In the last blog reference was made to the failed 2014 PBAC submission, simply because I could not find the PBAC outcome. Somebody has been kind enough to flag my attention to the PBAC 2015 recommendation papers which you can read here:
- http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2015-03/sofosbuvir-sovaldi-psd-03-2015
- http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2015-03/harvoni-ledipasvir-sofosbuvir-psd-03-2015
Sadly the original analysis still largely holds. In no particular order, here are some key points for patients to consider.
Rationing
Treatment criteria: Must be treated in an accredited treatment centre.
So the same Hep C clinic waiting list system will continue.
Patient Treatment Targets
6.26 The PBAC recalled that for the submissions for boceprevir and telaprevir the ICER range presented for a time horizon of 30 years was $15,000/QALY – $45,000/QALY. The PBAC noted, though the prevalent CHC population was approximately 230 000 patients, that approximately 60 000 patients could be treated within the estimated health system capacity over 5 years
Here is a table of the targets:
|
Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
|
6,600 |
9,900 |
15,000 |
15,000 |
15,000 |
With over 10,000 new infections a year we don't even make headway until year 3 at which stage we will only be reducing the number of people with Hep C by 5,000 a year.
Harvoni will only be for GT1 and for all other Genotypes Sovaldi is approved for use with PEG/Ribavirin or Ribavirin
The proposed treatment regimens for patients with different genotypes
|
Genotype |
Treatment duration |
Treatment regimen |
|
Treatment-naïve (no prior treatment with interferon) |
||
|
1, 4, 5, 6 |
12 weeks |
SOF12 + PR12 |
|
2 |
12 weeks |
SOF12 + R12 |
|
3 |
12 weeks |
SOF12 + PR12 |
|
24 weeks |
SOF24 + R24 |
|
|
Treatment-experienced (prior therapy with an interferon based regimen) |
||
|
2 |
12 weeks |
SOF12 + R12 |
|
3 |
12 weeks |
SOF12 + PR12 |
|
24 weeks |
SOF24 + R24 |
|
Price
Although PBAC have redacted some numbers they have not redacted enough:
1.1 Taking account of the proposed drug prices, treatment targets in the Fourth National Hepatitis C Strategy and assuming that care continues to be delivered through specialist treatment centres, DUSC estimated the following number of patients of all genotypes would be treated over the first five years of listing at a net cost to the PBS/RPBS of approximately $3 billion over five years.
Over 5 years, it is estimated that approximately 61 500 patients would be treated….
So the whispers of France's 41,000 ($65,000 AUD) price appear correct – it's at least $50k a patient to take 61,500 over 3 billion.
Patient Subsidy Scheme
Here's a thought.
Rather than fund this through the PBS if the government gave patients $1/2 a billion in direct subsidies (@$2000/head) we could treat everyone in the community using generic imports and GPs to make it happen. At that point we would have effectively no hep C in the environment, new infection rates would fall towards zero because IVDUs would struggle to find an infected needle to share, and as a country we would be $2.5 billion dollars better off.
We could almost put an end to Hep C by this time next year.
We should have massive factories making this stuff and distribute it like polio vaccine – to everyone, everywhere.
How about it Malcolm? Now that would really be leadership…
