How To Ace Market Access For Drugs And Devices In Out-Of-Pocket Markets

How To Ace Market Access For Drugs And Devices In Out-Of-Pocket Markets

A comprehensive out-of-pocket market access strategy is one of the critical cornerstones of launch into emerging markets.

Given the time lag in emerging market governmental agencies reimbursing innovative drugs and devices, out-of-pocket segments constitute an important business source in the first years after launch. More importantly, adequate penetration and usage in out-of-pocket segments paves way for entry into the reimbursement segment.

In this post, we will set out some of the critical success factors in building an out-of-pocket market access strategy.

In our previous post, we saw how to optimise pharmaceutical pricing research and the importance of identifying the ability to pay of self-pay markets, as well as their willingness to pay. In this one, we’ll make the case that an effective out-of-pocket market access strategy needs to go beyond just price.

Identify barriers to initiation and adherence

Self-pay access schemes should always be solutions to specific barriers to the use of your brand. So, identifying the barriers to, and drivers of, patient initiation and adherence to the therapy is vital for informing the right strategy. Pricing research, when conducted in the right way, can shed light on these.

It is critical that such barriers and drivers look beyond pricing.

Even the traditional ‘3-A’s – Awareness, Affordability and Accessibility – do not cover all the potential barriers to use of your brand

Arbitrage (by the provider) is a critical fourth ‘A’, since hospitals and clinics provide many drugs and devices to patients as part of a service, which may, for example, include an administration fee and / or a mark-up. How providers apply pricing arbitrage to the product can create financial incentives or disincentives, which need to be considered when deciding on the pricing and access strategy. Finally, it is vital to investigate such barriers and drivers through the prism of your brand’s specific attributes.

The most effective way of identifying the various barriers is by mapping the patient pathway. Better insight on the barriers usually translates into greater confidence in the solution. However, a pragmatic approach is sometimes needed, in which case a workshop with the project team (involving market access, commercial and medical team members) can be sufficient to generate hypotheses on barriers, which can be validated during research conducted to test the viability of potential solutions.

Define an holistic strategy

The impact of a self-pay access strategy depends on how holistically it addresses all of the barriers to patient initiation and adherence.

[quote]It needs to take a broader perspective than just affordability or pricing.[/quote]

For instance, the success of a patient assistance programme depends not only on how effective it is in addressing affordability and willingness-to-pay barriers, but also on how well it is understood by potential users of the programme and how effectively it engages all of the stakeholders in the value-chain. The right strategy will minimise the rate of (eligible) patient drop-off at each point of the care continuum from first onset of symptoms, through diagnosis, initiation of therapy and maintenance treatment, as well as, ultimately, optimising their clinical outcomes.

There is no one-size-fits-all self-pay solution: the right solution to a particular barrier will vary from manufacturer to manufacturer, according to the level of capability and capacity on the ground, as well as the over-arching strategic goals in emerging markets. For some manufacturers a standard third-party run patient assistance programme will make sense. But for others, alternative strategies, such as differential list pricing or out-licensing to local manufacturers will be the right option. The right self-pay strategy is brand-, barrier-, market- and manufacturer-specific.

Implementation is key: needs to balance access on one hand and risk on other hand

Implementation is usually the biggest challenge than devising a robust strategy when it comes to self-pay access solutions.

There is always a trade-off involved in balancing the commercial opportunities on one hand with the risks on the other.

It is important to have a clear view on the scale of potential ROI, as well as a realistic understanding of the timescale required for it to be realised. The size of the opportunity then needs to be considered in relation to the risks involved. These include pricing risks, such as parallel trade, leakage of discounted goods into other market segments and international referencing, as well as compliance risks.

Ultimately, a successful self-pay strategy needs to be feasible: the resources required at country level to execute the strategy become an important determinant of the implementation pathway.