50,000 people have Hep C in New Zealand, but a recent Pharmac
announcement about funding for two new drug treatments will not help
all of them, CATE BROUGHTON writes.
Naomi Wickens lived with Hepatitis C (HVC) for 45 years, but was cured with a generic drug imported from India this year at a cost of $2500.
Wickens, 67, is one among many Kiwis forced to use generic drugs sourced from overseas to treat their condition.
"The ease with which I got access to treatment was extraordinary. This is how it should be. It's life saving treatment, saving the country untold money by avoiding the need for severe liver disease and liver transplants," says the Masterton-based counsellor.
This month, Pharmac announced it would fund two new hepatitis C treatments, Harvoni and Viekira Pakbut, but doctors say it will only help 50 per cent of those with the illness.
Why will only some people get help and not others?
The issue, like most involving money for expensive life-saving drugs, is a complicated one.
Pharmac's money will help patients with genotype 1 and a small number who are on death's door with severe liver failure, giving them hope for a healthy future.
But for 50 per cent of patients with other genotypes there is no celebrating.
"While it is good news for those with genotype 1 Hepatitis C, there is no funded Direct Acting Anti-Virals (DAAV) for people with the other strains so that's difficult for those patients," says hepatitis specialist Catherine Stedman.
Faced with this news many sufferers will do like Wickens and consider
importing generic drugs produced in India, China or Bangladesh which
they are legally entitled to do with a prescription from a New Zealand
doctor.
However, in recent weeks, doctors who have prescribed drugs for HCV patients have been sent a warning letter and prescription form to complete from Medsafe about "unapproved" medications.
An Australian doctor who set up a "buyers club" to help patients access generic HCV treatments, Dr James Freeman, says the Medsafe letter is an attempt to intimidate doctors and dissuade them from prescribing generics.
"It appears from the outside as though Medsafe is being used as a proxy to look after the interests of a big pharma and their profits because it is not about patient safety - it's a change in the way these regulations have worked for a long time... and it's new."
Freeman says the letter has put some GPs off and the number prescribing has halved in recent weeks from about 24 to 12.
Other doctors had sought legal advice, and after being reassured had resumed prescribing.
"It's [the letter] framed in unpleasant and threatening terms, enough to frighten a number of people who were prescribing off," Freeman says.
Medsafe confirmed there had been a change and a letter and form was sent to prescribers because some patients were getting prescriptions to import unapproved medicines without the prescriber's knowledge.
However, this did not apply to HCV patients, compliance manager Derek Fitzgerald says.
"There is no evidence that this applied to the importation of medicines to treat Hep C."
This year 78 parcels containing Hepatitis C treatment medicines have been imported.
Christchurch GP Ben Hudson says he won't be put off prescribing imported medicines by the Medsafe letter.
"For the worst-case scenario if the patient has a bad outcome and you hadn't had a discussion with the patient about the potential risk of this being an unapproved medicine then there's likely to be a greater burden of responsibility that a complaints process would put on the shoulders of the prescriber, that's the bottom line."
Christchurch Hospital clinician and chair of the South Island Hepatitis C working group Dr Alan Pithy says he has written several prescriptions for generic medication and had not received a Medsafe letter, but he knew two colleagues who had.
One of them told him it was a bit off putting but he filled it out anyway.
"You do take responsibility when ever you prescribe something - but usually it is branded and has been through Medsafe so it is different but we're not unfamiliar with the concept of taking responsibility for prescribing."
So should all patients follow Wickens' example and try to source cheaper generic drugs from overseas?
BATTLING A DREADFUL DISEASE
Wickens did not notice the virus for the first 20 years, but by 2000 she had acquired haemachromatosis - a severe accumulation of iron in the body linked to HVC - and was exhausted.
"The exhaustion was both mental and physical it was like trying to function through a fog."
Wickens was forced to stop working due to the fatigue and she was unresponsive to treatments then available.
In March this year she turned to Freeman to help source generic treatments.
Wickens says the work Freeman did to check the drug suppliers, test the medicines and report on their efficacy with a clinical trial gave her confidence to go ahead.
Manufacturers are based in countries including India, China and Bangladesh that have not recognised the patent on the drug.
In April this year at a prestigious International Liver Conference Freeman presented data from clinical trials on the generic drugs showing they had a 90 per cent success rate.
Wickens says by day six on her treatment the viral load in her blood dropped from 1.3 million to 480. By week four the virus was undetectable.
"I have not had to have a sleep during the day for three months and am back tramping and doing more in my days than I could ever have done three months ago."
Despite her own GP's support, in the end a specialist wrote a script for Wickens.
He told her she would not need to see him again after she had taken the medication.
She also had an appointment with an Indian doctor by Skype who wrote a script required to purchase the medication there.
Four months down the track she wants others with the virus to know the generic drugs are just as good as the branded variety.
"They're not approved in New Zealand and yet it's the specialists in the field that are encouraging people to look at that for treatment for themselves so there's quite a contradiction there."
PRICED OUT OF A CURE
Cost is at the heart of the Pharmac decision, with the new HCV drugs considered to be the world's most expensive medication.
Funding for treatment of all genotypes would be "a substantial commitment of some tens of millions of dollars'', says Pharmac operations director Sarah Fitt.
"Any decision to fund a medicine depends on our ability to negotiate the best possible deal within the funding available."
Simply put, the miracle cure has been priced out of reach for most patients and many governments worldwide.
One of the drugs, Harvoni, would cost New Zealand patients up to $140,000.
The Australian Government announced a $1 billion funding deal for four HCV treatments for all patients. As a result Australian patients will pay up to $38 for a cure.
The multinational pharmaceutical companies who hold the patents including Gilead Sciences and Abbie Vie have been widely condemned by doctors, patients and politicians.
Last year Democratic presidential primary candidate Bernie Sanders even suggested the US Veterans Department should ignore the patent held by Gilead Science to access generics of the drugs.
Forensic psychiatrist and spokesman for doctors without boarders Erik Monasterio says parallel importing is a concern to the industry.
"Obviously that is one way of circumventing the very high cost of medications locally and as we know quite a few people are doing this because the cost is prohibitive."
He says the industry has lobbied governments "in different ways" to make parallel importing illegal.
Naomi Wickens lived with Hepatitis C (HVC) for 45 years, but was cured with a generic drug imported from India this year at a cost of $2500.
Wickens, 67, is one among many Kiwis forced to use generic drugs sourced from overseas to treat their condition.
"The ease with which I got access to treatment was extraordinary. This is how it should be. It's life saving treatment, saving the country untold money by avoiding the need for severe liver disease and liver transplants," says the Masterton-based counsellor.
This month, Pharmac announced it would fund two new hepatitis C treatments, Harvoni and Viekira Pakbut, but doctors say it will only help 50 per cent of those with the illness.
Why will only some people get help and not others?
The issue, like most involving money for expensive life-saving drugs, is a complicated one.
Pharmac's money will help patients with genotype 1 and a small number who are on death's door with severe liver failure, giving them hope for a healthy future.
But for 50 per cent of patients with other genotypes there is no celebrating.
"While it is good news for those with genotype 1 Hepatitis C, there is no funded Direct Acting Anti-Virals (DAAV) for people with the other strains so that's difficult for those patients," says hepatitis specialist Catherine Stedman.
However, in recent weeks, doctors who have prescribed drugs for HCV patients have been sent a warning letter and prescription form to complete from Medsafe about "unapproved" medications.
An Australian doctor who set up a "buyers club" to help patients access generic HCV treatments, Dr James Freeman, says the Medsafe letter is an attempt to intimidate doctors and dissuade them from prescribing generics.
"It appears from the outside as though Medsafe is being used as a proxy to look after the interests of a big pharma and their profits because it is not about patient safety - it's a change in the way these regulations have worked for a long time... and it's new."
Freeman says the letter has put some GPs off and the number prescribing has halved in recent weeks from about 24 to 12.
Other doctors had sought legal advice, and after being reassured had resumed prescribing.
"It's [the letter] framed in unpleasant and threatening terms, enough to frighten a number of people who were prescribing off," Freeman says.
Medsafe confirmed there had been a change and a letter and form was sent to prescribers because some patients were getting prescriptions to import unapproved medicines without the prescriber's knowledge.
However, this did not apply to HCV patients, compliance manager Derek Fitzgerald says.
"There is no evidence that this applied to the importation of medicines to treat Hep C."
This year 78 parcels containing Hepatitis C treatment medicines have been imported.
Christchurch GP Ben Hudson says he won't be put off prescribing imported medicines by the Medsafe letter.
"For the worst-case scenario if the patient has a bad outcome and you hadn't had a discussion with the patient about the potential risk of this being an unapproved medicine then there's likely to be a greater burden of responsibility that a complaints process would put on the shoulders of the prescriber, that's the bottom line."
Christchurch Hospital clinician and chair of the South Island Hepatitis C working group Dr Alan Pithy says he has written several prescriptions for generic medication and had not received a Medsafe letter, but he knew two colleagues who had.
One of them told him it was a bit off putting but he filled it out anyway.
"You do take responsibility when ever you prescribe something - but usually it is branded and has been through Medsafe so it is different but we're not unfamiliar with the concept of taking responsibility for prescribing."
So should all patients follow Wickens' example and try to source cheaper generic drugs from overseas?
BATTLING A DREADFUL DISEASE
Wickens did not notice the virus for the first 20 years, but by 2000 she had acquired haemachromatosis - a severe accumulation of iron in the body linked to HVC - and was exhausted.
"The exhaustion was both mental and physical it was like trying to function through a fog."
Wickens was forced to stop working due to the fatigue and she was unresponsive to treatments then available.
In March this year she turned to Freeman to help source generic treatments.
Wickens says the work Freeman did to check the drug suppliers, test the medicines and report on their efficacy with a clinical trial gave her confidence to go ahead.
Manufacturers are based in countries including India, China and Bangladesh that have not recognised the patent on the drug.
In April this year at a prestigious International Liver Conference Freeman presented data from clinical trials on the generic drugs showing they had a 90 per cent success rate.
Wickens says by day six on her treatment the viral load in her blood dropped from 1.3 million to 480. By week four the virus was undetectable.
"I have not had to have a sleep during the day for three months and am back tramping and doing more in my days than I could ever have done three months ago."
Despite her own GP's support, in the end a specialist wrote a script for Wickens.
He told her she would not need to see him again after she had taken the medication.
She also had an appointment with an Indian doctor by Skype who wrote a script required to purchase the medication there.
Four months down the track she wants others with the virus to know the generic drugs are just as good as the branded variety.
"They're not approved in New Zealand and yet it's the specialists in the field that are encouraging people to look at that for treatment for themselves so there's quite a contradiction there."
PRICED OUT OF A CURE
Cost is at the heart of the Pharmac decision, with the new HCV drugs considered to be the world's most expensive medication.
Funding for treatment of all genotypes would be "a substantial commitment of some tens of millions of dollars'', says Pharmac operations director Sarah Fitt.
"Any decision to fund a medicine depends on our ability to negotiate the best possible deal within the funding available."
Simply put, the miracle cure has been priced out of reach for most patients and many governments worldwide.
One of the drugs, Harvoni, would cost New Zealand patients up to $140,000.
The Australian Government announced a $1 billion funding deal for four HCV treatments for all patients. As a result Australian patients will pay up to $38 for a cure.
The multinational pharmaceutical companies who hold the patents including Gilead Sciences and Abbie Vie have been widely condemned by doctors, patients and politicians.
Last year Democratic presidential primary candidate Bernie Sanders even suggested the US Veterans Department should ignore the patent held by Gilead Science to access generics of the drugs.
Forensic psychiatrist and spokesman for doctors without boarders Erik Monasterio says parallel importing is a concern to the industry.
"Obviously that is one way of circumventing the very high cost of medications locally and as we know quite a few people are doing this because the cost is prohibitive."
He says the industry has lobbied governments "in different ways" to make parallel importing illegal.
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