Drug Pricing

Researchers Find Overspending in Generic Drug Market, Advocate for More Transparency

Researchers from the USC Leonard D. Schaeffer Center for Health Policy & Economics are pushing for more transparency in the pharmaceutical supply chain and policy changes in the generic drug sector. Their recommendations, published in a white paper on May 31, were based on their findings that PBMs and health insurers cost patients, employers and the federal government billions of dollars per year in the generic drug market.

Karen Van Nuys, Ph.D., one of the paper’s authors and executive director of the Center’s Value of Life Sciences Innovation Project, tells AIS Health, a division of MMIT, that she recommends changes in the way pharmacies set their cash prices as well as in some formularies that favor branded drugs over generics and so-called spread pricing, where PBMs reimburse pharmacies one price, charge health plans a higher price and pocket the difference.

Plans Are Likely to Treat Paxlovid Like Other Drugs if U.S. Isn’t Paying

With COVID-19 infections surging once again, the Biden administration has stepped up efforts to increase the supply of Paxlovid, the Pfizer Inc. antiviral that garnered emergency use authorization as a therapeutic treatment for the coronavirus. However, increased availability for Paxlovid might end in coming months — Congress has stalled on providing the increased COVID-19 response funding that the administration requested, and experts say health plans are likely to treat the drug like any other if the federal government isn’t picking up the tab for treatments.

The Biden administration has pushed in recent weeks to increase the availability of Paxlovid, free of charge, to COVID-19 patients. On May 26, the White House released a statement touting the rollout of more than 2,500 “test-to-treat” sites where free testing and Paxlovid courses are available, along with 40,000 locations where antivirals are available for patients. The administration also noted that it had “increased the number of people benefiting from oral antivirals in the last seven weeks, from about 27,000 prescriptions filled each week to more than 182,000 last week.”

FTC to Investigate PBM Business Practices, Consolidation

The Federal Trade Commission (FTC) said on June 7 that it will investigate the business practices and consolidation of PBMs, following months of pressure from health care stakeholders.

The FTC’s investigation, which is just the latest escalation in a nationwide regulatory push to clamp down on PBMs’ most controversial methods, was praised by plan sponsors and pharmaceutical groups.

The FTC’s leadership, a panel of five commissioners, voted unanimously to launch the investigation under section 6(b) of the Federal Trade Commission Act of 1914. The commissioners are a mix of two Democrats and two Republicans, with the fifth seat filled by the party that holds the White House.

News Briefs: Inflation Hasn’t Yet Affected Health Care Prices

Inflation has not yet impacted health care prices, according to new research from the Kaiser Family Foundation (KFF). The KFF study reports that in the 12 months ending in April 2022, “overall prices grew by 8.3% from the previous year, while prices for medical care increased by only 3.2%.” The authors added, “This is unusual, as health prices historically outpace prices in the rest of the economy. However, the relatively high rate of inflation seen in the rest of the economy may eventually translate to higher prices for medical care. This may lead to steeper premium increases in the coming years.” Generally speaking, according to the report, prices have grown faster for commercial insurance than public payers, a trend that held up in 2022. Though inflation is greater than it has been for a generation, its impact is likely delayed in health care because of contracting cycles. “Health prices are generally set in advance, administratively or via private insurance contracting, so there may be a delay in observable price increases,” the authors observe.

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FDA’s Rinvoq Approval Brings New Ulcerative Colitis Option

The FDA recently gave an additional indication to AbbVie Inc.’s Rinvoq (upadacitinib) in ulcerative colitis, broadening that therapeutic class even more. And while a study revealed some concerns around another agent with a similar mechanism of action, payers and gastroenterologists last year expressed interest in Rinvoq over other late-stage pipeline agents.

On March 16, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) blocker. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. The recommended starting dose for the tablet is 45 mg once daily for eight weeks, followed by a maintenance dose of 15 mg once daily. The wholesale acquisition cost for a 30-day supply is $5,671.26.

FTC to Investigate PBM Business Practices, Consolidation

The Federal Trade Commission (FTC) said on Tuesday that it will investigate the business practices and consolidation of PBMs, following months of pressure from health care stakeholders. The FTC’s investigation, which is just the latest escalation in a nationwide regulatory push to clamp down on PBMs’ most controversial methods, was praised by plan sponsors and pharmaceutical groups.

The FTC’s leadership, a panel of five commissioners, voted unanimously to launch the investigation under section 6(b) of the Federal Trade Commission Act of 1914. The commissioners are a mix of two Democrats and two Republicans, with the fifth seat filled by the party that holds the White House. The unanimous vote is a reversal for the two Republican panelists appointed by former President Donald Trump. The Republican commissioners voted against a similar inquiry in February, deadlocking with the two Democratic commissioners — the swing seat on the panel was unfilled at the time. That fifth commissioner, Democrat Alvaro Martin Bedoya, was confirmed by the Senate in May on a party-line vote.

Payers Worry About High Costs, Low Evidence for Gene Therapies

So far, the FDA has approved eight cell and gene therapies, but the agency is expected to approve several more medications in those classes in the next few years. That has caused concern for payers because such medications have high costs and limited clinical evidence, according to speakers who participated in an Avalere Health webinar on May 25.

As such, the federal government, PBMs, health insurers and other payers are testing innovative ways to reimburse hospitals, providers and pharmaceutical companies for administering cell and gene therapies.

News Briefs: Launch Prices Grew Dramatically in Recent Years

Between 2008 and 2021, drug launch prices increased by 20% per year, according to new research published in JAMA. In 2020 and 2021, prices rose 11% each year, even after adjusting for manufacturer discounts. In addition, nearly half of all drugs launched in the last two years initially cost at least $150,000 per year. “Rising brand-name drug prices often translate to payers restricting access, raising premiums, or imposing unaffordable out-of-pocket costs for patients,” the study’s authors observed.

An opinion article published in the New England Journal of Medicine argued that the 340B drug program creates “perverse incentives” for preexposure prophylaxis (PrEP) medications that prevent HIV infection by encouraging safety-net clinics to prescribe the most expensive PrEP treatments. The article observes that “insurers reimburse 340B clinics for medications at an amount close to their list price; the difference between the list price and the discounted 340B price results in revenue — known as the ‘340B spread’ — that clinics can allocate toward other health services. The higher the drug’s price, the bigger the spread….The high cost of PrEP medications has made 340B central to the ability of some safety-net clinics…to provide HIV-prevention and other services....Brand-name oral medications for PrEP, Descovy and Truvada… produc[e] a spread of as much as $1,600 per patient per month. That revenue can fund...important services provided by 340B clinics.” That results in “costs to the health care system that far exceed the clinical benefits.”

News Briefs: Consumer Satisfaction With Plans Hits Roadblocks

While health insurers have made gains in consumer satisfaction in recent years, that progress stalled over the last year, according to a new report from J.D. Power & Associates. “Overall satisfaction has increased…during the past five years, but there is no change in 2022 from 2021, due in part to declines in satisfaction in customer service and dissatisfaction with coverage options and desired network providers,” a J.D. Power press release said. The report said that the health plans that members call “responsive” and “innovative” received the best satisfaction scores. Members also critiqued long hold times at call centers and have found decreasing satisfaction from electronic contact tools like texting and mobile apps. The highest scores for health plans, which were separated by region, were awarded to Kaiser Permanente, Humana Inc., Anthem, Inc., Geisinger Health Plan and several Blue Cross Blue Shield affiliates.

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Biden Administration Has Options for Drug Pricing Reform

Democratic lawmakers are discussing a plan that would allow CMS to negotiate the price of certain medications and place a cap on Medicare beneficiaries’ out-of-pocket spending, an effort they hope could lead to the resuscitation of the drug pricing controls contained in the Build Back Better Act (BBBA). While those talks are far from a sure thing to pass, the Biden administration could institute policies to combat high drug prices that do not need congressional approval, according to health policy experts who participated in a Kaiser Family Foundation (KFF) webinar on May 23.

Rachel Sachs, an attorney and professor at the Washington University School of Law in St. Louis who spoke during the webinar, said the administration could particularly make an impact in federal insurance programs such as Medicare and Medicaid. One way could be via the approval of certain Section 1115 Medicaid waivers that states request. For instance, in Oregon’s Section 1115 renewal application in February, the state asked CMS for permission to exclude from its Medicaid formulary drugs approved under the FDA’s accelerated approval program that have “limited or inadequate evidence of clinical efficacy.”