Apremilast in the UK on the NHS

I’m not sure if this has been reported here as I tend to come and go from the forum, but NICE in the UK has reversed its decision not to fund this new (to the UK) drug on the NHS. So, it IS now available, whereas last summer there was seemingly no chance.

The following is from the Arthritis Digest website:

A new oral treatment for psoriatic arthritis has been approved for use by the UK’s National Institute for Health and Care Excellence (NICE).

The regulatory body has recommended that apremilast (Otezla) can be used to treat adults with active psoriatic arthritis. People who will qualify for apremilast are those who have had an inadequate response to (or are unable to tolerate treatment with) disease-modifying anti-rheumatic drugs. They must also have peripheral arthritis with three or more tender joints and three or more swollen joints.

Apremilast is the first oral psoriatic arthritis treatment of its kind to be approved for NHS use.

Apremilast reduces the activity of a particular enzyme that drives the inflammation associated with psoriatic arthritis, and so reduces the signs and symptoms of psoriatic arthritis._

Trials have shown that apremilast helps to relieve swollen and tender joints and improves physical function.

“Psoriatic arthritis is a chronic disease that causes significant strain on NHS resources,” explains Dr Helena Marzo-Ortega who is involved in the work. “Addressing the symptoms of both psoriasis and psoriatic arthritis, the availability of Otezla on the NHS marks a major milestone in the management of psoriatic arthritis.”

Well, that certainly sounds like good news. Sounds like maybe a step between DMARDs and biologics?

it’s a different kind of DMARD (small cell inhibitor) with decent results and less expensive than biologics. in the US it has been approved as a lower tier drug by some insurers (Aetna, for example) which should continue to bring down it’s still relatively high cost. Search for “Otezla” in our search doo-dad and you’ll get all manner of helpful discussion threads. Just watch out for the side effects. I could be up-wind of no sentient being for the first 2 months I took it… :dash:

Otezla is neither purely a biologic or a DMARD. it initially could be used with Biologics but then in 2014 they decided it shouldn’t. So its debated whether it is DMARD or something else the the something else is more like a synthetic bio. Pretty exciting if it develops. Celgene was actually looking for an entry into the market that was a pill. itsthe only one (so far) that is pills not injection.

Reviews are generally negative for its effect on PsA where A>P, but seems to work very well for Psoriasis. The difficulty for many patients is that it really has to be used as a monotherapy, so can;t be coupled with either a biologic or a DMARD to pick up the slack. (none of us have JUST PsA)

There is actually a higher number of folks reporting bad headaches and nausea than with MTX. (it does as with MTX resoleve in a few week to a month for most) FWIW the two rheumy groups here (which include Seattle Childrens Clinic) because of the mono therapy have it on the bottom of their list for prescribing) Most of the scripts are written by the Dermies.

Pretty much sounds like any other med we take… If it works its great if it doesn’t its not so great. I think as the docs have more experience with it and share more experience at conferences it will be more appropriatly prescribed and have pretty good results’

Now if you want some PERSONAL opinion about the mahufacturer and the marketing of this medication read on…

Its going to be interesting how the drug plays out in the USA as Celgene has chosen a limited distribution model. Or in short you buy it from them (or one of their “specialty pharmacies” or you don’t buy it. (Aetna is one of them) They are non-negotiable on price so its tough to get past many insurers. My hope is I never have to use it. I find those ethics on the far end of unacceptable. FWIW in the US a years supply is just short of $23,000.00. In countries where there is open market paharmacies its is just a hair over $16,000.00.

The initial non-approval in UK had to do with manipulated Data (in short Celgene lied) drug cost is not based on the cost of the script, but rather on ICER (incremental cost-effectiveness ratio) which measures how much IMPROVEMENT on a set scale developed by the docs (NOT pharma) costs each unit is called a QALY. In Europe its an organization called NICE.

NICE claims that TNF inhibitors are estimated to result in an incremental cost-effectiveness ratio (ICER) of £18,997 per QALY gained. By comparison, apremilast is estimated to produce an ICER of £23,487. The committee suggested apremilast should not be used prior the use of a TNF inhibitor due to greater costs.

Where it got dicey is Celgene claimed it to be 30% cheaper than either Enbrel or Humira hoping to snag the market. Thy darn near went bankrupt when the lie was discovered and announced. The problem is the press (who is always accurate in their reporting) took that to mean the medication didn’t work.

1 Like

ooooh I love a good story like this. Chewy.

Thanks for the info folks. My understanding is that, rather like the Hydroxychloroquine that I take now, there is no requirement for ongoing blood tests etc every month to watch out for negative effects. That has to be something of a plus for those of us who struggle with that kind of thing.

Never heard of any that requires monthly blood tests other than Plaquenil. In the US blood tests are required (by law) every 6 mos when on MTX. If you are taking any DMARD, NSAID, or Steroid regularly you should have blood tests every 3 mos.

Once again things are misleading. Their official stance is “no requirement for ongoing lab monitoring or initial lab testing” have been established. LEADING one to believe its not required. The fact is THOSE requirement are not established by the Drug company but various authorities. For the eample the VA is doing at the min every 6 mos. My guess is that will be close to the final number. With a Elimination being Renal excretion 3%, Fecal excretion 7% and Protein Binding 68% with Bioavailability 73% the rest is showing up in either the Kidneys or liver. the half life is only 6 -9 hours so it does need some monitoring.

You can read it all here: http://www.pbm.va.gov/clinicalguidance/drugmonographs/Apremilast_OTEZLA_Monograph.pdf

I just don’t understand why this potentially very cool medication (granted it is primitive but future generations could be really cool) is being destroyed by marketing??? Neat and misleading commercials on TV won’t convince Docs to prescribe it. And patients asking for a specific med frequently backfires (for good reason)

That’s the beauty of the NHS - we don’t see any advertising.