Market Access refers to the process of getting your medicine from the R&D labs into the hands of those who will benefit from it. The process can be long and protracted, and it can seem like a dark art at times balancing your desire to break even quickly against pricing your product so that governments will adopt it under pressure to keep drugs bills as low as they can.
The approvals procedure differs from country to country – even within the UK Scotland, and England have different systems, and the amount of influence you can exert on your actual customers varies as some will wait for “permission” from
NICE or similar bodies whilst others are solely driven by a cost-benefit analysis.
1. NICE can be nice, but not always
In England, NICE essentially holds the purse strings, so it is NICE that you need to convince. Your medicine may have passed the trials required to gain approval, but without the stamp of cost-effectiveness from NICE most NHS channels will remain closed to you and adoption will be almost non-existent.
NICE can take up to two years to consider a new drug, and although during that time CCGs can choose to use it they all have their own internal procedure for doing so, and many will opt to wait for NICE to base their decision on the NICE ruling. With over 200 such bodies it can take a very long time before your new product is widely prescribed.
2. The statutory regulations have changed to align more closely with PPRS
On 1st April 2018 new statutory regulations came into effect which aligns more closely with voluntary Pharmaceutical Price Regulation Schemes (PPRS). If a PPRS does not cover your product then it will be subject to the new regulations unless it meets one of the exemption criteria – the contract was closed before the regulations came into force, the list price is less than £2, your total sales are less than £5m or if there are multiple sources of the medicine.
3. You need to provide the right data at the right time
A lot of market access is about convincing those with the purchasing power that your drug is cost-effective. In the case of established medicines it is easy to point to data showing how many lives have been saved, how many hospital admissions have been averted or how the spread of a disease has been slowed.
There is no magic bullet for getting your medicine prescribed, just lots of hard work and market research. Your message to each stakeholder needs to be tailored to what they want to hear, and this needs to be based on local knowledge of the target clinical settings.
4. Market Access Consultants specialize in market access!
Your business has put a lot of effort into researching, developing and trialing drugs. You learn what does and doesn’t work and stop throwing money at known dead-ends.
Similarly, Market Access Consultants have vast quantities of experience of gaining market access for new products. It’s their job to keep bang up-to-date on alterations to the legislation, to NICE’s guidelines and assessment procedures. They know the marketplace and can help you to navigate your way through to the business managers trying to balance budgets, to prescribers who want to improve their patients standard of care, to clinical leads who will recommend adoption of your product. If you are unsure about the best way to approach market access then your first step should be to consult market access consultants.