SMC okays Novartis’ Jakavi as competition looms

Novartis’ Jakavi will be available to patients in Scotland with the bone marrow cancer myelofibrosis after a positive verdict from the Scottish Medicines Consortium (SMC).

Jakavi (ruxolitinib) is the only licensed oral treatment for myelofibrosis in the UK but was turned down in guidance issued by the National Institute for Health and Care Excellence (NICE) in 2013 on the grounds that it was not cost-effective.

It is currently available to patients in England through the Cancer Drugs Fund (CDF) – surviving the recent cull of CDF-supported medicines – but Novartis remains hopeful that NICE will support the drug when it re-evaluates its guidance for the drug later this year.

“Given that longer term data are now available, which include survival data, Novartis is hopeful that NICE will consider ruxolitinib favourably in line with today’s SMC recommendation,” said the company in a statement.

Jakavi is an inhibitor of JAK1 and JAK2, originally developed by Incyte of the US – and was approved for myelofibrosis in the EU in August 2012. Its indications were recently expanded in the US to include the rare blood cancer, polycythemia vera, which analysts have predicted could drive sales to more than $1 billion a year from its 2014 level of a little over $630 million.

Novartis has marketing rights to the drug outside the US and recorded sales of just under $280 million last year.

Jakavi could also face competition in the near future in the US, however, after a rival JAK-targeting drug from CTI BioPharma and partner Baxter showed promising activity in a phase III trial.

CTI reported that pacritinib reduced spleen volume in myelofibrosis patients better than best-available therapy (which did not, however, include Jakavi) in the PERSIST-1 study, including patients with low platelet counts (thrombocytopenia).

A second pivotal trial called PERSIST-2 is due to report data later this year and will allow a direct comparison with Jakavi, setting up a possible regulatory filing in 2015.

Jakavi (sold as Jakafi in the US) is known to cause reductions in platelets in some patients, and CTI believes pacritinib’s activity regardless of platelet status could give it an edge in the market. Baxter licensed rights to pacritinib in 2013 in a deal valued at up to $272 million.

SMC backs six more drugs

In addition to Jakavi, the SMC gave its blessing to six other medicines, including Hospira’s Inflectra and Celltrion/Napp’s Remsima, two biosimilar versions of Johnson & Johnson’s Remicade (infliximab) for rheumatoid arthritis, psoriatic arthritis, psoriasis and inflammatory bowel disease.

The cost watchdog also backed GlaxoSmithKline’s Tafinlar (dabrafenib) for certain types of melanoma that cannot be treated with surgery or have spread to other parts of the body, and Gilead Sciences’ chronic lymphocytic leukaemia (CLL) therapy Zydelig (idelalisib).

Gilead also secured a positive verdict for its combination hepatitis C virus (HCV) product Harvoni (sofosbuvir/ledipasvir) in patients with genotype 1 and 4 infection, while Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) got a green light for the treatment of deep vein thrombosis and pulmonary embolism (DVT/PE) as well as prevention of recurrence.

There was bad news, however, for Swedish Orphan’s Cometriq (cabozantinib) for a rare form of thyroid cancer, which did not make the cut because of unanswered questions regarding its clinical benefits and tolerability.

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