When is healing healing?

02.12.2011 15:52

With the just presented benefit assessment of the active ingredient "Boceprevir" (Victrelis) based on a dossier from the pharmaceutical company MSD, IQWiG has now published its second early benefit assessment and submitted it to the G-BA for a decision. In the dossier, MSD presented two relevant studies from the approval, “SPRINT-2” and “RESPOND-2”, each double-blind, randomized and actively controlled.

The benefit assessment was very different for the four approved areas of application. In addition, on the basis of the results presented and taking endpoint categories and effect sizes into account, the extent and probability of the additional benefit was assessed as follows: “For the indication of treatment-naïve patients without cirrhosis, there is an indication of an additional benefit (extent not quantifiable) of 'Boceprevir' + ' PegInterferon' + 'Ribavirin' versus 'PegInterferon' + 'Ribavirin'. But with the caveat: “Both positive and negative results remained with the same certainty of results (note), whereby on the side of the additional benefit the extent was “not quantifiable” and on the side of the greater harm the extent was “considerable”. The extent to which a possible downgrading of the extent of the additional benefit would make sense cannot be conclusively assessed due to the non-quantifiability of the additional benefit. However, it seems inappropriate to question the indication of an additional benefit with regard to the serious secondary complication (HCC) entirely because of the greater harm caused by the non-serious adverse events (anaemias).”
According to IQWiG, the reason for the rating “extent not quantifiable” is that the endpoint “sustained virological response (SVR)” used in the studies was considered to be sufficiently valid to be used as a surrogate for a patient-relevant endpoint that was not collected in the included study (hepatocellular carcinoma) should be taken into account in the benefit assessment: a statistically significant difference in favor of boceprevir in the SVR would also have been shown. However, at the endpoint level, it should be taken into account that the SVR as a surrogate has not been formally validated and the assessment of “sufficient validity” is based exclusively on data from observational studies. This increased uncertainty is taken into account by classifying the extent of the additional benefit as “unquantifiable”.

The institute does not recognize that the elimination of the virus equates to a cure for hepatitis C and thus a reduction in secondary diseases, however, explains MSD on the benefit assessment presented. And even though “the elimination of the hepatitis C virus is considered a cure internationally,” as Hanspeter Quodt, Managing Director of MSD Germany, emphasizes, “Boceprevir” has already received positive reviews in benefit assessments from other countries. However, since such a cure represents a significant additional benefit according to the Drug Benefits Ordinance, MSD hopes for patients in Germany that the Federal Joint Committee (G-BA) will recognize the possible cure of hepatitis C through our drug Boceprevir as a significant additional benefit. How the G-BA decides will become clear in the next few weeks. The G-BA will take a close look at the cost dimension: “Boceprevir”/“Victrelis” (200 mg, 336 tablets, original preparation) costs 3,986.79 euros, while the comparison therapies “PegInterferon alfa 2a” (e.g. the original preparation “Pegasys”) 180 μg, 12 pre-filled syringes, original preparation) 3,374.77 or “Ribavirin” (e.g. the original preparation “Copegus” 200 mg, 168 tablets, original preparation) only cost 1,022.10 euros.
According to IQWiG, it is unclear how high the additional burden could be. The pharmaceutical company is unable to calculate the annual therapy costs because the underlying consumption (e.g. number of packs used) is not shown. Furthermore, the calculations for the drug to be evaluated were based on the weighted average of treatment durations, and there was also a lack of differentiated representation for the combination of PegInterferon alfa 2a with ribavirin or PegInterferon alfa 2b with ribavirin. The IQWiG assessment: “It can therefore be assumed that the calculated annual therapy costs per patient and the annual therapy costs for the GKV as a whole are underestimated.”