Sofosbuvir With VelpatasvirEPCLUSA
Not recommended Infectious diseaseRestricted 💬 consumer voice
Treatment of chronic hepatitis C virus infection (all genotypes 1, 2, 3, 4, 5 or 6).
2
Submissions
1 resub
2016–17
On the record
—
ICER range
Not modelled
Cost basis
Access path
- TGA registered · EPCLUSA
TGA label equal than the PBS population
- Nov 2016Recommended · restricted
vs Ledipasvir/sofosbuvir, daclatasvir plus sofosbuvir…
- Jul 2017Not recommended
Comparator changed: Ledipasvir/sofosbuvir, daclatasvir plus sofosbuvir, sofosbuvir plus…
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC confirmed its previous advice for sofosbuvir with velpatasvir with regards to interchangeability on an individual patient basis under Section 101(3BA) of the National Health Act 1953, with the following: ledipasvir with sofosbuvir, and paritaprevir with ritonavir with ombitasvir and dasabuvir +/- RBV for genotype 1 (GT1) CHC; sofosbuvir in combination with RBV for genotypes 2 (GT2) and 3 (GT3) CHC; daclatasvir and sofosbuvir for GT3 …PSD · Jul 2017
6.2 The PBAC also recalled that at its July 2016 meeting it advised that grazoprevir with elbasvir should be treated as interchangeable on an individual patient basis with ledipasvir with sofosbuvir, and paritaprevir with ritonavir with ombitasvir and dasabuvir +/- RBV when used in the treatment of GT1 CHC.PSD · Jul 2017
Economic analysis
6.34 The submission presented a cost-minimisation analysis based on published prices.PSD · Nov 2016
The PBAC noted that the department would need to conduct an alternative cost- minimisation analysis on the basis of the effective prices for the regimens included in the General Statement, compared with the regimen approved by the TGA for sofosbuvir/velpatasvir FDC.PSD · Nov 2016
Clinical claim
Table 13: Summary of the clinical claims made in the submission of sofosbuvir/velpatasvir FDC (12 weeks) versus the nominated comparators across the various subgroups HCV Clinical claimPSD · Nov 2016
Consumer comments
6.2 The PBAC noted and welcomed the input from individuals (3) and organisations (10) via the Consumer Comments facility on the PBS website. The comments described how this drug will improve cure rates, reduce treatment duration and offer simpler administration with fewer side effects. The simplified administration, and the fact that this drug can be used against all genotypes, may result in more prescribing by GPs.PSD · Nov 2016
The comments also noted that this drug would provide an interferon-free treatment option for some patients with genotypes 4-6.PSD · Nov 2016
Financial management – risk sharing
6.40 The PBAC recommended that sofosbuvir/velpatasvir FDC enter the Risk Sharing Arrangement (RSA) currently in place for other drugs used for the treatment of CHC, and be subject to the same Subsidisation Caps and rebate arrangements.PSD · Nov 2016
Cost-effectiveness
This is a minor submission regarding interchangeability advice under Section 101(3BA); no economic evaluation was conducted.
The PBAC considered that, for the purposes of providing advice under Section 101(3BA) of the Act, therapies with comparative health outcomes at the population level do not need to be identical with regards to patient-specific considerations, as these factors are a clinical practice decision taken into account when selecting the appropriate treatment for an individual patient. PBAC · 2017
Economic model disputed
Decision context
PopulationAdults with chronic hepatitis C virus infection of any genotype (1–6).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Not recommended | ledipasvir with sofosbuvir, paritaprevir with ritonavir with ombitasvir and dasabuvir +/- RBV, sofosbuvir in combination | — | Other |
| Nov 2016 | Recommended · restricted | Ledipasvir/sofosbuvir, daclatasvir plus sofosbuvir, sofosbuvir plus ribavirin, sofosbuvir plus peginterferon alfa-2a and | — | RCT · SVR12 |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ASTRAL-1 | Ph 3 | 741 | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Disconti… | completed |
| ASTRAL-2 | Ph 3 | 269 | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Disconti… | completed |
| ASTRAL-3 | Ph 3 | 558 | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Disconti… | completed |
| ASTRAL-4 | Ph 3 | 268 | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Disconti… | completed |
| ASTRAL-5 | Ph 3 | 107 | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuatio… | completed |
Consumer voice
Consumer input from 3 individuals and 10 organisations described how this drug will improve cure rates, reduce treatment duration, and offer simpler administration with fewer side effects. Organizations emphasized the importance of ensuring broad GP prescribing access, interferon-free treatment options for all hepatitis C patients, and multiple treatment options for each genotype.
The comments described how this drug will improve cure rates, reduce treatment duration and offer simpler administration with fewer side effects. Consumer comments · PSD
treatment efficacytreatment burdenside effectsaccess barriersunmet needsimplified administration
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify treatment of chronic hepatitis C (all genotypes 1–6) with no additional population restrictions.