"Carve Outs" Harm Patients, Increase Cost

For more than a year, we haveseen a disturbing trend in statelegislatures across the country—efforts to make it more difficult forpatients to access certain classes ofsafe, effective, and affordable genericmedicines. These efforts not only raise awarning flag for patients, but for pharmacistsas well. If successful, they wouldimpose significant burdens on pharmacistsand would adversely affect thedelivery of patient care.

Kathleen Jaeger, GPhA president and chief executive officer

This year alone, in >20 states, variousgroups have been encouraging lawmakersto "carve out" transplant drugs(immunosuppressants) and epilepsy andmental health medicines from state formularies.These proposals would make itharder for pharmacists to substituteimmunosuppressant or epilepsy drugswith equivalent generics unless the pharmacistfirst obtains additional consentfrom both the physician and the patient.Some proposals go even further byrequiring the pharmacist to maintainwritten documentation of this consent.

Mandating that a pharmacist obtainadditional consent from a physicianbefore dispensing an FDA-approvedgeneric medicine would create unnecessaryrequirements for pharmacists andphysicians to perform in their alreadybusy days. The extra time that this newprocess would require would take awayfrom the health care provider's ability toserve the needs of the patient. Pharmacistswould experience serious logisticalproblems in attempting to obtain additionalconsent from physicians; theymight not be able to reach health careproviders who are treating patients andmight have to wait hours or days for aresponse. The likely result would bepatients needlessly waiting for their prescriptions.These delays are unacceptablefor patients who must strictly complywith their medications. Moreover,convenience and ease also play intooverall clinical results.

Requiring a pharmacist to contact aphysician to obtain additional consentsimply does not improve care. All it doesis needlessly reconfirm the physician'searlier decision and create extra work forpharmacists. Would not that time be betterspent helping patients?

Carve-out claims also run counter toscience and the law. By law, a genericmedicine must meet the same high standardsas its brand counterpart to receiveFDA approval. This means that the FDAmust ensure that the generic and brandhave the same active ingredient in thesame amount (strength) and dosageform, labeling, and use. Generics mustalso adhere to the same high-qualitymanufacturing standards as the brands.Only after all of those strict standards aremet will the FDA make the determinationas to whether a generic can be labeledas interchangeable with the brand.

Groups supporting carve outs havebeen unable to cite any scientific studiesto bolster their claims. They also fail todisclose that there are numerous factorsthat can play into reactions with changesin medicine, whether brand or generic.When questioned about epilepsy medicinesin particular, the FDA has said thatto date it has "no scientific evidence thatdemonstrates a particular problem with[anti-epileptic drug] products. Further,there are frequently circumstances otherthan the switch that may cause untowardresponses."

Carve outs also have a dramatic negativeimpact on state budgets. Due to difficultiesin contacting prescribers and toavoid any delay in patient care, pharmacistscould be forced to fill prescriptionswith more expensive brand name productseven if patients prefer—and physiciansprescribe—a generic version. As aresult, patients and health care plans,including Medicaid and Medicare Part Dprograms, would be forced to pay higherprices for the more expensive brandproduct.

Recognizing this concern, some stateMedicaid programs have taken a look athow these carve-out proposals wouldimpact their budgets. The state ofFlorida's Agency for Health Care Administration,for example, estimated the fiscalimpact of an epilepsy carve-out lawon current claim levels for the Medicaidfee-for-service population to be $52 millionannually. There is also a risk thatthese proposed mandates could beinterpreted as implying that generic substitutionis not appropriate for variousdrug classes, and they could thereforedrive a higher use of more expensivebrand name medicines.

In a time of rising health care costs,lawmakers should be encouraging theuse of cost-saving generic medicinesand not creating unnecessary barriers tosubstitution.