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Pharm Exec speaks with Ramita Tandon, executive vice president, ICON Commercialization & Outcomes, about the potential impact of UK and European regulators’ market access plans for the industry.
Pharm Exec spoke with Ramita Tandon, executive vice president, ICON Commercialization & Outcomes, about how the UK and European regulators’ market access plans for 2017 will affect the industry.
PE: How will the Office for Market Access (OMA) impact the industry in the UK?
Tandon: We see the OMA acting as a gatekeeper for NICE, potentially prior to horizon scanning, which can direct technologies into the right pathway for market access in England. Early interactions with the OMA serve as an enhanced version of the NICE scientific briefing meetings, allowing manufacturers to benefit from input earlier in the development process to inform evidence generation and market access strategies. In theory, the OMA will also become a key stakeholder in directing manufacturer proposed technologies to the Accelerated Access Partnership.
NICE, in collaboration with the OMA, is moving toward a more commercially focused model where it will work with industry and stakeholders to identify “win-win” scenarios. Manufacturers can expect an increasing use of financially-based managed entry agreements to be implemented through patient access schemes (PAS), along with opportunities for earlier interaction with NICE and the NHS to inform evidence generation and commercialization strategy.
Industry should be prepared to enter into earlier dialogue with the OMA and NICE, using their input to inform clinical development and scenario-based market access strategies earlier in the development lifecycle. This interaction should help manufacturers better ensure that the evidence being generated will fully demonstrate the value of their innovative technologies.
PE: Are you optimistic about the UK’s Accelerated Access Review (AAR)?
Tandon: The goal of AAR is to improve patient access to new and innovative medicines in the UK. The AAR’s centerpiece is the “transformative” designation, which would provide access to the Accelerated Access Pathway to speed transformative products to market. This proposes to reduce the time to reimbursement access by up to four years, which could be a great boon for both patients and industry in the UK.
To be designated as “transformative,” a combination of the following will be considered: substantial magnitude of health gain; impact on unmet need; alignment with NHS England’s clinical priorities; impact on system efficiency; potential cost impact; opportunity for clinical pathway transformation; and the innovative nature of the technology.
Obtaining a “transformative” designation will require cross-collaboration between NHS, NICE, providers, physicians and patients, and very early dialogue between industry and the relevant stakeholders; it will not be an easy feat. Of the products selected, further decision-making will hinge on other criteria to align with NHS goals, where uptake will be positively impacted by the AAR and have clear and measurable outcomes. This restricts the potential pool of technologies expected to quality for transformative status to 5-10 per year. Furthermore, the AAR still requires the technology to be assessed by NICE. Rarely do innovative technologies that could enact such change come at a low cost. The AAR does provide a provision to account for this based on flexible reimbursement and innovative pricing models-so the reality is more likely a convoluted way of introducing price controls to the NHS, with the benefit to the manufacturer of more rapidly supported access for their technologies.
PE: What can we say at this stage about the market access implications of Brexit?
Tandon: While it is possible that the UK could remain within the centralized procedure of the EMA, Prime Minister Theresa May’s recent speech outlining plans for a “clean” Brexit make this outcome unlikely. Companies would be best served to develop contingency plans for accessing the UK market individually.
In a post-Brexit era, companies will have to actively seek regulatory approval in the UK rather than submitting to the EMA. Further to regulatory approval, Brexit is not expected to have a large impact on market access pathways, as NICE and the Scottish Medicines Consortium will remain the gatekeepers. However, the ability of UK citizens to access new medications may be delayed if manufacturers primarily target the EU and US and manage the UK regulatory approval and reimbursement in a second wave of submissions, e.g., with Switzerland or Japan.
Julian Upton is Pharm Exec’s Online and European Editor. He can be reached at firstname.lastname@example.org