Instead of gambling, validate your strategy with payers.
You just raised your first round of capital and your team is eager to get into the lab and develop that sophisticated prototype (or the new drug) that will change the medical industry forever. But wait, will it ever be reimbursed? You may think: "This is so far away. Let's first see if we can actually develop it and get it through the US FDA, Australia's TGA and the EU's Notified Bodies. Afterwards, we will take care of reimbursement".
Such a serial process is a recipe for joining the startup graveyard, which hosts companies that developed a great product, got it approved by the relevant regulatory entity, but have never been able to successfully commercialize it due to the lack of reimbursement.
Having worked with almost 200 different biomed companies, I still find it hard to believe that so many companies postpone the integration of reimbursement considerations into their early design and strategy decision making process, and just hope for the best. To me, this is just like gambling with other peoples' money.
This is especially surprising since payers - the entities that are in charge of making reimbursement decisions in each country - have set up specific pathways for companies to obtain their feedback in advance, before making strategic decisions regarding their regulatory pathway or clinical study design.
In the following sections we detail a few such pathways. We encourage pharma and medical device companies to take advantage of these pathways to obtain payers' feedback and guidance early on, and step out of the reimbursement casino.
USA
Here are a couple of options that may be used to obtain public and private payers' feedback on regulatory strategy and clinical study design:
- Prior to submitting a Pre-Submission to CDRH for review, companies may obtain payers' feedback under these two pathways:
- For products that require premarket approval (PMA) or the granting of a de novo request by the FDA, companies may apply for the Parallel Review Program, which established a mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA's approval of a premarket application and the subsequent CMS national coverage determination (NCD).
- Companies who may not be eligible for a Parallel Review (since, for example, they plan to get their product cleared under the 510(k) FDA process), may request CMS' input on clinical trial design and other considerations by asking for CMS' participation in a Pre-Submission meeting, or asking for private payer input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions.
- Companies seeking Medicare coverage for IDE studies:
- Upon request, CMS can meet with study sponsors/applicants for coverage and provide feedback about favorable study protocol adjustments to help improve the likelihood of approval upon resubmission.
Germany
Companies may apply to the Federal Joint Committee (G-BA) seeking reimbursement for a 'controlled study', which involves new medical diagnostic and treatment methods that present a potential for improvement of care, compared with the current alternatives (§137e SGB V).
As part of the process, the company may request a meeting with the G-BA to provide guidance on its clinical study protocol. The meeting, typically scheduled within 8 weeks, is non-binding, confidential and fee-based (€500 - €10k, depending on study complexity and company status).
France
The 'Innovation Package' (Forfait Innovation), enables the minister of health (DGOS) to provide funding for certain clinical studies, designed to demonstrate the benefit of innovative devices.
The company may request an 'Early Meeting' with representatives of the French National Authority for Health (HAS) to review protocol and seek guidance. The meeting is non-binding, confidential and free.
UK
The National Institute for Health Research (NIHR) provides funding for various types of clinical studies at different stages.
As part of the process, the NIHR's clinical and delivery experts may provide the company with 'early feedback' to optimize study design for delivery in the NHS.
Summary
We have seen cases where a payer's feedback convinced the company to modify its selected comparator, changed the study's patient population and even its end points, in order to better address the requirements for reimbursement. Learning about payers' requirements early on, prior to initiating a clinical study, may save the company from having to conduct another study, post marketing clearance/approval, just to address payers' needs, significantly lowering costs and shortening the time to market.
Mediclever would be happy to guide you through these pathways in the above mentioned countries and others.
Flat fees, concrete timelines, and support through your entire reimbursement process
