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After discount row, NICE finally says yes to first line Revlimid

England catches up with rest of Europe

NICE

NICE has recommended Celgene’s Revlimid as a first line treatment in transplant ineligible multiple myeloma patients – a full four years after its European approval.

While Revlimid has become the ‘backbone treatment’ for multiple myeloma patients in most developed countries, it has been used only as a third line treatment on the NHS, until now.

Since it gained an EU licence in first line use back in 2015, the drug’s appraisal by NICE has been held up by disagreements about the patient access scheme (PAS), or discount scheme applied to the drug.

The drug’s list price in England is up to £4,368 a month, or over £52,400 a year per patient, with the confidential PAS discount cutting this substantially.

NHS England last year called for NICE’s appraisal to be halted so that it could address concerns about Celgene’s existing PAS – which was both complex and failed to return savings made by hospitals to its central budget.

The scale of this expenditure is what has driven cost-conscious NHS England to seek a better deal, and reflects its growing control of secondary care drug budgets and market access.

Now Celgene and NHS England have agreed a new confidential PAS which addresses these concerns, and Revlimid can finally be used as a first and second line option.

The decision is a breakthrough for Celgene in England, where newer entrants – most notably Janssen’s Darzalex – are now making rapid in-roads.

However Revlimid still not the first choice in these patients: in its final draft guidance, published today, NICE recommends Revlimid in combination with dexamethasone as an option for previously untreated myeloma in adults who are not eligible for a stem cell transplant only if patients cannot tolerate the older drug, thalidomide, which can cause bruising, breathlessness and increased risk of infection.

NICE says the new decision will benefit around 2,100 patients.

In a second piece of final draft guidance published today, NICE has also recommended Revlimid as a second line therapy with dexamethasone. One trial showed this helped patients live seven months longer compared to those given chemotherapy.

The new guidelines for first line use mean Revlimid its use in the second line setting will be limited, with NICE predicting around 320 patients expected to benefit.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: “We are pleased to recommend lenalidomide for these patients. Not only will this drug improve the length of time people live, but it will also have fewer side effects compared with current treatments.

“Multiple myeloma is normally treated with a thalidomide -based therapy at first line, however, there is considerable need for new therapies for those who cannot take thalidomide. The new decision by NICE now means that those patients have an effective alternative.”

However time is running out for Revlimid’s patent in Europe, which is due to expire in 2022, and could face generic challengers before then.

Nevertheless, the company received some further good news yesterday when the European Commission approved Revlimid and its other myeloma Imnovid in triplet combinations with bortezomib and dexamethasone, in first and second line therapy respectively.

The drug remains Celgene's biggest seller, earning nearly $10bn globally last year, and was an important factor in BMS' $74bn takeover of the company, which is set to be finalised this year.

Article by
Andrew McConaghie

17th May 2019

From: Healthcare

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