With the future of patient access schemes and flexible pricing under threat, pharma could do more ensure patients get access to their medicines

In early 2016, chapter five of the Pharmaceutical Pricing and Regulation Scheme (PPRS) is scheduled for mid-term review, affecting arrangements for patient access schemes and flexible pricing.

Both were negotiated into the PPRS in 2009 and retained in 2014 in spite of Department of Health (DH) warnings of their possible demise in the face of value-based pricing.

Since they were first seen in 2007, patient access schemes (PAS) have evolved to become a standard part of positive recommendations in NICE appraisal for high-cost medicines. Now, around half of all positive recommendations involve such a scheme, the majority of which are simple discount schemes. The NICE Expert Panel review of complex PAS proposals has resulted in only simple discounts passing the test; to date, no flexible pricing schemes are in operation.

A key part of the simple PAS equation is that the price agreed must apply to all indications or the lowest value for multi-indication medicines. This proposition may be unpalatable for manufacturers with innovative products showing promise in many indications.

Alternatively, the flexible pricing option does offer the potential for upward price change in new higher-value indications and/or if new evidence supports a better value proposition. However, this can only occur when NICE believes the review is justified, and such assessment can take a year or more to report. With NICE in control of the decision-making, flexible pricing is a high-risk option.

While chapter five of the PPRS offers an agreed menu of options, the rules and assessment hurdles are set so restrictively high that the only viable option becomes a simple discount.

Possible outcomes

With DH and the Association of the British Pharmaceutical Industry (ABPI) due to conduct the review in Q1/Q2 of 2016, what might it achieve? One possible option is the creation of an NHS-wide tracking system to assist with the administration of patient access schemes that allows tracking by indication in a similar way to the system used for Cancer Drug Fund medicine management. More possibilities include a shift in the assessment balance to enable outcome-based ‘pay for performance’ schemes in the NHS or the development of ‘commissioning through evaluation’ options linked to patient access schemes in order to address uncertainties identified in the NICE appraisal.

Finally, the review may consider improvements in the mechanisms of flexible pricing, for example a lighter touch NICE review available on demand, or a shortening in the time it takes to agree a price with a scheme/appraisal combination.

The above review is not the only one with the potential to change the market access landscape. The Accelerated Access Review (AAR) aims to identify options for speeding-up access to new drugs, while NHS England is consulting on proposals to translate the Cancer Drugs Fund into a ‘managed access’ fund routed through proposed entry and exit criteria decided on by NICE. While the proposed change to the CDF may offer some short-term access to new cancer drugs, the existing NICE and patient access scheme arrangements would still limit post-CDF reimbursement for cancer drugs, also other disease areas remain excluded.

Reform of the PPRS patient access scheme and flexible pricing systems has much greater potential to extend or contract the options for pricing than the AAR or CDF revision. These changes could be fundamental, potentially broadening the scope for pricing or limiting the future to discounting to the value of the least competitive indication.

Yet, we also have an opportunity to update the PPRS to facilitate more rational approaches to patient access schemes and flexible pricing that reflect multi-indication market access realities.

Taking action

If the outcome of the review of chapter five is that the flexible pricing is no longer available and/or patient access schemes are further restricted, companies will lose the potential for novel approaches to patient access. By contrast, improvements in their range would give companies greater flexibility to offer value and access propositions to the NHS, particularly for multiple indications and non-cancer treatments.

In 2009, the mid-year review took the form of a discussion between the ABPI and DH, with NICE as an observer and no public consultation. Therefore, companies wishing to contribute their views can approach the ABPI’s Value and Access section to request that their views be taken into consideration. The Medicines Pharmacy and Industry Group (MPIG) is the lead section at the Department of Health.

The author:

Dr Andrew Stainthorpe is market access lead for Research Health

‘The PPRS’ rules and assessment hurdles are so restrictively high that the only viable option becomes a simple discount’

PPRS: Chapter 5

5.1 The Pharmaceutical Price Regulation Scheme (PPRS) 2014 allows companies who are members of the scheme to submit proposals for patient access schemes and flexible pricing proposals as part of an ongoing or published NICE technology appraisal.

5.2 A patient access scheme is... agreed between the Department of Health (with input from NICE) and the company. Patient access schemes can facilitate patient access to a technology when NICE's assessment of value, on the current evidence base, is unlikely to support the list price.

5.3 Flexible pricing recognises that the initial launch price of a technology may not fully reflect its longer-term value to patients in the NHS. It therefore allows a company to propose an initial price for a technology that reflects value that can be demonstrated at launch, while retaining the freedom to apply to increase or decrease this original list price either as further evidence or as new indications emerge and change the effective value that the technology offers to NHS patients.