An editorial in The New England Journal of Medicine on Wednesday took the unusual position of challenging a study published in the same issue.
The exchange highlighted a growing debate in American medicine: how much should health care providers pay for expensive treatments that make relatively small improvements?
The published study proved that a blood-thinning medicine could prevent problems from worsening in some people with a sometimes painful, usually short-term, blood clot near the surface of the leg, called superficial-vein thrombosis.
But the editorial challenged the unreported cost of the treatment in the study — more than $180,000 for 88 patients to receive injections for 45 days — to prevent one of them from having a more dangerous, but rarely fatal, deep vein clot.
The issue of cost-effectiveness is taking on new importance as more Americans become eligible for Medicare insurance, and some 30 million uninsured people are promised health coverage by 2019.
The United States already spends more on health care than any other country, yet it does less than many countries to control the costs. That has also been an issue with biologic drugs — some that can cost $100,000 a year — that prolong life in late-stage cancer patients, as well as some expensive medical devices for heart patients.
Dr. Stephen Resch, deputy director of the Center for Health Decision Science at the Harvard School of Public Health, said, “My feeling is resources are limited, and you have to ration care somehow because all of our money can’t be spent on health care.”
Last year, Congress backed away from plans to limit health care spending after opponents claimed it would lead to so-called death panels. Lawmakers have also declined to give Medicare the authority to negotiate lower prices directly with drug makers.
Congress did, however, authorize a Patient-Centered Outcomes Research Institute that can do cost-effectiveness studies and an Independent Medicare Advisory Board that could eventually press for lower prices.
The reports on the blood thinner pitted Dr. Lee Goldman, dean of health sciences and medicine at Columbia and a critic of higher costs, against a team of European researchers financed by the drug maker GlaxoSmithKline.
The study of 3,002 people with superficial-vein thrombosis showed that the condition worsened to deep vein thrombosis or pulmonary embolism in 1.3 percent of those who took a placebo for 45 days and 0.2 percent of those who took the drug Arixtra.
It was an excellent, randomized, double-blind study that reported statistically significant results, Dr. Goldman and Dr. Jeffrey S. Ginsberg, a blood expert, wrote in the editorial.
But the study did not talk about the costs, they wrote, which could range from $2,124 to $7,380 a person for 45 days of injections, or at least $186,000 for 88 people to avoid one new problem.
“The paradox is, it’s effective, but for a condition that’s usually not considered an overwhelmingly serious medical problem,” Dr. Goldman said in an interview. “The fact that it’s a medicine that’s expensive really raises an issue, not just for this trial, but we tried to make the point more broadly.”
Cost-effectiveness researchers in America have benchmarks that suggest that “good value for the money” is $50,000 per added year of high-quality life, Dr. Resch said. In some cases, where cheaper treatments are unavailable, up to $120,000 per added year have been suggested, he said.
The editorial did not analyze long-term outcomes. Dr. Resch, who was not involved in either article, said it appeared the cost would not provide that value.
But the drug is nearing approval for shallow-vein use in Europe, where costs are considered by regulators. GlaxoSmithKline is not seeking such approval by the Food and Drug Administration, which considers only safety and efficacy.
The F.D.A. has already approved the drug to treat and prevent deep vein thrombosis and embolism. Sarah Alspach, a spokeswoman for GlaxoSmithKline, said the price of Arixtra was a good value for those conditions. She said the company would discuss pricing for the new treatment with individual countries in Europe.
Karen P. Buckley, spokeswoman for the journal, said it published the study because it addresses an unmet medical need, and it published the editorial to point out the high cost of treatment to help one in 88 cases.
Dr. Hervé Decousus, lead author of the study, said he thought that the editorial was unfair.
“If we give this drug, we avoid a great number of surgical procedures, which are risky for patients and cost a lot of money,” he said in a telephone interview from Saint-Étienne, France.
Further, he said, patients and doctors can see clots expand in the veins under skin toward deeper veins where they can also migrate to the lungs.
“It’s painful, and you can see the clot in front of you,” he said. “Patients are frightened; physicians are frightened. We don’t want to wait for a fatal pulmonary embolism.”‹
See MNTA ReadMeFirst for info on Lovenox and M118.
General information #msg-51227061How large is the anticoagulant market? #msg-26451612 VTE is a big, big problem (Lancet 2008) #msg-53285442 Clinical overview of the new oral anticoagulants (Blood) #msg-53493902 Drug-design overview of the new oral anticoagulants (C&EN) #msg-26701803 Technical overview of traditional anticoagulants
Pradaxa (dabigatran) #msg-51498625 Musings on Pradaxa in various indications #msg-54614812 FDA panel backs Pradaxa for AF/stroke prevention #msg-41018490 Pradaxa bests warfarin in AF/stroke prevention (Reuters) #msg-41014644 Pradaxa bests warfarin in AF/stroke prevention (WSJ) #msg-41024424 Pradaxa bests warfarin in AF/stroke prevention (Forbes) #msg-27956748 EU approves Pradaxa for VTE prevention #msg-32382343 NICE approves reimbursement for VTE prevention #msg-51315844 Non-inferior to Lovenox in VTE prevention (RE-NOVATE 2) #msg-21155926 Non-inferior to Lovenox in VTE prevention (RE-NOVATE) #msg-44244839 Phase-3 Pradaxa data in acute VTE (ASH 2009) #msg-25152872 BI starts phase-2 trial in ACS
Xarelto (rivaroxaban) #msg-53887547 Xarelto matches Lovenox/warfarin in acute DVT #msg-47110232 Response to FDA in VTE prevention due 2H10 #msg-44245112 Troublesome bleeding in VTE extension study #msg-30972846 EMEA approves Xarelto for VTE prevention #msg-34103973 Phase-3 data in VTE prevention (JNJ PR) #msg-29661234 Phase-3 data in VTE prevention (Reuters) #msg-31857009 Bayer accelerates Xarelto development in ACS, but… #msg-39151366 ...Xarelto still has a long way to go in ACS! #msg-33517140 Phase-2 data in ACS #msg-29662519 Checklist rationale for Xarelto program
Apixaban #msg-54576974 Phase-3 succeeds in warfarin-free AF/stroke prevention #msg-47461590 ADVANCE-2 in VTE prevention succeeds, but… #msg-31742223 ADVANCE-1 in VTE prevention fails #msg-29928836 Phase-3 trials begin for VTE treatment #msg-32024540 Tepid phase-2 results in ACS #msg-19134406 PFE, BMY ink $1B deal to co-develop Apixaban
Edoxaban #msg-48661173 Daiichi Sankyo files for approval in Japan #msg-46218043 Largest-ever phase-3 begins in VTE prevention #msg-34100821 Phase-3 begins in AF #msg-34100787 Comparable safety to warfarin in AF (phase-2) #msg-31950663 Phase-2 data in VTE prevention after hip surgery
Betrixaban #msg-39418241 MRK licenses betrixaban (WSJ) #msg-39388813 MRK licenses betrixaban (MRK/Portola PR) #msg-47847796 Phase-2 safety data vs warfarin in AF #msg-21106352 Phase-2 data vs Lovenox in VTE prevention
Miscellaneous (in alphabetical order) #msg-41143344 Ablynx starts phase-2 of ALX-0081 in PCI #msg-40720487 Ablynx phase-1 ALX-0681 results in healthy volunteers #msg-54742945 Arixtra is wasteful in treatment of SVT #msg-10569101 Arixtra bests Lovenox in ACS (2006 study) #msg-53285279 Astellas’ YM150 in ACS, AF, and VTE prevention #msg-39348082 ARYX’s Tecarfarin whiffs in phase-3 #msg-36811828 AZN reports phase-2 data for AZD0837 #msg-30965016 LLY terminates FXa program #msg-30353872 MYRX MPC-0920 begins phase-1 #msg-31461171 NUVO reports phase-1b data for NU172 #msg-46648382 Otamixaban ho-hum in phase-2 ACS study #msg-27187973 Paion’s Solulin completes phase-1 #msg-28742653 Paion acquires flovagatran rights #msg-50887012 PYMX phase-1b data for Lovenox reversal #msg-53193787 PYMX phase-1b/2a data for heparin reversal #msg-32171800 Regado reports phase-1 data for aptamer #msg-46648462 Sanofi’s stable of anticoagulant aspirants #msg-53375883 Takeda’s TAK-442 in ACS and VTE prevention #msg-52169431 TB-402 (FVIII inh) bests Lovenox in VTE prevention #msg-37562465 Warfarin genetic test rejected by Medicare
Market Data 
Markets 
AI
