An Umhlanga woman (53) is battling cancer and bureaucracy in attempts to acquire medication that might save her life.
Ina Requilet has an aggressive mutation of colorectal cancer and despite having already undergone radiation and 12 sessions of 48-hour chemotherapy, reports News24, the disease is spreading to her uterus, pelvic area, bones, spine and liver.
And while she has faith that access to one pill will allow her to see her four grandchildren grow up, red tape means she is unable to access the drug she believes might treat her cancer, which doctors say is likely to kill her in the next two years.
Her oncologist, Dr Lucille Heslop, said studies have shown that targeting this mutation is more effective than chemotherapy, but needs to be initiated as soon as possible.
While the drug, Encorafenib, is not registered in SA, it had been tested and proven – in phase 3 studies – to be superior in terms of the objective response rate as well as overall and disease-free survival, she said.
This when used in combination with another targeted drug, Erbitux, which is registered and already approved by Requilet’s medical aid.
Pfizer, which manufactures and markets Encorafenib, has agreed to provide the drug free on an expanded access programme – reserved for people suffering from a serious or life-threatening disease with no viable treatment options available to them.
“But to import the drug we need a SAHPRA (South African Health Products Regulatory Authority) approval Section 21 number … for it to clear customs to be allowed into this country,” Heslop said.
Two applications have been made to SAHPRA, both of which have been rejected.
“Despite six emails from me – with supportive documents to show it is registered in the US; that the company is providing the drug with patient, doctor and company consent, and all of the supporting studies – SAHPRA has failed to respond. A separate appeal submitted with the recent scan (demonstrated) the rapid disease progression,” Heslop added.
She said SAHPRA’s telephone lines are non-functional and email submissions go unanswered.
“There are other doctors with patients waiting for the same drug with no joy – although one patient apparently received SAHPRA approval about 18 months ago.”
SAPHRA spokesperson Madimetja Mashishi told News24 that Heslop had submitted two Section 21 applications for Encorafinib, both of which were rejected.
This was because SAHPRA Border Medicines Control previously found that the Encorafinib was brought in as clinical trial material for patients authorised under Section 21.
“This was not in accordance with the motivation for the application being access programme based,” he said.
While an application was approved to import a registered drug 18 months ago, SAHPRA denied the release of the imported material, saying it was not the medicine registered in another jurisdiction but clinical trial material.
“If the unregistered medicine is being brought into SA as clinical trial material, then a clinical trial application must be submitted to us for authorisation. Alternatively, the patient and importer should import a medicine already registered in another jurisdiction in line with their application and motivation.”
Mashishi said SAHPRA had yet to receive an application for marketing authorisation from Pfizer for Encorafenib, registered under the brand name Braftovi in certain markets.
“SAHPRA is engaging Pfizer in relation to this patient’s situation… and providing guidance on the documents required for motivation. Should the requirements for a named-patient Section 21 authorisation be met, we will review the case within three days of receipt of all required information.”
A decision to authorise or deny a request is made on a case-by-case basis, taking into consideration the nature of the unmet medical need, the availability of marketed alternatives, and the information provided in support of the request regarding the use, safety, efficacy and quality of the medicine, Mashishi said.
See more from MedicalBrief archives:
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Lorlatinib a potential first-line option for ALK-positive lung cancer patients
More younger people being diagnosed with colorectal cancer
Local drugmakers must move to top of registration queue – SAHPRA