Key Services

We are committed to launching products that make a difference in people’s lives. We work across a product’s lifecycle, supporting biotech, pharmaceutical, and medical technology companies across the globe.

Outcomes Research

Our team provide unequalled accuracy and quality whilst delivering all aspects of systematic reviews, meta-analyses and patient-level data analyses.

Economic Modelling

We develop a range of robust health economic models that meet the commercial needs of our clients from simple Markov models to complex discrete event simulations.

Health Technology Assessment

We have extensive experience delivering successful HTA submissions in the UK and across the globe.

Value Communication

We effectively communicate the value of your products in a logical and insightful manner; from internal value dossiers to external scientific publications.

Pricing & Reimbursement

We partner with our clients to develop strategies for global pricing and reimbursement, harnessing our extensive KOL and payer network.

COMMERCIALISATION IN EUROPE

Our white paper 'Is European market access becoming an incubator for rare disease development?' explores the hypothesis that successful commercialisation in Europe is the biggest commercial opportunity for orphan drug manufacturers right now.

PATIENT PERSPECTIVES PODCASTS

Patient advocacy is now the key to a successful product launch. Establishing relationships between patient advocacy groups and the pharmaceutical industry will ensure objective measures of efficacy are realised, and improved patient outcomes are achieved.

FIECON has launched a series of podcasts, talking to patients and patient advocacy leaders about the burden, unmet needs, patient journey and possible future treatment options to better understand the patient perspective.

Our hope is that a more comprehensive understanding of that patient perspective will help to optimise drug development, expenditures, and care into the future.


Patient Perspectives podcasts

 

OVER 50 GLOBAL HTA SUBMISSIONS

We have delivered over 50 global HTA submissions in the last three years, with a success rate exceeding 90% across all indications, 100% in orphan conditions!. We have a wealth of experience and knowledge that we utilize to navigate the requirements and nuances ofHTA processes to ensure market access and a commercially acceptable price.

HAS APPRAISES EARLY ACCESS IN FRANCE

On 1 July 2021, two new pathways were introduced in France to streamline early access to innovative therapies before market authorisation and compassionate access in indications with high unmet medical need.

The new system aims to simplify the complex ATU (Authorisation Temporaire d’Utilisation) and RTU (Recommandation Temporaire d’Utilisation) processes. According to the Ministry of Health, the goals of the new law are to process applications more quickly, and to ensure sustainability by helping to reduce costs to the public health system through changes to the pricing regulations.

Key changes to the early access and compassionate use pathways

 The new law has reduced the previous programmes into two processes:

  • Early access authorisation for drugs seeking marketing authorisation (AAP - autorisation d’accès précoce)
  • Compassionate access for drugs not seeking marketing authorisation (AAC if requested by prescribers orCPC if requested by the Ministry of Health)

The conditions for a drug to be granted early access authorisation under the new law are the same as those of the ATUc (cohort ATU) and include the following:  

  • The patient is affected by a serious, rare, or disabling disease
  • no appropriate treatment exists
  • The treatment cannot be delayed
  • There is a strong presumption that the product is effective and safe based on the results of therapeutic trials.

One of the crucial changes is the inclusion of the HAS (French National Authority for Health) as a decision-maker in addition to the regulatory agency, the ANSM (National Agency for the Safety and Medicines and Health Products), to provide an HTA perspective in the process. This can potentially mean greater scrutiny of new applications for early access.

The HAS will have 3 months after an AAP application is filed to communicate its decision; if the conditions for access and data collection are met, a positive decision is made, and reimbursement is automatically granted. The manufacturer can freely set the price of their product, but the rebate system has changed. The rebate system now consists of an annual rebate based on actual turnover rather than forecasted turnover, which follows a progressive scale. It is important to note that these rebates will be applied retroactively when the final price is negotiated. Crucially, if granted early access, the manufacturer will have to commit to funding of data collection in addition to ensuring continuity of treatment and providing yearly updates on turnover, sales forecast and number of patients treated.

For a drug to be granted compassionate access for off-label use, they must meet the following conditions:

  • The product is not undergoing clinical research for commercial purposes
  • No appropriate treatment exists
  • Clinical data demonstrates some level of efficacy and safety of the product

The compassionate access process will now be limited to products not undergoing commercial clinical research with the ANSM evaluating the above-mentioned conditions for access over a 3-year renewable period. For products that are reimbursed in another indication, the same pricing and reimbursement rate will be applied to the compassionate use indication. If this is not the case, either an annual flat rate will be applied per patient by ministerial order, or reimbursement will be based on the price invoiced to the health establishment. Similarly, to the early access authorisation, the manufacturer is subject to annual rebates based on turnover.  

Another major change the new law has brought for compassionate access is the requirement that it only applies in the absence of commercial clinical research. However, the ANSM can in some cases grant compassionate access, upon request, for medications that are in the early stages of clinical trials. For such requests to be granted the product must meet similar eligibility criteria to the early access conditions mentioned above.

Impact for the pharmaceutical industry

For the pharmaceutical industry, the re-organisation of the early access and compassionate use processes will make the application process more straightforward and transparent, thus enabling patients to get quicker access to otherwise unavailable medicines. The involvement of the HAS at the early stages through to the HTA assessment will ensure a more consistent approach throughout the whole process for commercialisation. On the flip side, the inclusion of the HAS may lead to a more stringent selection of therapies as products now need to demonstrate innovativeness vis-à-vis a potential comparator to access the AAP - potentially leading to a reduced number of therapies achieving early access. The pricing system for early and compassionate access products is now based on actual turnover rather than forecasts and applies a progressive scale which could potentially lead to lower prices as compared to the previous system. A final implication of these changes for both early access and compassionate use is that the manufacturer will now have to fund data collection, thus potentially creating additional barriers to access particularly for companies subject to more stringent budgets.

Sources:

https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000042665307

https://minefi.hosting.augure.com/Augure_Minefi/r/ContenuEnLigne/Download?id=26C2D5A8-A9FE-496B-A731-62FB47790A14&filename=DP%20PLFSS%202021.pdf

https://solidarites-sante.gouv.fr/soins-et-maladies/medicaments/professionnels-de-sante/autorisation-de-mise-sur-le-marche/article/autorisation-d-acces-precoce-autorisation-d-acces-compassionnel-et-cadre-de

 

 

 

PLATINUM AWARD WINNER 2020/21

We were delighted to be recognised for our outstanding contribution to workplace philanthropy and presented with the Platinum Award for our Payroll Giving efforts in 2020/21, by the Charities Trust.

Payroll Giving is one of the most effective ways to give. It offers a simple way for our team members to donate to the good causes they are passionate about, tax free, direct from their pay and provides a regular income for the charities they support, which is especially important in these uncertain times.

We support and encourage our people to give back to causes close to their hearts by matching Payroll Giving donations too.

MODELS IN MINUTES

FIECON Model Builder is an online platform which automates the design and building-process of Excel-based cost-effectiveness models.  High quality Excel models can be built in a matter of minutes rather than weeks. Models are set up with complete functionality, flexibility, and transparency. But most importantly our automated process removes the risk of human error and guarantees accuracy. Give yourself the best chance of success; save time and money with the right cost-effectiveness model from FIECON Model Builder.
Get in touch with our Head of Business Development, Karl Freemyer -
karl.freemyer@fiecon.com, to book a demo or find out more.

HOLISTIC MARKET ACCESS PLATFORM

FIECON Value Platform can help you manage and optimise your product’s pricing and market access processes. Your online portal helps Global teams quickly understand progress, priorities, and support needs in local markets, saving you time, increasing team efficiency, and ensuring unity and alignment. Save time, increase efficiency and ensure unity and alignment to give your products the best chance of achieving successful pricing and market access.
Get in touch with our Pricing and Market Access Director, Martin Schuchardt, to book a demo or find out more.