What You Missed From Regulatory Agencies Last Week—August 11-15, 2014

Roche’s RoActemra Approved By Scotland

Roche announced last week that its subcutaneous formulation of its rheumatoid arthritis drug RoActemra was approved by the Scottish Medicines Consortium (SMC). The NHS will be making the drug available to those either taking the medication at home or in the hospital. RoActemra, an anti IL-6 receptor inhibitor, is the first of its kind to receive SMC approval for subcutaneous and intravenous formulations in combination with methotrexate or as monotherapy. The treatment underwent the phase 3 SUMMACTA and BREVACTA trials, which both revealed its comparability to the intravenous formulation and its overall efficacy.

NICE Votes No On Roche’s Kadcyla

Kadcyla was rejected by NICE for the NHS because of its hefty price tag, numerous publications reported early last week. The drug, indicated for women suffering from aggressive, inoperable breast cancer, is a new treatment from the company and is expected to rake in roughly $3billion — coming in among the top 5 drugs released by Roche in upcoming years.  The drug aims to eliminate the side-effects that patients often get when being treated with chemotherapy and has been found to grant patients an extra 6 months of life. However, because of its $151,000 price tag per patient, NICE rejected it on the grounds it was too expensive to be used on the NHS. The drug can still be prescribed following funding from the centralized Cancer Drugs Fund.

Eylea Approved As DME Treatment

Regeneron Pharma announced that its Eylea (aflibercept) injection received European Commission (EC) approval to treat visual impairment caused by Diabetic Macular Edema (DME). Eylea is a vacular endothelial growth factor (VEGF) inhibitor, which is injected into the eye to block blood vessel growth, VEGF-A, and placental growth factor (PLGF). The drug, which was approved in the U.S. for DME earlier this year and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012, is expected to be launched by Bayer Healthcare in the EU this quarter. The drug has also been approved for the treatment of Wet AMD and Macular Edema following CRVO in the EU and other countries.

NICE Recommends Sovaldi For Hep C Treatment

Gilead’s hepatitis C drug Sovaldi, another drug with a highly contested price tag in the U.S., received a positive recommendation for inclusion on the NHS last week — however, with some limitations. Following the submission of additional data about certain patient populations, the drug was deemed by NICE to come in a cut above other existing treatments with a record of curing 9 out of 10 patients. The drug will cost roughly $56,000 in the U.K., compared to $84,000 for a 12-week regimen in the U.S. While it received a positive recommendation, NICE has ruled it should not be available to those patients with genotype 1 hepatitis C who cannot handle a combination treatment of Sovaldi and interferon because of its hefty price.

Zytiga Not Approved By NICE

NICE made another controversial decision when it issued final guidance not recommending Janssen’s Zytiga for prostate cancer treatment before chemotherapy. The drug was previously recommended by NICE for the treatment of prostate cancer following treatment with docetaxel and chemotherapy. However, in this case, NICE has passed on recommending the treatment for people who have received hormone therapy but have seen their illness metastasize, or for those who are experiencing few symptoms or who are not yet ready for chemotherapy. The U.K. watchdog stated that it understood the blow that this decision was for patients, however claims that the price to benefit ratio was not well enough balanced to warrant approval.

Pharma Talking Points

Following a week of controversial decisions by NICE following drug pricing concerns, The Guardian features an article entitled “How the NHS can deal with soaring drug prices.” The article argues in favor of different prescribing practices by doctors, addressing in turn a trend known as “indication creeping” in which drugs are prescribed to patients that are less likely to benefit from taking them (i.e. statins). The Guardian also calls for more data transparency during the drug development process.