Name:
RMN-2020-002
Description:
An interview with Pilar Pinilla Domínguez_V7_28.01.20
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Duration:
T00H05M36S
Embed URL:
https://stream.cadmore.media/player/e225d1b9-466a-4862-ac6e-80d36b303dee
Content URL:
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Upload Date:
2020-02-14T10:46:48.6170000Z
Transcript:
Language: EN.
Segment:0 .
PILAR PINILLA DOMINGUEZ: My name is Pilar Pinilla. I'm one of the senior scientific advisors within the NICE (London, UK) scientific advice team. And I've been working at NICE for over seven years now. I used to work in the technology appraisals team and in the highly specialized technologies team, doing appraisal evaluations. And now I've been working for about four years in the NICE scientific advice team, providing advice to developers in terms of the evidence generation plans.
Segment:1 Measuring value in advanced therapies.
PILAR PINILLA DOMINGUEZ: Advanced therapies come with a very interesting value proposition. It's quite exciting, and we are actually, as a stakeholder, very excited about what they have to bring in terms of the value proposition for the healthcare system and for the patient. But they have associated quite important challenges. It's not just about the clinical effectiveness, but also around adverse effects.
PILAR PINILLA DOMINGUEZ: And we, as an health technology assessment (HTA) body, we are having a trade off in terms of managing that bit in terms of uncertainty, and also ensuring timely patient access for those transformative technologies.
Segment:2 Health technology assessments of advanced therapies.
PILAR PINILLA DOMINGUEZ: In terms of value framework and the HTA assessment, there is nothing in particular for advanced therapy medicinal products (ATMPs) that shouldn't necessarily work. We just did that with the appraisal that we conducted in 2016 with that was fronted by the Department of Health's Regenerative Expert Medicines Group (UK), and we actually tested whether appraisers' methods were fit for purpose.
PILAR PINILLA DOMINGUEZ: And one of the conclusions that actually, our methods are completely applicable for evaluating ATMPs. And to be fair, we've recommended a lot of ATMPs, all but one, through our useful methods that we have in place at the moment. So there is nothing to say at the moment that there is a need to change the value framework. There may be a need to modify certain things within the methods that we use.
Segment:3 Lessons from CAR-T approvals.
PILAR PINILLA DOMINGUEZ: I believe that the example of the CAR-T are an exemplar of a good collaboration between our stakeholders. We've seen the willingness of NHS England and the health care service to be ready for adopting these technologies in the health care service. We've also seen companies being really open in terms of that engagement. They've been open in terms of where the clinical uncertainties are and how to mitigate those, and they've also been willing to negotiate with the NHS. I think that taking that as a lesson will be really relevant.
Segment:4 Randomized controlled trials vs the real world.
PILAR PINILLA DOMINGUEZ: Obviously, randomized controlled trials has always been considered the gold standard. And I have to say that they will always be. And we would like to see randomized controlled trials when those are possible, but we acknowledge studying many situations, or for generating specific types of evidence, perhaps, randomized controlled trials may not be the most suitable way of generating that evidence.
PILAR PINILLA DOMINGUEZ: We at NICE have always been considering all sorts of evidence that we've been presented. And for example, we recognize the value of real world evidence, particularly post-license, in terms of collecting further data, alongside clinical trials. That real world evidence will allow us to match whether what we've been seeing in the clinical trials is actually reflected in the general population in the country and in clinical practice. So we think that real world evidence, particularly in that setting, will be particularly valuable.
Segment:5 Advanced therapy payment models.
PILAR PINILLA DOMINGUEZ: I recently spoke at a symposium from the Advanced Therapy Network (London, UK) at a Phaciliate's Leader Europe. And actually, we had a really interesting debate around innovative payment models and how to put a price on these innovative therapies. And actually, I think that that's come up with the very basics of why we're taking economics into account.
PILAR PINILLA DOMINGUEZ: And I will have to say that it is almost unethical not to do so, because we have a context where we are operating with fixed health care resources, where those are limited, and we need to ensure that we are spending those resources in maximizing the health for the general population and making sure we take into account equity and efficiency at the same time.
Segment:6 Involving all stakeholders.
PILAR PINILLA DOMINGUEZ: It's really crucial to involve every single stakeholder into these conversations, not just regulators, industry, HTAs, and the payers, but also patients. I think that NICE has always tried to involve patients in their decision making. We've been doing that for so long in the appraisals program, for example. But we now – I think that we started in 2012 to involve patients actually in our scientific advice meetings. And that's proven really insightful, because then we are able to tell companies what is most important for the patients so they are able to collect that data from the very beginning, and to incorporate that in their evidence development plans.
PILAR PINILLA DOMINGUEZ: And sometimes what we think that is the most important for the patients is not necessarily what the patients find more important, and also what we think that is feasible in terms of a trial, entering a trial, specific trial design is not necessarily what patients think that is more feasible. So having patients are around the table, feeding into clinical development plans, is actually really, really insightful for everybody.
PILAR PINILLA DOMINGUEZ: [MUSIC PLAYING]
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