A milestone day for patients with confirmation the Pharmaceutical Benefits Advisory Committee recommended breakthrough therapies for hepatitis C and melanoma at its March meeting. Also, a fascinating outcome on biosimilars with Lilly's insulin glargine.
Publication of outcomes from the March meeting has confirmed that the PBAC recommended MSD's much-anticipated PD-1 antibody KEYTRUDA (pembrolizumab) for the treatment of advanced melanoma.
According to the outcomes statement, the PBAC recommended KEYTRUDA under a managed entry scheme with treatment limited to patients who have not been exposed to Bristol-Myers Squibb's YERVOY (ipilimumab).
"The PBAC considered that based on the early data provided, pembrolizumab appears to be more effective than ipilimumab, but the magnitude of this benefit is uncertain, particularly for overall survival," it says.
The PBAC did express concern over a "mismatch between the sponsor’s data and public expectations of the drug", based on patient group testimony at the March meeting's consumer hearing.
Reflecting comments made by the PBAC earlier this week at the Senate inquiry into access to cancer medicines, the outcomes statement said: "...patient groups indicated that they believed the response rate with pembrolizumab was 90% rather than 33% to 37% as reflected in the data presented by the sponsor, with consumers also considering that the response to pembrolizumab is durable and sustained."
The detailed conditions remain unclear, however, the outcomes statement says the PBAC recommended a "listing via a managed entry scheme (MES) to be made transparent to affected patients, prescribers and competing companies."
"The sponsor has provided reassurances that more robust evidence will be forthcoming in the foreseeable future to better inform its modelling, and the PBAC has proposed a plan to review this evidence in the near future. Should the modelled extent of benefits not be realised, the Committee has recommended measures to minimise risk of unjustified health care expenditure," it says.
Dr Susanne Fiedler, MSD Managing Director, welcomed the outcome, saying the importance of KEYTRUDA for many patients with advanced melanoma was well recognised and that the company looked forward to confirmation of a PBS listing in the near future.
“We know that many patients with advanced melanoma are anxiously waiting for access to KEYTRUDA and we stand ready to provide the medicine at the earliest opportunity,” Dr Fiedler said.
MSD thanks the PBAC for reviewing data from the KEYNOTE 006 trial that compared KEYTRUDA to ipilimumab and acknowledging the superiority of KEYTRUDA in treating advanced melanoma.
“We will continue working with the Department to ensure the significant benefits and value offered by KEYTRUDA over the current standard of care are available to patients through this listing,” Dr Fiedler added.
The outcomes also show that the PBAC recommended new hepatitis C therapies, including Gilead's SOVALDI (sofosbuvir) and HARVONI (ledipasvir with sofosbuvir), along with Bristol-Myers Squibb's DAKLINZA (daclatasvir dihydrochloride). It rejected BMS' SUNVEPRA (asuneprevir).
According to the outcomes, "The PBAC noted that there was a prevalent population of approximately 230,000 patients with CHC in Australia. The estimates of the number of patients treated with the availability of an all oral interferon free treatment, presented by the DUSC, indicated that approximately 62,000 patients could be treated in the next years. Treating this range of patients, the PBAC noted that at the price submitted by the sponsor, the proposed budget impact was exceeding $3 billion over 5 years."
In a statement, Gilead welcomed the recommendation, noting that HARVONI is currently under evaluation by the Therapeutic Goods Administration and is not yet approved for use in Australia.
"While discussions with the Department of Health to finalise the listing of SOVALDI are ongoing, Gilead will continue to offer a Patient Access Program which provides SOVALDI at no cost to patients with an urgent medical need. For all other patients SOVALDI can be prescribed by a physician in line with the approved Product Information. Ledipasvir/sofosbuvir is not yet approved by the TGA but approval is anticipated mid-year," the company said in a statement.
“SOVALDI is recognised in all major guidelines as a treatment for hepatitis C," said Mr Rob Hetherington, General Manager of Gilead Sciences ANZ. "In these guidelines, following treatment with sofosbuvir-based regimens, the majority of chronic hepatitis C patients can be cured in as little as 12 weeks eliminating the lifetime burden of treating a chronic disease for both patients and the healthcare system.”
“We are pleased that the PBAC recognises the clinical value of treatment with sofosbuvir-based regimens,” said Mr Hetherington. “The PBAC’s positive recommendation is the first step in the process to obtain a PBS listing.”
He continued, “We are committed to working with the relevant government departments, to ensure an agreement is reached as quickly as possible for the benefit of patients.”
The outcomes also show the PBAC decision on Amgen's cholesterol-lowering biologic REPATHA (evolocumab) is not being made public pending finalisation of TGA approval.
Biosimilars also featured in the outcome, with Lilly's insulin glargine recommended on a cost-minimisation basis to Sanofi's LANTUS.
Interestingly, the outcomes statement does not reveal whether the PBAC recommended it be 'a' flagged and treated as a substitutable generic, immediately raising speculation that it has.
"The Minister requested the advice of the PBAC on the marking as equivalent (i.e. “a” flagging) in the Schedule of Pharmaceutical Benefits of the insulin glargine products, Basalgar and Lantus. The advice is not being published at this stage," the statement says.
Health Minister Sussan Ley told the recent Medicines Australia annual parliamentary dinner that recommendations from the March PBAC meeting represented $2.5 billion in new PBS spending.
