Boston ADA.

Diabetes medications will continue to rise, the cost of developing and introducing new medication is also on the rise. In terms of diabetes drugs, we have seen very large studies, trials and the lengthening cost money, which suggest larger than average development costs.

At a Meeting during a special Symposium the cost of medications was discussed in more detail.

1. The average cost to develop a small molecule or biologic agent, considering failure and time costs, has risen to 2,558 US billion dollar (in Swedish around 15 miljarder SEK). That is up from around 1,084 billion US dollar a decade arlier, representing an annual compound growth rate of 8,5 per cent.

2. The reason is in part because of drug candiates failures is rising. Other factors are the costs of clinical trial size and complexity, more expensive inputs from the medical sector, changing trial design to incorporate health technology, assessment of data, and etsting against active comparators to provide comparative safe and effectiveness data.

Regulatory regimes and reimbursements policies also play a role in rising drug costs. Every country has a system for to limit access and utulization based on specific medical critera and sets pricing levels. In China most of the modern drug with still a patent must be paid for out-of-pocket.

3. The total time to approval averaged today 128 months, 10 years, according to the presented Tufts survey.

4. We must have more health care costs outcomes proportionate in parallel to our helath care investment to speed up the process faster. The price is different in countries, for examples the cost for the patient or the insurance company, is several times higher in US than in Sweden – the manufacturers in US have been steadily increasing the price of all insulins in US in anticipation of biosimilar insulins. 

Europe and US have separate system for access of new treatments and regulatory processes – and other price system.

5. In US as in many countries whatever insulin we are prescribing now, we will likely have a change as payers negotiate new contracts with drug makers. It means that the doctor will havet o prescribe a new drug to the patient and some problems for the patient because of this

6. Lutz Heinemann, from Germany, said that ”my understanding is that the price reduction for biosimilar insulins will not be in the range we have seen with other gerenric drugs.” That means that 90 percent price reductions that we have seen with generic drugs, will not be there – the production cost is still too high for that. We will see 20 percent, 30 at the most, like we have seen with other biosimilar agents. There will be saving with biosimilars, but probably not the huge savings that some people have been hoping for, according to dr Heinemann.

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