Long established as a premier early launch country for innovative medicines within Europe, the Danish market access system has become more complicated of late as the Danish Medicines Council – the body charged with providing guidance about new medicines for use in the Danish hospital sector – adjusts to the new era of targeted and personalised therapies. Here, five country managers from pharma multinationals weigh in on what the Medicines Council does well and where they feel it has room to improve.
Serving its Purpose, But Scope for Speed
Amgen’s Tore von Würden is broadly positive about the work of the Danish Medicines Council but identifies a growing reluctance from the Council to engage in dialogue with industry which is lengthening the timelines within which medicines are assessed.
The Danish Medicines Council has been very effective in curbing expenditures – which is positive from a taxpayer perspective – as well as implementing the best possible treatments as standard.
Naturally, it takes a lot of dialogue to get to a common understanding, and I would like to see the Medicines Council working more closely with the industry on [recognising the value of innovation], bringing the relevant stakeholders to sit together face-to-face
Where I see scope for improvement is in how long it takes for the system to recognize the value of new products and innovation. Naturally, it takes a lot of dialogue to get to a common understanding, and I would like to see the Medicines Council working more closely with the industry on this, bringing the relevant stakeholders to sit together face-to-face to have these discussions. This is the best way to find opportunities and solutions. From my perspective, the Medicines Council has become more reluctant to meet with industry than previously, which is a shame because there is so much value in dialogue.
Overall, the system works well although we as an industry will always push back against tools to limit access to treatments. As long as we maintain good dialogue, we are hopeful that we can together find a way to ensure that new products are approved and used.
‘Extremely Restrictive’ Situation for Rare Disease Drugs
Tashia Lentz of Biogen, which has been engaged in a long battle with the Danish Medicines Council over the indications for which its spinal muscular atrophy (SMA) compound is approved, is scathing of the Council’s processes and describes Denmark as “the most difficult Nordic market in which to launch new medications.”
There is significant room for improvement [on market access]. Biogen has submitted six different offers to the Danish authorities on our SMA compound. I was involved in submitting the sixth offer to the Medicines Council, which was also rejected. And Denmark has of course not been treated any differently by Biogen than all the other EU countries, that have basically all approved the treatment for a wider usage than Denmark.
Unfortunately, it has become heart-breakingly clear, that the Medicine Council does not believe in treating older individuals with SMA with the treatments at hand, neither Biogen’s, nor our competitors’
In terms of treating SMA, the Danish Medicine Council is extremely restrictive. For the sake of the patients, I had hoped for our competitors to succeed and prove my perception wrong, but unfortunately, it has become heart-breakingly clear, that the Medicine Council does not believe in treating older individuals with SMA with the treatments at hand, neither Biogen’s, nor our competitors’.
Especially for a company like Biogen with so many products targeting rare diseases, there is a huge gap in the current Danish system and structure, where down-pressured flat pricing seems to be the main target for the system and there’s only little taste for innovative pricing schemes. Additionally, the models being used to determine the quality-adjusted life year (QALY) values of a treatment do not leave any room for flexibility. Many rare disease trials lack hard endpoints in the way that cancer trials, for example, have in terms of mortality reduction rates. Without these hard endpoints, it is very difficult to strike deals. Denmark needs to open up to more innovative pricing schemes and models to ensure better patient access.
Having worked across Sweden, Norway, and Finland, I can say that, unfortunately, Denmark has become the most difficult Nordic market in which to launch new medications. The Danish Medicines Council’s data demands are extremely tough, which results in fewer approvals. For our SMA treatment, Denmark is the only one of all EU countries that has not opened up for all paediatric population. I know, the perception in the Danish system is that the children are not in fact treated despite approvals in the different countries, but I can assure you, that in the countries I know best: Norway, Sweden and Finland all peds are in treatment.
I am more than willing to transform our approach to become as agile and innovative as possible to find solutions. We have done so with our SMA product, but unfortunately it does not currently fly with the Danish authorities.
In Danger of Losing Early Access Status?
Janssen’s Julie Enevold Brooker, with 20 years of Danish pharma industry experience behind her, warns that the access situation in her country has worsened in recent years. She calls for a more holistic approach to assessing innovative medicines and believes that through greater levels of dialogue, this access slide can be reversed.
The market access situation today is not perfect, despite the best of intentions. Over the last four or five years, looking at EFPIA comparisons, Denmark is no longer leading to the same extent it was before on fast access to patient populations. There are some scratches on the surface. Without being too pessimistic, we need to watch out; other countries that used to grant access to new medicines after Denmark are suddenly ahead of us. All stakeholders want to maintain our leading position on access, which will perhaps require even closer collaboration with the Medicines Council and Amgros, making sure that we understand each other and have full clarity.
Without being too pessimistic, we need to watch out; other countries that used to grant access to new medicines after Denmark are suddenly ahead of us.
We have seen examples where data from study setups endorsed by the European Medicines Agency (EMA) was not considered sufficient in Denmark. As a small country, is that how we want to operate?
Moreover, there is the potential to take a more holistic approach in assessing new innovation. For some older treatments, comparing price alone does not tell the full story of all the indirect costs from the treatment. I believe there are plentiful opportunities to address these challenges together and get back on the right track.
Holistic Assessment Approaches Badly Needed
Merck’s Enrique Alvarez strikes a similar tone to Janssen’s Brooker, warning that if price becomes the sole value for medicine evaluation, Denmark risks losing its position as a thriving life sciences hub.
Speaking honestly, it has become very difficult to introduce innovation into Denmark in the last two years. The number of recommendations for new medicine approvals has decreased while assessment times have increased.
If Denmark wants to continue to be a thriving life sciences hub, it must remain an attractive place in which to launch new technologies and innovation
Moreover, the largest number of rejected applications are within oncology. Price has become the main factor in evaluation and there are several examples of price overruling the clinical value of a new medicine in Denmark.
If Denmark wants to continue to be a thriving life sciences hub, it must remain an attractive place in which to launch new technologies and innovation, and not let price alone be the deciding factor in all decision making.
The British Perspective: A Call for Greater Transparency & Industry Engagement
MSD’s Catherine Williams compares the Danish Medicines Council with NICE in her native UK and pinpoints greater transparency in the Council’s evaluation process and better engagement with the industry as key points for improvement moving forward
There are definite parallels between the Danish Medicines Council and NICE in the sense that stakeholders are always willing and interested to hear about innovations. However, like all of us who work in science, they want that to be backed up by data and by science. That holds true across all markets.
I fully appreciate the need for a thorough HTA process, however, I think the political dialogue around how to improve this process should be reinforced to avoid unnecessary delays and misunderstandings
This appetite to understand the innovations that the industry is bringing to market makes for some very interesting discussions with NICE in the UK and with the Danish Medicines Council here. Fundamentally, their outlook and ambition is to assess the clinical and cost-effectiveness of our products, which is a very fair objective.
It has been interesting to see the evolution of the Danish Medicines Council. Whilst I was not in Denmark when the quality-adjusted life year (QALY) system was introduced, there are parallels that I can draw from the NICE process which also uses QALY evaluations.
One thing that could be improved in Denmark is greater transparency in the Danish Medicines Council’s evaluation process and better engagement in ongoing conversations with us as an industry group. I fully appreciate the need for a thorough HTA process, however, I think the political dialogue around how to improve this process should be reinforced to avoid unnecessary delays and misunderstandings. This could be done by introducing a systematic annual review of the Council’s recommendation in order to ensure that all parties involved in the process continue to optimise their contribution – to ultimately secure fast access to new treatments for those who need it.
