Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Key clinical point: Rimegepant was more effective than placebo in reducing pain and most bothersome symptoms in patients with moderate to severe migraine, while also showing favorable safety and tolerability.

Major findings: At 2 hours post dose, rimegepant was more effective than placebo in providing freedom from pain (risk difference 4.9; P = .0298) and the most bothersome symptoms (risk difference 8.9; P = .0016). Similar proportions of participants in the rimegepant vs placebo group experienced at least one adverse event (12.6% vs 10.7%), with nausea (0.9% vs 1.1%) and dizziness (0.7% vs 0.4%) being the most common adverse events.

Study details: This randomized, double-blind, placebo-controlled trial (Safety and Efficacy Study in Adult Subjects With Acute Migraines, NCT03235479)  included 1084 patients with migraine with or without aura who were randomly assigned to receive 75 mg rimegepant (n = 543) or placebo (n = 541).

Disclosures: This study was supported by Biohaven Pharmaceuticals (acquired by Pfizer, Inc.). Four authors declared being employees or stockholders of Biohaven Pharmaceuticals, Pfizer, or having other ties with various sources.

Source: Lipton RB, Thiry A, Morris BA, Croop R. Efficacy and safety of rimegepant 75 mg oral tablet, a CGRP receptor antagonist, for the acute treatment of migraine: A randomized, double-blind, placebo-controlled trial. J Pain Res. 2024;17:2431-2441 (Jul 22). Doi: 10.2147/JPR.S453806 Source

Key clinical point: Rimegepant was more effective than placebo in reducing pain and most bothersome symptoms in patients with moderate to severe migraine, while also showing favorable safety and tolerability.

Major findings: At 2 hours post dose, rimegepant was more effective than placebo in providing freedom from pain (risk difference 4.9; P = .0298) and the most bothersome symptoms (risk difference 8.9; P = .0016). Similar proportions of participants in the rimegepant vs placebo group experienced at least one adverse event (12.6% vs 10.7%), with nausea (0.9% vs 1.1%) and dizziness (0.7% vs 0.4%) being the most common adverse events.

Study details: This randomized, double-blind, placebo-controlled trial (Safety and Efficacy Study in Adult Subjects With Acute Migraines, NCT03235479)  included 1084 patients with migraine with or without aura who were randomly assigned to receive 75 mg rimegepant (n = 543) or placebo (n = 541).

Disclosures: This study was supported by Biohaven Pharmaceuticals (acquired by Pfizer, Inc.). Four authors declared being employees or stockholders of Biohaven Pharmaceuticals, Pfizer, or having other ties with various sources.

Source: Lipton RB, Thiry A, Morris BA, Croop R. Efficacy and safety of rimegepant 75 mg oral tablet, a CGRP receptor antagonist, for the acute treatment of migraine: A randomized, double-blind, placebo-controlled trial. J Pain Res. 2024;17:2431-2441 (Jul 22). Doi: 10.2147/JPR.S453806 Source

Key clinical point: Rimegepant was more effective than placebo in reducing pain and most bothersome symptoms in patients with moderate to severe migraine, while also showing favorable safety and tolerability.

Major findings: At 2 hours post dose, rimegepant was more effective than placebo in providing freedom from pain (risk difference 4.9; P = .0298) and the most bothersome symptoms (risk difference 8.9; P = .0016). Similar proportions of participants in the rimegepant vs placebo group experienced at least one adverse event (12.6% vs 10.7%), with nausea (0.9% vs 1.1%) and dizziness (0.7% vs 0.4%) being the most common adverse events.

Study details: This randomized, double-blind, placebo-controlled trial (Safety and Efficacy Study in Adult Subjects With Acute Migraines, NCT03235479)  included 1084 patients with migraine with or without aura who were randomly assigned to receive 75 mg rimegepant (n = 543) or placebo (n = 541).

Disclosures: This study was supported by Biohaven Pharmaceuticals (acquired by Pfizer, Inc.). Four authors declared being employees or stockholders of Biohaven Pharmaceuticals, Pfizer, or having other ties with various sources.

Source: Lipton RB, Thiry A, Morris BA, Croop R. Efficacy and safety of rimegepant 75 mg oral tablet, a CGRP receptor antagonist, for the acute treatment of migraine: A randomized, double-blind, placebo-controlled trial. J Pain Res. 2024;17:2431-2441 (Jul 22). Doi: 10.2147/JPR.S453806 Source

Key clinical point: This Mendelian randomization study showed that leisure screen time (LST) worsens migraine, whereas moderate to vigorous physical activity (MVPA) alleviates it, with hypertension and diastolic blood pressure (DBP) being responsible for the effects of MVPA or LST on migraine.

Major findings: Genetically predicted LST was associated with a significantly increased risk for migraine (odds ratio [OR] 1.28; P < .001), whereas MVPA was linked to a significantly reduced risk (OR 0.73; P = .000006). Hypertension mediated 4.86% and 24.81% of the effects of MVPA and LST on migraine risk, respectively, and DBP accounted for 4.66% of the effects of MVPA on migraine risk.

Study details: This study included 18,477 patients with migraine and 287,837 control individuals without migraine from the FinnGen consortium and 26,052 patients with migraine and 487,214 control individuals without migraine from the large-scale genome-wide association studies.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and others. The authors declared no conflicts of interest.

Source: Gan Q, Song E, Zhang L, et al. The role of hypertension in the relationship between leisure screen time, physical activity and migraine: A 2-sample Mendelian randomization study. J Headache Pain. 2024;25:122 (Jul 24). Doi: 10.1186/s10194-024-01820-4 Source

Key clinical point: This Mendelian randomization study showed that leisure screen time (LST) worsens migraine, whereas moderate to vigorous physical activity (MVPA) alleviates it, with hypertension and diastolic blood pressure (DBP) being responsible for the effects of MVPA or LST on migraine.

Major findings: Genetically predicted LST was associated with a significantly increased risk for migraine (odds ratio [OR] 1.28; P < .001), whereas MVPA was linked to a significantly reduced risk (OR 0.73; P = .000006). Hypertension mediated 4.86% and 24.81% of the effects of MVPA and LST on migraine risk, respectively, and DBP accounted for 4.66% of the effects of MVPA on migraine risk.

Study details: This study included 18,477 patients with migraine and 287,837 control individuals without migraine from the FinnGen consortium and 26,052 patients with migraine and 487,214 control individuals without migraine from the large-scale genome-wide association studies.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and others. The authors declared no conflicts of interest.

Source: Gan Q, Song E, Zhang L, et al. The role of hypertension in the relationship between leisure screen time, physical activity and migraine: A 2-sample Mendelian randomization study. J Headache Pain. 2024;25:122 (Jul 24). Doi: 10.1186/s10194-024-01820-4 Source

Key clinical point: This Mendelian randomization study showed that leisure screen time (LST) worsens migraine, whereas moderate to vigorous physical activity (MVPA) alleviates it, with hypertension and diastolic blood pressure (DBP) being responsible for the effects of MVPA or LST on migraine.

Major findings: Genetically predicted LST was associated with a significantly increased risk for migraine (odds ratio [OR] 1.28; P < .001), whereas MVPA was linked to a significantly reduced risk (OR 0.73; P = .000006). Hypertension mediated 4.86% and 24.81% of the effects of MVPA and LST on migraine risk, respectively, and DBP accounted for 4.66% of the effects of MVPA on migraine risk.

Study details: This study included 18,477 patients with migraine and 287,837 control individuals without migraine from the FinnGen consortium and 26,052 patients with migraine and 487,214 control individuals without migraine from the large-scale genome-wide association studies.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and others. The authors declared no conflicts of interest.

Source: Gan Q, Song E, Zhang L, et al. The role of hypertension in the relationship between leisure screen time, physical activity and migraine: A 2-sample Mendelian randomization study. J Headache Pain. 2024;25:122 (Jul 24). Doi: 10.1186/s10194-024-01820-4 Source

Key clinical point: The meta-analysis showed that atogepant was effective and well tolerated in patients with migraine in a non–dose-dependent manner, with rare incidences of serious treatment-emergent adverse events (TEAE) reported.

Major findings: Atogepant vs placebo led to a significant reduction in monthly migraine days (standardized mean difference [SMD] −0.40; P = .00001) and headache days (SMD −0.39; P = .00001), with consistent results observed across all dosage groups. The risk for TEAE (relative risk [RR] 1.11; P = .02) was significantly higher in the atogepant vs placebo group, with constipation (RR 2.55; P < .00001), nausea (RR 2.19; P < .00001), and urinary tract infection (RR 1.49; P = .03) being the most common.

Study details: This meta-analysis of four randomized controlled trials included 2813 patients with migraine who were treated with atogepant (10 mg, 30 mg, or 60 mg).

Disclosures: This study was supported by the Chongqing Clinical Pharmacy Key Specialties Construction Project, China. The authors declared no conflicts of interest.

Source: Hou M, Luo X, He S, et al. Efficacy and safety of atogepant, a small molecule CGRP receptor antagonist, for the preventive treatment of migraine: A systematic review and meta-analysis. J Headache Pain. 2024;25:116 (Jul 19). Doi: 10.1186/s10194-024-01822-2 Source

Key clinical point: The meta-analysis showed that atogepant was effective and well tolerated in patients with migraine in a non–dose-dependent manner, with rare incidences of serious treatment-emergent adverse events (TEAE) reported.

Major findings: Atogepant vs placebo led to a significant reduction in monthly migraine days (standardized mean difference [SMD] −0.40; P = .00001) and headache days (SMD −0.39; P = .00001), with consistent results observed across all dosage groups. The risk for TEAE (relative risk [RR] 1.11; P = .02) was significantly higher in the atogepant vs placebo group, with constipation (RR 2.55; P < .00001), nausea (RR 2.19; P < .00001), and urinary tract infection (RR 1.49; P = .03) being the most common.

Study details: This meta-analysis of four randomized controlled trials included 2813 patients with migraine who were treated with atogepant (10 mg, 30 mg, or 60 mg).

Disclosures: This study was supported by the Chongqing Clinical Pharmacy Key Specialties Construction Project, China. The authors declared no conflicts of interest.

Source: Hou M, Luo X, He S, et al. Efficacy and safety of atogepant, a small molecule CGRP receptor antagonist, for the preventive treatment of migraine: A systematic review and meta-analysis. J Headache Pain. 2024;25:116 (Jul 19). Doi: 10.1186/s10194-024-01822-2 Source

Key clinical point: The meta-analysis showed that atogepant was effective and well tolerated in patients with migraine in a non–dose-dependent manner, with rare incidences of serious treatment-emergent adverse events (TEAE) reported.

Major findings: Atogepant vs placebo led to a significant reduction in monthly migraine days (standardized mean difference [SMD] −0.40; P = .00001) and headache days (SMD −0.39; P = .00001), with consistent results observed across all dosage groups. The risk for TEAE (relative risk [RR] 1.11; P = .02) was significantly higher in the atogepant vs placebo group, with constipation (RR 2.55; P < .00001), nausea (RR 2.19; P < .00001), and urinary tract infection (RR 1.49; P = .03) being the most common.

Study details: This meta-analysis of four randomized controlled trials included 2813 patients with migraine who were treated with atogepant (10 mg, 30 mg, or 60 mg).

Disclosures: This study was supported by the Chongqing Clinical Pharmacy Key Specialties Construction Project, China. The authors declared no conflicts of interest.

Source: Hou M, Luo X, He S, et al. Efficacy and safety of atogepant, a small molecule CGRP receptor antagonist, for the preventive treatment of migraine: A systematic review and meta-analysis. J Headache Pain. 2024;25:116 (Jul 19). Doi: 10.1186/s10194-024-01822-2 Source

Key clinical point: The presence of migraine aura exacerbated migraine-related disability, mainly due to concurrent non-pain symptoms of migraine rather than the aura itself.

Major findings: The presence of aura on the first day of the migraine episode was significantly associated with increased odds of disability across all migraine days (odds ratio [OR] 1.40; P < .001); and non-pain symptoms, such as allodynia, photophobia, phonophobia, and nausea or vomiting (P < .001 for all). No association was observed between aura and headache-related migraine symptoms.

Study details: This observational prospective cohort study included 554 adults with episodic migraine, with complete data on migraine symptoms and psychological variables collected daily for 90 days using the N-1 Headache™ digital app (N = 11,156 total migraine days).

Disclosures: This study did not receive funding from any sources. The authors declared no conflicts of interest.

Source: Denney DE, Lee AA, Landy SH, Smitherman TA. Headache-related disability as a function of migraine aura: A daily diary study. Headache. 2024 (Aug 1). Doi: 10.1111/head.14796 Source

Key clinical point: The presence of migraine aura exacerbated migraine-related disability, mainly due to concurrent non-pain symptoms of migraine rather than the aura itself.

Major findings: The presence of aura on the first day of the migraine episode was significantly associated with increased odds of disability across all migraine days (odds ratio [OR] 1.40; P < .001); and non-pain symptoms, such as allodynia, photophobia, phonophobia, and nausea or vomiting (P < .001 for all). No association was observed between aura and headache-related migraine symptoms.

Study details: This observational prospective cohort study included 554 adults with episodic migraine, with complete data on migraine symptoms and psychological variables collected daily for 90 days using the N-1 Headache™ digital app (N = 11,156 total migraine days).

Disclosures: This study did not receive funding from any sources. The authors declared no conflicts of interest.

Source: Denney DE, Lee AA, Landy SH, Smitherman TA. Headache-related disability as a function of migraine aura: A daily diary study. Headache. 2024 (Aug 1). Doi: 10.1111/head.14796 Source

Key clinical point: The presence of migraine aura exacerbated migraine-related disability, mainly due to concurrent non-pain symptoms of migraine rather than the aura itself.

Major findings: The presence of aura on the first day of the migraine episode was significantly associated with increased odds of disability across all migraine days (odds ratio [OR] 1.40; P < .001); and non-pain symptoms, such as allodynia, photophobia, phonophobia, and nausea or vomiting (P < .001 for all). No association was observed between aura and headache-related migraine symptoms.

Study details: This observational prospective cohort study included 554 adults with episodic migraine, with complete data on migraine symptoms and psychological variables collected daily for 90 days using the N-1 Headache™ digital app (N = 11,156 total migraine days).

Disclosures: This study did not receive funding from any sources. The authors declared no conflicts of interest.

Source: Denney DE, Lee AA, Landy SH, Smitherman TA. Headache-related disability as a function of migraine aura: A daily diary study. Headache. 2024 (Aug 1). Doi: 10.1111/head.14796 Source

Key clinical point: Patients with migraine and a history of abuse had a greater migraine burden than those without a history of abuse, with this association being mediated by depression and anxiety.

Major findings: Patients with migraine who did vs did not have a history of abuse had significantly higher migraine-specific disability (68 vs 49), subjective cognitive impairment (10 vs 7), and pain interference (65 vs 62.5) scores, as well as greater overall work impairment (47.6% vs 38.6%) and activity impairment (49.3% vs 39.3%; all P < .001). Depression and anxiety mediated the association between history of abuse and migraine burden.

Study details: This cross-sectional study included 866 patients with migraine from the American Registry for Migraine Research, of whom 316 (36.5 %) had a history of abuse.

Disclosures: This study was supported by the American Migraine Foundation and American Academy of Neurology. Some authors declared receiving research funding from or having other ties with various sources.

Source: Trivedi M, Dumkrieger G, Chong CD, et al. A history of abuse is associated with more severe migraine- and pain-related disability: Results from the American Registry for Migraine Research. Headache. 2024 (Jul 25). Doi: 10.1111/head.14787 Source

Key clinical point: Patients with migraine and a history of abuse had a greater migraine burden than those without a history of abuse, with this association being mediated by depression and anxiety.

Major findings: Patients with migraine who did vs did not have a history of abuse had significantly higher migraine-specific disability (68 vs 49), subjective cognitive impairment (10 vs 7), and pain interference (65 vs 62.5) scores, as well as greater overall work impairment (47.6% vs 38.6%) and activity impairment (49.3% vs 39.3%; all P < .001). Depression and anxiety mediated the association between history of abuse and migraine burden.

Study details: This cross-sectional study included 866 patients with migraine from the American Registry for Migraine Research, of whom 316 (36.5 %) had a history of abuse.

Disclosures: This study was supported by the American Migraine Foundation and American Academy of Neurology. Some authors declared receiving research funding from or having other ties with various sources.

Source: Trivedi M, Dumkrieger G, Chong CD, et al. A history of abuse is associated with more severe migraine- and pain-related disability: Results from the American Registry for Migraine Research. Headache. 2024 (Jul 25). Doi: 10.1111/head.14787 Source

Key clinical point: Patients with migraine and a history of abuse had a greater migraine burden than those without a history of abuse, with this association being mediated by depression and anxiety.

Major findings: Patients with migraine who did vs did not have a history of abuse had significantly higher migraine-specific disability (68 vs 49), subjective cognitive impairment (10 vs 7), and pain interference (65 vs 62.5) scores, as well as greater overall work impairment (47.6% vs 38.6%) and activity impairment (49.3% vs 39.3%; all P < .001). Depression and anxiety mediated the association between history of abuse and migraine burden.

Study details: This cross-sectional study included 866 patients with migraine from the American Registry for Migraine Research, of whom 316 (36.5 %) had a history of abuse.

Disclosures: This study was supported by the American Migraine Foundation and American Academy of Neurology. Some authors declared receiving research funding from or having other ties with various sources.

Source: Trivedi M, Dumkrieger G, Chong CD, et al. A history of abuse is associated with more severe migraine- and pain-related disability: Results from the American Registry for Migraine Research. Headache. 2024 (Jul 25). Doi: 10.1111/head.14787 Source

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) were effective and showed a similar time to onset in patients with chronic migraine (CM), irrespective of disease duration.

Major findings: At 10-12 months of follow-up, anti-CGRP mAb reduced monthly migraine days by an average of 12 days across all tertiles of CM duration (P = .946). Additionally, monthly headache days and acute medication use significantly decreased from baseline to 10-12 months (P < .001) across all tertiles of CM duration, indicating no difference in the time to onset of anti-CGRP mAb across tertiles.

Study details: This cohort study included 335 patients with CM treated with anti-CGRP mAb for at least 12 months. Patients were categorized into different tertiles of CM duration: 0-7 years, 8-18 years, and 18-60 years.

Disclosures: This study did not disclose any funding sources. Four authors declared receiving personal fees from or having other ties with various sources.

Source: Ornello R, Baldini F, Onofri A, et al. Impact of duration of chronic migraine on long-term effectiveness of monoclonal antibodies targeting the calcitonin gene-related peptide pathway-A real-world study. Headache. 2024 (Jul 16). Doi: 10.1111/head.14788 Source

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) were effective and showed a similar time to onset in patients with chronic migraine (CM), irrespective of disease duration.

Major findings: At 10-12 months of follow-up, anti-CGRP mAb reduced monthly migraine days by an average of 12 days across all tertiles of CM duration (P = .946). Additionally, monthly headache days and acute medication use significantly decreased from baseline to 10-12 months (P < .001) across all tertiles of CM duration, indicating no difference in the time to onset of anti-CGRP mAb across tertiles.

Study details: This cohort study included 335 patients with CM treated with anti-CGRP mAb for at least 12 months. Patients were categorized into different tertiles of CM duration: 0-7 years, 8-18 years, and 18-60 years.

Disclosures: This study did not disclose any funding sources. Four authors declared receiving personal fees from or having other ties with various sources.

Source: Ornello R, Baldini F, Onofri A, et al. Impact of duration of chronic migraine on long-term effectiveness of monoclonal antibodies targeting the calcitonin gene-related peptide pathway-A real-world study. Headache. 2024 (Jul 16). Doi: 10.1111/head.14788 Source

Key clinical point: Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) were effective and showed a similar time to onset in patients with chronic migraine (CM), irrespective of disease duration.

Major findings: At 10-12 months of follow-up, anti-CGRP mAb reduced monthly migraine days by an average of 12 days across all tertiles of CM duration (P = .946). Additionally, monthly headache days and acute medication use significantly decreased from baseline to 10-12 months (P < .001) across all tertiles of CM duration, indicating no difference in the time to onset of anti-CGRP mAb across tertiles.

Study details: This cohort study included 335 patients with CM treated with anti-CGRP mAb for at least 12 months. Patients were categorized into different tertiles of CM duration: 0-7 years, 8-18 years, and 18-60 years.

Disclosures: This study did not disclose any funding sources. Four authors declared receiving personal fees from or having other ties with various sources.

Source: Ornello R, Baldini F, Onofri A, et al. Impact of duration of chronic migraine on long-term effectiveness of monoclonal antibodies targeting the calcitonin gene-related peptide pathway-A real-world study. Headache. 2024 (Jul 16). Doi: 10.1111/head.14788 Source

Key clinical point: Childhood abuse was significantly associated with an increased risk for migraine, with specific types such as physical, sexual, and emotional abuse showing a positive association with migraine onset.

Major findings: Individuals who experienced childhood abuse had a higher risk for migraine than those who did not (odd ratio [OR] 1.60; 95% CI 1.49-1.71). This risk was increased in those who were exposed to sexual abuse (OR 1.71; 95% CI 1.43-2.04), physical abuse (OR 1.47; 95% CI 1.38-1.56), and emotional abuse (OR 1.71; 95% CI 1.52-1.93).

Study details: This meta-analysis of 12 studies evaluated the association between childhood abuse and migraine in 110,776 patients with migraine.

Disclosures: No funding source was disclosed for this study. The authors declared no conflicts of interest.

Source: Liu J, Guo Y, Huang Z, et al. Childhood abuse and risk of migraine: A systematic review and meta-analysis. Child Abuse Negl. 2024;155:106961 (Aug 2).  Doi: 10.1016/j.chiabu.2024.106961 Source

Key clinical point: Childhood abuse was significantly associated with an increased risk for migraine, with specific types such as physical, sexual, and emotional abuse showing a positive association with migraine onset.

Major findings: Individuals who experienced childhood abuse had a higher risk for migraine than those who did not (odd ratio [OR] 1.60; 95% CI 1.49-1.71). This risk was increased in those who were exposed to sexual abuse (OR 1.71; 95% CI 1.43-2.04), physical abuse (OR 1.47; 95% CI 1.38-1.56), and emotional abuse (OR 1.71; 95% CI 1.52-1.93).

Study details: This meta-analysis of 12 studies evaluated the association between childhood abuse and migraine in 110,776 patients with migraine.

Disclosures: No funding source was disclosed for this study. The authors declared no conflicts of interest.

Source: Liu J, Guo Y, Huang Z, et al. Childhood abuse and risk of migraine: A systematic review and meta-analysis. Child Abuse Negl. 2024;155:106961 (Aug 2).  Doi: 10.1016/j.chiabu.2024.106961 Source

Key clinical point: Childhood abuse was significantly associated with an increased risk for migraine, with specific types such as physical, sexual, and emotional abuse showing a positive association with migraine onset.

Major findings: Individuals who experienced childhood abuse had a higher risk for migraine than those who did not (odd ratio [OR] 1.60; 95% CI 1.49-1.71). This risk was increased in those who were exposed to sexual abuse (OR 1.71; 95% CI 1.43-2.04), physical abuse (OR 1.47; 95% CI 1.38-1.56), and emotional abuse (OR 1.71; 95% CI 1.52-1.93).

Study details: This meta-analysis of 12 studies evaluated the association between childhood abuse and migraine in 110,776 patients with migraine.

Disclosures: No funding source was disclosed for this study. The authors declared no conflicts of interest.

Source: Liu J, Guo Y, Huang Z, et al. Childhood abuse and risk of migraine: A systematic review and meta-analysis. Child Abuse Negl. 2024;155:106961 (Aug 2).  Doi: 10.1016/j.chiabu.2024.106961 Source

Key clinical point: The daily step count increased noticeably after initiating treatment with anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) in adults with chronic migraine, with a positive association seen between the increase in daily steps and the treatment response to CGRP mAbs.

Major findings: The average number of steps per day increased from 4421 before initiation of anti-CGRP mAb treatment to 5241 at 3 months after initiation of treatment (P = .039), reflecting a mean percentage increase of 21.3% (95% CI 0.5-42.1). There was a positive association between an increase in daily steps and a reduction in monthly migraine days (correlation coefficient 0.521; P = .013).

Study details: This single-center, cross-sectional, retrospective study included 22 patients with chronic migraine who were treated with anti-CGRP mAbs (erenumab or fremanezumab).

Disclosures: The study was supported by the Lundbeck Foundation. Several authors declared receiving grants, honoraria, or personal fees from or having other ties with various sources.

Source: Jantzen FT, Chaudhry BA, Younis S, et al. Average steps per day as marker of treatment response with anti-CGRP mAbs in adults with chronic migraine: A pilot study. Sci Rep. 2024;14:18068 (Aug 5). Doi: 10.1038/s41598-024-68915-5 Source

Key clinical point: The daily step count increased noticeably after initiating treatment with anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) in adults with chronic migraine, with a positive association seen between the increase in daily steps and the treatment response to CGRP mAbs.

Major findings: The average number of steps per day increased from 4421 before initiation of anti-CGRP mAb treatment to 5241 at 3 months after initiation of treatment (P = .039), reflecting a mean percentage increase of 21.3% (95% CI 0.5-42.1). There was a positive association between an increase in daily steps and a reduction in monthly migraine days (correlation coefficient 0.521; P = .013).

Study details: This single-center, cross-sectional, retrospective study included 22 patients with chronic migraine who were treated with anti-CGRP mAbs (erenumab or fremanezumab).

Disclosures: The study was supported by the Lundbeck Foundation. Several authors declared receiving grants, honoraria, or personal fees from or having other ties with various sources.

Source: Jantzen FT, Chaudhry BA, Younis S, et al. Average steps per day as marker of treatment response with anti-CGRP mAbs in adults with chronic migraine: A pilot study. Sci Rep. 2024;14:18068 (Aug 5). Doi: 10.1038/s41598-024-68915-5 Source

Key clinical point: The daily step count increased noticeably after initiating treatment with anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) in adults with chronic migraine, with a positive association seen between the increase in daily steps and the treatment response to CGRP mAbs.

Major findings: The average number of steps per day increased from 4421 before initiation of anti-CGRP mAb treatment to 5241 at 3 months after initiation of treatment (P = .039), reflecting a mean percentage increase of 21.3% (95% CI 0.5-42.1). There was a positive association between an increase in daily steps and a reduction in monthly migraine days (correlation coefficient 0.521; P = .013).

Study details: This single-center, cross-sectional, retrospective study included 22 patients with chronic migraine who were treated with anti-CGRP mAbs (erenumab or fremanezumab).

Disclosures: The study was supported by the Lundbeck Foundation. Several authors declared receiving grants, honoraria, or personal fees from or having other ties with various sources.

Source: Jantzen FT, Chaudhry BA, Younis S, et al. Average steps per day as marker of treatment response with anti-CGRP mAbs in adults with chronic migraine: A pilot study. Sci Rep. 2024;14:18068 (Aug 5). Doi: 10.1038/s41598-024-68915-5 Source

Key clinical point: Women with an increased adherence to a pro-inflammatory diet, as measured using a dietary inflammation score (DIS), had an increased risk for chronic migraine (CM).

Major findings: Women with CM had a significantly higher DIS than those with episodic migraine (EM) (0.08 vs 0.62; P = .002). The risk for CM was two times higher in women with a high DIS than in those with a low DIS (adjusted odd ratio 2.02; P_trend = .03).

Study details: This cross-sectional study included 285 women with migraine, of whom 169 (59.3%) had EM and 116 (40.7%) had CM.

Disclosures: This study was supported by the Student Research Committee of Ahvaz Jundishapur University of Medical Sciences. The authors declared no conflicts of interest.

Source: Bakhshimoghaddam F, Shalilahmadi D, Mahdavi R, et al. Association of dietary and lifestyle inflammation score (DLIS) with chronic migraine in women: A cross-sectional study. Sci Rep. 2024;14:16406 (Jul 16). Doi: 10.1038/s41598-024-66776-6 Source

Key clinical point: Women with an increased adherence to a pro-inflammatory diet, as measured using a dietary inflammation score (DIS), had an increased risk for chronic migraine (CM).

Major findings: Women with CM had a significantly higher DIS than those with episodic migraine (EM) (0.08 vs 0.62; P = .002). The risk for CM was two times higher in women with a high DIS than in those with a low DIS (adjusted odd ratio 2.02; P_trend = .03).

Study details: This cross-sectional study included 285 women with migraine, of whom 169 (59.3%) had EM and 116 (40.7%) had CM.

Disclosures: This study was supported by the Student Research Committee of Ahvaz Jundishapur University of Medical Sciences. The authors declared no conflicts of interest.

Source: Bakhshimoghaddam F, Shalilahmadi D, Mahdavi R, et al. Association of dietary and lifestyle inflammation score (DLIS) with chronic migraine in women: A cross-sectional study. Sci Rep. 2024;14:16406 (Jul 16). Doi: 10.1038/s41598-024-66776-6 Source

Key clinical point: Women with an increased adherence to a pro-inflammatory diet, as measured using a dietary inflammation score (DIS), had an increased risk for chronic migraine (CM).

Major findings: Women with CM had a significantly higher DIS than those with episodic migraine (EM) (0.08 vs 0.62; P = .002). The risk for CM was two times higher in women with a high DIS than in those with a low DIS (adjusted odd ratio 2.02; P_trend = .03).

Study details: This cross-sectional study included 285 women with migraine, of whom 169 (59.3%) had EM and 116 (40.7%) had CM.

Disclosures: This study was supported by the Student Research Committee of Ahvaz Jundishapur University of Medical Sciences. The authors declared no conflicts of interest.

Source: Bakhshimoghaddam F, Shalilahmadi D, Mahdavi R, et al. Association of dietary and lifestyle inflammation score (DLIS) with chronic migraine in women: A cross-sectional study. Sci Rep. 2024;14:16406 (Jul 16). Doi: 10.1038/s41598-024-66776-6 Source