The U.S. Food and Drug Administration (FDA) has cleared the way for Teva Pharmaceuticals and Mylan Pharmaceuticals to market the first generic versions of Celebrex capsules to treat arthritis, paving the way for other generic companies to jump on the bandwagon once the exclusivity period expires.
Teva Pharmaceuticals has received the
According to the Centers for Disease Control and Prevention (CDC), 52.5 million adults, or just over one in five adults, in the U.S. have doctor-diagnosed arthritis.
Celecoxib helps prevent the inflammation and pain caused by arthritis, acute pain, and dysmenorrhea, by decreasing an enzyme that helps make prostaglandins, which cause inflammation, swelling, and pain.
Usually taken once every 24 hours, celecoxib is easy for patients to take; it is a member of the Cox-II inhibitor drug class, which was originally thought to be less likely to interfere with treatment for heart disease and also less likely to cause stomach bleeding.
In recent years, the Cox-II drugs, including celecoxib, have a boxed warning, which states that non-steroidal anti-inflammatory drugs (NSAIDS), including celecoxib, are associated with an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including myocardial infarction (heart attack), and stroke. All NSAIDS also may increase the risk of serious gastrointestinal ulceration, bleeding, and perforation (may be fatal). Common side effects include nausea, dizziness, diarrhea, cough, and water retention in extremities.
Lawsuits and competitive wrangling over drug products is often the norm before generic versions of popular and expensive prescription drugs finally appear at the corner pharmacy.
In fact, in 2010, the Federal Trade Commission published a report, Pay to Delay, which describes the way some drug companies stall the release of new generics by compensating the generic company after it agrees to delay the release of their generic drug product.
Several organizations, including the Coalition on Health Care, and the American Association of Retired Persons (AARP), have taken up the issue of large prescription drug costs in recent years. AARP operates the Public Policy Institute (PPI), which sponsors and regularly publishes Rx Price Watch reports.
A report, co-authored by Stephen W. Schondelmeyer, Pharm.D., of the University of Minnesota, and Leigh Purvis, MPA, of the AARP PPI, found unusually high price increases of brand name drugs just before the generic versions became available. Another report found that some drug manufacturers gave special discounts to patients, sold “authorized generics” (which, the authors explain, are approved by the FDA for marketing by the brand-name company during the true generic’s 180-day exclusivity period, thereby reducing the generic company’s revenues), and used other means to help maintain their market share longer after the generic product was released.
In 2013, the Supreme Court decided there could be a conflict between patent laws, which protect the rights of the originator of a drug, and anti-trust laws in contracts between brand and generic drug manufacturers. Their interpretation opened the door so lower courts may study each situation and weigh the potential financial hardship to consumers, as well as patent protections, in each deal.
The PPI has found that consumers could be paying more than $3 billion extra for prescription drugs each year when the release of generic versions is delayed.
Many other costly drugs are now hitting the marketplace, prompting wide discussion of the escalating costs, including specialty drugs for patients with serious illnesses. Some of these drugs are so costly that insurers are simply refusing to pay for them, a policy that varies from company to company and from state to state.
What can patients do to reduce or limit the increase of their own drug costs? Purvis confirms what most pharmacists tell their patients: You need to be willing to have that conversation with your doctor, who may be able to find an alternative or a therapeutic alternative that is less expensive.
A therapeutic alternative or substitute is another drug that will have the same result as the original, costly drug. This kind of substitution requires a discussion between a pharmacist and a physician, and it involves a new prescription drug order. This is different from generic substitution laws, which may allow patients in some states to decide whether or not they would like to try a generic product.
To find a therapeutic substitute, a patient may simply ask the physician, or the pharmacist, Is there another drug for this purpose, that I could take, that costs less?
Asking for generic products or talking about therapeutic substitutions are both strategies that are far better than simply paying for a high cost drug, unless there are no alternatives, or even worse, skipping treatment entirely.