Discontinuing TKI Therapy
One potential cost-saving measure is TKI treatment discontinuation. Dr Kantarjian said if patients are PCR-negative for 3 to 5-plus years, TKI therapy can be stopped, though molecular relapse is predicted to occur in 50%.
Results from the European stop TKI (EURO-SKI) study presented at the 2016 American Society of Hematology annual meeting found that “using standardized molecular monitoring, stopping TKI therapy in a very large cohort of CML-patients appears feasible and safe and high MRFS [molecular recurrence-free survival] rates are achievable.”9
The study authors concluded that “A true pharmaco-economic study will be necessary but taking into account the number of months without treatment in 603 patients, imatinib front line (with a median observation time of 24 months for patients still off treatment) and the cost of imatinib in each of the 11 European countries (range: 1.734-3.370 Euro per month) the total estimated savings amounted to 27.85 million Euro.”
Writing in Cell, Dr Paul Workman and colleagues noted that “as early as 2012, 12 of the 13 newly approved cancer drugs were priced above $100,000 annually, and the situation has only gotten worse since.”10
They called “for the formation of new relationships between academic drug discovery centers and commercial partners, which can accelerate the development of truly transformative drugs at sustainable prices.” One goal is to reduce inefficiency: to date, 803 clinical trials testing checkpoint immune-therapeutics are set to enroll more than 166,000 patients, with an “enormous redundancy in these studies.”
The authors noted that “there is a clear and urgent necessity to lower cancer drug prices to keep lifesaving drugs available and affordable for patients. As one patient advocate recently put it: ‘Innovation is meaningless if nobody can afford it.’”
The great unknown, of course, is the future of the Patient Protection and Affordable Care Act (ACA), which provides access and treatment to many who would have had to go without care.
When asked whether anticipated changes to the ACA will prevent patients from being able to obtain and/or afford to take TKIs, Dr Kantarjian replied: “Of course.”
- Padula WV, Larson RA, Dusetzina SB, et al. Cost-effectiveness of tyrosine treatment strategies for chronic myeloid leukemia in chronic phase after generic entry of imatinib in the United States. JNCI J Natl Cancer Inst. 2016;108(7):djw003.
- Kantarjian H. The arrival of generic imatinib into the U.S. market: an educational event. ASCO Post website. http://www.ascopost.com/issues/may-25-2016/the-arrival-of-generic-imatinib-into-the-us-market-an-educational-event/. Published May 25, 2016. Accessed February, 2017.
- Imatinib mesylate tablets. Apotex Corp. website. https://www.apotex.com/us/en/products/detail.asp?m=61086. Accessed February 7, 2017.
- Frequently asked questions. Teva website. https://www.tevagenerics.com/patients/frequently-asked-questions#q-6725. Accessed February, 2017.
- Hill A, Gotham D, Fortunak J, et al. Target prices for mass production of tyrosine kinase inhibitors (TKIs) for global cancer treatment access. Poster presented at: European Cancer Congress; September 2015; Vienna, Austria.
- Understand your out-of-pocket costs for Gleevec. Novartis website. http://www.gleevec.com/index.jsp. Accessed February 6, 2017.
- Winn AN, Keating N, Dusetzina S. Factors associated with tyrosine kinase inhibitor initiation and adherence among Medicare beneficiaries with chronic myeloid leukemia. J Clin Oncol. 2016;34(36):4323-4328.
- Information for patients on Medicare Part D. Novartis website. http://www.gleevec.com/assets/pdf/patient/GLI-1126472_GLEEVEC_PartD_Patient_Brochure.pdf. Accessed February 3, 2016.
- Mahon FX, Richter J, Guilhot, et al. Cessation of tyrosine kinase inhibitors treatment in chronic myeloid leukemia patients with deep molecular response: Results of the Euro-Ski trial. Paper presented at: 58th American Society of Hematology Annual Meeting & Exposition; December 2016; San Diego, CA.
- Workman P, Draetta GF, Schellens JHM, Bernards R. How much longer will we put up with $100,000 cancer drugs? Cell. 2017;168(4):579-583.