Biosimilars in Massachusetts – Event Recap

On Thursday, September 12th, MassBio convened a panel discussion for the state legislative Biotech Caucus to learn about the issue of biosimilars, and what important factors should be considered when crafting sound policy around biosimilars. The meeting was attended by more than two dozen legislators and their staff.

DSC_0015Senator Karen Spilka, co-chair of the Biotech Caucus, began by explaining to her colleagues that biosimilars present an opportunity for the Commonwealth to once again be a leader in healthcare, but also present challenges in policy-making.

“We need to do what we can to foster their development,” she said, “But at the same time ensure we have appropriate regulations to make sure patient safety is at the forefront at all times.”

At the heart of discussion was legislation filed by Representative Mark Cusack which incorporates BIO’s five principles on biosimilars, which MassBio has adopted. The legislation is a re-file of a bill Rep. Cusack filed earlier in the session, improved, he said, by industry and stakeholder suggestions.

“I filed a bill to start the conversation,” Cusack said. “And since then I’ve had a number of very interesting discussions with patients, doctors, industry, MassBio. This is another opportunity for Massachusetts to lead.”

Fritz Bittenbender, Vice President of Alliance Development and State Government Affairs at BIO, said Rep. Cusack’s legislation “puts Massachusetts at the vanguard of the delivery of healthcare around the country.”

Some of the key tenets of the legislation include requiring both patient and physician notification in the event of substitution. The panelists pointed to Massachusetts’ mandate for electronic medical records as an easy way to ensure patients and their doctors are notified of any biologics substitutions.

Dr. David Charles, Chairman of the Alliance for Patient Access and Chief Medical Officer at Vanderbilt University’s Clinical Neurosciences Institute, explained that a system of unrestricted substitution impacts the sanctity of the relationship between patients and doctors.

“What we hear from doctors all the time is, ‘If I see patients on a Tuesday, prescribing biologics or other treatments and what have you, and I come in on Wednesday morning, there is a stream of communications trying to undo what I did the day before.’ That is not a system that works,” he said.

Lynne Morin, Senior Patient Services Manager, Leukemia & Lymphoma Society’s Massachusetts chapter, herself a patient advocate, said there were already significant patient concerns with generics substitution rules and that it is crucial for patients to know and understand what they’re being prescribed and what they’re receiving.

“Patients need to be assured that they don’t have to worry,” she said, stressing the patient education and notification required for any policy on biosimilars substitution.

Rep. Cusack encouraged industry, patients, doctors and other stakeholders to share their viewpoints at a future hearing of the Health Care Financing Committee, where the legislation will be sent once it has been processed by the House Clerk’s office and given an official bill number.

Robert K. Coughlin, President & CEO of MassBio, closed by thanking legislators and staff for their time to learn about a complex policy issue.

“It’s not what patients are taking now, it’s what they’ll be taking next year, five years, 10 years down the road, the treatments and cures that are being developed now here in Massachusetts,” he said. “We need to ensure safe access for patients in need.”


Panelists from left: Fritz Bittenbender, Robert K. Coughlin, Rep. Mark Cusack, Dr. David Charles, Lana Gladstein – Partner at Pepper Hamilton, & Lynne Morin.

Posted on September 18, 2013, in MassBio, Policy Briefs and tagged , , , , , , , . Bookmark the permalink. 2 Comments.

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