by Helen Collis at the NICE board meeting
COVENTRY, Nov 19 (APM) - The UK’s NICE on Wednesday adopted a policy on biosimilars that will see all near-copies of originator drugs signed off for National Health Service use also approved for state funding.
NICE will consider cost effectiveness testing of biosimilars when the originator drug failed to show acceptable value-for-money, attendees at its board meeting heard.
The health technology assessment (HTA) body voted in favour of adopting a six-point position statement on biosimilars, during its board meeting in Coventry, following a draft policy and subsequent consultation period that lasted six weeks, ending early April.
NICE is among the first HTA bodies in Europe to define its position on biosimilars. While the copycat biologicals have been on the market for some time, soon biosimilars of more complex monoclonal antibodies used to treat a wide variety of illnesses, from cancer to inflammatory disease and neurological disorders, will become available.
Once approved for use by the European Medicines Agency (EMA), EU officials have said it is down to member states to decide how to incorporate the treatments into clinical practice, given the need to monitor patients’ responses, particularly in light of side effects.
The board meeting on Wednesday heard that in the UK, once a biosimilar has been approved by the EMA, the Medicines and Healthcare Products Regulatory Agency (MHRA) has advised all biosimilar products be prescribed under their branded name, “to avoid automatic substitution at the pharmacy level,” the policy paper says.
The MHRA has also requested that all biosimilar medicines’ packaging carry a black triangle “in the first years after approval to make providers aware of the importance of pharmacovigilance that is, monitoring patients for adverse reactions”. The black triangle is the EU's approved symbol to highlight the need for added pharmacovigilance.
The HTA body adopted a six-point position statement to “summarise NICE’s approach to developing guidance and advice for the managed introduction and optimum use of biosimilar medicines”.
First; NICE will consider similar biological medicines notified to it by the National Institute for Health Research Horizon Scanning Centre for referral to the Technology Appraisal topic selection process.
Second; These products will “usually be considered in the context of a Multiple Technology Appraisal in parallel with their reference products in the indication under consideration”.
Third; In other circumstances, “where it is considered review of the evidence for similar biological medicinal product is necessary, NICE will consider producing an ‘Evidence summary new medicine’.”
Fourth; For technology appraisals, NICE will “use the name of the active drug substance, including reference products and brand named similar biological medicinal products in its documentation where appropriate to inform clinical decision making and to reflect the remit received from ministers”.
Fifth; NICE noted “the Department of Health in England has confirmed that a technology appraisal remit referred to NICE enables NICE to decide to apply the same remit, and the resulting guidance, to relevant licensed biosimilar products which subsequently appear on the market”.
Sixth, Iterating the recommendations of the MHRA, NICE said “evidence summaries will use the brand names of the medicines because substitutability and interchangeability cannot be assumed. Evidence summaries do not make recommendations hence the decision regarding the choice of biosimilar or originator biologic for an individual patient rests with the responsible clinician in consultation with the patient.”
In a public question and answer sessions prior to NICE signing of the above, NICE also said health technology assessments for biosimilars in cases where the originator product had been rejected by NICE would be possible.
Questioned by APM on this issue, professor Mark Baker, director of NICE’s Centre for Clinical Practice, who compiled the policy, said that in these circumstances, “we are not excluding the possibility of doing health technology assessments on a biosimilar where we do not have a positive opinion (from NICE)”.
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