ORLANDO, Florida — Drug pricing, and in particular the cost of cancer care, is a hot topic within oncology circles, and it was given prominent billing during the recent annual meeting of the American Society of Hematology.
Speaking at an educational session on drug costs, Scott Huntington, MD, MPH, of Yale School of Medicine, New Haven, Connecticut, used the case of a real patient of his to illustrate his talk.
David M., 32 years old, was referred after he had been treated initially with two rounds of prednisone, which provided temporary relief for pruritus. However, he subsequently developed anorexia, experienced night sweats, and weight loss.
On referral, a CT scan of his chest, abdomen, and pelvis showed diffuse non-bulky lymphadenopathy. Lymph node biopsy and blood chemistry established a diagnosis of high-risk classic Hodgkin lymphoma (cHL).
At this point, Huntington commented, David could be treated with the established standard of ABVD (Adriamycin [doxorubicin], bleomycin, vinblastine, and dacarbazine), or he could receive the new standard of BV+AVD (brentuximab vedotin, Adriamycin, vinblastine, dacarbazine).
This new standard was established by the ECHELON-1 study, published in 2018, which showed superior progression-free survival (2-year PFS was 82.1% vs 77.2% with ABVD).
However, Huntington pointed out that BV is priced at $168,000 for a 6-month course, and asked whether a gain in progression-free survival provided enough value for a price tag of over $25,000 per month?
He noted that price is not taken into account when drugs are approved. Regulatory agencies worldwide consider only safety and efficacy of the investigational drug. "Prices and comparative effectiveness do not factor into the licensing decisions of US [US Food and Drug Administration/FDA] nor ex-US regulatory bodies [European Medicines Agency/EMA]," he said.
But reimbursement for drugs differs, he noted. Outside the United States, health economics factors into whether approved drugs add enough value compared with already approved therapies — and whether they will be reimbursed. He noted that blinatumomab (Blincyto, Amgen) received a nod from the EMA in 2015 for the treatment of acute lymphoblastic leukemia, but remained shut out from coverage in the majority of European nations. However, in the US, cancer drugs are a "protected class" and all have to be covered, regardless of type of coverage (commercial or Medicare/Medicaid).
In a system such as the US, when coverage is guaranteed, a value-based assessment is lacking, and the largest payer (Medicare) is prohibited from negotiating prices, drug costs soar. That's why drug prices increased 100-fold over the 50-year interval from 1965 to 2015, Huntington asserted.
"Rising cancer drug prices are not unique to newly approved therapies," Huntington said. One example is pegaspargase, an old chemotherapy drug used to treat acute lymphoblastic leukemia. Its price remained relatively stable for nearly two decades before increasing exponentially during the past decade (from $1000 in 1994, to $2890 in 2011, up to $15,000 in 2015).
"Prices for branded therapies already on the market also outpace inflation," he said. He noted that "100 mg of BV cost $13,940 at ASH 2017 and $16,240 at ASH 2019."
However, BV has been judged to be not cost-effective, as its incremental cost-effectiveness ratio (ICER) is estimated at $317,254/QALY [quality-adjusted life years], Huntington commented.
"Lowering the price of BV in the first-line setting would make BV+AVD cost-effective," he said, but pointed out that its price would have to be cut by 56% to provide an ICER of $150,000/QALY (which is considered to be the threshold of cost-effectiveness).
Since cHL is a rare condition, adopting BV+AVD for all newly diagnosed advanced stage cHL in the US would only add about 1% to cancer drug spending, he said.
However, adopting high-cost novel therapies is an increasing trend across oncology, Huntington noted. Replacing standard first-line immunochemotherapy in chronic lymphocytic leukemia (CLL) with continuously administered targeted therapies is estimated to increase the cost of treating CLL in the US from $0.92 billion in 2014 to $5.13 billion by 2025 — an increase of 500%.
Huntington showed that global cancer spending is mirroring what is seen in the US. Worldwide spending on cancer has gone from $65 billion in 2013 to $123 billion in 2018, and is projected to reach $218 billion in 2025 — an 11%-14% annual increase.
"Spending on newly approved therapies is the major driver of these annual increases and savings after loss of patent expiry (leading to generics) is modest," he said.
Barriers to Slowing or Reversing Cancer Drug Spending
High-priced drugs influence the delivery of cancer care in the US, Huntington said.
"Margins from 'buying-selling' office-administered therapies are responsible for 77% of US-based oncology revenue," he added. Huntington noted that rising drug prices have strained smaller practices and hospital-owned outpatient facilities can charge more for identical services as community-based practices. "There has been vertical integration of community oncology practices into the hospital setting. Hospitals are not innocent bystanders," he said.
In addition, he highlighted the federal 340B Drug Pricing program, which was created in 1992. It allows hospitals and clinics serving high-risk, high-need populations to buy medicines from drug makers at a significant discount.
More than 40% of all US hospitals have 340B status, he pointed out. "340B hospitals can purchase drugs at an average of 34% below sales price, providing significantly greater drug margins than non-340B organizations."
Medicare currently reimburses office-administered chemotherapy drugs at an average sales price plus an additional 4.3% markup; therefore, a 340B hospital would be netting an additional 34% over the 4.3% mark up.
"With these potential chemotherapy-related revenues, it is not surprising hospitals gaining 340B status employ more oncologists than if they remained non-340B," Huntington said.
Current practices and hospitals are incentivized to give expensive chemotherapy, and pharmaceutical companies have an obligation to maximize profit. These are strong forces acting as barriers to a reduction in ever-rising cancer drug prices. Patients are increasingly facing the dilemma of choosing new therapies at the cost of financial toxicity or forgoing new therapy altogether, Huntington noted.
Moving Forward to Access Value Healthcare
"We are thankful for the innovations we have, but the dramatic increase in prices are unsustainable. New therapies come at a high price, and despite billions of [dollars in] cancer drug spending, we still have shortages of critical therapies," Huntington said.
Referring back to his patient David M., Huntington said that for him, the most important consideration was to reduce the risk of ever needing additional lymphoma-directed care in the future.
Huntington added additional color to his case study to drive home his points. David is an immigrant in the US on a temporary work visa. He has been between jobs in the last 3 years and expected similar change in employment in the future, which means there will be periods where he will have no health insurance.
Not surprisingly, he opted to receive BV+AVD, which his insurance company approved within a week. On this regimen he achieved complete remission.
However, shortly thereafter, he moved across the country seeking employment opportunities, and Huntington has had no further follow-up.
Huntington reports employment at an academic medical center with 340B status. He consults with Celgene, Bayer, Genentech, Pharmacyclics, and AbbVie, and has received research (institutional) funding from DTRM Biopharma, Celgene, and TG Therapeutics.
American Society of Hematology (ASH) 2019 Annual Meeting: Educational Program. Presented December 7 and 9, 2019.
Medscape Medical News © 2020
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