Engaging with NICE: The Office for Market Access

Nina Pinwill, Office for Market Access, NICE

Policy Landscape

• Policy landscape evolving with initiatives aiming to ensure timely patient access to products addressing unmet medical need:– Accelerated access review (England)– The NEW Cancer Drugs Fund (England)– Early Access to Medicines Scheme (UK)– EMA adaptive pathways pilots (Europe)– EMA PRIME (Europe)

• So NICE get products to appraise sooner & therefore with less evidence

Exciting Times!

• Very strong pipelines of pharma and biotech products with potential for major patient benefits

• Patients and healthcare systems need these products

• Challenges– High cost of some products– Timely patient access while the evidence is

still emerging

• Effective engagement necessary to address

challenges– NICE Scientific Advice– The Office for Market Access

NICE Office for Market Access (OMA)

• Opened in October 2015

• Through tailored engagement and expert advice, the Office for Market Access (OMA) helps companies optimise the journey through NICE

• OMA provides opportunities to engage with NICE at any stage in the development to adoption pathway

• Covers all health technology products

OMA services Bespoke packages to meet company needs

•Early engagement– to help companies understand NICE methods, processes and evidence requirements– To discuss managed access approaches for products that are expected to first come

to market with immature evidence– To discuss NICE methods and processes related to the Early Access to Medicines

Scheme and products included in the EMA led Adaptive Pathways pilots•Portfolio reviews•Multi-stakeholder safe-harbour meetings

The story so far

Multi-stakeholder Safe Harbour

They are collaborative events, including participation from a range of stakeholders, designed to help companies deliver a market access plan that is patient & healthcare system focussed

A safe harbour meeting is a multi-stakeholder discussion that is supported by rules of engagement to ensure a broad, open and free discussion within a confidential framework

Areas of discussion could include:

EAMS, managed access, methods and processes,

adaptive pathways, evidence requirements, meeting patient and NHS needs

The Background• Complex pathway from product R&D to widespread NHS adoption of health

technologies• Need to get innovative products addressing unmet need to patients asap• Many organisations involved who all need to engage effectively with product developers

In response…• NICE Office for Market Access brokers discussions between companies, NICE and other key stakeholders in a

‘safe harbour’ environment• Available, for a fee, on a not-for-profit basis• Non-binding and non-attributable discussions – no obligation, advice• A multi-stakeholder safe harbour discussion gives the opportunity for:

• Collaboration• Understanding• Barriers to be exposed – participants think beyond own area• Broad exploration of the issues• Facilitated, confidential, safe, open & free discussions

Benefits Collaborative approach can help companies deliver a market access plan that is patient and

healthcare system focussed

Engaging at an early stage provides the greatest opportunity for the company to understand what is feasible and desirable for the health system

The discussions can help the company prepare for the processes they will need to follow as they move toward product launch

The safe harbour pilot

Feedback

 

 “The meeting was valuable – there was a breadth and depth of relevant stakeholder input”

“NICE’s Office of Market Access fostered a safe environment to have open discussions”

Looking forward; focus, priorities and challenges

NICE Strategic plan 2014-17: System Partnerships: ….. Work with government and industry to help promote innovation and growth in the life science industries….

NICE Health Technology Evaluation (medical devices, medicines, diagnostics &

digital):

• managing access to promising new medicines, devices and diagnostics

• assessing value• scientific advances• budget impact

Follow us on Twitter @NICEcomms

Keep up to date with the latest from NICE...

Subscribe online to NICE News, our monthly newsletter - containing information about new guidance, quality standards and implementation resources launched each month.

Sign up at: www.nice.org.uk/newsletter

14