NCDs, Part III: Agency Mandates, Decisions, Coverage and Access

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Tune into the third episode in the Avalere Health Essential Voice podcast series focused on Agency decisions define patient access. In this segment, our experts continue the conversation around national coverage determinations (NCDs) by considering how potential policy and market catalysts 3 to 5 years out may help stakeholders think through opportunities and risks at key decision points ranging from early in development to implications for Part D.


Ryan Urgo , Managing Director, Policy

Ryan Urgo provides strategic advice to drug manufacturers, health plans, and advocacy groups to help them navigate the health policy environment and understand the impact of legislative and regulatory policies on their business goals.

Kelly L. George , Principal, Market Access & Reimbursement

Kelly L. George, PhD, RAC, supports clients in navigating the FDA policy environment for the development and lifecycle of drugs and biologics.

This interview was originally published as a podcast. The audio is no longer available, but you can read the transcript below. For updates on our newly released content, visit our Insight Subscription page.


Ryan: Hello and welcome to another episode of Avalere Health Essential Voice. Our podcast show covers a wide range of healthcare topics. My name is Ryan Urgo. I’m a Managing Director in the Policy Practice here at Avalere, and I’m joined today by Kelly George, a principal on our market access team, and Kelly also leads our FDA Regulatory Strategy team within Market Access.  

Today’s episode is Part Three of a three- part mini- series focused on how the implications of CMS and Medicare coverage decisions help to better define patient access. In the first two episodes, we focused on an overview of the NCD process for monoclonal antibodies and the evidence development requirements necessary to fulfill the CED.  

In this episode today, we’ll take a more forward- looking approach and look into how the NCD could impact what we could expect from CMS and FDA as well as how plans may approach coverage and access decisions for products that are more likely to undergo accelerated approval or fall under a potential NCD in their own right.  

So to start, Kelly, first question for you. How do you think the recent monoclonal antibody NCD decision could impact downstream interactions between FDA and CMS?  

Kelly: When we think about this recent NCD and CED decision and try to piece together how we expect this to impact downstream decisions, interactions with the agency, the first thing to do is for us to take a step back and really think about what role each of these agencies play in the series of decisions between a potential product and a patient accessing product.  

For example, FDA, their role is to gate keep market entrance. Their evidence expectations are well- defined in statutes and regulations. There’s two different bars of evidence, substantial evidence and reasonably likely to be of clinical benefit, right, so that’s the difference between overall survival and progression- free survival, but really that focus on safety and efficacy.  

CMS, however, when we’re thinking about Medicare coverage, they’re the six protected classes but then they have this term reasonable and necessary, and that goes a step beyond safe and effective with FDA, right? The reasonable and necessary, it’s not defined in statute, it’s in the program integrity manual, and it includes not just safe and effective approved by FDA but also non- experimental or investigational.  

This term appropriate, so it means if it doesn’t exceed medical need, correct setting, and a pile of other criteria that CMS is using to determine that next level of decision and gatekeeping, which is coverage.  

So flagging that as we think about how this plays out, these decisions play out for products in the pipeline, simply that each of these agencies play different roles. One of them, FDA has two different evidence requirements. CMS has essentially one bar, but a bar that’s not necessarily restricted by statute and has an opportunity for flexibility.  

Thinking going forward, I think there have been attempts for collaboration. There’s been the 2011 parallel review medical devices that had mixed reviews of CURES 2.O, where there’s draft bill techs proposing these two agencies to really work together for certain endpoints and rare diseases.  

Each of this really may give opportunity for the agencies to streamline approval and coverage decisions going forward. But speaking of coverage, I’d be interested to hear from you, Ryan, on the role of Part D, providing coverage for this product and these types of products.  What’s going on there?  

Ryan: Yeah, so part D was an interesting element of this recent NCD. As it’s stipulated in the FAQ, if a drug is not covered under Part B for failing to meet medical necessity criteria then it’s considered a Part D drug.

For all intents and purposes, Aduhelm, outside of the context of CED, may be considered a Part D drug. But importantly, part D plans have the option to exclude the drug from coverage if CMS determines that its use does not meet medical necessity conditions when the drug is used.  

So at the end of the day, plans have the right to exclude these Aduhelm and related monoclonals from their formularies. It’s also possible, however, that they may cover the product, the formulary, but add in pretty restrictive utilization management.  

The plan has some discretion within the Part D program as to how that language can be written so it’s quite possible that the could be modeled on similar terms that we see in the NCD itself, so there could be a CED- like component to the utilization management protocols.  

It’s possible that there is also utilization management or prior authorization that is a little bit softer, but really it’s going to come down to the individual Part D plan in that instance, Kelly.  

Kelly: Yeah, and among the products that are treating unmet medical needs that may be likely to undergo these accelerated approval pathway or be candidates for an NCD, how do you see these insurers handling management of these products?  

That’s a really interesting question, which is how current experience may inform the way that plans manage the broader set of products that treat unmet needs and that may be candidates for an NCD, certainly those products that have undergone accelerated approval.  

I think we’ll certainly see more planned scrutiny on accelerated approval products in the wake of this NCD. Just like I mentioned earlier with respect to how Part D plans may treat Aduhelm, if you think more broadly about how plans may treat accelerated approval products, they will have the flexibility.  

There won’t be a one- size- fits- all approach, and I think that they will take a look at the existing evidence requirements and, particularly the products labeled, and look to tailor their prior off criteria along those lines.  

They may also take use from the emerging package just in terms of the FDA having potentially a little bit more ability to keep manufacturers accountable to when they need to furnish full confirmatory trial data.  

It’s possible that there could be some limitations that plans place around those types of products before that information comes through. But I think the important thing to stress here is that payers also need to consider the potential benefits of these products as well, just in terms of fulfilling the unmet need that they do fulfill.  

The reality is that products that have gone through accelerated approval have been widely used by patients to fulfill unmet needs. Really, it goes beyond just cancer treatments, which are the first that tend to come to mind here, but into classes that treat orphan and rare conditions, immunology conditions, and neurological conditions as well.  

There’s also another element to this where limiting access to these types of products could also have implications on disparities in care, and I think that’s another important consideration.  

So needless to say, Kelly, payers will have a lot to think about as it relates to the broader management of these types of products that to fill an unmet need that have undergone accelerated approval. It will be important to not over- correct based upon some of the lessons that they’re learning from the current monoclonal NCD process.  

If I were to bring us home though and ask you one final question, looking to the near future, how are we expecting things to play out over time? Can you give us a little bit of a hint of what may be to come and what challenges or opportunities may exist as it relates to how the FDA and CMS may consider these types of products?  

Kelly: Yeah. We’re looking at the pipeline, the types of products that are going to come through this decision matrix, and the near future and the near term really leans heavily into orphan drugs, into products for small populations, for rare diseases, plenty of products in pipeline for oncology and immunology, all these types of products.  

These are a strong medical need, certainly an urgency to move quickly, and a real urgency to create early access to critical products. But, at the same time, they have a shifted risk benefit to some of the older products that we saw coming through in the early 2000s or in the ’90s and it’s much more challenging to run a clinical trial for these types of products.  

It might be less appropriate for us to have the two pivotal trial criteria of the past. These types of products really align strongly with the accelerated approval criteria, but at the same time create a level of uncertainty that will result in conflicting opinions for decision makers.  

Whether that be FDA, CMS, payers or physicians, there’s certainly an opportunity as these products come through the market for us to figure out what’s the best system for checks and balances as this landscape for drugs continues to shift.  

Right? And identify what’s the best jurisdiction and programs to put in place to meet the needs of the US healthcare system and really make sure that those right products reach the right patients.  

Ryan: Wonderful. Well, I think we are just about at time for this segment so I just want to thank you, Kelly, for joining me today and thanks to all of you for tuning in to the Avalere Health Essential Voice. Please stay tuned for more episodes in this series and, if you’d like to learn more, please do not hesitate to visit us at Thanks so much.  

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