NICE – U.K. cost gatekeeper gives thumbs-up to Gilead’s Zydelig for CLL

Good news for leukaemia patients, but bad news for the health services as a whole. Treatments are post-coded and regionalised, and these new treatments are usually expensive. Given the current finances of the different UK Health Services, we are going to see more and more covert rationing (restrictions on Hearing Aids, perhaps one lens for glasses, and only one hip? (hop!). Read the NICE statement

Emily Waaserman for “FiercePharma” September 24th 2015 reports: U.K. cost gatekeeper gives thumbs-up to Gilead’s Zydelig for CLL (Chronic Lymphocytic Leukaemia)

Gilead Sciences ($GILD) has been working hard to build momentum for its cancer fighter Zydelig (idelalisib), racking up approvals for the drug in the U.S. and Europe. Fortunately for the company, a pricing setback in Germany didn’t signal disaster elsewhere; after some initial skepticism–and a discount offer from Gilead–the U.K.’s cost watchdog gave its thumbs-up to the drug for chronic lymphocytic leukemia (CLL).

The National Institute for Health and Care Excellence (NICE) in final draft guidance recommended Zydelig in combination with Roche’s ($RHHBY) Rituxan. The green light covers the combo for previously untreated adults with CLL who have a specific genetic mutation, and patients whose cancer came back less than two years after treatment.

NICE earlier this year asked the company for more information about Zydelig’s cost-effectiveness, and Gilead responded with new stats and a discount to the drug’s £37,922-per-year ($57,717) price tag. The cost watchdog is staying mum on the exact size of the discount, but says it is “delighted” that Gilead followed its recommendations, NICE director Carole Longson said in a statement.

“For people whose cancer has returned less than two years after their last treatment, their options are currently limited. With this new positive recommendation, the NHS will have another clinically effective option for treating adults with chronic lymphocytic leukemia,” Longson said.

Meanwhile, Gilead is doing everything it can to set Zydelig apart from its competition–and pricing plays heavily into that plan. The company priced the drug in the U.S. slightly slower than its head-to-head competitor, Johnson & Johnson’s ($JNJ) Imbruvica, at $7,200 for the former compared with $8,200 for the latter.

And a recent string of approvals could move Gilead closer to achieving blockbuster sales for the med, which some analysts expect to rake in $1.2 billion by 2020. Others predict even faster growth, with $1.5 billion in sales by 2017.

Zydelig was approved by the FDA in 2014 to treat relapsed CLL and two types of non-Hodgkin’s lymphoma. But regulators slapped the drug with a black box warning to highlight serious risks including potentially fatal liver problems. Imbruvica’s label does not carry the same warning. EU authorities last year also signed off on Zydelig to treat adults with CLL who have a specific genetic mutation and who’ve had at least one prior therapy, as well as patients with follicular lymphoma who have not responded to two previous treatments.

But in January Gilead faced a setback for Zydelig in Germany, as the country’s notoriously strict price watchdog, IQWiG, found that the drug has no added benefits for patients with CLL compared to other therapies on the market.

and Walesonline reported 4 days later: New drug set to be made available for adult leukaemia patients in Wales

Oliver Moody in The Times reported on new treatment for Chronic Myeloid Leukamia 2nd September 2015: New treatments boost chances of beating leukaemia

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This entry was posted in A Personal View, Commissioning, Good News, Post Code Lottery, Rationing, Stories in the Media on by .

About Roger Burns - retired GP

I am a retired GP and medical educator. I have supported patient participation throughout my career, and my practice, St Thomas; Surgery, has had a longstanding and active Patient Participation Group (PPG). I support the idea of Community Health Councils, although I feel they should be funded at arms length from government. I have taught GP trainees for 30 years, and been a Programme Director for GP training in Pembrokeshire 20 years. I served on the Pembrokeshire LHG and LHB for a total of 10 years. I completed an MBA in 1996, and I along with most others, never had an exit interview from any job in the NHS! I completed an MBA in 1996, and was a runner up for the Adam Smith prize for economy and efficiency in government in that year. This was owing to a suggestion (St Thomas' Mutual) that practices had incentives for saving by being allowed to buy rationed out services in the following year.

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