BMS condemns long wait for Opdivo access in UK

Patients in the UK may have to wait another year to gain access to groundbreaking lung cancer treatment nivolumab – despite the drug being launched last week.

The likely delay has been condemned by pharma company Bristol-Myers Squibb (BMS), who says patients with advanced lung cancer cannot wait that long.

The PD-1 immunotherapy drug was recently approved in Europe in advanced melanoma as Opdivo, and in advanced relapsed squamous non-small cell lung cancer (SQ NSCLC) as Nivolumab BMS.

Along with Merck’s rival therapy Keytruda, the drug been hailed as a major step forward in hard-to-treat cancers – early data shows BMS’s drug can extend survival in SQ NSCLC, and is predicted to become the new standard treatment against the disease.

BMS’ CheckMate -017 trial showed patients on nivolumab lived on average three months longer than patients taking standard second line treatment docetaxel (9.2 months versus 6 months) – a small but significant gain.

Nivolumab BMS was launched in the UK on 7 August for lung cancer, but patients will have to wait until May 2016 before cost effectiveness watchdog NICE issues its guidance on the drug.

If recommended by NICE, the health service then has a further three months to implement guidance, which means it could be August next year when NHS patients finally gain access.

Patients have been able to get fast-track access to new treatments via England’s Cancer Drugs Fund (CDF), but recently-announced plans to reform this leaves access to Nivolumab BMS in doubt.

A spokesperson for the company said this left a ‘huge gap’ in funding and access to the drug. She added that the nine-month delay until NICE’s ruling was too long: “Patients don’t have that time to wait.”

BMS says it has applied for a review by the CDF, but has not had any confirmation that it will be assessed by the panel.

The delay is particularly ironic as the drug was one of the first to go through the Early Access to Medicines Scheme (EAMS), a new fast-track scheme aimed at getting breakthrough treatments to UK patients faster.

More than 450 people gained accessed to nivolumab in the UK across all indications (including clinical trials, EAMS and Named Patient Programme).

A further 47 patient applications have been approved through the squamous lung EAMS scheme, which involves the pharma company covering the cost of treatment. But EAMS programmes stop enrolling new patients once a drug gains marketing approval.

Cost an issue

Despite the huge potential of immunotherapy and the PD-1 drugs, healthcare systems are worried about the high cost of the drugs. Earlier this year, UK health secretary Jeremy Hunt said there was ‘incredible excitement’ about the drugs, but admitted that they gave him and NHS England chief Simon Stevens ‘a heart attack’ because of the cost implications.

Nivolumab BMS has been priced at around £5,700 per month for an average patient, based on the licensed dose of 3mg/kg every two weeks.

This is in line with its price for its other licensed indication in melanoma and equivalent to $8,800 – significantly cheaper than its US price of $12,500 a month.

BMS says patients are likely to receive on average 2.71 treatment cycles, which would bring the cost of treatment to £15,447. This is significantly cheaper than some other new cancer treatments, such as BMS’s other melanoma drug Yervoy, which costs around £70,000 for four cycles of treatment.

However lung cancer is far more common than melanoma, which means the total cost to the NHS could be much higher.

More than 40,000 people are diagnosed with NSCLC in the UK every year, and the disease kills more people annually than breast and bowel cancer combined.

SQ NSCLC accounts for around 25-30 per cent of all lung cancer cases, but the non-squamous variant of the disease is more common. BMS is expected to gain a licence to treat these patients too shortly. NICE already has this appraisal scheduled, with an anticipated publication date of September 2016.

Related article

UK backs early access to BMS’s Opdivo for lung cancer

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