Insider interview: Roche discusses efficacy of CDF and NICE

pharmafile | November 25, 2016 | News story | Medical Communications, Sales and Marketing CDF, NICE, Roche 

Deborah Lancaster, Head of Market Access at Roche, discusses, in the latest issue of Pharmafile, the efficacy of the National Institute of Health and Care Excellence (NICE) and the reformed Cancer Drugs Fund (CDF) for pharma companies seeking drug approval in England and Wales.

NICE has said that the revamped Cancer Drugs Fund (CDF) means that they are able “to make decisions on cancer drugs faster than ever before.” They’ve also said the new system will reduce uncertainty. Would you agree?

It definitely will be earlier, because with the new way that NICE are going to assess cancer medicines, we’re going to be looking, hopefully, at a decision pretty much close to launch. That means we need to actually be submitting to NICE roughly about the same time as we’d be submitting to the license, so sometimes we wouldn’t necessarily have all the pricing and everything set, so we’re just going to have to change the way we work so that we do it earlier. But having that decision early on is a really good thing. I think the worry is with the initial high volume of things that NICE have now got to review because they’re going to be doing every cancer drug, not just the latest ones. I think they’re going to struggle with capacity and I think they’re going to struggle to schedule things in in a timely fashion.

I think we’ve got to suck it and see. NICE seem to feel like they’re going to be able to cope with assessing not only all the things that are in the CDF at the moment, but assessing everything that’s in the pipeline early, and doing all the things that they haven’t assessed before because they were too small. I’m not sure if, without a major expansion, they’re going to be able to do that in a timely fashion.

With this reformation, how is the CDF affected on a functional day-to-day basis?

I think it’s going to be really different because the CDF might still be called the CDF, even though it’s a managed entry fund, so only the medicines that get a ‘maybe’ from NICE will go into the CDF. And speaking from our point of view, we don’t think there are going to be many medicines that get a ‘maybe’. Say for instance a rare treatment comes to market with very minimal data then there’s going to be a lot of uncertainty in the assessment process. So, by going into the managed access fund – the CDF – and gathering data for a couple of years, we might be able to answer the questions that could then settle that uncertainty. Say you had a neoadjuvant treatment and pathological complete response is used as the endpoint; you do have a wide range of uncertainty there. The ISA range could be anything from 2-99; you’re not going to be able to answer that question in a two-year data assessment, it would take a decade to get proper overall survival data.

So a two-year timeline isn’t very practical then?

For some drugs it may well work, but I think for anything where you’re going to be looking at overall survival in cancer, the majority, especially in the early setting, you aren’t going to be able to answer questions in two years.

Because NICE hasn’t changed, in effect we’re taking things that didn’t get through NICE in the first place and putting them back through without changing the system. We know that there hasn’t been a breast cancer drug approved by NICE in the last seven years, and yet the CDF has enabled access for thousands and thousands of women for innovative breast cancer treatments, and in fact [Roche’s] Perjeta was the highest-rated on the Cancer Drugs Fund; we submitted that to NICE in the metastatic testing in 2013 and it’s still with them because they simply cannot make it cost-effective, even if we gave to them at something stupid like a 95% discount.

We’re tipping it back into the same bucket that didn’t let it go through in the first place. I think we need a bit of flexibility because the UK is the only country which works to a very, very strict ISA threshold and doesn’t take other things into account. Many other countries use the ISA, it’s a well-known tool, but not as the only thing; there will be ISA modifiers put into place in other countries. We’ve got evidence to show that it’s getting stricter as well over the past four or five years.

Do you think it’s a real problem that NICE suffers from when compared to other appraisal systems in Europe and the US?

I do; NICE are very well respected all around the world and they’re very influential, and they do have a really, really robust way of assessing medicine, and it does tend to work in the primary care setting because that ISA threshold is realistic, but when you move to cancer and you think about the way the pharma industry develops cancer medicine, we always start in the metastatic setting. We always get proof of concept and the first license in the metastatic setting, and we know that you’re not going to cure these people, all you’re going to do is extend their life, and that isn’t given the same sort of value that it would be given in the early breast cancer setting. In the metastatic setting the ISA was around about 38,000, but when we came five or six years later, it was 18,000, so it’s always going to be less cost-effective in the first indication that you bring to patients, and NICE just doesn’t work for that.

It’s been 15 years and NICE haven’t changed their methodology or the ISA threshold since then, and now we have products like Perjeta rewriting the science books and they are more high-cost. The world has moved on, and it’s virtually impossible for us to hit that threshold with those medicines without giving discounts that would put us at risk of selling below cost of goods, which of course is illegal, by giving 90-odd% discounts. It’s simply not sustainable for us, and I think the important thing to realise is that whichever way it changes in the future, it has to be sustainable for industry to be available to supply those medicines as well as for the system to pay for them.

Do you feel that cancer drugs are at a fundamental disadvantage under this system?

It hasn’t kept up, and going back to 2010, that was exactly the reason the CDF was brought in. It was recognised that there was a problem; it was recognised that UK outcomes were dropping below the rest of Europe, and it was recognised that the use of innovative cancer drugs was also well behind the rest of Europe, so that’s why the government at the time brought in the CDF. It was meant to be bridge until we got value-based pricing or some other solution that was going to fix the issue. That fell by the wayside; nothing’s changed, and now the sticking plaster has been ripped off and the wound underneath hasn’t healed. So what we need the government to do is to review NICE’s assessment technology and the methodology they use to stop patients having the anxiety of knowing that something they could get in Spain or France or Germany or wherever else, they can’t get in the UK.

How did you feel about the CDF when it was first set up? Were you sceptical?

I don’t think we were sceptical; we saw it as a really good opportunity for patients to start getting to the level we were seeing in the rest of Europe. And it had a slow start; it took a while to pick up because there were all sorts of teething problems with it, but it’s enabled over 80,000 patients to get access to medicines they wouldn’t have otherwise had, and all those extra years of survival add up and it’s had a huge impact. The UK moved from being 11th in Europe for the use of innovation to 7th in terms of cancer medicines for that period. So it was very effective, but it was meant to be a bridge, and that bridge hasn’t been finished at the other end.

Do you think cancer treatment needs to be judged under its own set of criteria?

That could be one way of approaching it, but then of course there are going to be innovative drugs coming along in other areas where it’s going to be really hard to get through the current system. We’ve got medicines in the fields of Alzheimer’s, multiple sclerosis, etcetera and they are biologics; they are things that take 15 years to develop and they’re not going to be as cheap as your standard beta-blockers, which is where NICE’s forte is. 

So you feel using the same old criteria is problematic?

I think it’s disadvantageous to our system to stick with methodology that isn’t working. It’s been there for a long time without change, and even the threshold hasn’t changed, so I think it’s time to look again and find a way of fixing it, because we’re willing to be flexible and we’re happy to put in different prices for different indications and come up with all sorts of innovative pricing ideas, but at the moment with the lack of flex that we’re seeing, it’s really hard to get through. There’s things like treatment caps, episode of care caps; we could say “treat everybody and you’ll never pay more than x”, but it just doesn’t work within the way NICE assesses things.

Do you think there’s any chance of reform in the near future or is it going to take a lot more pressure before we see any real change?

I think there’s going to be some pressure needed from all parties. It’s really urgent; things are coming off the Cancer Drugs Fund and being turned down by NICE now, and we know that that’s going to happen to more medicines as we move forward; and these are all affecting patients who are going to be going back to 2010 in terms of treatment options, and that’s really, really not fair. It’s important that this rigid approach gets challenged and changed quickly.

Do you think it is fit for purpose? What changes would you like to see?

I think we need to make sure that NICE have got the ability to positively assess innovative high-tech medicines and recognise the value in end of life, and remembering you launch it as end of life and then it becomes more cost-effective through the lifecycle. Innovative ways of pricing, innovative ways of looking at the way we can make things cost-effective, but NICE needs to be more flexible as well as the industry. It’s a two-way street.

It has come from government; it’s not up to NICE to say “we’re going to change.” There needs to be some pressure and they need to be given guidance. We’re moving more and more towards personalised healthcare where drugs are tailored to patients; something that’s only going to be suitable for 2% of the population is never going to hit a 30k ISA.

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