Chronic Myeloid Leukemia (Prescribing Decisions and Payer Landscape in a Crowded and Changing U.S. Market) | Physician & Payer Forum | US | 2014

Despite the comparatively low incidence of chronic myeloid leukemia (CML) in the United States, patient management requires extended durations of therapy, which in turn translates into a disproportionately large size market. Market dynamism is enhanced by the occurrence of resistance or intolerance to any one agent, resulting in many patients receiving three or more lines of therapy. This environment presents marketers with multiple opportunities to expand market share. CML treatment consists almost entirely of six targeted therapies, principally oral tyrosine kinase inhibitors (TKIs). First-to-market Novartis’s Gleevec (imatinib) is entrenched as the most commonly prescribed agent in newly diagnosed CML patients but battles against two other TKIs—Bristol-Myers Squibb’s Sprycel (dasatinib) and Novartis’s Tasigna (nilotinib)—in this setting. Market dynamism has been further stimulated by accelerated approvals of three agents in 2012: two oral TKIs, Pfizer’s Bosulif (bosutinib) and Ariad Pharmaceuticals’ Iclusig (ponatinib), as well as Teva’s Synribo (omacetaxine) for subcutaneous infusion.

Both physicians and payers expect CML treatment to enter a period of turbulence over the next two years following the anticipated launch of generic imatinib, which surveyed MCOs indicate will have a dramatic effect on tier placement of drug therapies. Managed care organization pharmacy directors/medical directors (MCO PD/MDs) will look for the demonstration of a clear efficacy advantage when making their decisions on formulary inclusion and tier status in CML, and marketers should look to address any weaknesses in their clinical dossiers. With adverse changes in tier placement likely to occur for most CML agents, the increasing cost burden borne by patients will be brought into even sharper focus. This coming period presents a window of opportunity for marketers to review their pricing strategies and patient payment assistance programs to counter an increasingly hostile climate.