Nosse Wants Law to Track Biosimilar Drugs Without Restricting Access

An ongoing controversy over generic equivalents to complex biological drugs is resurfacing in the 2016 session, as patient advocacy groups and drug companies try again to require pharmacists to take extra steps to notify prescribers of a substitution when they dispense something other than a brand-name biological drug.

Rep. Rob Nosse, D-Portland, is bringing back a bill that requires pharmacists to give extra notification to medication prescribers when the pharmacist dispenses a cheaper, biosimilar equivalent to a brand-name biological drug.

Pharmaceutical companies, including Genentech and Eli Lilly, have backed similar legislation several times to mixed results. Notification requirements for complex biological drugs were imposed on pharmacists in 2013, but the law has expired and was largely pre-emptive: No biosimilars were approved for use in the United States until last spring.

A second effort, to add less complex biological drugs like insulin to the list of drugs requiring this extra paperwork, failed in 2014, as did an attempt to lift the expiration date on the original legislation last year.

The legislation has been fought by health insurers and pharmacists, who have argued the bills have been designed for the drug companies to restrict access to cheaper alternatives than their brand-name products.

Nosse’s bill includes both the generic equivalents for insulin and the complex biological drugs pioneered by Genentech. But this time, rather than require pharmacists to notify providers in writing if they want to substitute a brand-name drug, pharmacists may only have to note the substitution in the electronic file with the pharmacy benefit manager, which they would have to submit to get paid anyway.

The big exception is for consumers who have opted out of paying a health plan to negotiate drug prices for them, and instead buy drugs directly with cash.

“We’re trying to find a hassle-free way for the pharmacist to notify the prescriber,” Nosse told The Lund Report. “I don’t think the barrier is really all that much.”

Niki Terzieff, the lobbyist for the Oregon State Pharmacy Association, disagrees that Nosse has found a workable solution. “It’s not feasible, and it’s costly and the cost is borne by the pharmacy,” she said.

She conceded that simply reporting to the PBM would not be difficult for pharmacists, but prescribing providers may not have easy access to this data. Health plans have worried that a manual, paper notification process would prove such a burden that pharmacists would opt not to prescribe the cheaper medications, but Terzieff said pharmacists would still dispense the cheapest effective medication for patients, and the extra paperwork would just add to their overhead, and they would not likely be compensated.

An optimal solution -- a seamless interactive electronic health record, which both pharmacist and physician could edit and know the exact brand of drug dispensed for both standard and biological medications  -- may still be five years off.

Drug companies and patient advocacy groups have argued that these drugs are much different than standard medications because their exact molecule cannot be replicated with a biosimilar.

But the distinction that the drug companies would like to make between regular generic drugs and generic biological drugs may be dubious. For these drugs to get approved for substitution by the FDA, they have to be the functional equivalent of brand-name drugs and deemed interchangeable. Europe and Canada have safely taken advantage of the cost savings from biosimilar drugs for years.

Biosimilar medications offer a lot of promise for stanching the flow of healthcare dollars toward pharmaceutical profits by providing some much needed competition. A Congressional Budget Office report estimated these drugs could cost health plans and consumers as much as 40 percent less than brand-name biologicals.   

Terzieff said her organization would ask for a delayed rollout of the biosimilar notification law.

Nosse said at the outset that competition is good for drugs, and he does not want to keep consumers from obtaining biosimilars. Aside from the drug companies, he said the Oregon Medical Association also supported the bill, although their lobbyist, Courtni Dresser, was unavailable for comment.

He offered a possible amendment to the bill to have it expire after a few years, after these drugs have become commonplace on the American market and their effects wider known.

News source: