HealtH tecHnology assessment
Reimbursement at risk
Germany expands its review of diabetes therapies
Market analysts are forecasting that sales of diabetes spokesman Arnd Prilipp told MedNous. "We provided IQWiG drugs will continue to grow robustly over the next decade with study data comparing linagliptin in monotherapy and in as the global diabetes epidemic continues to spiral out of dual (linagliptin+metformin) and triple combination control. Pharmaceutical manufacturers are stepping in to (linagliptin+metformin+insulins) therapy," he added. meet an unmet medical need and are launching innovative The IQWiG's second review of Trajenta follows a G-BA products worldwide, such as Boehringer Ingelheim and Eli decision of 'no additional benefit' for the drug in March Lilly's dipeptidyl peptidase-4 (DPP-4) inhibitor, Trajenta 2012. The original dossier was deemed incomplete because (linagliptin), for type 2 diabetes. In Europe, however, the companies had chosen a patented DPP-4 inhibitor companies are facing growing uncertainty about whether as the comparator to Trajenta, rather than the generic the return on investment will be sufficient to make new sulphonylurea comparator therapy recommended by the product launches worthwhile there. This stems largely from G-BA. Under a special transitional rule, however, Boehringer new policies in Germany, a critical market that many other Ingelheim and Eli Lilly - as well as others that found European countries follow when making their own pricing themselves in a similar situation - were allowed to resubmit new dossiers for reassessment up until the end of 2012. Since the country's pharmaceutical market reform Trajenta was the first to be reassessed under this rule. law, AMNOG, came into effect two years ago, its health Boehringer Ingelheim and Eli Lilly have yet to launch technology assessment (HTA) and reimbursement decision- Trajenta in Germany; ironically, they now find themselves in making bodies - the IQWiG and the G-BA, respectively a position where they are producing the drug there for export are still very confident in Trajenta. We "It is an
Prilipp. He said that it was "too early to challenging market,
makes a second 'no additional benefit' especially in the
determination" in its final decision due diabetes sector."
'no additional benefit' under an early drug in the country, particularly in the second time concluded on a technicality that Trajenta offers an additional medical benefit (whether 'non-quantifiable', patients no therapeutically significant additional benefits 'marginal', or 'considerable') may enter into pricing over comparator therapies on the market.1 The IQWiG's negotiations with the federal association of statutory health justification was that the companies had not submitted any insurance (SHI) funds (GKV-Spitzenverband). The better the rating, the more leverage a company may have in The G-BA had asked for studies testing linagliptin against 'appropriate' comparators in three situations: monotherapy, dual therapy and triple therapy. According to the IQWiG, DPP-4 class under scrutiny
however, the companies had only submitted the results of In light of the Trajenta review, the G-BA has decided to placebo-controlled studies for mono and triple therapies, and carry out a separate DPP-4 class assessment and has had included data from a dual therapy study whose design requested dossiers from all manufacturers of gliptins, ie was not relevant for the purpose of making an additional Merck's Januvia (sitagliptin), Bristol-Myers Squibb and benefit determination. That study had tested the generic AstraZeneca's Onglyza (saxagliptin) and Novartis' Galvus comparator glimepiride (a sulphonylurea) against linagliptin (vildagliptin) - and their combinations with metformin. This - each combined with the metformin - but the IQWiG is the first class assessment to take place under AMNOG, deemed it unsuitable because it not only compared the two said Thomas Müller, head of the G-BA's Pharmaceuticals drugs with each other, but also compared two different Department. (He noted that pre-AMNOG, the G-BA carried out a class assessment of all insulin analogues, but absent For its part, Boehringer Ingelheim stands firmly behind its from this lengthy review were the requirement for dossiers supporting evidence. "We were quite surprised that IQWiG questioned the scientific design of our study," company Dr Müller explained to MedNous that the drugs subject 10 February 2013 MedNous
HealtH tecHnology assessment
to the DPP-4 class assessment are already on the market in Germany, and the reason for the assessment is "to have a consistent assessment of all gliptins and to avoid distortion of competition between the gliptins". The six-month procedure • More than 55 million Europeans aged 20 to 79
is due to begin on 1 April 2013, after which any price have diabetes, with Germany ranking second in
negotiations with the GKV-Spitzenverband would take place the number of reported cases.4
over a further six months. Dr Müller did not rule out the • By 2030, 64 million Europeans are expected to
possibility that the outcome of the G-BA's class assessment could be different from its imminent decision on Trajenta. have the disease.5
What does this mean for the diabetes sector?
• European expenditure on diabetes was nearly
€139 billion in 2012.
Manufacturers of other new diabetes therapies will no doubt be wondering whether G-BA class assessments will become commonplace. For example, there may soon be a new glucagon-like peptide-1 receptor (GLP-1) agonist on the German market that could potentially trigger a class review reflect this. He also pointed out that "the impact of even of existing GLP-1 agonists. Sanofi's type 2 diabetes therapy a 40% price reduction across the board for the DPP-IV Lyxumia (lixisenatide) received a positive opinion from inhibitors would diminish the market value of this drug class the European Medicine Agency's Committee for Medicinal by over $400 million in Germany alone." Products for Human Use (CHMP) in November 2012 and The effects of German pharmaceutical policies will be felt marketing approval by the European Commission on further afield, too. Edith Frénoy, director market access of 4 February 2013. Although the company declined to comment the European Federation of Pharmaceutical Industries and on whether it plans to market the drug in Germany, the Associations (EFPIA), says that industry is closely watching developments in the German pricing and reimbursement There are currently three GLP-1 agonists on the German system "in general, [but] not limited to one therapeutic market: Novo Nordisk's Victoza (liraglutide) and Lilly area…Because of the widespread use of international Deutschland's Byetta and Bydureon (both exenatide). reference pricing in Europe, any decision to modify the price MedNous asked Dr Müller whether the G-BA anticipated a class assessment of GLP-1 agonists already on the market, of pharmaceuticals marketed in Germany will automatically to which he replied: "That is possible to avoid distortion of affect other European countries". She also noted that the competition, but not yet decided." He also pointed out that German healthcare system "is potentially a model for many the G-BA is "on the way to developing criteria to assess other healthcare systems in evolution, within and also outside drugs in the existing market. Until now, no list is available. We expect the next assessment out of the existing market Though EFPIA feels that the early benefit assessments performed under AMNOG "are very conservative", Mrs Diabetes manufacturers will also be watching the G-BA's Frénoy does not believe the G-BA's DPP-4 class assessment early benefit assessment of AstraZeneca and Bristol-Myers is the start of a new trend, and carrying out class reviews Squibb's Forxiga (dapagliflozin), a first-in-class therapy for is certainly not unique to Germany. She told MedNous, the treatment of type 2 diabetes that works in the kidney to however, that this type of review "would best look at all selectively inhibit sodium-glucose cotransporter 2 (SGLT2).2 treatment options, rather than only pharmaceuticals…This The drug was launched in Germany shortly after being would ensure that healthcare resources are efficiently spent granted an EU marketing authorisation in November 2012, and work has begun on its early benefit assessment.3 A final G-BA decision on Forxiga is due by June 2013, 1. IQWiG, Linagliptin: Renewed benefit assessment, 29 November Broader impact on the EU
Naturally, the most immediate impact of the G-BA's 2. EMA, European Public Assessment Report summary: Forxiga, reimbursement decisions and the subsequent pricing determinations for diabetes therapies will be seen in 3. IQWiG, [A12-18] dapagliflozin - benefit assessment pursuant to Germany. "It is an increasingly challenging market, § 35a SGB V (dossier evaluation), especially in the diabetes sector, which is very competitive," 4. 'Diabetes at a glance, 2012: Europe', International Diabetes Neil Grubert, director of pricing and reimbursement research Federation - Europe,
at the global consultancy Decision Resources told MedNous. 5. DiabetesDE, Deutscher Gesundheitsbericht: Diabetes 2013, Indeed, the company is in the process of reassessing an earlier forecast for the German market which had predicted that spending on type 2 diabetes therapies would increase from $1.5 billion in 2011 to $2.8 billion in 2021. The events in Germany "are slowing things down significantly," said the This article was written by Karen Finn, contributing company's senior director of cardiovascular and metabolic disorders, Donny Wong, and as such, the new forecast will
MedNous February 2013 11


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