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  • Brendan Shaw

NICE methods review, UK Life Sciences Strategy and the life sciences industry: lessons for Australia

Brendan Shaw

“We must balance ensuring the NHS gets the best value, delivering improved patient access and promoting innovation. These proposals mean we meet expectations to introduce effective products as soon as possible while maintaining a world-leading robust approach.”

- Professor Gillian Leng CBE, Chief Executive, NICE

“That’s why we are setting out our new Life Sciences Vision to bottle the formula we have developed to tackle COVID and improve health outcomes for patients across the board in the UK, and secure jobs and investment in the process as we build back better.”

- The Hon Boris Johnson MP, UK Prime Minister

There are some things that Australia should not copy from the United Kingdom.

Warm beer, the weather and haggis are things that come to mind.

But there are major developments currently under way in the UK’s health system and how it partners with the biotech and pharmaceutical industries that Australians should pay attention to.

NICE methods review

The UK’s National Institute for Health and Care Excellence (NICE) is in the final consultation phase of some major proposals to change the way it evaluates medicines, devices, diagnostics and other medical technologies for public funding.

NICE, the health technology assessment body that recommends medical technologies for funding under the National Health Service (NHS), has been undertaking a major review of its methods, processes and topic selection for the last few years.

This has involved substantial consultation and collaboration with patients, patient groups, health care professionals, the NHS and – just as importantly – the British life sciences industry.

From the start, the UK Government has put resources, time and support into the process and has been serious about working with the industry to make the UK a leader in providing access to new medical technologies to the public.

NICE has now developed its proposals for final consultation.

NICE is proposing reforms that it says will change how it assesses new medicines, devices, diagnostics and digital technologies to provide faster and fairer access in the NHS and (wait for it) will improve the way NICE works with patients, the NHS and the life sciences industry.

In a forward-looking strategy, NICE says it is “simplifying our approach and allowing more flexible decision-making, while continuing to be robust and responsive.”

Amongst other things, NICE lists four ambitions for health technology assessment in the UK:

· Earlier patient access to valuable innovative treatments

· More equitable access to treatments for severe diseases

· Greater predictability for health technology assessment outcomes, and

· Increased use of a broader evidence base, including real world data.

For patients NICE is promising faster access to a broader range of treatments and easier contribution to its evaluations.

For industry NICE is promising to expand the use of managed access agreements for promising but clinically uncertain medical technologies. The equivalent to Australia’s embryonic Managed Access Program, these agreements allow companies in the UK to offer new medicines at a reduced cost while collecting further evidence on their effectiveness for a future review of pricing.

NICE is also proposing to change the way it undertakes evaluations to give extra value to medical innovations that treat severe diseases at any stage, not only at the end of life. It is proposing to introduce modifiers to the value of the Quality Adjusted Life Year (QALY) it uses to assess the cost-effectiveness of treatments and diagnostics for severe disease.

The result is that a wider range of physical and mental health conditions, such as severe epilepsy and multiple sclerosis, could be assigned additional value in such evaluations.

NICE has also said it will commission research to understand if it should go further in the additional value placed on medicines for severe disease, stressing that society’s views on this are important.

What is breath taking about this process from an Australian perspective is NICE’s policy aspiration for doing this:

“The NHS will be the first to pilot the latest and most innovative treatments. We’ll support initiatives that let companies innovate and test their products in the UK ahead of launch. And we’ll aim to inform commercial discussions earlier. Pharmaceutical and life science companies will benefit from flexible, responsive discussions to ensure innovations can be recommended without delay.”

While there may still be a number of substantial issues to resolve between the government and industry on the details, the priority and engagement with the life sciences industry in developing these proposals for better patient access to new medical technologies is striking.

The HTA method changes being proposed are part of NICE’s new five-year strategy which aspires to make the UK a world-leader in making new, innovative medical technologies available to the community and in supporting the UK’s position as a hub for the life sciences sector.

Changes to its methods that NICE is proposing to stakeholders include:

  • Greater emphasis on treatments for people with severe diseases

  • Flexibility in dealing with uncertainty about the long-term benefits of new treatments

  • Using modifiers in NICE's analysis to put greater emphasis on redressing health inequalities, and

  • Reducing the discount rate NICE uses to discount future benefits and costs of medical technologies in its evaluations from 3.5% to 1.5% per annum (Australia's discount rate is currently 5%).

The current NICE methods review was an outcome of the most recent strategic agreement between the UK government and pharmaceutical industry, the Voluntary Scheme for Branded Medicines Pricing and Access.

Life Sciences Vision

These proposed improvements are backed up by the UK Government’s recent Life Sciences Vision. This sets out a comprehensive 10-year strategy for sector to solve some of the biggest healthcare problems of our generation, including cancer and dementia.

The Vision supports the development of the UK as an international hub for medical research and life sciences and contains seven critical health care ‘missions’ where government, industry, the NHS, academia and medical research charities will work together to achieve.

These missions are aimed at preventing, diagnosing, monitoring and treating disease early by developing breakthrough products and treatments quickly to save lives and accelerate the development and adoption of new medicines, diagnostics, medical technology and digital tools.

While history shows that government ‘vision’ documents can vary in quality from comprehensive long-term plans to fluffy marketing exercises of little substance, the UK Government’s Vision looks pretty comprehensive and, importantly, is a whole-of-government, cross-portfolio approach signed off by the Prime Minister, the health and industry ministers, their departments and the NHS.

The Vision is supported by a £1 billion Life Sciences Investment Program and has been endorsed by the Association of the British Pharmaceutical Industry and the UK Bioindustry Association.

Lessons for Australia's medicines policy

The lessons for Australia in all of this are striking.

At a time when Australian health experts in government, politics, industry and patient communities are awaiting outcomes from the House of Representatives Inquiry into approval processes for new drugs and novel medical technologies, the recently-announced National Medicines Policy Review and hot on the heels of the Australian government's just completed Medicines Australia Strategic Agreement, people in the know in Australia should have a look at what is happening in the UK right now.

The House of Representatives is spending a lot of time looking at detailed issues into how medicines are approved for funding in Australia.

The National Medicines Policy Review has just started its review of the NMP, a policy which includes as one of its four objectives maintaining a responsible and viable medicines industry in Australia.

And the just completed latest Australian Government - Medicines Australia Strategic Agreement includes a commitment from the government for the first independent review of Australia's HTA system in 30 years.

With these three Australian undertakings in mind, what is striking about the UK HTA methods review, the NICE Strategy and the UK Life Sciences Vision is their scope and the depth of collaboration with that country’s biotech and pharmaceutical industries.

There is a recognition and commitment from government in the UK that the pharmaceutical and biotech sector is critical.

Crucially, in the UK the engagement of the health department, the portfolio and its agencies in collaborating with and supporting the industry is seen as pivotal.

The fact that the health agencies of government see their partnership with the life sciences industry as a crucial factor in the success of health policy is a key lesson for Australia and should inform the evolution of Australia's medicines policy.

The recent Australia-UK free trade agreement might have provided opportunities here but this was a missed opportunity, so perhaps is something for another day.

Yes, the Brits might have their own reasons for doing all this, such as learning the lessons from the COVID pandemic, building a post-Brexit international economy and leveraging its extensive medical science capabilities for the benefit of its citizens and humanity.

But, if you think about it, Australia faces similar challenges and opportunities in a post-COVID world.

Australia’s impending reviews and agreements offer an opportunity for it to learn from the UK’s experience about how government and industry can partner to make for a better health system and grow economic opportunities in Australia in the future.

Here's hoping.

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