What Price Diabetes Care? Affordability Is New Buzzword

MELBOURNE, Australia — Collective action is required by a range of organizations and different groups of people if diabetes medications are to be made more affordable, leading experts in the field say.

The world is experiencing a diabetes pandemic, with cases of type 2 diabetes in particular set to balloon due to soaring rates of obesity, among other things, and 80% of diabetes cases now occur in low- and middle-income countries, so affordability is becoming the new buzzword.

Speaking at the World Diabetes Congress 2013 today, Edwin Gale, MB, BChir (Cantab), FRCP, from the University of Bristol School of Clinical Sciences, United Kingdom, said there are really only 3 "essential" medicines for diabetes: metformin, sulfonylureas, and human insulin.

While 98% of metformin worldwide is available generically, in sharp contrast, "90% of insulin is branded," he observed. And with just 3 companies — Lilly, Novo Nordisk, and Sanofi — controlling more than 90% of the global $16.7-billion insulin market, the time is ripe for an overhaul to try to make this a more equitable playing field, he argued.

Industry Needs to Engage in "Pragmatic Responsibility"

Dr. Martin Cross

But alienating the pharmaceutical industry is not the way to go, said Martin Cross, MD, chair of Medicines Australia, a discovery-driven pharmaceutical industry trade association.

"The average medicine takes 12 years to develop and $1.4 billion to bring to market, and only 3 out of 10 marketed drugs will produce revenues that match or exceed their development costs," Dr. Cross noted. Therefore, these " 'jewels in the crown' become important to keep companies moving forward," he stressed.

Rather, the industry needs to engage in "pragmatic responsibility," he said. It costs a much less eye-watering $4 million to bring a new generic to market, with 3 to 6 years of work involved, and thus a greater role for generic diabetes medicines is undoubtedly one logical way forward, he noted.

India has led the way in generic medicine development, and other countries have much to learn from it, Dr. Cross observed. Another possibility to help drive drug prices down in diabetes care is the greater engagement of large, not-for-profit organizations such as the Bill and Melinda Gates Foundation, he suggested.

Dr. Juan José Gagliardino

And Juan José Gagliardino, MD, from the Pan American Health Organization/World Health Organization (PAHO/WHO) Collaborating Center for Diabetes, in La Plata, Argentina, said that, importantly, "There is no relationship between improvement in care and money spent in diabetes."

"Just because you have a very good drug doesn't automatically mean you are going to have a good outcome. It's important to know how to use the tools," he told the meeting.

Hence, education is another essential part of the equation, he stressed, and not just for doctors but for other healthcare providers and patients with diabetes.

From < $300 a Year to $1750: Action Plan to Reduce Costs

Dr. Gagliardino described the capital expenditures available per person per year among different countries of the world and noted that half of all nations have less than $400 per person per year to spend on diabetes: 42% of countries have less than $300 a year and 20% currently limit spending to less than $100 a year.

Mean Annual Health Expenditure per Person With Diabetes by Region: 2010

For diabetes care, the most basic treatment regimen — including the oral hypoglycemic agents metformin and sulfonylureas, an ACE inhibitor for blood-pressure reduction, and a statin for dyslipidemia — costs around $264 a year, he explained.

But substituting just 1 older medication for a new one — for instance, by replacing a sulfonylurea with a dipeptidyl peptidase-4 (DPP-4) inhibitor — shoots cost to $1752 a year, he illustrated.

Hence, an "action plan" is essential, he stressed. This should include encouraging health authorities worldwide to strive to increase their healthcare budgets, as well as promoting earlier diagnosis and treatment of diabetes; the latter enables targets to be met at lower costs, he observed.

And the industry needs to acknowledge that it will have to work toward affordable new drug prices if innovative treatments are to be made available to a wider number of patients, Dr. Gagliardino said.

In addition, physicians and other healthcare providers must be trained to optimize timely drug prescription and use, and people with diabetes must be empowered "to play an active role in the control and treatment of their disease."

He conceded that education "is not an easy task," but that does not mean it shouldn't be attempted. He also lamented the fact that "postgraduate training of physicians is almost entirely in the hands of industry."

Insulin: A Great Opportunity to Cut Costs for Diabetes

Dr. Edwin Gale

Dr. Gale said that changing the way insulin is provided in particular offers one of the biggest opportunities to cut costs.

For type 1 diabetes, insulin is the go-to medicine, and for type 2 diabetes, patients typically start out on oral medicines but often progress to needing insulin injections. In the developing world, the only type of insulin that is used is human insulin, which is now off patent and is actually sufficient for diabetes control in most people, Dr. Gale argued.

The more expensive insulin analogues favored in developed nations are out of the price reach of most countries. "There is no evidence to suggest that you need insulin analogues; they have marginal advantages, but that is all," he said.

Amazingly, the "price of insulin around the world can vary by 5000%," Dr. Gale told Medscape Medical News, and that represents "a huge profit margin" for many companies.

He, along with several audience members, stressed that transparency on costs on the part of the pharmaceutical industry is essential and currently is sorely lacking.

Dr. Gale said he would like to see sharing of information, for example, to see how much people in different countries are paying for insulin. Patients could set up Web sites detailing such costs, he suggested.

"There are a lot of well-intentioned people, both inside industry and outside of industry, but we don't see collective action, and we need that," he commented.

He also believes generic availability of recombinant human insulin products, so-called "biosimilars," is a huge unexplored opportunity that for some reason has not yet been fully embraced.

Humulin (Eli Lilly) was the first human insulin introduced into clinical use in 1982, and as patents for this and other similar products have elapsed, the opportunity to develop and produce biosimilar human insulins exists. However, because the therapeutic window for insulin is narrow, there are robust regulatory requirements before marketing authorization can be granted for biosimilar insulins. Nevertheless, Dr. Gale believes this is the way forward.

And there is at least some good news on the insulin-analogue front, too, he noted: the world's leading such product, insulin glargine (Lantus, Sanofi), is coming off patent in 2015, with obvious huge cost savings to be achieved with generic versions.

Dr. Gale and Dr. Gagliardino reported no conflict of interest. Dr. Cross is chair of Medicines Australia.

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Cite this: What Price Diabetes Care? Affordability Is New Buzzword - Medscape - Dec 04, 2013.