Ibrutinib patent.

[MovingForward4423]

Interesting article on India trying to produce a generic version of Ibrutinib for 500USD per month. Imagine the difference for those not insured or living in places where drugs are incredibly expensive (USA). thepharmaletter.com/article...

[cajunjeff]

Its pretty complicated. I think everyone is in favor of having more affordable drugs. But we might not have our life saving drugs if pharma companies were not incentivized to spend millions and millions on research and development. For every blockbuster drug a company makes, it might lose millions on clinical trials for drugs that do not pan out.

The reward for creating a miracle drug like ibrutinib is patent protection where the companies can charge a hefty price to give them a profit taking into account the millions spent of development. Those of us with cll, of all people, do not want to de-incentivize drug companies from spending more millions on the development of even better drugs.

Pharma companies in India can produce cheap generics and in many cases ignore patent laws. Its easy enough to copy a drug someone else spent millions testing and developing.

Some courts in India have not provided patent protection for drugs that other countries recognize. If we do not have access to generics from India, an argument can me made that India is raising our drug costs by denying drug companies profits from selling their drugs in India, a loss that gets passed on to us.

And its also worth noting that all generics are not equal. Some drugs are quite easy to copy, others not so much. There might not be much difference between generic ibuprofen and advil. but a huge difference between generic ibrutinib and the real thing.

To be clear, I dont think drug companies should be allowed to price gouge. I do think if they spend millions on a new miracle drug that saves lives, they should be rewarded with patent protection to insure fair profits that cover the drug Rand D costs, including the costs of failed drugs.

And while there might be exceptions, I think in general that the practice of allowing India pharma companies to ignore patent laws and steal the drugs others spent millions and years developing is not only not fair, it could increase costs to us who do not have access to India generics and discourage pharma companies from investing in new drugs.

As I stated out to say, its complicated. We have to find the right balance where companies are rewarded for bring new drugs to market, but are not allowed to make obscene profits and price drugs out of reach. Allowing companies to, in essence, steal patents, can have unintended consequences.

[MovingForward4423 in reply to cajunjeff]

Pharma is a tough market. Those of us in developed counties are very lucky to be able to afford and have access to game changing drugs. Unfortunately for places like India, Africa, and some places in Asia you just have to die.

[cajunjeff in reply to MovingForward4423]

I agree. Its complicated. Pharma companies do have programs for underdeveloped countries, but I am sure its not enough. I think its generally true that access to doctors and meds is less in underdeveloped countries.

Pharma has a bog lobby everywhere, including India. Its hard to tell when their courts ignore patents whether its to make lifesaving drugs available to poor people or to help line the pockets of Indian pharma companies who reap profits copying drugs they incurred no research and development costs on.

[Driverps1 in reply to cajunjeff]

Interesting one. Most people in Nz can’t afford to pay for drugs that are considered standard therapy for Cll these days. They have to sell their biggest asset their house to fund themselves. I personally think if there’s a generic form that works and it saves someone’s life without having to go into financial ruin and put more stress on their shoulders is a good thing. I believe everyone on the planet should should have equal chance and not just the wealthy or be a post code lottery.

[MovingForward4423 in reply to Driverps1]

I get the drugs but at a huge cost of private healthcare. My premiums with BUPA are set to increase to 25k annually by 2025. I fighting them via the UK ombudsman right now. No doubt I will loose and BUPA will price me out of my plan. The NHS has approved Alcalabrutinib now, so I have a back up. It’s expensive to fall unwell, it’s even more expensive to stay alive.

[cajunjeff in reply to Driverps1]

I think everyone, or least I would hope everyone, would want all people to have access to life saving drugs.

The larger question might be that without patent protection affording pharma companies the ability to make substantial profits on their research and development investments, will lifesaving drugs still be created as they are now.

But for the enormous profit incentive associated with a successful drug like ibrutinib, it might never have been developed and tested for leukemia.

That’s why I think it’s complicated. I am not so much taking a position one way or the other, I am just observing it’s a two sided debate. But for the profit incentive for ibrutinib, none of us might have it. If you take away patent protection, we might not get new drugs for Cll.

[Driverps1 in reply to cajunjeff]

Yes agreed. I just think certain developed countries such as Nz which is in the top 10 richest per head of capita we shouldn’t have to pay out ridiculous amounts of money on mainstream medication that Uk , Australia get on the NHS systems. Nz government pays huge money to Pharmac to get these drugs in for lower costs to patients in need to stay alive. Investigations have shown this is not happening and they line their pockets instead, hence why a lot of Nzers look for generic forms of medication as the government can’t be trusted.

[AussieNeil Partner Administrator in reply to Driverps1]

There's a previous discussion on this ibrutinib copy from a year ago here:healthunlocked.com/cllsuppo...

I still can't find any information on independent testing or clinical trials,

of how closely the copy matches the chemical formula of ibrutinib, or the formulation of the capsules. Contrast that to what is disclosed for the 14 BTKi drugs approved or in clinical trials, one of which, vecabrutinib which bonds non-covalently, so might have been appropriate for patients developing resistance to currently approved BYKi drugs, didn't proceed with a phase 2 clinical trial. healthunlocked.com/cllsuppo... We also know that some side effects of approved BTKi drugs improve over time, but not all. How do we find out that very important information without an investment in long term trial data collection, analysis and reporting?

The other factor not yet mentioned is that CLL is categorised as an orphan disease in the USA and Europe in order to encourage the development of new treatments. There's a recognised need for new treatment drugs for those with aggressive CLL. Not having patent protection has to reduce the attractiveness of this research. Ibrutinib has 10 years of patent protection remaining, but I think it's still preferable to see competitors go through an approval process and those that do gain some protection for their investment.

Without more information, I don't know what to make of your mention of pocket lining. It's standard practice for governments to negotiate an acceptable price with pharmaceutical companies before approval for subsided supply, other than in the USA, where it is currently illegal.

Neil

[Driverps1 in reply to AussieNeil]

Hi Neil, There has been an enquiry into where the Nz governments funding to Pharmac has been going . Its an issue that seems to pop up in main news headlines.

[The-Man-with-a-Plan in reply to cajunjeff]

CanjunJeff

Does ibrutinib have a narrow therapeutic window? If it does, tight quality control standards are a must. I don't know if India's generic manufacturers are up to the task. It's easy to engineer manufacturing 'work arounds' for simple generic drugs. It's a whole different ball game for the more complex biologics.

I guess we will find out soon enough.

MwaP

[Big_Dee in reply to cajunjeff]

Hello cajunjeff

Yes very complicated. In a perfect world, governments would fund all health care needs. What really happens is all government parties sit around table to divide up THE tax money, first comes infrastructure, defense, police and etc down to CLL which is close to last due to small population. The US develops more new drugs than the rest of the world combined each year. There is not much money in developing drugs to treat CLL for pharma. Very little of the cost of manufacture of drugs enters into the public cost for same, but research and approval sure does. Most of the world does not fund their drug evaluations like the US does FDA. Many governments will negotiate drug costs from US pharma way below what US pays. Those countries that are not able to get reduced drug rates, will not do government purchase the drugs. Biggest reason for hold up in drug approval is cost/benefit approval other than USA. As we move into the future where big pharma starts doing custom tailored drugs for individuals, cost will sky rocket even more. I wish we had a better solution, but I don't see one. The profit motive is main reason for drug development. The non-profit organizations are our best resource for some funding help of drug research. We with CLL are fortunate that blood cancers lead the way in cancer research due to ease of testing for cancer progression.

[MovingForward4423 in reply to Big_Dee]

The problem in the US is healthcare is fundamentally private, and a big commercial business. The US has to find a way to adopt social policies that provide a point of care treatment for all free of charge. This is a mainstay of most European countries, we all pay tax to fund a service that is fair to all.

[Wishing1202]

I've had brand drugs and been switched to generic with complications, including anaphylactic shock. I've also had to stop meds because they contained cancer causing agents. Unfortunately, not all countries follow the same stringent protocols. If it was that simple to reproduce a drug, it wouldn't have taken a decade to produce and test.

[Jm954 Administrator]

Apart from the financial elements of this discussion, there is the manufacturing process to consider and India does not have a good track record of producing generic drugs to high levels of quality assurance.

India produces drugs under FDA oversight but quality data is often missing and there is some evidence that it occasionally fraudulent even though the FDA gives several months notice of 'inspections'.

Choose carefully if you are lucky enough to have the ability to be able to.

Jackie

[bennevisplace]

There has to be a real financial incentive for inventing and proving better drugs. It's a time consuming process, swallowing unimaginable amounts of cash long before the revenue starts to roll in - if ever, as most drug development projects fail. New compounds must be patent-protected from day one and patents last 20 years, leaving perhaps 5-10 years of market monopoly in which to recoup costs (including money spent on the losers) and make a profit for financial backers.

So goes the theory.

Big pharma, though, has become astute at gaming the system, evergreening products by securing multiple patents for small incremental changes that confer no real benefit to patients and are far removed from the idea of inventing something new. Ibrutinib, now a top 12 selling drug, is a good example i-mak.org/imbruvica/ where Abbvie-Janssen stand to gain $ tens of billions by extending its patent period out to 29 years. Other blockbuster drugs are set to enjoy more than that - 38 years is the most I've seen.

Without having read the full article, I guess this is what was at issue in the Indian court.

[ViPOR]

If they succeed,Ihope they could leave out the severe leg cramps that I got from 15 months of being on an Ibrutinib trial. Iwas so glad to have it fail and get off of it

[Upthenorth]

My monthly cost of ibrutinib goes up ~$1,000/year— started at ~$10,000/month and is approaching $15,000/month. That’s ridiculous. Big pharma relies on scientists who got through school on government loans and scholarships, work in labs subsidized by taxpayers, relying on discoveries made in universities and public labs. I’m sick of this “investments” justify prices. We are all investing. The only silver lining is my overpriced insurance theoretically covers the cost. We are pawns in a mafia-style world.

[MovingForward4423 in reply to Upthenorth]

Staying alive is expensive.

[MovingForward4423 in reply to Upthenorth]

I know Acalabrutinib is less expensive. I wonder how many have switched for a lower cost treatment.

[MovingForward4423]

Imbruvica racked up $8.43 billion in sales, an indication that it's not ready to surrender its dominance of the BTK inhibitor market. Imbruvica's 2020 sales are split between AbbVie ($5.31 billion) and Johnson & Johnson ($4.13 billion).3 May 2021

[MovingForward4423]

AbbVie has also raised the price of Imbruvica by 82% since launching the drug in 2013. Today, Imbruvica is priced at $181,529 per year for a patient taking three pills per day, compared to $99,776 per year at launch.18 May 2021

[MovingForward4423]

Although ibrutinib and idelalisib are profound treatment advances, they will dramatically increase individual out-of-pocket and societal costs of caring for patients with CLL. These cost considerations may undermine the potential promise of these agents by limiting access and reducing adherence.

[Fight-1964]

I can understand that big pharma has big investment allocated to the development of medicine, however the patent expiry for ibrutinib/improvica is 2036 !!. It is all about big pharma profits.

[MovingForward4423]

The good news is many are moving to Acalbrutinib which has fewer off-target effects, and it's cheaper. In time competition will force the price down as Ibrutinib will be the less preferred option. We also have next-generation reversible BTK inhibitors coming, again this increases competition in the market and will hopefully make the drugs more reasonable. Almost 9Billion in revenue on one drug is mind-boggling...