(Ref: Physician Views Desk)
December 9th, 2014
By: Simon King
Later this month, the FDA is expected to approve AbbVie's oral '3-DA' product - comprising Viekirax (ombitasvir/ paritaprevir/ ritonavir) plus Exviera (dasabuvir) - for the treatment of genotype 1 hepatitis C patients. European approval is expected to occur in early 2015 following a positive recommendation from a European Medicines Agency committee last month.
Payers in the US are hoping that AbbVie will deliver festive cheer by announcing a notable 'sticker price' discount versus Gilead Sciences' Harvoni brand, which costs $94,500 for a 12-week supply. Analysts are increasingly certain, however, that such a scenario is unlikely to play out – although rebating will play a key role in driving uptake.
Strategically, however, AbbVie is more likely to promote the 3-DA regimen as being more suitable in cirrhotic patients, based on an assumption that the scale of the hepatitis C market will support multi-billion dollar revenues at a lower penetration rate.
However, while the cirrhotic population may provide an entry point for the 3-DA regimen, perception of AbbVie's superiority may diminish over the next few years as Gilead publishes further data for Harvoni in these patients, argue analysts at Deutsche Bank. A strong early performance for 3-DA may therefore be critical in establishing AbbVie in the hepatitis C market.
The label approved for 3-DA could be crucial in driving uptake. For example, there remains uncertainty as to whether AbbVie will receive approval for a 12-week duration of therapy in treatment-experienced patients with cirrhosis, an indication for which Harvoni use is only approved over a 24-week period. Debate is focused on whether the FDA takes the view that a minimum 95 percent sustained virological response (SVR) rate is required to grant approval; in Phase III studies, 3-DA demonstrated a 92 percent SVR over 12 weeks.
Another uncertainty is focused on whether the FDA feels it is necessary that 3-DA is dosed in combination with ribavirin in genotype 1a treatment-experienced and cirrhotic patients, and whether physicians also use ribavirin in treatment-naive genotype 1a patients (given the 7 percent delta in SVR rate demonstrated with and without ribavirin in Phase III studies).
Away from the label for AbbVie's 3-DA, other key issues that will shape usage focus on Gilead's competing therapy Harvoni. Specifically, how frequently physicians will use the drug in genotype 1 treatment-naїve patients over an eight-week (rather than 12 week) duration, thereby potentially limiting AbbVie's ability to compete on price, and just how significant a role Harvoni's convenience and compliance profile will play in limiting uptake of 3-DA. AbbVie's drug will require six tablets a day (four in the morning, two in the evening), while Harvoni requires one tablet a day.
To better ascertain how these factors may shape uptake of AbbVie's product, FirstWord is polling US and EU5-based gastroenterologists/hepatologists and infectious disease specialists with the following questions...
At peak, what percentage of total genotype 1 treatment-naїve patients who receive therapy with Gilead's Harvoni do you expect to treat for an eight-week (rather than 12 week) duration?
At peak, what percentage of genotype 1 treatment-experienced cirrhotic patients would you expect to treat with AbbVie's 3-DA regimen if its label necessitates a 24-week duration of therapy (also assuming ribavirin co-administration in genotype 1a patients)? – Phase III data demonstrated a SVR of 96 percent.
As a follow-up...what percentage of genotype 1 treatment-experienced cirrhotic patients would you expect to treat with AbbVie's 3-DA regimen, if its label necessitates a 12-week duration of therapy in this indication (also assuming ribavirin co-administration in genotype 1a patients)? – Phase III data demonstrated a SVR of 92 percent.
Do you have any concerns using ribavirin in combination with either AbbVie's 3-DA regimen or Gilead's Harvoni in treatment-experienced cirrhotic patients if this allows the duration of therapy to be reduced?
Just how important a role do you think the convenience/compliance advantage associated with Gilead's Harvoni (one tablet a day) will play in limiting the competitiveness of AbbVie's 3-DA regimen?
You will be able to read the results and analysis later this week.
Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.
As always, FirstWord would very much like to receive your feedback and suggestions.
Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialities and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us atinfo@firstwordpharma.com.
To read more Physician Views articles, click here.
Payers in the US are hoping that AbbVie will deliver festive cheer by announcing a notable 'sticker price' discount versus Gilead Sciences' Harvoni brand, which costs $94,500 for a 12-week supply. Analysts are increasingly certain, however, that such a scenario is unlikely to play out – although rebating will play a key role in driving uptake.
Strategically, however, AbbVie is more likely to promote the 3-DA regimen as being more suitable in cirrhotic patients, based on an assumption that the scale of the hepatitis C market will support multi-billion dollar revenues at a lower penetration rate.
However, while the cirrhotic population may provide an entry point for the 3-DA regimen, perception of AbbVie's superiority may diminish over the next few years as Gilead publishes further data for Harvoni in these patients, argue analysts at Deutsche Bank. A strong early performance for 3-DA may therefore be critical in establishing AbbVie in the hepatitis C market.
The label approved for 3-DA could be crucial in driving uptake. For example, there remains uncertainty as to whether AbbVie will receive approval for a 12-week duration of therapy in treatment-experienced patients with cirrhosis, an indication for which Harvoni use is only approved over a 24-week period. Debate is focused on whether the FDA takes the view that a minimum 95 percent sustained virological response (SVR) rate is required to grant approval; in Phase III studies, 3-DA demonstrated a 92 percent SVR over 12 weeks.
Another uncertainty is focused on whether the FDA feels it is necessary that 3-DA is dosed in combination with ribavirin in genotype 1a treatment-experienced and cirrhotic patients, and whether physicians also use ribavirin in treatment-naive genotype 1a patients (given the 7 percent delta in SVR rate demonstrated with and without ribavirin in Phase III studies).
Away from the label for AbbVie's 3-DA, other key issues that will shape usage focus on Gilead's competing therapy Harvoni. Specifically, how frequently physicians will use the drug in genotype 1 treatment-naїve patients over an eight-week (rather than 12 week) duration, thereby potentially limiting AbbVie's ability to compete on price, and just how significant a role Harvoni's convenience and compliance profile will play in limiting uptake of 3-DA. AbbVie's drug will require six tablets a day (four in the morning, two in the evening), while Harvoni requires one tablet a day.
To better ascertain how these factors may shape uptake of AbbVie's product, FirstWord is polling US and EU5-based gastroenterologists/hepatologists and infectious disease specialists with the following questions...
At peak, what percentage of total genotype 1 treatment-naїve patients who receive therapy with Gilead's Harvoni do you expect to treat for an eight-week (rather than 12 week) duration?
At peak, what percentage of genotype 1 treatment-experienced cirrhotic patients would you expect to treat with AbbVie's 3-DA regimen if its label necessitates a 24-week duration of therapy (also assuming ribavirin co-administration in genotype 1a patients)? – Phase III data demonstrated a SVR of 96 percent.
As a follow-up...what percentage of genotype 1 treatment-experienced cirrhotic patients would you expect to treat with AbbVie's 3-DA regimen, if its label necessitates a 12-week duration of therapy in this indication (also assuming ribavirin co-administration in genotype 1a patients)? – Phase III data demonstrated a SVR of 92 percent.
Do you have any concerns using ribavirin in combination with either AbbVie's 3-DA regimen or Gilead's Harvoni in treatment-experienced cirrhotic patients if this allows the duration of therapy to be reduced?
Just how important a role do you think the convenience/compliance advantage associated with Gilead's Harvoni (one tablet a day) will play in limiting the competitiveness of AbbVie's 3-DA regimen?
You will be able to read the results and analysis later this week.
Results and related analysis will be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.
As always, FirstWord would very much like to receive your feedback and suggestions.
Note: FirstWord Polls are powered by MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialities and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us atinfo@firstwordpharma.com.
To read more Physician Views articles, click here.
No comments:
Post a Comment