Biological drug bill advances to full Senate

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The Indiana Senate is set to consider legislation that could give patients access to more options for drug treatments that derive from biological organisms.

The drugs in question – which are expected to be interchangeable with brand-name options – are not yet on the market. But supporters of the bill say they could be soon and they want Hoosiers to be able to get them.

Biological drugs are usually injectable and they’re expensive. Biological means that the drugs come from living organisms. They treat an array of diseases including cancer, Lupus and diabetes.

Some drug makers have been working on what’s called “interchangeable” biological options. Company officials say they will not be generics but will serve a similar function and have the same therapeutic outcomes as their brand name counterparts.

Senate Bill 262 creates what supporters say is a “pathway” to let Hoosiers have access to the interchangeable drugs – when they become available. Indiana could be among first states to make that possible.

The Senate Public Health & Provider Services Committee passed the bill Wednesday and it moved to the full Senate for consideration.

But with the regulation of interchangeable drugs comes new rules for the pharmacists, who would be able to choose whether to give patients the brand-name biological drug or substitute it with an interchangeable. The bill would require those pharmacists to notify doctors within 10 days of how the prescription is filled.

“The relationship between doctor and patient is important. Doctors must carefully monitor patients’ medication,” said Carla Day, a spokeswoman for the Lupus Foundation. Day has Lupus and sometime takes between five and 20 medications a day. She said she’d want her to doctor to know if there was a change.

The General Assembly has considered legislation about biological drugs in the past, but the bills have never passed, in part because of strong opposition from a variety of companies. But now, some drug companies that had opposed the bill support it because of the way doctors must be notified about the way the prescriptions are filled.

Sandoz, a generic pharmaceutical firm, was one of those companies. That’s because the previous bills only would have required doctor notification if the pharmacist used an interchangeable drug. But the bill under consideration now requires notification whenever an interchangeable is available – regardless of whether it is dispensed.

That provision is meant to ensure that pharmacists don’t discriminate against the interchangeables to avoid the notification process.

But Express Scripts, the largest pharmacy benefits manager in the nation, had other ideas about the notification.

“Express Scripts opposes prescriber notification as it as an unnecessary step and will dissuade physicians from even allowing substitution,” said a company spokeswoman, Allyson Blandsord.

But it was Sen. Brandt Hershman, R-Buck Creek, that ended the discussion before the bill passed: “Wouldn’t you want your doctor to know?” she asked.


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