"Carve Outs" Harm Patients, Increase Cost

JUNE 01, 2008
Kathleen Jaeger, GPhA President and Chief Executive Officer

For more than a year, we have seen a disturbing trend in state legislatures across the country— efforts to make it more difficult for patients to access certain classes of safe, effective, and affordable generic medicines. These efforts not only raise a warning flag for patients, but for pharmacists as well. If successful, they would impose significant burdens on pharmacists and would adversely affect the delivery of patient care.

Kathleen Jaeger, GPhA president and chief executive officer

This year alone, in >20 states, various groups have been encouraging lawmakers to "carve out" transplant drugs (immunosuppressants) and epilepsy and mental health medicines from state formularies. These proposals would make it harder for pharmacists to substitute immunosuppressant or epilepsy drugs with equivalent generics unless the pharmacist first obtains additional consent from both the physician and the patient. Some proposals go even further by requiring the pharmacist to maintain written documentation of this consent.

Mandating that a pharmacist obtain additional consent from a physician before dispensing an FDA-approved generic medicine would create unnecessary requirements for pharmacists and physicians to perform in their already busy days. The extra time that this new process would require would take away from the health care provider's ability to serve the needs of the patient. Pharmacists would experience serious logistical problems in attempting to obtain additional consent from physicians; they might not be able to reach health care providers who are treating patients and might have to wait hours or days for a response. The likely result would be patients needlessly waiting for their prescriptions. These delays are unacceptable for patients who must strictly comply with their medications. Moreover, convenience and ease also play into overall clinical results.

Requiring a pharmacist to contact a physician to obtain additional consent simply does not improve care. All it does is needlessly reconfirm the physician's earlier decision and create extra work for pharmacists. Would not that time be better spent helping patients?

Carve-out claims also run counter to science and the law. By law, a generic medicine must meet the same high standards as its brand counterpart to receive FDA approval. This means that the FDA must ensure that the generic and brand have the same active ingredient in the same amount (strength) and dosage form, labeling, and use. Generics must also adhere to the same high-quality manufacturing standards as the brands. Only after all of those strict standards are met will the FDA make the determination as to whether a generic can be labeled as interchangeable with the brand.

Groups supporting carve outs have been unable to cite any scientific studies to bolster their claims. They also fail to disclose that there are numerous factors that can play into reactions with changes in medicine, whether brand or generic. When questioned about epilepsy medicines in particular, the FDA has said that to date it has "no scientific evidence that demonstrates a particular problem with [anti-epileptic drug] products. Further, there are frequently circumstances other than the switch that may cause untoward responses."

Carve outs also have a dramatic negative impact on state budgets. Due to difficulties in contacting prescribers and to avoid any delay in patient care, pharmacists could be forced to fill prescriptions with more expensive brand name products even if patients prefer—and physicians prescribe—a generic version. As a result, patients and health care plans, including Medicaid and Medicare Part D programs, would be forced to pay higher prices for the more expensive brand product.

Recognizing this concern, some state Medicaid programs have taken a look at how these carve-out proposals would impact their budgets. The state of Florida's Agency for Health Care Administration, for example, estimated the fiscal impact of an epilepsy carve-out law on current claim levels for the Medicaid fee-for-service population to be $52 million annually. There is also a risk that these proposed mandates could be interpreted as implying that generic substitution is not appropriate for various drug classes, and they could therefore drive a higher use of more expensive brand name medicines.

In a time of rising health care costs, lawmakers should be encouraging the use of cost-saving generic medicines and not creating unnecessary barriers to substitution.