Generic Gleevec 'Fail First' Coverage Policy Would Be Cost Effective – Study

Reimbursement policies requiring that chronic myeloma leukemia patients new to treatment try and fail the generic version of Novartis AG’s Gleevec (imatinib) before covering treatment regimens with newer branded products would be cost effective, according to a study led by health economics researcher Rena Conti, University of Chicago.

The first generic version of Gleevec is scheduled to launch Feb. 1 in the US and payers are gearing up to actively promote the less expensive option (Also see "The Cancer Patent Cliff: Why Watchful Waiting May Be The Best Rx For High Drug Costs" - Pink Sheet, 30 Jun, 2014.).

The test will be whether payers can drive widespread use of the generic versus second-generation therapies for chronic myeloid leukemia (CML) like Bristol-Myers Squibb Co.’s Sprycel (dasatinb) and Novartis’ follow-on to Gleevec, Tasigna (nilotinib).

The newer drugs have been shown to be more effective than Gleevec on secondary endpoints but not on overall survival.

The study was designed and conducted in collaboration with the European Leukemia Network. Co-authors include Richard Larson, director of the Hematologic Malignancies Program at the University of Chicago and William Padula, Johns Hopkins Bloomberg School of Public Health. It is expected to be published in the coming weeks.

“From a US commercial payer perspective, when imatinib loses patient protection in 2016 and lower cost generic drugs equivalent to branded imatinib become available, it will be the most cost effective initial treatment strategy for incident CML compared to the current standard of care – physician’s choice of imatinib, dasatinib or nilotinib over five years,” the study says.

Gleevec, Sprycel and Tasigna are the top three branded tyrosine kinase inhibitors (TKIs) for CML. US sales in the first nine months of 2015 for Gleevec, which is the leading treatment, totaled $1.86bn, followed by $601ml for Sprycel and $496ml for Tasigna. Gleevec’s sales reflect a broader range of oncology indications beyond CML than the other two.

“While imatinib-first offers slightly lower effectiveness” than a physician’s choice strategy, estimated quality-adjusted life years for both treatment strategies “fell in a narrow range for which differences do not appear clinically meaningful,” the researchers say. In addition, “generic imatinib costs much less than alternative TKIs, holding greater value per QALY.”

Conti et al. estimate that the price of imatinib will fall 70% to 90% in the first year, including the possibility that the first generic will have a 180-day period of exclusivity. As a result, the total cost of imatinib treatment will be reduced to about $46,000 annually following introduction of the generic, the researchers estimate.

Based on Truven MarketScan data on actual commercial insurance charges, the average per-person cost of treatment with Gleevec is $79,000 per year, while treatment with Sprycel and Tasigna each costs in the range of $87,000 to $92,000 per year, according to the study. Treatment costs measured include the cost of the drug as well as the cost of evaluation and management, diagnostic testing and the possibility of stem cell or bone marrow transplants.

For most patients, treatment for CML is life-long, though there is some preliminary data suggesting that second-generation TKIs can produce treatment-free remission in some patients. The prospect of eventually being relieved from the responsibility of paying for the drug may be appealing to payers, making the treatments more attractive despite their higher cost. But that would depend on how long payers anticipate managing drug costs for a particular patient.

Savings Of $91,000 Per Patient Over Five Years

For a commercial plan covering 100 CML chronic phase patients in 2016, a generic imatinib-first strategy would save $9.1m over five years, or an average of $91,163 per patient, according to the research.

The cost reduction estimate likely reflects the lower boundaries of possible savings because it assumes the imatinib-first strategy would only be adopted for newly-diagnosed patients who have not yet started treatment, the researchers point out. Patients already started on Sprycel or Tasigna or who have already been on Gleevec for a year with good results are excluded from the analysis.

The fact that the study does not include an estimate of the likely cost savings that could be obtained by switching patients who are already on branded Gleevec to the generic does not mean the authors are ruling out savings from that route, Conti emphasized in an interview. The study focused on patients starting treatment because the available data are best suited to that analysis, she explained.

Physicians might choose to adopt a generic substitution strategy “based on their patients’ expressed cost consciousness, which might be related to the common use of formularies by insurers with differential patient out-of-pocket copayment requirements between generic and branded drugs,” the authors point out.

The majority of CML patients are covered by Medicare. Part D plans typically place the TKIs in the highest cost sharing specialty tier of formularies and require members to pay coinsurance, often equal to 33% of the drug’s cost, which presents a significant cost burden on patients. High cost sharing has been linked to lower adherence for the CML therapies (Also see "Non-Adherence To Chronic Leukemia Drugs Tied To High Copays In Study" - Pink Sheet, 10 Feb, 2014.).