As the US Senate considers legislation to toughen oversight of compounding pharmacies, one group of physicians is lobbying the Senate to create an exception for biologics. The American Academy of Ophthalmology is concerned about a provision in the Senate bill that requires patients to have specific prescriptions for each medicine that is ordered from a compounding pharmacy (here is the bill).
The language is designed to prevent compounding pharmacies from expanding into large-scale production, which is what the New England Compounding Center had been doing before producing medicines that led to a nationwide outbreak of fungal meningitis last year that has been called the worst public health crisis in the US in decades (back stories here and here).
But the AAO argues that the language would have unintended consequences by raising costs for both physicians and patients. Specifically, the physician group notes that such a law would preclude many patients from being able to afford compounded versions of Avastin, a biologic that is widely used for treating age-related wet macular degeneration.
As you may recall, Avastin is an older medication approved to treat various cancers, but not the eye affliction, which is common among the elderly. However, many ophthalmologists use repackaged Avastin on an off-label basis, because the price tag is low – up to $50 for an injection. By comparison, Lucentis, which is approved to treat AMD, can cost up to $2,000 for an injection.
The AAO argues Avastin would become unaffordable. “Ophthalmologist will no longer have the option of having (Avastin) available at the time of their patients’ monthly appointment. If a patient-specific order was placed for that patient prior to their regular monthly examination, the ophthalmologist would be responsible for the product cost if the patient didn’t need it or didn’t show up,” the AAO writes.
[UPDATE: The AAO plea is, so far, being ignored. The Senate Health, Education, Labor & Pension Committee has approved its legislation (see this) and also released a report that justifies the need for giving the FDA greater oversight of compounders.]
Here is some interesting background, though: Both drugs are sold in the US by Roche, which has worked hard to preclude use of Avastin on an off-label basis. Five years ago, for instance, Avastin was pulled from compounders, but its Genentech unit relented after ophthalmologists caused a ruckus, which caught the attention of a US Senate committee that conducted a probe into Medicare expenditures for the drugs.
Medicare costs are a big issue. A study released three years ago found that, in 2008, Medicare paid for 480,000 Avastin injections and 337,000 Lucentis injections, but paid only $20 million for Avastin and $537 million for Lucentis. Avastin was used in 65 percent of Medicare patients, while 40 percent were treated with Lucentis.
In the statement circulating on Capitol Hill, the AAO notes that Medicare will bear the brunt if biologics are not excluded from the patient-specific prescription requirement. Medicare beneficiaries pay an average of $11 for one Avastin treatment for AMD, but $400 per dose for either Lucentis or Eylea, a newer treatment sold by Regeneron Pharmaceuticals (REGN).
At these prices, the annual cost of either approved treatment is about $4,800, while the yearly cost of Avastin to a Medicare...