By Jon Plant, DVM, DACVD
There is a huge demand for Apoquel®, the new Zoetis (NYSE: ZTS) drug for dogs with atopic dermatitis or “allergic” dermatitis. I predict that Apoquel sales will exceed $1 billion per year for Zoetis after the supply issues are resolved. It has dramatically improved the quality of life of most of the dogs that I have been able to treat thus far. The dogs are happy, the pet parents are grateful, and I feel like a hero.
BUT, I am in the fortunate minority of veterinarians that has a reasonable supply, thanks to placing a large order early on, and the Zoetis policy of directing the available supply of Apoquel to the dogs which are already taking it. Many veterinarians are understandably upset that a) they can’t order Apoquel after having talked it up to their clients before the launch, and b) communication from Zoetis was a little herky-jerky for a few months regarding the supply issues that were emerging.
Some veterinarians are voicing conspiracy theories – Zoetis is trying to gin up the demand in order to raise the price, or there is some problem with the manufacturing process that they are hiding. I’ve even read speculation that the shortage is due to a conspiracy by veterinary dermatologists to buy it all up because it could be seen as a threat to referrals!
I don’t buy any of those theories. I suspect the real story goes like this:
- Zoetis managers remembered the disappointing launches of some other companion animal drugs.
- A very well-managed marketing strategy was executed, complete with flashy video animations, numerous research presentations, and webcasts for veterinarians at dinner meetings throughout the US.
- The price was set reasonably, within the reach of many pet owners. This invalidated comparisons to the Atopica® launch, if they were using that to forecast.
- Someone made a decision not to invest in the facilities that would have allowed for a higher level of Apoquel production, should the need arise.
- A cumbersome manufacturing and packaging process was chosen which involves shuffling the active ingredient, tablets, and packaged product between countries. Is this really efficient and cost effective, or is it to avoid taxes? I don’t know.
- Within a few weeks of the launch, it became clear that the amount of Apoquel available would not meet the demand.
- The decision was made to allocate the available Apoquel supply such that dogs that had already started it would have priority.
- No veterinarians are able to buy as much Apoquel as they want – some are just able to buy more than others in order to keep some of their current patients on it.
No conspiracy. Someone at Zoetis just didn’t quite believe their own data on the potential size of the market and Apoquel’s effectiveness. In a few years, this shortage will be behind us and many dogs will benefit. That is little consolation for pet owners who are seeking Apoquel now for their itchy dogs.
I wonder if the Eli Lilly purchase of Novartis has anything to do with the shortage.
Great columns and blog!!
Hmmm. I don’t see the connection between Eli Lilly / Novartis and Zoetis’ Apoquel. It seems like the decisions that resulted in the shortage were probably made a few years ago.
I would be curious to hear about your experience following the ‘loading dose’; my doxy did well on the full 5.4mg daily for two weeks. On 2.7mg once a day – scratching has returned and is nearly as bad as before she began.John, New Mexico
John,
I do see an uptick in the itching in maybe half of my patients on Apoquel when we switch from twice to once daily, but not usually back up to the original level. I warn pet owners about this ahead of time. In most cases, there is a gradual reduction in itching again over the next two weeks. Dogs that haven’t responded well should be double checked for secondary skin infections with bacteria or yeast by their veterinarian. Apoquel is not effective in every patient, either. We still need to use other treatments like RESPIT, Atopica, and cortisone in some.
Thank you Dr. Plant for writing this excellent editorial. We all are frustrated that a drug that shows so much promise is not available. Personally, I believe heads should roll at corporate.
Thank you for the comment Valerie!
I don’t believe that Zoetis is being honest about the shortage because a company as large as Pfizer/Zoetis doesn’t just hazard a guess at when they can produce supplies of anything, and they are not giving any information to vets. or dog owners. I left a message on Facebook and the answer was keep checking with your vet. Allergies is the number one reason people take their dogs to the vet other than annual vaccinations and for this drug to have been out for as long as it has been it is inconceivable they haven’t a clue when they can fill demands. Pharmaceutical companies have and do manipulate to hike prices and it is shameful. My Jack Russell has to be on Hills Z/D hypoallergenic food which has ingredients that dogs should not be given but there is no other choice right now. In addition he has environmental allergies and nothing has helped. He has lost his sight now and his feet and underbelly and inner thighs and legs are raw, sores on top of his head and he is so depressed it breaks my heart. Millions of dogs all over the world are suffering and many will die before this company decides to tell the truth. It truly is all about the bottom line and not about dogs suffering. They don’t care!
I think it’s time to remove the “To order Apoquel today” banner from the website.
Ironic! I hadn’t noticed that!
My dog has been taking this drug for over a month with great results. She is finally back to her normal happy self. Now, I cannot get it because of the shortage. VERY ANGRY over this. I don’t care about rumors, I just want my dog to be healthy and happy. When will I be able to get Apoquel again?
It is frustrating for everyone, but Zoetis is telling us that it will be mid-2015 before their Apoquel production catches up with demand.
I don’t know if you are still monitoring this blog for comments and questions, but I am going to give it a shot. What reason has been provided as to why the shortage is ongoing? I mean when something is in short supply, isn’t production increased or at least a planned increase exists. I don’t understand what the purpose of the big mystery is and why we can’t be given an anticipated date for availability. I may not understand the way this all works but it sure seems like it would be appropriate if not customary to provide more information about availability. Has production stopped? Is the drug being banned or discontinued? If not, I am wondering why there is no information about when Apoquel will be supplied according to demand. Just wondering if you can help me understand. Thanks, Jamie
Hi Jamie,
This blog was mainly aimed at other veterinarians, some of whom have made suggestions that the back order is somehow intentional. Zoetis has, indeed, put the word out to veterinarians that they expect the back order to continue through mid-2015. They give the reason as much higher demand than anticipated, nothing to do with recalls or production problems. They also state that gearing up production of this particular drug is not a simple matter that can be solved by running the existing production line faster. I believe that the chemical is first manufactured in the US, made into tablets in Italy, then packaged in another country. Beyond that, I don’t know what the rate limiting steps are, but there are surely a lot of points in the supply chain that could be a factor and may require FDA inspections. Incidentally, even a common and widespread human drug like prednisolone can go on back order for many months, even after it has been in production for many years. This is not that uncommon, but still frustrating.
It’s my understanding that this drug had been used in Europe for several years before being approved in the US. Would it be possible to order from European supply sites? I am really upset that my dog will be suffering without this drug.
I believe it was launched in Europe around the same time as in the US. In both regions, as well as others, clinical trials were conducted several years earlier to demonstrate safety and efficacy.
You never bothered to answer K. Gilmore’s question. I’d like to know why!
My answer to that comment was to gently point out that Apoquel has NOT been available in Europe for several years, as was asserted.
When I have briefly looked at some of the European sites that claim to sell Apoquel, it is always listed as being on back order. Importing a prescription drug with packaging not approved by the FDA (even if the tablets are identical) is risky, on a number of levels.
After lots of struggles with my Beagle and her itchy feet, she was put on Apoquel. I took her to a veterinary dermatologist and testing determined she was allergic to grass. At that time, the shortage was starting to happen (April of 14). Luci was originally put on the medication in October of 2013. I was informed to order from England. Overjoyed that I was able to “score” 100 pills, I figured I had the in on this ordeal. I shared that news with my regular vet. Low and behold, England was out when I tried to reorder. I then tried to get more from my regular vet and an assistant gave me a print out of the place in England. How ironic, I was trying to help other patients with “my secret” and now my baby struggles. I have tried the Kangaroo diet, omega 3/6, salmon, baths, coconut oil, home-cooked meals, and even food delivery for my dog. I read you ordered a lot. Are you selling any? Desperate in Ohio!
Sorry to hear you are no longer able to get Apoquel. I am not selling Apoquel except to my clients that have dogs taking it already. I hope to have enough to keep these dogs supplied, but nothing is certain.
Our veterinarian has begun to offer a compund similar to Apoquel, which they order from a pharmacy and which takes 5-7 days to process. It costs a whopping $290 for 14 pills (which I cut in half anyway). Luckily, my dog’s itching has returned but not to the desperate extent that it was initially, or I would seriously consider buying it. Have you heard of a subsitute such as this and would it be safe? Thanks for your attention to this topic. Itchy dogs everywhere appreciate it!
I can’t comment specifically on what your veterinarian is offering, as I don’t know the details.
There have been reports of compounding pharmacies claiming to formulate oclacitinib, the active ingredient of Apoquel. Do not waste your money on this! In it’s basic form, the chemical oclacitinib is apparently not soluble or well absorbed by dogs. It may be illegal to offer this substitute to an FDA-tested and approved product, no matter how difficult it might be to get. Even if it were absorbed, the dosing of Apoquel is of a narrow enough range that I wouldn’t trust that your dog was getting the right amount of oclacitinib in each tablet or capsule from a compounded formulation.
Like one of the commenters above, my “white boxer” Betsy had tried everything, and was basically stuck on steroids until Apoquel came along. It worked like a miracle for about a month, but now, the one pill only lasts about half a day ad she’s itching again, about as bad as before. She’s about 70 pounds; she takes the 16 mg pill once a day…. I was told by my vet’s office not to go back to a “loading dose.” I’m at the end of my rope now. I wish dogs had a “Calomine lotion” that they couldn’t lick off.
Ever since my dog ran out of apoquel he has been itching like he is chasing fleas but he has none. Winston is now back to,chewing his feet which was the reason we started the drug in the first place. I swear I think this crazy flea chasing is a withdrawal symptom from the Apoquel. Anyone else have this problem?
Make sure your pets are on flea control, even if using Apoquel to control flea allergy dermatitis (or in this case, after running out). Food allergy and atopic dermatitis (environmental allergies) would be other considerations.
We were lucky as so far our vet can get Apoquel. He told us that when the drug first came out he was going to buy a large supply in case of a shortage such as this but his salesman said not to worry there would be no shortage. So he did not buy the quantity he originally thought he would. Goes to show never trust sales men.
I also wonder why the government hasn’t looked into it as they stick their noses everywhere else.
I’m pretty sure Zoetis is kicking themselves for not projecting the demand correctly. The lost profit during the past year is substantial, I’m sure.
My Dachsi has allergies too, and I tried everything. Benedryl works a little but nothing else has, until my vet prescribed apoquel. Hopefully he won’t run out and the shortage will be over soon.
Thanks for the informative article.
Our Jada has taken variations of all three available doses- basically, whatever we can get a supply of! The best dose for her seems to be the 16 mg pills, cut into quarters, but we are on 3.6 mg pills right now. She didn’t even need the “loading” dose, her first pill completely stopped her scratching and foot chewing on day one. It’s hard to get, and she occasionally has to miss a day or two at the end of the month while they are getting re-stocked. Hopefully they will get this supply thing figured out soon!
Was thrilled when approx a month ago my GSD was prescribed Apoquel. Within 24 hours there was remarkable improvement. Unfortunately the shortage has occurred again. So sad to be watching my dog be so miserable again.
Apoquel is the only thing that makes a difference in my dog’s life but I cannot get a steady supply and recently moved to a place where no vet in my area can get any. Is there a place online to order apoquel?
Hi Theresa,
Your primary care veterinarian or a veterinary dermatologist (find the closest one at http://www.acvd.org) are still your best bets. Apoquel and other ethical drugs are not sold directly to online pharmacies, so for them to get it, they themselves would either have to find a veterinarian willing to sell some of their supply (not likely for Apoquel), import it illegally, or sell counterfeit drugs.
Jon Plant, DVM, DACVD
SkinVet Clinic, Lake Oswego, OR
It is simply unbelievable that, over a year after launch, Zoetis still cannot offer any appreciable explanation for the shortage of Apoquel. This leads me back to theories that it is artificial. When, and if, this medication is ever available for purchase by new patients, I expect that the pricing, passed along to vets from the company, will be very different, indeed.
I don’t know if you are aware of this, but Zoetis, has just obtained a conditional license from the USDA, for their Canine Atopic Dermatitis Immunotherapeutic. “It will be available in a ready-to-use, sterile liquid administered as a once-monthly subcutaneous injection and will help provide sustained relief from the itching associated with atopic dermatitis in dogs of any age.”
This is revolutionary in the treatment of the atopic dermatitis, and I am wondering if this is impacting their work with Apoquel. Imagine once-a-month dosing, as opposed to a pill each and every day:
https://www.zoetisus.com/news-and-media/zoetis-receives-a-conditional-license-from-usda-for-canine-atopic-dermatitis-immunotherapeutic.aspx
Of course, they are only in the conditional licensure phase, but they will be supplying veterinary dermatology specialists with the drug, first, in the fourth quarter of this year, to help the company obtain full licensure.
Perhaps you have been advised of this already, but this big news for those of us awaiting Apoquel.
Thankfully, we received a supply of Apoquel for our dog from our vet. It is everything everyone says it is. She is exponentially better, is no longer so itchy she cried 24/7 and was utterly and completely exhausted from the trauma, and has returned to her normal sweet-tempered self. That this drug is not available to all dogs who need it, is more than egregious, as far as I am concerned. That dogs continue to suffer this scourge in 2015, when a drug is available for use, makes me deeply, deeply sad.
It is my sincere hope that whatever is preventing Zoetis from increasing availability, is corrected poste haste. No dog should have to endure such woeful discomfort when relief is just one small pill away.