The Scottish Medicines Consortium has presented its latest recommendations which reveal backing for drugs including Sanofi unit Genzyme’s multiple sclerosis treatment Lemtrada and a subcutaneous formulation of Roche’s MabThera but a rejection for Celgene’s multiple myeloma drug Imnovid.

First up, the cost regulator has endorsed Lemtrada (alemtuzumab) for unrestricted use within NHS Scotland for the treatment of adults with relapsing-remitting MS. The latter accounts for 85% of all initial diagnoses of the disease which affects over 10,000 people in Scotland.

Brendan Martin, general manager for Genzyme UK and Ireland, noted that the decision brings a treatment option to people with MS developed in Cambridge UK “that could really reshape the management of their condition”. Lemtrada is the second of Genzyme’s treatments for MS to receive approval for use from the SMC, following a thumbs-up in March for its oral treatment Aubagio (teriflunomide).

Meantime, Scottish patients with non-Hodgkin lymphoma will now benefit from subcutaneous MabThera (rituximab) which can be administered in five minutes, compared to the current two and a half hour intravenous (IV) infusion of the Roche blockbuster. Andrew Davies of University Hospital Southampton noted that as well as patients spending less time in the clinic, “it is also good news for chemotherapy units in hospitals, who will be able to free up time and resources”. Also NHS Scotland could gain more than £500,000 every year through time saved preparing and administrating the treatment.

The regulator also accepted AstraZeneca’s diabetes drug Forxiga (dapagliflozin) for restricted use as part of a triple therapy in combination with metformin and sulphonylurea, as an alternative to dipeptidyl peptidase-4 (DPP-4) inhibitors (though it is still not recommended as monotherapy). There was also backing for UCB’s Cimzia (certolizumab pegol) in combination with methotrexate for the treatment of active psoriatic arthritis in adults who failed on disease-modifying antirheumatic drug (DMARD) therapy and a new indication for Allergan’s Botox (botulinum toxin type A), this time for restricted use in the management of bladder dysfunction.

Imnovid improves survival but costs too much: SMC

However the SMC has issued negative guidance on Imnovid (pomalidomide) in combination with dexamethasone for use in relapsed and refractory myeloma patients who have received prior treatment with both Velcade (bortezomib) and Revlimid (lenalidomide).
In its guidance, the SMC noted that the Imnovid/DEX “significantly increased progression free survival” compared with high-dose DEX but added that Celgene “did not present a sufficiently robust economic analysis”. Adrian Kilcoyne, medical director of Celgene UK & Ireland, said “we are obviously disappointed ..especially since the SMC acknowledged that pomalidomide substantially improved life expectancy”, noting that the firm has already re-entered into discussions with the regulator.

Myeloma UK chief executive Eric Low added that “it is a very disappointing decision for myeloma patients in Scotland [as] the absence of approved treatments in the multiply relapsed setting is a major area of unmet need and we know that Imnovid offers a significant survival advantage compared to currently available treatments”.

He added that the charity understands the SMC “has a very difficult job to do in assessing new medicines and often has to deal with new treatments that are priced very highly and for which the health economic case has not been made”.  However, “we are frustrated that the SMC and the manufacturer did not resolve their differences regarding the cost-effectiveness of Imnovid during the appraisal process”.
If a solution cannot be agreed, Celgene will need to resubmit, meaning myeloma patients in Scotland may go without Imnovid for another six-12 months. Mr Low said “this is something that is unacceptable for patients and a solution is needed as a matter of urgency”.