NICE invites angry J&J to make a Cancer Drugs Fund case for Imbruvica

Imbruvica

Earlier this year, England’s cost watchdogs shot down chronic lymphocytic leukemia med Imbruvica for patients with certain genetic changes who weren’t a good match for chemotherapy. Now, they’re inviting maker Johnson & Johnson to make its case for inclusion on the Cancer Drugs Fund--but J&J isn’t exactly thrilled with the development.

Wednesday, the National Institute for Health and Care Excellence (NICE) asked the New Jersey pharma giant’s Janssen unit to gather further evidence on first-line use of Imbruvica in patients with the 17p deletion. It wants to see details on how it would collect data that could “address uncertainties about the clinical benefits” of the drug, as well as “any necessary commercial access agreements to reduce the overall cost” to the National Health Service, it said.

If Janssen makes a compelling argument, “conditional funding will be made available” to cover Imbruvica on the Cancer Drugs Fund while Janssen goes about gathering additional evidence and NICE continues its evaluation process, Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said in a statement. But while the invitation provides the company with a chance to nab some extra coverage, the drugmaker isn’t pleased.

“Once again, the UK lags well behind other European countries that have already opted to fund or reimburse the medicine for a patient population who have very few treatment options,” Janssen said in a statement seen by PharmaTimes, with Janssen UK managing director Mark Hicken adding that “such decisions are likely to become commonplace” now that NICE is set to decide which drugs feel the love from the special cancer fund.

Janssen isn’t the only player that’s been lashing out over the Cancer Drugs Fund changes, which are set to go into effect next month. Under the new system, products that receive a "maybe" from NICE will be considered for CDF funding while the body collects real-world efficacy data over the course of two years. The Association of the British Pharmaceutical Industry (ABPI), an outspoken critic, has claimed the move will turn the clock “back 5 years” and potentially set back patient access.

Janssen, meanwhile, is looking to Imbruvica for some major revenue help while sales of hep C med Olysio dwindle in the face of stiff new competition. And Janssen isn't the only one: AbbVie, which is fighting to build up sales around IP-threatened Humira, last year shelled out $21 billion to buy Pharmacyclics, which shares sales on the drug.

The pair did get some good Imbruvica news earlier this week, though, in the form of a first-line approval from the European Commission. That green light will widen Janssen’s patient pool and bring in patients who will stay on the drug for longer.

- read NICE's release
- get more from PharmaTimes
- see the EC approval release from Janssen

Special Reports: Top 20 orphan drugs by 2018 - Ibrutinib | The 25 most influential people in biopharma today - 2013 - Carole Longson - NICE

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