SMC welcomes Roche’s Gazyvaro but rejects Shire’s Onivyde

Patients with follicular lymphoma in Scotland have gained a new treatment option for the condition after the Scottish Medicines Consortium (SMC) published advice accepting Roche’s Gazyvaro for routine use by NHS Scotland.

Follicular lymphoma is a type of cancer of the white blood cells and the most common type of indolent non-Hodgkin's lymphoma.

Gazyvaro (obinutuzumab) has been accepted by the SMC for use alongside bendamustine chemotherapy for the treatment of patients with follicular lymphoma who don’t respond to or whose condition gets worse on other treatments.

The drug is a 'type II' anti-CD20 monoclonal antibody designed to attack blood cancers more aggressively than 'type I' treatments such as MabThera, shown in clinical trials to significantly reduce the risk of disease progression or death.

Its European approval in June last year came on the back of data showing that, in patients whose disease progressed during or within six months of prior Rituxan-based therapy, those given the Gazyvaro-based regimen experienced a 52 percent reduction in the risk of disease worsening or death compared to bendamustine alone.

Median progression-free survival was more than double that with bendamustine alone (29.2 months vs. 13.7 months), and those taking Gazyvaro also showed a 38 percent reduction in the risk of death.

"From the evidence the Committee heard from the PACE meeting, we know that this decision will be welcomed by patients and clinicians alike," said Dr Alan MacDonald, chair designate of the SMC.

The drug acceptance for use on the NHS in Scotland is dependent on the continued provision of a patient access scheme that improves the cost-effectiveness of the drug.

Onivyde rejected

Meanwhile, the cost regulator turned down Shire’s pancreatic cancer drug Onivyde in combination with fluorouracil (5-FU) and leucovorin (folinic acid) "due to a lack of robust evidence from the submitting company about the clinical benefits and value for money of the medicine when compared to other currently available treatments".

"It is disappointing that we were unable to accept liposomal irinotecan for the treatment of pancreatic cancer. While patient groups and clinicians presented a good case in the PACE meeting, the evidence provided by the company on the clinical benefits and value for money of liposomal irinotecan was not strong enough to justify making it available for routine use by NHS Scotland," said Dr MacDonald, commenting on the decision.

The National Institute for Health and Care Excellence issued draft guidance in November rejecting the drug, which costs £1,846.05 per two-week treatment cycle, after concluding that it does not fall within the range of what is normally considered cost effective for routine NHS use.