Daraprim price jump raises concerns among ID groups, providers

Issue: October 2015

A recent spike in the price of Daraprim and supply problems have raised concerns among health care providers, expert organizations and the media.

Acquired by Turing Pharmaceuticals on Aug. 10, Daraprim (pyrimethamine) is part of first-line and alternate treatment regimens for the parasitic disease toxoplasmosis, according to the Department of Health and Human Services. The drug was approved by the FDA in 1953 and is often necessary, along with a sulfonamide and leucovorin, to treat toxoplasmosis patients with conditions that compromise their immune systems such as HIV.

Since its acquisition, the price of pyrimethamine has increased from $13.50 per tablet to $750 per tablet, according to the IDSA and HIVMA. In an open letter to Turing, the organizations urged the pharmaceutical company to revise its pricing strategy for the generic medication.

“Under the current pricing structure, it is estimated that the annual cost of treatment for toxoplasmosis, for the pyrimethamine component alone, will be $336,000 for patients who weigh less than 60 kg and $634,500 for patients who weigh more than 60 kg,” they wrote. “This cost is unjustifiable for the medically vulnerable patient population in need of this medication and unsustainable for the health care system.”

Turing announced its intention to lower the drug’s price following attention from news and social media, but as of Sept. 25 no details had been revealed.

“Turing’s CEO Martin Shkreli has committed to adjusting the price of Daraprim, but there is no timetable as to when that will occur or at what price point,” Allan Ripp, who represents the drugmaker, told Infectious Disease News.

This price increase has had a significant effect on the prescription of toxoplasmosis therapies, Wendy S. Armstrong, MD, FIDSA, FACP, medical director of the Ponce de Leon Center in Atlanta and vice chair of HIVMA, told Infectious Disease News. If maintained, it would be especially damaging to patients who are already at the highest risk for complication, she said.

Wendy S. Armstrong

“What we’re seeing is that this is going to disproportionately impact individuals who may not have insurance … [and] may be more likely to have other barriers to health care, including transportation, poverty and stigma,” Armstrong said. “It becomes almost a double whammy. Although this can affect anybody of any socioeconomic status with AIDS, we will see more of it in patients who are vulnerable in other ways simply because that coincides with the folks who are less likely to be in care or previously diagnosed.”

The pricing issue was accompanied by an apparent shortage in supply. According to IDSA and HIVMA, multiple hospitals have reported an inability to obtain pyrimethamine, including those with 340B pharmacies. Armstrong confirmed seeing similar issues affecting her own practice and various drug assistance programs.

“The supply issues have been very significant for us,” Armstrong said. “We’ve been, frankly, unable to get the drug for a significant period of time. The Georgia AIDS Drug Assistance Program — which provides medications to patients with HIV who have no other insurance or payer source — has been unable to obtain a supply of this medication for a few months. They have been putting out alerts to those of us who use those services.”

In response to the letter from IDSA and HIVMA, Eliseo Salinas, MD, MSc, president of research and development at Turing Pharmaceuticals, said that while the company is “determined” to ensure full patient access to the medication, there are additional factors complicating the associations’ pricing appraisal.

“We fully understand your concerns about the cost to hospital pharmacies,” Salinas wrote in the letter obtained from IDSA/HIVMA. “The pharmaceutical pricing model is extraordinarily complex, but I believe your estimate of treatment costs cannot be generalized.”

In a separate statement, Nancy Retzlaff, chief commercial officer at Turing, recognized the supply problems experienced by several health care facilities. These issues were related to the drug’s recent acquisition from Impax Laboratories, she said, and have since been corrected.

“Our No. 1 priority is to ensure that all patients diagnosed with toxoplasmosis have an efficient and affordable means to access Daraprim,” Retzlaff said. “As soon as we learned that some hospitals and clinics were having trouble accessing the product, we developed an immediate corrective plan to ensure quick, efficient access for patients in need.”

“We are committed to improving the care of patients who are diagnosed with toxoplasmosis, and have developed an innovative and sustainable model that we believe will allow us to serve today’s patients and help meet tomorrow’s needs,” Craig Rothenberg, chief communication officer of Turing Pharmaceuticals, told Infectious Disease News in regard to the raised price. “There have been no new therapies for toxoplasmosis in decades, and innovation is urgently needed. We are investing in the scientific development of new and improved formulations of Daraprim, as well as investigating new therapeutics that we hope will help eradicate the disease.”

Attributing the price increase to the development of new treatments is troubling, Armstrong said, as pyrimethamine is well-tolerated and has not shown a decline in effectiveness that would provoke such research.

“This is not an infection where we have been looking for more effective drugs,” Armstrong said. “It is a single pill — once a day — that has minimal side effects and, while it can lead to low blood counts, that effect is very well-mitigated simply by the coadministration of a vitamin.”

To aid toxoplasmosis patients in financial need, Rothenberg said, Turing is maintaining commitments to various programs that offer financial support and alternative payment. These actions include sustaining a co-pay assistance program for commercially insured patients, contributions to an independent OIG-approved charity that supports cost-sharing obligations for toxoplasmosis therapies for Medicare patients, and the extension of a system that provides the treatment to uninsured patients in financial need.

Despite these commitments, expert organizations still pushed for changes to pyrimethamine’s pricing structure and were “pleased” upon news of Shkreli’s commitment to a repricing.

Stephen B. Calderwood

“We are encouraged by the quick attention Turing’s 5,000% price increase for the drug received from policymakers and heartened by the swift response of the company to address this,” IDSA President Stephen B. Calderwood, MD, and HIVMA Chair Adaora A. Adimora, MD, MPH, wrote in a joint statement. “We remain concerned that substantial price increases for generic drugs continue to occur.

“We hope to see continued attention to distribution and drug pricing practices that affect the accessibility of essential medicines for patients.” – by Dave Muoio