Key clinical point: Patients with recurrent hepatocellular carcinoma had increased recurrence-free survival after rHR compared to RFA, but significantly lower morbidity and shorter hospital stays with RFA compared to rHR; overall survival rates were not significantly different between groups.

Major finding: The median recurrence-free survival was longer in recurrent HCC patients treated with rHR compared to RFA (23.6 months vs 15.2 months, hazard ratio 0.76). However, RFA was significantly association with lower morbidity of grade 3 and above (0.6% vs 6.2%) and with a shorter hospital stay (8.0 days vs 3.0 days) compared to rHR.

Study details: The data come from a retrospective, multicenter study including 847 HCC patients; of these, 307 underwent repeat hepatic resection (rHR) and 540 underwent radiofrequency ablation (RFA) between January 2003 and January 2018.

Disclosures: The study was supported by the Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Guangxi BaGui Scholars’ Special Fund, the Gunagxi Natural Science Foundation, and the Science Research and Technology Development Programme of Guangxi. The researchers had no financial conflicts to disclose.

Source: Zhong J-H et al. Br J Surg. 2021 Oct 13. doi: 10.1093/bjs/znab340.

Key clinical point: Patients with recurrent hepatocellular carcinoma had increased recurrence-free survival after rHR compared to RFA, but significantly lower morbidity and shorter hospital stays with RFA compared to rHR; overall survival rates were not significantly different between groups.

Major finding: The median recurrence-free survival was longer in recurrent HCC patients treated with rHR compared to RFA (23.6 months vs 15.2 months, hazard ratio 0.76). However, RFA was significantly association with lower morbidity of grade 3 and above (0.6% vs 6.2%) and with a shorter hospital stay (8.0 days vs 3.0 days) compared to rHR.

Study details: The data come from a retrospective, multicenter study including 847 HCC patients; of these, 307 underwent repeat hepatic resection (rHR) and 540 underwent radiofrequency ablation (RFA) between January 2003 and January 2018.

Disclosures: The study was supported by the Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Guangxi BaGui Scholars’ Special Fund, the Gunagxi Natural Science Foundation, and the Science Research and Technology Development Programme of Guangxi. The researchers had no financial conflicts to disclose.

Source: Zhong J-H et al. Br J Surg. 2021 Oct 13. doi: 10.1093/bjs/znab340.

Key clinical point: Patients with recurrent hepatocellular carcinoma had increased recurrence-free survival after rHR compared to RFA, but significantly lower morbidity and shorter hospital stays with RFA compared to rHR; overall survival rates were not significantly different between groups.

Major finding: The median recurrence-free survival was longer in recurrent HCC patients treated with rHR compared to RFA (23.6 months vs 15.2 months, hazard ratio 0.76). However, RFA was significantly association with lower morbidity of grade 3 and above (0.6% vs 6.2%) and with a shorter hospital stay (8.0 days vs 3.0 days) compared to rHR.

Study details: The data come from a retrospective, multicenter study including 847 HCC patients; of these, 307 underwent repeat hepatic resection (rHR) and 540 underwent radiofrequency ablation (RFA) between January 2003 and January 2018.

Disclosures: The study was supported by the Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Guangxi BaGui Scholars’ Special Fund, the Gunagxi Natural Science Foundation, and the Science Research and Technology Development Programme of Guangxi. The researchers had no financial conflicts to disclose.

Source: Zhong J-H et al. Br J Surg. 2021 Oct 13. doi: 10.1093/bjs/znab340.

Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.

Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was

Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.

Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.

Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was

Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.

Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.

Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was

Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.

Results of a new analysis based on benchmarks from the National Institute for Occupational Safety and Health (NIOSH) suggest that the levels of metals and volatile organic compounds generated during laser tattoo removal procedures are generally safe.

While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”

For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.

For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”

For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”

He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.

Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
 

Picosecond lasers

“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.

Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.

“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”

In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”

In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.

This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.

Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”

Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”

In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

Results of a new analysis based on benchmarks from the National Institute for Occupational Safety and Health (NIOSH) suggest that the levels of metals and volatile organic compounds generated during laser tattoo removal procedures are generally safe.

While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”

For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.

For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”

For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”

He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.

Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
 

Picosecond lasers

“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.

Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.

“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”

In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”

In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.

This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.

Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”

Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”

In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

Results of a new analysis based on benchmarks from the National Institute for Occupational Safety and Health (NIOSH) suggest that the levels of metals and volatile organic compounds generated during laser tattoo removal procedures are generally safe.

While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”

For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.

For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”

For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”

He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.

Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
 

Picosecond lasers

“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.

Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.

“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”

In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”

In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.

This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.

Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”

Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”

In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”

Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.

[email protected]

Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.

Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was

Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.

Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.

Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was

Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.

Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.

Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was

Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.

Key clinical point: A combination of hepatic artery infusion chemotherapy (HAIC), anti-PD-1 immunotherapy, and tyrosine kinase inhibitors (TKIs) yielded a median of 10.6 months for progression-free survival with no treatment-related deaths over a 4- to 24-month follow-up period in advanced HCC patients.

Major finding: Combination chemotherapy and immunotherapy resulted in a median progression-free survival of 10.6 months with a median 12.9 months’ follow up; objective response rates and disease control rates were 63.0 and 92.6%, respectively.

Study details: The data come from a retrospective study of 27 adults with advanced hepatocellular carcinoma treated between May 2019 and November 2020 in a single center. Patients received hepatic artery infusion chemotherapy (HAIC), anti-PD-1 immunotherapy, and tyrosine kinase inhibitors (TKIs). 

Disclosures: The study was supported by the National Key R and D Program of China, the Key Projects of CSCO-Bayer Cancer Research Fund, the Beijing Municipal Science and Technology Commission, and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

Source: Liu B-J et al. Immunotherapy. 2021 Oct 5. doi: 10.2217/imt-2021-0192. 

Key clinical point: A combination of hepatic artery infusion chemotherapy (HAIC), anti-PD-1 immunotherapy, and tyrosine kinase inhibitors (TKIs) yielded a median of 10.6 months for progression-free survival with no treatment-related deaths over a 4- to 24-month follow-up period in advanced HCC patients.

Major finding: Combination chemotherapy and immunotherapy resulted in a median progression-free survival of 10.6 months with a median 12.9 months’ follow up; objective response rates and disease control rates were 63.0 and 92.6%, respectively.

Study details: The data come from a retrospective study of 27 adults with advanced hepatocellular carcinoma treated between May 2019 and November 2020 in a single center. Patients received hepatic artery infusion chemotherapy (HAIC), anti-PD-1 immunotherapy, and tyrosine kinase inhibitors (TKIs). 

Disclosures: The study was supported by the National Key R and D Program of China, the Key Projects of CSCO-Bayer Cancer Research Fund, the Beijing Municipal Science and Technology Commission, and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

Source: Liu B-J et al. Immunotherapy. 2021 Oct 5. doi: 10.2217/imt-2021-0192. 

Key clinical point: A combination of hepatic artery infusion chemotherapy (HAIC), anti-PD-1 immunotherapy, and tyrosine kinase inhibitors (TKIs) yielded a median of 10.6 months for progression-free survival with no treatment-related deaths over a 4- to 24-month follow-up period in advanced HCC patients.

Major finding: Combination chemotherapy and immunotherapy resulted in a median progression-free survival of 10.6 months with a median 12.9 months’ follow up; objective response rates and disease control rates were 63.0 and 92.6%, respectively.

Study details: The data come from a retrospective study of 27 adults with advanced hepatocellular carcinoma treated between May 2019 and November 2020 in a single center. Patients received hepatic artery infusion chemotherapy (HAIC), anti-PD-1 immunotherapy, and tyrosine kinase inhibitors (TKIs). 

Disclosures: The study was supported by the National Key R and D Program of China, the Key Projects of CSCO-Bayer Cancer Research Fund, the Beijing Municipal Science and Technology Commission, and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.

Source: Liu B-J et al. Immunotherapy. 2021 Oct 5. doi: 10.2217/imt-2021-0192. 

Key clinical point: Cabozatinib significantly improved overall survival and progression-free survival in HCC patients with ALBI grades 1 and 2 compared with placebo.

Major finding: Median overall survival in HCC patients with ALBI grade 1 was 17.5 months for in the cabozantinib group vs 11.4 months in the placebo group; median overall survival in patients with ALBI grade 2 was 8.0 months in the cabozantinib group vs 6.4 months in the placebo group.

Study details: The data come from a randomized trial of 707 adults with HCC with albumin-bilirubin (ALBI) grades 1 or 2 at baseline who received 60 mg of cabozantinib daily or a placebo.

Disclosures: The study was supported by Exelixis. Lead author Dr. Kelley disclosed relationships with multiple companies including Exelixis.

Source: Kelley RK et al. Br J Cancer. 2021 Oct 7. doi: 10.1038/s41416-021-01532-5.

Key clinical point: Cabozatinib significantly improved overall survival and progression-free survival in HCC patients with ALBI grades 1 and 2 compared with placebo.

Major finding: Median overall survival in HCC patients with ALBI grade 1 was 17.5 months for in the cabozantinib group vs 11.4 months in the placebo group; median overall survival in patients with ALBI grade 2 was 8.0 months in the cabozantinib group vs 6.4 months in the placebo group.

Study details: The data come from a randomized trial of 707 adults with HCC with albumin-bilirubin (ALBI) grades 1 or 2 at baseline who received 60 mg of cabozantinib daily or a placebo.

Disclosures: The study was supported by Exelixis. Lead author Dr. Kelley disclosed relationships with multiple companies including Exelixis.

Source: Kelley RK et al. Br J Cancer. 2021 Oct 7. doi: 10.1038/s41416-021-01532-5.

Key clinical point: Cabozatinib significantly improved overall survival and progression-free survival in HCC patients with ALBI grades 1 and 2 compared with placebo.

Major finding: Median overall survival in HCC patients with ALBI grade 1 was 17.5 months for in the cabozantinib group vs 11.4 months in the placebo group; median overall survival in patients with ALBI grade 2 was 8.0 months in the cabozantinib group vs 6.4 months in the placebo group.

Study details: The data come from a randomized trial of 707 adults with HCC with albumin-bilirubin (ALBI) grades 1 or 2 at baseline who received 60 mg of cabozantinib daily or a placebo.

Disclosures: The study was supported by Exelixis. Lead author Dr. Kelley disclosed relationships with multiple companies including Exelixis.

Source: Kelley RK et al. Br J Cancer. 2021 Oct 7. doi: 10.1038/s41416-021-01532-5.

Key clinical point: Barcelona Clinic Liver Cancer staging is applicable to recurrent HCC and should be used to formulate clinical stage criteria and develop treatment plans.

Major finding: The median time to tumor recurrence differed significantly among the BCLC staging groups A, B, and C (16 months, 10 months, and 6 months, respectively; P < 0.05). Median overall survival also differed significantly among groups A, B, and C (42 months, 22 months, and 13 months, respectively; P < 0.05).

Study details: The data come from a retrospective cohort study of 81 adults with recurrent HCC who were admitted to a single center between January 2013 and December 2017; they were divided into three groups based on the Barcelona Clinic Liver Cancer (BCLC) staging system to compare median time to tumor recurrence and median overall survival.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Yao S-Y et al. World J Clin Cases. 2021 Sep 26. doi: 10.12998/wjcc.v9.i27.8020.

Key clinical point: Barcelona Clinic Liver Cancer staging is applicable to recurrent HCC and should be used to formulate clinical stage criteria and develop treatment plans.

Major finding: The median time to tumor recurrence differed significantly among the BCLC staging groups A, B, and C (16 months, 10 months, and 6 months, respectively; P < 0.05). Median overall survival also differed significantly among groups A, B, and C (42 months, 22 months, and 13 months, respectively; P < 0.05).

Study details: The data come from a retrospective cohort study of 81 adults with recurrent HCC who were admitted to a single center between January 2013 and December 2017; they were divided into three groups based on the Barcelona Clinic Liver Cancer (BCLC) staging system to compare median time to tumor recurrence and median overall survival.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Yao S-Y et al. World J Clin Cases. 2021 Sep 26. doi: 10.12998/wjcc.v9.i27.8020.

Key clinical point: Barcelona Clinic Liver Cancer staging is applicable to recurrent HCC and should be used to formulate clinical stage criteria and develop treatment plans.

Major finding: The median time to tumor recurrence differed significantly among the BCLC staging groups A, B, and C (16 months, 10 months, and 6 months, respectively; P < 0.05). Median overall survival also differed significantly among groups A, B, and C (42 months, 22 months, and 13 months, respectively; P < 0.05).

Study details: The data come from a retrospective cohort study of 81 adults with recurrent HCC who were admitted to a single center between January 2013 and December 2017; they were divided into three groups based on the Barcelona Clinic Liver Cancer (BCLC) staging system to compare median time to tumor recurrence and median overall survival.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Yao S-Y et al. World J Clin Cases. 2021 Sep 26. doi: 10.12998/wjcc.v9.i27.8020.

Key clinical point: The CoxNet machine learning model was validated as a predictor of recurrence of HCC in patients who underwent liver transplant.

Major finding: The concordance score of the CoxNet-based recurrence prediction model was 0.75, which significantly outperformed the alpha-fetoprotein score (0.64; P = 0.04) and MORAL score (0.64; P = 0.03).

Study details: The data come from 739 adults with hepatocellular carcinoma who underwent liver transplants between 2000 and 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ivanics T et al. Liver Transpl. 2021 Oct 9. doi: 10.1002/lt.26332. 

Key clinical point: The CoxNet machine learning model was validated as a predictor of recurrence of HCC in patients who underwent liver transplant.

Major finding: The concordance score of the CoxNet-based recurrence prediction model was 0.75, which significantly outperformed the alpha-fetoprotein score (0.64; P = 0.04) and MORAL score (0.64; P = 0.03).

Study details: The data come from 739 adults with hepatocellular carcinoma who underwent liver transplants between 2000 and 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ivanics T et al. Liver Transpl. 2021 Oct 9. doi: 10.1002/lt.26332. 

Key clinical point: The CoxNet machine learning model was validated as a predictor of recurrence of HCC in patients who underwent liver transplant.

Major finding: The concordance score of the CoxNet-based recurrence prediction model was 0.75, which significantly outperformed the alpha-fetoprotein score (0.64; P = 0.04) and MORAL score (0.64; P = 0.03).

Study details: The data come from 739 adults with hepatocellular carcinoma who underwent liver transplants between 2000 and 2016.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Ivanics T et al. Liver Transpl. 2021 Oct 9. doi: 10.1002/lt.26332. 

Key clinical point: Patients with unresectable hepatocellular carcinoma needed higher relative dose intensity (RDI) to achieve an objective response with lenvatinib, but the therapeutic line did not impact overall survival, time to progression, or best response.

Major finding:  RDI ≥0.8 during cycle 1 and RDI ≥0.4 during cycle 1 contributed to achievement of objective response with levatinib (odds ratio 3.28) and disease control (OR 4.85).

Study details: The data come from a retrospective study of 100 patients with unresectable hepatocellular carcinoma who received first- or later-line lenvatinib between April 2018 and December 2020 in a single center; they were assessed for time to objective response, disease control, overall survival, and time to progression.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Tokunaga T et al. Hepatol Res. 2021 Oct 9. doi: 10.1111/hepr.13720.

Key clinical point: Patients with unresectable hepatocellular carcinoma needed higher relative dose intensity (RDI) to achieve an objective response with lenvatinib, but the therapeutic line did not impact overall survival, time to progression, or best response.

Major finding:  RDI ≥0.8 during cycle 1 and RDI ≥0.4 during cycle 1 contributed to achievement of objective response with levatinib (odds ratio 3.28) and disease control (OR 4.85).

Study details: The data come from a retrospective study of 100 patients with unresectable hepatocellular carcinoma who received first- or later-line lenvatinib between April 2018 and December 2020 in a single center; they were assessed for time to objective response, disease control, overall survival, and time to progression.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Tokunaga T et al. Hepatol Res. 2021 Oct 9. doi: 10.1111/hepr.13720.

Key clinical point: Patients with unresectable hepatocellular carcinoma needed higher relative dose intensity (RDI) to achieve an objective response with lenvatinib, but the therapeutic line did not impact overall survival, time to progression, or best response.

Major finding:  RDI ≥0.8 during cycle 1 and RDI ≥0.4 during cycle 1 contributed to achievement of objective response with levatinib (odds ratio 3.28) and disease control (OR 4.85).

Study details: The data come from a retrospective study of 100 patients with unresectable hepatocellular carcinoma who received first- or later-line lenvatinib between April 2018 and December 2020 in a single center; they were assessed for time to objective response, disease control, overall survival, and time to progression.

Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.

Source: Tokunaga T et al. Hepatol Res. 2021 Oct 9. doi: 10.1111/hepr.13720.

The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.

Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”

For what it says is the first time in the industry, Pfizer has issued a warranty on crizotinib (Xalkori) and will refund the cost that was paid for the medicine if it doesn’t work within the first 3 months of use.

“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.

Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.

In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.

Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
 

Pfizer pledge

Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.

Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.

“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”

This program is only available for patients who reside in the United States.

If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.

“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.

The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.

So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.

“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
 

Previous scheme ended in court

Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).

Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.

Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.

The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.

Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.

The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.

A version of this article first appeared on Medscape.com.

The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.

Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”

For what it says is the first time in the industry, Pfizer has issued a warranty on crizotinib (Xalkori) and will refund the cost that was paid for the medicine if it doesn’t work within the first 3 months of use.

“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.

Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.

In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.

Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
 

Pfizer pledge

Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.

Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.

“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”

This program is only available for patients who reside in the United States.

If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.

“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.

The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.

So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.

“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
 

Previous scheme ended in court

Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).

Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.

Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.

The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.

Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.

The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.

A version of this article first appeared on Medscape.com.

The high cost of new cancer drugs has been the subject of many debates and discussions, but the issue remains largely unresolved.

Now, one pharmaceutical company is offering a refund if its drug “doesn’t work.”

For what it says is the first time in the industry, Pfizer has issued a warranty on crizotinib (Xalkori) and will refund the cost that was paid for the medicine if it doesn’t work within the first 3 months of use.

“Through this pilot program, Pfizer will offer a warranty to patients and health plans -- Medicare Part D, commercial and those who pay cash -- who are prescribed Xalkori for an FDA [US Food and Drug Administration]–approved indication,” said a company spokesperson.

Although Pfizer claims that its pilot program is a first in the industry, there have been others that are similar.

In 2017, Novartis offered something similar for tisagenlecleucel (Kymriah), the CAR T-cell therapy that launched with a daunting price tag of $475,000. After receiving backlash over the cost, Novartis announced that if the drug does not work after the first month, patients pay nothing.

Italy has been using this system for several years. Pharmaceutical companies must refund money if the drug fails to work. In 2015, the state-run healthcare system collected €200 million ($220 million) in refunds.
 

Pfizer pledge

Crizotinib is a selective tyrosine kinase inhibitor used mainly in the treatment of metastatic non–small cell lung cancer for patients whose tumors are positive for ALK or ROS1, as detected by an FDA-approved test. This indication was approved a decade ago. Another indication, ALK-positive anaplastic large cell lymphoma, was added earlier this year.

Details of the Pfizer Pledge are posted on Pfizer’s website. Eligible patients are those for whom crizotinib is discontinued before the fourth 30-day supply is dispensed by the patient’s pharmacy.

“The warranty will reimburse an amount equal to the cost paid for the medicine,” the spokesperson added. “The insurance-backed warranty pilot program will be insured and managed by AIG.”

This program is only available for patients who reside in the United States.

If use of crizotinib is discontinued and documentation of ineffectiveness is provided, Pfizer will refund the out-of-pocket amount that was paid for up to the first three bottles (30-day supply) of crizotinib, up to a maximum of $19,144 for each month’s supply, or a total of $57,432. Pfizer will also refund the cost that was paid by Medicare or a commercial insurer.

“Also, we have made sure to develop a program that also allows for Medicare patients to be eligible, since they are exempt from copay cards and at risk for significant financial burden when starting an oncology treatment,” said the spokesperson.

The pilot program is available to patients who began taking crizotinib from June 1, 2021, through December 31, 2021.

So far, Pfizer is offering this warranty only for crizotinib, but that may change in the future.

“Once the pilot is complete, we will assess learnings and consider whether to build a more robust, scalable program capable of supporting multiple products,” the Pfizer spokesperson commented.
 

Previous scheme ended in court

Pfizer had previously tried a different approach to reducing drug costs: it had attempted to offer copay support programs to Medicare patients who were prescribed its cardiac drug tafamidis (Vyndaqe, Vyndamax).

Tafamidis, launched in 2019, is used for patients with transthyretin amyloid cardiomyopathy. For those patients, it has been shown to reduce all-cause mortality and cardiovascular hospitalizations. It costs about $225,000 a year and has been described as the most expensive cardiovascular drug in the United States.

Earlier this month, a court dismissed Pfizer’s challenge to an anti-kickback law that prevented the company from offering copay support programs to Medicare patients.

The judge ruled that Pfizer’s plan to offer direct payments to patients violated a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even in the absence of corrupt intent.

Pharmaceutical manufacturers are forbidden from subsidizing copayments for Medicare beneficiaries but are allowed to donate to independent nonprofit organizations that offer copay assistance. Pfizer sued the U.S. Department of Health and Human Services in June 2020 to get a court ruling that their proposed programs were legal.

The new pledge program for crizotinib operates from a different premise, the Pfizer spokesperson commented.

A version of this article first appeared on Medscape.com.