Sustaining drug revenue or volume beyond Loss of Exclusivity

Entering the post- Loss of Exclusivity (LoE) zone is a complete game changer in terms of strategy and approach. What got you to this point, will not take you further. Because you are now defending your position in the face of competition from generics and/ or biosimilars. Dr. Martin Kamleiter-Borski, a Client Service Partner with a-connect’s Life Sciences Practice, outlines why this means you’ll need a new mindset and playbook.

7 Minutes By Martin Kamleiter-Borski Life Sciences 01/09/2020

At a Glance

  • This article focuses on dealing with Loss of Exclusivity (LoE). We discuss strategies you can employ to sustain drug revenue and/or volume in the face of new generic and biosimilar competition.
  • Ultimately LoE does not mean the end to your drug’s profitability but extending its life demands a change in mindset.

Be prepared to make adjustments in the face of new competition

For instance, marketing could shift from communicating product features to building brand trust and offering additional services and pricing messages. And your sales teams may need to pivot from market expansion to maintaining high volume levels. Medical teams may have to redirect their focus away from phase IV projects and KOL engagement. Similarly, Market Access could switch from HTA to tendering.

Any change will exert organizational pressure, which may require:

  • Establishing new processes
  • The acquisition of relevant skills and capabilities
  • Reviewing headcounts and the composition of your teams

It is vital to consider and undertake changes that will help drive cost reduction and protect the bottom line.

Embrace tendering to maintain volume and market share

This is an excellent way to demonstrate your drug’s value proposition. Always emphasize real-world evidence, cost-effectiveness, and patient outcomes in tenders. This can create transparency between your drug and generic alternatives.

Creating efficient processes and systems for promptly identifying tenders is crucial, and leveraging AI-driven solutions can significantly enhance this capability. Regular communication with healthcare systems, insurers, and government agencies overseeing tendering is essential. Establishing strategic collaborations with healthcare providers and advocacy groups can also boost your success rate.

Innovative pricing strategies are critical

To establish a correlation between cost and proven outcomes or patient benefits, explore value-based pricing models. By emphasizing distinctive attributes like enhanced efficacy, safety, or patient convenience, you can justify higher price points. This emphasizes the drug’s premium position and can enable continued revenue generation and patient access.

One strategy worth considering is a risk-sharing agreement. This involves sharing the financial risk associated with drug performance with payers of healthcare systems. It helps foster a sense of shared responsibility, whilst maintaining a reasonable price for the drug. Installment payment options are another way in which you can maintain price points. It reduces upfront costs, enhancing affordability and makes patient access easier.

Introduce a second brand to mitigate LoE and sustain revenue

It creates differentiation in the market and can extend the lifespan of a drug’s commercial success. However, make sure you comply with all regulatory guidelines and requirements to ensure eligibility and successful marketing of the second brand.

The introduction of a second brand during LoE offers these additional benefits:

1. Increased market segmentation

A new brand enables you to target different market segments. It can also potentially address needs the original could not meet.

2. Pricing flexibility

With an additional brand you can employ pricing strategies that help maintain price differentiation between the original and generic competitors.

3. Enhanced marketing opportunities

The new launch provides an opportunity for renewed marketing efforts. You can reposition the drug to create additional brand awareness.

4. Regulatory advantages

A second brand could enable you to take advantage of regulatory mechanisms that provide exclusivity or market protection for certain formulations, dosages, or indications. This can further delay the entry of generic competitors.

Effective lifecycle management is critical to sustaining revenue or volume

Research and development can be very beneficial here. This can encompass:

  • Identifying new indications
  • Dosing regimens or drug formulations
  • Enhancing drug formulation
  • Delivery mechanisms
  • Therapeutic profiles

It is also worth considering optimizing:

  • Efficacy
  • Safety
  • Convenience
  • Patient experience.

Additionally, investigate technological advancements such as novel drug delivery systems or combination therapies. All these activities combined with clinical trials that generate data on the improved product, can:

  • Further differentiate from generic alternatives
  • Prolong the life cycle
  • Create unique selling propositions

Finally, obtaining regulatory approvals for line extensions can help expand your target patient population, rejuvenating market potential. To maximize impact, ensure you run targeted marketing campaigns with robust clinical data highlighting the extension’s added value.

Patient support programs and adherence initiatives maintain loyalty and differentiation

These programs enhance the overall patient experience and can include:

  • Personalized patient education
  • Access assistance
  • Adherence support

Focusing on patient outcomes and delivering value beyond the drug itself, can foster long-term patient adherence, protecting market share and revenue.

Geographical expansion and market segmentation can maintain revenue and volume

You can extend a drug’s commercial presence by identifying new target markets with unmet medical needs. This can require entry to emerging markets or regions where generic competition may be limited or delayed. Focus marketing and sales efforts by identifying patient populations or subgroups that would benefit most from the drug.

Ready to reset your mindset and organization?

Sustaining revenue and/or volume for a drug beyond LoE is achievable. But you need to consider new sales, marketing and pricing strategies along with focused research and development. Our consultants and teams are highly experienced in this area, so please get in touch if you have any questions or require support in this area.

About the author

Dr. Martin Kamleiter-Borski is a Client Service Partner within a-connect’s Life Sciences Practice. Martin is a seasoned Life Sciences and Healthcare expert who leverages his deep expertise of many years of hands-on experience in the pharmaceutical industry to assist clients in mastering the challenges of change, evolution, and disruption in this dynamic ecosystem. Martin joined a-connect in 2021, and is a physician with a doctorate in neurosciences from Ludwig-Maximilians-University Munich, Germany. His extensive background includes research, clinical psychiatry, and consulting with EY. His primary areas of focus are Commercial Excellence, Innovative Business Models, and Digital Therapeutics.

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