What are stakeholders saying about the new CDF consultation?

This year’s National Chemotherapy Clinical Reference Group (CRG) conference, 30th November 2015, provided the first opportunity for all those involved in delivering cancer services to discuss and debate the recent consultation document on the proposed new system for commissioning cancer drugs.

Over 200 people with representation from NICE, NHS England, academia and the ABPI attended the event and nearly every speaker spoke about or alluded to the continued uncertainty around future funding of cancer drugs.

The 20-page consultation document was felt to be sparse with the plans described as “incredibly ambitious”. Peter Clark confirmed that all new cancer drug licensed indications will be appraised by NICE who will have three options regarding decisions: yes, no, or a conditional yes, with the latter based on uncertainty. It is this latter group that will be eligible for the CDF.

What else do we know?

• The NICE appraisal process will start much earlier, with the first technology appraisal committee meeting before the wording of licence is approved
• NICE will issue final guidance within 90 days of marketing authorisation
• Drugs with NICE provisional and conditional approval will get access at marketing authorisation
• There will be 2 years of CDF funding whilst the pharmaceutical companies ensure data collection, following which there will be a NICE reappraisal with a final yes or no
• The CDF will be capped at £340m and reimbursement to individual pharmaceutical companies adjusted according to pressure on the budget

There is still a lot we do not know. Some of the key questions and concerns raised throughout the meeting include:

• What data need to be collected, how and who will collect it?
• Will 2 years be long enough to collect the right data?
• What role should the SACT dataset play in providing evidence?
• What about off-label indications?
• What is the impact on Wales and Northern Ireland who currently adopt NICE recommendations but have no CDF? Will they adopt a no whilst the drug in question is being evaluated?
• Does the new process offer an incentive to provide as little evidence as possible? Are we moving away from evidence-based medicine for cancer drugs?

The process for transition for existing drugs was described as complex. Plans for how this will work have been developed but will not be made public until after the consultation has closed and responses evaluated, making timelines for April 1st extremely tight.

How can OPEN Health support our pharma clients?

At OPEN Health we have developed a number of workshops for the pharmaceutical industry, aligned to drugs currently on the CDF, those launching in the next 18 months or those launching further in the future. These workshops will help define the positioning, value and data to meet NICE requirements. They will also help reiterate, to all internal pharmaceutical stakeholders, the importance of the new timings and process.

Interested?

For any further information please contact:

Sean McGrath (Chairman and Director of Oncology, Succinct Medical Communications and OPEN Health, sean@succinctcomms.com)
Cathy Wright (Joint Managing Director, OPEN Access Consulting, cathywright@openaccessconsulting.com)
Cathy Jarrold (Joint Managing Director, OPEN Access Consulting, cathyjarrold@openaccessconsulting.com)

To discuss your real-world evidence needs please contact:
Sam Oliver, Director of Real-World Evidence Solutions, pH Associates (SamOliver@phassociates.com)