VACCINE, NEW GO TO MARKET MODEL AND FUTURE OF HEALTHCARE

So far, countries are managing state allocations of Pfizer and BioNTech’s vaccine, as well as Moderna’s shot, with the goal of getting millions more doses distributed by end of January. Both vaccines, and many others, require two doses taken several weeks apart. The second doses are being held in reserve until they’re ready to be administered. To date, there has only been one feasible single dose vaccine, created by Johnson & Johnson (my company), which could ease the process of delivery and tracking. Here below a quick summary of the vaccine available or almost available:

- Pfizer/BioNTech, Trial size 44k, Doses required 2, Storage temperature -70/-80 °C, Efficacy 95%, Distributed and available

- Moderna, Trial size 30k, Doses required 2, Storage temperature 2-8 °C, Efficacy 95%, Distributed and available

- Astra Zeneca/Oxford, Trial size 45k, Doses required 2, Storage temperature 2-8 °C, Efficacy 90%, Distributed in UK, waiting for EMA approval

- Johnson & Johnson, Trial size 70k (separated trial with two dosed included), Doses required 1, Storage temperature 2-8 °C, Efficacy still waiting. 

- Novavax, Trial size 45k, Doses required 2, Storage temperature 2-8 °C, Efficacy still waiting.

NEW AND INNOVATIVE BUSINESS MODEL

Considering the features of the vaccines, it is needless to say that they have a totally different Go To Market models (GTM) compared the previous drugs, we have to consider different aspects:

New and innovative business models are beginning to show promise in delivering better care and generating new interesting insights. The existence of these models and their initial successes are reflective of what we have observed in the market in recent years: leading companies in the healthcare industry are not content to simply play in attractive market segments, but instead are proactively and fundamentally reshaping how the industry operates and how care is delivered, helping the highest number of patients. Common among these new business models are greater alignment of incentives typically involving risk bearing, better integration of care, and use of data and advanced analytics.

Nevertheless, as well as vaccines, other business models are coming and may be more disruptive than anything created so far: think about the innovation in CAR-T cell therapies, where everything is focused on the process of the drug ship and delivery. Generally, to maximize a Go To Market model of a classical pharmaceutical product, you follow the same steps:

With Covid-19 vaccines and gene therapy, we must consider new key challenges facing up the commercialization:

complex manufacturing and supply chain, high touch business model (high-touch refers to the involvement of personal attention and service) and price setting challenges. Moreover, commercialization faces challenges on the patient journey who is completely different. Think about the injection of the vaccines: people cannot have the dose whenever they want; health care departments divide the population in clusters following the risk rate and calling the citizens (not patients, but citizens) who can have the first injection. To date, the majority of the vaccines has a double dose to be delivered exactly 2 or 3 weeks later the first one, then, it is essential having a perfect tracking system to ensure of injecting the same vaccine to the same person (new complexity). Furthermore, considering CAR-T patient journey as our example, we should take care about referrals, ideal eligibility, apheresis, infusion and monitoring (!). From my perspective, new capabilities have to be developed within pharmaceutical companies.

COMPLEX MANUFACTURING AND SUPPLY CHAIN

There are 3 main complexities:

- centralized manufacturing, low economies of scale, high cost of goods sold

- complex cold chain required (most of the vaccines and all CAR-T therapies)

- long vein-to-vein time affecting patient eligibility

All CAR T-cell therapies on the market have complex and costly manufacturing and supply chains driven by the one-batch, one-patient paradigm shifts. Manufacturing of autologous CAR Ts today is largely centralized, with limited economies of scale, a model more akin to modular clean rooms and lab-like environments than to manufacturing plants. A shortage of manufacturing slots for either the CAR T cell or requisite viral vector is often cited as a key bottleneck among CAR T centers.

HIGHT-TOUCH COMMERCIAL MODEL

There are 2 main complexities:

- High cost to set up, certify, and scale sites

- Complex center protocols and training requirements

The complexity of vaccines and CAR T care requires cooperation among multiple stakeholders, including the treating physician, nurse practitioner, payors, apheresis lab technician, transplant administrator, and financial coordinator. The challenge for CAR T manufacturers today is providing these stakeholders with high-touch, end-to-end customer service. Such service often involves large support coordinated staff teams, including an account manager dedicated to the site of care, a cell processing facilitator to manage logistics (such as cryopreservation or preparation for shipment), dedicated sales forces and medical field teams, nurse educators and a sufficient number of HCPs.

REIMBURSEMENT CHALLENGES

- Economic uncertainty set by the Centers for Medicare & Medicaid Services policies

- Delayed preapproval reimbursement can impact the patient’s CAR T eligibility

In addition to manufacturing and commercial models, particularly CAR T-cell therapies encounter significant market-access challenges in the United States and EU and in other countries around the world. Centers face uncertain economics regarding CAR T under current policies set by the Centers for Medicare & Medicaid Services. Because of the urgency of the situation, vaccines are not meeting commercial return targets.

Despite all the challenges above, several advances are applying to expand the usage of the new drugs with new business model; I will have a deeper dive on that in my next article, because there so many aspects to consider.

TAKE HOME MESSAGES

Never forget to keep in mind these points above, keep me updated on your thoughts and feedback!

In the next chapter I’m going to talk about the enhancements and advances, the pharmaceutical research never stop!