As you are probably aware NICE, true to past form, chose the Christmas period to toss a small grenade into the MS space. I assume they thought that by tossing it on Wednesday 20 December when most people were either away, or about to go away, on Christmas holidays the perceived explosion would be smaller than expected and the shrapnel would cause no collateral damage. NICE was wrong. They are wrong for several reasons.
At present the NICE ‘appraisal consultation document’ on the use of beta interferons and glatiramer acetate for treating MS in the NHS in England recommends that of these two classes of treatment that only Extavia is used to treat people with relapsing MS. Astonginglishly the appraisal states that Copaxone, Avonex, Betaferon, Plegridy and Rebif are not recommended. This proposed ruling only effects new patients; anyone already taking one of these drugs will not be affected by this guidance and can continue without change until they and their neurologist consider it appropriate to stop.
What about patient-engagement, shared-decision making, etc. The NHS has, or at least had, a policy of shared-decision making called concordance. This appraisal makes a mockery of shared decision-making. Extavia uses old technology. Of the interferon-beta preparations available it has the least friendly autoinjector and Novartis who market this product have not invested heavily in a support programme for patients starting Extavia. Our nurse specialists and pharmacists simply don't consider Extavia a treatment option and would opt for one of the other preparations.
We know from many earlier studies that interferon-beta-1b (Betaferon & Extavia) is more immunogenic than the other interferons. Over 30% of patients treated with IFNbeta-1b develop neutralizing antibodies (NABs) that stop the drug working. Why would anyone prescribe a more immunogenic biologic when there are less immunogenic alternatives?
This appraisal flies in the face of innovation. In fact is a kick in the teeth for innovation. Please note Avonex and Rebif have both been reformulated over their life cycles to improve their tolerability and immunogenicity. Plegridy is actually a new product; it uses pegylation to extend its circulating half-life. Plegridy investment and many years to be developed and licensed. What kind of message does this send to Pharma and academia about innovation? I thought NICE was meant to include innovation as one the variables they took into account when they made their decisions. In fact, why is Plegridy being considered part of this MTA (multi-technology appraisal)? Surely it deserves its own STA (single technology appraisal)?
On the cheap
Ever since the NICE turned down interferon-beta and GA as part of the initial tranche of single technology appraisals they have not changed the threshold for approving drugs. In other words, the cost per QALY that NICE deem cost-effective has been static for 15 years. Healthcare inflation has gradually reduced the actual cost per QALY that the NHS is prepared to pay for MS drugs. In addition, they have yet to incorporate indirect, in particular social, costs into their modelling. This explains why the NHS pays so little for MS DMTs. Is this fair? Patients in the USA are paying more than 5x the price for DMTs that we are.
Please note that Pharma profits are used for all sorts of things including R&D and new drug development. Why should the USA taxpayer continue to subsidize drug development for the rest of the world, including Britain? Don’t you think at a political level the NHS should pull its weight? When you look at drug costs as a proportion of the NHS budget these are going down compared to other countries. Is it realistic to expect this to continue long-term?
Lowering the bar
Another potential problem is that NICE use incremental costing models; they compare new high-cost drugs to a reference drug. If the Extavia ruling stands then all new DMTs will be compared to Extavia, i.e. this will lower the cost-effective price for all new drugs and possible existing licensed drugs as they come up for renewal. This may have consequences for pwMS in the future, i.e. we may not get access to newer, high-cost, innovative drugs. Pharma may stop dealing with NICE because of the potential consequences for them across Europe. Please note that many countries use basket pricing, i.e. they set a price for DMTs in their countries based on the average across many countries. The UK price is in the basket. The problem arises is if the negotiated NHS price for a drug gets out; if it does it automatically lowers the cost of DMTs in countries using basket pricing. Pharma is becoming increasingly wary about doing deals like this with the NHS. There has already been an example of the NHS deal price getting out for one MS drug that impacted on prices across Europe.
The public perception is that Pharma is all bad. This is wrong. Pharma is a big contributor to the UK’s economy. All the MS Pharma companies employ a large number of people to support their innovator brands. If the Extavia ruling goes ahead I am sure many hundreds of people will lose their jobs. Should we care? Yes, we should. With Brexit looming every high-skilled job is valuable to this country. Employed people are what make an economy work. Punishing Pharma unnecessarily threatens the livelihood of many people and an important part of the UK economy.
The problem with NICE is that its brief is very narrow, i.e. to save money for the NHS. NICE is very effective at doing that, but what about the impact of its decisions on the wider economy. Politicians really need to consider the wider impact of NICE on the UK-based Pharma industry. Since NICE was established almost all of the big Pharma have closed down their R&D labs in the UK and moved them elsewhere. Why? If the NHS doesn’t reward innovation and support Pharma then they will vote with their feet. The tragedy is that this has happened already and not easily reversed.
Summary In summary, I think the NICE ‘appraisal consultation document’ is flawed with an undefined long-term impact for pwMS living with MS in the UK. It ignores patient choice and the principles of personalised medicine. It is not good for UK PLC. It sends out a very negative signal to Pharma, i.e. that it does not value innovation. The ruling will widen the gap between the UK and our other rich world partners. It is only a matter of time before NICE triggers a trade war with other rich countries over drug pricing. Several hundred high-skilled jobs will be lost as a result of this ruling and for what? The MS community has moved on and injectables are not used very often. Therefore a decision to save the NHS a very small amount of money will end up costing the UK much more in terms of future patient care and access to innovator drugs, reputation, jobs and future investment. I sincerely hope when NICE respond to feedback from the community common sense will prevail.