In the wake of the FDA’s ongoing drive to review unapproved older medications, interesting fiscal side effects continue to evolve. One recent case in point revolved around the off-label use of a progesterone related medication long used in the treatment of premature labor. The cost of the medication as generally prepared by compounding pharmacies was $10-20 per injection. KV Pharmaceuticals entered the market with the ‘new’ FDA-approved version of the drug which they named Makena. Based on their own clinical trial, they received FDA approval thus allowing KV Pharmaceuticals 7-year exclusive marketing rights of this now ‘rebranded’ drug. They then increased the price to about $1500 per injection. At this price a course therapy for an individual patient may cost as much as $25,000. Obviously, this is a substantial increase in price which is passed on to consumers and insurers. Not surprisingly, mark ups this substantial have generated considerable opposition. It has even sparked ongoing debate on Capitol Hill. Even the FDA has taken the position that it would still be in support of compounding pharmacies making this medication available on a prescription basis. This has, historically, not been their position.
Another fallout from this process of reevaluation is the medicine colchicine. Colchicine is an alkaloid extract from the autumn crocus (crocus autumnale). It is commonly used around the world to treat gout, a common form of arthritis. The first documentation, in written analysis, of the use in the treatment of gout was in the 6th Century A.D. However, references to colchicine in medicine are found in many ancient records from Egypt, India, and Greece. References were even noted in the most ancient medical texts known by the Egyptians, around 1550 B.C. It has been used in our country since 1820, and has been referenced in our own United States pharmacopoeia as a recognized treatment for gout and other associated conditions. Given that, its existence within the practice of medicine in the United States predated the development of the FDA. Therefore, this particular medication had existed in a ‘grandfathered’ medication.
However, in the course of reevaluation, the FDA has granted approval to the drug maker, URL Pharma, to market the prescription form of colchicine, known by the brand name Colcrys, as a treatment for gout and familial Mediterranean fever. Unfortunately, this medication that had usually cost pennies has now increased to $100-$300 per month, therefore making it, unfortunately, from a cost-containment perspective, unavailable to many patients with gout and associated disorders. This also is under investigation in terms of price structuring through the United States Congress, and a response is expected from the company by early June this year.
Colchicine has been used around the world both orally, and by injection, in the treatment of spinal disc inflammation and chronic pain syndromes. It may even have secondary benefits as an adjunctive anticancer therapy, particularly of the prostate, when administered with a chemotherapy drug. Dr. Michael Rask, a well-known orthopaedic specialist, had used colchicine in over 6000 patients suffering from spinal disc herniations and chronic pain conditions of various types with an impressive success rate. His writings are available from several sources online. I, myself, have seen many cases, including my own, of chronic disc pain improved dramatically with colchicine administration. Unfortunately, because of the changes in marketing status, the IV form of colchicine, in our country, is no longer available. For those using oral colchicine, the price has increased substantially. Therefore rendering colchicine another unfortunate statistic in the realm of pharmaceutical price escalations.
Interestingly, as a side note, colchicine is also used in plant breeding. By treating seeds with colchicine, genetic diversity can be enhanced by inducing genetic polyploidy. This is essentially doubling the genetic information in the plant, leading to what we recognize as flowers which are ‘double’.
It is unfortunate that a very useful medication that has been used for 30 centuries, and commonly available in our country, is now faced with dramatic cost escalation, potentially making it unavailable to many because of the current governmental statutes.
– Dr. Guyer