PBMs/Pharmacy Benefit Managers

Medically Integrated Dispensing Chops Waste, Signals Expansion

Newly released results of a Prime Therapeutics LLC oncology program suggest that if the PBM were to expand its highly coordinated oral oncology dispensing model beyond the pilot population, cost savings could exceed $1 million. And these promising results signal that the model may be on the brink of expanding into more disease states.

Prime’s medically integrated dispensing (MID) model, which takes a high-touch, care coordination-intensive approach, cut waste by limiting overfills, according to a Prime study released June 2. Compared with the traditional central specialty pharmacy dispensing of oral oncology drugs, the MID pilot involving 627 patients across three commercial insurance plans showed the potential to cut $1,800 in costs “per medication dose change,” according to the results.

News Briefs: FTC Ratchets Up Regulatory Pressure on PBMs, Targeting Rebate Practices and Insulin

The Federal Trade Commission (FTC) ratcheted up regulatory pressure on PBMs once again, announcing that it will apply more scrutiny to PBMs' rebating practices, particularly regarding insulin. The move follows the agency's announcement earlier this month that it would investigate PBM business practices and consolidation. In an official policy statement, the agency wrote that “some have suggested that high rebates and fees to PBMs and other intermediaries may incentivize higher list prices for insulin” and that “rebate and fee agreements may incentivize PBMs and other intermediaries to steer patients to higher-cost drugs over less expensive alternatives.” Actions the agency said it would pursue include cracking down on exclusionary rebates and intensifying scrutiny of formulary design.

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.

Judge Strikes Down ‘Accumulator Rule,’ Ending Potential Threat to Patient Assistance

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

The Medicaid rebate rule allows state Medicaid programs to get the same discounts on drug prices that manufacturers offer commercial plans purchasing prescription drugs. Manufacturers pay rebates to Medicaid programs that are calculated based on drugmakers’ best price, which is the lowest price the manufacturer gives to most providers of health care services or items, including hospitals, HMOs and MCOs — but not patients. It includes any price adjustments, such as discounts and rebates, but not manufacturer-provided assistance to patients.

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: Centene Settles New Mexico Medicaid Pharmacy Investigation for $13.7 Million

In the latest settlement with a state Medicaid program over its pharmacy benefit practices, Centene Corp. has agreed to pay $13.7 million to the state of New Mexico. Upon referral from the Office of the State Auditor in collaboration with the New Mexico Health Services Dept. — which oversees the Centennial Care Medicaid program — Attorney General Hector Balderas (D) conducted an investigation focused on “concerns that Centene was layering fees and not passing on retail discounts” to the program, according to a June 13 press release from the AG’s office. Centene has spent millions to settle claims by state Medicaid programs that it overcharged them for prescription drugs and is in the process of restructuring its pharmacy benefit management platform.

Judge Strikes Down CMS’s So-Called ‘Accumulator Rule’

A U.S. district court judge has struck down a CMS rule that would have narrowed the exclusions from Medicaid best price for manufacturer-provided patient-assistance programs. The rule, which was set to go into effect on Jan. 1, would have required drugmakers to determine exactly where their patient assistance is going. If 100% of it was not reaching the patient — particularly via copayment accumulators and maximizers when payers are taking this assistance rather than allowing it to count toward patients’ deductibles and out-of-pocket maximums — that assistance would need to have been included in Medicaid best price and average manufacturer price (AMP) calculations for prescription drugs. This decision, as well as a recent pharma lawsuit against a maximizer company, may spur more pushback against these copay programs, one industry expert tells AIS Health, a division of MMIT.

News Briefs: Biogen and Samsung Bioepis Launch Byooviz

Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz (ranibizumab-nuna), and the medication will be commercially available “through major distributors across the U.S.” on July 1. The drug is the first FDA-approved ophthalmology biosimilar and references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

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.

Looking to 2023, Employers Focus Benefit Changes on Specialty

Now that many large employers have finalized employee health benefits for 2023, some clear trends are emerging, pharmacy benefit consultants tell AIS Health. Among them: many plan sponsors have traditional drug benefits on auto-pilot but are hyper-focused on high-cost specialty drugs.

For non-specialty drugs, the cost trend is pretty flat, says Paul Burns, a pharmacy practice leader at the HR consulting firm Buck. “There’s been some increases over the pandemic, but it’s not wildly spiking — and that’s where 98% of the utilization is.”