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NICE says no to AZ and Vifor’s rival hyperkalaemia drugs

Both companies made same error in modelling, says NICE

NICE has rejected rival treatments for high levels of potassium in the blood, known as hyperkalaemia, AZ’s Lokelma and Vifor’s Veltassa, in draft guidance.

Most common in patients with poor kidney function, heart failure or liver disease, hyperkalemia can be fatal, and patients have had few options for treatment until now.

Between 1% and 10% of hospital inpatients have hyperkalaemia. Many patients won’t display any symptoms, but some severe cases can lead to cardiac arrest.

NICE’s preliminary decision is unwelcome news for the rivals, who have both seen their products so far fail to live up to high pre-launch expectations.

AZ acquired Lokelma (sodium zirconium cyclosilicate) via a $2.7bn acquisition of ZS Pharma three years ago, but suffered serious setbacks in its approval thanks to manufacturing compliance issues.

Vifor’s Veltassa (patiromer) gained US approval in 2015 and in Europe in 2017. However an initial US black box warning related to drug-drug interactions held it back, with AZ gaining EU approval for Lokelma in March and US approval in May.

Vifor has so far launched Veltassa in just a handful of European markets, Germany, the UK, and Switzerland, and has gained its first successful ex-US reimbursement approval in Sweden and Denmark.

This has given Vifor a head start overall, but Veltassa sales remain modest: it chalked up revenues of €36.8m in the first six months of 2018.

AZ will be hoping its greater marketing muscle will help it overhaul this figure, but the draft NICE judgement is one barrier to progress.

Hyperkalaemia is also seen in patients taking common medications for heart failure, such as RAASi therapy (e.g. ACE inhibitors and angiotensin receptor blockers [ARBs]), and dose reduction or stopping these drugs is one existing strategy for dealing with the problem.

The companies argue that this exposes patients to cardiovascular disease risk, and say managing potassium levels with the new treatments is a superior stratagem.

However NICE found the evidence presented by both companies to be flawed in the same way: it says both companies assumed that people would start treatment at lower blood potassium levels than is actually the case in current NHS clinical practice.

NICE says there is also no evidence to show that either drug extends life or improves quality of life compared with standard care, and therefore ruled to not recommend the treatments as cost effective.

The draft guidance is now with stakeholders and the closing date for comments is 19 November 2018.

AstraZeneca has responded to the draft ruling by saying it is preparing a “robust response” to address the questions raised by NICE, and wants to ensure adult patients in England with hyperkalaemia can access the treatment.

Article by
Andrew McConaghie

30th October 2018

From: Regulatory



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