CML

Prescription drugs

Credit: CDC

When their share of prescription costs becomes too high, many patients with chronic myeloid leukemia (CML) will skip doses of imatinib or stop taking the drug entirely, new research suggests.

In a study of about 1500 patients, the median co-payment for an imatinib prescription was about $30 per fill, but the range was $0 to $4792.

Patients with higher co-payments were 70% more likely than their peers to stop taking imatinib and 42% more likely to skip doses of the drug.

Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill, and her colleagues conducted this research and described the results in the Journal of Clinical Oncology.

Co-payment requirements vary

The researchers analyzed health plan claims from privately insured adults (ages 18 to 64) from 2002 to 2011. The data included 1541 CML patients beginning treatment with imatinib.

For the whole study period, the mean co-payment was $108 for a 30-day supply of imatinib. Patients in the lowest 25th percentile paid a mean of $17, and patients in the upper 75th percentile paid a mean of $53.

As expected, monthly co-payments increased over time. They averaged $55 in 2002 and $145 in 2011, with 6.4% of patients paying more than $500 a month.

Dr Dusetzina noted that the data only included patients on employer-based insurance plans, and most individuals had low out-of-pocket costs.

“We studied people who are part of large employer groups, so their insurance is probably more generous than someone who is buying insurance on a private market that does not have a lot of negotiating power,” she said.

Costs correlate with adherence

In the first 180 days of treatment, 30% of patients with higher co-payments were non-adherent to imatinib treatment, compared to 21% of patients with lower co-payments. Non-adherence was defined as having less than 80% of days with imatinib available.

Seventeen percent of patients with higher co-payments discontinued taking imatinib, compared to 10% of patients with lower co-payments. Discontinuation was defined as having a gap of more than 60 days after the exhaustion of imatinib therapy.

These data did not include patients who could not begin taking imatinib due to costs. Therefore, Dr Dusetzina said this study likely underestimates the effects of drug costs on treatment adherence.

“If you went to the pharmacy to obtain your prescription, and they said it was $5000, and you walked away because you couldn’t afford to pay, you’re not in the data,” she said. “We could only study individuals who filled at least one prescription.”

Dr Dusetzina also said these findings have implications beyond imatinib and CML. Many new treatments for rare conditions can cost insurers and patients more than $100,000 year.

“Our results are particularly relevant for specialty pharmaceutical products—those that cost over $10,000 a month,” she said.

“However, the lessons learned likely relate to any pharmaceutical product that has high out-of-pocket costs. It is important that we identify strategies to make effective but expensive medications more affordable to patients.”

Prescription drugs

Credit: CDC

When their share of prescription costs becomes too high, many patients with chronic myeloid leukemia (CML) will skip doses of imatinib or stop taking the drug entirely, new research suggests.

In a study of about 1500 patients, the median co-payment for an imatinib prescription was about $30 per fill, but the range was $0 to $4792.

Patients with higher co-payments were 70% more likely than their peers to stop taking imatinib and 42% more likely to skip doses of the drug.

Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill, and her colleagues conducted this research and described the results in the Journal of Clinical Oncology.

Co-payment requirements vary

The researchers analyzed health plan claims from privately insured adults (ages 18 to 64) from 2002 to 2011. The data included 1541 CML patients beginning treatment with imatinib.

For the whole study period, the mean co-payment was $108 for a 30-day supply of imatinib. Patients in the lowest 25th percentile paid a mean of $17, and patients in the upper 75th percentile paid a mean of $53.

As expected, monthly co-payments increased over time. They averaged $55 in 2002 and $145 in 2011, with 6.4% of patients paying more than $500 a month.

Dr Dusetzina noted that the data only included patients on employer-based insurance plans, and most individuals had low out-of-pocket costs.

“We studied people who are part of large employer groups, so their insurance is probably more generous than someone who is buying insurance on a private market that does not have a lot of negotiating power,” she said.

Costs correlate with adherence

In the first 180 days of treatment, 30% of patients with higher co-payments were non-adherent to imatinib treatment, compared to 21% of patients with lower co-payments. Non-adherence was defined as having less than 80% of days with imatinib available.

Seventeen percent of patients with higher co-payments discontinued taking imatinib, compared to 10% of patients with lower co-payments. Discontinuation was defined as having a gap of more than 60 days after the exhaustion of imatinib therapy.

These data did not include patients who could not begin taking imatinib due to costs. Therefore, Dr Dusetzina said this study likely underestimates the effects of drug costs on treatment adherence.

“If you went to the pharmacy to obtain your prescription, and they said it was $5000, and you walked away because you couldn’t afford to pay, you’re not in the data,” she said. “We could only study individuals who filled at least one prescription.”

Dr Dusetzina also said these findings have implications beyond imatinib and CML. Many new treatments for rare conditions can cost insurers and patients more than $100,000 year.

“Our results are particularly relevant for specialty pharmaceutical products—those that cost over $10,000 a month,” she said.

“However, the lessons learned likely relate to any pharmaceutical product that has high out-of-pocket costs. It is important that we identify strategies to make effective but expensive medications more affordable to patients.”

Prescription drugs

Credit: CDC

When their share of prescription costs becomes too high, many patients with chronic myeloid leukemia (CML) will skip doses of imatinib or stop taking the drug entirely, new research suggests.

In a study of about 1500 patients, the median co-payment for an imatinib prescription was about $30 per fill, but the range was $0 to $4792.

Patients with higher co-payments were 70% more likely than their peers to stop taking imatinib and 42% more likely to skip doses of the drug.

Stacie B. Dusetzina, PhD, of the University of North Carolina at Chapel Hill, and her colleagues conducted this research and described the results in the Journal of Clinical Oncology.

Co-payment requirements vary

The researchers analyzed health plan claims from privately insured adults (ages 18 to 64) from 2002 to 2011. The data included 1541 CML patients beginning treatment with imatinib.

For the whole study period, the mean co-payment was $108 for a 30-day supply of imatinib. Patients in the lowest 25th percentile paid a mean of $17, and patients in the upper 75th percentile paid a mean of $53.

As expected, monthly co-payments increased over time. They averaged $55 in 2002 and $145 in 2011, with 6.4% of patients paying more than $500 a month.

Dr Dusetzina noted that the data only included patients on employer-based insurance plans, and most individuals had low out-of-pocket costs.

“We studied people who are part of large employer groups, so their insurance is probably more generous than someone who is buying insurance on a private market that does not have a lot of negotiating power,” she said.

Costs correlate with adherence

In the first 180 days of treatment, 30% of patients with higher co-payments were non-adherent to imatinib treatment, compared to 21% of patients with lower co-payments. Non-adherence was defined as having less than 80% of days with imatinib available.

Seventeen percent of patients with higher co-payments discontinued taking imatinib, compared to 10% of patients with lower co-payments. Discontinuation was defined as having a gap of more than 60 days after the exhaustion of imatinib therapy.

These data did not include patients who could not begin taking imatinib due to costs. Therefore, Dr Dusetzina said this study likely underestimates the effects of drug costs on treatment adherence.

“If you went to the pharmacy to obtain your prescription, and they said it was $5000, and you walked away because you couldn’t afford to pay, you’re not in the data,” she said. “We could only study individuals who filled at least one prescription.”

Dr Dusetzina also said these findings have implications beyond imatinib and CML. Many new treatments for rare conditions can cost insurers and patients more than $100,000 year.

“Our results are particularly relevant for specialty pharmaceutical products—those that cost over $10,000 a month,” she said.

“However, the lessons learned likely relate to any pharmaceutical product that has high out-of-pocket costs. It is important that we identify strategies to make effective but expensive medications more affordable to patients.”

Omacetaxine mepesuccinate has been granted accelerated approval for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance or intolerance to 2 or more tyrosine kinase inhibitors (TKIs).^1,2 Approval was based on response rates observed in a combined cohort of adult CML patients from 2 clinical trials. As yet, no clinical trials have verified improved disease-related symptoms or increased survival with omacetaxine treatment.

Click on the PDF icon at the top of this introduction to read the full article.

Omacetaxine mepesuccinate has been granted accelerated approval for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance or intolerance to 2 or more tyrosine kinase inhibitors (TKIs).^1,2 Approval was based on response rates observed in a combined cohort of adult CML patients from 2 clinical trials. As yet, no clinical trials have verified improved disease-related symptoms or increased survival with omacetaxine treatment.

Click on the PDF icon at the top of this introduction to read the full article.

Omacetaxine mepesuccinate has been granted accelerated approval for the treatment of adult patients with chronic phase (CP) or accelerated phase (AP) chronic myeloid leukemia (CML) with resistance or intolerance to 2 or more tyrosine kinase inhibitors (TKIs).^1,2 Approval was based on response rates observed in a combined cohort of adult CML patients from 2 clinical trials. As yet, no clinical trials have verified improved disease-related symptoms or increased survival with omacetaxine treatment.

Click on the PDF icon at the top of this introduction to read the full article.

The FDA has approved bosutinib (Bosulif), an Abl and Src kinase inhibitor, to treat patients with relapsed or refractory chronic myelogenous leukemia (CML).

Bosutinib is intended for use in patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive CML who have failed therapy with first-generation and second-generation tyrosine kinase inhibitors (TKIs).

The recommended dose of bosutinib is 500 mg, taken once daily with food.

“[Bosutinib] is an important new addition to the CML treatment landscape,” said Jorge E. Cortes, MD, of MD Anderson Cancer Center in Houston.

“Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”

Dr Cortes was a lead investigator of the industry-sponsored study that led to bosutinib’s approval. The phase 1/2 trial included 546 adult patients who had chronic, accelerated, or blast phase CML.

Efficacy data

Patients were evaluable for efficacy if they had received at least one bosutinib dose and had a valid baseline efficacy assessment. Of the 546 patients enrolled, 503 were evaluable for efficacy.

Among the patients in chronic phase, 266 received prior treatment with imatinib only, and 108 received prior treatment with imatinib followed by dasatinib and/or nilotinib. There were 129 evaluable patients with advanced phase CML who were previously treated with at least one TKI.

The efficacy endpoints for patients with chronic phase CML were the rate of major cytogenetic response (MCyR) at week 24 and the duration of MCyR. The efficacy endpoints for patients with accelerated phase or blast phase CML were the rates of complete hematologic response (CHR) and overall hematologic response (OHR) by week 48.

In patients with chronic phase CML who received prior therapy with one TKI, 90 patients (33.8%) achieved an MCyR at week 24. Among the chronic phase CML patients who received prior therapy with more than one TKI, 29 (26.9%) achieved an MCyR by week 24.

Of the patients with chronic phase CML who had been treated with one prior TKI, 53.4% achieved an MCyR at any time during the trial. And 52.8% had a response lasting at least 18 months.

For the 32.4% of patients with chronic phase CML treated with more than one TKI who achieved an MCyR at any time, 51.4% had a response lasting at least 9 months.

In patients with accelerated phase CML who received at least one prior TKI, 21 (30.4%) achieved a CHR by week 48. And 38 patients (55.1%) achieved an OHR.

In the blast phase population, 9 patients (15%) achieved a CHR by week 48. And 17 patients (28.3%) achieved an OHR.

Safety data

The researchers evaluated bosutinib’s safety in all 546 patients. Of these patients, 287 had chronic phase CML, were previously treated with a single TKI, and had a median bosutinib treatment duration of 24 months.

There were 119 patients who had chronic phase CML, were previously treated with more than one TKI, and had a median bosutinib treatment duration of 9 months.

There were also 76 patients with accelerated phase CML and 64 patients with blast phase CML.  In these patients, the median treatment duration was 10 months and 3 months, respectively.

The most common adverse events observed in more than 20% of all patients were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.

The most common grade 3 to 4 adverse events observed in more than 10% of patients were thrombocytopenia, anemia, and neutropenia. Other serious adverse events included anaphylactic shock, myelosuppression, gastrointestinal toxicity, fluid retention, hepatoxicity, and rash.

Bosutinib is marketed as Bosulif by Pfizer. For more information on bosutinib, see the package insert.

The FDA has approved bosutinib (Bosulif), an Abl and Src kinase inhibitor, to treat patients with relapsed or refractory chronic myelogenous leukemia (CML).

Bosutinib is intended for use in patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive CML who have failed therapy with first-generation and second-generation tyrosine kinase inhibitors (TKIs).

The recommended dose of bosutinib is 500 mg, taken once daily with food.

“[Bosutinib] is an important new addition to the CML treatment landscape,” said Jorge E. Cortes, MD, of MD Anderson Cancer Center in Houston.

“Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”

Dr Cortes was a lead investigator of the industry-sponsored study that led to bosutinib’s approval. The phase 1/2 trial included 546 adult patients who had chronic, accelerated, or blast phase CML.

Efficacy data

Patients were evaluable for efficacy if they had received at least one bosutinib dose and had a valid baseline efficacy assessment. Of the 546 patients enrolled, 503 were evaluable for efficacy.

Among the patients in chronic phase, 266 received prior treatment with imatinib only, and 108 received prior treatment with imatinib followed by dasatinib and/or nilotinib. There were 129 evaluable patients with advanced phase CML who were previously treated with at least one TKI.

The efficacy endpoints for patients with chronic phase CML were the rate of major cytogenetic response (MCyR) at week 24 and the duration of MCyR. The efficacy endpoints for patients with accelerated phase or blast phase CML were the rates of complete hematologic response (CHR) and overall hematologic response (OHR) by week 48.

In patients with chronic phase CML who received prior therapy with one TKI, 90 patients (33.8%) achieved an MCyR at week 24. Among the chronic phase CML patients who received prior therapy with more than one TKI, 29 (26.9%) achieved an MCyR by week 24.

Of the patients with chronic phase CML who had been treated with one prior TKI, 53.4% achieved an MCyR at any time during the trial. And 52.8% had a response lasting at least 18 months.

For the 32.4% of patients with chronic phase CML treated with more than one TKI who achieved an MCyR at any time, 51.4% had a response lasting at least 9 months.

In patients with accelerated phase CML who received at least one prior TKI, 21 (30.4%) achieved a CHR by week 48. And 38 patients (55.1%) achieved an OHR.

In the blast phase population, 9 patients (15%) achieved a CHR by week 48. And 17 patients (28.3%) achieved an OHR.

Safety data

The researchers evaluated bosutinib’s safety in all 546 patients. Of these patients, 287 had chronic phase CML, were previously treated with a single TKI, and had a median bosutinib treatment duration of 24 months.

There were 119 patients who had chronic phase CML, were previously treated with more than one TKI, and had a median bosutinib treatment duration of 9 months.

There were also 76 patients with accelerated phase CML and 64 patients with blast phase CML.  In these patients, the median treatment duration was 10 months and 3 months, respectively.

The most common adverse events observed in more than 20% of all patients were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.

The most common grade 3 to 4 adverse events observed in more than 10% of patients were thrombocytopenia, anemia, and neutropenia. Other serious adverse events included anaphylactic shock, myelosuppression, gastrointestinal toxicity, fluid retention, hepatoxicity, and rash.

Bosutinib is marketed as Bosulif by Pfizer. For more information on bosutinib, see the package insert.

The FDA has approved bosutinib (Bosulif), an Abl and Src kinase inhibitor, to treat patients with relapsed or refractory chronic myelogenous leukemia (CML).

Bosutinib is intended for use in patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive CML who have failed therapy with first-generation and second-generation tyrosine kinase inhibitors (TKIs).

The recommended dose of bosutinib is 500 mg, taken once daily with food.

“[Bosutinib] is an important new addition to the CML treatment landscape,” said Jorge E. Cortes, MD, of MD Anderson Cancer Center in Houston.

“Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”

Dr Cortes was a lead investigator of the industry-sponsored study that led to bosutinib’s approval. The phase 1/2 trial included 546 adult patients who had chronic, accelerated, or blast phase CML.

Efficacy data

Patients were evaluable for efficacy if they had received at least one bosutinib dose and had a valid baseline efficacy assessment. Of the 546 patients enrolled, 503 were evaluable for efficacy.

Among the patients in chronic phase, 266 received prior treatment with imatinib only, and 108 received prior treatment with imatinib followed by dasatinib and/or nilotinib. There were 129 evaluable patients with advanced phase CML who were previously treated with at least one TKI.

The efficacy endpoints for patients with chronic phase CML were the rate of major cytogenetic response (MCyR) at week 24 and the duration of MCyR. The efficacy endpoints for patients with accelerated phase or blast phase CML were the rates of complete hematologic response (CHR) and overall hematologic response (OHR) by week 48.

In patients with chronic phase CML who received prior therapy with one TKI, 90 patients (33.8%) achieved an MCyR at week 24. Among the chronic phase CML patients who received prior therapy with more than one TKI, 29 (26.9%) achieved an MCyR by week 24.

Of the patients with chronic phase CML who had been treated with one prior TKI, 53.4% achieved an MCyR at any time during the trial. And 52.8% had a response lasting at least 18 months.

For the 32.4% of patients with chronic phase CML treated with more than one TKI who achieved an MCyR at any time, 51.4% had a response lasting at least 9 months.

In patients with accelerated phase CML who received at least one prior TKI, 21 (30.4%) achieved a CHR by week 48. And 38 patients (55.1%) achieved an OHR.

In the blast phase population, 9 patients (15%) achieved a CHR by week 48. And 17 patients (28.3%) achieved an OHR.

Safety data

The researchers evaluated bosutinib’s safety in all 546 patients. Of these patients, 287 had chronic phase CML, were previously treated with a single TKI, and had a median bosutinib treatment duration of 24 months.

There were 119 patients who had chronic phase CML, were previously treated with more than one TKI, and had a median bosutinib treatment duration of 9 months.

There were also 76 patients with accelerated phase CML and 64 patients with blast phase CML.  In these patients, the median treatment duration was 10 months and 3 months, respectively.

The most common adverse events observed in more than 20% of all patients were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue.

The most common grade 3 to 4 adverse events observed in more than 10% of patients were thrombocytopenia, anemia, and neutropenia. Other serious adverse events included anaphylactic shock, myelosuppression, gastrointestinal toxicity, fluid retention, hepatoxicity, and rash.

Bosutinib is marketed as Bosulif by Pfizer. For more information on bosutinib, see the package insert.