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Praluent (alirocumab), a PCSK9 inhibitor, chosen as a rapid uptake product by the Accelerated Access Collaborative

  • Having received positive guidance by NICE1 in 2016, uptake of PCSK9 inhibitors is 60 to 67% lower than NICE’s expected uptake for April 2017 to March 20182.
  • The Accelerated Access Collaborative (AAC) was announced in November 2017, following the Government’s Accelerated Access Review (AAR), with the aim of getting breakthrough products to market, and then to patients, as quickly as possible.
  • PCSK9 inhibitors have been chosen as one of a number of treatments requiring a joined up approach to improve rapid adoption in the NHS.


GUILDFORDOctober 24, 2018 – Sanofi welcomes the announcement by the Secretary of State for Health and Social Care that the PCSK9 inhibitor class has been selected as a treatment that needs to see a rapid increase in uptake to ensure that patients, and the NHS, get the benefits of this class of medicines.


Increasing the uptake of PCSK9 inhibitors in patients with high lipid levels, including those with primary familial hypercholesterolaemia and mixed dyslipidemia who maybe at high-risk of cardiovascular disease may help reduce their low-density lipoprotein. (LDL) concentrations towards recommended levels. Raised LDL levels are a risk factor for cardiovascular disease. NICE believed there would be a relevant benefit both to patients and also to the NHS.1


The effect of alirocumab on cardiovascular morbidity and mortality has not yet been determined.


By including the PCSK9 inhibitor class of medicines in this initiative, the AAC acknowledges that many more people could benefit from the use a of PCSK9 inhibitor. This initiative will help to overcome barriers such as improving identification of appropriate patients, as well as help in streamlining locally agreed referral pathways from primary to secondary care and adopting varied funding approaches.


“Sanofi is delighted that PCSK9 inhibitors have been selected for Government action in ensuring faster access for NHS patients” says Hugo Fry, Managing Director, Sanofi UK. “Despite the widespread use of statins and other lipid-lowering therapies, some people in the UK are unable to lower their cholesterol to levels indicated within national guidelines. It is critical that once medicines, like alirocumab, are

recommended by NICE, they get to the patients who need them as quickly as possible. Sanofi is looking forward to working together with the NHS to tackle the current barriers to uptake that exist for this class of medicines.”


“Including PCSK9s in the accelerated access review is great news for patients and clinicians. PCSK9s have clear benefit for patients at high risk that need to further manage or lower their cholesterol.” says a spokesperson from HEART UK. “However, we still need to identify more people with the inherited form of high cholesterol (familial hypercholesterolaemia) that may benefit from this innovative medicine.”


“Despite NICE criteria for patients who are suitable for PCSK9 inhibitors, observed uptake of these drugs is over 60% lower than expected. This means that a lot of potential patients who fulfil this criteria who could benefit are not being identified.” says Professor Kausik Ray, Professor of Public Health and Cardiologist Imperial College London. “Efforts to identify these patients in primary and secondary care and refer them to specialists who can initiate these therapies in accordance with NICE guidance would reduce the burden of elevated cholesterol and its consequences considerably.”


In June 2016, two PCSK9 inhibitors were recommended for use by National Institute for Health and Care Excellence (NICE) for primary familial hypercholesterolaemia (FH) and mixed dyslipidaemia i.e. people with raised low-density lipoprotein (LDL) concentrations, not adequately controlled on maximally tolerated lipid-lowering medications. NICE concluded the PCSK9i’s were clinically effective in reducing LDLC compared with placebo, ezetimibe or statins in people with hypercholesterolaemia.1


Despite the widespread use of statins and other lipid-lowering therapies to reduce raised cholesterol levels, some people in the UK are unable to lower their cholesterol to levels indicated within national guidelines.3 A European study of over 7,000 patients showed that significant numbers of high risk and very high risk patients (60% – 80% respectively) were unable to adequately lower their ‘bad’ cholesterol levels with statins or other lipid-lowering therapies.4 FH is an inherited disorder which causes people to have cholesterol levels which are higher than normal from birth. The prevalence of FH in the UK population is estimated to be 1 in 500,5 however an estimated 85% of people living with FH remain undiagnosed.6 28,740 people in England in 2016/17 were admitted to hospital for chest pain and 12% of these had elevated cholesterol.7


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Last Updated: 31-Oct-2018