By Dr. Andrée K Bates, November 2011
On the face of it, marketing Oncology drugs is a highly lucrative business for the Pharmaceutical industry.
- Patients with Cancer are increasing at higher levels than many conditions. In fact, Cancer is the leading cause of death in people under 85.
- Cancer is a priority for many governments and much investment has been made in improving screening procedures.
- With a few exceptions, Cancer has no certain cure, so there are still many unmet needs.
- We have seen important developments in genomics and proteomics that has allowed more Oncology drugs to be developed.
- High prices can be charged for innovative Cancer drugs, and Oncology has been one of the few growth drivers in the Pharmaceutical industry in recent years.
Therefore, the opportunities are obvious, but the reality is that not many companies with Oncology portfolios will enjoy success in line with what they are hoping for. This is due to several factors:
- Oncology is not one condition but many conditions that all have uncontrolled cell growth. However, there are essentially 3 main markets involved:
- The crowded but big market (e.g. all the main suspects e.g BC, CRC, LC)
- The niche market (e.g. renal, leukemia)
- The complex niche market (e.g. pancreatic, stomach, oesophagus)
- Many companies are focusing on Oncology leading to many options for treatment and leading to a crowded market.
- The financial crisis is taking its’ toll on payers which means that cost containment pressures will, no doubt, have their effect on Oncology drugs prices because of these main factors:
- growing Cancer population means increased drug expenditure
- more products means more competition
- generics eroding sales
- more combination therapies means more costs to the treatment protocol
So, what do you need to do?
These factors have implications for your activities in several ways, including:
1. Clinical trial approach and consequent indication sequence.
Should you pursue a ‘switch or add on’ strategy or a ‘do everything you can’ strategy or a sequential strategy in your clinical trials? An ‘add on’ approach is essentially adding on your drug to an existing treatment cocktail to enhance efficacy, while a ‘switch’ strategy is switching your drug with another one in an existing treatment cocktail because you have proven your drug in the cocktail provides enhanced efficacy. The strategy is sound and a proven route to success as was shown by Eloxatin coming in to switch from Camptosar. However, keep in mind that your trials would need to go head to head and show an advantage, and they may not show that in efficacy - that would be the one you want (overall survival time and progression free survival typically). It is possible that an advantageous safety or convenience profile may also be a winner, depending on the Cancer type and physician type and market. If you succeed, however, you are quickly in the treatment guidelines and have the added benefit of being in additional clinical trials that you are not paying for. However, if you go down the route of the ‘do everything you can’ strategy, which is to trial the drug in every possible indication in parallel, you gain the advantage of faster sales if you have multiple indications, and Avastin is a good example of this approach. However it cannot ethically be employed if the drug is highly toxic. In addition, another drawback of this approach is the high cost of multiple indication trials, as well as the need for high numbers of patients for trials that is becoming increasingly tough to get. The sequential approach is testing in one indication and patient segment and gaining approval and then extending to other indications or lines of treatment. This approach is a more cautious one but confers the advantages of being able to test in a more niche market with high demand and you have lower trial costs. In this case, you need to be careful which indication you go for first.
2. Market Access.
Due to the increasing incidence of Cancer, the increasing competition amongst players as well as the increased cost pressures faced by payers, market access is a critical component of planning. This is becoming more and more critical because of these factors. You must be able to ensure that your product can meet all the requirements for this in order to secure approval, registration, as well as command premium pricing and gain reimbursement. Full support of the International and National Key Opinion Leaders is critical. Product registration must be secured and the clinical comparators are up to date with current guidelines. Pricing and reimbursement changes must be anticipated and accounted for and should be part of the strategy from a very early stage of development. Sometimes companies in some markets are entering into risk share agreements with payers and this was pioneered in Italy and then UK but is expected to grow across numerous markets in Europe. The US is slightly different, given it is a managed healthcare environment, and this means a lot more flexibility in use but also a lot more emphasis will be give to efficacy compared to existing treatments and, of course, biomarkers and personalized medicine. In addition, in all markets, health economic studies showing the cost benefit of your drug against its competitors is very useful.
3. Positioning and Strategy Correctly for Sales and Marketing drivers.
We find in our analytics that Oncology is a less promotionally sensitive market than most markets, and there are typically only a few strong message drivers, and sales and marketing driver channels compared to say a primary care drug or even a less complex secondary care drug such as a Cardiology drug. These drivers even differ (and sometimes quite strongly) depending on the therapy segment (e.g. CRC adjuvant early versus CRC 2nd Line +) or public versus private hospital segment, or physician segment (e.g. for bladder Cancer, Oncologist versus Urologist), given that different geographic markets have different physicians as the target audience. For example, in Germany, BC may be treated by an Ob/Gyn instead of an Oncologist, while in UK it may be treated by a Breast Surgeon and an Oncologist. If you are looking at markets in which the treatment is not done by a pure Oncologist, then you will see differences in some of the positioning drivers required. Pure Oncologists are more used to using highly toxic drugs with none-too-pleasant side effects; however, other types of specialists can be more sensitive to some of those attributes. The weighing of your messages should be according to what is driving that segment of physicians in this therapeutic area. In one project we did in metastatic CRC in Asia, the aim was to maximize the 1st Line mCRC penetration using correct driver positioning and marketing channels, increasing duration of therapy in 1st Line mCRC and also blocking competitor entry. Sales grew by 57% in the following year without any budget changes to the brand by using analytics to fine tune the marketing and for war-gaming scenarios for different segments. Analytics is a powerful tool in the Oncology marketing arsenal in terms of knowing which therapy segments will yield the most lucrative source of growth (not always the big and crowded one depending on your drugs characteristics), as well as being able to see what the drivers are for each segment and line of therapy. In addition, seeing which physician segment will yield more growth for your brand and which sales and marketing aspects are drivers for that segment can all be uncovered by Eularis’ 94.8 Analytics. In addition, being able to war-game budget allocation across segments to see how budget allocation will give you what revenue is a strong argument for the power of analytics in this area of Oncology.
4. Global and Affiliates alignment in terms of segments targeted and how to work together.
The global strategy must be localized, given there are very different local issues in terms of market access, reimbursement and even which physicians treat that patient pool. Sometimes affiliates need to have approval to develop their own clinical studies for their local patient pool as we see is often the case in Japan especially. Companies typically employ a centralized or regional approach with more companies adopting a centralized approach given the need for larger patient pools, complex trial management and a constant increase in number of trials.
5. In-Licensing Deals.
Biotech has provided some innovative treatments in Oncology and the majority of treatments on the market today were originally discovered by Biotech companies. Larger companies need to secure the most promising compounds and accelerate the development process. Of course, partnering is competitive but, no doubt, there will be continued activity in this area. This way you can develop a stronger Oncology portfolio which provides synergy with your existing drugs.
6. Synergy with Other Therapy Areas.
Supportive Care (second largest segment after Oncology) and Diagnostics (e.g. for tumor markers) are heavily related to the Oncology market and provide strong synergistic opportunities. The growth of personalized medicine will only fuel growth of the diagnostics sector in relationship to Oncology. By combining an Oncology portfolio with a supportive care and diagnostic portfolio is recommended as a interesting area to consider.
Conclusions
Oncology is an attractive market to be in due to the increasing patient pool, government focus, ongoing unmet needs and premium pricing. However, it is not as easy and lucrative as one may think given all the ongoing and increasing market constraints of crowded market, payer pressures, and complexities within each indication. Many factors must be carefully considered and analyzed rigorously in order to enjoy the successes available to the winners in each therapeutic indication.
For any questions or if you would like to see a demo of the Oncology analytics tools discussed in this article, please contact Dr Andree Bates of Eularis - http://www.eularis.com - or contact your closest Eularis office - http://www.eularis.com/about-us/contact-us - and the message will be passed on to her or a local team member to speak with you.