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If you would like to watch the video version, please visit our video page. To learn more about this topic, check out our insight Navigating the Road to RSV Prevention. 

Transcription:  

Elif: Hi, and welcome again to another episode of Avalere Health Essential Voice. Our podcast show covers a wide range of healthcare topics, and today we’re continuing our series on respiratory syncytial virus, or RSV. My name is Elif Alyanak, and I sit in the policy practice here at Avalere, and I’m joined today by my colleagues Alessandra Fix and Tom Hess.  

We return to the RSV series with another episode looking at the future of RSV among older adults specifically. So far we’ve covered pediatric RSV disease prevention where we know that innovation is really bringing a mix of options forward to protect infants against RSV through both vaccines and monoclonal antibodies.  

But RSV disease burden is high in older adults too. It leads to more than 170, 000 hospitalization among individuals older than 65 years of age. And within the US roughly 14, 000 older adults are dying from RSV annually.  

Today, there is no vaccine to prevent infection in older adults, but like the pediatric space, there are a lot of products in late phase development. Do we anticipate that there might finally be a preventive option on the horizon for this at risk population, Alessandra?  

Alessandra: Oh, absolutely. There are several products moving through development right now, which I think is really positive news considering the data you mentioned on RSV disease burden among the older adult population.  

I think those data really showed that this population in particular is incredibly vulnerable to severe disease caused by the virus, and I think that truly demonstrates that there is an unmet need here. We also know that due to age related declines in immunity as well as increased rates of certain chronic illnesses and comorbidities, RSV in older adults can cause or exacerbate respiratory conditions, which leads to the potential for hospitalizations or even death.  

And while there aren’t any preventive options yet available for this population, as you mentioned, there are certainly some on the horizon.  

Tom: As such, Alessandra, an RSV vaccine for the older population will certainly be welcome. Historically, vaccines have targeted children, but immunizations for older adults are becoming increasingly common and necessary.  

We know that RSV hits hard in the fall, winter, and spring, and immunizations for the older population are becoming increasingly more common and necessary, especially in that time period. As life expectations change and the elderly adults become more prone to infection due to comorbidities and compromised immune systems, addressing vaccine preventable diseases in older adults is absolutely critical.  

Alessandra: Yeah, I think that’s exactly right. The Advisory Committee on Immunization Practices or the ACIP, this is the group that develops recommendations on the use of vaccines in the US, that group is anticipating, what this changing landscape could mean for pipeline adult vaccine products.  

We recently saw the development of a specific adult RSV vaccine work group, which indicates a willingness from the committee to consider policy questions related to adult vaccination, and I think a potential recommendation for the use of an RSV vaccine and older adults could be coming.  

The work group has even outlined an interim schedule for their upcoming review of efficacy, immunogenicity, safety and cost effectiveness data of these vaccines, which indicates that we could see an ACIP recommended RSV vaccine as early as June, 2023.  

Elif: So looking at a recommendation coming down the pipeline, I think it’s really important to also consider that this population is unique in terms of their types of insurance coverage, right? Individuals who are 65 years of age and older could still have coverage through employer sponsored private insurance or have Medicare and different types of Medicare at that, right?  

So what does that mean in terms of how these products will be covered? Tom, are there certain considerations or barriers to patient access that are unique?  

Tom: Elif, important question. Among individuals who currently have insurance coverage through Medicare without legislation to have an RSV vaccine added as a part B vaccine product like influenza and the Covid 19 vaccines, RSV vaccines will be added to Medicare Part D.  

However, not all beneficiaries have a Part D plan, which adds to the complexities. About 9.1% of Medicare beneficiaries lack a prescription drug plan. This means that while they could access RSV vaccines, they would be required to pay completely out of pocket.  

And while the Inflation reduction Act or IRA, which was passed recently in August will eliminate patient cost sharing for adult vaccines under Part D and under Medicaid, not all beneficiaries will have access.  

Alessandra: Yeah, I think that’s right. And then I would also add that adults lack kind of a true vaccine safety net in the United States, which is unlike pediatric patients age 18 and younger, who can access recommended vaccines completely free of cost through the vaccines for children or a VFC program if they do not have access through their insurance.  

This lack of a safety net program means that many uninsured adults may not be able to get a future RSV vaccine unless they pay out of pocket, and that could be a real barrier. Now, there has been some recent policy activity over the last several months or years aiming to abate this issue.  

For example, the Biden administration has a proposal to create a vaccines for adults type program that would likely share some structural qualities with the VFC program, and that could provide guaranteed coverage for uninsured adults.  

While discussions on a VFA have kind of somewhat renewed more recently, I think whether something progresses remains to be seen, especially after the recent vaccine related reforms within the IRA, which filled many of the remaining coverage gaps for insured adults specifically.  

Elif: And it sounds like the implications of part B versus Part D coverage plus the general lack of a social safety net are really interesting points in this population. Would we expect that to have downstream differences or implications for the coverage pathways to influence something like where beneficiaries receive their RSV vaccine?  

If we look to Part D first, do we see that individuals get vaccination in one type of clinical setting more than another? And is that an important consideration to keep in mind, Tom?  

Tom: Yeah, it’s a very important point, and we’ve seen a change to where adults are receiving their vaccines. Many adult Part D vaccines, for example, the shingles herpes zoster vaccine, are almost exclusively administered in retail pharmacies.  

Part of the design of Part D was to support accessibility and provide beneficiaries with prescription drugs at pharmacies, but this can make it more cumbersome for medical providers that aren’t pharmacists to bill Part D for a covered vaccine.  

As a result, if we work under the assumption that RSV is added to Medicare Part D, manufacturers should certainly prepare a go to market retail pharmacy commercial strategy.  

Alessandra: That’s right. And then there’s also the fact that the Part D market is managed by private plans, and those plans negotiate rates directly with pharmacies. Those plans will also need to account for added spending on a new adult vaccine when they submit their annual bids to CMS.  

To contextualize that in 2019, Part D spending on vaccines was 925 million dollars in total, and the majority of that, 93%, was spent on just one routinely recommended vaccine.  

So you can see how as more products potentially are added to Part D, plan spending on vaccines could increase by quite a bit. Though increased spending on prevention can also decrease costs in the long run through less spending on RSV treatment and management itself.  

And that could, I think, certainly benefit Medicare Advantage plans in particular as those plans manage patient care on both the medical and the pharmacy side.  

Tom: It’s a great point, Alessandra, and it’s important to remember that the RSV market could be far more competitive than what we’ve seen with some other vaccines, with multiple products working through different methods entering the market at the same time, and are unlike other routinely administered Part B vaccines.  

So manufacturers will need to really consider their go to market strategy.  

Elif: Yeah. These seem like really important considerations, at least to begin thinking about for both manufacturers and markets, particularly looking through the lens of individuals who have adequate health coverage.  

But I think it’s really essential to also have an understanding for adults who may lack coverage. How do we expect older adults who may be underinsured or even uninsured to access RSV vaccine products, Alessandra?  

Alessandra: Yeah, I mean, we touched on this a bit earlier, and as Tom noted, 9. 1% of Medicare beneficiaries do not have prescription drug coverage, and that’s more than 5. 7 million people. So if an RSV vaccine is covered under Part D, these patients could face full out- of- pocket costs if they want to get the vaccine.  

Now, we talked about a potential VFA program, but I’ll also note that both the federal government and state immunization programs could play a role in immunizing these individuals under current program structures.  

So for example, section three 17 of the Public Health Service Act authorizes the federal purchase of vaccines for some populations, but funding is limited and not really enough to cover all uninsured or underinsured adults.  

And then on top of that, those funds are also used to support other really important elements of vaccine infrastructure and so they’re sort of spread a bit thin as it is. And then just the one thing I’ll note on top of that, Section 317 dollars could also be used to purchase some Covid 19 vaccines as they transition away from a centralized government purchase system to a commercial market.  

And that might put further strain on the program.  

Elif: So given these new products and the anticipated recommendations that would come for them, how would we ultimately expect the RSV market to change? What does the future state of the RSV landscape look like in this population that seems to really be significantly impacted by RSV?  

Alessandra: Yeah, so like many of the other populations we’ve discussed throughout this miniseries, older adults do not currently have any preventive or prophylactic RSV options available to them. If you look at the development pipeline, older adult RSV vaccines are likely to be among the first to come to market and with multiple products anticipated from several different manufacturers at similar times.  

This level of competition means that future products will likely need to differentiate themselves using innovative therapeutic approaches. For example, the use of different technologies or different formulations to bolster an immune response such as the use of adjuvants or higher doses.  

These are aspects of technology that might play a key role in steering uptake within this older adult group.  

Tom: Some important insights there, Alessandra. Because this will likely need to be balanced with general growing vaccine hesitancy among adults is something that we need to take note of. As we mentioned, often vaccinations target children and adolescents to give them the immune boosting tools they need to for protection against vaccine preventable disease earlier in life.  

But as individuals are living longer and innovative research is successfully identifying tools to combat new illnesses, there can always be individuals who feel cautious to discuss or receive every new product.  

This hesitation is not necessarily due to common issues of fear of vaccination, but rather vaccine fatigue, particularly given the post pandemic environment.  

Alessandra: Agreed. And on top of that, we’ve also seen documented declines in vaccination rates since the start of the pandemic, and this is largely due to disruptions in routine care generally. There are some previous analyses out there that found that from January, 2020 to July, 2021, monthly vaccine claims decreased on average 32% for adults when compared to the same months in 2019.  

And in that same timeframe, total adult vaccine claims were between 15 to 62% lower than 2019 claims. I think that recovering from these pandemic disruptions will certainly be critical to make sure that we’re adequately preventing vaccine preventable disease and effective messaging of evidence based interventions is certainly an important piece of that.  

I’ll also say that there isn’t really one kind of clear policy based or programmatic intervention to return vaccination rates to pre- pandemic levels. And so cross- sector collaboration and multi prone approaches tailored to community needs is definitely important.  

Elif: Yeah, these are all great points, and I think through this discussion we’ve really highlighted how a resilient vaccination ecosystem is dependent on effectively improving vaccination rates, particularly routine vaccination rates, not just in children, but in older adults as well.  

Again, another really great discussion, and I want to thank you Alessandra and Tom for joining me today. And thank everybody else for tuning in and listening to Avalere Health Essential Voice. Please stay tuned. We’ve got one more episode in this RSV miniseries as we continue to explore the need for effective prevention, particularly among immunocompromised populations.  

If you missed our earlier episodes on pediatric monoclonal antibodies or mAbs, pediatric vaccines, maternal immunization, please see our podcast page. And if you’d like to more please on website, www.avalere. com.