Editor’s Note: The following post is adapted from IntegriChain’s 2021 Access Insights Conference panel session: Best Practices for Launch featuring DBV Technologies, Karyopharm Therapeutics, and Sesen Bio. Responses have been edited for clarity. Click here to view the full webinar recording.

In our previous best practices for launch blogs, we covered designing a successful launch during the pre-commercial stage, achieving your pre-launch forecast, and critical factors that go into a successful launch. 

In this latest and final blog of the best practices for launch series, we ask our panelists: 

What are some of the barriers to patient and market access you’ve faced in your careers and how were you able to overcome them? What are some of the challenges you face in patient initiation and adherence from a channel strategy perspective?

 

Our Panel:

 

Dan Ryan

For us, we’re actively trying to put programs in place so that if the patient runs into an obstacle getting their first prescription, we have they can receive a week’s worth of their therapy. We also have extensive copay programs to help out our patients. Due to the recent shakeups in copay programs, we also need to pay close attention to and monitor different legislation on coverage gap and Medicaid expansion post-COVID. So there are a lot of changes on the government side and legislation for copay and patient access that are coming back down to the manufacturer to cover more of the patient benefit. This is something we’ll continue to monitor and improve upon to get patients better access to the product.

As we have a specialty product, we are using some specialty distributors and specialty pharmacies, and we haven’t run into too many challenges. I think the biggest challenge really is from a data standpoint with our specialty distributors. We don’t have strong data downstream showing who is using the product, what the patient looks like, or the persistence. So there’s always that data component when you think of your channel strategy. 

I’ve seen it a few different ways: I’ve been with manufacturers in which we went full-line wholesaler, which was tough because we didn’t have anything besides our 867 data. I’ve also worked at a company where we did a drop-ship for every single one of our products, which gave us tons of data. Having seen different sides of it, I think the most important takeaway is this: when you’re developing your channel strategy and you might not have too much flexibility depending on the product, it is important to realize the data component expectations you will have and what you will need to make the right decisions from a patient standpoint. In my experience, the more cross-functionally you’re aligned the earlier on, the fewer surprises.

 

Steve Barbera

I’ll add that you can do all the preparation internally, but those external forces and unknowns are things you really have to be thinking about. Whether it’s your external partners like IntegriChain, what you’re going to end up leveraging them for, and definitely taking into account what your customers and government agencies are going to say. It’s important to take all of these data points together and then package them up to get a clear picture of how it affects patient access and gross-to-net. 

It definitely has a ripple effect on every aspect of patient access, so it’s important to collectively communicate extensively with our external partners to try to understand what’s going on and get a clearer idea of the types of delays and reimbursement issues your customers are facing. For me, it was just a matter of being able to course-correct and make sure all of our key stakeholders were ready to do that as we evolved into the marketplace. 

On the initiation and adherence aspect, our products have a unique delivery. For example, you have to go to a hospital outpatient department or ASC for treatment because of the way the product had to be instilled into the patient. So we were challenging our patients to go a long way once a week for six weeks in a row and then possibly continue on with maintenance therapy. We were challenged with how could we create that process where it seemed fairly straightforward and simple to both physicians and patients.

It was really making sure we leveraged the appropriate partners and created a strong ecosystem not only with our distribution channel folks that we’re going to get the product where it needed to be from Point A to B, and then assuring patients that the effort and the value will be worth it for the treatment of the type of cancer that they had. We needed to make sure it was a seamless and straightforward process, and we were all critically committed to making sure that the next treatment stayed in line.

 

Mike McCarthy

I agree with everything Steve just laid out and it makes complete sense and applies to most launches. The level of complexity varies on the type of product, the patient population, and the distribution model. What it boils down to for me is that things are changing on the affordability side and we continue to hear more about it. But every year patients are being asked to contribute more and they’re getting less. The average premium for family coverage increased 20% over the last five years and 55% over the last ten. So historically, pharma has been able to offset some of that, at least on the commercial side. But as you see increases on the copay accumulator models, it’s becoming more of a challenge as more people end up in high deductible plans. It’s not as simple as being able to price a product however you want and then provide a copay card or rebate. That model has been challenged pretty significantly on the commercial side. Then when you factor in the potential changes to Medicare Part D, it becomes increasingly uncertain what that will look like from a gross-to-net standpoint for manufacturers.

As my colleagues have stated and I will reiterate: alignment is key, both internally and externally. Equally important is to bring in experts pre-launch that are familiar with this space, can plan it out operationally, and have the foresight and the experience to know what an operational plan should look like. The sooner you can gauge what the future of the product is going to look like before launch, the better. 

 

Learn more: 

Best Practices for Launch: Redesigning the Perfect Launch

Best Practices: Achieving Your Pre-Launch Sales Forecasts

Drug Commercialization 101