A draft guidance issued by the National Institute for Health and Care Excellence (NICE) rejected use of Merck's programmed death-1 inhibitor pembrolizumab (Keytruda) in patients diagnosed with non-small cell lung cancer (NSCLC).
A draft guidance issued by the National Institute for Health and Care Excellence (NICE) rejected use of Merck Sharpe & Dohme (MSD)’s programmed death-1 inhibitor pembrolizumab (Keytruda) in patients diagnosed with non-small cell lung cancer (NSCLC), citing lack of robust information on long-term benefits of the treatment. The National Health Service (NHS) is bound to use NICE guidance as soon as it is published.
MSD’s submission to NICE assumed that patients would stop taking the drug at 2 years following treatment initiation if their disease had not progressed—an assumption that NICE disagrees with. This, the appraisal committee pointed out, would make the drug cost-ineffective.
“Even when making assumptions about the value of using pembrolizumab beyond 2 years, our lowest estimates showed it would be over the range of what we normally consider cost-effective,” according to professor Carole Longson, director of the center for health technology evaluation at NICE. Their calculations project that the incremental cost-effectiveness ratio for pembrolizumab would exceed £50,000 per quality-adjusted life years (QALY) gained. QALY calculations consider both, the length of years added to a patient’s survival and the person’s quality of life during those years.
The company is disappointed with the decision, as was Bristol-Myers Squib, whose nivolumab (Opdivo) received similar treatment from NICE at the end of last year. “This initial consultation document from NICE is very disappointing and we are working with both NICE and NHS England to ensure we can find a solution to get back on track and make sure this much needed treatment option is made available to people with previously treated advanced NSCLC as quickly as possible. This is particularly important as these patients have a very poor prognosis, with limited time,” said Louise Houson, UK managing director, MSD.
Going by the listed price of pembrolizumab in the United Kingdom, an average course of treatment would be about £29,114 ($37,382). Currently, the drug is approved for treatment of patients with NSCLC whose disease has progressed on chemotherapy. Also, not being cost-effective also means that pembrolizumab cannot be included in the list of drugs provided under the Cancer Drugs Fund, which was recently revived.
MSD had made pembrolizumab available for use as a second-line agent in 140 patients diagnosed with NSCLC, prior to its European approval, via UK’s Early Access to Medicines Scheme. With the new decision by NICE, patients can no longer access the drug.
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
Read More
Government agencies have created an online portal for the public to report potential anticompetitive practices in health care; there are changes coming to the “boxed warning” section for chimeric antigen receptor T-cell therapies (CAR T) to highlight T-cell blood cancer risk; questions about the safety of obesity medications during pregnancy have arisen in women on them who previously struggled with fertility issues.
Read More
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
Listen
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Pegcetacoplan for PNH More Cost-Effective Than Anti-C5 Monoclonal Antibodies
April 18th 2024A cost-utility analysis conducted from the perspective of the Italian health system found that pegcetacoplan was more effective and less costly than 2 complement 5 (C5) inhibitors for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Read More