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NICE wants to stop saying ‘no’ – but needs pharma’s co-operation

Suggests Orkambi row has undermined confidence in NICE process

England’s cost effectiveness watchdog NICE can shift away from its current default of starting with a ‘no’ to new drugs, and then negotiating a deal with pharma companies – but requires greater co-operation from industry, according to its chief executive.

Speaking at the international pharma conference eyeforpharma Barcelona last week, NICE’s chief executive Sir Andrew Dillon struck a conciliatory note with his audience, making it clear he understood the sector’s need to provide shareholders with a return on investment on novel medicines.

However, he cautioned that industry, healthcare payers and health technology assessment (HTA) authorities like NICE needed to do more to achieve ‘alignment’ on value, evidence and price for the sake of patients.

Dillon Barcelona

Sir Andrew Dillon addresses the eyeforpharma Barcelona conference

Praising the industry as "pulsating with some really fantastic science” including groundbreaking products which offer a cure for the first time, Dillon also noted:

“I'm not sure health systems around the world are prepared and I’m not sure either that you as an industry have thought enough about how to work with your customers [on these products].”

He says that NICE’s closer working with NHS England, the budget holder for the country’s specialised medicines, has helped create a more joined-up market access system for the industry.

Recent examples of this include rapid pricing deals on the two CAR-T therapies, Novartis’ Kymriah and Gilead’s Yescarta.

However, even in these cases NICE started off with a draft appraisal rejecting the drugs as not cost effective. This is seen by both sides as a formality, which allows the next stage of pricing and access talks to begin – but finding a way to eliminate this initial rejection is seen as the next goal for NICE.

“We want to turn that round so that by having conversations as early as possible, we can resolve much of the uncertainty around the evidence base,” he said.

“We can start wherever necessary to put the bones of an agreement in place, to enable the rest of the NICE appraisal process to move through as smoothly as possible.”

Dillon added that important factors in achieving this was a common view on value assessment and agreement on what the additional therapeutic benefits of a treatment are. Add to this openness and flexibility on accommodating uncertainties and risk-sharing, and he says discussions can proceed much more easily.

The industry audience raised questions about NICE and NHS England’s long-running dispute with Vertex over its cystic fibrosis drug Orkambi, which is still not resolved after three years of appraisals and negotiations.

Dillon said Orkambi was an exception to the industry norm, echoing remarks he made earlier this month at a parliamentary hearing. Not retreating from his earlier claims that Vertex had been exceptionally ‘inflexible’, he warned that patient group confidence in NICE process had been eroded by this row.

“I think you [the industry] and organisations like NICE have a responsibility to foster a relationship that generates confidence among patient groups so that they believe that this isn't just a row that goes on until one side blinks, but that there's a constructive, repeatable approach."

For its part, Vertex has counter-claimed that NICE's process and NHS England have been inflexible. While this row has been exceptional, this view has also been expressed elsewhere in the industry, and highlighted in a recent report by Map BioPharma.

Dillon expressed optimism about NICE and the industry being able to work more closely together, and said NHS England’s emergence as the primary market access negotiator had helped generate “ever more complicated, arrangements for sharing financial risk”.

Nevertheless, he said there remained a need for a more comprehensive solution to the challenges being presented by the new generation of medicines. This includes cell and gene therapies such as Novartis’ late-stage candidate Zolgensma, which the company has suggested could cost up to $4m per patient.

“I suspect… we’ll need a fundamental change in some cases where health systems want to get access to significant technologies but simply aren't able to afford to pay for them via a public sector annualised budget, which is the basis of the UK’s NHS.”

Pharma companies and healthcare systems are exploring new approaches, including reinsurance schemes and ‘Netflix’ style subscription payments, which spread the cost of a curative treatment over a long period.

Article by
Andrew McConaghie

18th March 2019

From: Healthcare

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