Cost regulators for treatments used by the NHS in England and Wales have published three sets of final guidances giving routine access to new options for lung cancer, rheumatoid arthritis and hepatitis C, and one rejecting a new therapy for melanoma.
AstraZeneca's Tagrisso (osimertinib) has been recommended as an option for use wihin the Cancer Drugs Fund for treating locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer in adults whose disease has progressed after first-line treatment with an EGFR tyrosine kinase inhibitor.
Every year in the UK, more than 45,500 people are diagnosed with lung cancer. About 87 percent of cases are NSCLC, and around 12 percent of people with NSCLC have tumours with EGFR mutations. Most patients with EGFR mutation-positive NSCLC develop resistance to existing targeted therapies (EGFR TKIs) because of a secondary mutation called T790M, and typically relapse after around one year of treatment, highlighting the urgent need for new treatment options.
UCB Pharma's TNF inhibitor Cimzia (certolizumab pegol) has been backed by the National Institute for Health and Care Excellence in combination with methotrexate as an option for treating active, severe rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other disease-modifying antirheumatic drugs (DMARDs) including at least 1 tumour necrosis factor‑alpha (TNF‑alpha) inhibitor.
As a monotherapy, Cimzia is recommended as an option for treating active, severe rheumatoid arthritis in adults whose disease has responded inadequately to, or who cannot tolerate, other DMARDs including at least 1 TNF‑alpha inhibitor.
The cost watchdog also published final guidance endorsing Merck, Sharp & Dohme's Zepatier - a once-daily, fixed-dose combination tablet containing elbasvir (50mg) and protease inhibitor grazoprevir (100mg) - as an option to treat chronic hepatitis in adults with genotypes 1a, 1b or 4.
The appraisal committee concluded that all incremental cost effective ratios for the therapy were below £20,000 per QALY gained, regardless of genotype, treatment history or cirrhosis status, and could therefore be considered a cost-effective use of NHS resources.
On the down side, it issued a final 'no' to funding for Roche's Cotellic (cobimetinib) with Zelboraf (vemurafenib) for people with advanced BRAF V600 mutation-positive melanoma that has spread and can't be surgically removed, after concluding that it would not represent a cost-effective use of resources.
Cotellic is an inhibitor of MEK 1 and MEK 2 kinases, while Zelboraf is an inhibitor of the BRAF protein. The BRAF protein and MEK 1 and 2 kinases are part of the same cell signalling pathway, and inhibiting these proteins stops proliferation and survival of melanoma cells.
NICE said its committee agreed that the combination offers life-extending benefit compared to Zelboraf alone but that, at a likely incremental cost-effectiveness ratio of more than £100,000 per QALY gained, is simply too expensive when compared to alternative treatments.