(1) Production costs and potential prices for biosimilars of human insulin and insulin analogues [PubMed Abstract] [Full Text HTML] [Full Text PDF]. BMJ Glob Health. 2018 Sep 25;3(5):e000850. doi: 10.1136/bmjgh-2018-000850. eCollection 2018.
High prices for insulin pose a barrier to treatment for people living with diabetes, with an estimated 50% of 100 million patients needing insulin lacking reliable access. As insulin analogues replace regular human insulin (RHI) globally, their relative prices will become increasingly important. Three originator companies control 96% of the global insulin market, and few biosimilar insulins are available. We estimated the price reductions that could be achieved if numerous biosimilar manufacturers entered the insulin market.
Data on the price of active pharmaceutical ingredient (API) exported from India were retrieved from an online customs database. Manufacturers of insulins were contacted for price quotes. Where market API prices could not be identified, prices were estimated based on comparison of similarity, in terms of manufacturing process, with APIs for which prices were available. Potential biosimilar prices were estimated by adding costs of excipients, formulation, transport, development and regulatory costs, and a profit margin.
The manufacturing processes for RHI and insulin analogues are similar. API prices were US$24 750/kg for RHI, US$68 757/kg for insulin glargine and an estimated US$100 000/kg for other analogues. Estimated biosimilar prices were US$48-71 per patient per year for RHI, US$49-72 for neutral protamine Hagedorn (NPH) insulin and US$78-133 for analogues (except detemir: US$283-365).
Treatment with biosimilar RHI and insulin NPH could cost ≤US$72 per year and with insulin analogues ≤US$133 per year. Estimated biosimilar prices were markedly lower than the current prices for insulin analogues. Widespread availability at estimated prices may allow substantial savings globally.
access; affordability; analogues; biosimilars; cost of production; generics; insulin; universal health coverage
(2) Insulin prices, availability and affordability in 13 low-income and middle-income countries [PubMed Abstract] [Full Text HTML] [Full Text PDF]. BMJ Glob Health. 2019 Jun 11;4(3):e001410. doi: 10.1136/bmjgh-2019-001410. eCollection 2019
Globally, one in two people needing insulin lack access. High prices and poor availability are thought to be key contributors to poor insulin access. However, few studies have assessed the availability, price and affordability of different insulin types in low-income and middle-income countries in a systematic way.
In 2016, 15 insulin price and availability surveys were undertaken (using an adaptation of the WHO/Health Action International medicine price and availability measurement methodology) in Brazil, China (Hubei and Shaanxi Provinces), Ethiopia, Ghana, India (Haryana and Madhya Pradesh States), Indonesia, Jordan, Kenya, Kyrgyzstan, Mali, Pakistan, Russia (Kazan Province) and Uganda. Data were collected in three sectors (public, private pharmacies and private hospitals/clinics) in three regions per survey. Insulin prices were standardised to 10 mL 100 IU/mL in US dollars ($). Data were also collected for four comparator medicines.
Mean availability was higher for human (55%-80%) versus analogue insulins (55%-63%), but only short-acting human insulin reached 80% availability (public sector). Median government procurement prices were $5 (human insulins) and $33 (long-acting analogues). In all three sectors, median patient prices were $9 for human insulins. Median patient prices for analogues varied between the public sector ($34) and the two private sectors ($44). Vials were cheaper than pens and cartridges. Biosimilars, when available, were mostly cheaper than originators. A low-income person had to work 4 and 7 days to buy 10 mL human and analogue insulin, respectively. For isophane human insulin, only three countries meet the WHO target of 80% availability of affordable essential medicines for non-communicable diseases in any sector.
Improving insulin availability and affordability needs to be addressed through national and global actions, including prioritising the supply of more affordable human insulin, increasing competition through the use of lower priced quality-assured biosimilars, negotiating lower prices from manufacturers and improving distribution systems.
affordability; availability; diabetes; insulin; low- and middle-income countries; prices
(3) Insulin prices could be much lower and drug makers would still make healthy profits Ed Silverman, STAT Sep 26, 2018, 10:53 AM.
Here are excerpts from Resource (3):
- The cost of insulin in the US has been notoriously high, and it has continued to increase in the past few years.
- To tackle this, cheaper versions of the medication has been introduced, and some states have even tried to pass drug pricing transparency laws.
- A new study suggests that manufacturers could make both human and analog insulins at low costs and still pocket a profit. The study also claims that more companies would need to enter the market to compete in order to drive down the cost.
As prices for diabetes treatments continue to roil consumers, a new study suggests that manufacturers could make both human and analog insulins at low costs and still pocket a profit.
After analyzing expenses for ingredients, production, and delivery, among other things, the researchers contend that the price for a year’s supply of human insulin could be $48 to $71 a person and between $78 and $133 for analog insulins, which are genetically altered forms that are known as rapid or long-acting treatments. Examples of analog insulins include Humalog, Lantus, and Novolog.
Put another way, the study estimated the cost of production for a vial of human insulin is between $2.28 and $3.42, while the production cost for a vial of most analog insulins is between $3.69 and $6.16, according to the study in BMJ Global Health.
Meanwhile, the median prices paid by more than two dozen countries for human insulin were 1.2 to 1.8 times greater than estimated prices. Median prices for other types of insulin were also higher: Lantus, which is sold by Sanofi (SNY), was 5.6 to 7.8 times higher; Humalog, which is sold by Eli Lilly (LLY), were at 2.7 to 3.7 times higher; and Novolog, a Novo Nordisk (NVO) treatment, was 2.6 to 3.5 times greater.
The study authors, who cited a 2016 study that examined government procurement prices paid and other data, argued their findings suggest greater competition would lead to sizable savings in most countries. They also maintain that existing insulin makers could set “significantly lower prices while still making a profit,” but they concede more companies would have to enter the market for this to occur.
“Anyone with Type 1 diabetes should be able to buy insulin for under $100 per year, including the long-acting forms,” said Andrew Hill, a study co-author and senior visiting research fellow at the University of Liverpool. “Pharmaceutical companies cannot justify charging governments $532 per person per year in the U.K. and $1,251 in the U.S., let alone similar amounts in low- and middle-income countries.”
For the rest of the article, including the drug companies weak predictable responses, go to the article link.