By Cheryl Clark
A total of 10 breakthrough drugs will drive up government healthcare spending by about $50 billion over the next decade, according to a report released Monday.
Pembrolizumab (Keytruda), a lung cancer drug; aflibercept (Eylea), a diabetic retinopathy drug; and daclatasvir, a hepatitis C drug -- these are just three of the 10 "breakthrough drugs" that one healthcare consulting firm, projects will cost taxpayers $49.3 billion over the next 10 years, according to the report, which was commissioned by a health insurer trade group. The list comprised mainly cancer drugs and hepatitis C treatments as well as ivacaftor (Kalydeco), a treatment for cystic fibrosis patients with a very specific mutation.
"This is an enormous price tag for only 10 drugs, and it's just the tip of the pharmaceutical iceberg and a fraction of the costs that patients in the country will bear for prescription drugs," CEO Dan Durham said during a teleconference on the report. These 10 drugs represent a fraction of the roughly 5,400 medications in the current drug pipeline.
The report estimated that over the next 10 years, the 10 drugs would add:
$31.3 billion to Medicare spending
$15.8 billion to Medicaid spending
$2.1 billion to subsidies on the health insurance exchange
Breakthrough therapy designation offers developers significant benefits from "intensive guidance" to "organizational commitment" from senior FDA staff. The label also allows such therapies to be eligible for "priority review," an abbreviated approval process with a goal time to decision of 6 months, or "expedited review" which lasts 5 months.
Durham called the $50 billion estimate "conservative" since the analysis excludes spending by other big government payers, such as the Department of Veterans Affairs and the Department of Defense. Projections also exclude the impact on commercial payers and patients paying out of pocket, as well as the cost of drugs used off-label and the effect of breakthrough drug costs on other medications.
"These findings also call for all stakeholders to seriously consider the financial consequences of a prescription drug pipeline and the cost of innovation for families across the country and for the future of our public programs," Durham said.
Sofosbuvir (Sovaldi), a curative therapy for hepatitis C and arguably the most well-known and controversial breakthrough drug, garnered significant attention for its $1,000-per-pill price tag, especially since about 3 million Americans have the disease. Other costly drugs, however, have escaped notice.
"Looking ahead, therapies that come with a high cost and serve a large patient population are most likely to have an impact on government costs and consumer premiums," the report noted.
Emerging PD-1 cancer therapies and cholesterol drugs such as PCSK9 inhibitors -- even those not dubbed "breakthrough drugs" -- also stand to have a significant impact.
The estimated annual cost for PCSK9 inhibitors falls anywhere from $7,000 to $12,000, according to a recent editorial. As many as 3.5 million Americans qualify for the treatment, according to the article, which means the drug could place an unprecedented burden of around $150 billion on the health system. "Even in a system that costs $4 trillion per year, a single therapy adding $100 to $200 billion in costs annually is extraordinary,"noted the authors.
For the full list of drugs, please download the whitepaper here
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