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New regulations of compounded medicines mean fewer options at higher prices

The requirement for an individual prescription has unintended consequences for patients, who will have fewer treatment options at a significantly higher cost.

Well-meaning regulations on medicine from compounding pharmacies have had some unintended effects.
REUTERS/Aly Song

Macular degeneration affects more than 2 million Americans, and is especially common in Minnesota due to a higher prevalence in populations of northern European heritage. By serendipity in 2006, a medication originally developed for colon cancer was found to avert blindness in advanced cases of macular degeneration. With monthly injections into the eye, patients may continue to read, drive, and live independently compared to a previous prognosis of eventual blindness. Today, there are three injectable medications available for the treatment of macular degeneration with enormous benefits for a patient’s vision. The three medicines are similar in safety, efficacy, and dosing; however, there is a shocking difference in cost: Avastin costs $50 per dose, while Lucentis and Eylea each cost $2,000.

Geoffrey Emerson
Geoffrey Emerson

Unfortunately, the option to use Avastin has been restricted by the debate on how to regulate medicine from compounding pharmacies. A compounding pharmacy is a pharmacy that offers compounding services were drugs and ingredients are mixed or processed to the specifications of a doctor’s order. Compounding pharmacies can offer a wider variety of mixtures and doses than are available at most pharmacies.

This debate follows the tragic outbreak in 2012 of fungal meningitis linked to tainted steroid from the New England Compounding Center (NECC) that led to 33 deaths. Despite multiple complaints, the Massachusetts Board of Pharmacy (BOP), the licensing agency responsible for the NECC, did not inspect the NECC and failed to correct inexcusable shortcuts in technique and an egregious lack of sterility. The offending pharmacy was closed permanently and the director of the Massachusetts BOP was fired. In an effort to prevent this from occurring again, many states (including Minnesota) strengthened existing requirements necessitating an individual prescription for each dose of medicine before it is compounded.

Avastin is considered a compounded medicine because of a technicality. Avastin is manufactured in larger vials for intravenous infusion in the treatment of cancer, but for macular degeneration, a compounding pharmacy repackages the medication into individual smaller doses. Although Avastin is not mixed, diluted  or altered in the traditional sense of compounding, it is repackaged by a compounding pharmacy and therefore the individual prescription rule now applies to this medication.

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This requirement is frustrating to doctors and patients, for several reasons.

First, it is impossible to have Avastin in stock and ready in the clinics where it is used. If a physician wanted to administer Avastin, a prescription would need to be sent to a compounding pharmacy before the dose would be dispensed and shipped back to the clinic. This is inconvenient at a minimum. For some patients with very aggressive forms of retinal disease, the resulting delay in treatment causes unacceptable permanent vision loss. Commercially prepackaged Lucentis and Eylea are stocked in offices and thus immediately available without an intermediary pharmacy or individual prescription. Thus, even though Avastin is the most affordable and has a history of safety and efficacy identical to its counterparts, doctors and patients have little choice due to the limitations of its availability.

Second, the costs implications of these regulations cannot be ignored and should be cause for great concern. Most health insurers cover all three options for macular degeneration. However, for the expensive options, the copay is often $400 every 1-2 months. In 2011, medications for macular degeneration accounted for 16% of the $12 billion total budget for Medicare Part B. This figure is likely to spike if the more expensive medications continue to be substituted for Avastin. Despite physician calls to lower the price of Lucentis and Eylea, the pharmaceutical companies have not, and these new regulations only strengthen their monopoly. This is not responsible stewardship of our Medicare or health care budget.

Most frustrating is that the recent increased regulation does nothing to improve safety or sterility. The root of the fungal meningitis tragedy was a deficiency in NECC’s sterile compounding technique and the State of Massachusetts’ lack of oversight. Absent or inappropriate prescriptions from physicians had nothing to do with the contaminated medicine.

Doctors, state boards of pharmacy and legislators all share a strong desire to improve safety for patients treated with compounded medications. Compounding is an important source of medication for our health-care system. We should focus on oversight of sterile processing at compounding pharmacies, rather than limit the choices available to patients and doctors. The current requirement for an individual prescription has unintended consequences for patients who will now have fewer treatment options at a significantly higher cost.

Geoffrey Emerson, MD, PhD, is an ophthalmologist specializing in macular degeneration at the Retina Center in Minneapolis. He is also vice chair of the Phillips Eye Institute and a member of the board of directors of the Minnesota Academy of Ophthalmology.

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