Millions of people who suffer from rheumatoid arthritis and diabetic neuropathy can get just as much pain relief from older and cheaper generic drugs than more expensive medications often prescribed by their doctors, according to two new studies. The cost difference could save patients thousands of dollars a year.
Researchers at the Mayo Clinic analyzed data from clinical trials of several different drugs used to treat diabetic neuropathy and found no major differences in how well they relieve pain – although some cost 10 times as much as others.
“These treatments all work about the same, but what’s different is their side effects and cost. The older medications are an order of magnitude cheaper, about $15 to $20 a month, compared with the newer ones at nearly $200 per month,” said lead author Brian Callaghan, MD, University of Michigan Medical School, in a commentary in the Annals of Internal Medicine,
“Patients are on these medications for many years, and it really starts to add up. Given that the effects of the medications are similar, why should we start patients on the expensive drugs until we’ve determined whether or not they respond to the less-expensive ones?”
Two of the most commonly prescribed drugs for neuropathy are pregabalin (sold under the brand name Lyrica) and duloxetine (Cymbalta). According to Drugstore.com, pregabalin is the most expensive at $190 per month, followed by duloxetine at $171 per month.
In contrast, gabapentin (Neurontin) comes in at $19 per month, followed by amitriptyline at $13 per month, and nortriptyline at $20 per month. A topical cream like capsaicin, which is available over the counter without a prescription, costs only $14 per month.
Over the course of a year, using one of the cheaper drugs instead of pregabalin would save over $2,000.
The newer more expensive drugs are marketed by big pharmaceutical companies, such as Pfizer and Eli Lilly, which have conducted clinical trials and received specific approval for diabetic neuropathy from the Food and Drug Administration.
The older generic drugs may not have FDA approval for neuropathy, but can still be prescribed “off label” by doctors to treat the condition. About half of patients with type 2 diabetes develop neuropathy over the course of their disease.
Callaghan, who treats diabetic neuropathy patients, says he usually prescribes a generic drug such as gabapentin or a tricyclic antidepressant as the first option for pain relief. He says more studies are needed to compare the effectiveness of different drugs head-to-head.
“The FDA has approved only pregabalin and duloxetine for the treatment of painful diabetic neuropathy despite similar evidence in support of other medications,” said Callaghan. “Because current evidence does not suggest that the effectiveness of these agents substantially differs, cost considerations should be a prominent part of clinicians’ decision making.”
Less is More for RA Drugs
A researcher in Belgium made similar findings when comparing drugs used to treat rheumatoid arthritis (RA). A combination of older generic drugs treated RA in its early stages just as effectively as more intensive treatment, but with less medication, fewer side effects, and at a significantly lower cost.
Because there is no known cure for RA, a chronic auto-immune disease that causes pain and stiffness in joints, physicians focus on suppressing disease activity to prevent permanent joint damage.
In a study published in in Annals of Rheumatic Diseases, researchers at University Hospitals Leuven tried to find the optimal combination and dosage of three commonly prescribed antirheumatic drugs (methotrexate, sulfasalazine and leflunomide) in combination with glucocorticoids (a class of steroid hormones).
Methotrexate is one of the most commonly used medicines in the treatment of RA. It is known as a disease-modifying anti-rheumatic drug because it can decrease joint damage and lower the risk of long-term disability. About 20 to 40 percent of patients don’t respond to methotrexate or have side effects.
RA patients who don’t respond to early treatment are increasingly being switched to expensive biologic injectable drugs that are made from genetically engineered proteins derived from human genes. Biologics inhibit parts of the immune system that cause inflammation, a central feature of RA.
The Belgian researchers divided 290 early RA patients into three groups. Each group received a different combination therapy: “COBRA Classic” (methotrexate, sulfasalazine and a high first dose of glucocorticoids), “COBRA Slim” (methotrexate and a moderate dose of glucocorticoids) or “COBRA Avant-Garde” (methotrexate, leflunomide and a moderate dose of glucocorticoids).
All three strategies worked well, causing disease remission in 7 out of 10 patients after 16 weeks of therapy. But the strategies varied significantly when it came to side effects.
The “COBRA Slim” strategy, which calls for the least amount of medication, had half as many side effects as the two other strategies. It is also easier to implement because it is less complicated.
“One surprising finding in the study was the high remission values recorded for all of the applied intensive treatment strategies,” says Diederik De Cock, doctoral researcher at the Research Centre for Skeletal Biology and Engineering at University Hospitals Leuven.
A broader use of the COBRA Slim strategy, according to De Cock, could lead to higher RA remission rates worldwide and would probably reduce the need for biologics.
“Methotrexate is very affordable, as are steroids,” says Diederik De Cock. “At the moment, RA treatment is not yet adequately standardized in Belgium, and this leads to treatment inefficiencies. As a result, more patients require expensive second-line antirheumatic therapies known as biologics, which can cost up to 15,000 euros ($18,719) per year. By comparison, the COBRA Slim strategy costs less than 1,000 euros ($1,247). In other words, we can treat up to 15 patients for the same price as a year of treatment with a biological.”
A similar study published recently in the New England Journal of Medicine found that RA patients who took a three drug regimen using oral generic drugs (methotrexate, sulfasalazine and hydroxychloroquine) saw just as much improvement in their symptoms as those who used methotrexate and Enbrel, an injectable biologic sold by Amgen (NASDAQ: AMGN).
The average annual cost of the three drug therapy is about $1,000, compared to about $25,000 per year for Enbrel, according to researchers at the Omaha VA Medical Center in Nebraska.