Clinical guidelines recommend that all patients diagnosed with chronic myeloid leukemia in chronic phase (CML-CP) immediately be treated with a tyrosine kinase inhibitor (TKI). And, since the introduction of imatinib mesylate (Gleevec) in 2001, those with CML now can largely live a normal lifespan, with one caveat: they must be able to pay for the drug.

Hagop M. Kantarjian, MD, professor and chairman of the department of leukemia at The University of Texas MD Anderson Cancer Center in Houston, long a critic of the high prices of cancer drugs, told Cancer Therapy Advisor he believes 25% to 30% of patients cannot afford imatinib. He also doubts introduction of generic imatinib will ease the cost burden.

Rena M. Conti, of the department of pediatric and public health sciences at the University of Chicago in Illinois, and colleagues constructed Markov models to compare 5-year cost effectiveness of using generic imatinib first before switching to other TKIs due to intolerance or lack of effectiveness. The study’s endpoint was 5-year overall survival, and “the main outcome of the models was cost per QALY,” with a willingness-to-pay threshold of $100,000/QALY. They found that “when imatinib loses patent protection and its price declines its use will be the cost-effective initial treatment strategy for CML-CP.”1

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Their model anticipated price of imatinib to drop 70% to 90%.

Sun Pharma introduced the first generic version of imatinib on February 1, 2016, enjoying a 6-month “first-to-file” lead before Teva Pharmaceuticals and Apotex Corp. launched generic versions in August 2016. Many predicted this competition would decrease costs to patients by 60% to 90%. To date, however, the needle has barely budged: there is an estimated $142,000 average wholesale price for generic imatinib 400 mg/day vs $145,750 for branded imatinib.

Why? “A major cause is the combination of oligopolies established by drug companies and the lack of transparency in the actual drug prices (eg, average wholesale price vs wholesale acquisition cost vs discounted pricing based on secret negotiations between pharmaceutical companies, health insurance companies, and drug distributors/outlets),” Dr Kantarjian wrote in the ASCO Post last May.2

When Novartis Pharmaceutical Corp. launched Gleevec in 2001, the annual price was $26,000. In 2015, global sales of Gleevec were $4.5 billion, $2.5 billion in the United States alone.

On the Apotex website, the suggested average wholesale price is $10,932.11 for a 30 tablet bottle in the 400mg strength, a month’s supply.3 Teva’s website notes: “Prices can vary between pharmacies. Simply contact your pharmacy to inquire about the cost of your medication, and be sure to tell your pharmacist if you have insurance.”4

More than 18 generic versions of imatinib are available worldwide. In Canada, generic imatinib costs $8000 annually and, in India, $400 annually.

In a presentation at European Cancer Congress 2015, Andrew Hill, PhD, senior research fellow in the department of pharmacology and therapeutics at the University of Liverpool in the United Kingdom, reported that “based on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $126-$212 for imatinib.” His analysis showed that globally, 48,000 people are eligible for imatinib annually.5