NICE has rejected regular NHS funding for Pfizer’s Vyndaqel (tafamidis) for a rare heart condition, although it has left the door open for negotiations if the pharma decides to drop its price.
Pfizer had appealed against draft guidance from NICE that rejected Vyndaqel for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) on cost grounds.
The pharma unsuccessfully appealed against the decision in first draft guidance issued in June last year, along with patient associations Cardiomyopathy UK and the British Society for Heart Failure.
But in a statement NICE said it is willing to conduct a rapid review of the guidance if NHS England and Pfizer are able to agree on a new “value proposition that might make this a cost-effective use of NHS resources.”
In other words, a price cut would make Vyndaqel acceptable to NICE, allowing patients access to the treatment for the life-limiting condition caused by a build-up of the protein amyloid in the heart.
The life-limiting condition affects around 800 people in the UK, with symptoms starting in adulthood and getting worse over time, causing the heart tissue to thicken and stiffen.
ATTR-CM can lead to heart failure, but current treatment options are limited to managing symptoms and best supportive care, such as diuretics.
NICE rejected funding for Vyndaqel because there is not enough evidence to back Pfizer’s claim that Vyndaqel could reduce delays in diagnosis and avoid healthcare costs and anxiety caused.
The cost-effectiveness body added that there is uncertainty about how long the benefit from the drug lasts after it is stopped in its final guidance.
NICE made its ruling just after the Scottish Medicines Consortium published its monthly round of decisions on which new medicines will be funded by Scotland’s devolved health service.
It included a “yes” for Alexion’s long-lasting Ultomiris for treatment of the rare disease atypical haemolytic uremic syndrome, moving faster than NICE and allowing Scots earlier access than patients in England.
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