German analogue insulin issue
In Germany, the Federal Government has decided to discontinue the reimbursement of short-acting analogue insulins for people with type 1 diabetes. This follows the conclusions of an evidence-based evaluation carried out by the German Institute for Quality and Cost Effectiveness in Health Care Sector (IQWiG) that was submitted to the German Joint Government Committee (G-BA). As the evaluation concluded that these insulins had no added value compared to human insulin, the decision to discontinue reimbursement was based purely on economic grounds.
The Federal Government decision is in contradiction of an assurance made by the German Petition Council in 2007 that the discontinuation would only apply to people with type 2 diabetes. In July 2006, the G-BA decided to discontinue the reimbursement of short-acting analogue insulins for people with type 2 diabetes unless they were no more expensive than human insulin. Following petitions sent to the German Petition Council expressing concern over the G-BA decision, the Council assured the petitioners that the decision to discontinue reimbursement would not be extended to people with type 1 diabetes.
Upon being informed, the International Diabetes Federation took up the issue through its Task Force on Insulin, Test Strips and Other Diabetes Supplies. Following discussion within the IDF Board of Management, the Federation decided to draft an official letter to the German Government, expressing its concern at the consequences of the potential discontinuation of reimbursement for short-acting insulin analogues to people with type 1 diabetes in Germany. The IDF position fully supports that taken by the German Diabetes Union (DDU). The full text of the letter follows below.
On 3 March, IDF received a reply from the Office of the German Chancellor, which stated that the Federal Ministry of Health can only assess the legal aspects of the G-BA decision, not the technical correctness. The reply also mentions that both the current G-BA decision and that of July 2006 stipulate that health insurance companies and the pharmaceutical industry can negotiate discount contracts for short-acting insulin analogues, thereby maintaining this treatment option accessible to people with type 1 and type 2 diabetes.
Various petitions have been sent to the German Government challenging the current proposal. With regard to the discount contracts, the following objections have been made:
- Not all insurance companies make such contracts with all pharmaceutical companies. This makes the situation very difficult for a physician to understand and therefore he/she is less likely to prescribe insulin analogues for fear of being liable to recourse.
- Some insurance companies deliberately do not make discount contracts as people with diabetes are considered 'expensive.'
- Regional differences exist in Germany with regard to access to insulin analogues, making the level of access dependent on where a person lives.
A study carried out in 2006 to assess the consequences of the G-BA decision to discontinue reimbursement of short-analogue insulins for people with type 2 diabetes found that these insulins accounted for only 41% of the total distribution of short-acting insulins in Germany, compared to 54% in Europe and over 80% in France, Switzerland, and the UK respectively.*
In order to raise awareness of the issue, the German Diabetes Association (DDG) held a press conference and public demonstration (pictured above) in Berlin on 13 March. This attracted considerable media interest and led to the German Health Ministry issuing a press release stating that the decision to prescribe a type of insulin should be made solely on medical grounds.
Letter from IDF to the German Chancellor, Angela Merkel
An die Deutsche Bundesregierung
Frau Bundeskanzlerin Angela Merkel
Willy-Brandt-Str.1
D-10 557 Berlin
Deutschland
08 February 2008
Dear Chancellor,
Re: Discontinuation of reimbursement for short-acting insulin analogues to people with type 1 diabetes mellitus
The International Diabetes Federation (IDF) and its Task Force on Insulin, Test Strips and Other Diabetes Supplies wish to express major concern about the potential discontinuation of reimbursement for short-acting insulin analogues to people with type 1 diabetes in Germany, which would result in many patients being excluded from this type of therapy.
By passing specific resolutions and declarations, respectively, on diabetes mellitus in 2006, both the United Nations (Resolution 61/225) and the European Parliament (Written Declaration Nr 01/2006) have recognized the enormous worldwide public health challenge posed by the staggering increase of diabetes mellitus and the associated devastating complications to the heart, brain, lower limbs, kidneys and eyes. All governments were urged strongly to do the utmost possible to halt, if not reverse, this dramatic development. Some 250 million people are presently known to be afflicted by diabetes worldwide, some seven million alone in Germany, of which two million are on daily insulin therapy.
Notwithstanding the rather limited database derived mainly from studies for official labelling, insulin analogues without question are a key component of current diabetes therapy, together with older insulins, insulin pens and infusion pumps, blood glucose self-monitoring, and structured education. In a recent statement, the International Diabetes Federation takes the position that the ability to choose and to tailor treatment to individual needs including the availability of insulin analogues with specific (unique) action profiles is important and should be supported. Clearly, the discontinuation of reimbursement for short-acting insulin analogues in Germany would lead to many people with diabetes being excluded from this treatment option. As the advocate for the rights of people with diabetes worldwide, the International Diabetes Federation urges the German Government to take all necessary measures to maintain this treatment option for the millions of people with diabetes mellitus in Germany.
Sincerely yours
Professor Martin Silink
President
International Diabetes Federation
Professor Larry Deeb
Chair
IDF Task Force on Insulin, Test Strips and Other Diabetes Supplies
* Calculations based on Data from SAP BW/ IMS® Health, Pharmacy- and Clinical Market, MAT November 2006
(Base: Sale in Millions of Units)
