Pharmac has put out for discussion a document about funding a $50,000
12-week treatment per patient for approximately 11,000 hepatitis C
carriers over the next three years. It appears it is to be provided in
general practice, by general practice.
The drugs Viekira Pak and Viekira Pak-RBV are both indicated for the treatment of people who have hepatitis C genotype 1.
The clinical advice Pharmac has received on Viekira Pak and Viekira Pak-RBV indicates that more than 90 per cent of people who take the drugs for their chronic hepatitis C will be free of the virus 12 weeks after their treatment has stopped. PTAC reviewed an application for Viekira Pak and Viekira Pak-RBV at its August 2015 meeting.
Initial recommendation low priority
In summary, the committee recommended that it should be funded for the treatment of chronic hepatitis C genotype 1 infection in adults with a low priority based solely on fiscal risk.
There would be no access criteria or restrictions for funded access to Viekira Pak and Viekira Pak-RBV. So no special authority, click-box request discussion with local specialists, just that the patient has type 1 hepatitis C and can be seen and monitored in general practice.
The long-term benefits of curing about 10,000 patients with hepatitis C, and the presumed flow-on reduction in potential health expenditure from eliminating the virus in this population and reducing the risk of cirrhosis and hepatocellular cancers down the track, is perceived as an excellent, cost-effective intervention to undertake now.
Local hepatologist researches drug
Studies were done in Auckland by hepatologist Ed Gane on Havroni, a more expensive drug for more advanced hepatitis C, also included in the Pharmac consultation document (Gane EJ et al. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A Inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology, 2014;146[3]:736–743)
Okay, I haven’t read it but I would like to think the quality of the investigators would be to some extent indicative of quality research and appropriate numbers and evidence.
No long-term studies
There are obviously no long-term studies of any of these new drugs’ long-term risks and outcomes, and the speed at which they are devised to the time they appear on the market, heavily promoted by the companies and demanded by the patients looking for the miracle cure, seems to be getting increasingly short. To a conservative that causes some concerns.
With something like hepatitis C there is possibly a longer window of opportunity to be slow off the block when there is more evidence and longer-term data.
With other conditions, such as treatment of disseminated malignant melanoma in younger patients, the time frame is much more critical and the short-term outlook much worse.
Three hep C patients per GP
Effectively it opens up treatment of hepatitis C to all GPs, about three patients each under current GP numbers (11,000 patients: 4000 GPs).
Most of us will have had little or no direct experience of these drugs due to previous cost and access restrictions, and it is becoming more problematic keeping abreast of all the new drug forms, their side effect profiles and general management.
I would suspect the initiation of, and management of, the treatment of hepatitis C by GPs, if this is open access, will mean quite a steep learning curve and a lot of patient time as we will not have an established knowledge base, or experience base to inform our patient discussions.
Where on the scope?
Is this top of scope for GPs or really out of scope? Are they trying to bring the top of the medical hierarchical pyramid to the bottom of the pyramid, are they adding more resources, more GPs and additional funding to pay for the new learning, and knowledge acquisition?
Will there be GP/drug representative face-to-face activities and education included in the nominal $500-$600 million return to the drug companies involved?
Relooking at the data presented by Pharmac, the number to treat 11,000 patients at a nominal cost of $50,000 per patient is $550 million. This is clearly a high nominal price given the total Pharmac budget of around $800 million and realistically is it possible for the public to make a rational assessment of the cost-benefit analysis of that presumptive price per patient as opposed to spending that nominal presumptive amount of money on any other treatments?
Nothing in the Pharmac document said the two drugs proposed are better than other drugs that are not proposed for funding. Perhaps that is in the fine print!
The Government has already announced an extra $50 million annually to the budget of Pharmac taking the total nominal annual budget to $850 million for community drugs.
There has been nothing out there about an additional campaign funded at a nominal additional $200 million a year for three years.
Vaccination programmes set precedent
There is a reasonable history of vaccination programmes funded with one-off government appropriations in the past, with the hepatitis B programme initiated in the 1980s to catch all under-18-year-olds.
This was carried out in surgeries and long queues in the primary schools reminiscent of the third form line-ups for TB screening and vaccination phased out in the early 1970s.
The Menz B youth vaccination programme carried out in response to the on-going epidemic was also worth a few hundred million dollars. Precedent for funding such programmes is there.
Nagging doubts
I have some nagging doubts. There are very short time frames for consultation; implementation is planned for July 2016! There is no long-term data regarding medication effects and side effects.
At what stage does elimination of the virus not stop the progression of the disease? Does elimination of the virus after 20 years of hepatitis C carriage prevent the long-term consequence of hepatitis C liver disease and progression?
For example, stopping smoking reduces the risk of lung cancer but the duration of smoking remains associated with increased risk nevertheless as the history and duration of smoking remains a risk factor for cancer.
Several hepatitis C patients have already been treated and have zero viral load on RNA testing. How many have already been “effectively cured” already?
So the bottom line. The proposal sounds like a good idea!
The last word
Or let’s become conspiracy theorists and suggest this is a cunning plan to allay fears of what the real TPPA agreements will bring in when signed, ie, an agreed sweetener/loss leader with “cheap” access to new medications early on.
As a “demonstration of an act of good faith”, New Zealand signs the TPPA and then gets hammered by the cartel thereafter with long agreements and exclusivity clauses, patent life and high costs. Paranoia?
The drugs Viekira Pak and Viekira Pak-RBV are both indicated for the treatment of people who have hepatitis C genotype 1.
The clinical advice Pharmac has received on Viekira Pak and Viekira Pak-RBV indicates that more than 90 per cent of people who take the drugs for their chronic hepatitis C will be free of the virus 12 weeks after their treatment has stopped. PTAC reviewed an application for Viekira Pak and Viekira Pak-RBV at its August 2015 meeting.
Initial recommendation low priority
In summary, the committee recommended that it should be funded for the treatment of chronic hepatitis C genotype 1 infection in adults with a low priority based solely on fiscal risk.
There would be no access criteria or restrictions for funded access to Viekira Pak and Viekira Pak-RBV. So no special authority, click-box request discussion with local specialists, just that the patient has type 1 hepatitis C and can be seen and monitored in general practice.
The long-term benefits of curing about 10,000 patients with hepatitis C, and the presumed flow-on reduction in potential health expenditure from eliminating the virus in this population and reducing the risk of cirrhosis and hepatocellular cancers down the track, is perceived as an excellent, cost-effective intervention to undertake now.
Local hepatologist researches drug
Studies were done in Auckland by hepatologist Ed Gane on Havroni, a more expensive drug for more advanced hepatitis C, also included in the Pharmac consultation document (Gane EJ et al. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A Inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology, 2014;146[3]:736–743)
Okay, I haven’t read it but I would like to think the quality of the investigators would be to some extent indicative of quality research and appropriate numbers and evidence.
No long-term studies
There are obviously no long-term studies of any of these new drugs’ long-term risks and outcomes, and the speed at which they are devised to the time they appear on the market, heavily promoted by the companies and demanded by the patients looking for the miracle cure, seems to be getting increasingly short. To a conservative that causes some concerns.
With something like hepatitis C there is possibly a longer window of opportunity to be slow off the block when there is more evidence and longer-term data.
With other conditions, such as treatment of disseminated malignant melanoma in younger patients, the time frame is much more critical and the short-term outlook much worse.
Three hep C patients per GP
Effectively it opens up treatment of hepatitis C to all GPs, about three patients each under current GP numbers (11,000 patients: 4000 GPs).
Most of us will have had little or no direct experience of these drugs due to previous cost and access restrictions, and it is becoming more problematic keeping abreast of all the new drug forms, their side effect profiles and general management.
I would suspect the initiation of, and management of, the treatment of hepatitis C by GPs, if this is open access, will mean quite a steep learning curve and a lot of patient time as we will not have an established knowledge base, or experience base to inform our patient discussions.
Where on the scope?
Is this top of scope for GPs or really out of scope? Are they trying to bring the top of the medical hierarchical pyramid to the bottom of the pyramid, are they adding more resources, more GPs and additional funding to pay for the new learning, and knowledge acquisition?
Will there be GP/drug representative face-to-face activities and education included in the nominal $500-$600 million return to the drug companies involved?
Relooking at the data presented by Pharmac, the number to treat 11,000 patients at a nominal cost of $50,000 per patient is $550 million. This is clearly a high nominal price given the total Pharmac budget of around $800 million and realistically is it possible for the public to make a rational assessment of the cost-benefit analysis of that presumptive price per patient as opposed to spending that nominal presumptive amount of money on any other treatments?
Nothing in the Pharmac document said the two drugs proposed are better than other drugs that are not proposed for funding. Perhaps that is in the fine print!
The Government has already announced an extra $50 million annually to the budget of Pharmac taking the total nominal annual budget to $850 million for community drugs.
There has been nothing out there about an additional campaign funded at a nominal additional $200 million a year for three years.
Vaccination programmes set precedent
There is a reasonable history of vaccination programmes funded with one-off government appropriations in the past, with the hepatitis B programme initiated in the 1980s to catch all under-18-year-olds.
This was carried out in surgeries and long queues in the primary schools reminiscent of the third form line-ups for TB screening and vaccination phased out in the early 1970s.
The Menz B youth vaccination programme carried out in response to the on-going epidemic was also worth a few hundred million dollars. Precedent for funding such programmes is there.
Nagging doubts
I have some nagging doubts. There are very short time frames for consultation; implementation is planned for July 2016! There is no long-term data regarding medication effects and side effects.
At what stage does elimination of the virus not stop the progression of the disease? Does elimination of the virus after 20 years of hepatitis C carriage prevent the long-term consequence of hepatitis C liver disease and progression?
For example, stopping smoking reduces the risk of lung cancer but the duration of smoking remains associated with increased risk nevertheless as the history and duration of smoking remains a risk factor for cancer.
Several hepatitis C patients have already been treated and have zero viral load on RNA testing. How many have already been “effectively cured” already?
So the bottom line. The proposal sounds like a good idea!
The last word
Or let’s become conspiracy theorists and suggest this is a cunning plan to allay fears of what the real TPPA agreements will bring in when signed, ie, an agreed sweetener/loss leader with “cheap” access to new medications early on.
As a “demonstration of an act of good faith”, New Zealand signs the TPPA and then gets hammered by the cartel thereafter with long agreements and exclusivity clauses, patent life and high costs. Paranoia?
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