Physicians voice concern over ibrutinib flat pricing

A group of oncologists is urging the Food and Drug Administration to review a new, flat-pricing strategy for all doses of ibrutinib (Imbruvica), calling the shift potentially dangerous for patients.

Pharmacyclics, an AbbVie company based in Sunnyvale, Calif., recently introduced a new, single-tablet formulation of ibrutinib in varying strengths (140 mg, 280 mg, 420 mg, and 560 mg) and set a flat price across all doses. At the same time, they removed the drug’s original 140-mg capsules – which cost about a third of the new, flat-rate price – from the market. The drug company says the new, single-tablet formulations give patients a convenient, once-a-day dosing regimen that could improve therapy adherence.

Ibrutinib is approved to treat a number of hematologic cancers, including mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, and marginal zone lymphoma.

But in an April letter published in the Cancer Letter, nine physicians from cancer centers across the country expressed concern that the new dosage and pricing scheme could compromise patient safety and limit doctors’ dosage decisions.

“While the prescribing information is complex, prescribers and patients have had the flexibility of taking anywhere from one to four 140-mg capsules, readily permitting dose reduction to all but the lowest labeled dose [70 mg],” the authors wrote. “However, the new formulation and its associated marketing scheme [YOU&i] greatly impact the ability of the prescriber and patient to follow the prescribing information, resulting in the potential for a greatly enhanced risk of toxicities relative to that observed in the clinical trials which utilized multiples of the 140-mg capsules.”

The problems stem from a cancer drug that often requires dosage adjustments, the authors noted. The specific dosage for an ibrutinib patient depends on the indication, prior toxicities, concomitant medications, occurrence of ibrutinib intolerance, and current hepatic function. Because of such diverse criteria, dosage modifications are made frequently.

The new pricing system makes it harder for physicians to adjust the dose without running afoul of insurers and potentially affecting access for patients.

 

“In order to ensure that all patients receive a single tablet rather than multiple 140-mg tablets, the manufacturer has priced all tablet strengths at the same price, so that a physician who wished to prescribe 420 mg as three 140-mg tablets would be unlikely to get payer approval to do so, since the cost would be 300% of the single 420-mg tablet,” the letter states. “Furthermore, patients who have been on a daily dose of 140 mg now find that the cost of their 140-mg tablet is more than threefold higher than the cost of their prior 140-mg capsule.”

Pharmacyclics – which jointly markets the drug with Janssen – defended the new pricing regimen, asserting that it was designed to help patients take their medication as prescribed.

“The price is based on the most widely prescribed and lower of the two FDA-approved dosages, which is 420 mg per day. While a patient’s out-of-pocket cost for Imbruvica is ultimately determined by their insurance plan, the vast majority of patients [i.e., patients taking 420-mg and 560-mg doses of Imbruvica] will likely see no increase in out-of-pocket costs when transitioning to the single-tablet formulation,” Pharmacyclics said in a statement. “In fact, current patients on the 560-mg dose will likely see a decrease in their out-of-pocket costs. Out-of-pocket expenses may increase for patients who are taking a lower dose of Imbruvica [140 mg or 280 mg].”

Pharmacyclics stressed that there is “extremely limited data” on the use of lower doses of the drug and said they do not know if lower doses will yield the same clinical outcomes.

 

The authors of the letter on the other hand, want the FDA to review the safety of the You&i program in the context of the approved drug label.

The FDA should take another look at ibrutinib and make some necessary changes, said letter coauthor Mark J. Ratain, MD, of the University of Chicago.

“The FDA should reconsider whether the drug can be prescribed as labeled,” Dr. Ratain said in an interview. “I would like to see the pricing changed to linear [constant $/mg] pricing, so that prescribers and patients can select the most appropriate strength.”

At this article’s deadline, the FDA had not returned messages seeking comment for this story.

 

Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program at the Cleveland Clinic’s Taussig Cancer Institute, prescribes ibrutinib fairly regularly. He was not involved in the drafting of the letter but said he supports the intent.

“This is a significant inconvenience and a potential problem for patients taking this medication because patients frequently require dosage modifications, typically dose reductions,” Dr. Hill said in an interview. “Having this new program in which the medication has to be exchanged for a single-tablet dose makes it much more difficult and onerous to make those changes.”

A group of oncologists is urging the Food and Drug Administration to review a new, flat-pricing strategy for all doses of ibrutinib (Imbruvica), calling the shift potentially dangerous for patients.

Pharmacyclics, an AbbVie company based in Sunnyvale, Calif., recently introduced a new, single-tablet formulation of ibrutinib in varying strengths (140 mg, 280 mg, 420 mg, and 560 mg) and set a flat price across all doses. At the same time, they removed the drug’s original 140-mg capsules – which cost about a third of the new, flat-rate price – from the market. The drug company says the new, single-tablet formulations give patients a convenient, once-a-day dosing regimen that could improve therapy adherence.

Ibrutinib is approved to treat a number of hematologic cancers, including mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, and marginal zone lymphoma.

But in an April letter published in the Cancer Letter, nine physicians from cancer centers across the country expressed concern that the new dosage and pricing scheme could compromise patient safety and limit doctors’ dosage decisions.

“While the prescribing information is complex, prescribers and patients have had the flexibility of taking anywhere from one to four 140-mg capsules, readily permitting dose reduction to all but the lowest labeled dose [70 mg],” the authors wrote. “However, the new formulation and its associated marketing scheme [YOU&i] greatly impact the ability of the prescriber and patient to follow the prescribing information, resulting in the potential for a greatly enhanced risk of toxicities relative to that observed in the clinical trials which utilized multiples of the 140-mg capsules.”

The problems stem from a cancer drug that often requires dosage adjustments, the authors noted. The specific dosage for an ibrutinib patient depends on the indication, prior toxicities, concomitant medications, occurrence of ibrutinib intolerance, and current hepatic function. Because of such diverse criteria, dosage modifications are made frequently.

The new pricing system makes it harder for physicians to adjust the dose without running afoul of insurers and potentially affecting access for patients.

 

“In order to ensure that all patients receive a single tablet rather than multiple 140-mg tablets, the manufacturer has priced all tablet strengths at the same price, so that a physician who wished to prescribe 420 mg as three 140-mg tablets would be unlikely to get payer approval to do so, since the cost would be 300% of the single 420-mg tablet,” the letter states. “Furthermore, patients who have been on a daily dose of 140 mg now find that the cost of their 140-mg tablet is more than threefold higher than the cost of their prior 140-mg capsule.”

Pharmacyclics – which jointly markets the drug with Janssen – defended the new pricing regimen, asserting that it was designed to help patients take their medication as prescribed.

“The price is based on the most widely prescribed and lower of the two FDA-approved dosages, which is 420 mg per day. While a patient’s out-of-pocket cost for Imbruvica is ultimately determined by their insurance plan, the vast majority of patients [i.e., patients taking 420-mg and 560-mg doses of Imbruvica] will likely see no increase in out-of-pocket costs when transitioning to the single-tablet formulation,” Pharmacyclics said in a statement. “In fact, current patients on the 560-mg dose will likely see a decrease in their out-of-pocket costs. Out-of-pocket expenses may increase for patients who are taking a lower dose of Imbruvica [140 mg or 280 mg].”

Pharmacyclics stressed that there is “extremely limited data” on the use of lower doses of the drug and said they do not know if lower doses will yield the same clinical outcomes.

 

The authors of the letter on the other hand, want the FDA to review the safety of the You&i program in the context of the approved drug label.

The FDA should take another look at ibrutinib and make some necessary changes, said letter coauthor Mark J. Ratain, MD, of the University of Chicago.

“The FDA should reconsider whether the drug can be prescribed as labeled,” Dr. Ratain said in an interview. “I would like to see the pricing changed to linear [constant $/mg] pricing, so that prescribers and patients can select the most appropriate strength.”

At this article’s deadline, the FDA had not returned messages seeking comment for this story.

 

Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program at the Cleveland Clinic’s Taussig Cancer Institute, prescribes ibrutinib fairly regularly. He was not involved in the drafting of the letter but said he supports the intent.

“This is a significant inconvenience and a potential problem for patients taking this medication because patients frequently require dosage modifications, typically dose reductions,” Dr. Hill said in an interview. “Having this new program in which the medication has to be exchanged for a single-tablet dose makes it much more difficult and onerous to make those changes.”

A group of oncologists is urging the Food and Drug Administration to review a new, flat-pricing strategy for all doses of ibrutinib (Imbruvica), calling the shift potentially dangerous for patients.

Pharmacyclics, an AbbVie company based in Sunnyvale, Calif., recently introduced a new, single-tablet formulation of ibrutinib in varying strengths (140 mg, 280 mg, 420 mg, and 560 mg) and set a flat price across all doses. At the same time, they removed the drug’s original 140-mg capsules – which cost about a third of the new, flat-rate price – from the market. The drug company says the new, single-tablet formulations give patients a convenient, once-a-day dosing regimen that could improve therapy adherence.

Ibrutinib is approved to treat a number of hematologic cancers, including mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom macroglobulinemia, and marginal zone lymphoma.

But in an April letter published in the Cancer Letter, nine physicians from cancer centers across the country expressed concern that the new dosage and pricing scheme could compromise patient safety and limit doctors’ dosage decisions.

“While the prescribing information is complex, prescribers and patients have had the flexibility of taking anywhere from one to four 140-mg capsules, readily permitting dose reduction to all but the lowest labeled dose [70 mg],” the authors wrote. “However, the new formulation and its associated marketing scheme [YOU&i] greatly impact the ability of the prescriber and patient to follow the prescribing information, resulting in the potential for a greatly enhanced risk of toxicities relative to that observed in the clinical trials which utilized multiples of the 140-mg capsules.”

The problems stem from a cancer drug that often requires dosage adjustments, the authors noted. The specific dosage for an ibrutinib patient depends on the indication, prior toxicities, concomitant medications, occurrence of ibrutinib intolerance, and current hepatic function. Because of such diverse criteria, dosage modifications are made frequently.

The new pricing system makes it harder for physicians to adjust the dose without running afoul of insurers and potentially affecting access for patients.

 

“In order to ensure that all patients receive a single tablet rather than multiple 140-mg tablets, the manufacturer has priced all tablet strengths at the same price, so that a physician who wished to prescribe 420 mg as three 140-mg tablets would be unlikely to get payer approval to do so, since the cost would be 300% of the single 420-mg tablet,” the letter states. “Furthermore, patients who have been on a daily dose of 140 mg now find that the cost of their 140-mg tablet is more than threefold higher than the cost of their prior 140-mg capsule.”

Pharmacyclics – which jointly markets the drug with Janssen – defended the new pricing regimen, asserting that it was designed to help patients take their medication as prescribed.

“The price is based on the most widely prescribed and lower of the two FDA-approved dosages, which is 420 mg per day. While a patient’s out-of-pocket cost for Imbruvica is ultimately determined by their insurance plan, the vast majority of patients [i.e., patients taking 420-mg and 560-mg doses of Imbruvica] will likely see no increase in out-of-pocket costs when transitioning to the single-tablet formulation,” Pharmacyclics said in a statement. “In fact, current patients on the 560-mg dose will likely see a decrease in their out-of-pocket costs. Out-of-pocket expenses may increase for patients who are taking a lower dose of Imbruvica [140 mg or 280 mg].”

Pharmacyclics stressed that there is “extremely limited data” on the use of lower doses of the drug and said they do not know if lower doses will yield the same clinical outcomes.

 

The authors of the letter on the other hand, want the FDA to review the safety of the You&i program in the context of the approved drug label.

The FDA should take another look at ibrutinib and make some necessary changes, said letter coauthor Mark J. Ratain, MD, of the University of Chicago.

“The FDA should reconsider whether the drug can be prescribed as labeled,” Dr. Ratain said in an interview. “I would like to see the pricing changed to linear [constant $/mg] pricing, so that prescribers and patients can select the most appropriate strength.”

At this article’s deadline, the FDA had not returned messages seeking comment for this story.

 

Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program at the Cleveland Clinic’s Taussig Cancer Institute, prescribes ibrutinib fairly regularly. He was not involved in the drafting of the letter but said he supports the intent.

“This is a significant inconvenience and a potential problem for patients taking this medication because patients frequently require dosage modifications, typically dose reductions,” Dr. Hill said in an interview. “Having this new program in which the medication has to be exchanged for a single-tablet dose makes it much more difficult and onerous to make those changes.”