'Disappointment' as NICE Rejects Migraine Treatment

Peter Russell

January 11, 2019

A migraine charity said patients would be devastated by a decision from the National Institute for Health and Care Excellence (NICE) not to recommend a new treatment for the condition for routine NHS use in England and Wales.

Other announcements from NICE this week included guidance on lung cancer, Crohn's disease, and kidney stones.
 

'No' for Migraine Treatment

The Migraine Trust said it was very disappointed that the National Institute for Health and Care Excellence (NICE) decided not to recommend erenumab (Aimovig, Novartis) as a treatment to prevent migraine.

The draft guidance looks at erenumab for preventing chronic and episodic migraine in adults who experience four or more migraine days every month and where at least three previous preventive treatments have failed.

Erenumab is the first treatment to target the release of a protein called calcitonin gene-related peptide, a pro-inflammatory vasodilating neuropeptide believed to be important in the pathogenesis of migraine. 

The treatment, given as a monthly self-administered injection, costs around £5000 per year, although the manufacturer had agreed to provide it at a discount to the list price.

Appraisers acknowledged that erenumab was a clinically effective treatment but considered that trial evidence did not fully reflect patients seen in clinical practice in the NHS. They also decided that the treatment was too costly, despite the discount offered.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said:  "Erenumab is a promising new preventive treatment for migraine that has been shown to be clinically effective compared with best supportive care.

"However, there was not enough evidence to suggest that it is more effective than botulinum toxin type A for people with chronic migraine, which NICE already recommends. And for both the chronic and episodic migraine populations there was no evidence to show that erenumab is effective in the long-term in people for whom three previous preventive treatments had failed."

Commenting on the announcement, Wendy Thomas, chief executive of The Migraine Trust, said: "This is extremely disappointing, and devastating for people whose lives are blighted by migraine.

"It is terrible that people with migraine have had to wait so long for their own treatment, the first medication dedicated to treating migraine.

"Now, after proving effective to many, it is not accessible to those who can’t afford to purchase it privately."

NICE said it would work with the manufacturer to try to overcome barriers to making the treatment available for routine NHS use in England and Wales.

A public consultation on the draft recommendations closes on January 31st 2019.

Crohn's Disease Treatment

Darvadstrocel (Alofisel, Takeda) was not recommended for previously treated complex perianal fistulas in adults with non-active or mildly active luminal Crohn's disease.

In a single clinical trial comparing remission rates for darvadstrocel and placebo, only an additional 14% of people showed a beneficial effect from darvadstrocel, an appraisal committee said. Also, reliable follow up results were only available for up to a year, during which time more than 50% of patients who had remission subsequently relapsed in both the darvadstrocel and placebo arms.

In final published guidance, NICE said that further research into the long-term benefits of darvadstrocel would be beneficial.

Regorafenib for Liver Cancer

NICE gave a positive assessment of regorafenib (Stivarga, Bayer) as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib (Nexavar, Bayer).

In final guidance, it said regorafenib was a possible treatment option for patients who could not tolerate sorafenib, or whose disease progressed on sorafenib.

Patients would be eligible for treatment with regorafenib if they had Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

NHS use was dependent on the manufacturer supplying the drug at an agreed discount.

Lung Cancer Treatment Option

In final guidance, NICE recommended pembrolizumab (Keytruda, Merck, Sharp & Dohme), with pemetrexed (Alimta, Eli Lilly) and platinum chemotherapy, as a treatment option for some people with lung cancer.

It said the treatment should be made available on England's Cancer Drugs Fund (CDF) for patients with untreated, metastatic, non-squamous non-small-cell lung cancer in adults whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations.

Treatment should be stopped at 2 years of uninterrupted treatment, or earlier in cases where the disease had progressed, NICE said.

Inclusion on the CDF was also dependent on the manufacturer supplying the drug at an agreed discount.

Pressure Ulcers

Mepilex Border heel and sacrum dressings (Mölnlycke) show promise for preventing pressure ulcers in people who are considered to be at risk in acute care settings, NICE said. However, appraisers found insufficient evidence to support the case for routine adoption in the NHS in England and Wales.

They called for further research into the incidence of heel and sacrum pressure ulcers in NHS acute care settings and into which patients would benefit from the technology.

Renal and Ureteric Stones

NICE updated guidance for assessing and managing renal and ureteric stones.

The guidance for commissioners was aimed at improving the detection, clearance, and prevention of stones in order to reduce pain and anxiety, and improve the quality of life.

Drug Safety Update

A warning was issued that treatment with opioid analgesic tapentadol (Palexia, Grünenthal) may increase seizure risk in patients taking other medicines that lower seizure threshold, such as antidepressants and antipsychotics.

The Medicines and Healthcare products Regulatory Agency (MHRA) said that serotonin syndrome had also been reported when tapentadol was used in combination with serotoninergic antidepressants.

Tapentadol should be prescribed with care in patients with a history of seizure disorders or epilepsy, the MHRA advised.

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