In the JournalsPerspective

Monthly cost of oral cancer drugs rises steadily over time

The cost of oral cancer drugs in their first year on the market has increased significantly since the year 2000, according to a research letter published in JAMA Oncology.

High drug prices can affect patient adherence to cancer therapies and increase the financial burden of medical care, according to Stacie B. Dusetzina, PhD, assistant professor of pharmaceutical outcomes and policy at University of North Carolina Eshelman School of Pharmacy.

Stacie Dusetzina

Stacie B. Dusetzina

“Patients are increasingly taking on the burden of paying for these high-cost specialty drugs as plans move toward use of higher deductibles and co-insurance,” Dusetzina said in a press release. “The major trend here is that these products are just getting more expensive over time.”

Dusetzina sought to estimate changes over time in reimbursements for orally administered anticancer drugs paid by commercial health plans. She focused her research on reimbursements during the year of product launch.

Using TruvenHealth MarketScan outpatient prescription drug data from 2000 through 2014, Dusetzina identified claims for oral anticancer therapies approved in 2000 or later, excluding claims in which the total paid was $0 or less or greater than $250,000. The analysis only included pharmacy fills for a single month of therapy to ensure comparable estimates over time, which represented 483,587 drug fills.

The study included data on 32 orally administered anticancer drugs introduced since 2000, representing approvals in all study years except three (2002, 2008 and 2010). The incidence of oral therapies increased over time, with 17 therapies brought to market from 2011 to 2013.

Mean monthly spending during the year of product launch increased over time, from $1,869 (95% CI, 1,648-2,121) in 2000 to $11,325 (95% CI, 10,989-11,671) in 2014.

Monthly spending during the first year increased 63% across all products when comparing those launched between 2000 and 2010 to those launched from 2010 onward. This represented a price increase from $5,529 (95% CI, 5,444-5,615) to $9,013 (95% CI, 8,917-9,110).

The price of the majority of studied products increased between year of launch and 2014, with the largest monthly increases seen for thalidomide (Thalomid, Celgene; approval year, 2000; increase, $5,695) and imatinib (Gleevec, Novartis; approval year, 2001; increase, $5,133).

Mean monthly spending decreased over time for two products: lenalidomide (Revlimid, Celgene; approval year, 2006; decrease, $469) and vorinostat (Zolinza, Merck, approval year, 2007; decrease, $2,163).

There were wide variances in year-to-year drug prices, from –15% to 30%.

Dusetzina acknowledged study limitations, including the exclusive use of reimbursement data from commercial health plans. This reliance may have excluded rarely prescribed or recently used drugs, and did not capture data from Medicare and Medicaid.

“In addition to higher launch prices, most existing therapies have had substantial price increases since product launch,” Dusetzina wrote. “Monitoring changes in spending on anticancer medications may help to identify excessive price changes and highlight potential affordability challenges for patients.” – by Cameron Kelsall

Disclosure: Dusetzina reports no relevant financial disclosures.

The cost of oral cancer drugs in their first year on the market has increased significantly since the year 2000, according to a research letter published in JAMA Oncology.

High drug prices can affect patient adherence to cancer therapies and increase the financial burden of medical care, according to Stacie B. Dusetzina, PhD, assistant professor of pharmaceutical outcomes and policy at University of North Carolina Eshelman School of Pharmacy.

Stacie Dusetzina

Stacie B. Dusetzina

“Patients are increasingly taking on the burden of paying for these high-cost specialty drugs as plans move toward use of higher deductibles and co-insurance,” Dusetzina said in a press release. “The major trend here is that these products are just getting more expensive over time.”

Dusetzina sought to estimate changes over time in reimbursements for orally administered anticancer drugs paid by commercial health plans. She focused her research on reimbursements during the year of product launch.

Using TruvenHealth MarketScan outpatient prescription drug data from 2000 through 2014, Dusetzina identified claims for oral anticancer therapies approved in 2000 or later, excluding claims in which the total paid was $0 or less or greater than $250,000. The analysis only included pharmacy fills for a single month of therapy to ensure comparable estimates over time, which represented 483,587 drug fills.

The study included data on 32 orally administered anticancer drugs introduced since 2000, representing approvals in all study years except three (2002, 2008 and 2010). The incidence of oral therapies increased over time, with 17 therapies brought to market from 2011 to 2013.

Mean monthly spending during the year of product launch increased over time, from $1,869 (95% CI, 1,648-2,121) in 2000 to $11,325 (95% CI, 10,989-11,671) in 2014.

Monthly spending during the first year increased 63% across all products when comparing those launched between 2000 and 2010 to those launched from 2010 onward. This represented a price increase from $5,529 (95% CI, 5,444-5,615) to $9,013 (95% CI, 8,917-9,110).

The price of the majority of studied products increased between year of launch and 2014, with the largest monthly increases seen for thalidomide (Thalomid, Celgene; approval year, 2000; increase, $5,695) and imatinib (Gleevec, Novartis; approval year, 2001; increase, $5,133).

Mean monthly spending decreased over time for two products: lenalidomide (Revlimid, Celgene; approval year, 2006; decrease, $469) and vorinostat (Zolinza, Merck, approval year, 2007; decrease, $2,163).

There were wide variances in year-to-year drug prices, from –15% to 30%.

Dusetzina acknowledged study limitations, including the exclusive use of reimbursement data from commercial health plans. This reliance may have excluded rarely prescribed or recently used drugs, and did not capture data from Medicare and Medicaid.

“In addition to higher launch prices, most existing therapies have had substantial price increases since product launch,” Dusetzina wrote. “Monitoring changes in spending on anticancer medications may help to identify excessive price changes and highlight potential affordability challenges for patients.” – by Cameron Kelsall

Disclosure: Dusetzina reports no relevant financial disclosures.

    Perspective

    The findings provided here are something that those of us in practice are all too familiar with — the rising cost of oral cancer medications and the associated burden placed on our patients. In the past several years there has been significant attention given to this issue in both peer-reviewed publications as well as the mainstream media.

    In 2013, a group of more than 100 experts in chronic myeloid leukemia brought attention to this issue with particular focus on the prices of approved tyrosine kinase inhibitors for the treatment of CML. The authors noted that despite the many complex factors involved in determining the price of a drug, the decision “often seems to involve a simple formula: Start with the price for the most recent similar drug on the market and price the new one within 10% to 20% of that price (usually higher).”

    Dusetzina Perspective Table

    In 2014, Peter B. Bach, MD, director of Memorial Sloan Kettering Cancer Center’s Center for Health Policy and Outcomes, highlighted a similar concern in Forbes with the release of a new oral agent for the treatment of lung cancer. Here he noted that a new agent from Novartis, ceritinib (Zykadia), released in April 2014 was priced at $13,200 per month, whereas its competitor from Pfizer, crizotinib (Xalkori), costs $11,500 per month, despite both having similar primary mechanisms of action and targeting the same type of lung cancer (at the time).

    Unfortunately, the concerns related to costs of the CML and lung cancer drugs still exist today (see Table 1).

    With the growing number of new orphan drug indications and new orphan drugs available in the United States, and given the incentives provided to manufacturers, we might expect to see price decreases, but that is clearly not the case.

    The Orphan Drug Act of 1983 incentivized the development of orphan drugs as it includes, among other things, 7 years of market exclusivity from approval and a 50% tax credit on research and development costs. The industry has rushed to develop orphan drugs because they cost less to put through clinical trials. Despite this, “on average their cost per patient is six times that of nonorphan drugs, a clear indication of their pricing power,” according to the Orphan Drug Report 2015 from EvaluatePharma.

    Oral chemotherapy agents represent an important breakthrough in cancer treatment and with certain cancers, their targeted actions, tolerable side effects compared with traditional cytotoxic chemotherapy, and convenience have resulted in an oral agent becoming the choice of therapy. Moreover, in most cases, an oral targeted therapy is the best and only treatment option for a patient based on tumor markers and patient characteristics.

    Despite health care reform efforts, we have observed payers continue to shift the cost burden of oral cancer medications to patients in the form of higher deductibles and higher coinsurance. Health care providers have responded by dedicating resources to assist patients with gaining assistance through manufacturer programs/copay cards or nonprofit grants funded by the very companies who are charging the exorbitant prices.

    Although the CML experts focused on one specific disease, their opinions are applicable across the majority of oral cancer therapies: “The prices are too high, are unsustainable, may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national health care systems.”

    References:

    Bach PB. “Cancer: Unpronounceable Drugs, Incomprehensible Price.” Forbes. Aug. 13 2014. 

    Orphan Drug Report 2015. EvaluatePharma. October 2015. Available at: info.evaluategroup.com/rs/607-YGS-364/images/EPOD15.pdf. Accessed May 5, 2016.

    Experts in Chronic Myeloid Leukemia. Blood. 2013;doi:10.1182/blood-2013-03-490003.

    • Niesha Griffith, MS, RPh, FASHP and Sarah Hudson-Disalle, PharmD, RPh
    • The James Cancer Hospital at The Ohio State University
      Hematology/Oncology Pharmacy Association

    Disclosures: Griffith reports an advisory board role with Ariad. Hudson-Disalle reports no relevant financial disclosures.