State policies impacting access to innovative medicine, panel says

With issues like Accelerated Approval, anti-vaccine legislation, and biomarkers being taken up in state capitals, these are busy times for patient advocates working at the state level to improve access to medicine.

“You’ve heard the famous Justice Brandeis saying that states are the laboratories of democracy, and they really are,” Patrick Plues, BIO’s Vice President on State Government Affairs, said at the opening of a panel on state policy at this week’s BIO Patient and Health Advocacy Summit. “What we see in the states will eventually end up in Congress.” 

The panel featured leaders in state legislative policy:

  • Rekha Lakshmanan, Chief Strategy Officer of The Immunization Partnership
  • Jamie Sullivan, Sr. Director of Policy at Everylife Foundation For Rare Diseases
  • Pam Traxel, Senior Vice President of the American Cancer Society Cancer Action Network, Inc.

And states have been busy.

“State legislatures consider and act on 23 times the amount of bills that Congress acts on,” Plues said. “Averaging roughly 130,000 bills a year nationally with about 19% of those bills becoming enacted into law. So, while what Congress is doing is incredibly important and has national implications, state legislatures are equally important for patient advocacy organizations to focus on because they have the ability to regulate medicines, as well as the ability to provide access to medicines.”

Access to Accelerated Approval drugs at the state level

Oregon’s recent 1115 waiver, a document outlining the state’s Medicaid policy, is a case study for issues on the state level when it comes to protecting Accelerated Approval.

“While much of the 1115 waiver consisted of great provisions that ensured great affordability and accessibility changes,” Sullivan explained, “tucked in the waiver was initially a proposal to have a closed formulary for adults and a provision that would have allowed them to separately evaluate whether there was enough evidence of efficacy of medications approved via the Accelerated Approval pathway.”

“That would have essentially set up a situation where (if it had been approved) the state of Oregon would have been able to exempt itself from the rules of the Medicare rebate program and adjudicate the FDA on decision making and evaluate whether there’s enough evidence for medication,” Sullivan explained. “This was very concerning immediately.”

Sullivan’s comments hinted at larger issues politically around the assumption that Accelerated Approval is a somehow less-diligent process. “The message that was sent if it was approved would mean that it was okay to treat Accelerated Approval therapies as experimental—which they are not!” she said.

While the provisions in the waiver were ultimately removed, this case study set the tone for just how consequential state policymaking is on the national level. And Oregon is not alone in its opposition to Accelerated Approval;  Massachusetts, for one, also tried to undermine the program in the past.

State-level vaccine legislation is changing the political landscape.

Vaccines were a recurring theme, as well. As Lakshmanan of the Immunization Partnership recalled: “For years, vaccine coalitions and organizations used to beg to have time with people to talk about vaccines. Fast forward to 2020, and vaccines are now the topic on hand. While the pandemic has really accelerated the discussion around vaccines—COVID-related, as well as routine, childhood and adult immunizations—unfortunately, the change in the conversation we have seen lately has not been for the good.”

“In February and March of 2020,” Lakshmanan continued, “many of us thought, ‘This is what it’s’ like to live through a global health crisis and not have a vaccine to help us get out of it. Surely this will spur a lot of advocacy and a new appreciation for the value of vaccines.’”

Needless to say, vaccine advocacy groups were disheartened when they found the opposite became true, and they would have to double, if not triple, their efforts to support vaccine legislation.

“What we’ve seen across the states over the past year-and-a-half to two years is an increase in anti-vaccine legislation filed in state legislatures,” Lakshmanan explained. “In 2022, we saw over 1,300 vaccine-related bills filed across state legislatures. It was in response to some of the federal mandates that came down, but what we are starting to see is kind of a breach that really attempts to erode or to dismantle routine vaccine policies in the states.”

“I think what we’re going to see next year is a few different things,” she said. “Number one, we’re going to see attacks on school entry requirements. Number two, we’re going to see more and more legislation prohibiting employers and businesses from setting their own health and wellness policies. Number three, we’re going to see vaccines meld with civil liberties issues, meaning that people who choose not to be vaccinated will claim that vaccine requirements are a form of discrimination. And then lastly, we’ve seen in some states attempting to shift the power away from state health departments.”

Biomarkers and personalized medicine on the state level

As the somewhat “new kid” of state legislative policy, biosimilar technology and biomarker medical practices have started to gain a foothold on the state level—which will eventually prove to be a gamechanger when it comes to treating and including minority and underserved patient populations, especially in the hematological and cancer spaces.

“Biosimilar companies are creating some really cool and innovative therapies,” explained Traxel of the American Cancer Society. “And a lot of those therapies are being targeted to a particular patient based on a biomarker test. In cancer, this means that there’s a specific genetic mutation that’s causing cancer to grow in our body. And these therapies are designed to actually block that. Today, we’re seeing some really, really effective impacts with these therapies.”

However: “Communities of color have less access to biomarker testing,” Traxel continued. “This is true across the country.”

Now, state laws requiring insurance coverage of biomarker testing are becoming more and more common.

“We’ve had the opportunity to pass this legislation—in four states so far, Illinois, Arizona, Louisiana, and Rhode Island—that says patients who have either Medicaid, a state marketplace plan, or a state government employee plan, have access to biomarker testing, if there is medical evidence to say that that’s’ medically appropriate for that patient,” Traxel explained. “Many of you will undoubtedly see more of me in your state legislatures in the coming years as we work to expand this legislation.”

A united front for patient advocacy

One common theme agreed on by the panel is that better Medicaid coverage is essential to solidifying universal patient access to care.

“We should be expanding Medicaid in every state in this country,” Traxel asserted. “Medicaid is a really important safety net. And unfortunately, states that have not expanded Medicaid are states with large communities of color—that’s not okay!”

But there is always more work to be done, and that work is built on the connections that patient advocates can make with their states’ politicians.

“Change begins with awareness,” Traxel said. “And awareness begins with a conversation.”

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