We spoke with Stephan Heumann, Director Market Access International for Urology and Pelvic Health at Boston Scientific, to discuss the challenges in gaining positive medical technology guidance from the National Institute for Health and Care Excellence (NICE).
Could you please tell us about your career in the medical-technology industry?
I studied Health Economics and Reimbursement at a university in Osnabruck dedicated to hospital management. After graduating, I started at a small orthopedic hospital with 150 beds in Bad Oeynhausen, the Auguste-Viktoria-Klinik, as an administrative assistant to the CEO, where I became responsible for purchasing, reorganizing the finance department and strategic planning.
I left after 2 years to join a larger, 500 bed hospital, the St.-Barbara-Klinik, which had 15,000 patient admissions per year. I was responsible for DRG calculations, but at that time a hospital information system didn’t really exist. Therefore, I had to collect data points from each individual patient folder and draft all of the clinical pathways of this hospital, which by the end of my term included 7 million patient data points. This enormous job leaked into the industry and I was shortly thereafter recruited by KCI.
Initially I was hired to cover Germany, for which I collaborated strategically with the management team in order to build a strong team consisting of members with professional backgrounds in insurance, hospitals and consulting to better support the sales and marketing at the customer level. Together we developed budget impact models and coding brochures. We discovered some hospitals lost up to one hundred thousand euros because of incorrect coding. As a result, we made coding analyses, presented them and educated the physicians to code correctly. The customers appreciated this approach, especially in the German and Swiss market, because the value behind it was that the treatment is covered, depending on the patient/treatment mix. This success led to a promotion to cover the DACH region and then onwards to cover bigger parts of Europe.
I ultimately left KCI to start my own company. American Medical Systems (AMS) was a client at the time and asked if I could join to support with two projects, but as they were so big, I agreed to take a full-time position with AMS. I was hired as a director responsible for international markets and after 1.5 years we were acquired by Boston Scientific.
What is your current role and what are your responsibilities?
I am currently part of the European Health Economic & Government Affairs (HEGA) team, serving as the Director Market Access International for Urology and Pelvic Health at Boston Scientific. Due to the multitude of products and locations in Urology and Pelvic Health, I have shared responsibilities with another director. We split the regions so that I take Italy, Spain, the DACH region and Russia, where I am responsible for all strategies with regards to health economics, reimbursements and everything that belongs to HEGA (Health-Economic and Government Affairs). We do everything for urology and pelvic health, for example, prolapse treatment, urinary incontinence and for men, erectile dysfunction, stone management and the benign prostate syndrome, an enlarged prostate which we treat with LASER technology.
In your opinion, what are the main difficulties medical companies face when launching products into the market?
The biggest challenge is that we, as Market Access experts, get involved in the entire product development process too late. I think it’s critical to get involved at the tailend of the R&D process to determine if a product design makes sense to launch. Gaining answers to questions on market size and the actual need for the product with support from Health Economic and Market Access teams can save companies money during the expensive R&D phase, as well as with pricing and product launch. For me, Market Access includes clinical evidence, health-economic and clinical value outcome, reimbursement and market size/need evaluation. We need to check what kind of evidence is needed to demonstrate value on the market to achieve reimbursement for the right market before the decision is made to launch a product.
Can you describe how you supported the company to gain positive guidance from the National Institute for HealthCare Excellence (NICE)?
It was a long process, which started as a part of the Interventional Procedure Guidance IPG_120 from NICE in 2005. Since then, several different groups within NICE were involved in that HTA process to get the GreenLight XPS™ Laser Therapy System accepted as a treatment option for patients with benign prostatic hyperplasia (BPH). The CG (Clinical Guideline) group included the IPG_120 in the CG97 group, but ultimately we got the guidance by the NICE MTEP group.
In the CG97 review from 2010, it turned out that Greenlight has a big potential for patients with BPH, but the economics behind the potential were a problem and higher evidence was necessary. Therefore, NICE decided GreenLight therapy systems should only be recommended to patients that are included in a randomized control trial under study conditions in special centers.
In 2013, a huge trial, called the GOLIATH study, which is the biggest study besides the Transurethral Resection of the Prostate (TURP) for the standard of care, was published for GreenLight to demonstrate a potentially new standard of care. The TURP treatment has existed for many decades, but no one has done a high-level randomized controlled, multi-center, multi-country prospective study for this as it is the standard for care. In this study the Greenlight technology was compared to TURP.
The study was published it in October 2013 and in Spring 2014, NICE was starting to update the guideline CG97 (Surveillance review of CG97). As this update was focused more on drug treatment, NICE didn’t include the GOLIATH study. This was a problem, however, as the entire review of the guideline was set to follow only several years later. Therefore, we asked NICE to find a solution, and they offered us the opportunity to join the MTEP group for single device appraisal. We were able to be admitted to this group as long as there was no prior evaluation for laser BPH treatment, which was for us in fact the case. For these discussion with NICE, we hired an external Consultant, which is an expert in this area.
Once part of this group, the work really began. Even after getting excepted into the group, you can still fail. We were required to build an economic model, process many documents, hold some challenging interviews and naturally have all of our evidence checked. Finally, NICE concluded that the adoption of the GreenLight XPS™ Laser Therapy System to treat non-high-risk patients with BPH can significantly reduce costs for the NHS. NICE estimates that broad adoption of the GreenLight XPS™ Laser System over the current traditional surgical treatment, transurethral resection of the prostate (TURP), could result in savings of around £2.3 million and possibly up to £3.2 million annually for the NHS as the GreenLight XPS™ System therapy is typically done on an outpatient day-case basis.
It was really hard work to get it done, and it demonstrated, how important it is to collaborate between the functions Clinical, Marketing, and Market Access etc. within a company and to have high level clinical evidence with economic data. The biggest part of this project was done by my manager, Kathy Sherwood, out of the US, because I am also running the GBA HTA process for GreenLight in Germany for the company.
How do you see the role of external partners in that type of collaboration?
I absolutely agree that external support has a major impact on this process and all of the projects I do at the moment. We sometimes need the help of consultants, which are experts in the countries you are looking for, to get jobs done faster. Ultimately, this means gaining faster access to the markets which we are all looking for. The advantage of big companies, like Boston Scientific, is that you have access to a strong Market Access and Health Economic team so you don’t need to hire consultants to manage Market Access projects. The in-house Health Economic guys can do a lot, but sometimes we need local experts, too.
A good example during my experience with NICE was when we needed to organize a meeting with the highest management level of NICE. We reached out to our local UK consultant and within minutes we had a meeting organized for two weeks later. In other countries I use other experts, depending on the job which needs to be done. There are many consultants on the market that think they can do everything, but it really depends on the product. Most consult on value messages, budget impact models, reimbursement applications and sales training, but when it comes to a point where you need to meet with local experts, KOLs or authorities, then you need someone who has access to these partners. In my experience, most of the organized globalized consultants don’t have this, especially when their core business is not health care.