Small Mercies – TPPA discussions and biologics

We have heard this morning about new developments within TPPA talks, after several days of delays brought about by continued discussion on various topics, including dairy, the automotive industry, and biologic medications.

People understand what dairy means to New Zealand, and what the automotive industry means to other players in the TPPA, but ‘biologic’ is something of a mystery word. Some articles refer to cancer sufferers, some go into no detail at all, just that word, ‘biologic’.

It seems like it’s important for people to understand the significance of biologic medication for individuals with a variety of different conditions – and why it’s particularly important that issues like patents dealt with reasonably.

At their root, biologic medications or biopharmaceuticals are those derived in some manner from biological sources, rather than created chemically. The category can include vaccines, chemotherapy agents and blood products – but some of the most well-known biologics are immunomodulators that are used in the treatment of various inflammatory diseases.

‘Inflammatory diseases’ covers some things that you might never consider to be related. IBD (inflammatory bowel disease – most often Crohn’s or colitis), rheumatoid arthritis, ankylosing spondylitis, psoriasis – these are all diseases involving the immune system that have severe inflammatory components – whether it’s joints, skin or intestines. All can have major complications. All are chronic conditions that the patient potentially has to deal with every day of their lives. There is no cure, there is only treatment. And, you guessed it – biologic medications are the frontline of care for such conditions.

Biologics are complicated. The molecules of the drugs themselves are highly complex – and because they are taken from cells rather than cooked up to a recipe by chemists, when patents expire, things get a little tricky. The original developer company does not have to provide any original cells or materials. Competing companies can access the final publicly accessible product, but that’s about it.

So unlike situations with ‘regular’ drugs, where there’ a particular combination of compounds to put together, and that’s the drug, biologics can’t be perfectly replicated. Instead, competing companies can create what are called ‘biosimilars’, from their own research into the original product. There is rigorous testing in place before these biosimilars can go on the market – they are even more tightly investigated and controlled than the original biologic. So if they make it to market, they are a viable alternative.

Alternatives are great. They create competition in pricing, which results in a cheaper product to the consumer – which in a country like New Zealand means both the tax payer and the patient themselves. And pricing is a huge issue here.

Case in point: adalimumab. Currently known mostly by its brand name, Humira, adalimumab is used in the treatment of all of the inflammatory conditions listed earlier. It is administered via subcutaneous injection – either a pen, or a syringe – mostly on a fortnightly basis. It was, according to Pharmac figures, the highest expenditure medicine in 2014, with a total spend of $62.2 million. This was slightly lessened by supplier rebates, but still. Adalimumab usually incurs the regular $5 prescription fee per three month supply – and this is where we thank our lucky universal healthcare stars, because the actual cost of a two-pack of syringes is nearly $1800.

This is all good to know. But more important to the issue at hand is that the patent expires next year. Which means that all of a sudden, it might not be AbbVie’s Humira that provides the best product at the best price. It might be an alternative version of adalimumab by another drug company. That’s up to Pharmac to decide, when such options become available and legal.

Whichever company’s product is chosen, the price will almost certainly go down considerably. Which means a number of things. Other medications could now be budgeted for that couldn’t in the past. The criteria for patients to be considered for adalimumab treatment could be widened.

Adalimumab’s future looks to be fairly steady, going by information available at this time. But the future of forthcoming biologics is an issue that has kept TPPA negotiators battling it out. The US fought for twelve years of patent protection, claiming it was needed to encourage innovation. Every other nation involved in the talks was against it – affordability being a key factor.

Though it appears that the wording is yet to be finalised, the deal as it now stands is that countries will maintain their previously existing patent periods – five years for Australia and New Zealand. Concerns have been voiced that this is not yet set in stone – Annette King, acting leader of Labour, has pointed out that Doctor Without Borders are claiming it is effectively going to end up being an eight year period. In the coming days, hopefully more will be made clear about precisely what has been agreed to – in practice as well as in writing.

New medical innovations are being developed all the time. For now, adalimumab is a key component to the wellbeing of many patients. Should another biologic drug come along that is more effective, it’s only natural that people would want to give it a go, and Pharmac is going to be able to exercise much more leeway with criteria if the costs involved with funding the drug are likely to drop significantly in five years, rather than twelve.

Regardless of your stance on the TPPA as a whole, the fact that this element of healthcare has been fought for is drastically important.

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