Hep C centre sufferers to lose access to lifesaving drugs

The closure of a Dunedin Hepatitis C resource centre may mean local patients will no longer be directed to overseas drug buying clubs to access necessary medicines.

The local centre provides a range of services to patients who have contracted Hepatitis C, including facilitating access to overseas buyer’s clubs which provides cheaper generic copies of experimental medicines.

The Ministry of Health has not renewed the contract held by the centre, in favour of funding a centralised approach to managing Hepatitis C throughout the South Island. The South Island Alliance, an organisation comprising of five district health boards, has acquired the contract to manage Hepatitis C. 

According to Allison Beck, a peer-based educator for the Dunedin Hepatitis C Resource Centre, the South Island Alliance is unlikely to encourage patients to look overseas in order to buy their medicines, meaning many could be stuck using outdated and ineffective drugs currently supplied in New Zealand. 

“In New Zealand is a situation where PHARMAC won’t fund the top brand [drugs] and they cannot fund the generic [copies], for legal reasons, so we’ve got a population heading into end stage liver disease whose only hope is the purchase through the buyer’s club.”

The South Island Alliance were unavailable to comment on whether they would direct patients towards overseas drug buyer’s clubs under their new contract. However, due to the group comprising of district health boards, it is unlikely they would engage in the practice.

For a Hepatitis C sufferer located in New Zealand the only medicine readily available at an affordable price that is currently subsidised through PHARMAC – New Zealand’s drug buying mechanism which supplies subsidised medicines to the public health system – are weekly injections of pegylated interferon and a twice-daily tablets of ribavirin. 

According to Margaret Fraser, a Clinical Nurse specialist at the Dunedin gastroenterology department, current treatments of pegylated interferon and ribavirin are “ineffective”.

“[Pegylated interferon and ribavirin] have around a 50 percent success rate, and as low as 10 percent in patients who have advanced liver failure. I would say the [treatment] is relatively ineffective.”

In the recent years a number of developmental drugs have become available to patients suffering from Hepatitis C; sofosbuvir, lepdispavir or declatasvir have all been clinically proven to be effective against Hepatitis C. 

However, the patents for sofosbuvir, lepdispavir, or declatasvir are held by an American biopharmaceutical company called Gilead Sciences, who so far have received negative media attention for the obscene prices of the medicines. The current market price of lepdispavir-sofosbuvir, branded by Gilead Sciences as Harvoni, can cost up to US $84,000 for a 12 week regime or as much as $1000 per pill.

PHARMAC does not currently fund sofosbuvir, lepdispavir or declatasvir and were unable to disclose what priority they were on the pharmaceutical schedule, or if they would be funded in the future due to “commercial sensitivity”. 

However, lepdispavir with sofosbuvir or Harvoni has been reviewed and subsequently recommended for purchase by the Pharmacology and Therapeutics Advisory Committee (PTAC), the official advisory committee to PHARMAC. 

The minutes from a May 2015 PTAC meeting shows that the committee does recommend the purchase and supply of Harvoni to urgent cases of Hepatitis C or pre and post liver transplants caused by Hepatitis C. 

As many patients are unable to afford the branded versions of the pharmaceuticals, a drug buyer’s club operating in Australia has been facilitating supply of generic forms of sofosbuvir, lepdispavir or declatasvir. The buyer’s club, managed out of an online general practitioner’s office called GP2U, is allowing patients access into markets where patents held by large pharmaceutical companies are not recognised, allowing the drugs to be deconstructed and remade in a generic form and then sold at a fraction of the original price. 

According to Dr James Freeman, founder of GP2U, the purpose was to find a “loophole” which allowed patients access to the drugs at an affordable price, rather than attempt to lobby Gilead Sciences who is using “monopoly power” to unfairly elevate the price of the drugs.

“In essence we looked at the legal landscape and said Gilead [Sciences] is using monopoly power to demand high prices. Rather than get mad we looked for loopholes to allow patients to get even.”

GP2U assists patients who wish to take the medications which so far has proven to be effective against Hepatitis C, according to Dr Freeman.

“The [buyer’s] club simply assist the patient in having a medical consultation with a doctor in India, who writes a local script, which is then used to source medications within the licence territory (India) which then conveniently falls into a FedEx box exiting India on the Indian prescription and entering NZ on the New Zealand prescription.” 

“The Buyers Club does not source any of [the drugs], it simply acts in the role of a guide or agent to assist the patient to source the medications. Splitting hairs perhaps but it is the difference between illegal and legal,” says Dr Freeman.

This article first appeared in Issue 8, 2016.
Posted 10:25am Sunday 24th April 2016 by Henry Napier.