Facing criticism from academic oncologists, Imbruvica’s makers bring back low-dose pill

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Pharmacyclics, a unit of AbbVie, and Janssen, a unit of Johnson & Johnson, backed away from their plan to eliminate the lowest-dose capsules of Imbruvica (ibrutinib), a treatment for several hematologic malignancies.

Earlier this year, the two companies announced that they would no longer offer Imbruvica in 140 mg capsule form, and instead would market only single-tablet formulation of all four strengths of Imbruvica: 140 mg, 280 mg, 420 mg and 560 mg.

The move triggered objections from a group of nine cancer experts, who wrote in a column in The Cancer Letter that elimination of a lower-dose pill would add to waste and expense and could compromise patient safety (The Cancer Letter, April 13).

“This new formulation is associated with removal of the 140 mg capsules (priced at about one third the cost of the new 140 mg tablet) from the market, as well as a marketing and pricing scheme that raises concerns regarding patient safety and access for lower socio-economic groups,” the nine oncologists wrote.

“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 payor approval to do so, since the cost would be 300% of the single 420 mg tablet.

“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 three-fold higher than the cost of their prior 140 mg capsule.”

In a response that was published simultaneously with their opinion piece, Imbruvica’s makers disputed the allegations, say that their objective was to provide the drug in single-pill daily doses.

However, on May 11, the company said it would reverse its earlier decision to do away with the 140 mg dose.

The May 11 statement by the two companies reads:

For the past five years, we have been proud to offer Imbruvica (ibrutinib) to patients facing serious blood cancers, such as leukemia and lymphoma. We are privileged and honored to be part of the blood cancer community and we look forward to building on that legacy.

Earlier this year, we introduced a new single-tablet formulation of Imbruvica as an innovation for patients with a convenient one pill, once-a-day dosing regimen. This new formulation was developed with the intention of improving daily adherence. Since the introduction of this new tablet formulation in late March, it has been adopted by the majority of patients on Imbruvica.

However, we have received feedback regarding the availability of Imbruvica capsules, and as a result will continue to offer 140 mg Imbruvica capsules as an option in addition to our one pill, once-a-day tablet.

Consistent with our commitment to optimal customer experience, we are also looking at ways to improve our service offerings….

We are committed to exploring ways of providing Imbruvica in a form that works best for patients and healthcare professionals by continuing to listen to their insights and medication preferences by maintaining an ongoing dialogue.

The companies’ statements are posted here.

Mark Ratain, one of the nine authors of the guest editorial in The Cancer Letter, praised the companies for reviving the lower-dose pill.

“I am very pleased that Pharmacyclics and its marketing partner Janssen, have reversed their prior decision to remove the 140 mg capsules from the market,” Ratain, the Leon O. Jacobson Professor of Medicine and director of the Center for Personalized Therapeutics at the University of Chicago, said to The Cancer Letter. “This decision is important to patients and prescribers, who will continue to be able to titrate the dosage of this important drug, as suggested by the approved prescribing information. In addition, the Value in Cancer Care Consortium remains interested in comparing the efficacy and toxicity of the labeled dose of 420 mg daily to alternative doses and schedules that could significantly reduce both toxicity and cost.”

While Ratain et al. stated in their editorial that they would like to experiment with lower doses of Imbruvica, the company said its current dosing is thoroughly studied.

“While physicians are free to exercise their independent medical judgment on what is right for their patients, there is extremely limited data investigating the use of lower doses of Imbruvica,” the company said in a statement April 19. “We do not know if lower doses will result in the same clinical outcomes as the approved doses.”

The decision comes at a time when the Trump Administration is signaling intent to rein in drug prices (The Cancer Letter, May 11).

However, when oncology luminaries—especially those who control the formularies of cancer centers—raise questions about drug prices, pharma companies listen. In one notable case—that of Sanofi’s colorectal cancer drug Zaltrap—the sponsor halved the price of the drug after a group of researchers from Memorial Sloan Kettering Cancer Center sounded off on the Op-Ed pages of The New York Times. (The Cancer Letter, June 19, 2015)

Imbruvica is approved for:

  • Chronic lymphocytic leukemia/Small lymphocytic lymphoma;

  • Chronic lymphocytic leukemia/Small lymphocytic lymphoma with 17p deletion;

  • Waldenström’s macroglobulinemia;

  • Mantle cell lymphoma patients who have received at least one prior therapy (accelerated approval);

  • Marginal zone lymphoma patients who require systemic therapy and have received at least one prior anti-CD20-based therapy (accelerated approval);

  • Chronic Graft-Versus-Host Disease patients who failed one or more lines of systemic therapy.

Correction: This story has been updated May 25 to accurately reflect the changes the two companies made in marketing the hematologic Imbruvica (ibrutinib).

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