Medsafe boosts Redemption trial in NZ generics market

This topic has 2 replies, 3 voices, and was last updated 8 years, 5 months ago by Hazel.

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11 June 2016 at 3:20 am #18860
Chapel
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- Guardian Angel
@chapel
Just reading the letter Medsafe insists NZ doctors sign for patients taking delivery of generic DAAs
http://fixhepc.com/new-zealand-redemption-etrials-process.html
In the letter, the GP is asked to confirm that “The INN (generic drug)
is sourced from either Cipla, Hepro, Mylan, Dr Reddy’s
or Natco for ClinicalTrials.gov Identifier: NCT026576941”
(Hepro should read Hetero, I suspect and the Redemption ID I found was NCT02657694)

Now, if this is the same letter for all NZ doctors, it seems to make things much harder for other generics suppliers into NZ – for example, a GP who knows the source is a Sydney chemist can hardly confirm the above, likewise for all the other well known sources.
Meanwhile, the letter has become just another step in the Redemption process for NZ patients.

M, 57, Live in Wellington,NZ.
Genotype 1a diagnosed in 2013.
Treating for the first time since October 31 with Buyers Club Sof/Led. Thanks so much guys. Minimal side effects apart from sore throat at the start..
Viral load 5.4m when treatment started, Undetected at 4 weeks, 8 weeks, End of Treatment and 12-weeks post EOT. Yay!
11 June 2016 at 6:09 am #18873
Gaj
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- Guardian Angel
@gaj
“if this is the same letter for all NZ doctors”

I suspect the question should be “Is this letter the same for all generic imports?”

But it looks to me that this letter is specific to participants in the Redemption eTrials and presumably any patient wanting to individually import (any?) generic medications outside of that trial would need their doctor to furnish an equivalent letter that stated their specific case? Perhaps one of our NZ members could check that with the relevant authorities over there on Monday?

G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
11 June 2016 at 8:51 am #18895
Hazel
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@hazel
On to it. But if that is the case, then it makes sense to me: the doctor training things we did were well received, but the thinking too seemed- once they have written script they can’t watch over the process to ensure that it IS fixhepc / Redemption, they are happy with that process but not direct internet buying.
This regulation does that for them, if that is the case, and if so sounds good. I have been building up a head of steam about the regulation change because I thought, they have had months to check out Redemption, and if it is good enough for EASL it should be for little old NZ.
Good spotting Chapel, if so, then basically Redemption is the endorsed generic pathway for all in NZ geno 2-6, and the geno 1’s that don’t want to wait.

Genotype 3 30 years, 2x treatment interferon/ribavirin non responder. Cirrhosis 17 years. Fibroscan, decompensating, 40 down to 22 by 29/3/16- now down to 6.5, normal, no cirrhosis. Started Buyers Club Sof/Dac 14 Nov 15. SVR 12 29/0716
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