Developing Winning Life Cycle Management Strategies in Pharma
What can the success stories teach us?
Pharma companies invest enormous amounts of time and resources (>10 years) and resources (>$1 billion) to develop high-performing new drugs – drugs that reach millions of patients, improve quality of life and save lives. Yet all those years of hard work and investment can fall to the wayside as a drug approaches loss of exclusivity (LoE) if a company does not have a well-thought-out and robust Life Cycle Management (LCM) plan and the learnings to maintain market share and defend against competitors. This blog looks at the critical success factors of a ‘good’ LCM plan and the learnings from success stories where pharmaceutical companies leveraged innovative LCM strategies to maintain market share and revamp their strategies for even more successful brands post-LoE.
Well-Known LCM Strategies
• New Indications: Indication expansion to cover new uses or the positioning of a product – this can be used to extend the profitable life of a product
• Reformulations: Reformulating the drug with a new delivery platform – this requires a much shorter approval time and can result in an additional three years of exclusivity
• Drug Combinations: Drug combinations to extend exclusivity – combination products usually move through the regulatory process more rapidly than the originally developed drug products; patents for combination products can be applied for if there are clear improvements in patient treatment and management
• Patenting Approaches: Biosimilar companies commonly leverage these strategies. Stronger protection against biosimilar competitors can be driven by submarine patents, which can be applied for to cover all elements of a product, as well as the final product
• Generic Settlements: Branded companies can either offer a license to use their name or be encouraged to drop a challenge to their patents
• Product Differentiation: Differentiation approaches include new formats for delivery (route of administration, tablet design, patches, liquid, etc.) and revised packaging
• Pricing Strategies: A competitive pricing approach can lead companies to focus on segments of the market that are not sensitive to price and thus maintain or even increase prices
• Rebranding: Dual branding prevents biosimilar companies from using products as a reference standard for biosimilar development.
LCM Success Stories
There are numerous success stories in which pharmaceutical companies have optimized the LCM process and developed innovative strategies to meet the demands of today’s pharmaceutical landscape and, in doing so, earned higher returns than their counterparts.
Critical Success Factors to Consider While Developing an LCM Plan: What Does "Good" Look Like?
A “good” LCM plan maximizes the value of products for customers (through newer indications, improved formulation, new delivery systems or packaging, etc.) to expand the utility and improve the patient experience. In addition, a “good” LCM plan for an asset should be flexible to adapt to emerging portfolio needs. Developing such a plan requires maneuvering among competing priorities and challenging dynamics within the organization. Still, developing a plan that forecasts a maintained market share down the line is one thing, but making it successful is another. There are examples of well-laid LCM plans that did not lead to the end goal, and once-successful drugs have been removed from the market because they could not keep up with the pressure in the competitive market environment. Consequently, it is imperative to learn the critical factors for success from those who succeeded.
Learnings from LCM Success Stories
This is especially relevent if a company is thinking about implementing a product-based LCM approach. Established knowledge, state-of-the-art manufacturing capabilities and robust commercial infrastructures can help lower the costs of developing a new and improved brand, so before investing in an improved product, it is critical to remove potential hiccups
Many LCM strategy examples noted above must be planned early in the product development process in order for them to succeed. In addition to the early consideration of LCM, the “right” time is important for execution, especially when it comes to pricing strategies
Innovation is one of the most common themes to emerge from the success stories about implementing a good LCM plan. Whether it is innovating the patient support that complements the product or digitization in customer engagement models, innovation is key. Traditionally, pharmaceutical companies have been better executors than innovators, but this is changing
With ever increasing competition between pharmaceutical players and drugs and glaring scrutiny from regulators, payers and providers, companies cannot leave any loose ends when curating their LCM plans. Newer products are disrupting established players by innovating R&D and commercial models. Innovation has taken on the additional dimension of digitization, especially now in the post-pandemic “new normal”. Due to these challenges, pharmaceutical companies must refine and rechallenge how they approach LCM for their assets, and they need to ensure that learnings from LCM success stories are reaped and implemented well and well in time.
- AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023https://www.reuters.com/article/us-abbvie-amgen-humira-idUSKCN1C32G5(September 2017).
- Pfizer files lawsuit against J&J’s exclusionary contracts for Remicade https://www.pharmaceutical-technology.com/news/newspfizer-files-suit-against-johnson-johnson-for-healthy-biologics-competition-5930952/(September 2017).
- Supporting you and your patients https://www.benepali.eu/en/home/supporting-you-and-your-patients.html
- AbbVie’s successful hard-ball with Humira legal strategy unlikely to spawn similar efforts; potential appeals outcome unclear https://www.pharmaceutical-technology.com/comment/abbvies-successful-hard-ball-with-humira/ (February 2021).
- India’s Emcure to manufacture Roche’s Herceptin, MabThera https://www.fiercepharma.com/manufacturing/india-s-emcure-to-manufacture-roche-s-herceptin-mabthera (March 2012).
- Authorized Generics of Epclusa, Harvoni Will Soon Be Available for HCV Treatment https://www.empr.com/home/news/generics-news/authorized-generics-of-epclusa-harvoni-will-soon-be-available-for-hcv-treatment/(September 2018).
- Insulin glargine biosimilar – Boehringer Ingelheim/Eli Lilly and Company https://adisinsight.springer.com/drugs/800033492 (October 2021).
- Reformulation-Focused Life Cycle Management of the FDA-Approved Drugs https://www.iomcworld.org/articles/reformulationfocused-life-cycle-management-of-the-fdaapproved-drugs-53091.html (February 2020).
- FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers https://www.roche.com/media/releases/med-cor-2019-02-28 (March 2019).
- A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (CheckMate-67T) https://clinicaltrials.gov/ct2/show/NCT04810078 (April 2022).
- FDA Approves Genentech’s Avastin (Bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery https://www.gene.com/media/press-releases/14729/2018-06-13/fda-approves-genentechs-avastin-bevacizu (June 2018).
- Update on the role of lenalidomide in patients with multiple myeloma https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6041862/ (May 2018).
- FDA Approves Triple Drug Combo for Melanomahttps://www.medscape.com/viewarticle/934934 (July 2020).