Germany's Federal Joint Committee (G-BA) has asked for a benefit assessment of antidiabetic drugs sitagliptin, vildagliptin, and saxagliptin, as well as the combination treatments metformin plus sitagliptin and metformin plus vildagliptin.
IHS Global Insight Perspective | |
Significance | The Federal Joint Committee (G-BA) has asked the manufacturers of sitagliptin, vildagliptin, and saxagliptin, as well as metformin plus sitagliptin and metformin plus vildagliptin, to submit a value dossier by 31 December 2012. |
Implications | The decision to evaluate the five medicines was made on the grounds that they are direct competitors to German firm Boehringer Ingelheim's new antidiabetic Trajenta (linagliptin), for which the G-BA issued a negative verdict on 29 March. |
Outlook | The evaluation of the gliptin class will start in January 2013 and will most probably have an impact on the second evaluation of Trajenta if Boehringer decides to file a new value dossier. |
Benefit Assessment of Gliptins
Germany's Federal Joint Committee (G-BA) yesterday (7 June) decided to ask for a benefit assessment of antidiabetic drugs sitagliptin, vildagliptin, and saxagliptin, as well as combination therapies metformin plus sitagliptin and metformin plus vildagliptin. Manufacturers have until 31 December to submit a complete value dossier to the committee. The decision to evaluate the five medicines was made on the grounds that they are direct competitors to German firm Boehringer Ingelheim's new antidiabetic Trajenta (linagliptin), for which the G-BA issued a negative verdict on 29 March.
In IHS Global Insight's view, the decision owes to the recent amendment of the early benefit assessment bill. Since March 2012, the G-BA must provide arguments to explain its choice of appropriate comparator. Besides, manufacturers now have one year to file a new value dossier in the case of a lack of comparative data versus the appropriate comparator.
Impact on Trajenta's Benefit Assessment
Following the negative verdict issued for Trajenta in March, Boehringer is expected to submit a new value dossier within the next few months. If the G-BA does not change its mind, it will have to provide arguments to explain why it chose a drug from the sulphonylurea class, a combination of metformin and a sulphonylurea, and a combination of insulin and metformin, depending on the patient population, as appropriate comparators; and not a gliptin. Results of the benefit assessment of gliptins will thus be need to provide robust data in favour of or against such a choice.
Trajenta Early Benefit Assessment Results, March 2012
In line with the opinion of the Institute for Quality and Efficiency in Health Care (IQWiG), the G-BA issued a negative verdict on Boehringer's type 2 diabetes medicine Trajenta, estimating that data included in the value dossier were not appropriate to demonstrate an added value of linagliptin in monotherapy, in combination with metformin, and in combination with metformin and a sulphonylurea. The G-BA's decision is available here.
Trajenta: Early Benefit Assessment | |||
Indication | Appropriate Comparator | Final Innovation Score | Patient Population |
Administration of linagliptin alone (monotherapy) as a substitute for metformin if this drug is not tolerated by patients or should not be taken because of impaired kidney function. | A drug from the sulphonylurea class (glibenclamide or glimepiride) | No additional benefit proven | 522,500 |
Dual therapy combining linagliptin and metformin, indicated if treatment with metformin alone is insufficient to control blood glucose levels. | Combination of metformin and a sulphonylurea | No additional benefit proven | 634,600 |
Triple therapy combining linagliptin, metformin, and a sulphonylurea, used if dual therapy with metformin and a sulphonylurea is no longer a sufficient treatment option. | Combination of insulin and metformin | No additional benefit proven | 62,400 |
Source: G-BA | |||
Outlook and Implications
This is the first time the G-BA has asked for a benefit assessment of drugs that have been launched prior to 2011. Under the Act for Restructuring of the Pharmaceutical Market in Statutory Health Insurance (AMNOG), the G-BA may request a benefit assessment for medicines launched prior to January 2011 if they compete with products for which an early benefit assessment exists, or if they are of importance for medical care. In such cases, the manufacturer has three months to provide a value dossier to the G-BA.
The results of this benefit assessment will be key for the future of Trajenta in Germany. The drug is not yet available in the country, as Boehringer made the decision not to launch its medicine due to a disagreement on the appropriate comparator; this choice has been confirmed with the negative opinion issued by the G-BA (see Germany: 9 September 2011: AMNOG Blocks Second New Medicine in Germany, Industry Group Calls for Fairer Pricing Rules and Germany 10 April 2012: G-BA Makes Final Conclusions on Five New Medicines). Early on, the G-BA indicated that it will not select a gliptin to evaluate the benefit of Trajenta, contrary to what was expected by the manufacturer. In its value dossier, Boehringer compared linagliptin with sitagliptin—a drug from the gliptin class—in all three treatment situations. The G-BA thus concluded that the reimbursement dossier deviated from its specifications in terms of appropriate comparator and granted a negative innovation score level (no proven added benefit) to Trajenta.
Boehringer will most probably wait for the results of this benefit assessment before resubmitting a value dossier for Trajenta. The firm is very likely to retain sitagliptin as comparator in its reimbursement dossier.