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LOS ANGELES -- For those keeping score, here is yet another example of drug price escalation: the cost of alteplase, aka tPA, the clot-busting agent used to treat stroke, increased by 111% from 2005 to 2014 -- but Medicare payment for the drug has increased by 8% during the same period.
The decision to use tPA or other clot-busting drugs, also called thrombolytics, is based on numerous factors, including age, gender and medical history. In general, tPA is not recommended for patients who are pregnant or have: A history of bleeding problems. Uncontrolled high blood pressure or endocarditis (infection of the lining of the heart). Alteplase is a tissue plasminogen activator (t-PA), used as a 'clot buster' for myocardial infarction and stroke. Marketed as Cathflo™ Activase, it can also be used to de-clot a central line. Alteplase is an enzyme that converts plasminogen into plasmin, which then degrades the fibrin existing in blood clots. Catheter-directed Thrombolysis (Clot-Busting) Thrombolytic Therapy. This treatment is used if the blockage in an artery is caused by a blood clot. Thrombolytic drugs that dissolve clots are injected through a catheter to eliminate the clot and restore blood flow. According to the American Stroke Association the most promising treatment for ischemic stroke is the clot-busting drug tPA (tissue plasminogen activator), given in the first three hours after the onset of symptoms. A 2011 study found that the typical cost of treatment with tPA is $2,200.
A standard alteplase vial contains 100 mg, and in 2014 the cost for that vial was $6,400, said Dawn Kleindorfer, MD, of the University of Cincinnati. Kleindorfer reported the results of her cost-analysis here at the International Stroke Conference.
Medicare and Medicaid pay for alteplase through a DRG, which is intended to cover the cost of the drug and hospital services related to stroke care. As it now stands, about half of the DRG payment is going to cover just the cost of the drug.
Kleindorfer said she feared that the escalating drug price will make hospitals think twice about offering the clot-busting therapy, although she added that she had no evidence that any such cutbacks have already occurred.
But Brian Silver, MD, of Rhode Island Hospital in Providence and a spokesperson for the American Stroke Association, told MedPage Today that the pressure on hospitals is likely to increase. He noted that 'this year the cost of alteplase is not $6,400 but $8,300. If the hospital's reimbursement is only around $15,000, simple math tells us that after paying for the drug, it only leaves $6,700 for the rest of the admission.'
If the price continues to increase, Silver said, 'at what point does it become impossible to deliver the care?'
A possible alternative to alteplase is tenecteplase, which like alteplase is manufactured by Genentech. 'The cardiovascular community has already switched to tenecteplase, which has a price of $2,000,' Silver said, adding that a trial now underway in Norway (NORTEST) is comparing the two agents in stroke patients.
Genentech lists the cost for tenecteplase as $5,000, not $2,000.
'There is some thinking -- not yet proven -- that there is a lower bleeding risk with tenecteplase,' he said.
But Silver said there has been little support for such a head-to-head study in the U.S. since a similar trial was discontinued when it failed to recruit the needed patients.
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Asked for a comment, Genentech spokesperson Tara Iannuccillo sent this email reply:
'Activase's price remained the same for 15 years following its initial approval in 1987. Since then, we have taken incremental price increases as part of our overall plan for investment in Activase, stroke, and development of new medicines for people with serious diseases.'
She said the reasons for price increases include:
- How well a medicine works and how it compares to other treatments
- How to ensure price doesn't prevent our medicines from getting to people who need them
- The amount of money we need to allow us to continue discovering new medicines for people with serious diseases.
Tenecteplase is, Iannuccillo wrote, 'indicated for use in the reduction of mortality associated with acute myocardial infarction .. At this point, we don't have a current clinical development plan seeking other indications. We do not comment on non-Genentech supported trials.'
In her study, Kleindorfer and colleagues used publicly available quarterly payment amounts obtained from the Centers for Medicare and Medicaid services website. The prices used by CMS, she said, were 'manufacturer's average sales price plus 6%, a differential that was lowered to 4.3% in 2014.
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'Estimates for DRG base payments were calculated within MEDPAR for FY 2006 (DRG 559) and 2013 (MS DRGs 61,62, and 63) as: (DRG relative weights) x (standardized operating and capital amount). The Consumer Price Index (was also queried for all prescription drugs, urban areas, during the same study period as reference,' they wrote.
Clot Busting Drug Stroke
From the American Heart Association:
