You might have heard about England’s Cancer Drug Fund (CDF), but you may not know exactly how it works or how they are related to the National Institute for Healthcare and Excellence (NICE), the UK’s primary Health Technology Assessment (HTA) decision-making body. At Context Matters, we have been spending a lot of time in recent months looking at CDF data and working to understand how this data fits into the larger Oncology picture in England. The CDF is a program designed to pay for cancer treatments that have not received positive reimbursement decisions from NICE or that not yet been reviewed and are therefore not available within the National Health Service (NHS) in England. Unlike NICE, The CDF’s jurisdiction is limited to England; CDF decisions have no legal standing in Scotland, Wales, or Northern Ireland. The Cancer Drug Fund was started in April 2011 and is currently funded through March 2016, with a budget of 200 million pounds per year.
What is the CDF?
The rising costs of cancer treatments are having a significant effect on patient access to these Oncology drugs. National budgets are also effected (NHS in the case of the UK) as countries need to find ways to fund increasingly expensive drugs. Further complicating patient access to and payment for Oncology drugs, NICE has issued a high proportion of “do not recommend” decisions for Oncology drugs in recent years. The snapshot above is from our Reimbursement Risk Tracker (RRT) data platform, and clearly shows the prevalence of DNR decisions in recent years.
For patients, the CDF is important because it provides an avenue for accessing Oncology treatments that would not be available based on NICE decisions alone. For anyone trying to understand the full market access landscape in England, the CDF is an important part of the larger picture. NICE is still the largest and most influential HTA body in the UK, but if we only pay attention to NICE, we miss out on important data and context for understanding both the cost of Oncology drugs in the UK and how those drugs are being evaluated. Plus, with a budget of 200 million pounds a year, the CDF has influence and data worth paying attention to.
Gaining Access to Drugs
There are two routes to gaining access to drugs funded through the CDF:
- Applying for access to drugs already on the drug “priority list,” or
- Submitting an Individual CDF Request
The CDF currently publishes a list of drugs and associated indications that are funded through the CDF (referred to as the “priority list”). As NICE updates the drugs that are available (via the NHS) and new drugs gain regulatory approval, the CDF priority list will change. Given the dynamic nature of the priority list, it is reviewed at least quarterly. If NICE issues a “do not recommend” decision for a cancer drug or restricts access to a smaller group of patients than that specified by the market authorization (“optimized recommendation”), the drug can be added to the priority list after a positive review by the Chemotherapy Clinical Reference Group.
If the cancer specialist and patient want to have a drug that is not on the “priority list” funded, the cancer specialist can submit detailed information regarding the patient’s treatment for special consideration. These special considerations are evaluated by regional panels, which make their decision based on:
- Specialist explanation of patient needs
- Stage of disease and general health of patient
- Other available treatments
- Evidence on how well the drug works, side effects, and cost
CDF’s Evaluation Process
The Chemotherapy Clinical Reference Group is a panel of experts (cancer specialists, pharmacists, public health specialists, and patient representatives) that evaluate potential new drugs. They rank the drug treatment versus other treatments, based on the strength and quality of the clinical efficacy (using the National Cancer Drug Fund Scoring Tool).
Cost-effectiveness is not a part of the standard decision making process; it is only be considered if ranking scores of clinical efficacy are similar between the drug and its comparators. The CDF Scoring Tool is completed for each drug/indication under consideration and scores drugs on evidence of clinical efficacy, survival and quality of life benefit, and toxicity/safety.
The Scoring Tool uses pivotal trial data to score the following characteristics of the drug:
- Survival: scored on a scale of 0 (<2 months) to 7 (>12 months) depending on the absolute difference in survival times between the drug and its comparator
- Quality of Life (QoL): scored from 2 (published evidence of significant improvement in QoL) to minus 2 (published evidence of a deterioration in QoL)
- Toxicity: scored from 2 (significant improvement) to minus 2 (significantly worse).
- Unmet Need: If there are no alternative treatments the drug receives a score of 3 for unmet need
- strength of evidence: given a grade of A through D with two grades for unpublished data only
Based on this data, the score is calculated and a decision is made on whether or not the drug should be added to the priority list.
A New Approach for Oncology?
The need for a CDF in England demonstrates the limitations of the NICE evaluation process, and this problem is not unique to the UK. Agencies around the globe are struggling with Oncology products, prompting some important questions:
- What are the inherent difficulties with HTA evaluations for Oncology?
- Should these agencies (like NICE) change their evidentiary criteria and cost-effectiveness thresholds to accommodate Oncology projects?
- What is the best method for evaluating the clinical efficacy and cost-effectiveness of cancer drugs?