Tofa, would be nice if as cheap as Tofu

Tofa, would be nice if as cheap as Tofu

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By Dr Irwin Lim, Rheumatologist

My twitter feed was abuzz with the Presidential election results (congrats, Mr Obama).

The other item making the rounds and retweets was the news that the Pfizer drug, Tofacitinib, had been approved by the US Food & Drug Administration as a treatment for moderate to severe rheumatoid arthritis in patients who can’t take Methotrexate or who haven’t been helped by it.

This is exciting but expected news. There’s been a buzz about Tofacitinib for a couple of years and I thought you might be interested in a rheumatologist’s perspective.

Please note that I was not involved in any of the clinical trials and therefore, do not have personal experience with the use of Tofacitinib.

Why Tofacitinib is a potential blockbuster drug:

  • It’s a new ORAL agent, in the era of biologic medications (usually given as subcutaneous injections or intravenous infusions).
  • A novel action. Tofacitinib belongs to a new class of agents called JAK inhibitors. These drugs block enzymes involved in the signalling systems of cells, including the signalling systems involved with many cytokines.
  • It should be a relatively CHEAP medication to manufacture unlike the other biologic medications such as the TNF inhibitor.
  • There is good quality scientific trial evidence of it’s effectiveness in a variety of scenarios: as mono therapy, in patients who haven’t responded well enough to Methotrexate, and in those who haven’t responded well enough to TNF inhibitor therapy.

But I, like many of my colleagues, have many questions.

The field of new therapies for Rheumatoid Arthritis is crowded (which is a good thing) but it’s also confusing and we aren’t quite sophisticated enough to be able to personalise the choice of medication to each individual patient.

For those who don’t respond adequately to traditional DMARDs, the biologic agents are used (in countries that can afford them). In Australia, we have access to 5 different TNF inhibitor medications as well as 3 other drugs with different mechanisms of actions: Abatacept (Orencia), Rituximab (Mabthera) & Tocilizumab (Actemra). We will soon have biologic drug no.9.

Which patient should receive which drug?

They all seem to be effective in the majority of patients. But there are still significant numbers of patients who don’t respond well enough. They all have potentially worrying side effects but overall have been tolerated better than expected, as can be seem by the many drug registries set up to track side effects.

Where do I use Tofacitinib?

It’s a new drug and has to battle familiarity. After a decade, most rheumatologists are quite comfortable using the older biological drugs.

Does price matter? 

The 8 biologic drugs I currently have access to are all EXPENSIVE. In Australia, I think costs are around $25000 a year per patient. Yes, each year.

Now, Tofacitinib is meant to be a much simpler, and therefore cheaper drug to manufacture than the other biologic drugs mentioned.

This doesn’t however mean that it will be cheap. It’s only right that pharmaceutical companies recuperate their development costs and make some profit. Otherwise, new medication development will be stymied.

So, one big question is how will Tofacitinib be PRICED?

Given all countries are struggling to contain medical costs, and the use of these expensive medications are regulated, the price could very well determine how Tofacitinib is used, and indeed, how much is used.

Dr Irwin Lim is a rheumatologist and a director of BJC Health. You should follow him on twitter here.
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  • Lisa

    Great post! Seeing how the first JAK does in the real world will be interesting. :)

  • Jeanette

    My doctor and I have been anxiously awaiting the approval, in Australia, of the first of the “nibs” for many months now. We have been forced to avoid trials given that it would have been possible to have received a placebo for up to 16 weeks and with the severity of my disease we were not prepared to risk no meds for that length of time…..so we wait. We have used IV steroids every few weeks when I am no longer able to function…they fix me (somewhat) …until the next time….and so it continues and the side effects pile up.

    So for me, as approval from the TGA looms in the next few weeks…once again I am placing all of my eggs in one basket! We have done….Enbrel, Humira, Cimzia, Orencia, Mabthera and Actemra (twice…) ……Tofa, unlike the others, is actually not a biologic by definition and I hope that this very difference may indeed be my answer…fingers, toes and everything crossed!

  • Kim Byrne

    Excellent post… My rheum and I discussed this medication yesterday. Since I am having success w Rituxan we have decided to continue with that therapy and watch and see what Tofacitinib does… So we wait… And it will be interesting to watch the cost…
    Kim

  • Julie

    I may well be considering tof soon as well. I haven’t had any response to 6 bios. and am not scoring well with the Rituxan as of yet. Sounds like January is the time of decision for me. I am not sure how much our personal pharmacy insurance will cover with the tofa. It will be an important factor in the decision to use it. It is the only one left at this time.

    Ironically, when I have had infusions, they have been covered 100% by our medical insurance. According to my rheum, the standard response level required to be considered successful in a study , is only 20% with all the drugs, and there is no way of predicting which patient will respond to which drug. When the technology is developed to be able to individualize each patient’s RA, that will be a true breakthrough.

    Thanks once again, for a very timely, and thoughtful blog, Dr Lim!

    And as an American ,I can only add that thank God, the elections are over. It has been like a feeding frenzy. Time for some peace and cooperation! ;)

    • http://bjcconnectedcare.com Dr Irwin Lim

      Yes Julie, the ACR20 criteria is the usual response criteria (easiest to achieve) but there is also an ACR50 (50% response) & ACR70 (70% response) reported. As well as other remission criteria such as using the DAS28.

      From this side of the world, the election is such a circus. It’s amazing how much money is spent & I just heard a statistic that 1 million political advertisements have been aired in the lead-up! That seems absurb and is probably an over-estimation but the real figure is still probably a very high number.

      If only some of that was spent on arthritis awareness….

  • http://bjcconnectedcare.com Dr Irwin Lim

    Thanks all for your comments. You’re obviously a well informed bunch.

    Not sure when we’ll be able to use Tofa in Australia but we’ll no doubt be watching the American experience with interest.

  • Kim Byrne

    Julie, it took me 8 mos until I found success w Rituxan… I almost gave up, and I am so glad I did not. So keep that in mind with your treatment. As for the election… Sooooo glad it is over, the attack ads and phone calls were awful… Kim

  • http://therheumatologypodcast.com SiMBa37

    I just found your post via Irwin.

    My local Pfizer rep here in the USA quoted me a wholesale cost of $2400 per month. Equates to $28800/year. Cost to manufacture marketing?

    • http://bjcconnectedcare.com Irwin Lim

      Suleman, welcome to the blog and thanks for commenting.

      It’s always nice to have another rheumatologist here.

      That is ridiculously expensive! But I am so interested how this aggressive pricing plays out and how government bodies are going to respond in whether & then how they let us prescribe it.