XDR-TB patients smuggle pills as treatment priced out of reach

With treatment priced out of reach, some extensively drug-resistant tuberculosis (XDR-TB) patients face a tough choice: Break the law or die.

Phumeza Tisile was cured of XDR-TB with the help os MSF-sponsored linezolid.

Phumeza Tisile was cured of XDR-TB with the help os MSF-sponsored linezolid.

During the dark days of AIDS denialism, activists smuggled antiretrovirals (ARVs) into the country in suitcases and airfreight cargo. Now, history may be repeating as some patients are looking at ways outside the law, including ordering drugs online, to fill doctors’ prescriptions as linezolid continues to cost more than R700 per daily pill. According to international humanitarian organisation Medicines Sans Frontiers (MSF), the only thing standing between South Africans and a cheaper, R80 per pill generic is the drug regulatory body, the Medicines Control Council (MCC).

By the time Andaleeb Rinquest-January was diagnosed with XDR-TB in 2011, she – and the life she once knew – were unrecognisable. As she wasted away to just 29 kgs – her once round face and rosy cheeks receded to reveal sharp cheekbones. She had so little muscle mass that she was eventually unable to receive the intramuscular injections as part of her treatment. Too sick to work, she had also lost her medical aid cover.

After Rinquest-January failed to respond to public sector treatment, a doctor suggested her family approach University of Cape Town (UCT) Private Academic Hospital specialists.

In 2011, she spent seven months at the hospital where she regained the ability to walk and talk. Although her family fundraised about R60,000 by holding events like high teas and dinners, they have been left with about R300,000 in unpaid hospital bills.

Too pricey even for medical aids?

Patients report trying to buy the cheaper generic through online pharmacies, have friends smuggle it into the country or pursue donated supplies from overseas

By the time Rinquest-January was admitted into hospital again in 2013 she had joined Discovery Health Medical Scheme. While she says the scheme covered her hospital stay, it refused to pay for more than one month of linezolid. Instead, the scheme suggested she seek public sector care, she alleges.

Pooling money and taking out loans, her family eventually raised about R150,000 to buy linezolid.

Rinquest-January recently lodged a complaint with Discovery with the help of public interest law organisation Section27, which argued that Discovery’s conduct not only violated her Constitutional Right to Health but also unfairly burdened the public health sector.

“It’s a serious problem for medical schemes to push people with the disease onto the public sector,” Section27 legal researcher John Stephens told Health-e News. “They are taking the position that they treat disease that are affordable to treat and if a patient with a more expensive disease comes along, then they can push that case onto the public sector.”

Discovery CEO Dr Jonny Broomberg confirmed that it suggested Rinquest-January get care in a specialised public health facility. He also alleged that the scheme had not been provided with the information it needed to agree to cover access to the drug for Rinquest-January.

“Our medical review team did discuss the treatment choice with the treating doctor after receiving this request,” said Broomberg. “We were however not provided with all the clinical data required to justify approval of extended treatment with Linezolid beyond the initial 28 days.”

“It’s a serious problem for medical schemes to push people with the disease onto the public sector”

According to Broomberg, additional information contained in Section27’s complaint has led its medical review team to fund Rinquest-January’s treatment and cover her outstanding claims. He added that the scheme has approved 11 of the 14 doctor’s requests for linezolid received this year.

Health-e News asked Discovery Health, the Government Employees Medical Scheme, Fedhealth and Momentum what their policies were regarding linezolid. All medical schemes noted that while they had previously paid for some patients to receive the drug, the decision to do so was taken on a case-by-case basis largely because linezolid was not considered as standard therapy as per national guidelines.

Fedhealth admitted that it evaluated all requests for linezolid on a “case-to-case basis due to the high cost of the medication”.

While linezolid is not part of South Africa’s initial standard drug-resistant TB treatment regimens, guidelines say that the drug should be considered for patients with few other options if cost permits. Most of the XDR-TB patients in a government-run programme offering patients access to a new XDR-TB drug bedaquiline are also receiving linezolid – provided their provinces can pay for it, according to data presented at the recent South Africa TB Conference.

Break the law or die

“This is medicine, not an illegal drug and it’s crazy to put patients in that situation”

While Rinquest-January may have won a small victory, she says others are still dying for the drug.

“I thought I was never going to get this drug,” she told Health-e News. “There are so many patients in the same situation.”

One XDR-TB patient who spoke to Health-e News on condition of anonymity reported trying to order generic linezolid product through online pharmacies. This shipment was stopped at customs. This patient has since received a six-month supply of the drug through a small, Western non-profit that collects unused drugs.

Similar approaches were used to get HIV treatment into South Africa when the government refused to allow antiretrovirals.

Another XDR-TB patient also said she was considering asking friends to bring the cheaper generic back from India on their next trip.

Erica Lessem works with the US-based health advocacy organiation the Treatment Action Group. She says due to the high cost of the Pfizer drug is pushing patients internationally to take risks.

“We’ve heard of patients in Eastern Europe who are having to pay out of pocket and have ordered linezolid from Canadian pharmacies,” she told Health-e News. “It’s unfairly putting the burden on patients in terms of how to understand and get treatment, and navigate the intricacies of ordering medications.”

“There are some areas in which (these ways) might not necessarily be legal so the patients has to take on a big risk,” she added. “This is medicine, not an illegal drug and it’s crazy to put patients in that situation.”

Cheaper treatment just an MCC decision away?

“No patent barriers currently exist, the actual blocking factor to more affordable access is the registration of a generic by the MCC”

In July, the MCC granted MSF special permission to import generic linezolid made by the Indian pharmaceutical company Hetero Drugs into South Africa for use in MSF programmes. The decision came after MSF was able to successfully argue that the brand name drug’s cost was a barrier to health for South Africans.

From George in the Western Cape and with only hospital cover, Morgan Scholtz has also been forced to buy the medication monthly at R 12 000. He says his doctor has begun the months-long process to apply to the MCC for similar access to the drug.

“My family can’t keep paying that kind of money,” Scholtz told Health-e News.

Pfizer holds two patents on linezolid in South Africa – both of which have technically lapsed, according to MSF Advocacy Campaign Officer Julia Hill.

“Both of these patents have lapsed, meaning the Pfizer has not paid its annual renewal fees – in this case – for several years,” Hill said. “In the case of linezolid, since no patent barriers currently exist, the actual blocking factor to more affordable access is the registration of a generic by the MCC.”

“The same generic linezolid product that MSF has permission to use in Khayelitsha…was submitted to the MCC for full registration in South Africa, and fast-tracked for expedited registration over one year ago,” she added. “The deadline of nine months has now passed, with no decision reaching (generic drug maker) Hetero (Drugs), to our knowledge.” – Health-e News Service.

Edited versions of this article first appeared in the 2 October editions of  the Cape Times, The Star and The Mercury newspapers. The article was also published in the 8 October edition of the Daily News newspaper.

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