Contested Biosimilars Bill Clears Committee

by David Gorn

TOPIC ALERT:

The Assembly Committee on Appropriations yesterday passed a bill to require pharmacies to notify physicians when dispensing biosimilar drugs as a replacement for biologic medication. Biosimilars are a new type of biologic that isn't yet on the market, but is expected to be sold by 2015.

SB 598 by Sen. Jerry Hill (D-San Mateo) has struggled through committees, in part because of the time necessary to explain the esoteric subject and in part because of vociferous opposition to it.

"Physicians already know what they're prescribing, so having pharmacists telling them back what they already know, it's simply a huge amount of work," said Barry Broad, legislative advocate for labor organizations including United Food and Commercial Workers, representing pharmacists.

"The federal government hasn't even determined the federal regulations on biosimilars yet, so we don't know if this [bill] will be in conflict with federal regulations," Broad said. "We're creating a unique system for one class of drugs here. We need to make sure impediments are not placed in front of these drugs."

According to bill author Hill, the idea is to have regulation in place so that there is less confusion about dispensing biosimilars when they do hit the market. At the root of the legislation, he said, is a simple notification from a pharmacist to the prescribing physician that a biosimilar has been substituted for a biologic.

"The pharmacy has discretion and the physician just wants to know what the pharmacy does," Hill said. As for the issue of the burden the bill might place on pharmacists, Hill said notifications are routine and that the number of biologics prescribed is relatively low, so the burden would be slight.

Tom Bone, legislative advocate for CVS Caremark pharmacies, said the issue was not policy-related, but entirely financial.

"It's that the provision of physician notification creates a psychological barrier to prescribing biosimilars," Bone said.

He cited notification that was required in Tennessee for an anti-epilepsy drug, which resulted in lower rates of generic prescriptions, he said. "We think this will have the same effect on California," Bone said.

Hill said the Tennessee law applied to notifications before replacements could be made, whereas his bill only requires notification after a less-expensive replacement has been dispensed.

"Pharmacists need to notify physicians five days after the drug is dispensed," Hill said. "How is that an impediment to prescribing biosimilars?"

Assembly Appropriations Committee member Bill Quirk (D-Hayward) said that concern was central to his decision about the bill.

"Is this reporting requirement burdensome, and will it change physicians' prescribing practice?" Quirk asked. "To my mind, this will not be burdensome, because there won't be many of these [substitutions]."

Committee co-chair Diane Harkey (R-Dana Point) pushed Hill to take an amendment that would delete the notification requirement, but Hill demurred.

"That has been discussed thoroughly in every committee it's been through," Hill said.

SB 598 has already passed the full Senate, as well as Assembly Health. Assembly Appropriations passed the bill on a 15-0 vote, with two abstentions.


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