Claudia Rubin and Tom Jaggs explore the implications of the High Court ruling against Novartis and Bayer for pharma.
High Court ruling against Novartis and Bayer
On 21 September, the High Court ruled against Novartis and Bayer who had challenged the lawfulness of a policy adopted by 12 clinical commissioning groups (CCGs) in the North East.
The policy, entitled Treatment for Age-related Macular Degeneration (AMD) refers to three different drugs for treating patients with the neovascular form of AMD, known as ‘wet AMD’. Under the policy, the CCGs would offer certain patients with wet AMD Roche’s Avastin “as the preferred treatment option” over Bayer’s Eylea and Novartis’ Lucentis “because of the significant difference in price between Avastin and the other two medicines”.
However, the victory for the NHS may seem less of a clear win if the repercussions of it gather pace and spread. At stake may be the authority of, and thus protection afforded to the public by, the whole medicines regulatory process. As a further consequence too, the prospects for British patients’ early access to medicine innovation.
The 12 CCGs recommended bevacizumab (Avastin) as the preferred treatment option for patients with wet AMD, even though it is not manufactured or licensed for use in the eye. It is to be routinely used in place of two licensed products (Eylea and Lucentis) that have previously been closely assessed and recommended by National Institute for Health and Care Excellence for the condition.
Setting a precedent
In responding to the High Court decision, David Hambleton (NHS South Tyneside CCG) suggested that: “Now they have the option of allowing the use of so-called ‘off-label’ drugs.” However, clinicians have always had some degree of ability to prescribe off-licence. The precedent has now been set for doing so on a system-wide level, based on upfront costs rather than patient need.
It is likely that this judgment, if it stands, will further undermine the appeal of the UK market. On the back of Brexit’s impact on everything from the European Medical Agency to R&D investment, as well as an increasingly challenging pricing and reimbursement system that already often demotes the UK market to 2nd, or even 3rd wave launch site, this further uncertainty threatens to be one step too far. Attempting all the hurdles to medicines access for British patients is already a tight commercial decision, and if after all those hurdles are overcome, system-wide local commissioning policy can blow a hole in the whole approval process, that judgement will become even harder.
How the NHS as a system handles the prescribing of products outside of their intended marketing authorisation is a long-standing issue, of course, but striking the right balance between clinical discretion and confidence in the regulatory structure remains essential.
Patient access to new products is the result of decades of development closely overseen at a European and national level, the principal purpose of which is to ensure the highest level of patient safety. As such, the development of cutting-edge technologies takes a considerable length of time and comes with an unsurprisingly high price tag. A study by Deloitte has shown that the cost of developing new medicines has increased by approximately 70% in just seven years, to £1.2bn on average for each new medicine.
A key reason for this is that regulators and health technology assessment bodies require evidence of high-quality and convincing randomised clinical trials demonstrating the safety and efficacy of products in the specific patient populations these products aim to treat, arguably with an ever-increasing level of certainty of clinical benefit. In demanding this from companies as a universally accepted pre-requisite for their products to reach the market, it is of some significance if commissioners are to demote this rigour from their considerations.
This is not to say that there is no place for ‘off-label’ prescribing, as there are very valid reasons for it. Most commonly, when there is no suitable licensed medicine for meeting a patient’s specific need, or where a medicine licensed in adult populations only would meet the needs of a child. The crucial factor in both cases though is that the decision is clinically-driven by patient need, not a desire to find savings in a medicines budget. In these scenarios, the decision is taken by the prescribing clinician together with their patient.
This is supported by the General Medical Council, which states: “You should usually prescribe licensed medicines in accordance with the terms of their licence. However, you may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.”
Following the recent High Court judgment however, sovereignty of decision-making lies not with the regulator, or the clinician-patient relationship, but arguably with the commissioning bodies themselves.
It is vital of course, to recognise the massive budgetary pressures CCGs are under and savings in the prescribing budget can and must be made. The question is where to draw the line. Is it wise to conflate the financial needs of CCGs with the prescribing agility of individual clinicians and, moreover, with the guidance and assurance of regulators?
The public is right to be concerned that the NHS pays the right price for medicines. However, close regard for patient safety and the long-term attractiveness of the UK as a hub for life sciences and as an early access market, cannot be put to one side in the interest of short-term medicine acquisition costs.