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UK pharma calls for cost-effectiveness assessments of biosimilars


The UK pharma industry on Wednesday called for NICE to conduct cost-effectiveness assessments of biosimilars, even though the organisation has stated it does not wish to do so.

The Association of the British Pharmaceutical Industry (ABPI) made its claim in a position paper on biosimilars designed to be used by regulators, HTA agencies, National Health Service (NHS) commissioners and healthcare professionals who prescribe or dispense biosimilars.

The ABPI said biosimilars should be subject to health technology assessment processes in the UK, even though NICE has rejected the idea in a draft policy.

In its paper, the ABPI said NICE and other UK HTAs should "state clearly" that the medicine appraised is a biosimilar, adding that the guidance should also state the brand name of the medicine.

Biosimilars should be recorded on the UK PharmaScan database for new medicines as soon as they enter Phase III or within three years of their expected launch date, so as to notify cost effectiveness bodies, according to the document.

The ABPI said the Scottish Medicines Consortium (SMC) and All Wales Medicine Strategy Group (AWMSG) should "routinely" appraise biosimilars, adding that biosimilars should be included in NICE's topic selection process.

Other recommendations included that automatic substitution is not appropriate for biological medicines, including biosimilars.

It added that biological medicines should be substituted only under direct supervision and with the consent of the treating physician.

Paul Chrisp, programme director at NICE's Medicines and Prescribing Centre said at a conference last month that the cost-effectiveness body had rejected technology appraisals for biosimilars in a draft document that is out to public consultation.

In a policy statement on its website, the SMC says nothing about conducting cost-effectiveness assessment of biosimilars, focusing instead on the need for robust pharmacovigilance, adding that automatic substitution is inappropriate.

It said, however, that a "managed introduction of biosimilar medicines into clinical practicc in NHS Scotland is desirable", adding that its policy will be reviewed next year.

In guidance published on its website, the AWMSG has stated that a "cost minimisation analysis" is appropriate for biosimilars only when the reference product has been recommended by it or NICE for the intended indication, or when the reference product is already in widespread use for the indication.


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