May 17, 2018 Source: Ddu 431
This year AbbVie launched Imbruvica, a single tablet for blood cancer treatment. It has been designed as a convenient therapy measure for patients who used the old tablets as often as four times a day. Adapting the new single tablet in their treatment regimens will prove to be an expensive proposition for some patients as the new tablet comes with a price tag of $400 each, triple the cost of the older tablets.
Several drugmakers who initiated single pills and other convenient drugs with older drugs, have stopped selling the old ones after the launch of the new version. At a time when companies are under tremendous pressure to cap prices, this move is not eliciting the desired positive results. It was tacitly announced by AbbVie last week that it would market the original 140-milligram tablet.
Pharmacyclics which co-markets Imbruvica with Johnson & Johnson’s Janssen, said in a statement that they have received “feedback” on Imbruvica plans that caused its change in time. Last month, nine oncologists stated in an analysis report that the company was building a barrier to safe prescribing practices as the old tablets gave prescribers a choice to select dosages that were fitting to individual patients.
The doctors requested the FDA to review the safety of You&i, AbbVie’s patient-access program for Imbruvica, which is a “marketing strategy” for the new single-tablet product that creates risks of toxicities relative that observed in the clinical trials which utilized multiples of the 140 mg capsules.”
The oncologists also urged FDA to consider the combination of the high price per pill and the flat pricing scheme which are the limitation to safe administration, and that ignoring the marketing approach for [Imbruvica] is antithetical to fostering optimally safe dosing and administration.
In reply, AbbVie and Janssen published that the prescribing information for the new tablet was approved by the FDA and that the companies believed the single-tablet switch would benefit patients.By editor
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