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.

Self-administered external trigeminal nerve stimulation (E-TNS) that is available over the counter is superior to sham stimulation in relieving pain for patients with episodic migraine, results from a phase 3 study show.

This is great news for headache patients who want to explore nondrug treatment options, said study investigator Deena E. Kuruvilla, MD, neurologist and headache specialist at the Westport Headache Institute, Connecticut.

She added that such devices “aren’t always part of the conversation when we’re discussing preventive and acute treatments with our patients. Making this a regular part of the conversation might be helpful to patients.”

The findings were presented at ANA 2021: 146th Annual Meeting of the American Neurological Association (ANA), which was held online.
 

A key therapeutic target

The randomized, double-blind trial compared E-TNS with sham stimulation for the acute treatment of migraine.

The E-TNS device (Verum Cefaly Abortive Program) stimulates the supraorbital nerve in the forehead. “This nerve is a branch of the trigeminal nerve, which is thought to be the key player in migraine pathophysiology,” Dr. Kuruvilla noted.

The device has been cleared by the U.S. Food and Drug Administration for acute and preventive treatment of migraine.

During a run-in period before randomization, patients were asked to keep a detailed headache diary and to become comfortable using the trial device to treat an acute migraine attack at home.

The study enrolled 538 adult patients at 10 centers. The patients were aged 18 to 65 years, and they had been having episodic migraines, with or without aura, for at least a year. The participants had to have received a migraine diagnosis before age 50, and they had to be experiencing an attack of migraine 2 to 8 days per month.

The patients used the device only for a migraine of at least moderate intensity that was accompanied by at least one migraine-associated symptom, such as photophobia, phonophobia, or nausea. They were asked not to take rescue medication prior to or during a therapy session.

Study participants applied either neurostimulation or sham stimulation for a continuous 2-hour period within 4 hours of a migraine attack over the 2-month study period.

The two primary endpoints were pain freedom and freedom from the most bothersome migraine-associated symptoms at 2 hours.

Compared to sham treatment, active stimulation was more effective in achieving pain freedom (P = .043) and freedom from the most bothersome migraine-associated symptom (P = .001) at 2 hours.

“So the study did meet both primary endpoints with statistical significance,” said Dr. Kuruvilla.

The five secondary endpoints included pain relief at 2 hours; absence of all migraine-associated symptoms at 2 hours; use of rescue medication within 24 hours; sustained pain freedom at 24 hours; and sustained pain relief at 24 hours.

All but one of these endpoints reached statistical significance, showing superiority for the active intervention. The only exception was in regard to use of rescue medication.

The most common adverse event (AE) was forehead paresthesia, discomfort, or burning, which was more common in the active-treatment group than in the sham-treatment group (P = .009). There were four cases of nausea or vomiting in the active-treatment group and none in the sham-treatment group. There were no serious AEs.
 

Available over the counter

Both moderators of the headache poster tour that featured this study – Justin C. McArthur, MBBS, from Johns Hopkins University, Baltimore, and Steven Galetta, MD, from NYU Grossman School of Medicine – praised the presentation.

Dr. Galetta questioned whether patients were receiving preventive therapies. Dr. Kuruvilla said that the patients were allowed to enter the trial while taking preventive therapies, including antiepileptic treatments, blood pressure medications, and antidepressants, but that they had to be receiving stable doses.

The investigators didn’t distinguish between participants who were taking preventive therapies and those who weren’t, she said. “The aim was really to look at acute treatment for migraine,” and patients taking such medication “had been stable on their regimen for a pretty prolonged period of time.”

Dr. McArthur asked about the origin of the nausea some patients experienced.

It was difficult to determine whether the nausea was an aspect of an individual patient’s migraine attack or was an effect of the stimulation, said Dr. Kuruvilla. She noted that some patients found the vibrating sensation from the device uncomfortable and that nausea could be associated with pain at the site.

The device costs $300 to $400 (U.S.) and is available over the counter.

Dr. Kuruvilla is a consultant for Cefaly, Neurolief, Theranica, Now What Media, and Kx Advisors. She is on the speakers bureau for AbbVie/Allergan, Amgen/Novartis, Lilly, the American Headache Society, Biohaven, and CME meeting, and she is on an advisory board at AbbVie/Allergan, Lilly, Theranica, and Amgen/Novartis. She is editor and associate editor of Healthline and is an author for WebMD/Medscape, Healthline.

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

Self-administered external trigeminal nerve stimulation (E-TNS) that is available over the counter is superior to sham stimulation in relieving pain for patients with episodic migraine, results from a phase 3 study show.

This is great news for headache patients who want to explore nondrug treatment options, said study investigator Deena E. Kuruvilla, MD, neurologist and headache specialist at the Westport Headache Institute, Connecticut.

She added that such devices “aren’t always part of the conversation when we’re discussing preventive and acute treatments with our patients. Making this a regular part of the conversation might be helpful to patients.”

The findings were presented at ANA 2021: 146th Annual Meeting of the American Neurological Association (ANA), which was held online.
 

A key therapeutic target

The randomized, double-blind trial compared E-TNS with sham stimulation for the acute treatment of migraine.

The E-TNS device (Verum Cefaly Abortive Program) stimulates the supraorbital nerve in the forehead. “This nerve is a branch of the trigeminal nerve, which is thought to be the key player in migraine pathophysiology,” Dr. Kuruvilla noted.

The device has been cleared by the U.S. Food and Drug Administration for acute and preventive treatment of migraine.

During a run-in period before randomization, patients were asked to keep a detailed headache diary and to become comfortable using the trial device to treat an acute migraine attack at home.

The study enrolled 538 adult patients at 10 centers. The patients were aged 18 to 65 years, and they had been having episodic migraines, with or without aura, for at least a year. The participants had to have received a migraine diagnosis before age 50, and they had to be experiencing an attack of migraine 2 to 8 days per month.

The patients used the device only for a migraine of at least moderate intensity that was accompanied by at least one migraine-associated symptom, such as photophobia, phonophobia, or nausea. They were asked not to take rescue medication prior to or during a therapy session.

Study participants applied either neurostimulation or sham stimulation for a continuous 2-hour period within 4 hours of a migraine attack over the 2-month study period.

The two primary endpoints were pain freedom and freedom from the most bothersome migraine-associated symptoms at 2 hours.

Compared to sham treatment, active stimulation was more effective in achieving pain freedom (P = .043) and freedom from the most bothersome migraine-associated symptom (P = .001) at 2 hours.

“So the study did meet both primary endpoints with statistical significance,” said Dr. Kuruvilla.

The five secondary endpoints included pain relief at 2 hours; absence of all migraine-associated symptoms at 2 hours; use of rescue medication within 24 hours; sustained pain freedom at 24 hours; and sustained pain relief at 24 hours.

All but one of these endpoints reached statistical significance, showing superiority for the active intervention. The only exception was in regard to use of rescue medication.

The most common adverse event (AE) was forehead paresthesia, discomfort, or burning, which was more common in the active-treatment group than in the sham-treatment group (P = .009). There were four cases of nausea or vomiting in the active-treatment group and none in the sham-treatment group. There were no serious AEs.
 

Available over the counter

Both moderators of the headache poster tour that featured this study – Justin C. McArthur, MBBS, from Johns Hopkins University, Baltimore, and Steven Galetta, MD, from NYU Grossman School of Medicine – praised the presentation.

Dr. Galetta questioned whether patients were receiving preventive therapies. Dr. Kuruvilla said that the patients were allowed to enter the trial while taking preventive therapies, including antiepileptic treatments, blood pressure medications, and antidepressants, but that they had to be receiving stable doses.

The investigators didn’t distinguish between participants who were taking preventive therapies and those who weren’t, she said. “The aim was really to look at acute treatment for migraine,” and patients taking such medication “had been stable on their regimen for a pretty prolonged period of time.”

Dr. McArthur asked about the origin of the nausea some patients experienced.

It was difficult to determine whether the nausea was an aspect of an individual patient’s migraine attack or was an effect of the stimulation, said Dr. Kuruvilla. She noted that some patients found the vibrating sensation from the device uncomfortable and that nausea could be associated with pain at the site.

The device costs $300 to $400 (U.S.) and is available over the counter.

Dr. Kuruvilla is a consultant for Cefaly, Neurolief, Theranica, Now What Media, and Kx Advisors. She is on the speakers bureau for AbbVie/Allergan, Amgen/Novartis, Lilly, the American Headache Society, Biohaven, and CME meeting, and she is on an advisory board at AbbVie/Allergan, Lilly, Theranica, and Amgen/Novartis. She is editor and associate editor of Healthline and is an author for WebMD/Medscape, Healthline.

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

Self-administered external trigeminal nerve stimulation (E-TNS) that is available over the counter is superior to sham stimulation in relieving pain for patients with episodic migraine, results from a phase 3 study show.

This is great news for headache patients who want to explore nondrug treatment options, said study investigator Deena E. Kuruvilla, MD, neurologist and headache specialist at the Westport Headache Institute, Connecticut.

She added that such devices “aren’t always part of the conversation when we’re discussing preventive and acute treatments with our patients. Making this a regular part of the conversation might be helpful to patients.”

The findings were presented at ANA 2021: 146th Annual Meeting of the American Neurological Association (ANA), which was held online.
 

A key therapeutic target

The randomized, double-blind trial compared E-TNS with sham stimulation for the acute treatment of migraine.

The E-TNS device (Verum Cefaly Abortive Program) stimulates the supraorbital nerve in the forehead. “This nerve is a branch of the trigeminal nerve, which is thought to be the key player in migraine pathophysiology,” Dr. Kuruvilla noted.

The device has been cleared by the U.S. Food and Drug Administration for acute and preventive treatment of migraine.

During a run-in period before randomization, patients were asked to keep a detailed headache diary and to become comfortable using the trial device to treat an acute migraine attack at home.

The study enrolled 538 adult patients at 10 centers. The patients were aged 18 to 65 years, and they had been having episodic migraines, with or without aura, for at least a year. The participants had to have received a migraine diagnosis before age 50, and they had to be experiencing an attack of migraine 2 to 8 days per month.

The patients used the device only for a migraine of at least moderate intensity that was accompanied by at least one migraine-associated symptom, such as photophobia, phonophobia, or nausea. They were asked not to take rescue medication prior to or during a therapy session.

Study participants applied either neurostimulation or sham stimulation for a continuous 2-hour period within 4 hours of a migraine attack over the 2-month study period.

The two primary endpoints were pain freedom and freedom from the most bothersome migraine-associated symptoms at 2 hours.

Compared to sham treatment, active stimulation was more effective in achieving pain freedom (P = .043) and freedom from the most bothersome migraine-associated symptom (P = .001) at 2 hours.

“So the study did meet both primary endpoints with statistical significance,” said Dr. Kuruvilla.

The five secondary endpoints included pain relief at 2 hours; absence of all migraine-associated symptoms at 2 hours; use of rescue medication within 24 hours; sustained pain freedom at 24 hours; and sustained pain relief at 24 hours.

All but one of these endpoints reached statistical significance, showing superiority for the active intervention. The only exception was in regard to use of rescue medication.

The most common adverse event (AE) was forehead paresthesia, discomfort, or burning, which was more common in the active-treatment group than in the sham-treatment group (P = .009). There were four cases of nausea or vomiting in the active-treatment group and none in the sham-treatment group. There were no serious AEs.
 

Available over the counter

Both moderators of the headache poster tour that featured this study – Justin C. McArthur, MBBS, from Johns Hopkins University, Baltimore, and Steven Galetta, MD, from NYU Grossman School of Medicine – praised the presentation.

Dr. Galetta questioned whether patients were receiving preventive therapies. Dr. Kuruvilla said that the patients were allowed to enter the trial while taking preventive therapies, including antiepileptic treatments, blood pressure medications, and antidepressants, but that they had to be receiving stable doses.

The investigators didn’t distinguish between participants who were taking preventive therapies and those who weren’t, she said. “The aim was really to look at acute treatment for migraine,” and patients taking such medication “had been stable on their regimen for a pretty prolonged period of time.”

Dr. McArthur asked about the origin of the nausea some patients experienced.

It was difficult to determine whether the nausea was an aspect of an individual patient’s migraine attack or was an effect of the stimulation, said Dr. Kuruvilla. She noted that some patients found the vibrating sensation from the device uncomfortable and that nausea could be associated with pain at the site.

The device costs $300 to $400 (U.S.) and is available over the counter.

Dr. Kuruvilla is a consultant for Cefaly, Neurolief, Theranica, Now What Media, and Kx Advisors. She is on the speakers bureau for AbbVie/Allergan, Amgen/Novartis, Lilly, the American Headache Society, Biohaven, and CME meeting, and she is on an advisory board at AbbVie/Allergan, Lilly, Theranica, and Amgen/Novartis. She is editor and associate editor of Healthline and is an author for WebMD/Medscape, Healthline.

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

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.