Successful Transition from Bortezomib Subcutaneous (SubQ) to Generic Intravenous (IV) Bortezomib: Cost Savings Initiative with Global Economic Impact

Background:

It is estimated that the U.S. will spend $370 billion in 2019 on pharmaceuticals and by 2020 the cost of cancer care will be approximately 158 billion. Cost containment strategies for high cost drugs are needed. In 2019 global sales from subcutaneous (SubQ) bortezomib manufactured by Takeda® will exceed $1 billion. There exists an opportunity to decrease overall cost related to bortezomib by $300-400 million across the globe by switching patients to bortezomib intravenous (IV) (manufactured by Fresenius Kabi®). Generic bortezomib was first approved by the FDA in January 2018 but it can only be administered intravenously. A phase 3 randomized controlled trial of twice weekly SubQ vs IV bortezomib showed no difference in time to progression or 1 year overall survival, however rate of Grade 3 peripheral neuropathy doubled in the IV arm compared to SubQ (Moreau et al, 2011). Although twice weekly bortezomib has fallen out of favor and there are retrospective data suggesting that neuropathy from weekly subQ and weekly IV bortezomib may be similar, there exist no prospective data to date to confirm this. Bortezomib induced peripheral neuropathy (BIPN) typically occurs by cycle 4 of twice weekly therapy, and the majority of cases are partially reversible (Dimopolous et al, 2011). We hypothesized that patients who have not developed neuropathy after or during 4 cycles of subcutaneous bortezomib could be switched to IV bortezomib without greatly increasing neuropathy.

Methods:

Boston Medical Center Health System is a 500 plus bed integrated delivery network which not only functions as payer but also as a provider. A protocol was implemented to switch patients from SubQ to IV bortezomib. Patients had to complete 4 cycles of SubQ bortezomib and have either Grade 1 or no BIPN to qualify to switch to IV bortezomib generic formulation. Patients were eligible to be switched regardless of indication or dose, if other criteria were met. After approval from the hematology/oncology providers and nursing department, this protocol was implemented to start accrual in November 2018. Patients eligible for the switch were identified primarily by pharmacists. After provider approval, pharmacists would update the treatment plan orders and also notify nursing and patients of the change. Nursing and patient satisfaction surveys were also administered to obtain input from all stakeholders.

Results:

Eleven patients have received at least 1 cycle of IV generic bortezomib for various indications from Nov 2018 to June 2019, with minimum of 2 doses and maximum of 16 doses. The diseases for which bortezomib was being used included multiple myeloma (n= 6) and AL amyloidosis (n= 2), renal transplant rejection and thrombotic thrombocytopenic purpura (TTP). One of the 11 patients had Grade 1 BIPN prior to switching, while all others reported no neuropathy prior to the switch. None of the patients have developed new neuropathy after making the switch from subQ to IV bortezomib. Results of the nursing and patient satisfaction surveys are being collected and will be presented.

Conclusion:

We describe a method to switch from subcutaneous bortezomib to generic IV bortezomib instituted at a large academic medical center as a cost containment strategy. This has resulted in no new cases of neuropathy in our growing data set. Global adoption of this protocol has the potential to substantially reduce drug costs related to multiple myeloma.