Nice extends price-negotiation talks for PTC’ muscle wasting drug
pharmafile | May 4, 2016 | News story | Research and Development, Sales and Marketing | Duchenne Muscular Dystrophy, NICE, PTC Therapeutics, Translarna, market access, regulation
UK regulators have extended the cost negotiation talks with PTC Therapeutics (Nasdaq: PTCT) by a week for the drug to treat a muscle wasting condition.
The National Institute for Health and Care Excellence (Nice) on Wednesday agreed to extend price discussions for Translarna (ataluren) a therapy for Duchenne Muscular Dystrophy caused by nonsense mutation before publishing its recommendation.
Sir Andrew Dillon, chief executive of Nice, said: “We have allowed this extra time with the expectation that an agreement can be reached. The Nice committee was clear that ataluren has the potential to offer benefits to children with this cruel disease and their families and considered that it should be made available. However because of its high cost, a financial agreement must be reached between NHS England and the company.”
NHS England and the company, PTC Therapeutics, have been asked to reach agreement on the cost of the drug to the NHS within 8 weeks. The negotiations will now go on till May 11, the regulator said in a statement.
“We have granted this extra time in order for that to happen. It provides an opportunity for NHS England and the company to act quickly to resolve any outstanding issues on price so the guidance can be published,” Dillon said.
Last month, Nice issued draft guidance recommending ataluren for eligible children under certain circumstances.
One of those was that a confidential agreement on the overall cost of ataluren be reached between NHS England and PTC Therapeutics. Because agreement has not been reached Nice has allowed further time to enable agreement to be reached and the medicine made available.
Duchenne Muscular Dystrophy caused by nonsense mutation causes progressive muscle wasting and is usually fatal by age 30. Children gradually become weaker and are often dependent on a wheelchair by the age of 12.
Ataluren is licensed for children with the condition who still have the ability to walk unaided.
Ataluren is licensed for children with DMD caused by a nonsense mutation aged 5 and over who are able to walk. Its list price is approximately £220,000 per year.
Anjali Shukla
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