# First to Market: Unlocking Switzerland’s Pharma Potential

An episode of [Pharma Market Access Insights - from Petauri Evidence](https://invisiblenetwork.ai/podcast/1516640440), 12 Nov 2025, 45 min.

Audio: https://www.buzzsprout.com/1053412/episodes/18178462-first-to-market-unlocking-switzerland-s-pharma-potential.mp3

Send us Fan Mail What makes Switzerland a compelling first-launch market for Pharma? How does its healthcare system compare to other European countries? What do manufacturers need to know about reimbursement, pricing, and evidence requirements? How might the evolving Joint Clinical Assessment (JCA) landscape influence launch sequencing? This episode explores Switzerland’s potential as an early launch market. In this session, Louise Maddison (Senior Consultant – Global Pricing and Market Access, Petauri Evidence) interviewed Dr Elisabeth Brock (Independent expert in market access in Switzerland), who has extensive experience in Swiss healthcare, including regulatory and payer engagement, dossier preparation for the Swiss Specialities List (SL), and strategic launch planning. Together, we explored what global market access teams need to know about launching in Switzerland – from regulatory routes and pricing frameworks to the nuances of payer expectations and evidence generation. We discussed: - What makes Switzerland attractive as a first-launch market - Key differences between Swiss and European Union (EU) market access pathways - How to prepare for inclusion on the SL and what “economically efficient pricing” really means - The role of cantonal (state) variation and decentralised healthcare in shaping access - How Swiss decisions may be influenced by the EU’s JCA - What global teams can learn from Swiss strategy to inform broader launch planning This episode was first broadcast as a live webinar on Thursday 16th October 2025 Learn more at https://petauri.com/insights/market-access-switzerland/ Subscribe to our newsletter to hear more news, insights and events from Petauri Evidence

## Chapters

- 0:00 Intro & Topic Overview
- 1:29 Guest Introduction: Elisabeth Brock
- 3:13 Overview of the Swiss Healthcare System
- 4:52 Role of Cantons in Healthcare Planning & Financing
- 7:26 Compulsory Health Insurance: How It Works
- 9:08 Supplementary Private Insurance in Switzerland
- 10:02 Role of the Federal Office of Public Health (FOPH)
- 10:45 Role of Swiss Medic: The Regulator
- 12:38 Similarities & Differences with Other European Markets
- 14:20 Opportunities for Launching First in Switzerland
- 18:58 Challenges for Launching First in Switzerland
- 20:35 Main Routes to Reimbursement
- 22:18 What Manufacturers Need to Prepare for Reimbursement
- 25:24 Economic Efficiency & Price Calculation Explained
- 28:03 Evidence Requirements for Swiss Dossiers
- 32:56 Importance of Local Insight & KOL Engagement
- 36:45 Routes for Diagnostics & Devices
- 38:48 Upcoming Changes & EFAS Reform
- 41:49 Swiss Openness to Confidential Discounts
- 43:40 Closing Remarks & Wrap-Up

## Transcript

[0:01] - \[Narrator\] Welcome to this Petauri Evidence webinar.
[0:03] At Petauri Evidence, we deliver market access and HEOR support throughout the product lifecycle to bring new treatments to patients across global markets.
[0:14] Follow us on LinkedIn for more great content from our team.
[0:19] We hope you enjoy the discussion.
[0:24] - The topic today is First to Market: Unlocking Switzerland's Pharma Potential.
[0:27] - The topic today is First to Market: Whilst a small country, it can be a great first launch market for several reasons, which we will fully explore today.
[0:34] - The topic today is First to Market: I'm Louise Maddison, and I'm a senior consultant at Petauri Evidence.
[0:39] - The topic today is First to Market: We have a great mix of audience today across industry and healthcare systems, and I'd particularly like to welcome our global affiliate partners, who play a key role in the work that we do.
[0:51] - The topic today is First to Market: For those who don't know us well, Petauri Evidence was formally Mtech Access and Delta Hat, and we are a global specialist, health economics, outcomes, and market access consultancy.
[1:03] - The topic today is First to Market: We have a track record in expert delivery.
[1:05] - The topic today is First to Market: We provide specialist support to pharmaceutical and MedTech clients and work as a collaborative partner to healthcare systems worldwide.
[1:16] Today, we focus on First to Market: Unlocking Switzerland's Pharma Potential, and I'm delighted to welcome our guest today, Dr. Elisabeth Brock, who is a Swiss market expert with extensive experience in market access and reimbursement.
[1:27] Today, we focus on First to Market: Welcome, Elisabeth.
[1:29] Today, we focus on First to Market: Please, could you take a moment to introduce yourself, your background, and experience?
[1:34] Today, we focus on First to Market: - Sure, I'd be happy to, Louise, thank you very much for having me.
[1:37] Today, we focus on First to Market: I'm excited to talk to you about one of my favourite topics, market access, Switzerland.
[1:43] Today, we focus on First to Market: So my name is Elisabeth Brock, and I'm based in Basel in the northwest of Switzerland, also known as the global headquarters of Roche and Novartis that may be familiar to you.
[1:55] Today, we focus on First to Market: I've worked in market access HTA and HEOR consulting for 21 years, although it doesn't feel that long.
[2:05] Today, we focus on First to Market: By training, I'm a health economist.
[2:07] Today, we focus on First to Market: I provide strategic and operational support to pharma, biotech, device, and diagnostic clients that are seeking market access for their products in Switzerland.
[2:21] Today, we focus on First to Market: I think my experience in Switzerland is a bit unusual in terms of being quite broad, so covering not just one type of technology or one type of access pathway.
[2:35] Today, we focus on First to Market: At the same time, I have in-depth experience, so being able to support with both the strategy and the implementation, and I've done three ATMPs, for example, with complex managed entry agreements.
[2:53] Today, we focus on First to Market: I've also been, in those 21 years, directly responsible for whole reimbursement submissions and early trial planning consultations in Germany and the UK, as well as supporting submissions in several other countries.
[3:11] Today, we focus on First to Market: - Great, thank you for that.
[3:13] Today, we focus on First to Market: I think maybe we can get stuck into exactly understanding a little bit more about the Swiss healthcare system.
[3:20] Today, we focus on First to Market: So could you just provide a brief overview around that, please?
[3:24] Today, we focus on First to Market: - Sure.
[3:25] Today, we focus on First to Market: So Switzerland is at or near the top of OECD rankings for healthcare spending, as well as for access and quality of care.
[3:40] Today, we focus on First to Market: Healthcare spending is more than 11% of GDP, which is one of the highest tiers among developed countries as far as I'm aware, it's only the US that spends more per capita than Switzerland.
[3:53] Today, we focus on First to Market: One example of this would be generics, so the OECD average is 54%, and in Switzerland, it's only 23%.
[4:06] Today, we focus on First to Market: We have a mandatory health insurance, which covers 68% of spending, and this is lower than the OECD average of 76%.
[4:17] Today, we focus on First to Market: In contrast, out-of-pocket spending is 22% of health expenditure, which is higher than the OECD average of 18%, but the satisfaction is also high with the Swiss healthcare system.
[4:32] Today, we focus on First to Market: So again, OECD numbers, 94% of people are satisfied with the availability of quality healthcare, and only 0.5% of the population actually report unmet needs with respect to the healthcare system.
[4:50] Today, we focus on First to Market: - Wow.
[4:52] Today, we focus on First to Market: And what role do the cantons or the regions play in planning, delivery, and financing the healthcare systems and services?
[5:01] Today, we focus on First to Market: - They're really important.
[5:03] Today, we focus on First to Market: There's 26 of them, and they can range from, let's say a single town, such as my own canton of Basel City, to much larger rural areas with a much lower population though.
[5:19] Today, we focus on First to Market: So the responsibility of those 26 cantons in healthcare is they have core responsibilities for planning healthcare services, delivering, and financing.
[5:35] Today, we focus on First to Market: With respect to planning, they're primarily responsible for hospital care and advanced medicine planning.
[5:46] Today, we focus on First to Market: They're required to coordinate hospital planning with other cantons to avoid unnecessary treatment and to optimise resource use.
[5:56] Today, we focus on First to Market: There are cantonal health departments in each canton that develop and implement plans, and they're guided by both federal criteria and regional needs.
[6:08] Today, we focus on First to Market: So that covered the planning aspect.
[6:10] Today, we focus on First to Market: I also mentioned two other aspects, which was delivering and financing healthcare services.
[6:15] Today, we focus on First to Market: So with respect to delivery, the cantons are responsible for supervising and operating hospitals, psychiatric clinics, care homes, and overseeing licencing and the quality of institutions and professional standards.
[6:33] Today, we focus on First to Market: They also provide direct sponsorship and infrastructure for hospitals.
[6:38] Today, we focus on First to Market: And lastly, they're also responsible for financing a lot of healthcare.
[6:45] Today, we focus on First to Market: So they co-finance inpatient care.
[6:47] Today, we focus on First to Market: At the moment, this is typically 55%, together with the mandatory health insurance through premiums.
[6:55] Today, we focus on First to Market: They also subsidise long-term care and they distribute financial support to low-income households.
[7:02] Today, we focus on First to Market: And at the moment, outpatient care is primarily financed by insurance premiums, but there are changes underway so that cantons are increasingly co-financing outpatient treatments as well.
[7:17] Today, we focus on First to Market: And lastly, the cantons set tariffs in collaboration with insurance companies and then negotiate budgets with institutions.
[7:26] Today, we focus on First to Market: - Okay, and I know we briefly mentioned about the compulsory health insurance.
[7:32] Today, we focus on First to Market: Could you tell me a little bit more about that and how that works as well?
[7:36] Today, we focus on First to Market: - Sure, so we've had compulsory health insurance since 1996, and that ensures universal coverage for all residents.
[7:48] Today, we focus on First to Market: It covers 68% of spending.
[7:52] Today, we focus on First to Market: This is a bit lower than the OECD average spending.
[7:56] Today, we focus on First to Market: Like I mentioned before, out-of-pocket spending is 22%.
[8:01] Today, we focus on First to Market: So how does it work?
[8:03] Today, we focus on First to Market: You purchase basic health insurance from private, nonprofit insurers, and there are no exclusions for age or preexisting conditions.
[8:17] Today, we focus on First to Market: Premiums vary by insurer, canton, and a deductible choice, but government subsidies help low-income residents with their premiums.
[8:29] Today, we focus on First to Market: Dental, adult, optometry, and certain therapies are not covered by basic insurance, but there are supplemental plans available privately.
[8:39] Today, we focus on First to Market: And perhaps of interest, the deductible works like this, so the patient pays the first, let's say, 300 francs to 2,500 francs.
[8:47] Today, we focus on First to Market: Francs are roughly equivalent to US dollars, so the patient pays the first 300 to 2,500 francs depending on what you chose as your deductible.
[8:58] Today, we focus on First to Market: And then you pay, on top of that, 10% of all other healthcare costs beyond that up until you reach an annual cap.
[9:08] Today, we focus on First to Market: - And you mentioned there about some supplementary private insurance that the population might also have can you tell me a little bit more about that?
[9:17] Today, we focus on First to Market: - Yeah, sure, so about 70% of the population has private, supplementary health insurance in addition to that mandatory health coverage that I mentioned before.
[9:30] Today, we focus on First to Market: This covers a range of additional services, such as private or semi-private hospital rooms, treatment by a more senior physician, complimentary medicine, dental care, and also certain treatments that are not covered by the mandatory health insurance.
[9:46] Today, we focus on First to Market: To me, this is interesting in this context because perhaps it provides an additional access route that you may not have in all other countries.
[9:57] Today, we focus on First to Market: - And the Federal Office of Public Health, FOPH, what role does that play in health system in Switzerland?
[10:06] Today, we focus on First to Market: - That's a super important actor in the health system as well.
[10:11] Today, we focus on First to Market: So this is the national authority, which is responsible for setting health policy, overseeing public health measures and managing health insurance regulation.
[10:22] Today, we focus on First to Market: They supervise compulsory health insurers and they manage data and national health quality initiatives.
[10:29] Today, we focus on First to Market: And in our context, they set prices for reimbursed medicines and services in negotiations with insurers, providers, and manufacturers.
[10:42] Today, we focus on First to Market: - And then the role of the regulator, Swiss Medic, how does that fit as well?
[10:48] Today, we focus on First to Market: - So we have our own independent national regulator.
[10:54] Today, we focus on First to Market: They authorise and supervise drugs and devices, and they also supervise the laboratories involved in diagnostic tests.
[11:05] Today, we focus on First to Market: It is independent or separate from EMA, the European regulator, although it does offer a regulatory pathway based on an EMA dossier as well.
[11:16] Today, we focus on First to Market: They collaborate with other regulatory agencies to streamline and speed up access.
[11:23] Today, we focus on First to Market: So for example, they're part of the Orbis project, which was initiated by the FDA, which has the aim of speeding up access for new cancer drugs.
[11:34] Today, we focus on First to Market: They're also part of the Access Consortium, which is a coalition of mid-sized regulatory agencies, including Australia, Canada, Singapore, and the UK.
[11:47] Today, we focus on First to Market: Why does that matter?
[11:50] Today, we focus on First to Market: To give you one example, so if you deal with the reimbursement of a drug that came through the Orbis project pathway, sometimes the indications are quite similar to EMA indications, but not always.
[12:06] Today, we focus on First to Market: So if it comes through the Orbis project, it would have the FDA wording of the indication, and sometimes, that can make a difference in what your comparator would be to negotiate your Swiss pricing and reimbursement.
[12:25] Today, we focus on First to Market: - Yeah, that's quite an interesting point, isn't it, around the nuance there, so it's quite...
[12:30] Today, we focus on First to Market: - Delayed, sometimes it can make a major difference.
[12:34] Today, we focus on First to Market: - Yeah, and I guess thinking more broadly, what are the similarities and differences between Switzerland and those larger markets in Europe, like Germany, France?
[12:48] Today, we focus on First to Market: - So like Germany and France, Switzerland has universal coverage, but in contrast to those, to Germany and France, they do this through private insurance companies from nonprofit insurers at least, sorry, nonprofit as far as the mandatory health insurance element is concerned, not the supplementary one.
[13:17] Today, we focus on First to Market: So in contrast to Germany and France, that means it's done through the private sector rather than being government run or based on employer systems.
[13:30] Today, we focus on First to Market: Our premiums tend to be higher and residents shoulder greater costs themselves, but in return, we receive rapid access, high service levels, and broad, free provider choice.
[13:48] Today, we focus on First to Market: In contrast to the UK, where you have single-payer public funding, the UK has lower costs and generally longer waiting times, and the market-driven approach adopted by Switzerland prioritises access and choice at higher personal expense.
[14:07] Today, we focus on First to Market: - Thank you, thanks for explaining that context of how healthcare system works in Switzerland and some of these similarities and differences with the other markets in Europe.
[14:20] Today, we focus on First to Market: So if I was a manufacturer and I wanted to go first into Switzerland, what are the opportunities for launching first in Switzerland?
[14:32] Today, we focus on First to Market: - So opportunities would be, first of all, that proper regulator, which is independent, so Swiss Medic, both Swiss Medic and the institutions through which you would negotiate reimbursement and pricing, they've made efforts to open up new access routes, to speed up access.
[15:04] Today, we focus on First to Market: So for example, there's a new early dialogue slash early access pathway to general reimbursement, not to be confused with the existing pathway, which is, I guess, early access, which is based on individual patient reimbursement.
[15:23] Today, we focus on First to Market: So this new pathway for early access to general reimbursement, that's a process which you can start submitting your pricing and reimbursement documents as soon as you submit for regulatory approval with Swiss Medic.
[15:42] Today, we focus on First to Market: So the two processes run in parallel, and that means if it goes well, ideally, you can get general reimbursement through the mandatory health insurance immediately following Swiss Medic approval.
[15:57] Today, we focus on First to Market: So that should cut about, say on average, a year off the time to market.
[16:06] Today, we focus on First to Market: That's a second new access pathway, especially for ATMPs that are expected to cost more than 80,000 Swiss francs.
[16:17] Today, we focus on First to Market: Again, Swiss francs similar to US dollars, so more than 80,000 Swiss francs per patient, and that goes through hospitals, so that's a different reimbursement pathway.
[16:33] Today, we focus on First to Market: And what they did for that is that they outlined a more tightly prescribed timeline and process to access, which gives you more security for your planning.
[16:49] Today, we focus on First to Market: Other opportunities, let me think.
[16:54] Today, we focus on First to Market: Switzerland is quite pragmatic in some respects.
[16:58] Today, we focus on First to Market: So if they think something is worth having, you talk to them, and talking to them, them meaning whatever institutions you're negotiating, whereas talking to them, in my experience, tends to be a little easier than in some other countries.
[17:19] Today, we focus on First to Market: So you can talk to them and you make your arguments, and it's still a bureaucratic process, but it's, in some ways, less tightly prescribed than in some other countries.
[17:33] Today, we focus on First to Market: For example, Germany, the interaction is polite and professional and it's a totally open negotiation, so that leaves scope in cases for, let's say, pragmatic solutions that may be more difficult in other countries, and you can break off the negotiations at any time.
[18:03] Today, we focus on First to Market: Then another opportunity, what is important is KOL support or other stakeholders depending on the situation.
[18:17] Today, we focus on First to Market: So some Swiss KOLs are actually quite influential at the global level, and they tend to look at the US more than some other European countries in my experience, and they provide high-quality care.
[18:37] Today, we focus on First to Market: It's a high-income country and they're willing to pay for real innovation, and the price level tends to be higher than other European countries.
[18:52] Today, we focus on First to Market: It also comes with some challenges, I think.
[18:56] Today, we focus on First to Market: - Yeah, I was going to ask you then, the other side of the coin, what the challenges were for launching first in Switzerland.
[19:03] Today, we focus on First to Market: - So when I say it's easier to talk to them, you still need an evidence package.
[19:11] Today, we focus on First to Market: It's not that you take your marketing material and you just pass it on to them and it passes.
[19:18] Today, we focus on First to Market: They also work to international evidence-based medicine standards, and they're no pushovers.
[19:25] Today, we focus on First to Market: If they see a product as not having the evidence that it really adds anything to the system for the patient, at least as far as they see it.
[19:39] Today, we focus on First to Market: What is a nice thing maybe is Switzerland is not a reference country for many other countries, so I guess it gives you the opportunity with the own regulatory agency, it gives you the opportunity maybe to try something in a high-priced countries, and you can maybe test your strategy and your value messages, which might be interesting also in the light of EU JCA, the European Joint Assessment.
[20:17] Today, we focus on First to Market: - Yeah, that sounds quite useful that it can act access this kind of test bed country before going to the larger markets, so you can shape and refine things prior to launch.
[20:29] Today, we focus on First to Market: - And it is being used like...
[20:31] Today, we focus on First to Market: - Sorry.
[20:31] Today, we focus on First to Market: - Sorry.
[20:35] Today, we focus on First to Market: - Yeah, I want to know a bit more about the main route to reimbursement as well.
[20:39] Today, we focus on First to Market: - Yep, so there's different route to reimbursement depending on several factors.
[20:51] Today, we focus on First to Market: So on the one hand, what type of product you have, so for example, if you're an ATMP, a drug, a device, a diagnostic test, a digital application, or actually, a general type of health service, then the route to access differs on the sector.
[21:10] Today, we focus on First to Market: If you're primarily an outpatient product or an inpatient product, the route to access may also be impacted by the unmet need.
[21:23] Today, we focus on First to Market: For example, this new early access path to general reimbursement, they would prioritise things that have fast tracked designation from Swiss Medic, Orbis designation, or a number of other that fulfil the number of other criteria that relate to unmet need basically.
[21:43] Today, we focus on First to Market: And then as a last element that matters for your reimbursement pathway is also the number of patients that are affected or that you expect to treat.
[21:54] Today, we focus on First to Market: So obviously, that's important for early access in terms of individual patient reimbursement, or if you only expect a very small number of patients, you might negotiate with insurers or consortium of insurers directly.
[22:15] Today, we focus on First to Market: - And I guess, what does the manufacturer then need to prepare to obtain that reimbursement for an innovative drug?
[22:24] Today, we focus on First to Market: - Using the example of drugs, to get covered by the mandatory health insurance, you would need to be included in a positive list of reimbursed drugs that is called the list of specialties.
[22:45] Today, we focus on First to Market: So you would need to apply for inclusion on that list of specialties, and maybe before I go into more detail of what is required for that, I'll start with the assessment criteria because they guide what you need to put into that dossier, into that application, and those assessment criteria, they're quite broadly phrased.
[23:14] Today, we focus on First to Market: So they would apply not just for drugs, so for this application, for a list of specialties, but also for, for example, for devices, tests, or other types of health services broadly.
[23:29] Today, we focus on First to Market: So these three criteria are what in German would be called the WZW criteria using the German words for it.
[23:39] Today, we focus on First to Market: So the first W would be...
[23:42] Today, we focus on First to Market: (Elisabeth speaking German) so that would be your efficacy and safety.
[23:46] Today, we focus on First to Market: The second letter, the Z would be...
[23:49] Today, we focus on First to Market: (Elisabeth speaking German) which there's no direct English translation, but let's say usefulness or adequacy, and it covers things like unmet need in Switzerland, how something fits into the Swiss diagnostic or treatment algorithm.
[24:09] Today, we focus on First to Market: It would also cover things like your pack size with respect to the dosage instructions.
[24:16] Today, we focus on First to Market: It would also cover what the regulatory agencies say, not just Swiss Medic, but also EMA and the FDA, and it would cover what HTA agencies or institutions might say, not just in Europe, but also in Canada and Australia, for example.
[24:32] Today, we focus on First to Market: And then, so we had the first W was the efficacy and safety, the second letter, that Z, was the adequacy, and the third letter, the second W would be economic efficiency.
[24:45] Today, we focus on First to Market: And I say deliberately economic efficiency, it is not the same as cost effectiveness as you would understand it in the UK, for example.
[24:56] Today, we focus on First to Market: So for that, you need to submit a budget impact, and then you can submit a formal cost effectiveness model, but it is not mandatory, and your economic efficiency would be determined by what they would call the economically efficient price.
[25:21] Today, we focus on First to Market: Do you want me to explain maybe how that is calculated?
[25:24] Today, we focus on First to Market: - Yeah, because it sounds like it's quite different to what perhaps we're more familiar with in the UK, and this term, economic efficiency, sounds quite interesting to know a little bit more about.
[25:36] Today, we focus on First to Market: - So this economically efficient price is calculated as a base case on a 50/50 weighting of a therapeutic cost comparison with a comparator or comparators in Switzerland, and the other 50% would be international reference pricing.
[25:58] Today, we focus on First to Market: That generally covers a basket of nine comparable European countries.
[26:04] Today, we focus on First to Market: However, do not be fooled, if they can use a generic price in Japan, they may do so if they don't have other prices.
[26:13] Today, we focus on First to Market: They may also use a US price if you do not have other prices.
[26:18] Today, we focus on First to Market: So the base case would be the 50/50 weighting of your therapeutic cost comparison within Switzerland and the international reference pricing.
[26:28] Today, we focus on First to Market: And then you can apply on top of the therapeutic cost comparison part of the 50/50 weighting, you can apply for a maximum of a 20% innovation premium.
[26:41] Today, we focus on First to Market: That can be applied under certain conditions.
[26:44] Today, we focus on First to Market: You would need a head to head for it at the very least, but it is quite rare that this is granted, but innovation is still rewarded.
[26:58] Today, we focus on First to Market: So let's say if you have a gene therapy that, for ethics reasons, you cannot have a trial against a comparator, they may give you an additional price for the innovation, not necessarily through this formal innovation premium that is more geared towards stepwise innovation rather than radical innovation like a gene therapy would be, but because it's an open negotiation where they would cover all three criteria of WZW, so the efficacy, the adequacy, and the economic efficiency, they'll put that, let's say, price increase for innovation somewhere else rather than formally giving you an innovation premium, but they have ways of making that happen.
[27:59] Today, we focus on First to Market: When you ask about the application for the list of specialties, there are certain evidence requirements.
[28:08] Today, we focus on First to Market: Would you like me to say something more about that?
[28:11] Today, we focus on First to Market: - Yeah, because you've outlined the WZW criteria, and then what actually do manufacturers need to do to meet those evidence requirement pieces, and how they would put together that SL dossier as well?
[28:28] Today, we focus on First to Market: - So for devices, lab tests, and general healthcare services, there's a two-step process where you would first submit a so-called notification form where you basically outline what your product is, what it does, what evidence you have, and also what price you want for it, and this is kind of used by the authorities, A, to kind of be aware of what's coming, but also they use this to guide you towards which reimbursement pathway they want you to go down so that you can fill in the proper application form and submit the proper dossier, which would be the second step.
[29:14] Today, we focus on First to Market: And for drugs, you don't have this notification form.
[29:19] Today, we focus on First to Market: It's very clear what application you fill in, unless you apply for this new early dialogue slash early access pathway to general reimbursement, where you also have a multi-step process because it's running in parallel with regulatory.
[29:35] Today, we focus on First to Market: And what I think is interesting probably for the audience is this dossier that you submit to the federal government has to be in an official Swiss language, which is, in this case, German, French, and Italian.
[29:53] Today, we focus on First to Market: That's also a fourth language, but you can't submit a dossier in this, you cannot submit a dossier in English, but the appendices can be in English or other languages.
[30:07] Today, we focus on First to Market: I think what is stunning about a Swiss application for inclusion on this list of specialties that is different to other countries and also different to devices or lab tests, for example, is that your dossier is limited to 30 pages, not counting the appendices, so you need to be very succinct and you need to be very clear in what it is you have to offer and where you're going.
[30:39] Today, we focus on First to Market: Yeah, so generally, the evidence that is required for one of those specialty list application form/ dossiers would be that you do not need to do an SLR, but you do need to describe broadly it's three main peer-reviewed publications regarding efficacy and safety from your phase three or phase two trials, depending on the indication.
[31:10] Today, we focus on First to Market: And generally, for premium price, you need a head-to-head trial against a comparator, which would be part of the standard of care in Switzerland.
[31:20] Today, we focus on First to Market: So depending what the standard of care is, and depending on the indication, a Swiss dossier would not be a copy/paste from a French or a German dossier quite apart from the limitation to the 30 pages.
[31:34] Today, we focus on First to Market: Then what else you need to supply is you need to tell them about medical diagnostic or treatment guidelines for Switzerland, Europe, and the US.
[31:47] Today, we focus on First to Market: You need to give them a summary of regulatory agency and HTA agency assessments.
[31:55] Today, we focus on First to Market: Optional, you can also submit a clinical expert statement.
[32:00] Today, we focus on First to Market: You need to tell them about unmet need and the size of the Swiss target population, and you also need a budget impact.
[32:10] Today, we focus on First to Market: And I already told you about how the economically efficient price is calculated.
[32:18] Today, we focus on First to Market: - Yeah.
[32:19] Today, we focus on First to Market: - Does that cover what you would be interested in?
[32:23] Today, we focus on First to Market: - Yeah, I think that the main differences in how they're put together, it's quite interesting that it is only limited to 30 pages.
[32:28] Today, we focus on First to Market: - Yes, it's a challenge sometimes.
[32:30] Today, we focus on First to Market: - Yeah, strategic and ensure that you have the right data to support everything, it's really interesting.
[32:38] Today, we focus on First to Market: - Yeah, what is funny about it is the formatting goes out of the window at the end because you're just trying to fit your content into those 30 pages instead of thinking,"Oh, maybe it would look nicer if I put a space there," but no.
[32:52] Today, we focus on First to Market: - Yeah, and I guess you mentioned a little bit about getting local insight into evidence generation processes and how there's some KOL interviews as well that might help support those things.
[33:06] Today, we focus on First to Market: Can you talk a little bit more about that?
[33:08] Today, we focus on First to Market: - Yeah.
[33:17] Today, we focus on First to Market: To me, local insight is absolutely crucial.
[33:24] Today, we focus on First to Market: I have done applications where the client decided not to get local input for whatever reasons, but generally, I would say it is absolutely crucial.
[33:39] Today, we focus on First to Market: So I would always suggest do KOL interviews.
[33:46] Today, we focus on First to Market: In some countries, you might do those KOL interviews to confirm, let's say, an economic model structure or validating model results, but in Switzerland, I think those KOL interviews can provide you with a lot more insight, for example, on general access topics, like pain points with access, obstacles that the KOL seek to access that can really help you, and also sometimes to generate, let's say, insight into what economic arguments you might pursue.
[34:17] Today, we focus on First to Market: And if you remember, I said cost effectiveness model, like for NICE in the UK, is not required for Switzerland.
[34:27] Today, we focus on First to Market: You may use it, but it is not required, but they do require a budget impact model.
[34:33] Today, we focus on First to Market: And for that you would, on the one hand, of course, compare, let's say drug costs in a list of specialties application, but you would also, if you can, try ensure certain cost offsets obviously.
[34:47] Today, we focus on First to Market: And for that, for example, KOLs would be useful depending on the situation.
[34:53] Today, we focus on First to Market: For example, get an insight into resource use or unit costs that you might prevent with this new product, or there might be a gap between the reimbursement value of something and the actual cost of providing that something that might give you kind of a gateway to an economic argument.
[35:19] Today, we focus on First to Market: Another aspect to bear in mind for that local insight is that Switzerland has four official languages, so I mentioned German, French, and Italian before, and that fourth language, Romansch.
[35:30] Today, we focus on First to Market: The majority of the population lives in that German and French-speaking regions.
[35:37] Today, we focus on First to Market: And these language regions are also culturally quite distinct.
[35:43] Today, we focus on First to Market: And this may be reflected in care patterns.
[35:45] Today, we focus on First to Market: So for example, regarding the frequency of doctor visits, the French-speaking region tends to mirror more what happens in France.
[35:52] Today, we focus on First to Market: The German region might mirror more what is culturally done in Germany, and I mentioned already that many doctors are trained in the US, so if there's no Swiss guidelines or expert statements, they may reference US guidelines far more than you might expect, but that you will only find out if you actually go and talk to them, so to me, local insight is a total must.
[36:25] Today, we focus on First to Market: - Yeah, sounds very key.
[36:27] Today, we focus on First to Market: And it's quite interesting that Switzerland looks to the US so much as well.
[36:31] Today, we focus on First to Market: That's quite an interesting point as well.
[36:34] Today, we focus on First to Market: - It depends on the indication.
[36:36] Today, we focus on First to Market: - Yeah.
[36:36] Today, we focus on First to Market: - But I think it reflects that it's a small country and that it has a high-income level and they value quality of the care.
[36:45] Today, we focus on First to Market: - Yeah, and I guess we've been talking about drugs here, but what about the specific routes for diagnostics and devices as well?
[36:56] Today, we focus on First to Market: - So for devices, you have another positive list that is called Omega list that has a separate application procedure, this two-step procedure that I mentioned before, and for diagnostic tests, you would have the list of analysis, another positive list.
[37:17] Today, we focus on First to Market: What distinguishes the access pathways of, for example, tests and devices from that of drugs is that the timeline to access would be very different, and also the degree of influence that the manufacturer can have on the timing of it.
[37:36] Today, we focus on First to Market: But so for example, the drugs list would be updated more frequently than the list of analysis or the list of devices, but they seem to want to increase those updates in the future as well.
[37:55] Today, we focus on First to Market: What is also relevant, the upfront effort required to do a dossier for the list of specialties to apply for a drug is less upfront than for a lab test or a medical device, because you need SLR for devices and lab tests, but you don't for the application for drugs.
[38:25] Today, we focus on First to Market: The negotiation process of those three pathways is different, but I think that maybe it goes into too much detail.
[38:37] Today, we focus on First to Market: - Yeah, it's good understanding that there's different routes and how they slightly change as well.
[38:44] Today, we focus on First to Market: And I guess now we're kind of coming into the last few minutes of the webinar, it might be useful to understand maybe some of the changes that are happening in Switzerland and what the audience should be aware of.
[38:55] Today, we focus on First to Market: - Yeah, so I guess regarding the Swiss institutions, they will continue to evolve regarding pricing and reimbursement.
[39:19] Today, we focus on First to Market: On the one hand, as they observe changes in other countries, I mentioned the EU JCA, again, the joint assessment, and also as they evaluate their own experience with their own new access pathways.
[39:33] Today, we focus on First to Market: I mentioned this early dialogue slash early access to general reimbursement pathway and the hospital ATMP pathway, so they keep evolving and looking what other countries do as well.
[39:48] Today, we focus on First to Market: And then I think it's worthwhile for your listeners to know that there's the one major reform that is underway in Switzerland is the so-called EFAS reform, which seeks to unify the financing of healthcare services to change how healthcare is financed between cantons and insurers.
[40:12] Today, we focus on First to Market: And the idea behind it is to remove, let's say, some perverse incentives within the system that, so far, have favoured inpatient treatment when you might as well do the same thing on an outpatient basis.
[40:32] Today, we focus on First to Market: And this reform is currently underway, it'll start being implemented in '26, and the acute services will transition to this new financing system in 2028, and other institutions to follow later.
[40:50] Today, we focus on First to Market: We're all kind of watching how this unfolds because there's an awful lot that is unclear, but that will become clearer in the next few months.
[41:01] Today, we focus on First to Market: - So I guess it's a kind of watch this space for how-- Yeah, definitely.
[41:04] Today, we focus on First to Market: - This will unfold.
[41:07] Today, we focus on First to Market: - Yeah.
[41:07] Today, we focus on First to Market: - Yeah.
[41:08] Today, we focus on First to Market: But that's also relevant to drugs, devices, et cetera, but we don't know how it'll pay out yet.
[41:16] Today, we focus on First to Market: - Interesting that they're shifting that care to the outpatient setting, and I guess we're seeing a bit of that within other countries as well, so it's quite interesting that they're following suit.
[41:26] Today, we focus on First to Market: - I think we're quite behind in that because of these perverse incentives.
[41:30] Today, we focus on First to Market: It's good that they're doing something because we also pay premiums.
[41:35] Today, we focus on First to Market: We don't just help get drugs and devices, et cetera, reimburse, but we also pay premiums, and they keep increasing and it's crazy.
[41:46] Today, we focus on First to Market: - So I guess now we ought to move to some of the questions that we've been sent in advance.
[41:51] Today, we focus on First to Market: So we have one interesting question here for Elisabeth that was sent ahead of the webinar.
[41:57] Today, we focus on First to Market: And the question is,"Are Swiss payers open for confidential discounts, and what is an acceptable range from your experience?"- Ooh, they're definitely open to this.
[42:12] Today, we focus on First to Market: This is common for high-priced new drugs, like I guess in most other countries too.
[42:23] Today, we focus on First to Market: So a new methods guideline has come out for the drugs pathway in January this year, where they make certain things more transparent and explicit than they used to be, so anything that is below 25% as a discount basically by nature is not confidential because that will be published.
[42:51] Today, we focus on First to Market: So in order to be a confidential discount, it has to be at least 25%, but I've encountered much higher discounts.
[43:00] Today, we focus on First to Market: It really depends on many factors, like which payer we're talking about.
[43:06] Today, we focus on First to Market: Are we talking about the Federal Office of Public Health that regulates what happened?
[43:13] Today, we focus on First to Market: What is covered by the mandatory health insurance premiums?
[43:16] Today, we focus on First to Market: Or are you talking to insurers directly?
[43:20] Today, we focus on First to Market: And other factors that matter for the confidential discounts is obviously what evidence package you have, the unmet need, and also the size of the population.
[43:30] Today, we focus on First to Market: So I think it's difficult to give a general answer.
[43:36] Today, we focus on First to Market: - Well, thank you for that.
[43:38] Today, we focus on First to Market: I guess we ought to probably wrap up so that we can keep to time.
[43:42] Today, we focus on First to Market: So thank you for a really interesting and fascinating discussion today.
[43:46] Today, we focus on First to Market: It was really great to hear more about Switzerland and how that market operates.
[43:52] Today, we focus on First to Market: And thank you to the audience for listening to our conversation.
[43:55] Today, we focus on First to Market: And we will follow up with any of the questions that we didn't cover today, and we're happy to help signpost anyone to the right place if they want to continue the conversation.
[44:04] Today, we focus on First to Market: So thank you again, Elisabeth.
[44:07] Today, we focus on First to Market: - Thank you, Louise, and thank you for having me, and thank you to everybody for spending your lunch, breakfast, or dinner with us.
[44:13] Today, we focus on First to Market: That was cool.
[44:16] Today, we focus on First to Market: - \[Narrator\] Thank you for watching.
[44:18] Today, we focus on First to Market: If you'd like to find out more about how we can support your market access goals, get in touch today.
[44:24] Today, we focus on First to Market: For more market access insights, follow us on LinkedIn.

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