New drugs force hospital P&Ts to make some tough decisions
New drugs force hospital P&Ts to make some tough decisions
Balance patients' needs with costs
Hospital pharmacy and therapeutics (P&T) committees continually face challenges in balancing the needs of patients for better, safer drugs with the need of the hospital to make formulary decisions that are financially, as well as therapeutically, feasible.
This year, P&T committees will find several new drugs particularly challenging.
"In the past we've dealt with a lot of antibiotics or heparins," says Tom Frank, PharmD, BS, an associate professor of pharmacy practice at the Area Health Education Center — Northeast (AHEC) of Jonesboro, AR.
"What's different about the current environment is there's definitely a wider range of drugs in conversation," Frank says.
"The drug I expect would have one of the greatest impacts on the hospital decision-making process is prasugrel, which is indicated for patients who've had cardiac catheterization," Frank says.
Prasugrel (Effient®) was approved by the FDA on July 10, 2009, for use in patients with acute coronary syndrome.
"This is a drug with three indications," Frank explains. "One indication is for acute coronary syndrome in patients with unstable angina."
Another indication is for patients with non-ST segment elevation myocardial infarction managed with percutaneous coronary intervention (PCI), and the third is for patients with ST-segment elevation myocardial infarction managed with primary or delayed PCI, he adds.
"The issue is to compare and contrast prasugrel with clopidogrel (Plavix®)," Frank says. "We want to make sure we do the best for patients with the drugs on the formulary."
While prasugrel is a more potent drug, it also causes more bleeding problems, he says.
"The pivot point of conversation is trying to get the good parts to work while minimizing the bad parts," Frank says. "The hospital pharmacist can try to make that balance to the patient's best advantage."
Hospital pharmacy directors and P&T committees need to review the most important study about prasugrel, which is called the Triton-TIMI 38 study, involving more than 13,000 patients, and published in the New England Journal of Medicine's on-line edition, Frank suggests.
This randomized, double-blind trial suggests the prasugrel group had less cardiac endpoints than the clopidogrel group, reducing deaths by 12.1% vs. 9.9%.1
"But there were more bleeding episodes with prasugrel," Frank says. "So that's one body of important conversation surrounding the drug."
The challenge from a hospital pharmacy perspective is to get the drug used in the appropriate patient and not used when there isn't enough information available about the patient, Frank says.
"We don't use this drug for clinical circumstances outside of the package insert," he notes. "It is limited to patients who have acute coronary syndrome or patients who are receiving a trip to the cardiac cath lab."
The hospital's P&T had decided to make it mandatory to have a pharmacist review prasugrel orders before they are filled, Frank says.
"The pharmacist looks at electronic orders and does order entry," he says. "Most of these problems have been worked out in advance because the cardiac care committees have reviewed the utilization."
Another new drug that should catch the eye of hospital pharmacy directors is methylnaltrexone (Relistor®), Frank says.
Wyeth and Progenics brought the drug, which has been under development for about three decades, to market for use in treating constipation among patients on opioids, especially for cancer patients receiving palliative care, Frank explains.
"The methyl group causes it not to cross the blood brain barrier, so it doesn't impact the analgesic effect of narcotics," Frank says. "But it does block the narcotic effects in the intestine."
The drug has demonstrated good efficacy in terms of patients who were on substantial doses of morphine, he adds.
"The drug costs about $40 per dose, which is in the form of a subcutaneous injection given every other day," Frank says.
But the cost is a bargain compared with the benefits to patients and to the potential cost savings from reduced lengths of stay (LOS) and hospitalizations, he says.
Cancer patients often find the side effects of opioids, including constipation and dry mouth, almost as miserable as the pain, he notes.
"These are folks who need to take narcotics two or three times a day, every day, to have quality of life," Frank says.
"This is the hospital pharmacy challenge to have the most appropriate use of this drug because this drug also has the potential to help with other side effects outside of the package insert," he adds.
For instance, the drug might be used to stop nausea and itching associated with opioids.
"So there are some very interesting things outside the package insert that are legitimate topics of consideration," Frank says. "I think it's a drug that will have a lot of potential, but it also will [inspire] a lot of discussions that will result in different answers in different places."
Each institution will need to decide how to limit methylnaltrexone's use in its formulary.
A third drug to watch is febuxostat (Uloric®) to treat hyperuricemia and gout.
"What's noteworthy is this is the first new drug for gout in 40 years," Frank says. "It's mechanism of action is similar to allopurinol, but its pharmacokinetic parameters are different."
For instance, allopurinol has serious side effects if the dosing is not properly adjusted in terms of renal function, he says.
"Some patients taking the medicine are 70-80 years of age," he adds.
When a P&T committee reviews the use of febuxostat, they will find that the answer to whether the newer drug brings down uric acid levels more effectively than allopurinol is "yes," he says.
But one question is whether the drug should be permitted for use outside package marketing for myeloproliferative disorders where there's a rapid turnover of protein in the body accompanied by extra uric acid, Frank says.
"This is outside package labeling for this drug, even though we feel it should be efficacious," Frank says.
"Basically the P&T and pharmacists balance the economic and therapeutic [considerations]," he says. "You have this new drug with a single source availability that is considerably more expensive than allopurinol, which is available generically."
Studies show the new drug is more effective at lowering uric acid, and it has a favorable side effect profile, so the dilemma is whether that benefit justifies the extra expense, Frank explains.
The AHEC pharmacy and therapeutics committee decided the benefit was not worth it at this time, he adds.
"We have decided not to be the first kid on the block and put this on the formulary yet," Frank says. "Part of our reason is because our patient population is not huge in terms of folks with uric acid-elevated conditions."
The P&T committee will revisit the issue down the road, but at present they are taking neither a positive or negative position, so physicians still could obtain the drug for patients visiting as outpatients, he adds.
Reference
- Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007;357:2001-2015.
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