-dose inhaler for the treatment of asthma or chronic obstructive pulmonary disease (COPD). This is the first-time a generic combination agent of Symbicort has been approved. The meter-dosed inhaler is available now in both strengths as the original brand name product, 160mcg/4.5 mcg and 80mcg/4.5mcg. The medication contains budesonide (an inhaled steroid to decrease inflammation) and formoterol (a long-acting beta-agonist that helps to open the airways by relaxing muscles). The inhaler is dosed the same for both COPD and asthma, two inhalations twice daily. The most common side effects are nose or throat irritation, increased risk of infection, stomach upset, and back pain.1 Patients should be aware that the medication should not be used as a rescue inhaler, they should rinse their mouth after use to decrease risk of thrush, and it may increase blood sugar levels. For full prescribing information please refer to the package insert for Symbicort. According to the National Heart, Lung, and Blood Institute asthma affects more than 25 million Americans whereas COPD accounts for 16 million. Work-related lung diseases, including asthma, can result from a worker being exposed to harmful substances such as chemicals, fumes, or dust in the work environment. The Impact Symbicort inhalers represent a small number of active prescriptions for Mitchell Pharmacy Solution clients, but this new generic approval currently shows around a 10% savings compared to the brand Average Wholesale Price (AWP) via Medispan.2 For more information on the place in treatment or future impacts assessments, pricing information, or recommendations, please contact your Account Manager or Account Pharmacist. References: 1. Symbicort (budesonide/formoterol) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2019. 2. Medi-Span®. Indianapolis (IN): Medi-Span®. Master Drug Data Base v2.5 (MDDB®); [cited 2022 MAR 20].Available from: http://www.medispan.com/master-drug-database.aspx
The Rise of Fentanyl in the Midst of an Already Troubling Opioid Epidemic
March 24, 2022
Each day we hear more and more stories of addiction, overdose, and deaths with heartbreaking stories of the individuals and the families who have been impacted by the opioid epidemic. In an attempt to address this crisis, more aggressive clinical intervention and opioid management programs are being adopted, and opioid use has steadily decreased for workers’ compensation patients; however, according to an NSC survey, 75% of employers are being directly impacted by employee opioid misuse. In another study of workers’ compensation claimants who were initially treated with an opioid prescription, approximately 30% continued to fill opioid prescriptions beyond 90 days from injury, and unfortunately, overdose deaths attributed to synthetic opioids and heroin are increasing and are more than making up for reductions in prescription opioid deaths. Due to its addictive properties, approaches that include opioid prescriptions can be followed by physical dependency, addiction, personal struggles, job losses, financial ruin, the need for substance use disorder treatment, and in some cases death by overdose or suicide. Complex sequences of events have propelled the overdose crisis forward including the dramatic rise in the supply of opioids coupled with inadequate access to treatment programs to address their use. During the COVID-19 pandemic, these already concerning circumstances seemingly pushed even more people to turn to drugs at a time when treatment facilities and other services were shutting down. As it stands today, drug overdose deaths in the U.S. have topped 100,000 annually, and deaths from synthetic opioids (primarily fentanyl) and psychostimulants such as methamphetamines are on the rise. Experts sum all this up this way: “If it’s easier to get high than to get treatment, people who are addicted will get high. The U.S. has effectively made it easy to get high and hard to get help.” As synthetic opioids began to appear more and more in the illegal drug supply, increasingly so did fentanyl, which was diverted for abuse due to its powerful potency and euphoric properties, added to heroin to increase its effects, or disguised as more intoxicating heroin. Sadly, often drug users believe they are purchasing heroin or other substances of abuse such as cocaine and actually don’t know that they are purchasing fentanyl or products laced with fentanyl. To address misconceptions, it’s critical that we understand the connection between fentanyl’s appropriate uses and the devastating effects it can have when no guards are in place to prevent abuse. Fentanyl is a powerful synthetic opioid and a comparatively recent addition to the list of all opioid medications used in clinical practice. First created by physician researcher Paul Janssen in 1960 and introduced in medicine as a general anesthetic in 1968, it continues to occupy a critical role in the treatment of a set of clearly-specified uses. It differs from other opioids (morphine, hydrocodone, oxycodone) in its high affinity for mu receptors, where it is 50 to 100 times more potent than morphine, contributing both to a benefit in effectiveness for treating severe pain and caution regarding its overdose potential. In medical practice, fentanyl is often used in hospitals, intravenously, to enhance anesthesia, and for pain management in obstetric and surgical settings. In the COVID-19 era, fentanyl is used in endotracheal intubation procedures that support emergency ventilation in the sickest patients. In outpatient settings, a variety of dosage forms (transdermal patch, buccal films, lozenge, lollipop) are available by prescription for use in opioid-tolerant* patients for severe chronic pain, cancer pain, and breakthrough pain episodes, which are often short-lived but severe in intensity. Fentanyl also plays an important treatment role in comfort care for terminally ill patients and in battlefield settings for pain from acute trauma and wounds. The synthetic analogues of fentanyl (acetylfentanyl, carfentanil, etc.), with even greater potency, are the subject of significant recent concern for illicit use and a growing contribution to drug overdoses. The illicit manufacture of fentanyl and fentanyl analogues incorporated into other substances of abuse are driving an overdose death trend in recent times for synthetic opioids other than methadone. These overdoses now eclipse those related to heroin or prescription opioids. The Centers for Disease Control and Prevention (CDC) reported that over half of all opioid overdose deaths involved synthetic opioids other than methadone, with illicit versions of fentanyl being the most common. The U.S. Drug Enforcement Administration (DEA) has issued a temporary order placing fentanyl-related substances (excluding fentanyl itself) in Schedule 1 of the Controlled Substances Act. A number of concerned clinician authors have recently called for a naming distinction between fentanyl used in medical settings for critical applications and fentalogues used in illicit channels that are responsible for a growing number of overdose deaths. They note that “linchpins of the opioid epidemic, such as overdose, misuse, and abuse occur largely outside of their use as legitimate pain treatments,” citing the rate of opioid use disorder among chronic pain patients as roughly 2 – 8%. While recognizing that a naming difference is largely symbolic, they also feel it’s important to establish a distinction in the mind of the public, government officials, and the media between a medicine of clinical importance and the illicit forms of fentanyl that are driving a nation-wide epidemic of overdose deaths. Despite continuous visibility in the media and public education campaigns conveying the dangers of fentanyl, access and exposure don’t seem to be waning as fentanyl continues to enter the U.S. in large part illegally from Mexico. With the U.S. claiming an overdose death every five minutes, the DEA has declared there are direct links between fentanyl-related overdose deaths and criminal drug networks. To help illustrate the severity of this problem, over a two-month period the Phoenix Arizona DEA Field Division launched a public safety surge targeting criminal drug networks utilizing social media apps to distribute deadly drugs. During this time over three million fentanyl pills and 45 kilograms of fentanyl powder were seized. Obviously, more must be done to address the deadly cycle of drug misuse, abuse, and overdoses and the synthetic opioids made available through illegal drug supplies. *The clinical literature generally defines patients who are considered opioid-tolerant as those who are taking at least 60 mg of oral morphine per day (or its equivalent dose with a different opioid) around-the-clock for one week or longer.
Ask the Pharmacist
February 14, 2022
Are there times when it’s better to dispense a brand drug instead of its generic equivalent? Before answering that it would be good to briefly review some basic information regarding the differences between brand name and generic medications. The Food and Drug Administration (FDA) is responsible for the approval of drugs in the U.S. In the case of a new drug, the process usually begins with “Discovery”. The drug will then typically proceed into a “Preclinical Research” phase where animal testing is applied. The drug manufacturer can then apply for an “Investigational New Drug” (IND) application. If approved, the IND would allow the drug manufacturer to proceed to “Clinical Studies”. All the while, the drug manufacturer is gathering data about safety (side effects, tolerance in specific patient populations, etc.) and efficacy. Once the manufacturer has enough information, a “New Drug Application” (NDA) will be filed, and if the drug is approved, it can be produced and made available for use in the U.S. When a new drug is produced the drug manufacturers typically give it a brand name, and the FDA grants a period of exclusivity during which time the drug maker has exclusive marketing rights to that drug. Once exclusivity expires for a particular drug, generic manufacturers may begin making their versions of the brand name drug. The generic manufacturer submits an “Abbreviated New Drug Application” (ANDA), which in essence allows them to request approval of the drug without having to include the Preclinical and Clinical Study data that the original manufacturer must supply. Instead, the generic manufacturer must prove to the FDA that the generic drug is comparable to the brand name drug in quality, purity, strength, dosage form, route of administration, efficacy, and intended use (aka, bioequivalent). That being said, the generic form will always have some differences as they cannot be exact copies of the brand, but these differences are not considered medically important in a bioequivalent drug. This abbreviated approval process allows the generic manufacturer to provide the drug at a significantly lower cost than the brand name counterpart. To address brand usage, Pharmacy Benefit Managers (PBMs) require medications be dispensed at the pharmacy as generics where possible and when substitution is not restricted by the prescriber or market conditions. To address missed generic opportunities, outreach programs and detailed reporting can also notify the claims examiner if a brand drug with a generic available was dispensed. While 9 out of 10 prescriptions in the U.S. are filled as a generic drug, there can be reasons a pharmacist or doctor chooses to dispense a brand over its generic equivalent, ranging from clinical to financial. The most common clinical scenario for use of brands over generics is for a group of drugs called “Narrow Therapeutic Index” drugs. The medications in this classification include anticonvulsants, which are used for treatment of seizure disorder but not pain, and blood thinners like Coumadin®. These medications are monitored via blood tests where a small change in blood concentration can affect the management of the disease. For example, if a patient is stable on a 5mg dose of Coumadin, switching to a generic warfarin may cause a small fluctuation in blood concentration and result in lower effectiveness and an increase in clotting. Another possible scenario where a brand might be substituted for a generic, although rare, is in the instance of a drug shortage. For example, if there are limited generics available of a specific drug or there is a recall or interruption in the supply chain, the pharmacist may choose to substitute the brand in order to fill the prescription with an available medication. An even less common scenario could involve a patient being allergic to an inactive ingredient in the generic product, as the generic may contain different ingredients including additives, coloring, etc. To find out more about brand and generic medications, visit the Food and Drug Administration (FDA) Generic Drug Facts website.