MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule

Pharmaceutical companies who make qualifying medicines can now take advantage of a streamlined approvals pathway for medicines much earlier than anticipated.

Aligned pathway will streamline decisions on licensing and value for medicines, helping patients benefit from them sooner.

The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) are now offering some pharmaceutical companies early access to the aligned pathway six months earlier than projected, as user research begins to shape the next phase of the programme. 

The pathway is now accepting applications from manufacturers who make medicines which have been designated by the NICE and the MHRA for early access.

The aligned pathway delivers on government ambitions in the Regulatory Action Plan, 10-Year Health Plan for England and the Life Sciences Sector Plan by streamlining regulation, accelerating access to medicines for patients and the NHS, and improving the UK’s global competitiveness in life sciences.

The pathway brings together the MHRA’s licensing process and NICE’s value assessment process, meaning decisions will be published at the same time, instead of consecutively. This will reduce the 90-day gap between marketing authorisation and NICE guidance decisions, meaning faster patient access, support for the NHS and a more efficient route for industry.

A new fully integrated joint scientific advice service, launching by April 2026, will provide a single-entry point for coordinated advice from the MHRA and NICE to help avoid delays and support alignment. The service is designed to help companies successfully adhere to aligned pathway timelines, providing enhanced clarity and confidence in investment decisions by providing evidence requirements early and avoiding unnecessary delays.

Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before marketing authorisation and to engage early with both organisations.

NICE and the MHRA will continue to work more closely to improve efficiency, transparency and timely access to innovative treatments.

Any companies with a technology appraisal already scheduled who believe their product may be suitable for the aligned pathway should contact the NICE scheduling team – scheduling@nice.org.uk.

NHS Postcode Lottery is Restricting Access to Drugs like Avastin and Abiraterone on the Cancer Drugs Fund

The government Cancer Drugs Fund enables cancer sufferers without private medical cover to benefit from treatment not available on the NHS. However, with a postcode lottery dictating the availability of this service, and with the initiative due to end in 2014, Brits may soon need to look for alternative ways of accessing lifesaving cancer drugs like Avastin, Abiraterone and Yervoy.

The Cancer Drugs Fund was set up in 2010 to give patients without private medical cover the chance to be treated with drugs deemed by the National Institute for Health and Clinical Excellence (NICE) as too expensive for the NHS. Patients can apply through their doctors for the funds which are then administered by health authorities across England.

Avastin is one of these drugs available through the Cancer Drugs Fund, licensed for use on breast cancers, colon cancer, gastrointestinal cancers, kidney cancers, lung cancers, ovarian cancer and rectal cancer. Although Avastin is licensed and can be prescribed in the UK, it has not been approved for use on the NHS because it is not considered cost-effective. Consequently, the drug is only available through the Cancer Drugs Fund or through private medical insurance. Self-pay patients would be set back around £21,000 for a course of Avastin.

Abiraterone is another drug available through the Fund. Abiraterone is a hormone based therapy drug which blocks the generation of testosterone in the tumours of men with late-stage prostate cancer. Trials of abiraterone found that it extended a patient’s life by an average of 4 months. Although it was licenced for use in the UK, NICE has decided that the drug is too expensive for use in the NHS in England. Abiraterone is now only available through the Cancer Drugs Fund or private medical insurance. Self-pay patients pay around £3,000 a month for treatment with Abiraterone.

Skin cancer drug Yervoy has also been turned down by NICE for use on the NHS. Yervoy is the first medicine proven to extend the lives of patients with advanced melanoma, the most deadly form of skin cancer. But the four necessary injections of Yervoy cost almost £80,000 per person in total. NICE has concluded that funding the drug would not be a cost effective use of NHS resources. Now, the only way people can be treated with Yervoy is through the Cancer Drugs Fund or through private medical insurance.

Whilst the Cancer Drugs Fund has helped thousands of patients get access to expensive cancer treatment, recent figures show that a postcode lottery is limiting the availability of drugs in certain parts of the country. Each health authority in England is awarded a budget to spend on cancer drugs from the Fund, ranging from around £9million to £30million depending on population size. But the Rarer Cancers Foundation has revealed that in some areas of the country less than one fifth of the money has been spent. In underspent regions, cancer patients are being turned away.

Richard Theo, of health insurance comparison website ActiveQuote.com said: “Rather than relying on the Cancer Drugs Fund for access to drugs like Avastin, Yervoy and Abiraterone you could compare health insurance policies online in order to find a policy that would fund these drugs if required. Private medical insurance complements the service provided by the National Health Service, and would guarantee you treatment with licensed drugs even if they are not approved by NICE.”

And with the Cancer Drugs Fund due to end in 2014, private medical insurance will give you peace of mind about you and your family’s healthcare for years to come.

http://www.activequote.com is the only true health insurance comparison website in the UK.