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Gillian McGovern

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PBMs’ tactics are causing United States citizens to suffer from rising health care premiums and costly drug prices, explained the House Committee on Oversight and Accountability Chairman James Comer during his remarks at a hearing to examine pricing tactics implemented by pharmacy benefit managers (PBMs). This hearing was the second hearing on PBMs to be initiated by the Committee.

“Congress can work in a bipartisan fashion to shine a light on PBMs, and this oversight hearing will examine how the PBM industry is making a concerted effort to drive up drug costs to line their own pockets,” explained Chairman Comer upon ordering the hearing. To improve the sustainability of generic drug markets and its medicines, Congress must ensure rapid plan coverage of new generics and biosimilars.

The Chairman emphasized during the hearing that there are deliberate, anticompetitive pricing tactics in place to prevent payers—including government stakeholders such as Medicare, Medicaid, Tricare, and the Federal Employee Health Benefits program—from understanding how PBMs are making profits at the expense of patients and taxpayers. Further, drug manufacturers pay rebates to PBMs, making it more difficult for competing prescriptions, often generics or biosimilars, to get on formularies. Patients often have to pay deductibles and coinsurance based on a medicine’s undiscounted price because PBMs deny or restrict coverage for these medicines.

“Instead of fierce competition, now just 3 PBMs control 80% of the market. Each of the 3 major PBMs—CVS Caremark, Express Scripts, and Optum Rx—is owned by a major health insurer [which] owns, or is owned, by a pharmacy,” said Chairman Comer at the hearing. “This means that when PBMs negotiate with a pharmacy or a health insurer, they are either negotiating with themselves or one of their direct competitors. This can create incentives to do things that have negative impacts on patients.”

The Committee hearing follows a prior investigation into PBMs’ role in rising health care costs, in which Chairman Comer requested CVS Caremark, Express Scripts, and OptumRx provide documents, communications, and information on their practices that are altering the pharmaceutical market. In addition, senior officials at the Office of Personnel Management, Centers for Medicare and Medicaid Services, and the Defense Health Agency provided documents and communications to determine the significance of the PBMs’ impact on health care programs.

Chairman Comer expressed that further transparency and accountability is required in the PBM industry. The lack of transparency and complexity of rebates and fees can make it difficult for plan sponsors to determine whether they are benefiting from the price concessions PBMs negotiate on their behalf. Comer noted that for this reason, the Committee will continue to push forward to develop legislative solutions to unveil the PBMs’ health practices.

“Greater transparency in the PBM industry is vital and the Oversight Committee will work to inform legislative solutions that can greatly benefit patients and reduce drug costs,” Chairman Comer said during the hearing. “We know that PBMs regularly engage in spread pricing, where PBMs overcharge payers and underpay pharmacies, and pocket the extra money. We also know that drug manufacturers pay rebates to PBMs in order to be placed in a favorable tier on a formulary, which can make it difficult for competing prescriptions—often generics or biosimilars—to get on formularies. These practices have real world consequences.”

According to Lori Reilly, COO, Pharmaceutical Research and Manufacturers of America, policies to establish transparency surrounding PBM practices and to de-link PBM compensation from the price of medicines has broad support from stakeholders, including from Medicare beneficiary advocates.

“Calls to increase PBM transparency have been a prominent theme in Congressional hearings,” Reilly said. “Lack of transparency and the complexity of rebates and fees can make it difficult for plan sponsors to assess whether they are fully benefiting from all price concessions that PBMs negotiate on their behalf.”

Craig Burton, executive director, Biosimilars Council, noted during the hearing that another concern is when PBMs pursue varying rebate agreements with plan sponsors. This can ultimately result in the coverage of generics being delayed, with patients suffering as a result.

“Delays in coverage restrict patient access to lower-cost generics and expose patients to unnecessarily high cost-sharing, even though lower-cost alternatives are available,” Burton said during the hearing. “To realize the full value of new generic competition, as well as savings from new biosimilar medicines, Congress must ensure rapid plan coverage of new generics and biosimilars to help improve the sustainability of generic drug markets and a stable supply of lifesaving generic medicines.”

1. The House Committee on Oversight and Accountability. Comer: Pharmacy benefit managers deploy drug pricing tactics to line their own pockets. News release. September 19, 2023. Accessed September 21, 2023.

2. The House Committee on Oversight and Accountability. Comer: Pharmacy benefit managers are harming patients by driving up drug costs to line their own pockets. News release. September 12, 2023. Accessed September 21, 2023.

3. The House Committee on Oversight and Accountability. Hearing wrap up: Pharmacy benefit managers push anticompetitive drug pricing tactics to line their own pockets. News release. September 19 2023. Accessed September 21, 2023.

4. @GOPoversight. “Instead of fierce competition, now just 3 PBMs control 80% of the market. ”And each of the 3 major PBMs—CVS Caremark, Express Scripts, and Optum Rx—is owned by a major health insurer and owns, or is owned, by a pharmacy. “This means that when PBMs negotiate with a pharmacy or a health insurer, they are either negotiating with themselves or one of their direct competitors. “This can create incentives to do things that have negative impacts on patients.” @RepJamesComer opens hearing on Pharmacy Benefit Managers. September 19, 2023. Accessed September 21, 2023. 

https://twitter.com/GOPoversight/status/1704136650610049056

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The House Committee members examined pricing tactics by PBMs and how they are harming patients across the country.

House Committee Hearing Addresses PBMs, Anticompetitive Drug Pricing Tactics

was originally published by Pharmacy Times

Biosimilars are commonly used in numerous clinical fields, including oncology. These drugs are different from the generic form of chemical products because it is impossible to develop molecules identical to their reference products due to natural variation and their heterogenic product process. Biosimilars are comparable to the reference product regarding structure, biological activity, efficacy, safety, and immunogenicity; however, there is some skepticism surrounding the safety and efficacy of these products among physicians and patients.

Prescription pill bottles | Eric Hood | stock.adobe.com

, researchers analyzed post-marketing pharmacovigilance data of biosimilar monoclonal antibodies used in oncology compared with their respective reference products. The study authors evaluated the distribution of medicine-reaction pairs related to biosimilars of 3 antitumor biological products—bevacizumab, rituximab, and trastuzumab—as well as their respective corresponding biosimilar drugs—

. The 3 drugs are monoclonal antibodies used in first- and second-line treatment regimens with other anti-cancer therapies for a plethora of common malignant diseases.

A total of 36,200 reported preferred terms (PTs) were analyzed, of which 23,592 (65%) were identified from reports for original products, and 12,608 (65%) for biosimilars. Of the reports, the proportions of females were higher than males (58.5% versus 36.2% for originator products; and 57.6% versus 26% for biosimilars), and 16.4% reports for biosimilars were missing information on sex. The majority of reports noted that patients were aged 18 to 64 years, with a lower percentage aged 65 to 85 years.

Study results indicated that the most frequently reported adverse drug reactions (ADRs) for biosimilars were non-serious and consistent with the safety profiles of reference products. ReportedADRs in 

 = 32 reactions, reporting odds ratio [ROR] 2.63 [CI 95% 1.81–3.82]), neuropathy peripheral (

 = 29, ROR 2.44 [CI 95% 1.65–3.61]), and abdominal pain (

 = 28 ROR 3.92 [CI 95% 2.58–5.94]); reported ADRs in 

 = 169 reactions, ROR 1.73 [CI 95% 1.42–2.09]), pruritus(

 = 163, ROR 1.96 [CI 95% 1.6–2.41]), and throat irritation(

 = 135 ROR 4.9 [CI 95% 3.55–6.74]); and reported ADRs in 

 = 68, ROR 2.07 [CI 95% 1.61–2.66]), chills (

 = 68, ROR 2.07 [CI 95% 1.61–2.66]), and nausea (

Although some severe ADRs (e.g., rheumatoid arthritis, mantle cell lymphoma, and systemic lupus erythematosus) were reported as well, these were less common. Additional reported ADRs included weight increase, blood pressure fluctuation, irregular heart rate, and physical deterioration.

Despite the potential ADRs, these results provide reassurance regarding the safety equivalence of biosimilars, supporting their use as acceptable alternatives to originator biologics, according to the study authors. Further, patients can feel reassured that they are utilizing adequate, cost-effective treatments for their medical conditions when choosing to use biosimilars. Because the number of biosimilars in development within oncology is rising, they have the potential to create a more sustainable health care system.

Study limitations include the lack of denominator data (e.g., number of patients exposed to a particular drug) and potential incomplete, inaccurate, and inconsistent data in reports. Further, the system was affected by underreporting, which could have affected the validity and accuracy of ROR estimates because the calculations are based on the assumption that the reporting rate is constant across all medications and ADRs.

Nikitina V, Santi Laurini G, Montanaro N, Motola D. Comparative Safety Profiles of Oncology Biosimilars vs. Originators in Europe: An Analysis of the EudraVigilance Database. 

. 2023; 15(14):3680. doi.org/10.3390/cancers15143680

Study finds patients with cancer feel reassured that biosimilars provide a safe, adequate, and cost-effective alternative to the pricier reference drug.

Gillian McGovern

House Committee Hearing Addresses PBMs, Anticompetitive Drug Pricing Tactics

Oncological Biosimilars Shown to Be as Safe as Their Reference Products