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Burich: Saving Grace for Biosimilars in 2021 Will Be Bipartisan Support


Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.

Several legislative initiatives supporting biosimilar use are active in Congress, and the encouraging part is that many have bipartisan backing, said Molly Burich, associate director for Public Policy at Boehringer Ingelheim Pharmaceuticals, who provided her take on the health of the biosimilars market at the Association for Accessible Medicines GRx+Biosims 2020 conference.

“We’re definitely seeing some good tailwinds on biosimilars, but I would caution everyone that we aren’t there yet. This is still a very nascent market, and while the oncology market is certainly showing us reasons to be optimistic, the immunology market is still trailing,” Burich said in her discussion.

“We have to make sure that we’re setting up a system—whether that’s a combination of regulatory administration activities and potential legislative goals—that is not only moving across all therapeutic areas, but also creating a sustainable, long-term biosimilar market,” she said.

Burich highlighted various pieces of legislation that she said would incentivize the use of biosimilars by stimulating providers, patients, and payers to push these lower-cost products into centerfield.

HR 4597, also known as the ACCESS for Biosimilars Act, would eliminate patient cost shares for biosimilars provided under Medicare Part B and drive biosimilar uptake from the patient direction. “It could serve as an incentive to get patients talking to their physician about these options,” Burich said. “While the majority of beneficiaries of Medicare Part B do have wraparound coverage that helps with the 20% coinsurance, there are a chunk of patients who do not, and so this bill would either lower their cost shares significantly or zero [the cost shares] out if, in fact, they’re given the biosimilar.”

HR 4455 would increase provider payments for use of biosimilars to average sales price plus 8%, up from plus 6%, Burich noted. Under the wording of the bill, this increased payment opportunity would extend for 5 years.

Another potentially useful stimulus for biosimilar circulation is HR 4629, Burich said. This bill would augment the Star Rating measures used to grade Medicare Advantage coverage plans. Star Ratings guide patients in their choice of plans, and the higher the ratings, presumably, the more patients select these plans. The measures under consideration for biosimilar stimulus include the following assessments:

  • Coverage: whether a biosimilar is included on plan formulary in lieu of or in addition to its reference biologic
  • Preferencing: tier placement or cost sharing for a biosimilar vs reference product
  • Utilization management: how and whether tools for utilization management are used for a biosimilar vs reference product
  • Utilization: the percentage of plan enrollees who are prescribed a biosimilar vs its reference product

HR 1520, the Purple Book Continuity Act, is a piece of legislation that would raise the Purple Book of patent information to a more practical level so that biosimilar developers are better equipped to anticipate the obstacles they’ll encounter in trying to bring their products to market, Burich noted.

“There has been a lot of talk that the Purple Book isn’t set up exactly the same way as the Orange Book [for generic medicines], so is there a way to take some of the provisions in the Orange Book around patents and other really important information that impacts a developer’s decision around that product and put that in the Purple Book?”

HR 2740 is a federal appropriations bill that contains language encouraging greater utilization of biosimilars in Medicare Part B, she said. Related to this, the House Appropriations Committee has encouraged the administration to support new policies for reducing patient co-pays and developing cost-sharing models to spur biosimilar uptake.

Finally, HR 4400 would require HHS to maintain a website and perform other activities to educate providers, patients, and other stakeholders about the value and importance of biosimilars.

“There’s definitely progress being made, and I don’t want to undersell that progress. But the reality is, we still have a ways to go, and we need to be looking at the incentives that will get us a little closer to biosimilar success,” Burich said.

The good news is the bipartisan consensus that these drugs can contribute to broader access and health care system savings and deserve a fighting chance, Burich said. “The focus on drug pricing, the focus on patient affordability, government spending—all of these things—they’re not going to go away.”

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