Turing Pharmaceutical’s purchase of Daraprim from Impax Laboratories in August 2015 for $55 million was followed by a huge frenzy in the news media. Daraprim, which is used to fight toxoplasmosis, was previously priced at 13.50 per tablet. Once Turing purchased the drug, they raised the price per tablet to $750.
Turing’s rationale behind the price jump was to place the additional money into research and development, to develop better treatments for toxoplasmosis, with fewer side effects, and to invest in marketing and education tools to make people more aware of the disease. Martin Shkreli, the founder and CEO of Turing, stands by his decision to raise the price of the drug, stating, “This isn’t the greedy drug company trying to gouge patients, it is us trying to stay in business.”
While Shkreli believes he and his company are doing a service to the pharmaceutical industry and patients as a whole by reinvesting in R&D, the Infectious Diseases Society of America and the HIV Medicine Association estimate that it would cost $336,000 a year to treat someone with toxoplasmosis at the $750/pill price. Both organizations believe that “this cost is unjustifiable for the medically vulnerable patient population in need of this medication.”
Dr. Judith Aberg of Mount Sinai said that some hospitals will now find Daraprim too expensive to keep in stock, possibly resulting in treatment delays. Mt. Sinai will continue to use the drug, but each use of the drug requires special review.
After the initial outcry over the price hike of Daraprim, Shkreli responded by stating they would lower the price of the drug to an unidentified price, which would still allow the company to break even or even retain a small profit. To date, they have still not noted the new, lower price of Daraprim, but a spokesman did state the company is capping patient copayments at $10.
Recently, however, Imprimis Pharmaceuticals a compounding pharmacy claims they can make a close, customized version of Daraprim for just $1 a tablet. Imprimis Pharmaceuticals is known of mixing approved drug ingredients to fill individual patient prescriptions.
Imprimis CEO Mark Baum states, “While we respect Turing’s right to charge patients and insurance companies whatever it believes is appropriate, there may be more cost-effective compounded options for medications, such as Daraprim, for patients, physicians, insurance companies and pharmacy benefit managers to consider.”
Not only is Imprimis working on a more cost-effective tablet for fighting toxoplasmosis, but they are also “forming a new program called Imprimis Cares, which is aligned to [Imprimis’] corporate mission of making novel and customizable medicines available to physicians and patients today at accessible prices.”
Imprimis says their version of the tablet, which would have to be compounded to order, has something extra known as leucovorin. “According to the Centers for Disease Control and Prevention, pyrimethamine [Daraprim’s generic name] works to block folic acid synthesis in the parasite T. gondii, the cause of toxoplasmosis, and leucovorin helps to reverse the negative effects on bone marrow caused by the mechanism of this action,” according to Imprimis. Imprimis is planning to sell their form of the tablet in oral capsules starting as low as $99.00 for a 100 count bottle.
Compounded drugs are typically made to fill a doctor’s prescription for an individual patient, sometimes because the mass-produced version is either in short supply or completely unavailable. Compounded drugs can also allow for customized patient-specific formulations or dosages. Unlike drugmakers who make huge batches of drugs on complex production lines, compounders do not need Food and Drug Administration approval to create their compounded drugs.
It is worth keeping an eye on Imprimis to see what other drugs they imitate for a lower price. Imprimis CEO Baum stated, “We are looking at all of these cases where the sole-source generic companies are jacking the price way up. There’ll be many more of these” compounded drugs coming in the near future.
It should be noted that the delay for a generic drug manufacture to gain permission from the FDA (god forbid the FDA doesn’t approve something) is reportedly 36 months. It should also be noted that under the Affordable Care Act insurance can only increase their revenues (capped at 15% of premiums collected) if the cost of treatment increases. Hence, the insurance companies would actually be penalized if they tried to stop this price increase…